institute of medicine

The Institute of Medicine report on cancer care: Is the system "in crisis"?

oracknows — Thu, 19 Sep 2013 01:01:09 +0000

The Institute of Medicine report on cancer care: Is the system "in crisis"?

Americans love to fight, traditionally. All real Americans love the sting and clash of battle...When you, here, everyone of you, were kids, you all admired the champion marble player, the fastest runner, the toughest boxer, the big league ball players, and the All-American football players. Americans love a winner. Americans will not tolerate a loser.

- General George S. Patton, Jr., June 5, 1944

General George S. Patton, Jr. was famous for his flamboyance and aggressiveness going on the attack, among other things. He was also known for a number of pithy quotes made throughout his lifetime, particularly during World War II, such as the one above in which he declared how much Americans love to fight. I sometimes wonder whether he was more correct in that assessment than he knew in that we seem to view almost everything through the lens of war and a crisis that calls for a war. In medicine, for instance, we have the "war on cancer" and the "war on obesity." We have a propensity for likening problems and their solutions to war, where the goal is to destroy the enemy.

Similarly, but less dramatic (although only slightly so), we have various crises. Indeed, Americans seem to love to compare problems to crises as much as they love to compare them to war. Of course, the two are closely related, as a crisis of some sort is a necessary prelude to a war. We can argue about the definition of a "crisis," but one thing is certain. No matter how one defines it the word "crisis" implies an urgent problem and further implies that something must be done now—or at least very soon—to prevent the catastrophic consequences of that problem, which usually involve a breakdown of a current system. It was with these thoughts in mind that I approached the Institute of Medicine (IOM) consensus report released last week, Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis. It's a behemoth of a report, weighing in at 360 pages, and it does indeed paint a picture of some very serious problems in cancer care that should be addressed. It is subdued in that it doesn't engage in that oh-so-American tendency to declare "war" on every problem, but is cancer care "in crisis"? Of that, I'm not so sure, but it's definitely got problems. But, as I've said, the system's had problems for a long time, as the IOM itself documented in its 1999 report Ensuring Quality of Cancer Care, which concluded that "for many Americans with cancer, there is a wide gulf between what could be construed as the ideal and the reality of their experience with cancer care." The report also recommended steps to improve cancer care and the evidence base for cancer care, and to overcome barriers of access to high-quality cancer care. As the introduction to the current report states:

These recommendations led to a number of efforts targeted at improving the delivery of cancer care. The Secretary of the U.S. Department of Health and Human Services (HHS) established the Quality of Cancer Care Committee to work on issues identified in the report. A number of organizations used the report to develop core indicators of quality of cancer care and recommendations for improving the quality of cancer care, including the Agency for Healthcare Research and Quality (AHRQ), the National Quality Forum (NQF), and the National Dialogue on Cancer (a collaboration organized by former President George H.W. Bush and Senator Dianne Feinstein, now known as C-Change). In response to the report, the American Society of Clinical Oncology (ASCO) undertook a national study of the quality of care delivered by oncologists, called the National Initiative on Quality Cancer Care (ASCO, 2013). In addition, the Cancer Quality Alliance, a diverse group of stakeholders committed to advocating for improvements in the quality of cancer care, used this report and several other IOM reports to develop five cancer case studies depicting a vision for high-quality cancer care and a blueprint for action to realize that vision (Rose et al., 2008). The report provided major input into quality of cancer care legislation drafted by the Senate Health, Education, Labor, and Pension Committee

Not to blow my own horn (too much, anyway), I happen to be involved with two major quality improvement initiatives, one national through the American College of Surgeons Committee on Cancer and another statewide initiative seeking to improve the quality of breast cancer care throughout the state, not just at the two NCI-designated comprehensive cancer centers in the state and the several large health systems but at community hospitals as well. After all, most cancer care in this country does not occur at the 41 NCI-designated comprehensive cancer centers. It is clear to me that, since 1999, there has been a sea change in the attitudes of physicians regarding outcomes tracking to improve quality and adherence to evidence-based guidelines for the better. Physicians in the past were all too frequently wedded to a view in which a physician's autonomy and every decision was unquestioned (and the choice of the word "his" was intentional, given how male-dominated the profession was) and they viewed attempts to persuade them to adopt evidence-based guidelines as intolerable infringements on their god-like autonomy. Today, they are much more receptive to following the guidelines, particularly in oncology. (Unfortunately, when it comes to the CDC's recommended vaccine schedule we've seen an example of a physician who still follows the old-school, haughtily dismissing the recommended schedule because he thinks his clinical experience trumps expert, evidence-based guidelines. But I digress.)

Here's a typical example of how the report is being discussed in the press:

Cancer treatment has grown so complex, many U.S. doctors can't keep up with new information and are offering incorrect treatment, failing to explain options and leaving patients to coordinate their own care, according to a report released on Tuesday by the Institute of Medicine, part of the National Academy of Sciences.

The 315-page report, "Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis," identifies a long list of reasons for the crisis, including a growing demand for cancer care as more people receive a diagnosis and a shrinking oncology workforce.

"Probably on average the quality of care is not bad, but we know there are people who are not getting the (highest) standard of care," said Dr Patricia Ganz, who chaired the institute's panel that wrote the report and is a professor at the Schools of Medicine and Public Health, University of California, Los Angeles. "Patients need to be asking, Is my doctor giving me appropriate treatment?"

On its web page for the report, the IOM even includes a video designed to zero in on the issues discussed in the report:

The first thing I noticed about this video is that it does indeed touch on a number of prominent problems with the cancer care system, but that most of the problems discussed are in reality problems with the entire health care system that tend to be magnified in cancer care. The IOM identifies six items that it used as a conceptual framework on which to drape its solutions:

Engaged patients
Adequately staffed, trained, and coordinated workforce
Evidence-based cancer care
A learning health care IT system for cancer
Translation of evidence into clinical practice, quality measurement, and performance improvement
Accessible, affordable health care

The IOM also articulates ten goals for its recommendations:

Provide patients and their families with understandable information about cancer prognosis, treatment benefits and harms, palliative care, psychosocial support, and costs.
Provide patients with end-of-life care that meets their needs, values, and preferences.
Ensure coordinated and comprehensive patient-centered care.
Ensure that all individuals caring for cancer patients have appropriate core competencies.
Expand the breadth of data collected in cancer research for older adults and patients with multiple comorbid conditions.
Expand the depth of data collected in cancer research through a common set of data elements that capture patient-reported outcomes, relevant patient characteristics, and health behaviors.
Develop a learning health care information technology system for cancer that enables real-time analysis of data from cancer patients in a variety of care settings.
Develop a national quality reporting program for cancer care as part of a learning health care system.
Implement a national strategy to reduce disparities in access to cancer care for underserved populations by leveraging community interventions.
Improve the affordability of cancer care by leveraging existing efforts to reform payment and eliminate waste.

I don't think I'll be able to address all the issues, because each of the six items in the conceptual framework and goals have several recommendations to achieve them and the discussion would quickly balloon beyond the already prodigious verbiage of a typical one of these posts. (Also, I'm trying to make like Harriet and keep my posts a bit brief, at least under 4,000 words for a change.) So I'll basically pick and choose, since a lot of these principles and recommendations are related. Let's start with the issues that are basically the same issues that plague all of medicine, for instance an adequately staffed and trained workforce, a better IT system, and accessible, affordable care. All three of these are clearly interrelated, and tend to boil down to money, perverse incentives in the reimbursement system, and systemic inefficiencies. For example, if we want an adequately staffed, trained, and coordinated workforce, it's going to require cash. From somewhere.

Fortunately, there are some actions that can be taken legislatively, and recommendations to change the system so that reimbursement for team-based care is more favorable are appreciated. Of course, recommendations for a shift to team-based care will conflict with recommendations to improve the number of trained providers, because team-based care can be quite inefficient. Multidisciplinary tumor care groups often see far fewer patients in a day because each patient is seen by all the specialties on the same day. For example, such systems can make it hard for surgeons to see enough patients to generate enough cases to generate enough revenue be financially viable. As long as surgeons are paid by the procedure, this will be a problem. Also, multidisciplinary teams require a significant infrastructure to maintain, and that doesn't come cheap. Come to think of it, two of these goals (better IT, an adequately staffed and trained workforce) will likely conflict with making cancer care more affordable. True, it's argued that this won't be the case because better coordination of care, better cancer IT, and better staffing will reduce costs, but the evidence is rather thin to support these assertions.

In the case of IT and a better electronic medical record (EMR), certainly there would be benefits, as described in the report and greatly touted in the video, where one of the patients complained that lack of coordination between her doctors led to her being overdosed with an antihypertensive medication. The problem with coordinating care in the US is that there is no single unified health system, nor is there a single, unified medical record. Large health systems have common medical records, but that only helps if a patient is receiving all of his or her care in a single health care system. EMRs from different health care systems often don't talk to each other. Transferring data from EMRs can be a nightmare. Worse, many of the existing EMRs are not exactly what one would call "user friendly." Indeed, the EMR I'm stuck using can best be described as "user hostile." After five years, I can honestly say that I still don't fully understand much of it, and I'm not exactly computer illiterate. In fairness, I will point out that I haven't put the time in to learn all the ins and outs of the system, but that brings up another point, namely that the up-front costs, in terms of money and time to implement an EMR, are enormous. Between lost productivity and the costs of implementation and maintenance, many private practices can't afford it. Worse:

To make matters tougher on physicians, today's EHRs are not really designed to "optimize speed of throughput for the clinician," Haughton says. In many instances, a quick handwritten note in a patient's chart is all that's needed to record the encounter. Today's EHRs, however, with their quality reporting and meaningful use integrations, make it challenging for doctors to complete their notes swiftly. They must enter, and often re-enter again and again, patient data that are not immediately germane to the medical issue at hand. Thus, it can take physicians a significantly longer time to input their notes into an electronic record than it took with their old paper processes—thereby increasing practice costs after EHR implementation.

Moreover, the advantages of adopting a health IT, for cancer or any other disease, are blunted if the systems can't communicate with each other. Politically, it might never be possible to have a single EMR as there is an inherent distrust of the government having too much of our health information, something that would be facilitated by a single, unified EMR.

Of course, the EMR is only part of the better health IT so I don't want to dwell on it too long. The overall recommendation was to have a "learning IT," but I think that my brief discussion of EMRs is quite relevant, because this is what the IOM's vision for a "learning health care system" includes:

Science and Informatics

Real-time access to knowledge – A learning health care system continuously and reliably captures, curates, and delivers the best available evidence to guide, support, tailor, and improve clinical decision making and care safety and quality.

Digital capture of the care experience – A learning health care system captures the care experience on digital platforms for real-time generation and application of knowledge for care improvement.

"Digital capture of the care experience" is, basically, the EMR. However, the IOM goes beyond that in wanting this digital capture to be able to be fed into a system that can track outcomes and be used for "real time" care improvement and improved clinical decision-making. This is a very tall order that would require considerable allotment of resources. The IOM states that many of the elements necessary are already in place, but if they are I can't see them, and I'm involved in quality initiatives in my own institution, with the American College of Surgeons, and with our statewide collaborative. Data are not entered into our databases in anything resembling "real time," despite our best efforts. I'd love to see such a system, although I'm perhaps a bit more skeptical of the claimed benefits for it; indeed, it would be highly useful to have such a system for all of medicine, not just cancer. Also in fairness, the IOM does recognize the difficulties and challenges involved in

Of most interest to me are the IOM recommendations regarding evidence-based oncology. Ironically, it's hard not to point out that the evidence base for a lot of the health IT recommendations being able to do what they are claimed to be able to do is currently thin to nonexistent, but in terms of actual treatment there has been a major initiative over the last 14 years to improve the adherence to evidence-based guidelines in treating cancer patients. Although this has largely been fairly successful, the IOM points out that there are areas where current oncology practices fall short, particularly in the elderly, for whom the evidence base supporting some common treatments is disappointingly thin.

However, the IOM does make a good point that cancer care has become more complex in the last 14 years. That is arguably true, with the proliferation of genomic tests for various cancers, the attempts to administer "personalized" cancer treatment (or, at it's now more often called "precision oncology"). Few diseases, or classes of diseases (which is what cancer really is, a large class of diseases) require as many specialties to treat it. Nearly every patient with a solid tumor (as opposed to hematologic malignancies) can expect to be treated—or at least seen—by a minimum of two specialties (medical oncology and surgical oncology) and most see a third specialist as well (radiation oncology).

