Tom Price

Public health officials call on HHS to restore grant funding for preventing teen pregnancies

kkrisberg — Tue, 22 Aug 2017 16:19:42 +0000

Public health officials call on HHS to restore grant funding for preventing teen pregnancies

In July, public health departments across the country got a letter from the Trump administration abruptly cutting off funding for teen pregnancy prevention efforts in the middle of the program’s grant cycle. The move means that many teens will miss out on receiving an education that could — quite literally — change the trajectory of their lives.

The abrupt funding cut — which came down without reason or explanation, according to grantees — also cuts off research efforts right at the evaluation stage. That’s the stage when public health practitioners rigorously assess a program’s outcomes, gather evidence of its effectiveness, and determine what works and what doesn’t. That’s exactly what we should want from our public investments — evidence, not anecdotes — and it’s exactly how you tackle a problem as complex and as costly as teen pregnancy. Teasing out the evidence is how we sort the aspirational from the effectual.

And determining what works to prevent and reduce teen pregnancy is a worthy endeavor. According to the Centers for Disease Control and Prevention, while the U.S. teen birth rate recently hit a record low — the birth rate among young women ages 15 to 19 dropped 8 percent between 2014 and 2015 — the U.S. is still home to one of the highest teen pregnancy rates in the industrialized world. And that rate comes with impacts, including upping the risk that teen girls won’t graduate from high school, which has a generational domino effect in and of itself, as well as racking up billions in societal costs related to health care, foster care and lost tax revenue. Plus, nearly all teen pregnancies are unplanned, which makes investing in their prevention sound public policy.

At a news conference held earlier this month and hosted by the Big Cities Health Coalition (BCHC), health officials from cities on opposite coasts — Baltimore and Seattle — spoke about the importance of preventing teen pregnancy in their communities and the on-the-ground impact of abruptly losing federal funding that had already been awarded and appropriated. Both the Baltimore City Health Department as well as Public Health — Seattle & King County are among the 81 grantees who received a letter from the U.S. Department of Health and Human Services (HHS) in July saying the five-year grant they’d already been awarded through the agency’s Teen Pregnancy Prevention Program would be ending two years early, in 2018 instead of 2020.

Both Leana Wen, Baltimore’s health commissioner, and Patty Hayes, director of Public Health — Seattle & King County, said there was no dialogue, discussion or explanation for the funding cut. The announcement didn’t even come in a special notice. Instead, both health officials found out about the cut when they received their usual, yearly notice-of-award letter in which the end date had been pushed up by two years. Hayes said Seattle’s program manager quickly reached out to HHS for an explanation and was basically told the agency was moving on to implement the cuts.

“It’s just an arbitrary decision that we’re trying to appeal,” Hayes said during the BCHC news conference.

Hayes and Wen are among 20 public health officials from around the country who signed onto a BCHC letter to HHS Secretary Tom Price asking him to reconsider the cuts. Also, in July, Democratic senators wrote to Price asking him to explain his plan to “unilaterally” cut the teen pregnancy prevention grants short. The letter states:

Since the start of the grant projects and prior to the recent notification of early termination, (the HHS Office of Adolescent Health) has ensured the program includes high quality implementation, rigorous evaluation, innovation and learning from results. The pace of progress has accelerated dramatically since the federal investments in evidence-based teen pregnancy prevention began. Since 2010, pregnancy rates among 15- to 19-year-olds has declined by 41 percent nationwide — more than double the decline in any other six-year period since rates peaked in 1991 — and is at a historic low. Seventy-five percent of pregnancies among this population remain unintended. The (Teen Pregnancy Prevention) Program has been proven to support young people in delaying sexual initiation and adopting sexual health behaviors that help them avoid unintended pregnancy.

In Baltimore, the grant termination means a cut of $3.5 million, which means 20,000 students in grades seven through nine will lose access to comprehensive reproductive health education, Wen said. The funding cut also means the agency won’t have the resources to continue training teachers or members of a local youth advisory council that does peer-to-peer education.

Wen said Baltimore has made huge progress in reducing its teen birth rate — it fell by 44 percent between 2009 and 2015. She’s worried that losing any ground on that front will only lead to fewer educational and economic opportunities for Baltimore youth, fewer young women graduating from high school and greater public costs to the community.

“We should be doing everything we can to empower youth to succeed and thrive,” Wen said during the BCHC news conference. “We see the impact in our cities, and we urge the federal government and HHS to reconsider this drastic cut, taking into account the future of all of our youth across the country.”

In Seattle and King County, where teen pregnancy rates have gone down by more than half since 2008, public health officials were using their $5 million Teen Pregnancy Prevention grant to evaluate the effectiveness of a sexual health curriculum they recently updated called FLASH, which includes a variety of strategies to help reduce teen pregnancy, sexually transmitted diseases and sexual violence. During the BCHC news conference, Hayes said FLASH has been used all over the U.S. and the world, with about 80,000 FLASH lessons downloaded in the span of just one year. She noted that the curriculum is designed to be inclusive of LGBT students and is just as relevant for young people who decide to abstain from sex as it is for those who don’t.

However, Public Health — Seattle & King County hadn’t had the chance to rigorously evaluate the curriculum to tease out its exact impacts, such as whether it increased the number of students who delay sex or the number of young people who practice safe sex. That’s what it was using its HHS grant funding for – to measure the effectiveness of the curriculum. The public health agency had already recruited more than two-dozen schools in multiple states to take part in the evaluation; thousands of students participated in the FLASH curriculum and an independent evaluator was hired to analyze the outcomes.

But now that HHS has shut down the grant funding early, that data will be lost. Hayes said she believed there was a “good chance” the evaluation would have shown that FLASH does, indeed, make a positive difference in young people’s lives. Without such evidence, however, it may become more difficult to persuade schools to adopt the curriculum. Hayes said her agency has filed an administrative appeal with the HHS Office of Adolescent Health in the hopes of getting the funding restored.

Hayes said she believes the funding cut is due to both across-the-board budget cuts, but also to an ideological shift on how to address teen pregnancy.

Beyond the particular efforts that the HHS grants were supporting, the abrupt funding cuts also impact both agencies’ overall capacity to prevent teen pregnancy in their communities. In Baltimore, Wen said the funding gap will “create a huge hole in our ability to deliver services.” At Public Health — Seattle & King County, Hayes said the grant supported a significant portion of the agency’s teen pregnancy prevention efforts.

“It does shrink our program,” Hayes said, “and so it’s not without great implications.”

Visit CDC to learn more about the benefits of investing in teen pregnancy prevention.

Kim Krisberg is a freelance public health writer living in Austin, Texas, and has been writing about public health for 15 years. Follow me on Twitter — @kkrisberg.

kkrisberg Tue, 08/22/2017 - 12:19

Tags

government

Pres Trump

Public Health - General

Research

teen pregnancy prevention

Everyday I read a heartbreaking report from this Whitehouse. The ignorance is dumbfounding and down right scary.

Federal biomedical science policy under Donald Trump, nearly 100 days in

oracknows — Mon, 17 Apr 2017 01:49:40 +0000

Federal biomedical science policy under Donald Trump, nearly 100 days in

From the moment that Donald Trump was unexpectedly elected President, I couldn't help but be concerned about what President Trump would mean for medical science and science in general. I was not alone in my concerns. Of course, now, five months later, we know that such concerns were quite valid. If funding is a primary indicator, then, if anything, my concerns expressed last November were understated. For example, in his first budget, Trump proposed cutting the National Institutes of Health (NIH) budget by 19%, and, then, not content with that, proposed cutting $1.2 billion from this fiscal year's NIH budget, even though the fiscal year was half over at the time. None of this even takes into account the massive proposed cuts at the Environmental Protection Agency (EPA) and many other agencies responsible for federal science policy. It looks as though we are entering a grim time for US science funding. Even though there is almost no Congressional support for massive cuts to the NIH, the Trump administration has signaled its intent, and there likely will nonetheless still be pain.

There are three places where the "rubber meets the road" when it comes to health and science policy. One is the director of the Centers for Disease Control and Prevention (CDC), but Trump hasn't appointed one yet. I know that when Robert F. Kennedy, Jr. announced that he had met with Donald Trump the first fear I had was that Trump was going to tap him for the CDC. Fortunately that didn't happen, but the fact that I briefly feared that Trump might have picked RFK, Jr. gives you an idea how much Trump's long, sordid history of antivaccine emanations coupled with his having met with antivaccine activists like Andrew Wakefield and RFK Jr. actually worries those of us who promote science-based medicine. Given that last week the Senate held confirmation hearings on Dr. Scott Gottlieb, Trump's nominee for FDA commissioner, I thought that it was a good time to revisit the topic of health and biomedical science policy as it's shaping up under Donald Trump. Any such policy first involves a brief discussion of the Department of Health and Human Services (HHS), because the federal agencies devoted to health and biomedical science policy fall under its purview. What we can expect, based on the rhetoric coming out of the Trump administration and Congress, as well as Trump's picks for key agencies, is increasing deregulation. I'll then look at the FDA and Scott Gottlieb again in light of recent developments.

Whither HHS under Trump?

HHS is a sprawling Department, with a budget of over $1 trillion. Most of that budget derives from the fact that HHS is the department that administers Medicare and Medicaid, but HHS also encompasses such critical agencies as the FDA, NIH, CDC, Agency for Healthcare Research and Quality (AHRQ), and Health Resources and Services Administration (HRSA). Also, the HHS is the department that administers the Affordable Care Act (colloquially called Obamacare) that Republicans promised to "repeal and replace" but failed to do so.

Unsurprisingly, President Trump tapped an ultraconservative Congressman, Dr. Tom Price, to run HHS. Price, as you might recall, belongs to an ultraconservative physician advocacy group masquerading as a professional society, the Association of American Physicians and Surgeons (AAPS). The AAPs, you might recall, fetishizes physician "autonomy" and the "patient-physician relationship" above all else, which doesn't sound bad on the surface, until you realize that this stance is married to an extreme anti-regulatory stance that opposes nearly all constraints, particularly government constraints, on physician "autonomy" and a free market fundamentalist approach to health care that views government funding and regulation as illegitimate or even unconstitutional. The AAPS also encourages "brave maverick doctors" to "challenge" the scientific consensus, even if it means quackery and pseudoscience.

This is easily demonstrated by perusing its official "journal" (if you can call it that), the Journal of the Association of American Physicians and Surgeons (JPANDS). As I've discussed many times before, JPANDS publishes a wide variety of antivaccine pseudoscience, including the vile claim that shaken baby syndrome is a misdiagnosis for "vaccine injury." Indeed, it also has published papers in support of a link between abortion and breast cancer, a link that is not supported by science, as well as papers promoting HIV/AIDS denialism. Indeed, as Kathleen Seidel noted, the descriptors of articles published in JPANDS are often quite indicative of the political and ideological stance of the organization: Criminalization Of medicine, eco-imperialism, government arrogance, incremental socialism, left illusions, medical herdology, physician slavery, police state of medicine, and, of course, socialized medicine. Indeed, AAPS very much views itself as an organization of doctors who don't "follow the herd," and heaps scorn on anything it views as following the herd, viewing evidence-based medicine in such terms and rejecting physician peer review as an unacceptable affront to physician autonomy.

Unfortunately, worshiping not "following the herd" leaves the organization open to a lot of pseudoscience, and it hasn't stopped. Indeed, in the Winter 2016 issue, JPANDS featured an outrageous bit of antivaccine pseudoscience, and its most recent issue features a new article promoting the debunked link between abortion and breast cancer, an article very similar to one I deconstructed seven years ago.

To be fair, I must point out that just because Dr. Price belongs to the AAPS does not necessarily mean that he ascribes to its views. Indeed, during his confirmation hearings he appeared to reject the claim that vaccines cause autism, but he was perhaps less forceful than one would like to see in a nominee for HHS Secretary:

“Do vaccines cause autism?” Menendez asked Price during Tuesday’s hearing, the first time the issue had been raised with the HHS nominee during his confirmation.

“I think the science in that instance is that they don’t,” Price said. He went on: “But there are individuals in our country who are very —”

Menendez cut him off.

“I’m not asking about individuals,” he said. “I’m asking about science.”

So, yes, Dr. Price knows the words to speak, but he couldn't resist trying to talk about anecdotes and the parents who fervently believe that vaccines cause autism. The press immediately portrayed this as reassurance that Price is not antivaccine, but I'm not so reassured. I've seen antivaccine-sympathetic physicians say basically the same thing, as in, "The science says that vaccines don't cause autism, BUT..."

Since then, Price seemed to waffle a bit on the issue of requiring vaccines:

In an interview with CNN Wednesday night, Tom Price was asked, “should it be required, measles, mumps, those kinds of immunizations?”

“I believe it’s a perfectly appropriate role for the government, this happens by and large at the state-government level, because they’re the ones who have the public-health responsibility … to determine whether or not immunizations are required for a community population.”

On the one hand, as has been noted, this could be interpreted as a simple statement of fact, because states are responsible for passing laws on school vaccine requirements. On the other hand, most states use the guidelines published by the CDC to determine the vaccine requirements for school entry; so Price's answer could also be interpreted as a bit of a dodge, which is how I interpret it, because he basically pointedly omitted support for any federal role.

Just yesterday in his weekly Daily Beast column, Dr. Paul Offit also noted that one of Dr. Price's answers during his confirmation hearing testimony suggested that he was open to further weakening the already weak regulation of supplements:

On January 18, 2017, then Congressman Tom Price (R, Georgia) testified before the Senate Health, Education, Labor and Pensions Committee. Price was Donald Trump’s pick to serve as Secretary of the Department of Health and Human Services. Not surprisingly, most of the questions—and most of the media’s attention—centered on Price’s views on the Affordable Care Act. One question and answer, however, went entirely unnoticed.

“One of the essential duties of the HHS Secretary is to be diligent and thoughtful when considering if federal regulation is necessary,” said Orrin Hatch (R, Utah). “Do you recognize dietary supplements in helping reach and maintain healthy lifestyles?” Price answered without hesitation. “Absolutely,” he said.

Given his efforts on behalf of the dietary supplement industry two decades earlier, Hatch’s question was predictable.

Orrin Hatch, as I have noted, is basically shill for the supplement industry, which should not be surprising given that Utah is the supplement manufacturing capital of the US. So is Rep. Jason Chaffetz, by the way, as he also comes from Utah.

In any event, Dr. Offit rattles off a long list of how even the weak regulation of supplements by the FDA mandated in the Dietary Supplement and Health Education Act (DSHEA) is inadequately enforced and has resulted in harm, concluding:

Most people assume that when it comes to dietary supplements, someone is watching. But they’re not. And until the FDA regulates this industry, people purchasing dietary supplements from a health food store are doing so at their own risk.

Tom Price, the new Secretary of Health and Human Services, which includes the FDA, could do something about this if he chooses. Unfortunately, given his response to Orrin Hatch’s question during his confirmation hearing, it doesn’t sound like he’s interested.

So when it comes to health policy, the person in charge of the vast majority of what the federal government does in this area is someone whose commitment to science is questionable, as evidenced by his wishy-washy answers about vaccines and his apparently enthusiastic buy-in to the idea that supplements are wonderful for health. Granted, he could just have been currying favor with Sen. Hatch, but that he wouldn't even include a little bit of skepticism in his remarks suggests otherwise.

Of course, the FDA is where any changes in policy and regulation will be crafted. So let's revisit Scott Gottlieb, Donald Trump's pick for FDA Secretary.

The least bad pick for FDA: A real, honest-to-goodness pharma shill

When I last discussed the candidates under consideration by the Trump administration for FDA Commissioner, I reserved most of my alarm for the two who are cronies of technolibertarian Peter Thiel, a man known for his belief in a technological singularity and all the woo that goes along with it, including parabiosis, to which Steve Novella has referred as “the next snakeoil.” Basically, it’s another “fountain of youth,” that postulates that the blood of the young (or, in this case, plasma) will reinvigorate and reverse aging in the old. The two candidates favored by Thiel included Balaji Srinivasan, CEO of bitcoin start-up 21.co, and Jim O’Neill, the managing director of investment firm Mithril Capital Management. O'Neill is on record as having suggested that the FDA should not require evidence of efficacy before approving drugs, only of safety. In other words, O'Neill wanted to party like it's 1959, which was three years before the Kefauver amendment to the law covering the FDA that said drugs must be proved safe and effective before they can be sold. Unfortunately, Balaji Srinivasan out did O'Neill in the deregulation department, having argued on Twitter that a "Yelp for drugs" would be a great way of ensuring that marketed drugs are safe and effective. It's hard to imagine anyone more deluded when it comes to how the FDA functions and has stated that the FDA has been responsible for "many deaths" due to overregulation. Srinivasan quickly fell out of favor because he was too out there even for Trump.

So, not surprisingly, when Trump ultimately decided to tap the ultimate pharma ~~insider~~ shill, Scott Gottlieb, to be the FDA commissioner, there was a collective sigh of relief in the press and pharma, given Trump's previous statements accusing pharma of “getting away with murder” by charging high drug prices and, of course, the fact that Jim O'Neill and Balaji Srivinasan were under consideration. Truly, my fears about the Trump effect on medical science were not unfounded. On the other hand, the FDA definitely dodged a bullet, as behind-the-scenes Thiel had been pushing hard for O'Neill, Srivinasan, or another radical pick to remake the FDA:

Behind the scenes, the process leading to Gottlieb’s selection was far more colorful than the announcement suggested.

Trump supporter Peter Thiel, an iconoclastic billionaire, had been pushing hard for a far more radical pick to head the FDA.

Thiel had Trump’s ear, and pitched him on two Silicon Valley libertarians who had publicly questioned the core mission of FDA. (One suggested the FDA need not ask for proof that a drug worked before releasing it onto the market. Another mused that the agency could perhaps be replaced with a consumer review site, a sort of Yelp for drugs.)

The Trump team seemed to toy with the idea of turning the agency on its head with such a pick.

In fairness, Gottlieb is the sort of nominee that might be expected of any conservative Republican administration, a very industry-friendly and regulation-unfriendly sort of bureaucrat who's served in the FDA before as Deputy Commissioner for medical and scientific affairs under the George W. Bush administration. During his actual tenure at the FDA as Deputy Commissioner, he had so many financial conflicts of interest with pharma companies that he had to recuse himself from resource planning for a potential bird flu epidemic because of his financial ties to Sanofi-Aventis, as well as work related to Eli Lilly, Proctor & Gamble, and, yes, five—count ‘em, five!—other drug companies. After leaving the FDA, the situation has only gotten murkier, with Gottlieb's now having ties to at least 25 pharmaceutical companies, including GlaxoSmithKline, Bristol-Myers Squibb, and Vertex Pharmaceuticals. If that's not a real pharma shill, I don't know what is. If that's not enough to convince you, then take a look at some of Gottlieb's activities when last he was in a position of authority at the FDA:

When three people in a multiple sclerosis drug trial lost blood platelets and one died, he called stopping the study “an overreaction” because the disease not the drug might be to blame.

And when FDA scientists rejected Pfizer’s osteoporosis drug candidate Oporia, forecast to earn $1 billion a year, underlings received accusatory emails from Gottlieb.

His on-to-Wall-Street approach succeeded in rushing Chantix, Pfizer’s stop smoking drug, varenicline, to market but a string of 2006 suicides and the violent death of Dallas musician Carter Albrecht leave many asking if that was such a good thing.

“The truth is, the FDA’s required trials reveal limited information,” Gottlieb wrote presciently in an oped in the Chicago Tribune in 2005. “In many cases, it is only afterdrugs are on the market for many years and given to thousands of patients that their true benefits (sic.) are revealed.”

Which is, of course, true, but not an argument for less rigorous pre-approval evidence but rather more rigorous post-approval surveillance. Indeed, Gottlieb is very much in favor of loosening regulations regarding off-label marketing of pharmaceuticals and has a history of arguing for such marketing during his previous stint at the FDA, even going so far as to refer to regulations against off-label marketing as an affront to the free speech of corporations. The term "off-label" refers to marketing a drug for an indication for which it is not FDA-approved but for which there is evidence of efficacy and safety. Physicians not-infrequently prescribe off-label. Although there is a debate about whether off-label prescribing is appropriate and when, there is also little doubt that in some cases it is justified. What is less controversial is that drug companies should not be allowed to advertise off-label uses of their products; indeed, off-label marketing is illegal. Not surprisingly, pharmaceutical companies have found ways to get around the prohibition on off-label marketing and continue to push against the prohibition with some success.

As I said, Gottlieb is probably the "least bad" choice of the options under consideration for the job of FDA Commissioner, and big pharma appears to love him, as does a group known for being closely aligned with the interests of big pharma, the food industry, and the chemical and pesticide industries that sees "chemophobia" even where it doesn't exist, the American Council on Science and Health (ACSH), whose president Hank Campbell and senior fellow of biomedical science Alex Berezow fell all over themselves in a column in USA TODAY praising Gottlieb:

The tougher regulations drag out approval times, increasing research and development costs. All the while, the patent clock is ticking. Once FDA approval is granted, companies must charge as much as possible to recoup their investment, driving up drug prices.

The higher regulatory cost also prevents the growth of startup biotechnology and pharmaceutical firms. Today, startups that are developing a promising new drug simply cannot afford clinical trials, so they hope to be bought up by a larger company. The result maintains the status quo in the marketplace, stacking the deck in favor of Big Pharma.

Gottlieb’s instinct toward deregulation could help reverse this trend, evening the playing field for new companies. His commitment to science-based policies is another reason to applaud his nomination.

I've pointed out before that it's a myth that deregulation evens the playing field for new companies. In actuality, smaller companies prefer a strong FDA because they can't compete in marketing muscle. They can, however, compete once they obtain FDA approval.

Also, as I've discussed many times before, it's a myth that the FDA is slow at approving drugs or that its requirements are particularly onerous compared to other industrialized countries. Indeed, I'm not the only one to have pointed out that the FDA in general approves drugs faster than Europe. President Trump's promise to cut 75% of FDA regulations is frightening in this context, but fortunately likely too radical to be accomplished even with a Thiel crony in charge.

Gottlieb, at least, appears more conservative, not politically, but in how he will do things. Even so, there are other reasons for concern. For instance, one aspect he shares with Jim O'Neill is a belief that drugs should be approved based on their effects on surrogate markers. However, as I've described, surrogate markers often don't correlate with efficacy. FDA data bear this out, as described in a BMJ feature article a couple of weeks ago:

The FDA report on 22 case studies, however, though primarily concerned with a defense of phase III trials, also includes a strong rebuttal to Gottlieb’s portrayal of the power of surrogate endpoints.

“While biomarkers have many important uses in clinical practice and product testing, most have not been shown to reliably predict clinical outcomes.” They cite six cases, noting that “promising biomarker data in phase II do not necessarily translate into effective product performance.” One such case was torcetrapib, a drug Pfizer called the “most important new development in cardiovascular medicine in years.”²⁰ Phase II studies had shown that it increased “good” high density lipoprotein cholesterol levels and lowered “bad” low density lipoprotein cholesterol. A phase III study confirmed these findings. But Pfizer ended its development program after another phase III study with over 15 000 participants found that those receiving torcetrapib “were 25% more likely to suffer a major adverse cardiac event, and were 58% more likely to die from any cause,” than those taking placebo. Both results were statistically significant.

Joseph Ross, associate professor of medicine at Yale University, concurs with the FDA report, noting that though some surrogate markers, such as viral load for HIV therapies, have proved reliable, many others are problematic. “Those used for regulatory approval of therapies for diabetes, cardiovascular disease, cancer, and many more have only been found to be weakly, or even not all, predictive of clinical outcomes after further study. If the FDA is going to continue to allow regulatory approval based on trials using surrogate markers of disease, there must be strong post-market requirements placed on manufacturers to complete studies that use clinical outcomes in order to ensure the clinical community understands the true benefits and risks of any approved therapy,” he says.

The FDA report basically describes 22 cases where phase II trials weren't confirmed by the results of phase III trials. The bottom line is that, while some surrogate markers are very useful, in general surrogate markers are too unreliable an outcome upon which to base drug approval.