Once the province of surgeons and local-regional therapies, cancer treatment has evolved rapidly in recent decades. Systemic treatments emerged in the 1950s and 1960s, initially as relatively nonspecific chemotherapies with limited efficacy in some human cancers. Empiricism dominated oncology drug development in this era, rather than an understanding of tumor biology. In recent years, researchers have developed treatments targeting specific molecular aberrations (e.g., imatinib for chronic myelogenous leukemia, trastuzumab for breast cancer). Molecularly targeted treatments have pervaded Food and Drug Administration (FDA) approvals in oncology in the past decade and have improved patient outcomes for many cancers. These agents commonly require a test to assess the drug target in the patient’s tumor. As such, companion diagnostic testing (e.g., estrogen receptor [ER] and human epidermal growth factor receptor-2 [HER2] in breast cancer, anaplastic lymphoma kinase [ALK] and epidermal growth factor receptor [EGFR] in non small-cell lung cancer) has increased in importance. The sheer number of targeted agents has increased the educational burden for cancer care clinicians and the financial burden for the healthcare system. In the near future, the implementation of genome-based diagnostics will likely alter both our ability to deliver precision medicine and the complexity of cancer treatment (IOM, 2010, 2012b; NRC, 2011).

Indeed, even the surgical treatment of breast cancer has become more complex. When we do a sentinel lymph node biopsy, for instance, what findings lead us to go back and take the rest of the lymph nodes? Should we do breast-conserving surgery or a mastectomy? When should neoadjuvant chemotherapy be given to shrink the tumor, and how do we predict the likelihood of success?

In any case, the recommendations of the IOM are on more solid ground here, and include requiring researchers evaluating the role of standard and novel interventions and technologies used in cancer care to include a plan to study a population that mirrors the age distribution and health risk profile of patients with the disease, as well as recommending that the National Cancer Institute should build on ongoing efforts and work with other federal agencies, the Patient Centered Outcomes Research Institute, clinical and health services researchers, clinicians, and patients to develop a common set of data elements that captures patient-reported outcomes, relevant patient characteristics, and health behaviors that researchers should collect from randomized clinical trials and observational studies. And, of course, the IOM is big on comparative effectiveness research (CER), which basically involves doing research that compares the effectiveness of two existing treatments. One problem with CER, however, as I've pointed out before, is that it sometimes takes so long to do clinical trials that by the time the results of CER studies are published their results might very well no longer be relevant to cancer care because the standard of care has moved to something different than the treatments being compared. So, yes, I like CER, too. However, I don't know that its power is as great as its adherents claim.

I'm also very impressed with the IOM's recommendations for improved palliative care and increased emphasis on palliative care. Five years ago, my mother-in-law was diagnosed with a recurrence of a particularly nasty form of breast cancer. This recurrence was in the form of widespread metastatic disease, clearly incurable. If there's one thing that resonates with me it's the deficiencies in palliative care in this country, particularly with respect to home care and home hospice. Once my mother-in-law was in inpatient hospice, the care she received was excellent, but while she was still at home the burden fell nearly entirely on my wife and her sister, with very little guidance. If there's a gap in US cancer care, it's there. I learned more than I ever had before about the "real world" during those months.

Finally, one very important part of the IOM report is its emphasis on patient-centered care. I've written about patient-centered care on multiple occasions before (for example, here), and I definitely believe that we do not always study the patient outcomes that matter to patients. The video above featured a woman who saw a "famous" oncologist about her cancer who recommended a very aggressive course of therapy even though she had stage IV (and therefore incurable) disease, and a man with stage I prostate cancer whose first doctor recommended very aggressive surgery. Neither, we're told, were asked what they wanted or what they valued. Although I like to think that this sort of paternalism and "go for cure no matter what" attitude is becoming less prevalent, it still exists in a lot of oncology. That's why it's hard not to agree that patient-centered care is important. However, I always raise one caveat. The decisions and the trade-offs patients decide to accept should be informed by the science. The options presented to the patient, and their cost in terms of potential complications and impact on the patient’s ability to go about his daily activities and in essence live his life, must be based on science. The key is that we, as clinicians, must make sure that the patient has accurate, up-to-date, science-based information upon which to base his or her choice.

Let me just finish by pointing out that, my skepticism towards parts of this report notwithstanding, the IOM has demonstrated once again the difference between science- and evidence-based medicine and CAM. SBM rigorously questions everything about how it does everything and is continually trying to improve. Nothing is off the table, and we discuss our deficiencies and failures openly. I can't help but contrast that to certain other areas of "medicine" that I discuss frequently on this blog. Even if I don't agree with everything in the IOM report and suspect that the use of the word "crisis" was a means of getting attention more than an accurate description of the situation, the IOM itself deserves plaudits for its work in this area.

oracknows Wed, 09/18/2013 - 21:01

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Why can't the government mandate that any hospital receiving Medicare or other government money must implement EMR based on a standard record format and supporting certain basic features? When I last went to Kaiser, the doctor made an appointment for me to see another doctor and, before that, to have some lab work done. I showed up at the lab, and there was no order for any tests, but they drew the blood anyway. They said that kind of thing happens every day. I showed up for the appointment on the day I was told it would be (and printed on the paper I was given), but the receptionist said the appointment was for the following day.

If Kaiser used computers in a competent way, the paper I had been given would have been generated from the database that holds the appointments, so there would never be a disagreement between the two. The first doctor should not have been able to make an appointment for me that requires lab tests without also ordering the lab tests. Software could coordinate all of this stuff, but not at Kaiser. There, software only replaces paper. It doesn't do any of the cool things that computers can do, like making sure the pieces of paper agree with each other or detecting if some pieces are missing.

Google or Amazon should get interested in solving this problem.

It seems to me that our medical system incentives are all wrong as an industry, leaning towards profit as a goal instead of medical care delivery. Denial of care delivers more profit for an insurance company. Delivering the wrong care can provide more profit for a hospital or medical practice (except in limited cases under Medicare). As such, traditional medicine shares many characteristics with woo-meisters' "alternative medicine", who also make big bucks off of sick people and do not provide real medical care. It is the underlying nature of medical care as a for-profit business that must change before the over-lying problems noted above will be allowed to change.

It also seems to me that there are so many woo-meisters precisely because of the inherent flaws in our medical care system. They fill a need for personalized attention- note that I did not say 'medicine', just attention- that has been removed in the name of efficiency, i.e. lowering cost of care and raising profit.

How NOT to do EMR: The way the IRS did e-file. Rather than building their own e-file system, they allowed several competing private companies to do it. Which means that now, you pay a third party for the privilege of saving the IRS money by filing electronically rather than on paper. They should make e-file free, and charge people for using paper (with maybe an exemption for seniors and low-income.)

Certainly, sometimes EMR adoption is driven by hospital administrators who need to file reports rather than by doctors and nurses who need to use the darned thing dozens or hundreds of times a day, and sometimes they do make it impossible to enter one simple fact without spending minutes checking boxes that aren't relevant.

Whatever system there is, the patient should have read access, and possibly the ability to add things in certain areas, like readings taken at home for a chronic condition. I've found any number of things in my medical records that the doctor allegedly told me during an appointment, but that I don't recall hearing. No way to know whose mistake it was, but putting in writing where I can find it later is the cure. I think letting individuals access their own records helps control the Big Brother fear, also.

...I could have sworn I e-filed for free, this year. I did it via H&R Block, though, so maybe they ate the cost (because, of course, they were able to sell me a state e-filing for $20, afterwards)

At the current level of understanding, some cancers are incurable, as Orac explains so well, and generally result in large expenses. Why then, does the system starve basic research at the expense of clinical studies that cannot hope to yield cures most of the time? I think the answer is obvious -- in the face of all this suffering and death, it is useful to try to develop improved methods, however modest they may be. But in the long term, we will undoubtedly require a lot more basic understanding before all those magic bullets become reality. Maybe I'm guessing wrong, and some new approaches will identify targets within the metastatic cells that lead to destruction of those cells, but in the meanwhile, we should be funding cell biology, biochemistry, molecular immunology, and other laboratory disciplines.

If you compare the growth in knowledge beginning in the mid 1970s when molecular cloning and DNA sequencing came into being, and the advent of the hybridoma, aka the monoclonal antibody, just a little later, and now the increasing use of new generation sequencing, there has been a lot of new understanding over the past 3 or 4 decades. Perhaps we need to go as far from now as we have already gone starting back then, and at that point we will understand enough to be able to build the effective cures. I like to compare the costs for doing this right to the costs of developing and building a new fighter aircraft. We really could fund an effective research effort for the costs of that F35. Figure $20 billion a year added to the NIH budget for basic research and equipment.

People fear cancer more than they fear war. It's strange that our budget priorities are so out of whack.

Bob, defense contractors and their captives in Congress make Big Pharma look like lemonade stand entrepreneurs. How else do you explain the government's funding weapons that even the Pentagon says it doesn't need.

There is obviously a crisis, because the effort toward "personalized" medicine is unsustainable. Not only in terms of costs, but in terms of evidence based medicine, since combination of treatments produce unexpected side effects, and it will be almost impossible make controlled trials for each individual.
https://www.researchgate.net/profile/Daniel_Corcos2/?ev=hdr_xprf

IoM proposes national public health research agenda to prevent gun violence

lborkowski — Tue, 11 Jun 2013 12:27:55 +0000

IoM proposes national public health research agenda to prevent gun violence

by Kim Krisberg

It seems we barely go a week now without news of another violent gun incident. Last week's shooting rampage in Santa Monica, Calif., has resulted in the deaths of five people. And since the Newtown school shooting last December — in the span of less than six months — thousands of Americans have been killed by guns.

Just a couple days before the Santa Monica shooting, the Institute of Medicine (IoM) and National Research Council released a new report proposing priority research areas for better understanding gun-related violence, its causes, health effects and possible prevention strategies. The report's authors said a public health research agenda addressing gun violence should address five high-priority areas: the characteristics of gun violence, risk and protective factors, prevention and other interventions, gun safety technology, and the influence of video games and other media. The research agenda was designed to produce results within three to five years.

The report was developed in response to a presidential executive order made in the wake of the Newtown school shootings and which charged the Centers for Disease Control and Prevention with identifying priority firearm-related violence research needs. President Obama also called on lawmakers to provide $10 million in funding to CDC to support gun violence prevention research. Of course, whether that funding becomes a reality is up to appropriators in Congress.

Conducting the research won't be easy, as there is currently no central repository for data on gun ownership, distribution, acquisition and storage. CDC does oversee the National Violent Death Reporting System; however, that system only collects data from 18 states and the data is limited. Still, CDC estimates that violent deaths cost the country $60 billion in medical costs and lost productivity every year.

In a National Academies news release, Alan Leshner, chair of the IoM Committee on Priorities for Research to Reduce the Threat of Firearm-Related Violence, called gun violence a topic of "considerable public health importance."

"Therefore, when developing its agenda, the committee took a public health approach that focused on gun violence problems associated with significant levels of injuries and fatalities," Leshner said. "Although this research agenda is an initial, not all-encompassing set of questions, it could help better define the causes and prevention of firearm violence in order to develop effective policies to reduce its occurrence and impact in the U.S. Similar approaches to public health problems have produced successes in lowering tobacco use, accidental poisoning and motor vehicle fatalities."

On the prevention and intervention front, the IoM report stresses that any successful intervention must involve cross-sector collaboration. Authors also note that the effectiveness of firearm-related violence prevention is mixed and not well understood. For example, policies that set time limits on alcohol sales in bars and clubs have been linked to reduced violence, while firearm safety education in schools has been shown less effective. The authors write:

The evidence generated by implementing a public health research agenda can enable the development of sound policies that support both the rights and the responsibilities central to gun ownership in the United States. In the absence of this research, policy makers will be left to debate controversial policies without scientifically sound evidence about their potential effects.

The U.S. is home to the highest rate of firearm-related deaths in the industrialized world, with suicides significantly outnumbering homicides in all age groups. In 2010, more than 105,000 people were injured or killed with a gun.

To read the full IoM report, click here.

Kim Krisberg is a freelance public health writer living in Austin, Texas, and has been writing about public health for more than a decade.

lborkowski Tue, 06/11/2013 - 08:27

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Quoth the Institute of Medicine: The current vaccine schedule is safe and effective. Quoth antivaccinationists: Gahhhh!

oracknows — Thu, 17 Jan 2013 07:00:38 +0000

Quoth the Institute of Medicine: The current vaccine schedule is safe and effective. Quoth antivaccinationists: Gahhhh!