This brings up other questions of how to speed up drug approval in the age of molecularly-targeted therapies. To this end, Gottlieb has heaped love on adaptive clinical trials. Such trials are designed so that the protocol can be altered based on data collected during the trial. I've described one such trial before, the I-SPY trial, and the 21st Century Cures Act encourages adaptive designs. Unfortunately, for all the buzz about adaptive trials, they are not a panacea. In particular, biostatisticians fear:

A recent survey of researchers’ attitudes toward adaptive trials—part of a National Institutes of Health and FDA-funded project on which Berry and Barsan collaborated—also found that biostatisticians were also generally less optimistic than other stakeholders about the validity of conclusions from adaptive trials. Some fear that dropping arms or changing randomization rules based on data in the trial will introduce problematic bias to the results, Berry says, though study conclusions can be adjusted to take potential bias into account.

In fairness, not everything about Gottlieb is questionable. If there's one area where he shines it's vaccines. Indeed, he's quite pro-vaccine and has no truck with antivaccine pseudoscience falsely linking vaccines to autism. Indeed, antivaxers are referring to him as the "FDA vaccine stooge," which leads me to feel schadenfreude, given how much hope that antivaxers had had in Donald Trump after he was elected. Assuming Gottlieb is confirmed, my main consolation will be responses like this:

This is Ginger Taylor, and antivaccine activist with whom I've butted heads periodically over the last decade, citing the Twitter feed of a disappointed Trump supporter. There is no need to worry that Gottlieb will pander to antivaccine pseudoscience, and that's a good thing. Whether that's worth all the other baggage is debatable. Still, it could have been much worse. On the other hand, Gottlieb also appears to support the cruel sham that is right-to-try, a topic I'm likely to have more to say about next week or the week after.

The answer to everything: More deregulation and more ties with business

It is now five months after I expressed my concerns about what would happen to federal health and biomedical science policy under President Trump. At the time I was very much afraid that much of what would happen would not be based on science. In fairness, I will mention right now that thus far my worst fears about vaccine policy have not been realized. Trump's FDA pick is solidly pro-vaccine, for instance, and even though Trump did meet with RFK Jr. there has been no evidence that the "vaccine commission" about which RFK Jr. bragged is anywhere near coming into being. On the other hand, the CDC director hasn't been appointed yet, and there's still a part of me that fears it will be someone like Andrew Wakefield or RFK Jr. I know that even Trump probably wouldn't do something like that, but I still can't help but wonder. In any case, thus far vaccine-related changes have not been as I feared. Thus far. On the other hand, we now know that deregulation is the order of the day for...pretty much everything health-related. It probably won't be as bad as I feared at the FDA with Scott Gottlieb at the helm, and the FDA certainly dodged a bullet when Peter Thiel failed to inflict his favored candidates on it, but there will be pharma-friendly deregulation.

Even for the NIH, this attitude permeates the administration. For example, the name of Dr. Patrick Soon-Shiong, the richest man in Los Angeles, a doctor and entrepreneur who is worth an estimated $11 billion, had been floated to be NIH director. (He seems to be out of the running for the NIH—if he was ever seriously in it to begin with—but his name has also been floated for other important science-related positions, as well, such as Presidential Science Advisor.) He's undoubtedly a brilliant man. There's no doubt about it. However, the myth making about him appears to have gotten ahead of his actual success against cancer. For example, a couple of years ago he was profiled by 60 MINUTES in what appeared to be more hagiography than profile, complete with a groaner like, "A cancer is not what people think, cells growing. Cancer is actually the inability of the cells to die." The way 60 MINUTES treated this statement as some sort of brilliant, radical new insight into cancer was downright cringe-inducing. The idea that defects in apoptosis (programmed cell death) are integral to cancer has been mainstream since before I was in graduate school 25 years ago. Indeed, many of Soon-Shiong’s “radical” ideas are conventional, something Matt Herper pointed out. That's not to say that he might not be on to something with his computational approach to cancer, but whether he is or not remains to be seen. He's a philanthropist, too, but the main target of his philanthropy appears to be companies and entities that he owns. He's apparently no longer under consideration for the NIH, but it appears likely that he'll have some role in the administration.

To be honest, though, what concerns me more than the ideology that deregulation über alles will fix everything that ails medical research and drug regulation, is the idea that the budgets of science agencies can be subjected to massive cuts and still function adequately. For instance, in total dollars the NIH has had budgets that have been flat or only slightly increasing for years, but in inflation-adjusted dollars the NIH budget has decreased approximately 25% since 2003. Similarly, I've often argued that there are no problems with the speed of FDA drug approval that couldn't be greatly ameliorated with more money. Given how important the FDA is, it's been criminally underfunded for years. Unfortunately, based on the first two and a half months of the Trump administration, I fear that we are in for a rough time in biomedical science and ensuring that our drugs and food are safe.

oracknows Sun, 04/16/2017 - 21:49

Tags

Skepticism/Critical Thinking

antivaccine

Department of Health and Human Services

Massive measles outbreak in Romania: A warning to the US?

oracknows — Tue, 21 Mar 2017 05:00:52 +0000

Massive measles outbreak in Romania: A warning to the US?

When it comes to the measles, antivaxers love to repeat a series of talking points. One is that measles is not a dangerous disease and was considered a normal part of childhood 50 or 60 years ago. This is what I like to refer to as the "Brady Bunch" gambit, mainly because antivaxers who try to make this argument often invoke an episode of The Brady Bunch from 1969, Is There a Doctor in the House?, in which all six kids contract the measles within a day of each other. Their illness is played for laughs, with the kids shown playing board games and enjoying having a few days off from school, while their concurrent illness provokes a conflict over whether the girls' pediatrician or the boys' pediatrician would be the family doctor. They also like to point to an episode of The Donna Reed Show from 1959 and an old episode of The Flintstones from around the same period, both of which portrayed measles as no big deal. It's a ridiculous and dangerous argument that relies primarily on nostalgia and cherry-picked bits of mid-century Americana, rather than the actual risk of severe complications due to the measles. Other common antivax tropes about the measles include the claim that "vaccines didn't save us" against it (they did) and that herd immunity is a myth or that "natural" immunity is better (it isn't, especially against a disease as contagious as the measles).

Unfortunately, one of the topics I missed blogging about last week due to the travel and power outages that kept me away from the blog more than I've been away in a long time put the lie to all three of those common antivaccine tropes in a highly compelling way. I'm referring, unfortunately, to the ongoing measles outbreak in Romania, which hit the news again last week. This outbreak shows not only that measles is serious, but that vaccines can save and herd immunity is real. More importantly, it shows what could be a glimpse of our future if we allow vaccination rates to fall, thanks to antivaccine activists, perhaps aided by not-so-benign neglect on the part of the Trump administration.

Behold the horror:

National public health officials said an ongoing measles outbreak in Romania has infected more than 3,400 people and killed at least 17 despite an aggressive nationwide vaccination campaign.

Meanwhile, the European Center for Disease Prevention and Control (ECDC) warned of a greater regional outbreak of measles as a result of below-target vaccination coverage numbers in Romania.

“This poses a risk of potential repeated exportation to other [European] countries and possible continuous transmission in some where vaccination coverage is suboptimal,” the ECDC said in a recent rapid risk assessment report on the Romanian outbreak.

As of March 10, Romania’s National Institute of Public Health said 3,446 cases of measles have been confirmed since the outbreak began last year. The country is one of six in the European Union or European Economic Area judged by WHO to still have endemic transmission of the vaccine-preventable disease, along with Belgium, France, Germany, Italy and Poland.

I'm sure that any antivaccinationists who read this will point immediately to the phrase "despite an aggressive nationwide vaccination campaign," as though the outbreak isn't being stopped by increased vaccination. Of course, this line of argument fails to take into account that, once there are outbreaks, authorities are going to be playing catch-up, and it will take a while for increased vaccination rates to slow and stop the fury of the outbreak.

More importantly, children are dying, and they're dying at roughly the rate we know from history to expect in developed countries. Normally, according to the CDC, the mortality rate from measles is typically quoted as 0.2% in the US but can be as high as 10% in areas with high levels of malnutrition. When measles is rare, as it fortunately still is in the US (for now, anyway), deaths are unlikely or likely only to be one, because you have to have thousands of cases before significant numbers of children die of the disease. Unfortunately, Romania has reached that level. So, right there, the case of Romania puts the lie to the claim that measles isn't a dangerous disease.

Indeed, what we're seeing in Romania is a mortality rate of around 0.5%. Worse, the deaths nearly all occurred among those who need herd immunity the most, as this report from the European Centre for Disease Prevention and Control found:

As of 17 February 2017 [2], 3 071 cases had been reported to the National Institute of Public Health, with 2 341 since October 2016 (Figure 2). These cases are either laboratory-confirmed, or have an epidemiological link to a laboratory-confirmed case. Cases have been reported in 36 districts with the districts of Caras Severin (n=703), Arad (n=617) and Timis (n=566) having reported the highest number of cases (Figure 3).

To date, 16 deaths have been reported, all of which occurred in persons who were immunocompromised or had other co-morbidities.

Infants <1 year old (n=549) and children 1–4 years old (n=1,247) made up the majority of cases. Ninety-six percent of cases were unvaccinated (n=2 958), 80 cases had received one dose of MCV and 33 had received two doses.

So right away we see two things. First, the vast majority of the cases of measles occurred in unvaccinated children, 96%! This is basically as close to a natural experiment as there is to see what happens when vaccine coverage falls below the rate necessary to maintain herd immunity. Second, it's exactly the children who most rely on herd immunity who are dying. Again, this is what happens when vaccine coverage falls.

And that's what happened in Romania:

MMR vaccination rates have fallen in recent years in Romania to below the 95% threshold recommended to interrupt transmission. According to the ECDC, coverage for one dose was just 86% in 2015 in Romania compared with 97% in 2007. In 2013, the last year when data were reported for two doses, 88% had received two doses compared with 96% in 2007. According to the CDC, two doses of the MMR vaccine are about 97% effective at preventing measles, and one dose is 93% effective.

In response to the outbreak, Romania lowered the age of the first MMR vaccine dose from 12 months to 9 months as part of an effort to fully vaccinate children between the ages of 9 months and 9 years. According to the ECDC, family doctors are registering unvaccinated children for vaccination — with the goal of giving one dose of the MMR vaccine to those under age 5 years and two doses to those between the ages of 5 years and 9 years — while community nurses are mobilizing children mainly in vulnerable population groups.

So that's all it took, a decline in vaccine coverage from 96% of children having received two doses of the MMR to 88%. Herd immunity is a function of how contagious a disease is and how effective the vaccine is. Measles is, unfortunately, very contagious, meaning that high rates of vaccination are required to provide herd immunity. Fortunately, the MMR is highly effective, but no vaccine is 100% effective. Even with 100% vaccine coverage, there would still be roughly 3% of the population who would not be immune. Obviously, with lower levels of vaccine coverage, more are vulnerable. Basically, to block the transmission of measles requires 90-95% coverage, the higher the better. What Romania shows is just how tenuous the situation can be with respect to keeping measles under control, even in developed countries. It doesn't take much. The measles virus is out there, and it will take advantage when there is an opening. The most effective way to give the virus the chance it needs is to let vaccination uptake fall, and it doesn't have to fall much.

But why has the uptake of MMR fallen in Romania? One story tells us:

But Bodog said only 80 percent of Romanians receive the first vaccination dose and just 50 percent receive the second.

In Romania, poverty, the lack of access to health services, and the percentage of parents who refuse to vaccinate their children are at the heart of the recent epidemic.

Religious organisations and public figures have led recent anti-vaccination campaigns.

It's not clear where the antivaccine sentiment came from or why it is so strong in Romania, but one study from UNICEF of antivaccine sentiment found on Eastern European social media sites found that fear of toxins in vaccines was the predominant, with fear of side effects and conspiracy theories as the other main reasons. It noted that in Romania school nurses perform mandatory vaccination during class, which is "seen as a human rights violation and a safety issue." Parents are also skeptical about the skills of the school nurses and "feel surpassed by authorities in its decision to have children vaccinated." Oddly enough, contrary to the case in the US and Western Europe, fear of autism or other developmental disorders is not nearly as major a driver of antivaccine sentiment, although there are a number of common conspiracy theories.

Here's one example:

Romanian discussions directly blame the U.S. for purposefully infecting people with HIV using polio vaccines. Users create a direct link between vaccines and widespread HIV in Romanian orphanages. In the same sense, users claim that vaccines are being used against the Romanian populations. According to members of the anti-vaccination sentiment, vaccines against polio and chickenpox are used in Romania, which are not used in the U.S. anymore.

Clearly, Romanians have been listening too much to Dr. Leonard Horowitz. I will say one thing about this UNICEF report that makes me question its validity is the fact that in a table entitled Common arguments by influencers: Romanian speaking, UNICEF described Left Brain/Right Brain as "Autism news science & opinion, Anti-Vax leaning. Um, no. Left Brain/Right Brain is an ally in the campaign to refute antivaccine misinformation. It is not in any way, shape, or form and antivaccine blog, or the least bit sympathetic to the antivaccine viewpoint.

In any case, whatever the cause of the decline in MMR uptake, poverty and neglect, antivaccine sentiments, or some unholy combination of the two, Romania is a cautionary tale of just how easy it is to lose hard won ground in the fight against infectious disease. It's also an example that worries me, because if you think it can't happen here you are deluded, especially with Tom Price in charge of the Department of Health and Human Services saying things like this:

HHS Secretary Tom Price says it should be up to states to regulate whether immunizations are required https://t.co/soyH0YpO5E

— CNN Politics (@CNNPolitics) March 16, 2017

Basically, Price is signaling that he doesn't think immunizations are a federal responsibility. Given his membership in the Association of American Physicians and Surgeons (AAPS), an organization that is basically an Ayn Rand-worshiping John Birch Society disguised as a medical professional society that routinely publishes antivaccine misinformation in its journal, as well HIV/AIDS denialism and other pseudoscience, it's not at all surprising that Price would think that way.

While it's true that states set the laws setting school vaccine mandates, but they rely on the work of the CDC to know what the latest science-based recommendations are for vaccine coverage upon which they base their mandates. Also, Price's view ignores the fact that viruses and bacteria do not respect arbitrary lines on a map that separate states. The federal government, although not primarily responsible for vaccine requirements, nonetheless plays a critical role in vaccine policy. Given that Donald Trump has consistently expressed antivaccine sentiments over the last decade and Tom Price seems to think that the federal government has little role in vaccine policy, I fear that Romania is a warning to us. It's a warning that, I fear, we will not heed.

oracknows Tue, 03/21/2017 - 01:00

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The crank medical organization to which HHS nominee Dr. Tom Price belongs lays down a heaping helping of antivaccine pseudoscience

oracknows — Thu, 22 Dec 2016 02:15:01 +0000

The crank medical organization to which HHS nominee Dr. Tom Price belongs lays down a heaping helping of antivaccine pseudoscience

Three weeks ago, I wrote a post that, much to my surprise, went viral, garnering more Facebook "Likes" than any before it, although it only came in maybe third in traffic after the all-time record-holding post from a couple of years ago. Maybe I shouldn't have been surprised. It was, after all, about Tom Price, Donald Trump's nominee for Secretary of the Department of Health and Human Services (HHS). What I noted that apparently caught the attention of many times more people than my usual daily brain droppings usually do was that Tom Price belongs to one of the wingnuttiest of wingnut medical groups I've ever encountered, the Association of American Physicians and Surgeons (AAPS). There's no need for me here to reiterate the group's Ayn Rand-like worship of the brave maverick doctor über alles in detail, as I've done that before multiple times beginning nearly eleven years ago. Basically, to the AAPS, doctors should not accept payment from Medicare (which it views as unconstitutional) and that the autonomy of doctors, who are portrayed as akin to John Galt and other "producers," should never be constrained by pesky, puny things like evidence-based guidelines, because, apparently, every doctor is expert enough to interpret the vast medical literature without any help.

On the other hand, it is worth briefly mentioning the pure antiscience and pseudoscience that emanates from the AAPS, particularly through its house organ, the Journal of American Physicians and Scientists (JPANDS). This journal is a veritable cornucopia of ideology-motivated quackery and pseudoscience, including antivaccine pseudoscience up to and including the despicable claim that shaken baby syndrome is a "misdiagnosis for mercury poisoning" and that sudden infant death syndrome might be caused by vaccines, the bogus claim that abortion causes breast cancer, and anthropogenic global climate change denialism (don't ask what that's doing there). Indeed, Dr. Jane Orient, the executive director of AAPS, denies the very concept of a scientific consensus.

Well, the Winter 2016 issue of JPANDS is out, hot off the presses, digitally speaking, and I can't help but wonder: What does Dr. Price think of some of the articles found therein. In particular, I'm interested in what he thinks of an article by Neil Z. Miller entitled Aluminum in Childhood Vaccines Is Unsafe. Well, you have to say one thing for Miller: He's consistent. Just two issues earlier, Miller published an article in JPANDS entitled Combining Childhood Vaccines at One Visit Is Not Safe. I'm eagerly looking forward to an ongoing series from Miller: MMR Is Not Safe. Thimerosal Is Not Safe. All Those Nasty Toxins in Vaccines Are Not Safe. Not surprisingly, I took notice of Miller's last article in JPANDS and applied a not-so-Respectful Insolence to misinformation and pseudoscience that deserved much worse. Even less surprisingly, once having seen Miller's second JPANDS publication, I can't resist a repeat, particularly now that I know that Dr. Price is a member in good standing of the AAPS. These are the sorts of misinformation-packed articles that need to be thrown into Price's face during his confirmation hearings in order to force him to justify why he belongs to an organization so opposed to accepted medical science.

So let's take a look, shall we?

Not content with just demonizing aluminum, which is used as an adjuvant for some vaccines. Basically, an adjuvant is a substance that, when injected with vaccines, can result in a more intense immune response. Miller has to start with the dreaded mercury-containing preservative thimerosal. There's a method to his madness, of course. It's not a method that makes any scientific sense, but rather is designed to draw attention from the very simple observation that, since the phase-out of thimerosal as a preservative in vaccines in the US, autism prevalence hasn't declined. Quite the contrary, actually. Miller opines:

From 1999 through 2002, several vaccines containing mercury were phased out of the childhood immunization schedule. Manufacturing of childhood vaccines with thimerosal ceased in 2001, but those that were not past their expiration date remained on the market for sale until January 2003.¹ They were replaced with low-mercury or “thimerosal-free” vaccines. In the years that followed, autism rates continued to rise, prompting health authorities to assert that autism is not linked to mercury in vaccines and that vaccination policies are safe and appropriate.^2-4 (If mercury in vaccines contributed to autism, then rates should have dropped after mercury was removed.) However, in 2002, during this so-called phase-out period, the Centers for Disease Control and Prevention (CDC) actually added two doses of mercury-containing influenza vaccines to the list of inoculations urged for all babies 6 to 23 months of age.⁵ Two years later, the CDC also added pregnant women in their first trimester to the list of people officially recommended and actively encouraged to receive influenza vaccines, even though a majority of available doses contained mercury.⁶

In addition to these questionable actions during this highly publicized “phase-out” of mercury, four doses of a new vaccine with high aluminum content were added to the childhood immunization schedule in February 2000 (for pneumococcus) and two doses of another aluminum-containing vaccine (for hepatitis A) were added in 2005.^7,8 These changes to the vaccine schedule resulted in a substantial increase of aluminum-containing vaccine doses—from 10 to 16 injections—that babies are still mandated to receive by 18 months of age.

Notice what Miller left out? Well, he left out multiple things. However, the most glaring is a simple matter of quantity. How much mercury was in the childhood vaccination schedule after 2003 compared to before? The answer, of course, is a lot less, even with the addition of the new vaccines. For instance, in an Italian study from the 1990s testing the existing DTaP vaccine versus a then-new thimerosal-free version, children received 137.5 μg of mercury and just eliminating the thimerosal from the DTaP in that schedule cut mercury exposure by more than half. Moreover, while it's true that most flu vaccines then still contained thimerosal, it didn't take long for manufacturers to get rid of the thimerosal, particularly in the childhood vaccines. These days, it's so hard to find thimerosal-containing flu vaccines that when I get my yearly dose, I often joke about asking to add extra thimerosal.

Of course, the narrative that Miller is selling is that the reason autism prevalence didn't plunge a few years after the removal of nearly all the thimerosal from the childhood vaccine schedule by early 2003 is because of an increase in aluminum exposure. This idea is as much a pile of nonsense as the idea that thimerosal was responsible for an "autism epidemic," not the least of which because it would be an incredibly coincidence that, if you accept the rationale of someone like Miller that both thimerosal and aluminum can contribute to autism, just as one autism-containing vaccine ingredient was removed another was added in sufficient quantity to cause autism prevalence to keep climbing at the very same rate that it was climbing before. That's because antivaccinationists have always known that if autism prevalence kept climbing after thimerosal was removed from vaccines it would be a deadly blow against their belief that thimerosal causes autism when it doesn't. So basically, Miller tries to argue that a 25% increase in aluminum exposure due to vaccines was enough to make up for—scratch that, more than make up for—the loss of thimerosal in its claimed evil autism-causing properties.

To demonstrate the "toxicity" of aluminum, Mr. Miller has to do some rather major contortions, so much so that it looks very much as though he's playing Twister with vaccine science, and the construct can't stand:

Aluminum is neurotoxic and has a long history of well-documented hazards.¹⁴ For example, as early as 1921 The Lancet described a 46-year-old metal worker in whom “aluminium produced a rather slow intoxication. In this case it caused memory loss, tremor, jerky movements and incontinence of urine.”¹⁵ In 1927, Dr. Victor Vaughn, a toxicologist with the University of Michigan, testified before the Federal Trade Commission that “all salts of aluminum are poisonous when injected subcutaneously or intravenously.”¹⁶ By 1951, Chusid et al. showed that chronic epilepsy could be induced in monkeys through intra-cerebral administration of aluminum hydroxide cream.¹⁷ In 1968, Driver et al. performed a similar experiment by placing aluminum hydroxide cream unilaterally on the posterior parietal cortex of six monkeys.¹⁸ From 3 to 8 weeks after surgery, electrical abnormalities could be seen on an electroencephalogram and the monkeys exhibited “episodic twitching of the limbs and face.” The animals were also impaired at learning new tasks and at re-learning tasks first learned prior to the intervention.

Aluminum exposure in a metal worker in the 1920s was due to a much larger exposure than any vaccine or series of vaccines would be expected to produce. Slathering large quantities of aluminum onto the cerebral cortex is much different than injecting tiny quantities into the muscle. Dose and poison, Mr. Miller. Dose and poison. Learn it, live it, love it. The dose makes the poison, and the dose of aluminum in vaccines is quite safe. I also can't help but notice some of the articles referenced by Miller are not exactly from reliable sources. For instance, reference #16 is from David Ayoub's talk to the National Autism Association Conference in 2007. That's a serious antivaccine conference, and David Ayoub is know for his conspiratorial thinking and belief in black helicopters and the Illuminati. It's not for nothing that Ayoub was inducted into the Encylopedia of American Loons. If you don't believe me, just look for yourself at this typical talk by Ayoub:

That's some weapons-grade crazy.

Mr. Miller also liberally cites Lucija Tomljenovic and Christoper Shaw, two antivaccine cranks par excellence whose abuse of science has been discussed many times here and elsewhere. Let's just put it this way: Tomljenovic and Shaw very much believe that Gardasil causes premature ovarian failure (it doesn't, and here's why) and that it kills (it doesn't, and here's why). Mr. Miller even cites one of the most hilariously misbegotten articles blaming aluminum in vaccines for autism, one that so hilariously confuses correlation with causation that it makes blaming global warming on the decrease in number of pirates seem reasonable by comparison. Yes, it's a Tomljenovic and Shaw paper.

The rest of the paper basically defines the term "cherry picked." Mr. Miller lists, in maximally frightening terms, a series of studies that purport to find significant negative health consequences (as opposed, for instance, to injection site pain or complications, something common to all vaccines, regardless of whether they contain aluminum or not), often by antivaccine cranks, and unsurprisingly ignores the vast existing literature on the safety of aluminum adjuvants. These studies often ignore the principle of "the dose makes the poison":

According to the American Academy of Pediatrics (AAP), “Aluminum is now being implicated as interfering with a variety of cellular and metabolic processes in the nervous system and in other tissues.”¹⁹ Bishop et al. published data showing that “aluminum accumulates in the body when protective gastrointestinal mechanisms are bypassed, renal function is impaired, and exposure is high.”²⁰ For example, in premature infants, “prolonged intravenous feeding with solutions containing aluminum is associated with impaired neurologic development” by 18 months of age. More recently, Kawahara et al. published research confirming that “aluminum can cause severe health problems in particular populations, including infants.”²¹ The authors of this paper also declared that “whilst being environmentally abundant, aluminum is not essential for life. On the contrary, aluminum is a widely recognized neurotoxin that inhibits more than 200 biologically important functions and causes various adverse effects in plants, animals, and humans.”

Bloody hell. He's quoting the data for aluminum toxicity in premature infants who have prolonged exposure to aluminum in their parenteral (intravenous) nutrition. We're talking about premature babies who are either too premature or too ill to be fed using their guts and as a consequence have to be fed intravenously and thus receive a lot of aluminum. Comparing this exposure to aluminum to exposure due to vaccines is akin to comparing Mt. Everest to the hill near your house that makes you tired if when you have to climb it.

Unbelievably, Mr. Miller even invokes a favorite antivaccine trope used for any scary-sounding ingredient in vaccines, elaborating on the "injection" aspect of vaccines above:

Moreover, vaccines with aluminum adjuvants are injected into the body, bypassing protective barriers of the gastrointestinal tract and skin. Absorption of aluminum by this mode is more efficient than through ingestion, increasing the likelihood of a toxic outcome. The authors summarized their findings: “Evidence has now emerged showing that autism may in part result from early-life immune insults induced by environmental xenobiotics. One of the most common xenobiotic with immuno-stimulating as well as neurotoxic properties to which infants under two years of age are routinely exposed worldwide is the aluminum vaccine adjuvant.”

At least he refrained from the more common variant of this trope, that vaccines are "injected directly into the bloodstream," when in fact they are usually injected intramuscularly. are talking about small amounts of aluminum injected into the muscle, where they are slowly abosrbed.

I could go on and on. Mr. Miller's paper is what we in the skeptic biz call a "target-rich environment." The reason I brought it up now to discuss has less to do with the misinformation in the article, of which there is plenty, or its unusualness, of which there is none. Rather, it's because, now, less than three weeks after Dr. Price was nominated to head HHS, the organization to which he belongs is still at it, publishing antivaccine propaganda every bit as egregious as it's been doing at least since 2006. I don't know about you, but I want to know how many beliefs Dr. Price shares with the organization to which he belongs. I want to see him have to read this article and explain himself, specifically, whether he shares the AAPS's antivaccine views.

Yes, there are a lot of other areas where Dr. Price's views are very worrisome, but this is one that shouldn't be ignored.

oracknows Wed, 12/21/2016 - 21:15

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Thank you for going through that.

It's a little sad that so many of the people for c. Whom he wrote that will just accept this.

Orac wrongly states:
"There’s no need for me here to reiterate the group’s Ayn Rand-like worship of the brave maverick doctor über alles in detail, as I’ve done that before multiple times beginning nearly eleven years ago. Basically, to the AAPS, doctors should not accept payment from Medicare (which it views as unconstitutional) and that the autonomy of doctors, who are portrayed as akin to John Galt and other “producers,” should never be constrained by pesky, puny things like evidence-based guidelines, because, apparently, every doctor is expert enough to interpret the vast medical literature without any help."
...wrong because of its malevolent manipulation of a fact/fiction interpretation;
1) Not only is Medicare unconstitutional, its anti-man. ie., it enslaves the doctor(forced service) & therefore evil.
2) The John Galt reference should be Dr. Thomas Hendricks: In Atlas Shrugged she explains explicitly the proper patient/physician heirarchy through the Dr. Hendricks (! house call !) speech.
3) In essence, what we're going thru now is a quantity/quality dilemma that cannot have a good ending as long as kids are mistakenly taught that democracy(majority) dictates over the individual(smallest minority).
Ideas and individuality have to reign dominant while the popular vote relegated to recessive status.
Yeah, like natures genetic(code) prioritizing - works and has worked for quite some time now ie., forever - in order to control nature, we're better off to obey it - as its got us to where we are today.
'Getting it right' percentages have increased since Ayn Rand laid out the hierarchy of Individualism and supremacy of reason. Evidently this is still not understood nor implemented completely.

Francisco Carlos Domingo Andres Sebastian d'Anconia

Jane Orient is dangerously crazy. She should have been stripped of her medical license years ago. From a 2000 newspaper article in Tucson (http://tucsoncitizen.com/morgue2/2000/11/18/172430-internet-blasted-for… ):

A lot of the current information on vaccines “is absolute garbage,” said Dr. Jay Lieberman, chief of pediatric infectious diseases at the University of California, Irvine.

Lieberman’s comments were part of his “Vaccine: Hit or Myth” address to Tucson area health care workers attending a Southern Arizona Immunization Coalition seminar this week.

Nationwide, there is increasing discussion over alleged but unproven effects of vaccines, including the emotion-laden suggestion that the measles, mumps and rubella vaccine, commonly called MMR, could cause autism in some children.

It’s a topic that’s recently received time or ink from “20/20,” “60 Minutes,” USA TODAY and other major media outlets. The Association of American Physicians and Surgeons, a 4,500-member professional group headed by Dr. Jane Orient of Tucson, earlier this month called for a moratorium on government-required vaccines for children.

“Our children face the possibility of death or serious long-term adverse effects from mandated vaccines that aren’t necessary or that have very limited benefits,” said Orient, who also is president of the Pima County Medical Society.

“This is not a vote against vaccines,” she said. “This resolution only attempts to halt blanket vaccine mandates by government agencies and school districts that give no consideration for the rights of the parents or the individual medical condition of the child.”

Lieberman said he found the first statement to be appalling.

“The measles vaccine has limited benefit?” he asked incredulously. “That’s a statement I would say is absolutely ignorant.”

Don't forget the AAPS had Andrew Wakefield as one of their distinguished speakers at their 2011 annual conference (https://www.youtube.com/watch?v=l67fWVrw8xU ).

Like you state, Dr. Price needs to be thoroughly questioned on his membership to this group of physicians who central views pose a threat to public health.

Can anyone translate what Francisco posted for me please? I don't speak fluent gibberish.

A while back I was going to review Neil Miller's book: "Vaccines: Are They Really Safe & Effective", unfortunately, just too many topics to write on.

Just to give you a taste, on p. 26, he writes: "In 2000, a new study in the Journal of Manipulative and Physiological Therapeutics confirmed earlier findings that children who received DPT or tetanus vaccines are significantly more likely to develop a 'history of asthma' . . . than those who remained unvaccinated." From the actual article: "The odds of having a history of asthma was twice as great among vaccinated subjects than among unvaccinated subjects (adjusted odds ratio, 2.00; 95% confidence interval, 0.59 to 6.74)." For those unschooled in statistics, a confidence interval of 1 means no difference between the groups. A number below 1 would mean that the unvaccinated had higher incidence of disease and, obviously, a number above 1 would be the vaccinated had the higher incidence. When a confidence interval range contains both and is as wide as this one, it means that any finding could be solely due to random chance. Either Mr. Miller just doesn't understand research methods and statistics or . . . ? In any case, this study clearly does not remotely show anything "significantly more likely." Don't believe me; the authors’ own conclusion is "Although it is unlikely that these results are entirely because of any sources of bias, the small number of unvaccinated subjects and the study design limit our ability to make firm causal inferences." The conclusion should have simply read the results were inconclusive. Claiming that they can't make "firm causal inferences" would be like tossing a coin a few times and claiming one couldn't make a firm causal inference as to the coin being balanced or not. The article Miller is citing is: Eric L. Hurwitz, DC, PhD, Hal Morgenstern, PhD (2000 Feb). "Effects of diphtheria-tetanus-pertussis or tetanus vaccination on allergies and allergy-related respiratory symptoms among children and adolescents in the United States," Journal of Manipulative and Physiological Therapeutics; 23(2): 81-90.

  So far the vast majority of citations in this book seem to be from other books and articles written by anti-vaccine advocates without any evidence the author checked out the original sources and, so far, when he has used original sources, as from the above example, he draws totally unwarranted conclusions.  

Finally, PubMed adds approximately 20,000 new articles per month. I could prove any point I wanted by finding a few articles. And some may be quite legitimate; but the difference between science and other endeavors is that once published other researchers will try to replicate findings or go beyond them. Even the results of well-done studies can be affected by random variables, which is why replication is necessary.

As an example, another study of DTP and asthma followed a population-based birth cohort of 13,971 children until they were 7.5 years old and found no significant association. (Anirban Maitra et al. (2004 Apr 17). “Pertussis vaccination in infancy and asthma or allergy in later childhood: birth cohort study,” BMJ; 328: 925-926)
 

https://cdn.meme.am/instances/18969897.jpg

"The dose makes the poison, and the dose of aluminum in vaccines is quite safe."
No, that's wishful thinking based on broken research, see below.

Dr. Mitkus,

I was reviewing aluminum safety information for vaccines at the FDA website and found your study.1

You provide the following description of the effect of aluminum adjuvants on the immune system.

“Aluminum adjuvants are important components of vaccines, since they stimulate the immune system to respond more effectively to protein or polysaccharide antigens that have been adsorbed to the surface of insoluble aluminum particles. Specifically, these coated particles are phagocytized by cells of the innate immune system (e.g., macrophages) and activate intracytoplasmic sensors of pathogen-associated molecular patterns located within the cells, such as the nucleotide-binding domain leucine-rich repeat-containing family of sensors ([6]; Schroder and Tschopp [30]). The functional consequence of activation of this intracellular system is the activation of certain enzymatic caspases that cleave pro-interleukin (IL)-1β to interleukin (IL)-1β. The secretion of the mature cytokine, IL-1β, leads to an inflammatory reaction and a downstream Th2-dependent antibody response [7], which amplify the immune response to the antigen. Adjuvanted aluminum, therefore, plays a vital role in facilitating the response that underlies the immunoprotection afforded by vaccines.”

The rest of the paper focuses on body burden of aluminum AFTER it is absorbed from the muscle into the blood.

I was taken aback that you have COMPLETELY IGNORED any negative immunological effects that aluminum can have while it is still in the muscle.

The quoted paragraph above assumes that the only proteins in the vaccine are viral/bacterial proteins. In that case, as you state, the stimulation by aluminum plays a vital role in generating immunoprotection.

But obviously, vaccines contain numerous other proteins including food proteins (ovalbumin, milk, soy, yeast, etc.)2 , culture medium cell proteins (Vero monkey kidney cell proteins, calf serum proteins, WI38/MRC5 fibroblast cell proteins, etc.) that are also adsorbed to the surface of insoluble aluminum particles. As you state then, aluminum adjuvants stimulate the immune system to respond more effectively to ALL these proteins as well. The effect is an immune response that includes synthesis of antibodies against any and all of these proteins. The result of such a response of course includes food allergy3,4,5 and autoimmunity6.

How can you perform a safety assessment of aluminum in vaccines by COMPLETELY IGNORING this effect?

Thanks,

Vinu

References

1. Mitkus RJ, King DB, Hess MA, Forshee RA, Walderhaug MO. Updated aluminum pharmacokinetics following infant exposures through diet and vaccination. Vaccine. 2011 Nov 28;29(51):9538–43.

2. Vaccine Excipient & Media Summary [Internet]. 2015 [cited 2016 Jan 16]. Available from: http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipi…

3. Arumugham V. Evidence that Food Proteins in Vaccines Cause the Development of Food Allergies and Its Implications for Vaccine Policy. J Dev Drugs. 2015;4(137):2.

4. Platts-Mills TAE. The allergy epidemics: 1870-2010. Journal of Allergy and Clinical Immunology. 2015. p. 3–13.

5. Alice Hoyt, Peter Heymann, Alexander Schuyler, Scott Commins TAEP-M. Changes in IgE Levels Following One-Year Immunizations in Two Children with Food Allergy [Internet]. 2015. Available from: https://wao.confex.com/wao/2015symp/webprogram/Paper9336.html

6. Dahan S, Tomljenovic L, Shoenfeld Y. Postural Orthostatic Tachycardia Syndrome (POTS)--A novel member of the autoimmune family. Lupus. 2016 Apr 1;25(4):339–42.

You cited yourself, and a study co-authored by Tomljenovic and Shoenfeld.
You really are making this too easy for us, Vinu.

They are peer-reviewed published references. Just because you disagree does not make the findings go away ...

Dr. Mitkus and the FDA made it very easy for me too ...

Absolutely, Julian. Not only does Vinu cite himself but in a predatory journal, too. Boasts a 4-5 week peer review and publish timeline. Not to mention that he completely mis-quotes his source #2. Fish in a barrel, really.

Could you please be specific about what you think was mis-quoted?

My publication was featured here:
Recent publications from the NIH Immunology Interest Group
https://list.nih.gov/cgi-bin/wa.exe?A2=ind1511&L=immuni-l&F=&S=&P=49179
Evidence that Food Proteins in Vaccines Cause the Development of Food Allergies and Its Implications for Vaccine Policy.
Arumugham V J Develop Drugs 4: 137, 2015 doi:10.4172/2329-6631.1000137

Response in the British Medical Journal
Vaccines cause the development of food allergies: the latest evidence.
http://www.bmj.com/content/355/bmj.i5225/rr-0

Comments in the New England Journal of Medicine
http://www.nejm.org/doi/full/10.1056/NEJMp1607762#t=comments
http://www.nejm.org/doi/full/10.1056/NEJMp1608967#t=comments

Dr. Orient is also head of the closely associated Doctors for Disaster Preparedness, and winner of their first "Petr Beckmann Award for courage and achievement in defense of scientific truth and freedom", named after a notorious relativity crank.

Apparently it's an award for the "courage" and "freedom" to be persistently, irrationally wrong.

Whenever I see 'JPANDS' I get a mental image of adult diapers.

Tom Price is one scary dude, but there's no reason to assume he's anti-vax because he's in an organization the includes anti-vaxers. I've belonged to a few academic organizations, and a couple political ones, over the years, and while each had some overall direction, there was a wide spectrum in interests and interest in the membership. By 'interest' (singular) I mean level of participation – I paid dues to one political organization because a friend was an organizer and i wanted to get the newsletter. I never went to a meeting, didn't necessarily agree with any positions taken by other members – which were hardly lock-step either, as there was a lot of internal debate...

Anyway, Price does not seem to be a 'stealth' kinda guy, and he has a public record. Beyond that, you could probably track whether he's been active in any AAPS activities – conference appearances, serving as an officer, working on the journal, etc. etc. – and, through that, which of the groups positions account for his membership, if any (he could just be keeping himself on the rolls for political purposes, hitting them up for campaign funds).

My guess, based on his public statements, is that his connection to the group is the Randian physician autonomy and anti-insurance stand – which he seems not to take exactly über alles, but pretty close. That's not anti-vax, but it's pretty obviously not pro-vax either: thou shalt not question thy fellow doctor-deities judgement that a medical exemption or delayed schedule is Right for His patient, thou shalt not abide by Big Government coercing anyone to inject their child-property with anything before sending them to the school of their choice. Etc. etc.

Laissez faire. Let the market decide. Free-dumb. It's been reported in the comments here that Price's personal opinion is that anti-vaxers are wackos. But if Price's own wacko is a radical 'hands off' of any other kind of wack spouted by anyone who can paste 'MD' after their name, it hardly makes any difference what he thinks of vaccines. Even if he did think they were behind some still advancing 'ASD epidemic', he wouldn't answer the AVs dreams and regulate against them.

We know the agenda: repeal Obamacare; play golf with Donald; talk about Health Savings Accounts; repeal Medicare... Lather, rinse, repeat.

Speaking of "dangerously crazy", Neil Z. Miller is known for his claims of communicating with extraterrestrials, and for facilitating interactions between said alien beings and his daughter. Both have authored books about their revelations. Here's one by Neil (a.k.a. "Z-Man"):

http://thinktwice.com/gadzooks.htm
http://thinktwice.com/poems.htm

It'd be fun and instructional to have reporters/members of Congress quiz Tom Price about how he feels belonging to an organization which publishes work by an antivaccine crank who claims to communicate with extraterrestrial beings.

Rich@4: I don't speak fluent gibberish either, at least the Ayn Rand variety, but the poster to whom you refer takes his nym from a prominent character in Atlas Shrugged. That tells me everything I need to know about him.

As for this from the original post:

It’s not a method that makes any scientific sense, but rather is designed to draw attention from the very simple observation that, since the phase-out of thimerosal as a preservative in vaccines in the US, autism prevalence hasn’t declined. Quite the contrary, actually.

At least our anti-vaccine loons are learning. Not fast enough, of course, but at least this one is aware that the thimerosal gambit won't work anymore.

@ # 2 Francisco d'Anconia

Thank you for your post. Posters who disagree with our host are usually not so specific, and kind as to directly provide such strong evidence in support of the Perspex Personage's points, even going so far as your Nom d' Internet. Your generosity will long be appreciated and your distinguished self held as an exemplar.

"communicating with extraterrestrials"

I've always wondered if all the people who claim to converse with extraterrestrials are talking to the same or different ones. And do the said ETs collaborate and share notes about their side of the conversations with us. And can they get their papers about us published in the ET-peer science journals.

Gotta love those who equate medicare with slavery, after all, being paid by an agreed upon schedule is slavery.
Just ask the pre-civil war slaves about their pay schedule.
Oh wait, slavery is by definition unpaid and paid per performance and payment schedules are not slavery. They're simply conducting an honest business.

As for aluminum being so toxic, if aluminum is so toxic to you, return to your planet of origin. You're an illegal space alien and don't belong here.
Aluminum is the most common metallic element on earth and the third most abundant element in the earth's crust. If you can't survive it, return to your home planet of Stupidia.

Now, please excuse me while I go make some french toast from the leftover bread that I baked yesterday evening - on an aluminum bake pan. A sheet pan that's seen decades of usage.

Their nonsense is nearly as bad as the dihydrogen monoxide ban efforts, Libertarian history and phlogiston.

"Aluminum is the most common metallic element on earth and the third most abundant element in the earth’s crust."
Water is abundant too. Have you tried living underwater?
Just because it is abundant, how does it become safe to inject yourself with it?

If "Francisco d'Anconia" thinks that Dr. Thomas Hendricks is a more appropriate representation of the AAPS's view of an ideal physician, I won't argue with him after reviewing this description of Dr. Hendricks:

After her crash landing in Galt's Gulch, Dagny has a sprained ankle and some mild cuts and bruises. (This is the worst injury that any of Ayn Rand's protagonists ever suffer, because if she allowed them to be seriously injured or disabled, it'd raise difficult questions of who would pay for their treatment and support them through their recovery.) So she arranges to be seen by the resident doctor, a surgeon named Dr. Thomas Hendricks.

Like the other inhabitants of the Gulch, Dr. Hendricks tells Dagny that he quit his practice because there was too much government red tape and he'd gotten fed up with it: "I would not let them dictate the purpose for which my years of study had been spent, or the conditions of my work, or my choice of patients, or the amount of my reward."

The only plausible reading of this is that Dr. Hendricks wanted the "freedom" to pick and choose his patients, charge as much as he pleased, and turn away sick people who couldn't meet his fees. Because, of course, how much a person can pay should be the first thing any good doctor thinks about.

He also tells her that he's continued to do medical research—where he procured test subjects for human trials is never addressed—and has invented a cure for strokes. Yes, all strokes. But he'll never share his finding with the world because ordinary peons don't deserve to benefit from his scientific genius:

"No, Miss Taggart, I have not given up medicine," said Dr. Hendricks, in answer to her question. "I have spent the last six years on research. I have discovered a method to protect the blood vessels of the brain from that fatal rupture which is known as a brain stroke. It will remove from human existence the terrible threat of sudden paralysis... No, not a word of my method will be heard outside."

You might think that a doctor's first responsibility is to help the sick, and not to deliberately withhold lifesaving medical advances (that is, if you were the American Medical Association). But, if you live in Galt's Gulch, you'd be wrong.

Yes, that does sound very much like the AAPS vision of how medicine should be practiced: Total physician autonomy, money over patient care, and an unshakable belief that as a physician you are so superior that it's morally acceptable to withhold knowledge of a scientific discovery that could save millions of lives because you consider the rabble undeserving of the fruits of your genius and save that information only for those among your clique of "supermen."

I stand corrected. From this day forward, when discussing the AAPS, I will point to Dr. Hendricks as the epitome of what the AAPS thinks a good doctor should be and AAPS members think they are, given that Hendricks is portrayed as almost supernaturally skilled at surgery and medicine.

https://cdn.meme.am/cache/instances/folder857/400x400/46012857.jpg

“No, Miss Taggart, I have not given up medicine,” said Dr. Hendricks, in answer to her question. “I have spent the last six years on research. I have discovered a method to protect the blood vessels of the brain from that fatal rupture which is known as a brain stroke. It will remove from human existence the terrible threat of sudden paralysis… No, not a word of my method will be heard outside.”

My experience with Ayn Rand's writing has mercifully been limited to excerpts, but seriously, she's presenting this guy as one of the so-called good guys? In that paragraph, he sounds like a cartoonish villain. Dr. No and Lex Luthor are more convincing than Dr. Hendricks.

Reading Orac's reference in #17 ( which describes Rand's ..er.. art form) , I can only say- that 'Fall of NY' part sounds like what Mikey and the other idiot portray frequently- everything will come crashing down inevitably and only those who who know how to compete in chaos ( with woo-meisters' help, of course) will survive.

They have a very simplistic, black and white view of hoiw society functions.

Like Eric, my interactions with Rand's "literature" are thankully brief ( I read the Fountainhead when I was 15 or so) but enough to form a strong impression that I didn't want to read any more.

@ rs:

Probably they communicate with different ETs who then collaborate on what to reveal to earthlings so that sciifi screenwriters will get the message out correctly.
Ever notice how they tend to look alike after the Close Encounter film became popular? That was planned.

Like Eric, my interactions with Rand’s “literature” are thankully brief ( I read the Fountainhead when I was 15 or so) but enough to form a strong impression that I didn’t want to read any more.

I read Atlas Shrugged at about age 14. My advisor's wife once said that the only excuse for reading Ayn Rand is being a 14 or 15 year old girl.

# 19 Eric Lund

My experience with Ayn Rand’s writing has mercifully been limited to excerpts,

I am not sure but I think it takes a very bizarre mindset to read Rand other than as an academic exercise. As a teenager living in the country where reading material could be a bit sparse I found myself so disgusted with the horribly unrealistic plotting and characters that I stopped reading the book. And I'd read bus schedules for pleasure—though I preferred/prefer train schedules.

Dr. No and Lex Luthor are more convincing than Dr. Hendricks.

Sound par for the Rand course.

# 21 Denise Walters

I wonder if that was the one I tried reading. My reaction was definitely the same.

Eric Lund: "My experience with Ayn Rand’s writing has mercifully been limited to excerpts, but seriously, she’s presenting this guy as one of the so-called good guys?"

At the beginning of the book the female protagonist encounter John Galt in what many would interpret includes rape. Which makes sense since Ayn Rand had sexual relations with her followers. Darryl Cunningham's graphic book Supercrash goes into details, it is a good read.

@JP: I assume you are familiar with the John Rogers quote on the subject:

There are two novels that can change a bookish fourteen-year old's life: The Lord of the Rings and Atlas Shrugged. One is a childish fantasy that often engenders a lifelong obsession with its unbelievable heroes, leading to an emotionally stunted, socially crippled adulthood, unable to deal with the real world. The other, of course, involves orcs.

I don't know whether my sample is representative, but I hear of far more male adherents of Ayn Rand than female adherents.

I find it hard to believe that these 'scientists' are really so ignorant about basic chemistry, even if they are just pseudoscientists. Not only do they ignore the basic adage "the dose makes the poison", but they seem to be completely ignorant about the actual chemical properties of vaccine adjuvants and their toxicity profile.
Apart from the insignificant dose from a viewpoint of toxicity (there is already more aluminum naturally present in the body than the amount in a vaccine), the aluminum is present in a compound form, either aluminum hydroxide or aluminum phosphate. Both compounds have a very low solubility, which means that they only disperse very, very slowly from the injection site -- IIRC, it can take up to two or three weeks for the 1-2 milligrams of aluminum adjuvants to disappear from the injection site (a rather persistent 'knot' at the site is also a common side effect of these vaccines). And most of what reaches the blood is excreted through the kidneys. What this means is that even if the aluminum from a vaccine somehow reaches the brain, it only does so in absolutely tiny amounts, in the order of a few micrograms per day. The daily exposure from aluminum through ingested food is already higher, even for small infants.

These simple facts must have been explained to antivaccine cranks thousands of times, yet still they keep trotting out their 'toxins' gambit... Either these people are not capable of learning, or they are plain dishonest, and willingly keep lying for their cause.