I sense another disturbance in the antivaccine Force.

Yes, I realize that it was just a couple of days ago that I sensed a previous disturbance rippling through the antivaccine Force. That's when antivaccinationists brought David Kirby out of mothballs from whatever journalistic slime pit he's currently residing in to use every trick at his disposal to convince you that somehow the government has compensated two families of children for vaccine-induced autism when in fact he's playing the same game he's always played: Claiming that if any child who's ever been compensated by the National Vaccine Injury Compensation Program (VICP) who at some point developed any syndrome resembling autism or autism spectrum disorders it means that vaccines caused the autism. It's such a transparent ploy that Kirby's used so often that it only induced ennui.

However, for some reason (probably because I only check out the antivaccine propaganda blog Age of Autism every now and then for yucks), I missed a post there by our old pal J.B. Handley pimping donations about a highly dubious study for which Generation Rescue is raising money. I blogged about this study a couple of months ago. Basically, it's a study that's the holy grail of the antivaccine movement, a study known colloquially as a "vaxed-unvaxed" study. Basically, it's the sort of study that antivaccinationists clamor for as a second choice. While most (but not all) antivaccinationists grudgingly accept that a prospective randomized study comparing vaccinated and unvaccinated children would be completely unethical, they are so convinced that vaccines are pure evil that they want to compare vaccinated versus unvaccinated populations for health outcomes, expecting to find enormous differences, with vaccinated children being all autistic and riddled with chronic diseases like asthma. Or something. For some reason, the investigators doing this study claim they need $500,000. To do what, I can't figure out, given that this "study" appears to be little more than an Internet survey examining home schooled children, who of course represent a highly unrepresentative population to be studying. Its principal investigator is Anthony R. Mawson, M.A., Dr.P.H., who is an admirer of Andrew Wakefield and clearly has antivaccine tendencies.

Then, a few days ago, J.B. Handley repeated his call for money for these science-challenged antivaccine investigators. He framed it as a a "Q & A" session about the study by Suzanne Humphries, which is not a good choice if you want to convince anyone that the study is anything other than an antivaccine study, given that Humphries is known for referring to vaccines as "disease matter." Particularly interesting is this bit:

Q: So if they need Internal Review Board approval, does this mean that there could be other sources of funding? $500,000 is a lot to come up from the grassroots. There needs to be a benefactor or some other creative financing.

A: IRB approval for the study was obtained at Jackson State University, where the study is based, in 2011. Approval was renewed for Year 2 a few months ago. There is no other current funding for the study. The pilot study was funded by Generation Rescue, whose support was financial. They are totally uninvolved in study design and analysis.

It's pretty sad when someone like Humphries or Handley apparently doesn't know that it's Institutional Review Board approval, not Internal Review Board approval, but it's about par for the course for these people. Be that as it may, one wonders what sort of IRB they have at Jackson State University or what they were smoking there to approve such a dubious study like this. Be that as it may, Handley showing up again made me wonder what's going on. Frequently, the antivaccine movement knows about things that are about to happen before I do because, well, they spend incredible amounts of time and effort finding these things out, and I have a job and a life. In any case, it didn't take long for me to find out what probably provoked this (besides, of course, Generation Rescue's only having raised $30,000 out of the needed additional $400,000). Just yesterday, a very telling screed appeared from our old friend Dan Olmsted about the recently released Institute of Medicine report on vaccines, Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies.

Olmsted begins, predictably enough, with a whine:

It isn't worth spending much time and energy to take on the new Institute of Medicine report on vaccine safety concerns-- bought and paid for by the Department of Health and Human Services -- except to note that as the Feds continue trying to bottle up the truth about the autism epidemic, it keeps leaking out everywhere else. The Vaccine Court rulings this week, uncovered by the outstanding reporting of David Kirby and validated over and over by the Unanswered Questions report of EBCALA, are far more important in the long run than the dying yelps of the medical-industrial complex.

In other words, the fact that vaccines are the main driver of the autism epidemic, validated every day by families across the county and now in the world, is far more important than the ginned-up claim by the special interests that they don't cause autism, or autoimmune disorders, or asthma, or ADHD, or juvenile diabetes, and etcetera and etcetera and etcetera.

It's the same ol', same ol'. The IOM is a pharma shill; vaccines are the cause of autism and all sorts of horrible diseases; and, of course, only Dan Olmsted, David Kirby, and their fellow antivaccine travelers know the truth. Of course, that EBCALA report referred to by Olmsted was in itself unauthorized human subjects research—and incompetently done research, to boot.

In fact, the report is nothing unexpected. The IOM, while acknowledging that

The committee acknowledges the evidence that reducing vaccine coverage is associated with increases in vaccine-preventable disease and found only ad hoc, inconsistent, and anecdotal evidence to imply that the recommended immunization schedule is not safe. Furthermore, existing systems for the detection of adverse events provide confidence that the existing childhood immunization schedule is safe, and the committee recognizes that the federal government invests considerable resources to ensure vaccine safety. Nevertheless, some stakeholders have suggested that further work is warranted, such as a comparison of vaccinated children with unvaccinated children or children receiving immunizations on alternative immunization schedules.

Ad hoc, inconsistent, and anecdotal evidence is exactly the sort of evidence that the antivaccine movement relies on is, of course, because it doesn't have any epidemiological evidence or scientific evidence worth bothering with. Its evidence comes from at best low quality, uncontrolled or poorly controlled studies, and studies done by antivaccine investigators like Mark and David Geier, Christopher Shaw, or Andrew Wakefield. In any case, the report goes on to point out that doing a prospective randomized trial of vaccinated versus unvaccinated children would be completely unethical and:

[T]he committee concludes that a randomized controlled trial comparing the recommended schedule with any alternative schedule would be unethical and infeasible and could increase the risk of vaccine-preventable diseases in individuals and in the community.

While I don't necessarily completely agree that testing alternative vaccination schedules would be inherently unethical, depending on the precise parameters of the schedule being tested (after all, we do that in essence when we add new vaccines to the existing vaccination schedule and it probably wouldn't be unethical to test schedules in which certain vaccines are moved up or extra doses are added), I agree completely that a prospective randomized "vaxed versus unvaxed" study would indeed be completely unethical. Moreover, even though a study testing various "alternative" vaccine schedules might be ethically acceptable, depending upon the specific schedules being tested, absent compelling evidence of harm from the existing vaccine schedule, there is no scientific rationale to do such studies. (Hint to antivaccinationists: Just because you want one is not a scientific rationale.) Given that such a study would be very expensive and that the end result of "spreading out" the vaccine schedule would result in more visits and more time for children to be unprotected against vaccine-preventable diseases, such a study would be a waste of time and money.

In fact, for the benefit of antivaccine activists who might read this, I'll explain why a randomized study comparing unvaccinated children versus vaccinated children or alternative vaccine schedules in which children are left undervaccinated too long would be completely unethical no matter what you believe. If vaccines are not dangerous and do not cause autism, as science shows and I accept, and the current vaccine schedule is safe and effective then doing a "vaxed versus unvaxed" study in which one group is randomized to receive no vaccines or a schedule that unnecessarily spreads out vaccines is completely unethical because the unvaccinated (or undervaccinated group) would be knowingly and intentionally left unprotected from vaccine-preventable diseases. Now, even if vaccines did cause autism and were a major cause of sudden infant death syndrome, asthma, and all the other diseases that antivaccinationists try to pin on vaccines, and there was compelling evidence to suggest that this was true, then the study would still be of questionable ethics, because the vaccinated group would then be knowingly placed into a group that would be likely to be harmed by the vaccination schedule. In this latter case, if there were truly evidence of harm, then decisions would likely have to be made on the basis of what that evidence is, what the specific harms suspected are, all balanced against the known harm that would come from cutting back on the vaccine schedule. None of this is to say that a randomized controlled trial of different vaccine schedules would always be unethical. The principle of clinical equipoise holds, after all. However, the classic "vaxed versus untaxed" randomized study some of the more clueless antivaccine activists want would indeed be unethical under pretty much any imaginable circumstance.

None of this stops Olmsted from laying down swaths of flaming antivaccine stupid:

So, it's prospectively unethical. OK, then what about a study of people who are already unvaccinated -- you know, the Amish, homeschoolers, the HomeFirst practice in Chicago? Chiropractors, Christian Scientists, Bushmen, Waldorfers, Spenglerians, Hippie-Dippies (not my term!) in Ashland.

No way. The report says: "Some people have suggested comparing vaccinated children with children in "naturally occurring" populations of unimmunized individuals, such as certain religious communities. With less than 1 percent of the American population refusing all immunizations, however, it would be very difficult to recruit enough willing unvaccinated participants, the committee concluded. It can take tens of thousands of study participants to discover uncommon health problems. Moreover, these populations tend to be much less diverse ethnically, racially, socio-economically, and genetically than the general population, and because such factors can influence health, it would be difficult to determine if differences between the study groups are the result of vaccines or these other factors. The costs of conducting this kind of study or a randomized controlled trial likely would be prohibitive."

The IOM, as it turns out, is completely correct about this. I've explained exactly why multiple times before, remarking that it’s so cute when anti-vaxers try to discuss epidemiology. Actually, it's not cute, but it is ignorant. As I pointed out, even if a researcher could sign up 10% of the entire estimated number of unvaccinated children in the U.S., then the smallest difference in autism prevalence that could be detected would be around a 70% increase in autism prevalence. The reason for this is that there are only estimated to be 50,000 total completely unvaccinated children between 3 and 6 in the entire country. This study would cost millions of dollars to do, as well. If we were to do a more conventional study (say, 5,000 matched controls and 500 unvaccinated children), we might be able to detect a seven-fold increase in the prevalence of autism, but only if we accept a beta error (the chance of erroneously saying there is no difference when there is a difference) of 50%. Check out Prometheus's post and my old post for the full details.

So the IOM is correct about this, and Dan Olmsted doesn't know what he's talking about when he rants and raves and insinuates dogmatism and conspiracy while dismissing scientists' objections to "vaxed versus unvaxed" studies of the type advocated by epidemiology-challenged antivaccine activists as the "Epistemological Obscenity." (So what else is new?) Of course, "Epistemological Obscenity" is a pithy phrase that makes Olmsted sound pithy and profound, but in reality his post and those of antivaccinationists about such "vaxed versus unvaxed" studies are the real Epistemological Obscenities because in them true ignorance about the validity and limits of human knowledge is not just demonstrated, but flaunted proudly, as demonstrated by Olmsted when he compares the simple analyses of ethics, statistical power, cost, and practicality that lead scientists to dismiss him to "some mad extrapolation of Heisenberg's Uncertainty Principle to the macro-atomic level" when it is anything but that. Thinking himself more knowledgeable about vaccines, autism, and biology than scientists who have spent their entire careers studying these issues, Olmsted doesn't even realize or accept that scientists and physicians are correct when they point out that one of studies that he so fervently wants (a prospective randomized trial) is completely unethical, and that his grudgingly suggested fallback (an epidemiological study of vaxed versus unvaxed children) is highly unlikely to give them the answer that they crave. This is not surprising, given that antivaccinationists like Olmsted seem to think that an incompetently performed phone survey or an Internet survey by a German homeopath named Andreas Bachmair that was even more incompetently performed (but that they tout anyway) represents good science.

Of course, ultimately I suspect that's the point. They already "know" vaccines cause autism, SIDS, asthma, and many other problems, and no study, no matter how convincingly negative, will ever change their minds.

oracknows Thu, 01/17/2013 - 02:00

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Dammit! Orac scooped me. I'm still reading the report. Extra-long hours at work and home life interfering with my blogging. I shouldn't be surprised, though. Much easier for a box of blinking lights to stay ahead of me.

Nicely written, Orac!

While we often complain about credulous reporting on vaccination and other medical/scientific issues, credit should go to wkyc.com for an intelligent look at "alternative vaccine schedules" in light of the IOM report:

ht_p://www.wkyc.com/news/article/278498/3/IOM-Childhood-vaccine-schedule-is-sa…

@Dangerous Bacon

I like how they include Dr. Sears' opinion, then immediately show that it's wrong.

@Todd - how soon do you think it will be before Dachel-bot shows up?

I'm sure there will be a deluge of spammy posts before the morning is gone.

The Dachelbot almost never shows up here anymore. She knows her spew will be destroyed if she does.

@Orac

She'll almost certainly show up on the story Dangerous Bacon linked to, though. Considering the story was posted last night around 7pm, I'm actually rather surprised she hasn't swooped in already.

I haven't read the details of the study they want to do, but if it does involve homeschooled children, that's sketchy. A lot of kids are homeschooled simply because they have special needs (like ASD) or health concerns (like food allergies), so in any homeschool cohort you will likely find vaccinated kids with ASD or health issues. You will also find plenty of unvaccinated kids (the opt-outers who refuse vaccines, public school, etc., on principle) who don't have ASD, or may simply be undiagnosed due to parental paranoia about "labels" and The Medical Establishment.

On my local homeschool Yahoo Group message board, I see parents looking for doctors who won't "push" vaccines and won't criticize homeschooling. The moms will post things like, "I love our pediatrician!!! She lets me decide which vaccines my kids get and which ones we skip!"

Does an IRB review the quality of the science, or is it just there to make sure patients are protected? I thought the latter, and as it's an internet survey they're talking about all they need to show is good anonymizing and no collection of personal data to clear that hurdle.

@Mu

The primary objective of the IRB is to ensure the safety of the subjects. Some review of the quality of the science can play a part, especially if there is increased risk to the subjects.

For an internet survey, I could see the IRB raising questions if there was a risk of loss of confidentiality that could lead to social repercussions against the subjects. Exposure of medical information is also a risk, both in terms of social impact and economic (e.g., if an insurance company finds something out, that may impact current or future coverage/fees). Loss of confidentiality could also have some ramifications on employment, depending on the info leaked. For this, that doesn't seem to be a huge issue to worry about. There is no physical risk from the study, so that part's okay.

As long as the researchers have adequate protections in place to guard against loss of confidentiality, even if the science sucks, I could see an IRB approving it. They're more concerned with studies that pose a genuine risk to subjects.

On the proposal to compare the small unvaccinated communities looking for correlation. Wouldn't it also work the other way, and with a much smaller pool of study subjects? Even N>0 in that population would indicate vaccines are not the cause of autism. Kind of a black swan thing.

One Amish kid with Autism basically confirms vaccines are not the cause.

No?

@Mike

One Amish kid with Autism basically confirms vaccines are not the cause.

No?

Nope. One Amish kid with Autism confirms that that particular Amish kid's autism was not caused by vaccines (if he/she were unvaccinated; remember, the Amish do vaccinated).

There are plenty of Amish with autism. Seen them with my own eyes.

In other anti-vax news:

It appears that John Stone ( AoA) is not at all happy with Dr Larson's ( of LSHTM, JCVI) position on mercury, which is, like that of WHO and the AAP.

She has a conflict of interest because of her connections with the Gates.

A commenter mentions the situation in Gouro, Chad that appeared in the "Journal du Tchad" and "La Voix" ( which several of us here read ).

Perhaps that will be their next big story: paralysis after vaccines.

"What's a Thinking Mom to DO?" ( @ TMR) :
ah yes, what to do when you find yourself in a difficult situation...
well, compare yourself to the late Dr ML King, that's what!
I'm sure that that's absolutely appropriate.

@ Mike:

I wonder if they would attribute ANY un-vaccinated child's ASD to the child's MOTHER'S vaccination - that's what their editor did when her third child, who is unvaccinated, was diagnosed with autism.

Either that or some type of a time warp or quantum entanglement, I suppose.

@Denise - isn't that what that nutjob in England has done? He doesn't believe there are any unvaccinated autistics - and he'll also throw in Mom's vaccines, plus dental fillings, right?

Tony Bates!**

Maybe I shouldn't have said his name: it might conjure up an appearance- perish rthe thought.

** I was refering to Kim Stagliano.

@Todd

Indeed, yeah.

But given their logic of "the court awarded damages to a kid with (maybe?) Autism, therefore we have proof that vaccines caused it!" it seems the same kind of game.

I was over-simplifying it there, obviously. The anti-vaccine crowd seems agile enough to say "vaccines are only one cause!" rather than the only cause.

@Denice

Yeah, they do like to move the goalposts. It's the Mercury! Take out the Mercury. It's too many too soon! Etc., Scary to think they blame the mother's vaccines and probably would try the quantum entanglement bit.

@ Mike:

rather than "agile", I'd call it sloppy, using loosely associated material etc.

But I know what your mean.
They'll use anything they find, even if they have to twist and manipulate it so much that it no longer resembles its former self..

what YOU mean--

sorry, gotta go,

The groupies at AoA were notified about an ABC TV story on the IOM report and some of them have posted there.

http://abcnews.go.com/Health/childhood-vaccine-schedule-safe-iom/commen…

Look for my two posts about the IOM Report and the value I place in the Vaccine Safety Datalink which resulted in the removal of RotaShield vaccine in 1999.

http://abcnews.go.com/Health/childhood-vaccine-schedule-safe-iom/commen…

Somehow (I must have posted under a different 'nym years ago), my 'nym there is "abcnurse". Does anyone want to come out and play with me?

As the mother of a child on the spectrum, I blame all the exotic fruit that is now imported into Canada year round. The kind that were unheard of when I was child, especially the mangoes. Oh yes, the presence of mangoes in the grocery store where I shopped when I was pregnant with my ASD daughter is what caused her austism. I just know it. And if it wasnt the presence of the mangoes, it was the number of mangoes especially when combined with the star fruit. It is an unholy alliance, I tells ya.....the Canadian government is covering all this up because they are in the pockets of big fruit (Richard Simmons??) and are only in it for the money...........my other children were never exposed to these fruit because I then only shopped at the local gas station and that is why they are not on the spectrum.....

@Agashem

the Canadian government is covering all this up because they are in the pockets of big fruit (Richard Simmons??)

you win the Internet for this. My Diet Coke can nearly became a neti pot when I read it. :)

offtopic: On the St. Lawrence

isn't it cold to be on the St Lawrence at this time?

Alain

Over on Facebook, there's an anti-vaccination, anti-circumcision activist named Hollie [redacted]. There is also a pro-science, pro-vaccination activist named Dorit Reiss, who is also a professor of law.

In this video (also at The Poxes Blog), Hollie threatens Dorit. At Dorit's work number. You know, the one at the law school.

Hollie "...was reported to CPS over having a pox party for her 6 year old and looking for a pertussis party. She has an infant. She was also smoking pot while pregnant and while giving birth. Out of everyone who was outraged, she picked the Jew to harass at work, and I'm not just playing the race card as she anti ritualistic circumcision and spends a ton of time critical of Jewish brisses."

Click on my name for the link.

@Liz Ditz

Wow...just went through a couple of fire extinguishers to put out the stupid.

OMH, Holly's a winner. Liz will you keep us updated?

Here's the link to The Poxes post

http://thepoxesblog.blogspot.com/2013/01/you-know-how-threats-go-right…

Thanks Liz, saw that and commented. I'd love to know what, if any action the lawyer takes.

Here's the link to Just the Vax post on the same subject

http://justthevax.blogspot.co.uk/2013/01/when-truth-calls.html

Heh, you're such a smart alec Liz. Catherina snuck that one right under my nose.

For more burning stupid, see Dr. Bob Sear's latest Facebook idiocy:

https://www.facebook.com/permalink.php?story_fbid=493206100717879&id=11…

For more burning stupid, see Dr. Bob Sear’s latest Facebook idiocy:

Why does this wanker keep supplying me with so much blog fodder in such a short amount of time?

He doesn't understand study ethics and cites a study which is not even applicable to the U.S. and EU. And I only just started reading his stupid screed.

Science Mom,

"Why does this wanker keep supplying me with so much blog fodder in such a short amount of time?"

The IAS does the same for me... (Admittedly I rarely convert it into actual blog posts, however.)

I think Dan Olmsted should read this:

http://www.livescience.com/11375-top-ten-conspiracy-theories.html

To any anti-science lunatics who are planning on unleashing their "If [vaccine] is safe then whyyyy are so many people living with chronic conditions like asthma, allergies, and diabetes?" schtick, let me save you the effort.

They're living with chronic health problems because they're living. That's it, full stop. Without scientific advances such as bronchodilators and corticosteroids, emergency preparations like epi-pens used alongside simple antihistamines, and synthetic insulin. and testing devices, a good chunk of people would not make it to double digits. The same goes for vaccines - not dying from measles,related encephalitis means you get to live with whatever else you have.

So please, don't go there.

And in slightly related news, the region in the U.K. where I lived until last year has currently a measles outbreak that is - of course - maily attributed to unvaccinated children (http://www.lancasterguardian.co.uk/news/lancaster-and-district-news/mea…). The anti-vaccine nutters were the first to comment but were luckily countered by some sane people.

http://www.ageofautism.com/2011/08/marie-mccormicks-iom-remarks-leave-a…

@Jake - so you finished your 666 degrees of separation between everyone on the planet (except yourself, of course) and the vaccine industry yet?

OOOOooooohhhhh Jake!

Is it a drive-by posting or you're here to stay for our enjoyment?

Alain

Indeed. Maybe Jake will actually try to make an actual argument this time, rather than ad hominems and "six degrees of separation" conspiracy mongering!

Wait. I don't get it. The "signature" at the end states that Jake will attend GW in August. I thought he was already in.

I'm kidding, of course. It was from his GW account that he emailed my bosses, clamoring that I be fired.

What we have in his latest post is the same old thing. This person has a conflict of interest. That person is corrupt. Dr. Offit is a millionaire vaccine industrialist. Unlike other MPH students at GW who volunteer their time in the underserved areas of DC and surrounding counties, Mr. Crosby seems to choose to sit at a computer and dream up stuff.

I wonder how the real world is going to treat him?

I'm still pissed that my alma mater would house a student as f'ed up as Jake, though with the issues GW has had lately, I guess any paying student will do.....

@Darwy

Wow. I'm a little amazed at how readily Dr. Sears displays is ignorance of science and ethics. I shot him a little email (or at least tried, but it bounced 'cause his mailbox was full) with links to my series on the ethics of a prospective vaxed vs. unvaxed study.

@ Ren:

I believe that that's an old post ( I recognise the photoshopped image)- it's not on today's AoA page ( where the continuing -and endless and meaningless- saga of Frua Koma- continues)

I wonder about his future as you do.

Pardon me that's FRAU...

@DW

Oops. My bad. Sorry, Jake... About some of that stuff.

Elburto -- Every time I take antibiotics, I think of all the times where, without modern medicine, something or other would have killed me. I probably would have died at birth , to be honest (I got cerebral palsy instead), but if that didn't kill me, the rubella I got as a tiny baby might have, or the bronchitis, or one of the two bouts of pneumonia I've had...and that's without taking all those now-rare vaccine-preventable illnesses (like polio, diphtheria, mumps, and so on) into account.

If I had actually lasted until adulthood, probably that bout of pneumonia/sinusitis/throat-ear infection I had in graduate school secondary to influenza would have killed me; it was well on the way to doing so before antibiotics beat it back.

I've had a lot fewer genuinely vicious bouts of sinusitis since Hib vaccination in children became widespread, I'll tell you that. I'm convinced I get fewer really bad ones because the damn little germ vectors aren't giving me Hib anymore...

More people should think seriously about stuff like that, rather than just sitting on their privileged asses and thinking they'd stay totally healthy because [insert spurious rationale here].

I'd probably have gone deaf from repeated ear infections. If I'd actually made it to be born and not been miscarried some time in the second trimester.

Not sure where to ask this, but what states keep county-by-county data on immunization levels, and how can one get the (summary) data? (I think Michigan does, & I think I didn't get a response from asking California.)

Anna: If you go to each State's Department of Health website and search for county-by-county immunization for kindergarten entry/school entry, you might be able to pick up data for immunization coverage.

Here's California's county-by-county data:

http://www.cdph.ca.gov/programs/immunize/Documents/KindergartenAssessme…

Yes vaccines are "generally" safe. Like it appears the 1983 schedule under which my children were vaccinated is safe- not many vaccine injuries reported. But now! I believe the science in the movie "The Greater Good" explains it all.
"Too many, too soon"

@ken - the vaccine schedule is 1983 contained a heck of a lot more antigens than the current one, even though there are more vaccines on it.....

Also, the 1983 schedule did not include the disease that gave my kid seizures, and some others that are now either in decline or almost gone.

Back again "ken"...with your nonsensical post about the 1983-vs-2012 vaccine schedule?

Here's where "ken" *sources* his inane post:

http://www.generationrescue.org/resources/vaccination/

It's also the *source* for the anti-vaccine trolls who post at AoA, the Ho-Po and all the other anti-vaccine blogs.