I notice that someone on this thread (you can guess who) has taken to e-mailing me at my work e-mail address. So I'm going to reiterate my longstanding policy: I ignore any blog-related e-mail sent to either of my work e-mail addresses, be it my cancer center e-mail address or my university address. The only exception I'll sometimes make is for reporters who want to interview me, and even then I'll usually ask them to use the blog e-mail address.

Richard #32,
"IIRC, it can take up to two or three weeks for the 1-2 milligrams of aluminum adjuvants to disappear from the injection site (a rather persistent ‘knot’ at the site is also a common side effect of these vaccines)."

Yes, please see #7. What happens at the injection for those two or three weeks, is being ignored. Aluminum adjuvants bias for allergy. With numerous allergens injected with vaccines, people develop allergies.

I notice that someone on this thread (you can guess who) has taken to e-mailing me at my work e-mail address . . .

Although I think that behavior on their part is indeed inconsiderate at best, at least it puts them a step above those that wail about your hiding your real/super secret identity behind a pseudonym. They have failed the how-to-use-the-internet test.

TWO? We now have two monomaniacal numpities blithering on here? Isn't one enough?

Ever notice how they tend to look alike after the Close Encounter film became popular? That was planned.

I imagine that Spielberg designed his aliens based on a composite appearance from former literature and 'abduction' (1961) reports.

In the 1893... H.G. Wells had envisioned the possibility of humanity transformed into a race of grey-skinned beings; who were perhaps 1 meter tall, with big heads and large, oval-shaped pitch black eyes....

In 1933, the Swedish novelist Gustav Sandgren,... published a science-fiction novel... in which he describes a race of extraterrestrials: "...the creatures did not resemble any race of humans. They were short, shorter than the average Japanese, and their heads were big and bald, with strong, square foreheads, and very small noses and mouths, and weak chins. What was most extraordinary about them were the eyes—large, dark, gleaming, with a sharp gaze...

Neurologist Dr. Steven Novella argues that the Grey idea is a byproduct of the human imagination, with the Greys' most distinctive features representing everything that modern humans traditionally link with intelligence.

https://en.wikipedia.org/wiki/Grey_alien#History

Praying mantis face aliens do seem to be the norm for quite some time though Speilburg did solidify it into modern culture.

To crib from my old friend, Driftglass:

DUMB^SS SHRUGGED

I notice that someone on this thread (you can guess who) has taken to e-mailing me at my work e-mail address.

Sheesh, you must have been low on the totem pole. There've already been, at a bare minimum, the really irritated guy from the mailing list and the CDC researcher who "thanked" APV for bringing the crankery to his attention. L-rd only knows whom else he's been spamming.

Aluminum is far more evil than you know.

http://www.watchthetower.net/alum2.html

As a retired emergency planner/current emergency volunteer, I don't know whether to laugh or kick the dog at "Doctors for Disaster Preparedness."

Vinu, #34
With all due respect, but vaccines are most definitely not associated with the development of allergies. Yes, the described side effect (nodule at the injection site) is in fact the symptom of an immune (over)reaction, but this always resolves without residual effects as soon as the aluminum compound is cleared from the site. As far as I can see in the literature, subsequent aluminum-containing vaccinations do not cause increasingly strong responses, something one would expect in the case of a newly acquired allergy.

So the claim that vaccines are a significant cause of allergies and other conditions of the immune system is plain nonsense.

"As far as I can see in the literature, subsequent aluminum-containing vaccinations do not cause increasingly strong responses, something one would expect in the case of a newly acquired allergy."

Please see this:
Extensive swelling after booster doses of acellular pertussis-tetanus-diphtheria vaccines.
https://www.ncbi.nlm.nih.gov/pubmed/10617749

And this:
https://wao.confex.com/wao/2015symp/webprogram/Paper9336.html
How do you explain that?

"With all due respect, but vaccines are most definitely not associated with the development of allergies."
Evidence shows otherwise ...

@ JP:

You are correct altho' I doubt that either of us were average 14 or 15 year old girls.

@ Eric Lund:

I think that you're right: I have heard MANY male adherents but I don't think that I ever heard of a single female.

There must be a reason for that .

@ vinu, #42
Sorry, but I have to call total BS on your 'evidence'. Had you done your homework, you would have found that these cases of limb swelling are exceedingly rare: researchers using the VAERS database identified less than 500 cases in a 13-year time period -- on a total of almost two billion vaccinations, see http://cid.oxfordjournals.org/content/37/3/351.full. This means that this particular reaction is observed in less than one in a million vaccinations. Your second link involves data on merely two children.

I really hope you enjoy them self-picked cherries. No doubt you'll offer us some more yet.

Yes, vaccines sometimes cause an allergic reaction, e.g. to egg protein or gelatin, or to the actual immunogen (the latter is also suggested in your first link). And I explicitly said that the aluminum can cause a local immune (over)reaction. But these reactions are rare, and do not lead to other allergies or immune system problems.
In general, there is no evidence that vaccination is a significant cause of allergies, and vaccinated children are no more prone to allergies than unvaccinated children.
The aluminum adjuvant also has no long-term effects that we know of.

Please explain this:

https://iom.nationalacademies.org/Reports/2011/Adverse-Effects-of-Vacci…

Document Pg. 65 (pdf pg. 94 ):

“Adverse events on our list thought to be due to IgE-mediated
hypersensitivity reactions
Antigens in the vaccines that the committee is charged with reviewing do not typically elicit an immediate hypersensitivity reaction (e.g., hepatitis B surface antigen, toxoids, gelatin, ovalbumin, casamino acids).
However, as will be discussed in subsequent chapters, the
above-mentioned antigens do occasionally induce IgE-mediated sensitization in some individuals and subsequent hypersensitivity reactions, including anaphylaxis.”

"two children"
In a WELL CONTROLLED experiment, it was IMMEDIATELY OBVIOUS with just two children, that food protein contaminated vaccines BOOSTED food allergy.
Please explain those results.

"rare vaccine reaction"
It is rare because of low levels of allergen quantities in a vaccine. With ingested foods, the protein quantities involved cause reactions to be more common and severe.

"exceedingly rare"
Rare or not, you have to accept now, that SENSITIZATION DID OCCUR.

@vinu, #47
So? Vaccines sometimes cause allergic reactions. We know that. And if you have children with existing allergies, yes, chances are that those allergies are exacerbated when the immune system is activated through immunization. And in the period after immunization, things return to normal -- i.e. those children will still have their food allergies, but not worse than before.

Let's put it like this: you come up with studies that clearly show that allergies of any sort are more prevalent among vaccinated children, and I will start believing you. Large population numbers, that's what I want to see. Not studies of just a (very) small subset of carefully selected individuals with pre-existing conditions, or speculative conclusions derived from known side effects.
So far, allergies are correlated mostly with urban life, i.e. less contact with animals and microbiota at a young age, and more air pollution. There is no compelling evidence that vaccination has anything to do with it, apart from rare individual cases.

"And if you have children with existing allergies, yes, chances are that those allergies are exacerbated when the immune system is activated through immunization."

So an influenza immunization can boost your protection against tetanus and pertussis due to "the immune system is activated through immunization"?

A tetanus booster shot only boosts tetanus protection, a diphtheria booster would do the same for diphtheria. You boost milk allergy with a milk containing vaccine. It is not rocket science.

You have not responded to the IOM finding.

https://www.omicsgroup.org/journals/evidence-that-food-proteins-in-vacc…

"Yamane et al. [8] demonstrated
a significant increase in anti-ovalbumin IgE in 36 out of 100 subjects
following influenza vaccination."

You wrote:
"Let’s put it like this: you come up with studies that clearly show that allergies of any sort are more prevalent among vaccinated children, and I will start believing you."

That's a joke.

1. One has to PROVE that it is safe to inject food proteins into people BEFORE injecting the whole population with it.

2. Unvaccinated populations are small, so you will conveniently dismiss any findings as insignificant.

3. No controlled studies are possible because of circular reasoning stating that "vaccines are safe and effective" so vaccines cannot be withheld from a group of children for study purposes, due to "ethical" reasons. While it is considered ethical to sicken 8% of the population with vaccine-induced food allergies.

"allergies are correlated mostly with urban life, i.e. less contact with animals and microbiota at a young age,"

Yes, that is PREDISPOSITION to allergy. How does that sensitize you to a PARTICULAR allergen?

The worst thing we can do to "urban life" children predisposed to allergy, is to inject them with aluminum adjuvanted food allergen contaminated vaccines. A perfect recipe for the disaster known as the food allergy epidemic.

Repeated bee stings cause bee sting allergy.
Repeated milk containing vaccinations cause milk allergy.
Repeating the same thing over and over and expecting a different result, is defined as insanity.

"Repeating the same thing over and over and expecting a different result, is defined as insanity."

How ironic.

"Repeated milk containing vaccinations cause milk allergy."

Really? Then, when my oldest child was diagnosed as having an allergy to cow's milk before he'd ever had any vaccination, it must have been the Alien Pharma Overlords in their time machine, sneaking into the hospital nursery and sticking needles into his tiny little body? I mean, what else could it be? Obviously nobody had any food allergies until vaccines were invented.

Never claimed vaccines are the ONLY cause of food allergies. They are the MOST EFFICIENT cause of food allergies. That is why, researchers use injections of food proteins + alum (same as vaccines) to RELIABLY induce food allergy in lab rats/mice.

Sensitization can occur through the following routes of allergen exposure. Injection, respiratory, damaged skin (lotion) and ingestion.
May be you can educate us on the route of exposure in your son's case?

vinu #51

Repeated milk containing vaccinations cause milk allergy.

What vaccines contain milk?

Any vaccine that uses casamino acids or casein is contaminated with milk proteins. Daptacel, Pentacel, Prevnar 13, Tenivac, Infanrix, Kinrix, Pediarix, Menomune and Boostrix are all contaminated with milk proteins.

http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm…

Kattan JD, Cox AL, Nowak-Wegrzyn A, Gimenez G, Bardina L, Sampson HA, et al. Allergic reactions to diphtheria, tetanus, and acellular pertussis vaccines among children with milk allergy. J Allergy Clin Immunol. 2011;Conference(var.pagings):AB238

"• Vaccination helps children with asthma or allergic disease by reducing their likelihood of getting a serious infection which could worsen their asthma or allergy symptoms.
• Vaccines very rarely produce an allergic response, and therefore most children with allergies (e.g. to most environmental and food allergens) can safely be vaccinated.
• Well-performed studies show no increase in allergy or asthma due to use of routine childhood vaccines. Although asthma and allergic disease rates have increased in the past few decades, the reason for this remains unknown.
• While it has been suggested that vaccines may contribute to the rise in allergic disease because they prevent childhood infections (the ‘hygiene hypothesis’), this theory does not apply to vaccine-preventable diseases."

http://www.ncirs.edu.au/assets/provider_resources/fact-sheets/vaccines-…

That is outdated.

The US Dept. of Health and Human Services (HHS) charged the Institute of Medicine (IOM) with providing a thorough review of the current medical and scientific evidence on vaccines and vaccine adverse events. They reviewed the entire vaccine related medical literature from 1950.

The IOM has concluded in its 2011 report that:

FOOD PROTEINS PRESENT IN VACCINES CAUSE THE DEVELOPMENT OF FOOD ALLERGIES.

https://iom.nationalacademies.org/Reports/2011/Adverse-Effects-of-Vacci…

Document Pg. 65 (pdf pg. 94 ):

“Adverse events on our list thought to be due to IgE-mediated
hypersensitivity reactions
Antigens in the vaccines that the committee is charged with reviewing do not typically elicit an immediate hypersensitivity reaction (e.g.,
hepatitis B surface antigen, toxoids, gelatin, ovalbumin, casamino acids).
However, as will be discussed in subsequent chapters, the
above-mentioned antigens do occasionally induce IgE-mediated sensitization in some individuals and subsequent hypersensitivity reactions, including anaphylaxis.”

Numerous details and references:
http://www.centerforinquiry.net/forums/viewthread/18997/

"Although asthma and allergic disease rates have increased in the past few decades, the reason for this remains unknown."

ex·pert
noun
1.a person who has a comprehensive and authoritative knowledge of or skill in a particular area.

When people admit they don't know, then they are admitting they are no longer experts. So, start looking for advice elsewhere.

Is it not interesting that people reject Dr.Richet's finding because it is from a hundred years ago, yet every time they step on a plane, they are depending on the findings of Bernoulli and Newton more than 300 years ago?

https://www.nobelprize.org/nobel_prizes/medicine/laureates/1913/richet-…

“We are so constituted that we can never receive other proteins into the blood than those that have been modified by digestive juices. Every time alien protein penetrates by effraction, the organism suffers and becomes resistant. This resistance lies in increased sensitivity, a sort of revolt against the second parenteral injection which would be fatal. At the first injection, the organism was taken by surprise and did not resist. At the second injection, the organism mans its defences and answers by the anaphylactic shock.”

Hmm...

According to Vinu @#59, Dangerous Bacon's 2014 reference @#58 has been outdated by a 2011 reference.

Methinks Vinu's not reading, or at the very least not comprehending, the references that others are giving.

The relevant references in Dangerous Bacon’s 2014 reference predate the 2011 IOM findings.

vinu: Do you know how time works? Here's a hint: 2011 comes before 2014, not the other way around.

Pl. see #64.

@ vinu, #50 and further
What you are perpetrating here is known as the Gish Gallop: as soon as an opponent addresses a particular point of yours, you retort by drowning the opponent in a whole lot of new BS points.
It really is quite simple: you cannot show solid evidence that vaccines are unsafe or cause allergies in any significant way -- simply because there is no solid evidence. So, for the time being, let's keep it at that, shall we?

What's you complaint about this evidence?

https://iom.nationalacademies.org/Reports/2011/Adverse-Effects-of-Vacci…

Document Pg. 65 (pdf pg. 94 ):

“Adverse events on our list thought to be due to IgE-mediated
hypersensitivity reactions
Antigens in the vaccines that the committee is charged with reviewing do
not typically elicit an immediate hypersensitivity reaction (e.g.,
hepatitis B surface antigen, toxoids, gelatin, ovalbumin, casamino acids).
However, as will be discussed in subsequent chapters, the
above-mentioned antigens do occasionally induce IgE-mediated
sensitization in some individuals and subsequent hypersensitivity
reactions, including anaphylaxis.”

Richard @ 67, whereas it's trivial to show the same relationship between vaccines and allergies that any other substance that contains an antigen has with allergies. Alas, that's very nearly entirely random and thankfully, rare.
Although, some things are less rare, such as latex (my wife and daughters are all allergic to latex and shellfish proteins (my wife and our youngest daughter are allergic to shellfish - badly so). But, some people can have a severe reaction to even sterile saline injection.

Of course, that's simple reality. Something vinu seems to be unacquainted with.

Vaccines were contaminated with latex (rubber vial stoppers) in the past. Pharmaceutical products can be contaminated with foods including seafood. You are what you eat and you are what you inject.

https://www.nap.edu/catalog/23658/finding-a-path-to-safety-in-food-alle…
NAM report pg.241
“Allergens in Vaccines, Medications, and Dietary Supplements

Physicians and patients with food allergy must consider potential food allergen exposures in vaccines, medications, and dietary supplement products (e.g., vitamins, probiotics), which are not regulated by labelling laws.
Also, excipients (i.e., substances added to medications to improve various characteristics) may be food or derived from foods (Kelso, 2014). These include milk proteins; soy derivatives; oils from sesame, peanut, fish or
soy; and beef or fish gelatin. The medications involved include vaccines; anesthetics; and oral, topical, and injected medications. With perhaps the exception of gelatin, reactions appear to be rare overall, likely because little residual protein is included in the final preparation of these items. The
specific risk for each medication is not known.
Vaccines also may contain food allergens, such as egg protein or gelatin.”

" With perhaps the exception of gelatin, reactions appear to be rare overall, likely because little residual protein is included in the final preparation of these items."

"Vaccines also may contain food allergens, such as egg protein or gelatin.”

Note how the two statements say pretty much the same thing, despite your repeated gish gallops.
Note also that only some vaccines are made from chicken eggs, hence would have egg proteins possibly present (and such is documented in the package insert).
Griping about what's already documented and indeed, something like an egg allergy is a listed contraindication for vaccines made from chicken eggs, isn't a valid argument whatsoever. It's like complaining that one could get rained upon because one got a sunburn.

You are confusing two separate concepts. We are NOT talking about REACTIONS. We are talking about the DEVELOPMENT of food allergy in healthy people, due to these contaminated injections. Once they develop allergy (sensitization), then of course all the warnings of reactions apply.
The MISSING part is that NO ONE will warn you (on the package insert) that a healthy person can develop allergy following the injection.

A healthy person can develop an allergy at any time. Not only via injection or a first exposure to an antigen, it can happen at any exposure to an antigen. First, five thousandth exposure, any time.

Vinu: You're still wrong. Nothing in 2014 can predate 2011. What you are saying is that 2014 was an earlier year than 2011, therefore the findings in 2011 are more valuable. However, here on planet earth, 2014 was three years later than 2011, and that is ample time for new information to be found. Did you drop out of grade school? The average first grader would know this stuff.
Also as far as Dr. Richet goes, I have no doubt he was probably a very smart man, but keep in mind that the state of medical practice in 1913 was very different from today. They didn't even know about viruses back then, or for that matter, have penicillin.
A lot of what was standard practice and accepted knowledge back in 1913 has been understood to be false or incomplete as doctors got access to new technology and improved their methods. That's this little thing we on planet earth like to call progress.

PGP @ 70, I dunno about progress.
Today, we'd be hard pressed to construct the pyramids the same way.
We'd use reinforced concrete and steel, being totally lazy and all. ;)

I'll just get my coat...

The 2011 report is an authoritative report from the IOM based on a review of ALL vaccine literature from the 1950s. It was commissioned to provide the scientific basis for the Vaccine Injury Table. The 2014 document is obviously missing the important findings from the IOM report and therefore is out of date.

Dr. Richet:
How do you explain the fact that the IOM report completely agrees with Dr.Richet's finding from a hundred years ago?

vinu, have you ever heard of the arrow of time?

You keep referring to the 2011 report as if it showed that the IOM concluded that vaccines can cause food allergies. But it does not say so in the clause you quote, and if you follow the other places where the IOM addressed "IgE-mediated" or hypersensitivity it's talking about allergic reaction to the vaccine, not about creation of allergies.

So not only, as pointed out, is your source less new than 2014, but I don't see what evidence in it supports your claim. A paragraph that can be interpreted to vaguely support it?

Would you like to point to any actual data in the report supporting you?

IOM:
"However, as will be discussed in subsequent chapters, the
above-mentioned antigens do occasionally induce IgE-mediated sensitization in some individuals and subsequent hypersensitivity reactions, including anaphylaxis."
Sensitization means DEVELOPMENT of allergy anew.
Subsequent exposure would of course result in hypersensitivity reactions, including anaphylaxis.

Show where in the report - where in subsequent chapters - was development of allergies anew.

You made a specific claim. That specific proteins in vaccines lead to the development of food allergies. You claimed the IOM report supports it. Please show where it shows that.

You are still not reading the whole paragraph?
It lists several antigens as examples.
It says the above mentioned antigens cause IgE mediated sensitization (development of allergy). So specific antigens casamino acids (cow's milk derived) cause milk allergy, ovalbumin causes egg allergy, gelatin causes gelatin allergy, toxoids cause allergy to tetanus/diphtheria vaccines, etc.

https://iom.nationalacademies.org/Reports/2011/Adverse-Effects-of-Vacci…

Document Pg. 65 (pdf pg. 94 ):

“Adverse events on our list thought to be due to IgE-mediated
hypersensitivity reactions
Antigens in the vaccines that the committee is charged with reviewing do not typically elicit an immediate hypersensitivity reaction (e.g.,hepatitis B surface antigen, toxoids, gelatin, ovalbumin, casamino acids).
However, as will be discussed in subsequent chapters, the
above-mentioned antigens do occasionally induce IgE-mediated sensitization in some individuals and subsequent hypersensitivity reactions, including anaphylaxis.”

And I'm asking you to point out where in subsequent chapters the IOM found that vaccines create those allergies.

Because aside from some small studies about gelatin from Japan that are not very strong as evidence of causation and were also covered by later sources, I don't see the IOM citing any such cases.

If you want to use the report to claim the IOM found that vaccines create allergies to these proteins you should be able to point to the actual cases cited, not one potentially badly phrased general paragraph in a general chapter. I looked. Can you show how the report supports your claim aside from the small Japanese gelatin studies?

"badly phrased general paragraph in a general chapter."

That is an unambiguous and absolutely clear conclusion statement. They did not say "may induce", they said "do induce". They had ABSOLUTELY no doubts.
As I wrote before, their conclusion was based on ALL the vaccine literature from the 1950s, including the gelatin studies. I cannot tell you what were ALL the specific studies that informed this conclusion. I have found several of them myself and they are listed or referred here:
http://www.protocol-online.org/forums/topic/35639-professional-miscondu…

So nothing in the subsequent chapters you can point to? Not one case?

pg. 306/277:
"Gelatin, both whole bovine and hydrolyzed gelatin, was used as a stabilizer in a number of vaccines in Japan, and it is likely that children experiencing anaphylactic reactions to the gelatin-containing varicella vaccine had developed IgE sensitization to gelatin from the administration of previous
vaccines. "

As the committee points out, ALL injected proteins can cause allergy. I have provided you with numerous references to influenza HA sensitization, HepA sensitization, viral/bacterial/parasitic protein sensitization, toxoid sensitization, bee venom sensitization, ovalbumin sensitization as well as gelatin sensitization.

So besides the small scale, problematic Japanese studies the report has no cases. No evidence the IOM referred to that anything but gelatin in vaccines causes allergies, rather than triggers an allergic reaction, and the evidence on that is, well, weak.

I don't see how you can use a report that says it will refer to the cases in subsequent chapters and only addressed one type of substance as supporting your case that vaccines cause other allergies. It's pretty clear to me the general paragraph was simply not well written. Trying to use it to claim the report supports your general claim when the report has no such evidence is simply wrong.

The IOM report does not claim vaccines cause food allergies the way you are trying to and does not support you.

"So besides the small scale, problematic Japanese studies"

Who are you to characterize the quality of the studies?
You know more than the IOM about study quality?

How do you know ALL the evidence that went into drafting that paragraph?

"It’s pretty clear to me the general paragraph was simply not well written."
May be you are looking for legalese?
Scientifically, that paragraph is absolutely clear and unambiguous. It leaves no doubt at all what the committee meant.

I didn't see the IOM offer a strong endorsement of those studies, either. Would you like to point to where they did?

A paragraph in the general section that referred to subsequent chapters as showing something is clearly drawing its meaning from what those chapters show. They don't show anything about most of the names proteins. Unless you can show that the report addressed them, you can't use that paragraph - which, again, clearly refers to what is shown in subsequent chapters - to support anything about them.

Taking that paragraph out of the context of the report is using it beyond its meaning. The IOM report does not support your claims.

Again, this is not a legal document.
Scientifically, it is perfectly clear.

Explain this:
Allergic reactions after egg-free recombinant influenza vaccine: reports to the US Vaccine Adverse Event Reporting System.
https://www.ncbi.nlm.nih.gov/pubmed/25428412

Yes, people can have allergic reactions to vaccines. Even if we ignore the fact that unverified VAERS report don't show amything besides the fact that someone filed a report, these reports don't show a vaccine caused an allergy.

I understand, from the scientists here, science actually does depend on evidence. Not on taking statements out of the context of the evidence.

"science actually does depend on evidence."

Yes, but you are unable to recognize the evidence. That's the problem.
There's another basic aspect of science. If you don't agree with an explanation for a phenomenon, YOU ARE EXPECTED TO PROVIDE A *BETTER* EXPLANATION. Can you?

" a vaccine caused an allergy."

A vaccine causing an allergy takes a few weeks. With doctors/allergists being ignorant about sensitization, vaccine package inserts OMITTING this information, no one reports it to the VAERS. A vicious cycle of incompetence continues to sicken our children.

"science actually does depend on evidence. "

Yes, let's see what you did with evidence from another part of the IOM report:

https://www.regulations.gov/docket?D=HRSA-2015-0003

This is what the NPRM said:

"1. The scientific evidence favors a rejection of a causal relationship between MMR vaccine and autism."

This is what YOU claimed the NPRM said:

https://www.regulations.gov/document?D=HRSA-2015-0003-0015

"as noted in the NPRM, the evidence supports
rejection of a connection between vaccines and autism."