Have you got any other *sources* ken...that prove that newer vaccines that have been added to the "Recommended Childhood Vaccine Schedule" and their rare "serious adverse events" exceed the number of "serious adverse events" associated with contracting the actual diseases that newer vaccines prevent?

http://www.pkids.org/immunization/consequences_not_vaccinating.html

Oh, and let us not forget that included in the American 1983 schedule is the MMR vaccine.

@Lawrence prove it

http://www.vaccineepidemic.com

opps checked with the wife- children vaccinated prior to '83

@ken - sure, here is a good place to start:

http://www.sciencebasedmedicine.org/index.php/the-infection-schedule-vr…

Fancy footwork to avoid the obvious- Why the increase in childhood diseases including autism? Where's the research brilliance displayed in trying to solve this puzzle?
Ped Drs are not neuroscientists- the brain is involved in immune reactions.

@ken

[citation needed]

ken:

Why the increase in childhood diseases including autism?

Have they really increased? From my perspective as a parent of college age children there has been a decrease in childhood diseases like measles, mumps, chicken pox, etc. Or has there been more autism awareness due to the Internet? Or is it organic food sales?

Whatever your "beliefs" it is unethical to "mandate" vaccinations
when there are known risks as stated in pharma inserts.
A parent has a right to choose. Hep B shot? No way for my grandchildren.

A parent has a right to choose. Hep B shot? No way for my grandchildren.

My condolences on the loss of your actual children.

@chris- silly graph

@ novalox
re increase in childhood diseases
http://www.boston.com/news/nation/articles/2007/06/27/chronic_illnesses…

http://www.cdc.gov/ncbddd/autism/data.html

Ken:

@chris- silly graph

Exactly. It points out the silly associations people make with things that are not associated with each other, like autism and vaccines.

Ken, newspapers are not actual citations. And from a glance, it looks like the organic food is leading to an increase in obesity: "Doctors and public health officials should be bracing for a wave of chronically ill young adults with weight-related ailments that include diabetes and heart disease, researchers said." Must be too much organically grown soy burgers and gluten free pasta.

And from what I can see, the autism numbers correlate to the rise of the Internets.

@ Chris
Oops it should be encephalopathy not autism-thestir.cafemom.com/toddler/149858/vaccine_court_awards_millions_to

www.thestir.cafemom.com/toddler/149858/vaccine_court_awards_millions_to

@ken

You do know that since children are not getting and dying form VPDs, the chances of getting other diseases increases, right?

You also do know that there are a lot of factors contributing to this, including poor diets and sedentary lifestyles, all of which are causative of chronic disease in children than what you think.

And your last link, encephalitis is NOT autism.

ken that is old news and the children were awarded damages by the Vaccine Court for encephalopathy...not autism.

You should be posting here...

http://scienceblogs.com/insolence/2013/01/15/david-kirbys-back-and-this…

@novalox
http://www.huffingtonpost.com/david-kirby/post2468343_b_2468343.html

Ken, I think you should know that around here, David Kirby is something of a joke. Put his name into the search box at the top. Orac has repeatedly dismantled him.

@lilady -in the link you provided Orac states-"There are also a lot of other oddities about this story. For instance, despite multiple visits to doctors in Iran, Ryan was not admitted to the hospital, and he appeared to be fine for seven weeks after his last visit to an Iranian doctor, up until the mother brought him home at the end of February."
The court documents state:
The next day, on January 6, 2004, shortly after the family’s arrival in Tehran, Ryan’s mother took him to the Children’s Hospital Medical Center in Tehran.12At the hospital, Dr. Goudarzi examined Ryan and determined that he had a temperature of 104 degrees Fahrenheit.13Ps’ Ex. 6 at 1. Dr. Goudarzi noted that Ryan was “covered from head to toe in a measles-like rash.” Id. Dr. Goudarzi diagnosed Ryan with a “febrile convulsion, probably related to MMR.” Id.
"The next day, on January 7, 2004, Dr. Allami examined Ryan in his clinic in Tehran.14He diagnosed Ryan with “high fever, skin rash, tremors, [and] lethargy” as “most likely due to an adverse reaction[] to multiple vaccines he received earlier.” Ps’ Ex. 22. Two days later, on January 9, 2004, Ryan returned to the Children’s Hospital Medical Center because he had a persistent high fever of 104 degrees Fahrenheit or greater.

Julian Frost, "ken" knows all about Kirby and the rest of the crank bloggers. Every time ken posts here is the same old arguments against vaccines. Time to put ken in the "Ignore Bin".

I'm still blaming the mangoes. :)

@ Agashem: I think you solved the mystery of mangoes-induced-autism. That causative agent theory is just as valid as the other *theories* out there. :-)

Fancy footwork to avoid the obvious- Why the increase in childhood diseases including autism?

"My children are sick because a witch hexed them" is "the obvious" to a resident of colonial Salem. Next time, ken, if you don't have any evidence to present better than that of the Salem witch trials, don't bother us.

Per google cache, the full statement is:

"It's like some mad extrapolation of Heisenberg's Uncertainty Principle to the macro-atomic level. You just can't measure it!"

As someone with multiple degrees in physics, I call gibberish on this statement. Sounds sciency, though, doesn't it?

the uncertainty principle states you can't know the momentum and position precisely at the same time. You can know (measure) both with some uncertaintly, but if you know one precisely, the other is completely unknown.

He might be thinking (again incorrectly) of the observer effect--whereby one can not know precisely the state of a system without measuring it, and in measuring it, one collapses the system into a single state. Schroedinger's cat. The observer effect is related but different from the uncertainty principle. But, again, Mr. Olmsted would be wrong. One can't know without measuring, but one can measure.

And, what is "macro atomic level"? It is either "macro" or it's atomic. The uncertainty principle *is* observable on the atomic level (whether one mistakenly adds "macro" or not).

All in all, it is a string of sciency sounding gibberish.

what about a study of people who are already unvaccinated — you know, the Amish, homeschoolers, the HomeFirst practice in Chicago? Chiropractors, Christian Scientists, Bushmen, Waldorfers, Spenglerians

Spenglerians? Followers of a pessimistic social historian with a cyclic view of civilisation? Why the feck would they be unvaccinated?

Fancy footwork to avoid the obvious- Why the increase in childhood diseases including autism?

With respect to autism the increase corresponds with broadened diagnostic criteria, diagnostic substitution, increased surveillance, reduction in social stigma associated with a diagnosis of autism spectrum disorder, etc.

One thing it doesn't appear to have anything to do with is routine childhood vaccination: lots of very large scale epidemiologic studies have looked hard for any hint of a causal association and come up completely empty.

bASED ON MY OBSERVATIONS, I believe that herr dokter said the magic word**- on the other thread- which initiated the numbering process.
Merci beaucoup, HDB.

** which was either "feck" or "Splenglerians".

@ JGC: you'll live to regret replying to that comment. :-)

IMO, the "Obvious correct reply" would be..

The increase in childhood diseases, including autism is correlated with the increase in male pattern baldness.

Oops,wrong thread.
At any rate, I think the numberig started with bimler here.

@Julian Frost - David Kirby is hardly a joke
en.wikipedia.org/wiki/David_Kirby_(journalist)
@JGC Some children were vaccine injured with resulting encephalopathy- and more children will be injured -those are the facts(Or the package inserts supplied by Pharma are lies) Giving those unknown vulnerable babies the Hep B at birth and a rigid one-size fits all schedule without knowing the genetic history of the baby is irresponsible. Orac is not a pediatrician thank goodness. I'm sure he is an excellent surgeon.

Ken:

Citation Needed.

And make sure to provide actual verifiable scientific literature to show those vaccine injuries.

And as far as those two resulting encephalopathy, the chance of encephalitis by actually getting measles is one out of a thousand. Over four million doses of the MMR vaccine is given in the USA each year. Do tell when with real evidence that it has caused 4000 cases of encephalopathy in one year.

@ ken:

It's also a straight-up flat-out lie that the vaccine schedule is "one size fits all." It already takes into account REAL contraindications and GENUINE reasons to adjust.

What's irresponsible is leaving children without protection from diseases simply because some moron makes some completely unfounded claims about vaccines.

@ken

Looked at the link. Considering all that kirby says that goes against established science without as much as a shred of proof, why should I take him seriously?

Again with the "unvaccinated Amish". For pete's sake. The Amish DO vaccinate, depending on their doctor's recommendations. They DO have autism. I wouldn't trust David Kirby if he told me the sky was blue without checking it; since he couldn't even find the Clinic for Special Children in Ohio, where they vaccinate AND see Amish children with autism. Kirby is a lazy inept reporter.

My bad...I meant the clinic is in Pennsylvania, not Ohio. Ohio has a large Amish/Mennonite population also, and that's the one I know better.

3-2-1 cue to "ken" and his link to baby Ian's death...just like he did months ago...when I went 20 rounds with him:

http://www.examiner.com/article/baby-ian-s-death-inspires-others-to-lea…

No comment to make- just the latest news
www.healio.com/pediatrics/vaccine-preventable-diseases/news/online/{3cc1d240-0f54-4763-b005-cb3829ddb8d0}/half-of-us-infants-fail-to-receive-full-series-of-recommended-vaccines-

@ken, doesn't that sort of contradict your claim in comment #88 that there's "a rigid one-size fits all schedule" of vaccinations?

lilady, that baby had several other issues at birth.

And again, there are around three million doses of HepB vaccines given at birth (there are almost four million births per year in the USA, the total is more as the full series is given). Again, there needs to be actual proof that a significant number of newborns have issues with the vaccine.

http://www.healio.com/pediatrics

So ken just likes to post links with no explanation?

So I can only assume that Ken is upset that kids aren't receiving the full series of vaccines & he wants it to be improved upon.....again, since he won't comment....

@Law
assume
make an (ass) out of (u) and (me)
good nite all......

@ken - actually just you.....since I already know what I'm talking about, as opposed to you.

@Ken, I'm curious what you think would be the correct way to go about this. You don't like “a rigid one-size fits all schedule” of vaccinations even though it's obvious less than rigid because according to your own link, half of all children aren't vaccinated in accordance with the schedule.

So what do you think there should be? A flowchart that the doctor follows, making the required choice at each box and finding at the end ... um ... a rigid one-size fits all schedule for children who fall in that box? No schedule at all, leaving it up to each doctor to decide for himself with no guidance?

Or is it better to have a standard schedule so doctors know what have been found to be good times for different vaccines, leaving it up to the individual doctor to vary the schedule for individual patients? You know, I've never heard of a doctor being punished for failure to vaccinate in accordance with the rigid one-size fits all schedule, not even Jay Gordon, MD, FAAP.

@LW - if that is true & lots more kids aren't getting all the vaccinations, why is the rate of Autism increasing?

Will the very thought of that make the logic-impaired individuals at AOA blow their minds?

@Lawrence: "if that is true & lots more kids aren’t getting all the vaccinations, why is the rate of Autism increasing?"

The evil Big Pharma, with the collusion of the corrupt CDC, is conspiring to add more undisclosed brain-killing contaminants to each shot to make up for children getting fewer shots. Sheesh, don't you know anything?

The AAP noted today that, "Over the years, some anti-vaccine activists have confused ethylmercury with the highly dangerous neurotoxin methylmercury and erroneously linked thimerosal to autism." However, the AAP also indicated today: "A newly signed international treaty banning mercury has granted an exception to the mercury-based preservative thimerosal, widely used in resource-poor countries that depend on delivery of vaccines in multi-dose vials."

http://aapnews.aappublications.org/content/early/2013/01/22/aapnews.201…

http://www.unep.org/newscentre/default.aspx?DocumentID=2702&ArticleID=9…

Cool.

@ brian:

And they're already seething about the exception at AoA today.
And ranting about Bill Gates in the comments.

@brian-
ethlymercury is harmless?
" The toxicity of ethylmercury is not well studied - exposure standards based on methylmercury (such as those currently recommended by the United States Environmental Protection Agency) have not been demonstrated to be equivalent for ethylmercury.[3]"
en.wikipedia.org/wiki/Ethylmercury

@brian- ethlymercury is harmless?

Where has brian said that?

ken -- you are correct that exposure standards for ethyl mercury are based on methyl mercury. This is for two reasons: 1) the toxicity of methyl mercury is well documented so it's a good reference, and 2) one thing we do know about ethyl mercury is that it is *less* toxic than methyl mercury. We just don't know exactly how much less toxic. So, better safe than sorry, wouldn't you say? Or would you prefer to read something into it that's not there?