Conveniently GENERALIZED MMR vaccine ALONE in the NPRM to ALL vaccines in your statement.

That's how you deal with evidence.

"I didn’t see the IOM offer a strong endorsement of those studies, either. Would you like to point to where they did?"

The very fact that they refer to those studies at all meant that they were significant.

"When people admit they don’t know, then they are admitting they are no longer experts."

I am bedazzled by the sheer and utter brilliance of this observation.

True, there are some who recognize limits of knowledge and are not ready to assign causes for phenomena in the absence of evidence. But they are simpletons! Real experts always have a facile explanation because it's, like, totally obvious if you follow the money and connect-the-dots.

"recognize limits of knowledge and are not ready to assign causes for phenomena"

Yes, like the vaccine "experts" who are clueless about the Flumist failure. They don't know why it works, how it works or why it fails. But they will go around telling you that the "benefits of the vaccine outweigh the risks", when they don't anything about the benefits or the risks.

It took the FDA 17 years to figure out that the acellular pertussis vaccine does NOT prevent disease transmission. They just ASSUMED it would prevent transmission.
It does not confer mucosal immunity. So people are colonized by pertussis bacteria and spread it. Worse, such colonization increases risk of multiple sclerosis. Who accounted for all these risks?

Again here ACIP ASSUMED that a meningococcal vaccine administered at 11 will be effective at 21. WRONG AGAIN.

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6003a3.htm

"The goal of the 2005 ACIP meningococcal immunization recommendations was to protect persons aged 16 through 21 years, when meningococcal disease rates peak. At that time, vaccination was recommended at age 11 or 12 years rather than at age 14 or 15 years because 1) more persons have preventive-care visits at age 11 or 12 years, 2) adding this vaccine at the 11 or 12 year-old visit would strengthen the pre-adolescent vaccination platform, and 3) the vaccine was expected to protect adolescents through the entire period of increased risk. Meningococcal conjugate vaccines were licensed in 2005 based on immunogenicity (because a surrogate of protection had been defined) and safety data. After licensure, additional data on bactericidal antibody persistence, trends in meningococcal disease epidemiology in the United States, and VE have indicated many adolescents might not be protected for more than 5 years. Therefore, persons immunized at age 11 or 12 years might have decreased protective immunity by ages 16 through 21 years, when their risk for disease is greatest."

IT IS OBVIOUS THAT THESE JOKERS DO NOT RECOGNIZE THE LIMITS OF THEIR KNOWLEDGE.
They are NOT experts and they are fooling with your children's lives.

@Wizrd1 #69

some people can have a severe reaction to even sterile saline injection.

If one is talking about the prefilled 'flush' vials then there is plenty of volatile organic compounds which leeched in from the plastic. I should think that this might trigger an 'allergic' response in some people. It bothers me that technicians will chide that what one is tasting/smelling is merely NaCl -- I had a powerful anxiety attack and blood pressure drop precipitated by knowing the glue taste I was experiencing was not 'only salt water' as the technician vehemently insisted that it was.

Becton Dickinson showed that the presence of volatile substances in the plastic material of the syringes was discovered in 2001 and that these substances were linked to the experience of minor reactions like bad taste or smell... The identification and saline-solution concentrations provided by Becton Dickinson were: 2-methyl-2-propanol: 8.5 ppm; 2-methyl-2-butanol: 0.7 ppm; ethyl-buthyl-ether: 0.4 ppm.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2806387/

...have you ever heard of the arrow of time?

People assume that time is a strict progression of cause to effect, but *actually* from a non-linear, non-subjective viewpoint - it's more like a big ball of wibbly wobbly... time-y wimey... stuff.

-The Doctor, 1969 (or 2007)

Hey, the new XMAS special is tomorrow, and I'm a little excited about that.

That one kind of got away on him. :)

The definition of irony.

vinu #58

IT IS OBVIOUS THAT THESE JOKERS DO NOT RECOGNIZE THE LIMITS OF THEIR KNOWLEDGE.

OK, it's illustration, not defintion.

Progress, arrow of time etc.,

https://www.omicsgroup.org/journals/evidence-that-food-proteins-in-vacc…

“O’Brien et al. [13] measured 7.4 mcg/ml of ovalbumin in
influenza vaccines in 1967. Goldis et al. [14] measured as much as 38.3 mcg/ml in influenza vaccines as recently as 2008.”

OTOH, it does demonstrate that as time progresses, we forget history, Dr.Richet's history.

Yes, like the vaccine “experts” who are clueless about the Flumist failure. They don’t know why it works, how it works or why it fails.

No, Vinu. This has already been provided, but you likely overlooked from the cups of your tedious monomania.

Among the many problems* with your fantastically stupid IgE notion is that the problem is only with the A(H1N1)pdm09 component. It's remained more effective for B/Yamagata, dipshіt.

* Including the fυcking time frame.

"the problem is only with the A(H1N1)pdm09 component. It’s remained more effective for B/Yamagata, "

A(H1N1)pdm09 component was in the formulation for several years before the 2014/2015 season, allowing people to develop strong IgE levels to it. B/Yamagata was not.
That would explain why A(H1N1)pdm09 would have the problem and not B/Yamagata.

"This has already been provided"

Yes, I saw that. My point was, if they were experts, they should have understood ALL this stuff BEFORE even approving the vaccine. Not after finding out that it was an abject failure.

^ Add "(PMID 27702768)" after "dipshіt," sorry.

My point was, if they were experts, they should have understood ALL this stuff BEFORE even approving the vaccine. Not after finding out that it was an abject failure.

Quick, Vinu, when was FluMist approved?

You don't need to be sensitized by Flumist for subsequent Flumist to fail.
Previous injected vaccines can induce IgE that can result in subsequent Flumist failure.

Repeated injection influenza failure:
http://cid.oxfordjournals.org/content/early/2014/09/29/cid.ciu680.full
It's a huge ONGOING disaster.

A(H1N1)pdm09 component was in the formulation for several years before the 2014/2015 season, allowing people to develop strong IgE levels to it. B/Yamagata was not.

You lose. Try to figure out what B/Yamagata denotes next time.

If they are called Phuket, Massachusetts, Brisbane, Wisconsin, I suspect they are different ...

@Vinu

I'd prefer to see some epidemiological evidence on this issue, especially concerning the type of allergic reaction and how incident each type is.

Also, I can't help myself:
http://www.naturalnews.com/055457_vaccines_food_allergies_CDC_study.html

You've been referred to as an "expert in immunology" by our friends at Natural News.

"some epidemiological evidence"

Please see #50.

"allergic reaction"
We are NOT talking about reaction to a vaccine (which are rare), we are talking about sensitization by a vaccine (development of a new allergy), which is much more common.

"expert in immunology"
Food allergy "experts" don't know what causes food allergy.
Autism "experts" don't know what causes autism.
Vaccine "experts" don't know how vaccines work.
So perhaps that's not way off ...

@Vinu

It's presumptive to dismiss the pertinence of epidemiological studies the way you did in #50, and also ignorant of how these sorts of studies are done. You realize vaccinated vs. unvaccinated studies have already been done for developmental disorders like autism, right? They're not unethical to perform, nor have they been routinely dismissed out of hand for small sample size.

You misunderstand: when I say "type of allergic reaction," I'm referring to the presentation of the induced food allergy I.e. is it characterized by hives, anaphylaxis, etc.

So when an expert doesn't know something that's not in evidence, they're no longer qualified as an expert. Good to know.

"It’s presumptive to dismiss the pertinence of epidemiological studies "

As I wrote before, ignoring Dr.Richet's warning and injecting our children with food protein contaminated vaccines (without thorough research AND understanding FIRST) is unconscionable. Epidemiological studies would be justified if this were some COMPLETELY new problem. Not something that has been known for over a hundred years.

"So when an expert doesn’t know something that’s not in evidence, they’re no longer qualified as an expert. "
No, in this particular case, we are talking about "experts" who were warned AND IGNORED the findings of the man who coined the very term "anaphylaxis". That is arrogance, stupidity, incompetence all rolled into one.

My understanding is that epidemiological studies look at whether a problem does, in fact, exist. Dr. Richet suggested a theory a long time ago. Studies looked to see whether the problem exists for vaccines and found that it didn't.

Dismissing and ignoring these studies doesn't make them go away.

"Dr. Richet suggested a theory a long time ago."

Are you kidding? Repeatedly demonstrating the induction of allergy and subsequent fatal anaphylaxis in multiple animals by multiple researchers, is NOT "a theory".

How do they induce food allergy in mice today if it is just "a theory"?

Since you are the know-it-all, why don't you explain what is causing the food allergy epidemic?
We have proof from numerous studies I have provided that proteins in vaccines cause sensitization. These results agree with Dr.Richet's findings. The results agree with the IOM's findings. So it is obvious that those isolated studies you are talking about are broken.

And explain this:
https://wao.confex.com/wao/2015symp/webprogram/Paper9336.html
The above study is also proof that those epidemiological studies with all kinds of confounding factors are a joke. The vaccine "surveillance system" is a joke.
The team above performed a simple very well controlled experiment with JUST TWO KIDS. Measure IgE before and after vaccines. The results were IMMEDIATELY OBVIOUS as to the cause. The stupid surveillance system missed it even though millions developed food allergy.

You provided isolated case studies that you think support your claims. I'm afraid those are the isolated incidents, not the large scale epidemiological studies you are trying to dismiss.

The very rare case studies do not support a claim that vaccines are causing an epidemic of food allergies. The IOM, even in the paragraph you are trying to build on, certainly said nothing of the sort. And certainly did not point to any evidence on that. I expect the authors would be very surprised at what you're trying to turn the report into.

I'm afraid that you have no case.

"isolated case studies"

What is an isolated case study?

"very rare case studies "

What is a very rare case study?

"The IOM, even in the paragraph you are trying to build on, certainly said nothing of the sort."
If you cannot understand it, does not mean the IOM did not say it.

@Vinu

Dr. Richet's "warning" came, what, 100 years ago? I.e. While medical science was in its infancy? I.e. When control of infectious diseases were of paramount importance? Who exactly are you holding responsible here, the experts who were more concerned with decreasing the infant mortality rate than the unverified possibility of an increase in persistent food allergies?

You're putting the cart before the horse. Your hypothesis has never been tested on the population-level (to my knowledge). I'm no immunologist and can't speak to whether or not the proposed mechanism if plausible, but if it is I doubt many would be opposed to exploring a possible association if no epidemiological research has been done before.

A study with two children is not going to demonstrate causation, especially when those two children were selected for their food allergy beforehand. You've clearly been doing a lot of hobby reading on immunology, now spend some time on epi.

No, scientists were certainly not opposed to examining this. Studies were done. This review is older, and other studies were done since, but it makes the point that the question was certainly not ignored.

http://pediatrics.aappublications.org/content/111/3/653

No link was found between vaccines and food allergies.

Let's look at this:

http://pediatrics.aappublications.org/content/111/3/653

The only reference to food allergy is this study:

https://www.ncbi.nlm.nih.gov/pubmed/9701130

Background of the study:

"Pertussis vaccination in infancy has been suggested to increase the risk for development of asthma and allergy."

So, they were NOT EVEN looking to investigate the RIGHT PROBLEM!

We know ALL vaccines are contaminated with various food proteins, not just the pertussis vaccine.

"placebo [diphtheria and tetanus toxoids]"

Oops! The placebo itself is another food protein contaminated vaccine! What results can you expect?

During this study, the children likely received numerous other food protein contaminated childhood vaccines per the schedule. Nothing is controlled.
This is a massive joke!

AND, the IOM already took this study into account (1950-2011 literature was covered) but still concluded that food protein contaminated vaccines DO induce food allergies.

Case closed.

Ben,

"When control of infectious diseases were of paramount importance?"

If we have a raging epidemic killing people, a quickly created, food protein contaminated vaccine that saves lives is perfectly understandable. We have had DECADES to clean up vaccines and NOTHING has been done.

Dr.Offit himself, a top vaccine advocate, has said that the regulators and pharmaceutical companies are NOT interested in cleaning up our contaminated vaccines and called for consumer activism.

http://www.pbs.org/wgbh/frontline/article/paul-offit-a-choice-not-to-ge…

"Yeah. I think there are a couple things. The influenza vaccine and the yellow fever vaccine are both made in eggs; therefore they contain small quantities or residual quantities of egg proteins. About a half a percent of the population is allergic to eggs, including severe allergies, including things such as bad hives and shock, and those people can’t get influenza vaccine. Well, there’s no reason you can’t grow influenza vaccine in mammalian cells, meaning non-avian cells. That can be done. The technology has been available to do that for decades, but there’s been little interest in doing that. It cries out for, in many ways, consumer activism.

Similarly, there’s a stabilizing agent that’s used in the chicken pox vaccine called gelatin. It allows the vaccine virus to be distributed equally throughout the vial. The question is, are there other stabilizing agents that you could use, that aren’t gelatin, that could accomplish the same thing? Absolutely. But again there’s [been] very little pressure, I think, to do that, even though it’s probably the most common allergenic material in vaccines."

"Your hypothesis"

Sorry, when the IOM agrees with Dr.Richet's findings, it is certainly NOT a hypothesis any more and certainly not "my hypothesis".

"A study with two children is not going to demonstrate causation, especially when those two children were selected for their food allergy beforehand."

A study EVEN with only children has proven valuable because it is so well controlled. Cause and effect were immediately obvious. And this is just the LATEST, not the only study. I have provided numerous references.

https://www.omicsgroup.org/journals/evidence-that-food-proteins-in-vacc…

"Yamane et al. [8] demonstrated
a significant increase in anti-ovalbumin IgE in 36 out of 100 subjects
following influenza vaccination."

If they are called Phuket, Massachusetts, Brisbane, Wisconsin, I suspect they are different …

Congratulations. You have just accidentally demonstrated that you were making things up when you said this:

A(H1N1)pdm09 component was in the formulation for several years before the 2014/2015 season, allowing people to develop strong IgE levels to it. B/Yamagata was not.

The kicker, of course, is that you're trying to weasel away from your actual assertion (emphasis added):

When you receive Flumist the first time, you develop IgG (short term, primary protection against the flu) and IgE (long term allergy) to the influenza proteins.
When you receive subsequent Flumist, you suffer a mild allergic reaction. Your IgE antibodies bind to the viruses and neutralizes them before they can infect you. So you don’t develop new IgG. Vaccine is ineffective.

Long Term Persistence of IgE Anti-Influenza Virus Antibodies in Pediatric and Adult Serum Post Vaccination with Influenza Virus Vaccine
http://www.medsci.org/v08p0239.htm

The reference I provided already showed IgE sensitization by BOTH Flumist and injected vaccines. What are you complaining about?

Quick, Vinu, when was FluMist approved?

You don’t need to be sensitized by Flumist for subsequent Flumist to fail.
Previous injected vaccines can induce IgE that can result in subsequent Flumist failure.

Would you care to answer the question rather than barfing up a non sequitur?

The reference I provided already showed IgE sensitization by BOTH Flumist and injected vaccines.

Not in any sense that you're trying to use it for. Moreover, you've now contradicted yourself, since your boneheaded idea should apply to IIV as well as the LAIV that you used as a springboard for this faceplant (not to mention that the magic IgE that "causes" LAIV failure should in fact have a protective effect against wild influenza, as the authors directly state).

What are you complaining about?

Your tediously repetitive, low-rent attention whoring, Vinu.

" (not to mention that the magic IgE that “causes” LAIV failure should in fact have a protective effect against wild influenza, as the authors directly state)."

Either IgE has a protective effect (long term 20 months) and so the CDC is wrong about needing annual flu shots, or the IgE protection is not as good as desired. IgE is likely first line of defense and you need both IgE+IgG for full protection.

Wow, you really don't understand anything about the influenza vaccine, do you?
Each year, the most likely strains of influenza that are anticipated to spread are selected and a vaccine is created against those strains, such as a trivalent vaccine (three strains) or quadravalent vaccine (four strains).
As influenza mutates rather rapidly, those strains will be quite different each year and last year's vaccine won't be effective against this year's strains.

"those strains will be quite different each year and last year’s vaccine "
Nope.
Repeated since 2012-13
A/California/7/2009 (H1N1)pdm09[note 1]-like virus
B/Brisbane/60/2008-like virus
https://en.wikipedia.org/wiki/Historical_annual_reformulations_of_the_i…
That is why it stops working.
AND, they test the vaccine in a third world country where there is no routine seasonal influenza vaccine. So the tests go very well and the vaccines fail in the US.
It's a disaster.

Uh huh, so the identified new strains listed don't exist in your Bizarro world, huh?
Pity that here on earth, they do exist and mutate quite often.

As for third world, do enlighten us where that alleged testing occurs? I've heard of old world, new world and developing nations, who would lack the infrastructure to test a vaccine.
So, citation needed. I'll wait. Until proton decay, if necessary.

As for "So the tests go very well and the vaccines fail in the US.", again, citation needed and I know damned right well that you'll fail to find a citation for that, as it's a bald faced lie.
Efficacy is around 30% - 65%, depending upon what one is looking for (hospitalization, pneumonia, etc).
http://annals.org/aim/article/709081/efficacy-influenza-vaccine-elderly…
Although, I'm quite certain that we'll now here from the nirvana fallacy.

Oh, for antigenic shift: http://jamanetwork.com/journals/jama/article-abstract/374844

Here's another that discusses various strains. The city name isn't where the vaccine was tested, it's where the virus sample was acquired.
http://www.sciencedirect.com/science/article/pii/S0264410X96003027

"third world"
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedPr…
https://clinicaltrials.gov/ct2/show/NCT01218308

http://cid.oxfordjournals.org/content/early/2014/09/29/cid.ciu680.full
“Current- and previous-season vaccination generated similar levels of protection, and vaccine-induced protection was greatest for individuals not vaccinated during the prior 5 years. “

You are truly pathetic. I called it early yesterday when I mentioned that you'd jump into the nirvana fallacy with both feet.
You dove into it.

Oddly, none of the documents that you presented mentions the "third world", meanwhile, when you present the same document twice, quoting one phrase out of the entire document twice, you gain precisely zero points.

If you don't know what third world means, please look it up. It is not that difficult ...

The proper term is "developing nations", not third world, which is an insult to all developing nations.
Apparently, you can't take a gentleman's hint.

Ah, forgot about political correctness police ...

"who would lack the infrastructure to test a vaccine."

I am not talking about infrastructure. I am talking about a population that gets routine influenza vaccination (US) vs. one that does not (third world). Repeated vaccination affects efficacy.

"new strains"

Basically, the vaccine is 50% useless, out of the gate.

I get the feeling that you have taken advantage of the holiday season, knowing that I wasn't paying much attention to the comments. That assumption was partially correct. It is correct no more. I tire of your nonsense.

What nonsense?
http://cid.oxfordjournals.org/content/early/2014/09/29/cid.ciu680.full
“Current- and previous-season vaccination generated similar levels of protection, and vaccine-induced protection was greatest for individuals not vaccinated during the prior 5 years. “

"I tire of your nonsense."

AND, they test the vaccine in a third world country where there is no routine seasonal influenza vaccine. So the tests go very well and the vaccines fail in the US.

You seem to be getting increasingly delusional, Vinu. I'm not leaving this killfile off forever.

Both the trivalent and quadrivalent influenza vaccines are formulated differently for the 2016-17 flu season compared to a year ago.

"For the vaccine for the northern hemisphere's influenza season that will begin in the fall of 2016, WHO recently recommended including the A/California/7/2009 (H1N1)pdm09-like virus, A/Hong Kong/4801/2014 (H3N2)-like virus, and B/Brisbane/60/2008-like virus (B/Victoria lineage), with the addition of B/Phuket/3073/2013-like virus (B/Yamagata lineage), for the quadrivalent vaccine"...

"The H3N2 strain and the B strain will be new for the US and northern hemisphere 2016-2017 trivalent vaccine. In 2015-2016, the trivalent vaccine included A/California/7/2009 (H1N1)pdm09-like virus, the A/Switzerland/9715293/2013 (H3N2)-like virus, and the B/Phuket/3073/2013-like virus. The quadrivalent vaccine included B/Brisbane/60/2008-like virus."

http://www.medscape.com/viewarticle/859922

Flu vaccine does not "stop working" because experts repeatedly select the same strains for the vaccine. It is more or less effective depending on how well vaccine strains match the ones causing infection. If similar strains circulate from year to year, it makes sense to keep including them in multivalent vaccines.

This is elementary immunology/vaccine science.

Well, there is a bit of luck in predicting which strain is most probable for global spread. Once in a while, that turns into a dice roll and we end up with much less effective vaccine.
Most of the time, that doesn't happen.

BTW, I do quite like the strain names, as they describe the specific virus very accurately. Of course, I also have my virus name decoder ring sitting on the nightstand... ;)
Seriously though, it does actually accurately describe characteristics and lineage of the virus of interest.

@vinu, a hint, an H1N1 or H3N2 virus isn't the only characteristics of an influenza virus, there are other antigens that the immune system "tags" as well and even those two variants are very different. There are literally hundreds of variants in the world, some which won't even infect a human.
But, you'd have to have a grasp of fundamental biochemistry, cellular receptors and nearly 101 level virology. To judge from the entirety of your commentaries, you lack all of the above.

"Flu vaccine does not “stop working” because experts repeatedly select the same strains for the vaccine."

http://cid.oxfordjournals.org/content/early/2014/09/29/cid.ciu680.full
"Current- and previous-season vaccination generated similar levels of protection, and vaccine-induced protection was greatest for individuals not vaccinated during the prior 5 years. "

"IT IS OBVIOUS THAT THESE JOKERS DO NOT RECOGNIZE THE LIMITS OF THEIR KNOWLEDGE.
They are NOT experts and they are fooling with your children’s lives."

This applies more to you than them.

Jay @ 133, at least I know the limitations on my knowledge. My knowledge of biochemistry is nearly 101 level, however the concepts are known well enough and I can reliably figure out various major groups of chemicals and their general behavior (although, I'm far better with drug families, such as macrolides, etc).
What receptors are, do and how they're generally structured is well enough understood.
How a virus enters into a cell and replicates is decently well enough understood at the arm length level.

But then, we see the spectacular examples of Dunning - Kruger...

All of my knowledge grants me one "superpower", knowing when my protocol list results in DOCTOR NOW.
That fine skill resulted in physicians trusting me a great deal with many drugs and even treatments, which they rarely trusted other SF medics with. Knowing when you've departed your depth, critically important. Knowing that you're reaching that point, priceless.*

*Many years ago, our unit surgeon suggested that I pack the ACLS drug kit, with the notion that morphine would be available for certain specific service members who had angina and hence, had a higher probability that they'd suffer an MI and require pain control.
All well and good, however, our treatment set lacked an ECG. Deliver morphine under the wrong conductive pathway condition, one might as well have simply shot the patient, they'd end up equally dead.
I explained that and my hesitancy toward carrying those chemicals in such a vacuum, as the majority of the drugs would be useless, for the same reason, but add accounting for expiration date, breakage, etc.
In the end, the only time I carried morphine was in combat and ACLS drugs, never. They stayed on the air ambulance, which wasn't mine. But, there was one thing on that air ambulance that I cared about more - they carried blood. That innovation saved a *lot* of lives!

~A man's got to know his own limitations. - A fictional character in a lousy movie

"I tire of your nonsense."

Food protein contaminated vaccines are sickening our kids with life-threatening food allergies.
You have the Flumist flip-flop.
For the flu vaccine to work, you must be unvaccinated for 5 years.
Do you ever tire of such nonsense?

For the flu vaccine to work, you must be unvaccinated for 5 years.

https://www.ncbi.nlm.nih.gov/pubmed/28007925

"healthcare workers who received a single AS03-adjuvanted H1N1pdm09"

Inapplicable in the US. We did not have an adjuvanted H1N1 vaccine.

"CONCLUSIONS:

This study provides the immunological evidence-base for continuing annual influenza vaccination in adults."

Enough said.

BTW, Orac is our host. Your response to his objection was entirely inappropriate and frankly, I wonder as to the quality of your upbringing.

"“CONCLUSIONS:

This study provides the immunological evidence-base for continuing annual influenza vaccination in adults.”

Enough said."

Unfortunately, coming to inappropriate conclusions like this one, is pretty common.

I see that Vinu is still at it. I don't know what I did recently to deserve the "honor" of his return, but now I am really tiring of his nonsense. Clearly, he took advantage of my being around the blog much less than usual due to Christmas Eve and Christmas. Even though I took a day off today producing new material and will not be posting as often as usual again until after New Years, I am back and I am around. There will be posts, and if Vinu continues to make up something like half the comments I see coming through my e-mail notifications, I might well have to put him into automatic moderate.

Normally, I have a very light to nonexistent touch moderating, as long time readers know, but it is possible to annoy me enough to be banned or placed in automatic moderation.

"if Vinu continues to make up something like half the comments"
Oh, so you hate the VOLUME of comments, not the facts provided. At least that's good to know ...

Orac,
"I am really tiring of his nonsense"
"it is possible to annoy me enough to be banned or placed in automatic moderation."

I take your threat of censorship as proof that you are unable to scientifically challenge anything I have posted.

You've been repeatedly refuted right in these comments, you pretend that the refutation doesn't exist, just as you pretend that papers say what they actually do not say.
Hint: Cherry picking a phrase from one article, then stitching it together from another paper's cherry picked phrase isn't evidence.
Inventing things from whole cloth also isn't evidence, it's invention and fabrication.
Calling something trash, when you're speaking of a vaccine is also not evidence.

Refutation? Not even close.

I demolished the food allergy part of Dr.Offit's paper that Dorit posted.

Oh, so you hate the VOLUME of comments, not the facts provided.

You're not so much presenting facts, it's more like presenting cherry-picked, out of context factoids, that don't support your point.

You claim that vaccines *cause* allergies, and the only real evidence you have is some guy 100 years ago said so.

"You claim that vaccines *cause* allergies, and the only real evidence you have is some guy 100 years ago said so."

Good to know that you accept that it is indeed REAL EVIDENCE.
But you forgot that the IOM report which agrees with Dr.Richet, is only 5 years old ...

Thank you, Orac. Vinu is also just so boring by persevering on allergies and someone's century old work.

Stop using electricity, it's many centuries old ...

Vinu writes (#151),

Oh, so you hate the VOLUME of comments, not the facts provided. At least that’s good to know …

MJD says,

You're a great presence Vinu, please consider throwing a quick knockout punch and then prepare for the next fight. Also, stop punching them when they're down - it's poor sportsmanship.

Thanks.

Sadly, in vinu there is not veritas.

You claim that vaccines *cause* allergies, and the only real evidence you have is some guy 100 years ago said so.

And he can't even hew consistently to that.

DB...you win the Internetz today.

"But you forgot that the IOM report which agrees with Dr.Richet, is only 5 years old "

Does the IOM also agree with the existence of Ectoplasm?

Some boring person: "Stop using electricity, it’s many centuries old …"

Lame, very lame. You have obviously not kept up with production, transmission and storage technology even in the last few years.

Vinu clearly didn't listen to my warning. Automatic moderation on.

"The team above performed a simple very well controlled experiment with JUST TWO KIDS"

Is it me, or is this one of the stupidest sentences of the year?

A "well controlled experiment", where n=2 and there is no control group?

Why did they stop there, why not push the boat out and do some more blood tests a month later, a year later, etc?

Hey, maybe these levels go up and down irrespective of vaccinations?

Food allergy after vacciination is coincidence.
Autism after vacciination is coincidence.
Kawasaki disease after vacciination is coincidence.
Specific IgE going up after vaccination is coincidence.
Specific IgE goes up and down, but going up somehow coincides with vaccination, correct?
It will be a lot easier, if you pay attention to the underlying scientific mechanism.

Does bees sting allergy go up and down randomly with no relation to bee stings? Why does it affect beekeepers? COINCIDENCE! What else can it be?!

Kawasaki disease and immunisation: Standardised case definition & guidelines for data collection, analysis
http://www.sciencedirect.com/science/article/pii/S0264410X16308386

Seriously, Kawasaki disease?
One of the rarest diseases on the planet is your primary "points"?!

Seriously, in that instance, I could be drunk, intoxicated with opioids and kicked in the head by a horse and still discard your idiocy.
Cherry picking a phrase out of multiple articles, as you've repeatedly done doesn't earn respect, it earns hard won disrespect and distrust.

Here, lemme help you a bit. I actually do know of this disease and hence, find your claim laughable.

"Kawasaki disease affects boys more than girls, with people of Asian ethnicity, particularly Japanese and Korean people, most susceptible, as well as people of Afro-Caribbean ethnicity. The disease was rare in Caucasians until the last few decades, and incidence rates fluctuate from country to country.

Currently, Kawasaki disease is the most commonly diagnosed pediatric vasculitis in the world. By far, the highest incidence of Kawasaki disease occurs in Japan, with the most recent study placing the attack rate at 218.6 per 100,000 children <5 years of age (about one in 450 children). At this present attack rate, more than one in 150 children in Japan will develop Kawasaki disease during their lifetimes.

However, its incidence in the United States is increasing. Kawasaki disease is predominantly a disease of young children, with 80% of patients younger than five years of age. About 2,000-4,000 cases are identified in the U.S. each year (9 to 19 per 100,000 children younger than 5 years of age)."

Well, rare, specific ethnic groups tend to have higher rates, zip on anything that you claim and even money, it'll be eventually discovered to be a point or three mutation.

Pathetic.

please see #184

Good to know that you accept that it is indeed REAL EVIDENCE.

Real, yes. Persuading, not so much.

But you forgot that the IOM report which agrees with Dr.Richet, is only 5 years old.

That's an example of cherry-picked, out of context factoids.

And that's all you (and MJD) got.

"Real, yes. Persuading, not so much."

Thanks for letting us know that REAL EVIDENCE DOES NOT PERSUADE you. Makes all your other comments understandable.

I didn't notice Vinu was on auto-moderation until after I posted above, and calling him out like that is unsportsmanlike. My bad.

Also, using the word 'factoid' isn't really correct in this case. Please substitute 'passages'.

If he responds, I'll let his response through.

Your hand is not that light, Orac. I recieved no warning before being placed on automatic moderation over the pharma-shill sensitive subject of Kratom.

And you just shadow ban without warning also.

Poor baby. If you don't like it, no one's forcing you to stick around.

http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedPr…

"Among subjects with symptom onset
within 42 days of vaccination (days 12, 25, 29), 3/12049 [0.02%, 95% CI: (0.01% ,
0.07%)] MENVEO recipients and 0/2877 [0%, 95% CI: (0%, 0.13%)] control
recipients were diagnosed with Kawasaki Disease. "

(bolding mine) -

Among subjects with symptom onset within 42 days of vaccination (days 12, 25, 29), 3/12049 [0.02%, 95% CI: (0.01% , 0.07%)] MENVEO recipients and 0/2877 [0%, 95% CI: (0%, 0.13%)] control recipients were diagnosed with Kawasaki Disease.

3 out of 12,049.

On the subject of odds (and nothing else) I note that according to http://www.lightningsafety.noaa.gov/odds.shtml
thats about the same as being struck by lightning in your entire life.

http://www.nmaus.org/disease-prevention-information/statistics-and-dise…
Assume meningococcal vaccine coverage is 80% in the US for teens.
Assume vaccine is 100% effective.
There are ~200 cases of bacterial meningococal disease per year in teens.
Number of teens in the US, ~40 million.
Risk of meningococcal disease in an unvaccinated teen is 40,000,000*0.2/200=40000 or 1:40000.
The risk over a 5 year period (vaccine effectiveness period) is 1:8000.
So we are being asked to choose between a 1:8000 chance of getting bacterial meningitis vs. 1:4000 risk of Kawasaki disease.

Laughably, I habituated myself with assisting commo in setting up their antenna.
With annoying frequency, thunderstorms rolled in while we were attempting to do so.
Oddly, despite a near unity risk exposure, none of us were struck by lightning.
Just as the overwhelming majority of the populace never suffered the claimed allergies or other claimed deleterious effects.

MJD @160

If Vinu had tried this sort of stunt in an under-grad seminar when I was at university in the '70s he would have been torn several new ones...He has yet to come up with a sustainable argument supported by consistent, repeatable, verifiable, falsifiable evidence.

"He has yet to come up with a sustainable argument supported by consistent, repeatable, verifiable, falsifiable evidence."

The HHS hired the IOM to do the job of finding the RELEVANT evidence. The IOM concluded with ABSOLUTELY no doubts at all that food protein contaminated vaccines cause the development of food allergies.
Your job is to provide COUNTER EVIDENCE. Not one person has provided ANY evidence that stood up to scrutiny.

So we are being asked to choose between a 1:8000 chance of getting bacterial meningitis vs. 1:4000 risk of Kawasaki disease.

Vinu, can you - with your superior grasp of statistics - calculate what is the probability that the rate for Kawasaki disease is the same for both vaccinated and control, and by mere luck none of the 2877 controls were the "one in four thousand"?

It's also nice to see you give due reverence to the role of vaccines in upholding herd immunity.

"Vinu, can you – with your superior grasp of statistics – calculate what is the probability that the rate for Kawasaki disease is the same for both vaccinated and control, and by mere luck none of the 2877 controls were the “one in four thousand”?"

Oh, yes, COINCIDENCE again!
Natural sepsis due to meningococcal bacterial infection can cause Kawasaki disease. So it is not some fantastic coincidence.
It IS the stupid vaccine. Molecular mimicry resulting in autoimmune disease.
H1N1 infection caused narcolepsy. The H1N1 vaccine Pandemrix also caused narcolepsy. Same problem here with Kawasaki disease.

Meningococcal group A sepsis associated with rare manifestations and complicated by Kawasaki-like disease.
https://www.ncbi.nlm.nih.gov/pubmed/19287280

http://stm.sciencemag.org/content/7/294/294ra105

And this molecular mimicry is not limited to N meningitidis alone. So guess what's causing this ONCE RARE disease to become not so rare any more?

Sorry about the formatting ...

Method used:
https://www.researchgate.net/publication/310021910_Significant_protein_…

Kawasaki results:
Sireci et al. below show molecular mimicry between Heat Shock Protein (HSP) 65 of Mycobacterium Tuberculosis and human HSP63.

Here are the results comparing protein sequence alignment between vaccine antigens and this epitope.

HSP63/Mycobacterial HSP65 is shown as baseline in the table below.

T Cells Recognize an Immunodominant Epitope of Heat Shock Protein 65 in Kawasaki Disease

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1949968/pdf/10997339.pdf

Score Expect Identities Positives Gaps Sequence
Saccharomyces cerevisiae 39.7 0.00006 13/19 (68%) 14/19 (74%) 0/19 (0%) Query 3 NIGAKLVQDVANNTNEEAG 21
N GAKL Q+VA TNE AG
Sbjct 89 NMGAKLLQEVASKTNEAAG 107
Clostridium tetani 32 0.029 12/21 (57%) 14/21 (67%) 0/21 (0%) Query 1 YKNIGAKLVQDVANNTNEEAG 21
Y N GA LV +VA TN+ AG
Sbjct 65 YENMGAQLVKEVATKTNDVAG 85
Streptococcus pneumoniae 48.1 0.00000006 16/21 (76%) 17/21 (81%) 0/21 (0%) Query 1 YKNIGAKLVQDVANNTNEEAG 21
Y N GAKLVQ+VAN TNE AG
Sbjct 65 YENMGAKLVQEVANKTNEIAG 85
Corynebacterium diphtheriae 29.5 0.23 11/21 (52%) 14/21 (67%) 0/21 (0%) Query 1 YKNIGAKLVQDVANNTNEEAG 21
Y IGA LV +VA T++ AG
Sbjct 65 YEKIGAELVKEVAKKTDDVAG 85
Bordetella pertussis 35 0.003 12/19 (63%) 13/19 (68%) 0/19 (0%) Query 3 NIGAKLVQDVANNTNEEAG 21
NIGA LV DVA T + AG
Sbjct 68 NIGAQLVKDVASKTSDNAG 86
Haemophilus influenzae 26.9 1.8 10/16 (63%) 10/16 (63%) 5/16 (31%) Query 5 GAKLVQDVANNTNEEA 20
G KLVQDV EEA
Sbjct 59 GVKLVQDV-----EEA 69
Hepatitis B virus 18.5 1482 6/8 (75%) 6/8 (75%) 0/8 (0%) Query 1 YKNIGAKL 8
YKN G KL
Sbjct 33 YKNFGRKL 40
Neisseria meningitidis 27.8 0.86 10/19 (53%) 13/19 (68%) 0/19 (0%) Query 3 NIGAKLVQDVANNTNEEAG 21
N GA +V +VA TN+ AG
Sbjct 68 NMGAQMVKEVASKTNDVAG 86
Mycobacterium tuberculosis
(Baseline)
29.5 0.22 11/21 (52%) 14/21 (67%) 0/21 (0%) Query 1 YKNIGAKLVQDVANNTNEEAG 21
Y IGA LV +VA T++ AG
Sbjct 1 YEKIGAELVKEVAKKTDDVAG 21
Measles virus 19.7 578 7/14 (50%) 10/14 (71%) 0/14 (0%) Query 6 AKLVQDVANNTNEE 19
A LV ++A NT E+
Sbjct 17 ARLVSEIAMNTTED 30

No significant alignments were detected with mumps virus or rubella virus.

Well, now I'm all confused about this horrible upsurge in Kawasaki disease in the United States. Except there isn't one.

"Analysis of the (Kids Inpatient Database) and other hospitalization databases revealed no clear evidence for a statistically significant increase in the incidence of KD in the United States for over 2 decades. In contrast, for reasons that are not well understood, a steady increase in KD incidence has been reported in many other countries, including Japan."

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3798585/

Antivaxers are fond of telling us that a horrific expansion of the U.S. vaccine schedule over that time period is responsible for increases in all manner of diseases in children. It must be a "fantastic coincidence" that Kawasaki disease hasn't found a place on that laundry list.

Probably the IOM, CDC, FDA, CIA and TVA are suppressing the data. :(

I see that Smith et al. proposed a much more compelling explanation than Vinu's completely idiotic one for the effect of repeated vaccination on influenza VE 16 years ago.

"16 years ago"

After 16 years, we have the Flumist fiasco.
And for injected influenza vaccines to be effective, you have to unvaccinated for the previous 5 years.

Either Smith et al. are wrong or the vaccine establishment is incapable of learning from Smith et al. Which one is it?

On the page Vinu cites at (currently) 180, I read "Of those who get meningococcal disease 10-15 percent die."

At http://www.merckmanuals.com/professional/pediatrics/miscellaneous-disor… I read "Without therapy, mortality may approach 1%, usually occurring within 6 wk of onset. With adequate therapy, the mortality rate in the US is 0.17%".

So, Vinu, using your own numbers, assuming all cases of Kawasaki disease are untreated, how many deaths does meningococcal vaccine prevent?

Again from the same page you cite, I read "Among those who survive, approximately 1 in 5 live with permanent disabilities, such as brain damage, hearing loss, loss of kidney function or limb amputations". What percent of Kawasaki patients suffer permanent disabilities?

"What percent of Kawasaki patients suffer permanent disabilities?"
Discovered in 1976. Who knows what the long term impacts are?
Look at the basic science. The risk of bacterial meningitis is 1:8000. Assume ALL of them develop sepsis. In that case, sometimes, the immune system creates autoantibodies because of molecular mimicry between N meningitidis and human proteins. The result is KD. With vaccination that involves injection of N meningitidis proteins, that 8000 factor is gone. So we just increased KD risk 8000X!

And as posted in #186, looking at protein sequence alignment, it is not just N meningitidis but many other vaccine antigens can cause the same problem.

Vaccines are a very important tool for health. But poorly designed vaccines and their abuse, is extremely dangerous as well.

Did Vinu just pull the exact same argument that RFK Jr. made against that particular vaccine?

Vinu: The IOM concluded with ABSOLUTELY no doubts at all that food protein contaminated vaccines cause the development of food allergies.

NO, THEY DID NOT!! I've just had a read, Vinu's quote comes from the beginning of the document discussing food antigens in vaccines. See below the true conclusion of the IOM:

"Anaphylactic reactions to several vaccines are likely caused by the presence of components introduced during manufacturing, such as egg protein, milk protein, or gelatin. When a specific inciting component of the vaccine has been identified and the manufacturers find ways to remove or drastically reduce the amount of the reactive antigen (e.g., egg protein in influenza vaccine), the number of reports of anaphylaxis in spontaneous reporting systems has decreased . It appears likely to the committee that the risk of anaphylaxis caused by vaccines is exceedingly low in the general population. The risk is obviously higher in people with known and demonstrably severe allergies to certain vaccine components, such as eggs or gelatin."

You are confusing TWO separate aspects.

Sensitization: Development of a new allergy in a non-allergic person.
Elicitation:Allergic reaction (including anaphylaxis) caused by allergen exposure in a person who is already allergic to the substance.

The paragraph I quoted makes it ABSOLUTELY CLEAR that food protein contaminated vaccines cause sensitization (development of new allergy).
You are quoting elicitation related material.

See this section for more interesting information:
"Sensitization needs less injected allergen than elicitation"
in
https://www.omicsgroup.org/journals/evidence-that-food-proteins-in-vacc…

No Vinu, I'm not, the only reason for that paragraph you quoted is in the context of the one I quoted.

They are talking about removing amounts of reactive antigens to decrease the incidence of anaphylaxis. Not vaccines causing food allergies.

Anybody else feel free to read the concluding comments on page 629. Or allow me to sum up:

1) Slight causal link between MMR and Febrile seizures. No long term sequelae.
2) Varicella vaccine contraindicated in those with severe immunodeficiency.
3) Evidence supports the association of anaphylaxis with certain vaccines in certain circumstances. Removing reactive antigens decrease anaphylaxis rates. the risk of anaphylaxis caused by vaccines is exceedingly low in the general population. The risk is obviously higher in people with known and demonstrably severe allergies to certain vaccine components, such as eggs or gelatin.

What you quoted says nothing about sensitization.
We are talking about sensitization.
So it is not directly relevant, except as I pointed out with "Sensitization needs less injected allergen than elicitation" ...

Whoops forgot link:

https://www.nap.edu/read/13164/chapter/15

I'm going out on a limb, and guessing that Vinu's favorite sport is dodgeball.

I'll ask again -
Using your own numbers, assuming all cases of Kawasaki disease are untreated, how many deaths does meningococcal vaccine prevent?

What percent of Kawasaki patients suffer permanent disabilities?

Your honesty is on display here. Got any?

Johnny @ 197, I consider vinu (sic) and the dodging, gish galloping and assorted cherry picking, then arrived long ago as to my opinion of the level of gravitas and honor possessed by the troll.
Hence, my decision not to feed the trolls, save if the goat is poisoned.
As trolls are infamously refractive to poisons, I await my resupply of effective poisons for that troll. Fortunately, part of the poison has arrived, via moderation.

That said, the morbidity and mortality rate for Kawasaki disease varies, depending upon one's origin, Japan or the rest of the world. That suggests a founder effect for that island.
It's still rather low, only higher in Japan.
Which is something vinu will likely dodge and dance around, then likely, gish gallop and cherry pick, as usual.
Wasting everyone's time.*

*After the fifth time someone's been called and proved a BS'er, it's time to stop wasting time. It only gives free advertisement, to be cherry picked and copypasta'd elsewhere as a "victory" point, even if the point was entirely disproved.
Waste of time, waste of food, oxygen and germ line cells to create such a creature.
Excellent poster child for barrier contraception though, "Don't let your progeny come out like this! Contraception is the key!".

Your questions demonstrate you are missing the point again.

The vaccine MUST BE SAFE ENOUGH that I should not have to worry about ANY OF THIS NONSENSE.

http://www.pbs.org/wgbh/frontline/article/paul-offit-a-choice-not-to-ge…
"But I think they should be, because I think that when you give things to healthy children, they should meet really the highest standards of safety testing."

THIS is the highest standards of safety in 2016?

In the same article Dr.Offit says:
"And of the million children then that got that vaccine, about 100 developed this intussusception, which is to say, one per 10,000. One child died from that vaccine. And it was immediately taken off the market. But it shows you, I think, how quickly and well we were able to respond to an unanticipated side effect. And again, even though the vaccine was tested in 10,000 children pre-licensure, you weren’t going to be able to detect an event that occurred in 1 per 10,000 children. "

Here we have 1 in 4000 developing KD PRE-LICENSURE, why did the vaccine get on the market at all? Where is the honesty in the safety claims?

Vinu "What you quoted says nothing about sensitization."

Great! I agree! That IOM report concludes nothing about sensitization.

You should retract that paper of yours keep linking to, now that you know you were in error.

Seriously, I think the IOM would be quite horrified at the use you put that out of context quote.

Sensitization conclusion with all the required context is right here for anyone who does not twist facts.

https://iom.nationalacademies.org/Reports/2011/Adverse-Effects-of-Vacci…

Document Pg. 65 (pdf pg. 94 ):

Vinu "Your questions demonstrate you are missing the point again.
The vaccine MUST BE SAFE ENOUGH that I should not have to worry about ANY OF THIS NONSENSE."

Thorny questions dodged; check. Goal post moved; check. All this done shamelessly; check. ;)

Your questions demonstrate you are missing the point again.
The vaccine MUST BE SAFE ENOUGH that I should not have to worry about ANY OF THIS NONSENSE.

Let me guess again - Your favorite band is Nirvana.

All medical interventions that have an effect, can also have side effects. This, of course, includes vaccines. Sometimes, these side effects can be serious, and they can be long lasting, and they can be fatal. Medical science should continue to work to develope medical intervention with fewer and less sevier side effects.

Nobody, and especially me, disagrees with this. If this is your point, then we are in violent agreement.

Now, answer the questions I asked, and I'll add another - do you think MENVEO should be used until something better comes along?

"All medical interventions that have an effect, can also have side effects. This, of course, includes vaccines. "

No. As Dr. Offit said, VACCINES MUST BE HELD TO A HIGHER STANDARD. They are administered to healthy people unlike other interventions.

"do you think MENVEO should be used until something better comes along"
When is this coming along? How many decades does it take?
The new Men B vaccine is EVEN WORSE than the Men ACWY that they don't even recommend it for routine use.

KD due to meningococcal sepsis was known in 2009.
https://www.ncbi.nlm.nih.gov/pubmed/19287280
So why was MENVEO approved without fixing this problem?

All of this points to one fundamental problem. There is no incentive to make safe vaccines. The SYSTEM IS TOTALLY BROKEN.
Why don't you trust crash tests performed by the automakers? We have independent government crash tests and EVEN BETTER, we have IIHS crash test ratings. That is what we need for vaccines. Ratings. So people can choose and REJECT poor quality vaccines.
Instead, we have this socialized medicine nonsense where we are supposed to believe that ALL vaccines are somehow created equally safe and effective.

Menactra was approved in 2005.
MENVEO in 2010. So it is not as if there was no vaccine available. This shows new vaccines are approved with the same old problems.

From year 2000:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1949968/pdf/10997339.pdf
So BOTH vaccine makers failed to do their homework by checking their vaccine antigens for KD risk.

If people are not able to choose the better vaccine, why would vaccine makers invest in a better vaccine design? Out of the goodness of their hearts? This is Soviet style medicine with Soviet quality results.

Narad,
How do you explain this:
"Administraton of Menactra one month after DAPTACEL has
been shown to reduce meningococcal antibody responses to Menactra" ?

Menactra is a Diphtheria Toxoid (DT) Conjugate Vaccine. So, if you have high DT antibody response from the DAPTACEL, it blocks Menactra, reducing meningococcal antibody responses.

Menactra
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedPr…

Got it. Vaccines must be perfect, or they must not be.

Wzrd1 had it right.
[singing]
Mamas don't let your babies grow up to be Vinu...
[/singing]

Sorry. I'll stop now.

vinu: "Vaccines are a very important tool for public health."
vinu: "There is no incentive to make safe vaccines. The SYSTEM IS TOTALLY BROKEN."

He sounds like RFK Jr. and his collaborators in "Thimerosal: Let The Science Speak" - who acknowledge on the one hand that vaccines have saved many lives, while fervently denouncing them and everyone connected with their development and promotion as corrupt liars.

No, those who play this game are not antivaccine. Why do you ask?

"Sensitization conclusion with all the required context is right here for anyone who does not twist facts."

It is clear you don't know the meaning and the use of the word "conclusion" AND that you haven't read the report you are quoting, which is about Anaphylaxis. The quote is talking about the general properties of allergens and you are using it incorrectly.