@Calli

http://www.ncbi.nlm.nih.gov/pubmed/15869795

@Calli- also
http://www.ncbi.nlm.nih.gov/pubmed/16273274

@ken

Neither of those studies was in a living system. They were bench studies. While interesting, they do not say anything about what happens in a living organism.

Here's some more info on thimerosal.

Ken (sorry, I am unable to use not capitalize the first letter in a proper name), please tell us which vaccine in the American pediatric schedule is only available with thimerosal. Do not include influenza because at least half do not have thimerosal.

assume
make an (ass) out of (u) and (me)
good nite all……

So you said something stupid and then didn't leave as promised?

@Chris-
http://www.vaccinesafety.edu/thi-table.htm

If pharma was so concerned they would have a separate vaccine for pertussis w/o a diphtheria component since.....
(From the CDC)
"A confirmed case has not been reported in the U.S. since 2003. Approximately 0.001 cases per 100,000 population in the U.S. since 1980; before the introduction of vaccine in the 1920s incidence was 100-200 cases per 100,000 population."
"Diphtheria is transmitted from person to person through close contact with the discharge from an infected person's eyes, nose, throat or skin."

@ken

Wait, you're saying that since the introduction of the vaccine resulted in drastic reductions in diphtheria that we should get rid of the diphtheria part of the DTaP? Really?

I warned you guys about the drive-by poster who drops endless links in endless posts:

I like these comments from Dr. Orenstein, etal, in support in of the WHO's use of multi-dose vials of vaccine that contain Thimerosal:

http://pediatrics.aappublications.org/content/131/1/149.full

"...Thimerosal, which contains ethyl mercury, has been used as a preservative in vaccines to prevent contamination of multidose vials from bacteria and fungi since the 1930s.2 Although there are clear neurotoxic effects of methyl mercury absorption, ethyl mercury has not been associated with those consequences. Nevertheless, before data were available on risks of thimerosal in vaccines, in 1999 the American Academy of Pediatrics and the US Public Health Service recommended moving toward removing thimerosal use in preservatives as a precautionary measure.3..."

And,

"...Overwhelmingly, the evidence collected over the past 15 years has failed to yield any evidence of significant harm, including serious neurodevelopmental disorders, from use of thimerosal in vaccines. Dozens of studies from countries around the world have supported the safety of thimerosal-containing vaccines. Specifically, the Institute of Medicine, and others have concluded that the evidence favors rejection of a link between thimerosal and autism.6–12 Careful studies of the risk of other serious neurodevelopmental disorders have failed to support a causal link with thimerosal.13–17 In May 2002, the American Academy of Pediatrics retired its 1999 statement on thimerosal after evaluating new studies.3..,"

And the best for last,

"...Had the evidence that is available now been available in 1999, the policy reducing thimerosal use would likely have not been implemented. Furthermore, in 2008 the World Health Organization (WHO) endorsed the use of thimerosal in vaccines.20..."

@Todd W- I had the smallpox vac as a kid. Should we now give the small pox shot again?

@ken
Neither of those studies was in a living system. They were bench studies. While interesting, they do not say anything about what happens in a living organism.

Both studies show that ethyl mercury, in sufficient concentration, will kill neuroblastoma cells by interfering with mitochondrial function. Please show where the authors use their data to estimate safe tolerances for human beings. Otherwise these papers have no relevance.

Ken, answer the question that was asked. List the vaccine on the American pediatric schedule that is only available with thimerosal. That means you actually type out what the vaccine is and not post a link.

So tell us which vaccine on the American pediatric vaccine schedule does not have a thimerosal version. Is it the DTaP? Or the HepB? Perhaps the MMR?

By the way, a couple of years ago a young woman in Australia died from diphtheria. Your concerns would only work if we completely closed the borders. Plus that nothing to do with my question.

So answer my question. If you bring up "mercury", you must know which vaccines contain it that are required without any other viable substitute.

@ken

False comparison. Smallpox has been eliminated worldwide. Diphtheria, not so much.

@Chris -No
Good nite

@ken
So, by your refusal to answer Chris' question, you admit that your position is null and invalid?

Ken, it is not a difficult question to answer. It has a very simple one syllable answer.

And in other news from the world of antivax lunacy - a former employee of a children's hospital in Cincinnati who was fired for refusing a flu shot (required of all employees), is now suing the hospital for $650,000.

You see, she's a vegan, she refused the shot because of the tiny amount of egg protein in the vaccine, and veganism is, dontcha know, a religion - and the hospital violated her religious rights.

ht_p://www.wlwt.com/news/local-news/cincinnati/Lawsuit-Vegan-fired-from-hospit…

@DB

Veganism is a religion? Huh. Who knew? All this time I thought it was a dietary choice. I wonder what the name of their god(s) is.

On a side note, anyone know if the hospital's policy allowed for mandatory masking for those who did not get vaccinated?

@ Dangerous Bacon: The hospital worker refused the flu vaccine back in 2010. Her lawsuit was original based on violation of her civil rights (which was tossed already) and violation of her religious rights (which the judge in the case has allowed her to proceed).

The hospital stated "veganism" is a life style source...not a religion.

http://mobile.dispatch.com/wap/news/text.jsp?sid=1003&nid=2753596860&ci…

Whether veganism is a religion or not, I do not see how her beliefs trump the safety of patients who trust the hospital to make them well, not infect them with disease.

Her beliefs, religious or not, will not protect her from the influenza virus. Her beliefs, religious or not, will not protect patients from the influenza virus which she breathes around.

She says her work does not bring her in contact with patients, but what about walking to and from her office? What about the bathrooms? What about the cafeteria? Why should she personally be entitled to decide what kind of risk she poses instead of the hospital which is responsible for the wellbeing of patients.

"The hospital stated “veganism” is a life style CHOICE…not a religion."

(I should not post until I've had my morning coffee)

@ Todd W.

"Veganism is a religion? Huh. Who knew? All this time I thought it was a dietary choice. I wonder what the name of their god(s) is."

Rutabaga The Merciful and Starchy

@Ren

Praise be Thy purple-tan skin and wholesome soup-flavoring goodness.

@ Todd

We eat this soup in remembrance of you...

Is it getting hot in here?

I also saw a post from a parent in Missouri, who claimed that he and his wife are Buddhists, who have been following a vegan diet for years. When their son was born, he too was fed only a vegan diet. At the time of his birth ~ 10 years before, he was given a Vitamin B (?) shot by hospital staff and he states the child received some/all of his early childhood immunizations. (It didn't matter whether or not he missed "a few" because he was home schooled).

When the child was about ten years old, the parents decided it would be a good idea to have the child attend school for socialization with his peers, etc..

The father was SHOCKED, TRULY SHOCKED when it was determined that his immunizations were not up-to-date. Then he started to investigate (using the NVIC as his source), the "ingredients" in vaccines, such as animal proteins and "fetal cells" and the testing of human vaccines using lab animals.

It all turned out well, according to the father, thanks to the very liberal "religious belief exemption" for which he credits his Christian and fundamentalist Christian Missourians who pushed for that liberal religious exemption.

Some children were vaccine injured with resulting encephalopathy- and more children will be injured -those are the facts.

Some of the facts, perhaps. Not all the facts, hoaver, and more critically not enough of the facts to determine relative risk associated with being vaccinated versus remaining vulnerable to infection.

Commuting to work in Boston today saw an article about Aisling McCarthy Brady, a nanny being charged in the death of 1 year old child in her charge due to subdural and retinal hemoraghing caused by blunt force trauma to the head. The child also showed signs of healing from multiple bone fractures.

The paragraph that's makes me consider dishing out a little trauma myself was "The lawyer of a nanny accused of killing a 1-year-old Cambridge girl she was caring for suggested that the baby may have died from symptoms from vaccines rather than by abuse from her client."

Is it at all possible to submit amicus briefs in a criminal proceeding? This is one anti-vaccine lie that needs to be buried.

Is it at all possible to submit amicus briefs in a criminal proceeding? This is one anti-vaccine lie that needs to be buried.

Keep in mind that amicus curiae means friend of the court; it's really supposed be neutral, not advocacy. Anyway, it's a matter of appellate practice.

Speaking of legal matters, has anything happened with Wakefield's appeal?

Speaking of legal matters, has anything happened with Wakefield’s appeal?

Wakefield's brief was filed, and he asked for the opportunity to present an oral argument. You can watch the paint dry here:

http://www.3rdcoa.courts.state.tx.us/opinions/case.asp?FilingID=17395

Her beliefs, religious or not, will not protect her from the influenza virus. Her beliefs, religious or not, will not protect patients from the influenza virus which she breathes around.

There's every reason to believe that the EEOC would be willing to consider veganism subject to protection under Title VII and require reasonable accommodation. See generally Donna Page's "Veganism and Sincerely Held 'Religious' Beliefs in the Workplace" (PDF here),

Thanks, Brian. Gah, another month delay.

I just wish he could be departed for not having an actual job, or for being a scam artist.

Narad: I'm no going to read that long PDF, but was the issue in that case specifically veganism and refusal to get an influenza vaccine or any other vaccine that uses any meat/egg proteins during the manufacturing practice?

I also interested in why one part of the current hospital employee's (she has not been identified as being a HCW who has patient contact), case (violation of her civil rights), was disallowed by the judge...as in...what particular civil right?

@ Brian: Aha, it appears that all the motions and delays are being filed by the appellant's (Wakefield) attorney. Interesting no? Wouldn't you think that the individual who commenced the action would have all his ducks lined up to present the case without the delaying tactics. Unless...Andy *omitted* some *minor details* and told his attorney it was a *sure win*.

@ Chris: I all in for Wakefield to be departed/deported. :-)
I've even offered to donate to a fund to assist the Wakefield clan to be repatriated back to the U.K.

We have a fairly sizable Indian community in this county -- many are devout Jains, who are forbidden by their religion from eating meat, fish or eggs (or even swat ting mosquitoes, as I understand it).

That doesn't prevent them from lining up for flu shots.

"swatting."

(Curse you, lack of preview function).

Narad: I’m no going to read that long PDF, but was the issue in that case specifically veganism and refusal to get an influenza vaccine or any other vaccine that uses any meat/egg proteins during the manufacturing practice?

The article is an overview, but yes, it's happened. A very similar case in California failed, but that was importantly a matter of having been brought under state rather than federal law. In the non-health-care case of Bruce Anderson, which was settled, though, a regional EEOC office stated that it would accept veganism.

Speaking of woo, Mothering.com gets it's turn under the microscope.

http://thefpl.us/

Just thought our host might be interested.

“The lawyer of a nanny accused of killing a 1-year-old Cambridge girl she was caring for suggested that the baby may have died from symptoms from vaccines rather than by abuse from her client.”

The lawyer seems to be appealing more to old-fashioned racism -- arguing that the baby's parents had relatives in dodgy places like Pakistan and Saudi Arabia and London, so she probably received her injuries on family trips there.

here's another one to tear apart
http://www.ageofautism.com/2009/10/hepatitis-b-vaccine-an-unmitigated-d…

Ken, you still need to answer my question:

What vaccine on the American pediatric schedule is only available with thimerosal?

As noted before, do not mention influenza vaccine because half do not have thimersal. It is just a one syllable answer, and yet has of last night you have refused to answer this simple question.

So do not expect any kind of response to your posting of an over three year old article until you answer my simple question.

Newsflash: In antiquated American terminology it is "01/13", which means any your cite that includes "2009/10", is over three years old. Plus it is a silly website with no relevance.

If you have real data, then post the title, journal and date of the PubMed indexed paper.

@Chris-I don't know.
The above article includes the testimony of M.Belkin whose daughter died within 16 hours after receiving the Hep B vaccine.
Parents observations don't count?
Pub Med- http://www.ncbi.nlm.nih.gov/pubmed/11164115

"Findings suggest that U.S. male neonates vaccinated with the hepatitis B vaccine prior to 1999 (from vaccination record) had a threefold higher risk for parental report of autism diagnosis compared to boys not vaccinated as neonates during that same time period. Nonwhite boys bore a greater risk." http://www.ncbi.nlm.nih.gov/pubmed/21058170

"The above article includes the testimony of M.Belkin whose daughter died within 16 hours after receiving the Hep B vaccine.
Parents observations don’t count?"

They count only if the evidence backs them up. This is what Mr. Belkin had to say about the whole thing in an interview:

"Yet it soon becomes even more apparent that there are a lot of unanswered questions about his portrayal of [his daughter's] death and its aftermath. Asked, for instance, if he is sure that the medical examiner talked to Merck before switching her assessment of [his daughter's] death, he says: "I think so. I told her to." In other words, [his] allegation is based on nothing more than his own suggestion to the examiner, prompted by his suspicions about the vaccine.
He's also not sure, now that he's asked about it, whether it was the examiner or, as seems more likely, the police who came to his apartment looking for evidence of child abuse. "I don't know . . . somebody . . . don't ask me," he says.
Most crucially of all, [he] says he doesn't know where the pediatrician's notes are that prove that the examiner initially determined that [his daughter] had a swollen brain. "You have to take my word for it," he says.
Later, asked whether he would consent to having the case file from the examiner's office released to Seattle Weekly, he declines. "To me, it's a very invasive and intrusive request," he says, questioning the Weekly's "fixation" with[his daughter's] death. "To me, it's not the story.""

We have to take his word for it? Why testify before Congress if he wasn't going to produce the goods?

@Ken

Do you have the whole paper or did you just google for an abstract that would back up your claims? Because you owe us a methods and a discussion section in order to evaluate that paper. "Parental reports of autism diagnosis" gives me great pause because it reeks of recall bias.

As to the first link...

Of the CLAIMED associations, two out of three have a 95% CI including 1, so are not associations at all. The third goes down to 1.05, so is arguably a very weak association... if one assumes they did the stats right and corrected for multiple comparisons. Which, if they claim a 95% CI including 1 is an association, I very much doubt they did. Nothing at all here.

So your evidence of a problem is a paper that looked for, but entirely failed to find, one.

Then, Ken, I suggest you find the answer to my question before bringing up the word "mercury" again. Here, I'll repeat it: tell us which vaccine in the American pediatric schedule is only available with thimerosal. Do not include influenza because half are thimerosal free.

Also, in the future restrict your cites to actual scientific papers or official public health pages (the latter is where you can find the answer to my question). Do not include any AgeOfAutism sites, because their veracity is questionable (like Mr. Belkin's personal anecdotes).

Oh, and the actual citation is still just parental anecdotes, it has nothing to do with the actual science. And still, millions of doses of HepB are given each year, and the numbers of "adverse vaccine reports" are still tiny.

My son is too old to have gotten the birth HepB vaccine, yet he had seizures when he was two days old and is developmentally disabled. My daughter got the HepB vaccine after she was born, and did not have seizures, and on Tuesday scored a 52 out of 50 on her bio-psych exam (she hates she missed one of the three extra credit questions).

My anecdote claims that getting the birth HepB is neurologically protective. And it is just as valid as Mr. Belkin's story, and the twelve year old paper you cited.

Do you have the whole paper or did you just google for an abstract that would back up your claims? Because you owe us a methods and a discussion section in order to evaluate that paper. “Parental reports of autism diagnosis” gives me great pause because it reeks of recall bias.

If you Google the title, you can exploit the fairly reliable tendency of antivaccine types to freely redistribute copyrighted material. It's NHIS questionnaire data. Basically they've got 9 of 33 boys aged 3–17 born prior to 1999 (so going back to the 1982 introduction of the birth dose) with autism and early Hep B dose, and 1258 of 7640 without autism. They don't seem to have taken the small step of looking at the same data from a window before the introduction.

Ah, so 9 cases is the triple rate. So the expectation was 3. IOW they're concluding that the Hep B vaccine is dangerous based on a grand total of 6 individuals. I don't have the time to check the numbers right now, though my gut does say that's statistically significant... but not by a lot, and WELL within the range of bias and systematic uncertainties.

Ah, so 9 cases is the triple rate. So the expectation was 3.

It's an adjusted odds ratio. I'm not competent to evaluate the analysis.

The birth dose for HepB did not start until 1991. It was only so-called high risk groups that were vaccinated before then, if they could be found (IV drug users are not terribly compliant).

The birth dose for HepB did not start until 1991. It was only so-called high risk groups that were vaccinated before then, if they could be found (IV drug users are not terribly compliant).

Thanks for the correction. That seems to muddy the waters even further.

As to the first link…
Of the CLAIMED associations, two out of three have a 95% CI including 1, so are not associations at all. The third goes down to 1.05, so is arguably a very weak association… if one assumes they did the stats right and corrected for multiple comparisons.

The 'Adverse Events after HepB" paper was a fishing expedition -- they trawled through the 1994 NHIS dataset looking for *any* adverse effects. No mention of multiple-comparison corrections.
Instead, for the three adverse events with raised odds ratios -- a significantly higher OR in the case of arthritis -- they go back to the 1993 NHIS dataset to see if the associations are replicable. In the cases of arthritis and pharyngitis, the OR was higher in 1993 but not significantly so. In the case of ear infections, the OR was actually *lower* in 1993.

Because the authors have done all this work, they argue that the absence of significant results in the 1993 data is still *confirmation* of the links dredged out of the 1994 data. There is hand-waving of the 'shut-up-that's-why' nature to explain why the *disconfirmation* of any association with ear infections doesn't really matter

The authors note that in a third of the data set, 'HepB' vaccination status was not recorded in medical records but based on parental report. I wondered whether the results were any different between the "recorded" and "parental report" data, but the authors didn't examine that, arguing instead that there was no reason to worry about retrospective memory bias in the absence of bad publicity about vaccines in the 90s.

When I become World Dictator, anyone running one of these retrospective trawls through a database will also have to report those adverse conditions turning up with a reduced odds ratio, i.e. the ones where the vaccination (or other intervention) seems to have had a protective effect.

I wonder if any of those who bring up the Gallagher and Goodman Hep B vaccine-ASD study have actually asked themselves this question: If the Hep B vaccine played no role whatsoever in the development of ASD, what results would have been EXPECTED from that study?

By way of an answer, if you note that the sample included children who were born between 1980 (when ASD prevalence and Hep B vaccination uptake were both low (the vaccine was, after all, introduced in 1981, and the birth dose was not mandated until 1991) up until the year 2000, when the prevalence of ASD was markedly higher and vaccine uptake was much increased, you should understand that even if there is NO connection between vaccination and ASD, the proportion of kids with ASD (most of whom were, of course, born in the later birth cohorts that have higher ASD prevalence) should ALSO have a higher rate of Hep B uptake than did earlier birth cohorts, since the vaccine was mandated for those later cohorts.

It’s useful to compare exposure to Hep B vaccine to the prevalence of other, also unrelated factors. For example, the proportion of US-born girls who were named Sophia increased ten-fold in the decades spanning the introduction of the mandatory birth dose of Hep B vaccine, between 1980 and 2000. In fact, if you compare the Social Security data for the four decades spanning the 1991 introduction of the birth dose mandate for Hep B vaccination, you’ll see that 91 percent of girls who were named Sophia in those decades were born in the years following the introduction of that mandate—and, moreover, according the most recent data, over 37 percent of all the Sophias born in the previous four decades were born just in the few years since influenza vaccination was recommended for all children six months of age and older!

The "Troll" is referring to the infamous Stony Brook University "study"... a "poster presentation" and a "David Kirby/Ho-Po" *special blog*, which Sullivan, Science Mom and Prometheus took apart here:

http://leftbrainrightbrain.co.uk/2009/09/17/another-weak-study-proves-v…

The PHBPP (Perinatal Hepatitis B Prevention Program) was started in NYS in 1988

http://www.health.ny.gov/diseases/communicable/hepatitis/hepatitis_b/pe…

Laws and Health Department Regulations were enacted which required every OB to test every pregnant woman, during each of her pregnancies, to test for the presence of acute hepatitis B infection or chronic hepatitis B carriage of the virus, so that infants at risk for vertical transmission of the virus would receive HBIG and the first hepatitis B vaccine within 12 hours of birth. Laws and Regulations were also enacted to require every laboratory to forward every Positive Hepatitis B Surface Antigen test result to the local (County) health departments, as well. NYS added "Pregnant Hepatitis B Carrier patients" to their "Reportable Communicable Diseases" list.

Chronic carriage of the Hepatitis B virus is estimated at 2 % of the United States population (considered by the WHO to be a "low endemic" country). Areas of the world that have higher endemic prevalence are all of Asia, with the exception of Japan, indigenous populations in Australia and New Zealand, the Indian sub-continent, the Middle East countries, Eastern European countries, all of Africa, all of the Caribbean and Latin America. The highest prevalence in the world are certain provinces in China where chronic carriage of the virus exceed 10 %.

Immigrants from those areas of the world who reside in the United States, as well as first and second generation children of those immigrants comprise the majority of women who test positive ( + Hepatitis B Surface Antigen) for hepatitis B chronic carriage.

(I recall the Troll being linking to this Stony Brook University grad student Poster Presentation last year, when "Lurker" and "Grandma Marsha" joined him in the fray).

Link to the letter clarifying the 2005 ACIP Recommendations for implementation of the universal birth dose of hepatitis B policy. Prior to the 2005 ACIP Recommendations, hospitals and birthing centers had the "option" to implement the hepatitis B birth dose.

http://www.immunize.org/acip/HBVinfant_dearcolleague.pdf

Steven Salzberg on his Forbes blog has a post up about the IOM Report.

I've posted there several times...I even *beat out* Dachel's "Media Updates" call for the usual suspects to post.

http://www.forbes.com/sites/stevensalzberg/2013/01/28/iom-finds-childho…

cookie.

National Academies Press celebrates first year of free PDFs

lborkowski — Fri, 15 Jun 2012 16:12:32 +0000

National Academies Press celebrates first year of free PDFs

Yesterday, that National Academies Press celebrated its first year of offering free PDFs of many of its reports. NAP reported in an anniversary email that website visitors have downloaded over 1.3 million PDF versions of books -- and that over the next year NAP will be adding more books (new and old alike) to the list of free downloads. Among the most downloaded so far are:

The reports on nursing and pain were released in 2011, but To Err is Human is a classic -- published in 2000, it warned about the thousands of people (98,000 by one estimate) who die each year from medical errors in US hospitals.

Over the past year, I'd been pleasantly surprised to find some new and old National Academies reports available as free PDFs, but I hadn't realized it was part of a special initiative to make more free PDFs available. (Because around 85% of National Academies funding comes from the federal government, it makes sense for taxpayers to be able to access publications easily and for free.) Here are just a few of the public health publications available:

Browsing through the NAP catalog reminds me how fortunate we are to have the National Academies (specifically, the National Research Council, the Institute of Medicine, the National Academy of Engineering, and the National Academy of Sciences) distilling the latest research and expert opinion into publications. And while it's always been possible to read the publications online by clicking through them page by page, I find the free PDFs to be much more user-friendly -- and therefore more likely to lead to dissemination of the valuable knowledge the National Academies collect.

You can browse National Academies Press publications at NAP.edu.

lborkowski Fri, 06/15/2012 - 12:12

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Nine chronic diseases and their varied impacts

lborkowski — Tue, 07 Feb 2012 17:54:09 +0000

Nine chronic diseases and their varied impacts

I wrote last month about the role of chronic diseases in healthcare-cost growth, so I was excited to see a new report from the Institute of Medicine called Living Well with Chronic Illness: A Call for Public Health Action.

When I think of chronic illness, diabetes and heart disease are what leap to my mind -- in part because they're so tied to the lifestyle factors of smoking, inadequate exercise, and poor nutrition, and in part because they cost our health system so much money. The IOM report notes that chronic illness represents 75% of the $2 trillion the US spends each year on healthcare, but it also emphasizes that the goal of addressing chronic diseases conditions isn't just to slow the growth of healthcare costs, but to improve quality of life. The report is a response to a request by CDC and the Arthritis Foundation to "help identify ways to reduce disability and improve the function and quality of life for people living with chronic illness."

Another refreshing aspect of this report is that it doesn't just focus on the usual suspects of chronic disease (diabetes, heart disease, kidney disease, etc.). While the authors seek to assist health officials in prioritizing the use of limited healthcare dollars, they're also careful to avoid ranking diseases by a single metric. The report highlights nine "clinical clusters" that together "encompass and flesh out the range of key issues that affect the quality of life of patients with the full spectrum of chronic illnesses." Here's my quick summary of the nine conditions, which I hope will encourage some of you check out the full report. (The diseases are described in Section 2 of the report, and the uncorrected proof is currently available for free downloading.)