Please see below a link to a list of conclusions of that report (a handy pointer here, it has the word conclusions in the title)

http://www.nationalacademies.org/hmd/~/media/Files/Report%20Files/2011/…

Now the big question that should be asked here is, what did the IOM conclude about food allergies caused by vaccines?

Well there's quite a bit of literature to wade through, so I'll cherry pick for a change and just use the latest, as it would be most up to date:

"The committee’s review did not reveal an evidence base
suggesting that the U.S. childhood immunization schedule is linked to autoimmune diseases, asthma, hypersensitivity , seizures, child developmental disorders, learning or developmental disorders, or attention deficit or disruptive disorders."

http://nationalacademies.org/hmd/~/media/Files/Report%20Files/2013/Chil…

Well that's a relief! Though to be fair to Vinu, they are keeping an eye on the issue. Did read that one committee stated that there was weak evidence to a biological mechanism (in 2004), so it's not implausible.

The title of the paragraph you quoted is:
"No Evidence of Safety Concerns "

"No evidence"? Really? Even top vaccine advocates would not make such a ridiculous claim. Seizures are associated with injuries on the vaccine injury table. How can they deny vaccines causing seizures?
THIS IOM committee and its report seem like a great example of vaccine associated scientific fraud. Given the egregious claims above, you cannot believe anything they say. They should be investigated for professional misconduct.

"Though to be fair to Vinu, they are keeping an eye on the issue. Did read that one committee stated that there was weak evidence to a biological mechanism (in 2004), so it’s not implausible."

Now that you have discovered it for yourself, why don't you give the IOM 2011 sensitization statement and the following results, an unbiased look? Does it not strengthen the evidence from 2004?

wao.confex.com/wao/2015symp/webprogram/Paper9336.html

"A committee of experts convened by the Institute of Medicine to review the scientific literature on possible adverse effects of vaccines found convincing evidence of 14 health outcomes -- including seizures, inflammation of the brain, and fainting -- that can be caused by certain vaccines, although these outcomes occur rarely."
http://nationalacademies.org/hmd/reports/2011/adverse-effects-of-vaccin…
"no evidence of safety concerns"?

I thought we'd determined in a previous thread that vinu is afraid of needles and therefore would prefer that everyone suffer VPDs than have to get a single shot, and is just using a misunderstanding of "allergy" as a smokescreen?

"misunderstanding of “allergy”"

What's the misunderstanding?

Yeah it's frustrating that he's so blind to anything that does not interest him, I've been doing some more reading on vaccine history. Fascinating stuff, people were really desperate, arm to arm vaccination, reports of vaccines having thousands of bacteria in them and of course the discovery that "dirty" vaccines work better, leading to the development of adjuvants.

Vaccines have come a long way.

"“dirty” vaccines work better, leading to the development of adjuvants."
What does "work better" mean? Well, the vaccine produced a stronger immune response to a smaller vaccine antigen dose.
That's of course great for disease protection.
Now consider what happens to tiny amounts of contaminating proteins in the vaccine. They too ENJOY the stronger immune response. Result, an allergy epidemic. But that's a dirty secret, nobody wants to talk about ...

Platts-Mills TAE. The allergy epidemics: 1870-2010. Journal of Allergy and Clinical Immunology. 2015. p. 3–13.

"Vaccines have come a long way."

Sometimes, it's several steps back before a step forward ...

" O’Brien et al. [13] measured 7.4 mcg/ml of ovalbumin in
influenza vaccines in 1967. Goldis et al. [14] measured as much as 38.3 mcg/ml in influenza vaccines as recently as 2008. "

https://www.omicsgroup.org/journals/evidence-that-food-proteins-in-vacc…

Unfortunately vinu's days here appear to be numbered.

Yet another crank brought down by the relentlessness of human inventiveness. . .

yep, so inventive, even the link does not work ...

And, borked the punchline

numbered

Goodness vinu @217, what haven't you misunderstood about allergies? I've strongly recommended a good textbook on the subject that discusses both vaccines and allergy (Janeway's Immunobiology, 7th edition or newer).

So, a few things you've missed: the different types of allergy and the cells that mediate those allergic responses. The mechanism by which allergic responses come to occur. the mechanisms by which allergic responses can stop happening. How the adaptive immune system works (the memory part of the immune system). The various immunoglobulins and their production and mechanisms of action.

Like MJD, with whom you share an unsupported theory and frustrating posting style, you are so totally fixated that you failed to learn the necessary background to actually make a contribution.

Yar, watch Vinu turn on his previously untouchable authority. That was predictable. In fact, I have loads more quotes saved up, but I'm on my phone in swanky hotel learning about VOIP. So gonna have to wait till Thursday Evening UK time ;)

"the different types of allergy"

We are talking about Type I IgE mediated hypersensitivity. Why do you bring up other irrelevant types of allergy?

Why don't YOU tell us exactly what this means:

https://iom.nationalacademies.org/Reports/2011/Adverse-Effects-of-Vacci…

Document Pg. 65 (pdf pg. 94 ):

“... the
above-mentioned antigens do occasionally induce IgE-mediated sensitization in some individuals and subsequent hypersensitivity reactions, including anaphylaxis.”

Perhaps another "American Loon" candidate?

So, a few things you’ve missed: the different types of allergy and the cells that mediate those allergic responses. The mechanism by which allergic responses come to occur. the mechanisms by which allergic responses can stop happening. How the adaptive immune system works (the memory part of the immune system). The various immunoglobulins and their production and mechanisms of action.

I don't think anything you said is wrong, but the way I read the tea leaves, you missed the big thing.

Vinu seems to think that anything that causes an allergic reaction is the same as causing an allergy. For example, while the flu vaccine can cause an allergic reaction in someone allergic to eggs, Vinu seems to think that reaction is the allergy, and not a symptom/result of the allergy. Vinu's words say that food proteins in vaccines cause people to become allergic, but the citations (other than some 100 year old musings of a long dead guy) are all of people having allergic reactions.

Unfortunately that is a complete mischaracterization of my posts.
In #194, I clearly explained the difference between sensitization and elicitation.

"For example, while the flu vaccine can cause an allergic reaction in someone allergic to eggs, Vinu seems to think that reaction is the allergy, and not a symptom/result of the allergy."

You have to understand that non-allergic people who get a flu shot can get sensitized to egg in the vaccine, in about three weeks time after the shot (develop a new allergy). They will have no symptoms, no reactions whatsoever. The next flu shot, they can suffer an allergic reaction.

If the IOM were only talking about reactions/anaphylaxis, you would be right. But as I have repeatedly pointed out, the IOM said, "do occasionally induce sensitization ...". Sensitization means DEVELOPMENT OF A NEW ALLERGY, not an allergic reaction due to an existing allergy.

Vinu @229: Let us say for the sake of argument that a single flu shot caused a person to develop an egg allergy. What is the probability that said person will not encounter egg protein again for a full year, before their next flu shot?
And what is the probability that this person had never been exposed to egg proteins before?

The average American, even one who eats a thoughtful and nutritious diet, will encounter more egg products than they think. Unless you are actively avoiding eggs because of dietary choices, or because you already have intolerance or allergy, then you will eat some egg between flu shots, to which you would have a reaction. Your statement is highly improbable.

But let's get to the bigger question: what do you want? You have stated your hypothesis. Now state your desired next actions, assuming that the data support your hypothesis.

Of course, once sensitized by egg in a flu shot, you can have a reaction to eating egg as well. In fact, this is the most common case we are discussing. People being sensitized by food protein contaminated vaccines, developing food allergies and being unable to eat those foods anymore.

"And what is the probability that this person had never been exposed to egg proteins before?"
By what route of exposure?
Eating allergen builds tolerance.
Injecting allergen causes sensitization.

"Now state your desired next actions"
What do you logically expect? REMOVE ALL FOOD PROTEINS FROM ALL VACCINES.

Like this:
Removal of gelatin from live vaccines and DTaP—an ultimate solution for vaccine-related gelatin allergy
http://www.sciencedirect.com/science/article/pii/S1045105603000630

http://jeeves.mmg.uci.edu/immunology/CoreNotes/Chap21.pdf

Pg. 157:
"A guinea pig can be sensitized by intramuscular injection of an antigen, say OVA (ovalbumin). Its immune system responds by producing antibody to OVA, including (but not
exclusively) IgE. Some of this circulating IgE will be fixed onto mast cells in various tissues, including the vasculature and respiratory tract. Three weeks later, the same animal can be
challenged either with an intravenous dose of OVA or by exposure to an aerosol containing OVA. Following IV injection, the animal will rapidly develop severe vascular shock and die within a few minutes (the combination of venule constriction and capillary dilation results in pooling of blood in the peripheral circulation and a drastic drop in blood pressure). If exposed to the aerosol, it will equally rapidly die from bronchial constriction, an experimental model for human asthma. "

Food allergy and asthma after intramuscular injection of food protein. What are the most common childhood diseases today, again? Food allergy and asthma. Another FANTASTIC coincidence, correct? At this rate, I think COINCIDENCE can be documented as a known vaccine adverse event.

I'd like to see documentation for the statement that food allergy and asthma are "the most common childhood diseases today". Aren't colds, ear infections, eczema etc. a wee bit more common?

But vinu will probably be allergic to backing this claim up too.

Aren’t colds, ear infections, eczema etc. a wee bit more common?

You mean like this?

In case you've ever wondered HOW vine does it:

https://youtu.be/ykGuOIMGbLI

I had absolutely no idea that it was such a team effort - I've always had an image of our valiant keyboard warrior working alone.

Damn autocorrect!!

vinu @231:
Reply the first. You said "Injecting allergen causes sensitization."
But what about allergy shots, which are injections that build tolerance?

Reply the second: You said " REMOVE ALL FOOD PROTEINS FROM ALL VACCINES."

OK. We are currently facing a nasty strain of influenza this year, that's already killed 9 people in my county. Can you, by next fall, have an egg-free flu vaccine in quantities that are sufficient to protect the whole country, that has passed all regulatory hurdles?

Or are we just supposed to not have a flu shot for however long it takes to develop a new manufacturing process?

"Reply the first. You said “Injecting allergen causes sensitization.”
Yes, that causes IgE mediated sensitization.
But what about allergy shots, which are injections that build tolerance?"
Once you are sensitized and have IgE mediated allergy, further injection of SMALL quantities of allergens causes IgG4 induced tolerance. This is better than anaphylaxis but it is a poor substitute for natural tolerance to foods acquired through eating them. IgG4 induced tolerance can cause GI diseases such as eosinophilic esophagitis (EoE).

"OK. We are currently facing a nasty strain of influenza this year, that’s already killed 9 people in my county. Can you, by next fall, have an egg-free flu vaccine in quantities that are sufficient to protect the whole country, that has passed all regulatory hurdles?"
You have had a 100 years (since Richet) to fix this problem and you make up this artificial false constraint?

"Or are we just supposed to not have a flu shot for however long it takes to develop a new manufacturing process?"

1. Due to repeated influenza vaccinations, your new flu vaccine may not work.
2. As in #232, you will develop IgE to HA proteins. When you inhale HA proteins, you can develop asthma.

Something to consider before the next flu shot, EVEN if it is free of all other proteins.

for years, the American Academy of Pediatrics (AAP) advised pregnant women with peanut allergies to stop eating peanuts while pregnant and to not feed peanuts to their children when they started on solid foods.

That changed in recent years, when two major studies proved that advice wrong. In one, the rate of peanut allergies was about 10 times lower for children who ate peanuts from an early age, compared to kids whose parents avoided giving their infants peanuts.

http://time.com/4622667/how-to-prevent-peanut-allergy/

That being said, vinu's assertion that peanut products being injected and combined with adjuvants to kick off an immune response which might include sensitization to the food stuffs seems a bit plausible to me.

Gilbert, well, yeah, that could happen, but what evidence is there that there are peanut proteins in vaccines? It's not like everyone doesn't know that peanuts are a common allergen.

Like, if I injected someone with peanut protein and, say, LPS, which is a hell of an adjuvant, I would not be at all surprised if they developed a peanut allergy. No one's disputing that. I'm just asking for evidence that there is peanut protein in vaccines. I can't think of any reason to introduce it into the manufacturing process.

"Like, if I injected someone with peanut protein and, say, LPS, which is a hell of an adjuvant, I would not be at all surprised if they developed a peanut allergy. No one’s disputing that."

Ok, then you do agree that vaccines can definitely cause egg, milk, soy, yeast, etc. allergies because they are documented contaminants. We don't have LPS, but we do have aluminum salts which are pretty good Th2 biasing adjuvants.

"Peanut"
There are two possibiliities:
1. As in #70, peanut oil is used in injectable products.
Since it is approved as an injectable, it can contaminant any other injectable product including vaccines due to shared manufacturing equipment ANYWHERE in the process.
2. https://www.researchgate.net/publication/310021910_Significant_protein_…

In a society bounded by the joke of prohibition, JustaTech, I'd just assume that pharma puts it in there for shits and giggles.

And thus, ignoring the Libertarian, in a heavily regulated environment that is heavily risk adverse, aversion of doing so?
That's quite a fascinating view.

Right I'm back. Sort off, laptop battery died. Can't get at my quotes or those IOM reports.

"Now that you have discovered it for yourself, why don’t you give the IOM 2011 sensitization statement and the following results, an unbiased look? Does it not strengthen the evidence from 2004?"

I bounced around all three, you are the one with the bias here. It is plain for everyone to see. You don't even read the documents and you are seemingly deliberately miss quoting them. Plausible mechanism does not equal "it happens" and also does not give a frequency.

That was 2004.

In 2011 they didn't even look at food allergies...
They were examining Anaphylaxis, which are really rare and can be made rarer by removing food allergies. Happy days.

2013 Catagorically states there are no safety concerns about vaccines causing hypersensitivity.

Great, so let's all agree, we should work to removing food allergens from vaccines to cut the rate of Anaphylaxis.

Then, when that's sorted, we can tease Vinu unmercifully when there is no change in food allergy rate ;)

"Plausible mechanism does not equal “it happens” and also does not give a frequency."

IOM:
"do occasionally induce IgE-mediated sensitization "
means IT HAPPENS, not just plausible.

So you have no answer for my argument, that the IOM states that vaccines don't cause food allergies? Didn't think so.

The IOM 2012 report said vaccines DO cause the development of food allergies.
I proved to you that the IOM 2013 report YOU QUOTED is a FRAUD. They listed vaccines as not causing seizure. Seizure causing adverse events are on the vaccine injury table.
The 2013 report is a joke that should be thrown out.

You are asking a lot here. The IOM states that antigens may cause sensitisation, you missread that as vaccines cause food allergies and the IOM is an untouchable authority.

The IOM clearly states that vaccines don't not cause food allergies and now you say the IOM are frauds.

Who do you think will be convinced by this?

"The IOM states that antigens may cause sensitisation, you missread that as vaccines cause food allergies and the IOM is an untouchable authority."

IOM 2012 report said:
"Antigens in the vaccines", "do occasionally induce sensitization". Anyone with even basic knowledge of immunology knows, that means vaccines cause food allergy.

"The IOM clearly states that vaccines don’t not cause food allergies and now you say the IOM are frauds."
The IOM 2012 committee is DIFFERENT from the 2013 committee. The 2013 committee/report is easily demonstrated to be a fraud.

"Anyone with even basic knowledge of immunology knows, that means vaccines cause food allergy."
Which leaves you out of any such group, as you have zero clue about immunology.

"The IOM 2012 committee is DIFFERENT from the 2013 committee. The 2013 committee/report is easily demonstrated to be a fraud."
Odd, so the committee is different because some members replaced other members? That invalidates all knowledge, education and experience? Why, my local hospital is an entirely different hospital at each shift change, who knew?!
As for the "committee/report" being easily demonstrated to be a fraud, it's a terrible shame that you've entirely been incapable of proving that.

I'm totally down with Narad, why put nickles into the jukebox when all of the records are broken?

"Which leaves you out of any such group, as you have zero clue about immunology."
And who are you to make that determination?

"Odd, so the committee is different because some members replaced other members? That invalidates all knowledge, education and experience? "
No, it changes the balance of corrupt vs. non-corrupt members.

"As for the “committee/report” being easily demonstrated to be a fraud, it’s a terrible shame that you’ve entirely been incapable of proving that."
Why did they claim vaccines do not cause seizures, when adverse events that include seizures are on the vaccine injury table?

"And who are you to make that determination?"
I'm someone who seems to know a great deal more than you about immunology, as most of the things that you've said are either incorrect, impossible or plain nonsense.

"No, it changes the balance of corrupt vs. non-corrupt members."
So, you are telepathic and read their minds to find corruption? Evidence of corruption? No, an assumption of corruption, as the committee had findings that differ from your inept understanding of immunology and vaccines.

"Why did they claim vaccines do not cause seizures, when adverse events that include seizures are on the vaccine injury table?"
The only way that that committee could be held responsible for what is on the table is if they had created the table. Congress created the table via an Act of Congress. If having two heads was on the table, would you then expect people to grow an other head when vaccinated? Congress has historically fouled up technology and medicine laws.

" Congress created the table via an Act of Congress."

The injuries on the table are determined by the Secretary on the advice of the ACCV and scientific evidence.
https://www.hrsa.gov/advisorycommittees/childhoodvaccines/Meetings/2016…
"The National Childhood Vaccine Injury Act of 1986 (Act), as
amended, authorizes the Secretary to create and modify a
list of injuries, disabilities, illnesses, conditions, and deaths
(and their associated time frames) associated with each
category of vaccines included on the Vaccine Injury Table."

So either the HRSA is using pseudoscience on the table or the 2013 IOM claim is pseudoscience.

IOM 2011 looked at ACTUAL EVIDENCE and said, pg.132/162
"Conclusion 4.4: The evidence convincingly supports a causal rela-
tionship between MMR vaccine and febrile seizures."

Your 2013 report says:
"Experts who addressed the committee pointed not to a body of evidence that had been overlooked but rather to the fact that existing research has not been designed to test the entire immunization schedule."
They had NO evidence about the safety of the entire immunization schedule (which is what they were charged to assess), so they just made it up.

As usual Vinu twists the truth. I cant duoble check at the loment, I'm in a carpark. The 2013 report does say it's one of the most comprehensive review of the entire schedule done to date...

Also yon 2011 report states that only "some" vacines cause seizures, maybe those aren't included in the 2013 schedule?

By the ways, who still does the MMR jab. Here in the UK we use a 5 in 1 jab.

"Also yon 2011 report states that only “some” vacines cause seizures, maybe those aren’t included in the 2013 schedule?"

The MMR causes seizures and it is on the 2013 schedule.
There's no escape ...

"The 2013 report does say it’s one of the most comprehensive review of the entire schedule done to date…"
2013 report:
"existing research has not been designed to test the entire immunization schedule."
When there is no evidence, a comprehensive review should be quick and easy.

Oh wait, the plot thickens:
2013 paper abstract:

"As reviewed by prior Institute of Medicine studies, a substantial literature exists on adverse effects of individual vaccines, but few studies have focused on elements of or the recommended childhood immunization schedule as a whole. The lack of conclusive evidence linking adverse events to multiple immunizations or other “schedule” exposures suggests that the recommended schedule is safe. "

Lack of evidence means exactly what it says. You cannot jump to ANY conclusion. Are vaccines safe? We JUST DON'T KNOW. The research is not there.
https://www.hrsa.gov/vaccinecompensation/resources/adverseeffects.pdf
" (135 vaccine-adverse event
pairs), the evidence is inadequate to accept or reject
a causal relationship. "

"made rarer by removing food allergies. Happy days."

Bloody spellchecker. That was meant to say "removing food allergens " of course.

The Israeli studies that have led to the AAP-etc's change in recommendations about when to introduce peanuts suggest that vinu has it all backwards.
https://www.washingtonpost.com/news/to-your-health/wp/2017/01/05/new-ni…

Were there any peanut proteins in the vaccines give to young infants, they would have help protect against developing the allergies.

Summary including original research references here (no, my bad, I haven't read all the source material but posting it anyway):
http://pediatrics.aappublications.org/content/136/3/600

"Were there any peanut proteins in the vaccines give to young infants, they would have help protect against developing the allergies."

Sorry, you have misunderstood. Young infants have to EAT peanut to get protection. If you inject peanut protein, they develop peanut allergy. At a high level, eating induces immune tolerance.
Injecting induces allergy.

@Chemmomo, oddly, the US also had introduced similar research.
It's good to have research confirmed, replication and all.

Let's review the engineering problem; child develops within a nearly sterile womb, receives limited antigens from immune compromised via pregnancy mom.
Upon delivery, child hopefully receives colostrum from mom, loaded full of antibodies, if not, child has to have a heavier load of "learning" of the immune system and has a significant disadvantage under primitive situations.
Child is then flooded by exposures with antigens, many will be upon skin that child occasionally finds and gradually finds his or her mouth. The rest are largely airway borne.
Both antigen sets meet in the upper thorax, where the thymus is and a *lot* of immune system attention is focused during development and development isn't finished, the child is half-baked, far from adult, indeed, far from a nymph stage.

All of that was expressed from less than a half second of consideration of the argument.
I could add hundreds of supporting citations and arguments, but the troll will never desist, as a paid asset never will fail to seek pay.
(insert your own cultural term of greeting, salutation and departure, I'm tired and have to go to work in the morning)

If there wasn't some fundamental difference between eating and injecting as a route to gen up an immune response then we'd all be eating Cornflakes and Cherrios fortified with MMR and folic acid.

You hit the nail on the head.

The FDA is too stupid to understand this fundamental concept.
They think injecting proteins is the same as ingesting proteins.

http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSaf…

"Why are sugars, amino acids, and proteins added to some vaccines?
These substances may be added as stabilizers. They help protect the vaccine from adverse conditions such as the freeze-drying process, for those vaccines that are freeze dried. Stabilizers added to vaccines include: sugars such as sucrose and lactose, amino acids such as glycine or the monosodium salt of glutamic acid and proteins such as human serum albumin or gelatin. Sugars, amino acids and proteins are not unique to vaccines and are encountered in everyday life in the diet and are components that are in the body naturally."

Cobra venom is a protein that can be safely eaten if you don't suffer from ulcers. So, per the FDA protein in vaccine rules, cobra venom is approved for use in vaccines. As per the geniuses at the FDA, If you can eat it, it is safe to inject.

The food allergy epidemic is the result when you put a monumentally incompetent agency like the FDA in charge of vaccine safety.

What a wonderful idiot who denigrates the hard work of thousands who, without appropriate staffing or budgets,most I'll manage to track and improve the safety of hundreds, if not thousands of different products.

"Who manage..."

Work is in progress on a vaccine against peanut allergies:

http://allergenbureau.net/melbourne-group-to-fast-track-peanut-allergy-…

Hopefully, tandem research will be able to prevent antivaxers' heads from exploding.

Humans seem to ALWAYS underestimate the difficulty of fooling nature.
Vaccines are about fooling the immune system into providing immunity without suffering the disease. With our unsophisticated vaccines, we have achieved disease protection at the cost of creating chronic life-threatening diseases (food allergy and asthma).

As I show here, food protein epitopes cross react with bacterial epitopes.
https://www.researchgate.net/publication/310021910_Significant_protein_…

Now if this peanut allergy vaccine makes you tolerant to peanut proteins, as a side effect, it could also make you to tolerant to bacterial proteins that look similar. In other words, the body will assume these bacterial proteins are safe and not attack those bacteria any more. So basically, you could lose the protection to vaccine preventable diseases that you had gained via vaccines. Putting you back to square one. Oops!

For a start I'm not clicking on any more of your "research", you are not a scientist, your assertations carry out weight, your conclusion flawed, biased, blinkered and nonsensical.

Allow me to demonstrate:
"as a side effect, it could also make you to tolerant to bacterial proteins that look similar."
Citation needed lol.
Even if it did, we would not be back to square one as this would only be given to those who had food allergies, the population would still be vaxed, therefore there would be herd immunity.

Again you are trying to create a scare over nothing. Fuxk off.

"Citation needed lol."
The researchers admit they understand very little of what's going on.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4713452/

So the citation you are looking for is here:
https://en.wikipedia.org/wiki/Murphy's_law

Captain Murphy was an incurable optimist. ;)

"herd immunity."

The latest guidance is now for early childhood exposure to peanuts.
After much study, where previously it was advised to avoid peanuts early in life, in order to avoid peanut allergy, that thinking is now believed to be in error.

Like John Kerry's:
"I actually did vote for the $87 billion before I voted against it."

Flumist flip/flop.

The AHA/ADA flip/flop on dental premedication.