Arthritis: Arthritis is the leading cause of disability in the US, with approximately one in five adults having received an arthritis diagnosis. Osteoarthritis (the most common type) is more common in women and people who are obese, and in miners, construction workers, and agricultural workers. "In 2008, 29 million persons over age 18, 13 percent of all adults in the United States, had self-reported activity limitations attributable to arthritis."
Cancer survivorship: In 2007, nearly 12 million people living in the US had previously been diagnosed with cancer. While their survival represents a victory, the treatments often have lasting health consequences, from heart failure and lymphedema (collection of fluid in a body part) to problems with fatigue and psychological distress.
Chronic pain: In the US, an estimated 116 million adults deal with chronic pain, and chronic pain's prevalence on the rise worldwide. Racial and ethnic minorities are at greater risk of having undertreated pain. Disablement from chronic pain affects sufferers, their families, and their workplaces.
Dementia: An estimated 5.4 million people in the US are affected by Alzheimers disease, and millions more have dementia from other causes. Complications from dementia place a heavy burden on caregivers; research suggests that these caregivers are at increased risk of coronary heart disease and depression.
Depression: Major depression affects around 7% of the US population at any given time, and 17% of us can expect to experience major depression during our lifetimes. It is often a complicating factor for other chronic illnesses, including diabetes.
Type 2 diabetes: An estimated 11.3% of US adults (25.6 million people) have diabetes, with 90-95% of diagnosed cases being type 2. The disease is the leading cause of end-stage renal disease and a major contributor to blindness, nervous system damage, and amputations. Self-management (monitoring blood glucose, taking medication, adhering to diet and lifestyle advice) takes a great deal of effort and resources. Those with multiple and severe complications are especially likely to experience reduced quality of life.
Posttraumatic disabling conditions: This category encompasses the effects of traumatic injuries and includes knee meniscus injuries, traumatic brain injuries, severe burn injuries, and injuries from falls and fractures. Disabilities and activity restrictions are among the long-term consequences from traumatic injuries.
Schizophrenia: This "severe, chronic, and disabling mental disorder" affects more than two million people in the US each year; while medications can relieve many of the symptoms (including hallucinations and disorganized speech and behavior), most sufferers experience some symptoms throughout their lives. Rates of alcohol abuse and homelessness are higher among schizophrenics than the general population. Families and caregivers face significant burdens from the disease, and these can be exacerbated by feelings of shame, guilt, or embarrassment.
Vision and hearing loss: An estimated 15% of US adults have hearing difficulty, and 11% have trouble seeing even with the aid of corrective lenses. Visual impairment can interfere with sufferers' ability to care for themselves, leading to dependence and worse emotional wellbeing. Research has found hearing loss to be associated with social isolation and depressive symptoms as well as impairment in walking and performing chores.

The IOM Committee gives 14 detailed recommendations for the Department of Health and Human Services (especially CDC), federal and state agencies, research funders, healthcare payors, and federal and state policymakers -- including working in partnership with "organizations representing health care, public health, and patient advocacy." The recommendations range from improving surveillance and pilot testing of interventions to adopting a "health in all policies" approach that evaluates the impacts of legislation and regulations on health-related quality of life.

A recurring theme in the report is the importance of focusing on the interactions between multiple chronic conditions. Since more than one-fourth of the US population has two or more chronic conditions and the prevalence of multiple chronic conditions increases with age, it's important to get out of the habit of focusing narrowly on one condition at a time. Another recurring theme is the importance of addressing racial, ethnic, and socioeconomic disparaties in both the incidence and impact of chronic diseases.

Addressing chronic diseases in the US is a daunting challenge, but this IOM report represents a useful step forward in what will need to be a sustained and multi-faceted effort by a wide range of individuals, providers, communities, organizations, and government entities.

lborkowski Tue, 02/07/2012 - 12:54

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Brain and Behavior

Smoking is definitely a cause f most major health problems. it leads to cancer, heart disease, etc. Alcohol is also a major problem in this country.

As far as poor nutrition goes, that is a factor as well, but let us discuss GMO foods and poison like aspartame in foods and sodium flouride in the water and aluminum nanoparticles and sulfur particles being sprayed into the atmosphere as well. Seems like government has a role in our poor nutrition and health as well. The we have laws that prohibit the use of raw milk and vegetables and even in some places people who grow their own food to get away from GMO foods and pesticides are being arrested and harrassed. Ths country has gone literally insane.

If one can get busted for selling raw milk then its time for regime change. Get rid of every polticians in office, disband every agency, and start all over new again. This control over the populace crap has to end somewhere. This is America, not north Korea. Let's start acting like it.

Smoking and alcohol are indeed major contributors to disease -- but remember, the agencies you want to disband have done a great deal to reduce tobacco and alcohol use in this country.

Sultan of Nonsense: you're completely misguided about most of your complaints, but all that axe-grinding will keep you fit, and that should add some years to your life. Good show!

I dont believe the IOM has the best interests of the public at heart- they seem to serve the occupational strategies of their colleagues in medicine and academia instead. In their report on pain- they offer no vision or plan for lowering the prevalence on chronic pain-and they clearly state they dont believe in cures. I guess its more profitable for them and their colleagues for chronic pain to continue to rise in prevalence-and they are unwilling to jump over the shadows in pain care to create the symbols of a new day.
The IOMs ideas are rigidified in predetermined ways that serve themselves and evolution is forbidden

It doesn't help solve any of those problems but IMO those very common complaints are something of a monument to the effectiveness of overall public health, mainly clean food and water, but a god bit of actual medicine, in allowing the population to get old enough to experience those chronic conditions. ie: When miners and construction workers were more likely than not to get planted around 55 years of age there were far fewer chronic cases. Dead men don't tell tails ... or complain about their chronic arthritis.

You have to survive cancer to qualify for the long term consequences of any treatment to manifest.

We are all getting older and this is, in large part, a success story for public health, food, and environmental safety. Being commonly able to live into our nineties is a blessing but it isn't a vertical light and sunshine. Getting old isn't for wimps. It means we are exposed to consequences of all the rough handling, abuse and insults we experience over this much longer time. It isn't pretty. Or comfortable. But it is real and it keeps the medical science and public health people off the streets and out of trouble by giving them something to work on. It's all good.

As soon as someone mentions the dangers of Aspartame, fluoride, GMOs, or chemtrails I pretty much know I'm talking to that particularly dangerous form of self deluding and credulous idiot that thinks they know what is going on because Alex Jones told them. There just aren't enough faces or palms to express how embarrassed I am for you.

Public health has failed people in pain- and that is why perhaps the IOM called for a public health approach to people in pain. The simple facts-which is mentioned in the June 2011 IOM report on pain is that chronic pain is expected to rise rapidly -much more rapidly then population growth. I dont consider that success but failuire. The lenght of life isnt considered the most important thing by many people- and why live a life of terrible suffering? Pain is considered a life ruining condition- a Lord more terrible then death. Its ashame there are people who for their own comfort and convenience wish to feel good about the sorry state of affairs in pain care- perhaps our Nation would be better served if they made a real effort to improve the sorry state of affairs rather then boast about the ever rising prevalence of suffering due to chronic pain-and poor medical care in our country

I'm glad they included chronic pain. Some diesases are relatively simple and straightforward to treat. But it is very hard to get good treatment for a condition that requires many different specialists to collaborate. Certain medical centers (Mayo, for example) claim to follow an "integrated approach" where teams of doctors treat a patient, but most medical practices are isolated and over-specialized.

While the authors seek to assist health officials in prioritizing the use of limited healthcare dollars, they're also careful to avoid ranking diseases by a single metric.

However, this does create a somewhat confusing situation.

Most of the conditions described here are symptom groups, not diseases. Furthermore, they are in many cases symptom groups that have massive diversity within them.

Arthritis, chronic pain, dementia, depression*, and "vision and hearing loss" are all symptom groups, descriptive of diverse situations and potentially caused by many different diseases. *Depression is the name of a primary disease, but it is defined purely by symptomology, and it can be secondary to many other diseases or conditions.

Schizophrenia, cancer, and trauma are medical conditions, not symptoms, but they are the names of groups of conditions, especially the latter two.

For full disclosure -

I very strongly support the idea that these symptoms and conditions deserve to be taken seriously and treated effectively.

I understand that authors' rationale for dealing with broad symptom groups and don't disagree with it. I am commenting only for clarity.

However, for effective treatment, the actual underlying cause in the individual patient usually needs to be determined.

Thank you...Arthritis, chronic pain, dementia, depression*, and "vision and hearing loss" are all symptom groups, descriptive of diverse situations and potentially caused by many different diseases. *Depression is the name of a primary disease, but it is defined purely by symptomology, and it can be secondary to many other diseases or conditions.

Schizophrenia, cancer, and trauma are medical conditions, not symptoms, but they are the names of groups of conditions, especially the latter two.

reply to harold #7

Your statement that the underlying cause usually needs to be determined for effective treatment is not true.

In many cases no cause is identified for these conditions -- they are idiopathic. Or else the diagnosis is complicated and unreliable, or there are multiple interacting causes and syndromes that interact. Or the underlying cause is not treatable.

Still, there are often treatments for these conditions, just not "cures".

RJ said -

Your statement that the underlying cause usually needs to be determined for effective treatment is not true.

I don't have any serious disagreement with what you say here, but note that I said "usually"; therefore, what I said is actually likely to be true.

In many cases no cause is identified for these conditions -- they are idiopathic. Or else the diagnosis is complicated and unreliable, or there are multiple interacting causes and syndromes that interact. Or the underlying cause is not treatable.

This is correct.

Still, there are often treatments for these conditions, just not "cures".

Also correct.

Allow me to clarify.

I did not object to the lumping done here, but I do think it is worthwhile to make the clarification I did.

Some of the terms used above are symptoms ("chronic pain" - there are many, many types of chronic pain, but it is a symptpom); others are names of disease groups that have many associated symptoms ("schizophrenia", and there are also multiple types of schizophrenia, but it is a family of diseases).

When symptoms are present, if an underlying etiology can be determined, treatment and evaluation of prognosis are more likely to be successful. For example, if a patient has fever, coughing, and severe shortness of breath, and the etiology is correctly determined to be community acquired pneumonia, caused by an organism that is resistant to some antibiotics but sensitive to other antibiotics that the patient can tolerate, a sufficient course of correct antibiotics, accompanied by whatever supportive therapy may be needed, is very likely to eliminate all the symptoms. An alternate, but less rational approach, would be to try to address the symptoms without making any investigation of the etiology. You might be able to support the patient through a prolonged bout of pneumonia, but the patient might die of pneumonia or due to spread of the infection. I realize that this is a very simple example and that real life is often (although by no means always) more complicated; I am merely using a simple example to make my point very clear.

I already said, and emphasized in bold, that "I very strongly support the idea that these symptoms and conditions deserve to be taken seriously and treated effectively."

Clearly, I am not at all suggesting that patients with such symptoms as chronic pain or dementia be denied support and treatment. Of course such patients deserve support and relief, even if an underlying etiology is difficult to establish, or is is a poorly understood one.

Nevertheless, when symptoms are present, it is overwhelmingly best to seek an underlying etiology. That is not mutually exclusive with treatment.

To say there is no cause or pain is idiopathic is scientific mumbo jumbo- trees fall in the woods without scientists being there to witness them. We know that science is less then concerned with people in pain. NIH spends less then 2% of budget on chronic pain research- even though pain effects more then 140 million people per year. A few years ago Senator Specter found that NIH was putting barriers to curative treatment. In A Call to Revolutionize pain care in america- doctors indicated pain has been "tragically overlooked"- when it comes to pain care the fault isnt in the stars- but in morally and mentally doctors, researchers, and government

What is the economic burden of diabetes? Proper management and control could save 49,000 lives and $196 million annually. http://www.healthcaretownhall.com/?p=2699

Health care costs will continue to escalate and send both governments and individuals broke. The orthodox approach to health care is flawed and unsustainable. We need true healthcare, not disease management; we need preventative care, not resuscitation. We need to teach our children to take responsibility for their health, rather than teach them to defer to higher authorities. Such a paradigm shift in healthcare would encourages approaches that are compatible with our bodies and our environment - i.e. sustainable healthcare.

We absolutely need more prevention and care that goes beyond addressing the most immediate symptoms. Even if we start implementing that now, though, it'll be many years before it starts to pay off in reduced burden of chronic diseases. So we need both a short-term and long-term approach to chronic diseases, while also addressing the overall misaligned incentives in our current system.