And now the peanuts flip/flop.

When these groping-in-the-dark "experts" claim vaccines are safe, most people swallow it hook line and sinker, and all the way to the elbow ...

Ah! So, now pediatric immunologists are vaccine developers and investigators, right?
A change in evidence in a distantly related field discredits all fields of science in your nirvana fallacy suffering world.

Well, EMS and emergency department procedures have changed over the years as well, don't trust them if you have a severe accident.
Go to your local butcher shop instead.

"Ah! So, now pediatric immunologists are vaccine developers and investigators, right?
A change in evidence in a distantly related field discredits all fields of science in your nirvana fallacy suffering world."

No. It demonstrates a pattern. They ignore the warning of a doctor from a hundred years. They ignore what they were taught in medical school. They ignore common sense because they are the "experts". They mess it up royally. And then they flip/flop. Again and again. Add corruption to the mix. That makes a great recipe for the disaster that is being served up now.

"They ignore the warning of a doctor from a hundred years."
Yes, they also stopped bleeding people for influenza. That was the cause of George Washington's death. They also stopped sticking unsterilized fingers into gunshot wounds, like they did with Abraham Lincoln and William McKinley.

"They ignore what they were taught in medical school."
Thank goodness that they do! Knowledge advances, new understandings emerge. Oncologists rarely cured many cancers, even during my early life. Today, many, many cancer patients are successfully treated, moving from remission to cure. All because physicians advanced our understanding of cancer and created new treatments, rather than sticking only with what they were originally taught.
Or do you want us to go back to the days when TB was a death sentence, cancer also a death sentence and female hysteria was thought to be a real thing?

"And then they flip/flop."
Yeah, doctors were trained that stress and diet caused stomach ulcers, then some upstart collected bacterial samples from patients with ulcers. Now, medicine has "flip-flopped" and treat those ulcers with proton pump inhibitors and antibiotics, curing them. How dastardly of them!

"Add corruption to the mix."
Again and again you claim corruption, not a single time have you provided evidence of corruption, only a conspiracy theory and conspiracy theory laden websites.

"That makes a great recipe for the disaster that is being served up now."
The only disaster that is being served up now is your spew wasting electrons and electrical current.
Actually, that's not a disaster, it's an annoyance. You and your ilk having your way and preventing physicians from preventing communicable disease would be a disaster.
I've saw with my own eyes what polio and measles can do to those without access to vaccines and I've saw when both diseases struck vulnerable populations, filling many tiny graves. I'd just as soon not see those things in a nation I spent the better part of my life in military defense of. I still have nighmares from those experiences.

"Thank goodness that they do! Knowledge advances, new understandings emerge. "

The concept in the UCI class notes below from 2011 is identical to Dr.Richet's finding more than a hundred years ago. Now since you claim to be the immunology expert, please show us the EVIDENCE that these concepts are OUTDATED.

http://jeeves.mmg.uci.edu/immunology/CoreNotes/Chap21.pdf

Pg. 157:
“A guinea pig can be sensitized by intramuscular injection of an antigen, say OVA (ovalbumin). Its immune system responds by producing antibody to OVA, including (but not
exclusively) IgE. Some of this circulating IgE will be fixed onto mast cells in various tissues, including the vasculature and respiratory tract. Three weeks later, the same animal can be
challenged either with an intravenous dose of OVA or by exposure to an aerosol containing OVA. Following IV injection, the animal will rapidly develop severe vascular shock and die within a few minutes (the combination of venule constriction and capillary dilation results in pooling of blood in the peripheral circulation and a drastic drop in blood pressure). If exposed to the aerosol, it will equally rapidly die from bronchial constriction, an experimental model for human asthma. ”

"Yeah, doctors were trained that stress and diet caused stomach ulcers, then some upstart collected bacterial samples from patients with ulcers. Now, medicine has “flip-flopped” and treat those ulcers with proton pump inhibitors and antibiotics, curing them."

EXACTLY. Doctors should know that they can easily be WRONG as above. Happens all the time. So, they have to keep an open mind and look at the EVIDENCE carefully again and again. THEY CAN NEVER EVER CLAIM VACCINES ARE SAFE AND THE SCIENCE IS SETTLED. Because as you have shown, the science is NEVER EVER settled.

And if your stomach is a little unsettled after your "cure", it is because the science is not settled ...
Helicobacter pylori: enemy, commensal or, sometimes, friend?
https://www.ncbi.nlm.nih.gov/pubmed/26142681

" have you provided evidence of corruption"
Which planet do you live on?

http://tdi.dartmouth.edu/press/press-releases/corruption-of-the-health-…
https://www.nytimes.com/2014/11/19/opinion/how-medical-care-is-being-co…

Young infants have to EAT peanut to get protection. If you inject peanut protein, they develop peanut allergy. At a high level, eating induces immune tolerance.
Injecting induces allergy.

And, once again, the halfwit who lies about being a medical student at Medscape demonstrates that TPN and blood transfusions are death sentences. There's no point feeding nickels into a jukebox full of broken records.

Hypersensitivity to total parenteral nutrition fat-emulsion component in an egg-allergic child.
https://www.ncbi.nlm.nih.gov/pubmed/21911353

It does not take 14 days to have a Type I reaction. The only explanation is that the egg containing IFE caused a new allergy or boosted a weak allergy.

TPN and blood transfusions are death sentences

Hmm. Those don't directly contain an adjuvant facilitating inflammation to give a 'heads up' for the collocated antigen. Total Parenteral Nutrition -- Inject a well-blended cheezeburger.
============

the child is half-baked

https://www.youtube.com/watch?v=Mkqmd0saSC4

Just to recap: vinu asserts that all vaccines are contaminated with food proteins. vinu asserts that these must and do cause the development of food allergies. (The number of additional people with allergies is no asserted or demonstrated.)

Therefore, to prevent the possible development of and unknown number of food allergies vinu demands that everyone everywhere stop using any injected vaccine until it has been shown to vinu's approval that it does not contain food proteins.

So that leaves us with only the vaccines we've already gotten (adults) and the oral polio vaccine, which is known to have serious side effects and is only used in places with high risk of polio and sub-optimal medical infrastructure.

So vinu: How many people have died of food allergies they have gotten from vaccination (and show that they did not develop these allergies naturally) and compare that to how many people will die of VPD's while we scramble to make your perfect vaccines.

"vinu demands that everyone everywhere stop using any injected vaccine until it has been shown to vinu’s approval that it does not contain food proteins."

Thanks for putting a lot of words into my mouth.

Here's what I actually said:
https://www.omicsgroup.org/journals/evidence-that-food-proteins-in-vacc…

" phasing out
food proteins from vaccines and injections as soon as possible would
be the real solution for food allergies caused by vaccines and injections"

"we should immediately stop multiple vaccines being administered
simultaneously. "

" we should add a warning in
vaccine package inserts about food allergy being a possible side effect. "

"we should add a warning in
vaccine package inserts about food allergy being a possible side effect. “

This is what I reckon is Vinu's true motivation, it's like Wakefield part two. Blame a condition that has evidentialy nothing to do with vaccines, on vaccines, to allow parents and lawyers to get rich suing presumably everyone involved.

IOM concludes food proteins in vaccines cause sensitization.
Dr. Richet said the same a hundred years ago.
UCI medical school notes say injectiing food proteins causes fatal food allergy and asthma.
I have numerous more scientifc references here:
https://www.researchgate.net/publication/312125211_Professional_Miscond…

NO ONE has provided any evidence to counter it.
Obviously, there is no place for science in this NON SCIENCE BLOGS.

"herd immunity."

Does not apply to tetanus, pertussis and may be others.
It took the FDA 17 years to figure out acellular pertussis vaccine does not prevent transmission. More flip/flops are possible ...

"“herd immunity.”

Does not apply to tetanus, pertussis and may be others."

Tetanus is not transmitted between people, so this statement is unusually ignorant even for vinu.
And it is untrue that herd immunity "does not apply" to pertussis. It's not sufficient to completely stop spread in highly vaccinated populations, but the more people are covered by vaccination, the less likely it is to infect susceptible persons.

vinu needs coursework in basic immunology and infectious disease, as well as help in developing critical thinking skills.
Fortunately, online assistance is available.

http://www.openculture.com/2014/02/oxfords-critical-reasoning-for-begin…

"It’s not sufficient to completely stop spread in highly vaccinated populations, but the more people are covered by vaccination, the less likely it is to infect susceptible persons. "
Relevant evidence please.

https://list.nih.gov/cgi-bin/wa.exe?A2=ind1606&L=immuni-l&F=&S=&P=40366

Long term persistence of inflammation in children vaccinated with Salmonella conjugate vaccine is associated with augmented Th9-Th17 cytokine

https://list.nih.gov/cgi-bin/wa.exe?A2=ind1606&L=immuni-l&F=&S=&P=36477
http://www.sciencedirect.com/science/article/pii/S1043466616306160

E-mails as evidence, how quaint. With a bit of searching, I can find e-mails and use them evidence for flying saucers and reptilian invaders.
That doesn't make them real.

Those emails show that unlike the bogus experts here, the REAL immunology experts value my input.

Uh huh, a cool response, within a degree of absolute zero cool is not welcoming your input.

FWIW, I'll add a thought that has been occurring to me for a few days.

I would characterize Vinu's entire reasoning process as a combination of yeah-but-ism and what I would call the square zero fallacy.

That is, no matter how many times we refute his allergy speculations and point out that there is no link between vaccinations and allergies, he responds with "yeah, but what about this other mechanism that might possibly cause a problem".

And his comment that we can say nothing about the safety of vaccines is a perfect example of the square zero fallacy.

He wants to go back to square zero, ignore all the mountains of vaccine safety (and effectiveness) research from development testing to large scale population studies to follow-up surveillance and talk about possible problems with vaccines as if we knew none of that.

But in fact we know that vaccines (at least the officially approved ones) are extremely safe, that they have a few significant side effects occurring at about the 1 in 100,000 rate, that long term severe side effects only happen at a rate of 1 in a million or less, and that they are much, much safer than the diseases they protect against.

"how many times we refute"

You have not done it even once.

We have loads, you are just to stupid/ mental to realise it.

I meant SCIENTIFIC REFUTATION.

But you don't understand the scientific Vinu, that's painfully obvious to everyone.

If you were serious, get at least a degree in a life science, learn the damn history. You wouldn't make the basic mistakes that earn you such ridicule.

Ref comment #258

Don't forget that vinu is also afflicted with the Nirvana fallacy, which allows him to claim that something does not exist (i.e. herd immunity protecting against pertussis infection) if it is not 100% perfect.

I found another course he should consider taking:

https://www.futurelearn.com/courses/logical-and-critical-thinking

"(i.e. herd immunity protecting against pertussis infection) if it is not 100% perfect."
Still waiting for the citation ...

I'm trying to imagine how people think that food proteins (other than chicken egg) get into vaccines, and I got the lovely mental image of a giant vat labeled "vaccines" and a worker on a catwalk dropping a sandwich into it.

It made me smile.

Naw, the worker on the catwalk over the vat of vaccines spilling a cup of soup, after dipping a PB&J sandwich into it.
"Butterfingers! That's the third time this week!"

No, actually food proteins get into our vaccines when pharma workers lose their footing on the catwalk and plunge into the boiling cauldron o'toxins, never to be seen again.*

*like in Upton Sinclair's "The Jungle", where slaughterhouse workers fell into the vat and went out into the world as Durham's Pure Leaf Lard.

"Mary had a little lamb And when she saw it sicken She shipped it off to Packingtown And now it's labeled chicken.”

Yeah, that book was required reading when I was in school.
It no longer is, but I bought that and Nineteen eighty four for both of our kids.

Mary had a little lamb

Gosh. That must have hurt.

More news on Tom Prices

Follow the money

First on CNN: Trump's cabinet pick invested in company, then introduced a bill to help it
http://www.cnn.com/2017/01/16/politics/tom-price-bill-aiding-company/in…

The new Secretary of Health and Human Services is a member of a fringe medical organization. Here's what that means.

oracknows — Wed, 30 Nov 2016 03:00:15 +0000

The new Secretary of Health and Human Services is a member of a fringe medical organization. Here's what that means.

I’m always hesitant to write about matters that are more political than scientific or medical, although sometimes the sorts of topics that I blog about inevitably require it (e.g., the 21st Century Cures Act, an act that buys into the myth that to bring "cures" to patients faster we have to neuter the FDA and a retooled version of which is still being considered). This is one of those times. Yesterday, I woke up to the news that President-Elect Donald Trump had chosen Rep. Tom Price (R-GA) as his new Secretary of Health and Human Services. The Department of Health and Human Services (DHHS), of course, figures fairly prominently in a some regular topics discussed on this blog because major federal agencies that I write about are within the DHHS, including the CDC (vaccine issues, Zika virus, etc.), the FDA (drug approval and drug safety), and, of course, the National Institutes of Health (billions of dollars worth of medical research). So the HHS Secretary matters, at least for purposes of discussing science-based medicine. Then there’s also the issue of Donald Trump’s long history of rabid antivaccine views, coupled with the other issue of his having met secretly with Andrew Wakefield in August in Florida and, after the election, antivaccine activists seeking to influence him based on that meeting. Heck, as I’ve noted before, Vice President Mike Pence apparently doesn’t believe that smoking causes cancer and premature death. So I was looking for a signal in whomever Trump picked regarding whether he would actually do anything about vaccine policy potentially harmful to public health.

So why did Tom Price catch my attention more than other Trump cabinet picks? Yes, he detests Obamacare and is likely to be fully enthusiastic about gutting it, but pretty much anyone Trump picked would have been expected to hold that view. It’s pretty much par for the course for the Republican Party these days. I would have been more surprised if Trump had picked someone who was was relatively neutral on the Affordable Care Act. No, what caught my eye was that I learned that Tom Price is a member of the Association of American Physicians and Surgeons (AAPS), and that told me a lot about him, none of it good. For instance, in 2015 Charles Pierce referred to Price as "one of Georgia’s wingnut sawbones” (Price is an orthopedic surgeon), and noted an article by Stephanie Mencimer, The Tea Party's Favorite Doctors, which included this description of the AAPS:

Yet despite the lab coats and the official-sounding name, the docs of the AAPS are hardly part of mainstream medical society. Think Glenn Beck with an MD. The group (which did not return calls for comment for this story) has been around since 1943. Some of its former leaders were John Birchers, and its political philosophy comes straight out of Ayn Rand. Its general counsel is Andrew Schlafly, son of the legendary conservative activist Phyllis. The AAPS statement of principles declares that it is "evil" and "immoral" for physicians to participate in Medicare and Medicaid, and its journal is a repository for quackery. Its website features claims that tobacco taxes harm public health and electronic medical records are a form of "data control" like that employed by the East German secret police. An article on the AAPS website speculated that Barack Obama may have won the presidency by hypnotizing voters, especially cohorts known to be susceptible to "neurolinguistic programming"—that is, according to the writer, young people, educated people, and possibly Jews.

I realize that just because Tom Price is a member of the AAPS doesn’t necessarily mean that he subscribes to all its views—or even most of them. Maybe he’s like the Trump voters who were attracted by other things about him or hated Hillary Clinton more than they were disturbed by his racism, embrace of ~~the alt right~~ white supremacist movement, misogyny, and conspiracy mongering. Maybe Price was attracted by the AAPS world view that rejects nearly all restrictions on physicians’ practice of medicine, purportedly for the good of the patient; its support of private practice and dislike of government involvement in medicine, either financially or regulatory; and its embrace of an Ayn Rand-style view of doctors as supermen and women whose unfettered judgment results in what's best for patients and medicine. Perhaps he was so attracted to the AAPS vision of doctors as special and "outside of the herd" to the point that he ignored its simultaneous promotion of dangerous medical quackery, such as antivaccine pseudoscience blaming vaccines for autism, including a view that is extreme even among antivaccine activists, namely that the “shaken baby syndrome” is a “misdiagnosis” for vaccine injury; its HIV/AIDS denialism; its blaming immigrants for crime and disease; its promotion of the pseudoscience claiming that abortion causes breast cancer using some of the most execrable “science” ever; its rejection of evidence-based guidelines as an unacceptable affront on the godlike autonomy of physicians; or the way the AAPS rejects even the concept of a scientific consensus about anything. Let’s just put it this way. The AAPS has featured publications by antivaccine mercury militia “scientists” Mark and David Geier. Even so, the very fact that Price was attracted enough to this organization and liked it enough to actually join it should raise a number of red flags. It certainly did with me, because I know the AAPS all too well.

I haven’t written much about the AAPS, but the first time I ever encountered the group was over a decade ago. Given that Tom Price is now in the news as Trump’s selection for DHHS, now appears to be a good time to revisit the AAPS, although I have already briefly done so because, not surprisingly, the AAPS has been a huge foe of Obamacare. Consistent with the conspiratorial bent of many AAPS leaders, AAPS CEO Dr. Jane Orient peddled medical conspiracy theories that Hillary Clinton was “medically unfit to serve.”

Since it’s been a long time, I decided to peruse the most recent episodes of the Journal of American Physicians and Surgeons (JPANDS), to see what the group has been up to, “scientifically” speaking.Not surprisingly, the Fall 2016 issue contained the usual rants against Medicare and taxes and complaints about the “end of fee-for-service medicine” (perhaps the “threat” that animates the AAPS perhaps more than anything else), but it also contained other typical AAPS bugaboos. For instance, there is this article decrying mandatory influenza vaccination for health care professionals, in which a fictional nurse named Rebecca is demonized by her coworkers for refusing the flu vaccine, along with some familiar anti-flu vaccine tropes.

Then, consistent with the hostility of the AAPS towards evidence-based medicine, there is this “gem” of an article, The Evidence-Based Transformation of American Medicine by Hermann W. Børg, MD. Let’s just say that Dr. Børg writes about evidence-based medicine as though it were a bad thing. If there’s another thing (besides Medicare or any hint of federal “control” of medicine) that the AAPS hates with a passion, it’s evidence-based medicine. Børg's an article that combines the reasonable, such as questions about pharmaceutical influence in generating EBM guidelines and the contention that for preventative interventions we should pay attention to the number needed to treat and to absolute risk reductions more than relative risk reduction, with real howlers, like this paean to anecdotal evidence:

The very low level of quality assigned to anecdotal evidence in this system requires a brief comment. In keeping with the mantra that “the plural of anecdote is not evidence,” any usefulness of “anecdotes” in clinical practice is dismissed outright by EBM. However, as one wise professor observed, “Every epidemic starts with a single case report” (R.L. Kimber, personal communication, 2000). Serendipitous breakthroughs are made by individuals who make careful observations of patients from close range, seldom or never by a team encumbered by a rigid experimental protocol and the huge number of subjects needed to reach statistical signicance. Single observations may be extremely important, even if not statistically significant in the context of a large trial. Say, for example, a rare, otherwise unexplained event follows a medical intervention: a patient takes a drug and inexplicably goes blind. It might be a coincidence, or it might be a side effect of the drug. One cannot rule out a causal relationship based on lack of a statistically significant difference in this occurrence between the drug and placebo groups in a trial of insufficient power to detect a rare event. One is obligated to investigate further.

This is, of course, a straw man so massive that, were it real, the astronauts living on the International Space Station could see it from orbit. EBM (and science-based medicine) recognize the importance of anecdotes, but as hypothesis-generating observations, not hypothesis-confirming observations. Moreover, serious adverse events, such as blindness, are not dismissed as “correlation not equaling causation” without investigation. Certainly the FDA would not dismiss multiple reports of blindness after a drug dose as “the plural of anecdotes not being data.” While I will concede that sometimes skeptics use that quip about anecdotes a bit too freely, in actual practice clinical observations of a reaction as serious as the example given by Dr. Børg are not dismissed as coincidence without investigation, consistent with the role of anecdotes as hypothesis-generating. Basically, Dr. Børg, again consistent with the AAPS view of the physician as supreme, wants the freedom to be able to use clinical observation in any way he wants without restriction by those pesky EBM guidelines and to interpret medical evidence any way he wants, even if it conflicts with how the vast majority of the field interprets it.

If you want a distillation of how the AAPS views EBM guidelines, Dr. Børg gives it:

Strict application of EBM implies a mechanistic algorithm- driven approach, similar to primitive pre-artificial-intelligence computer programs of the past. In such an approach, the doctor sees the patient as a statistic rather than an individual. This sort of medicine could be practiced by administrators. In the real world, however, clinical trials may tell which treatments are e ective, but not necessarily which patients should receive them.

Modern studies of the human genome and proteome have deepened our understanding of the importance and vast extent of biochemical individuality. The patient could be in a subset of patients whose excellent response to an intervention was diluted out in the large number of randomized subjects. It is recognized, for example, that two genes affect how patients process 25 percent of drugs now on the market. In fact, advances in pharmacogenetics may render the EBM model obsolete and replace it with “Genomic Medicine.” One of the major promises of pharmacogenomics is the ability to precisely predict the individual patient’s response to medical intervention, without the need to indirectly draw such conclusion from the large epidemiology-based studies.

Bloody hell. This is exactly the same sort of rationale that functional medicine quacks use to justify in essence, doing anything they believe in to treat patients, all in the name of respecting the patient’s “biochemical individuality” and as an excuse to make it up as one goes along. (Heck, he even uses the same term!) As I like to point out, there is already room in EBM guidelines for the physician’s clinical judgment. However, if a physician deviates from EBM guidelines significantly, it is expected that he or she should have a damned good reason for doing so.

Also, where nowhere near this precision medicine utopia yet, mainly because we lack understanding of the significance of various mutations and differences in gene expression when measured on a whole genome basis. Clinical trials are still necessary. They are also evolving in order to incorporate genomic data and biomarkers in treating patients. One form these new trials take is the so-called “adaptive trial,” which uses patient outcomes and biomarkers to immediately inform further treatment decisions. So, though, results from these trials have been disappointing. Again, Dr. Børg seems to be invoking genomics more as an excuse to dismiss EBM guidelines than anything else.

Now, one might say that Price might not know anything about articles like this, and that’s certainly possible. On the other hand, the reason I cited Dr. Børg is because his article represents what is perhaps the overarching view that is the cornerstone of the AAPS: The fetishization above all else of the individual doctor’s judgment and hostility to any restriction on physician autonomy, or, as I like to characterize it, anything that smacks of “telling doctors what to do.” Truly AAPS worships “brave maverick doctors” and castigates doctors following EBM as going with the herd. Basically, as I described the first time I discussed the AAPS, the leadership of the AAPS and apparently many who publish in JPANDS seem to be a bit too enamored of their self-proclaimed “maverick” status and give the appearance of thinking that, like Ayn Rand’s hero, they’re “supermen” whose egoism and genius will inevitably prevail over timid traditionalism and social conformism. Reigning them in with evidence only interferes with their autonomy and prevents them from exercising their genius for the good of their patients. If only the “herd” could appreciate that!

Oh, and as recently as the Summer 2016 issue of JPANDS, the AAPS was still publishing risible antivaccine pseudoscience in the form of an article by Neil Z. Miller entitled Combining Childhood Vaccines at One Visit Is Not Safe. Let’s just say that it lived down to the usual very low scientific standards of JPANDS, as I described in detail in June.

Tom Price probably doesn’t buy into all the quackery of the AAPS, but my reading thus far leads me to believe that he fully embraces the Ayn Rand-worshiping wingnuttery the organization. I do feel obligated to state here, though, that, although I do believe he’s a very bad choice for DHHS, fortunately thus far I have found no evidence that he is antivaccine and have even heard rumblings that antivaccinationists are not happy with this choice for DHHS. I do know that the One Crank To Rule Them All, über-quack Mike Adams, is practically twisting himself into a pretzel justifying a “wait and see” attitude even though he is clearly very upset over this choice because Price voted against GMO labeling. (No, I’m not going to link to Adams.) However, you can learn a lot about a person by the people with whom he associates and the groups he joins and supports. By joining the AAPS, Price has shown that he is clearly attracted to a pre-Medicare vision of a golden era of absolute physician autonomy with minimal or no government interference or programs like Medicare, as well as a hostility towards evidence that conflicts with that vision. There is no arguing this, as these are beliefs that are baked into the DNA of the AAPS; they are central to the organization. Attraction to such beliefs is not a good trait for a Secretary of HHS to be attracted to, and I haven’t even really gotten into Price’s fundamentalist antiabortion beliefs, and his implacable opposition to gun control. It’s going to be a long four years when it comes to health policy.

oracknows Tue, 11/29/2016 - 22:00