I’ve caught a fair amount of flak over my opposition to so-called “right-to-try” laws. Right-to-try laws have proliferated throughout the US like so much kudzu over the last three and a half years, to the point where 37 states now have some version of these profoundly anti-patient laws on the books. At the federal level, three weeks ago the Senate passed a federal version of right-to-try, with the House scheduled to take up the bill when Congress returns from recess next week. Granted, it’s watered down and therefore less horrible than the original version, which Senator Ron Johnson (R-WI_ has been trying to pass for two years, but it’s still plenty bad. In this post and a post later this week, I’m going to show you more circumstantial evidence that I was right all along. The first example you’ve almost certainly heard of, namely the offshore testing of a new herpes vaccine funded in part by über-Libertarian Peter Thiel. The second you probably haven’t heard of, and I’ll save it for later, given how long this post is.

But first, you need to understand what I mean about right-to-try. Basically, right-to-try laws rest on the false premise that the FDA is so slow and so bureaucratic that cures are being kept from terminally ill patients, or at least drugs that might hugely extend their life expectancies. The situation is presented as so dire that “right-to-try” is necessary, which basically allows terminally ill patients to bypass the FDA and receive experimental therapeutics from companies developing them without having to go through the FDA’s Expanded Access program (which basically does the same thing, providing access to experimental therapeutics before they are FDA-approved). It’s an idea promoted by a Libertarian think tank, the Goldwater Institute, and the branding has been very successful, to the point where, politically, opposing right-to-try is viewed as the equivalent of taking the terminally ill’s last chance away from them, wanting them to die horribly, all while pissing on an apple pie and burning an American flag. (I exaggerate, but not by much.) The Goldwater Institute and right-to-try advocates achieved this effect by cynically parading families of patients with terminal illnesses who were convinced that right-to-try would give their loved ones a shot at life in front of legislators, making it very difficult for them to vote no. Meanwhile, industry and medical groups that might have been able to persuade lawmakers that right-to-try is a terrible idea that is bad for patients, despite the optics created by the Goldwater Institute were cowed and remained silent until very late. For example, the American Society of Clinical Oncology (ASCO), an society to which I belong, spent the last three and a half years saying basically nothing. It was only four months ago that ASCO finally issued a statement opposing right-to-try, when it was basically far, far too late.

I’ve also caught flak for characterizing right-to-try as being part of a broader war against the FDA (indeed, as part of a broader war against regulation in general) by libertarian-leaning free market fundamentalists, some of whom claim (literally) that the FDA is killing people. Lots of people. How can you say that? proponents of right-to-try would ask, drawing themselves up in their best self righteous fury. This is about helping terminally ill patients! Maybe. But, as I’ve said before, the FDA already has a Compassionate Use program that achieves the same purpose and rarely turns requests down, a program that’s been improved over the last couple of years to be speedier and more responsive, with much less application time. Consistent with its libertarian origins, right-to-try tries to cut the FDA out of decisions between a drug seller and patients, but at the cost of eliminating many protections for patients. For instance, unlike the case in “expanded access” or “compassionate use,” the institutional review board (IRB), an ethics panel that oversees clinical trials does not oversee patients in right-to-try. There is no financial help; so only patients whose families are rich or can raise a lot of money fast are likely to be able to benefit. Even worse, as I’ve described, most right-to-try bills not only do not require insurance companies cover experimental therapeutics (and why should they?), but allow insurance companies not to cover charges for complications from using experimental therapeutics. However, perhaps the most egregiously false argument made by right-to-try advocates is that the laws’ allow use of experimental therapeutics after they’ve been “proven safe” through phase I testing. Yes, you read that right. As I’ve discussed multiple times, there is the requirement that the drug or device has only passed phase 1 trials, which, given how few drugs that have passed phase 1 actually make it through to approval, is a really low bar, especially since most phase 1 trials involve fewer than around 25 patients.

Although not commonly seen as such, right-to-try laws are of a piece with libertarian and radical fundamentalist free market views, some of which claim that the FDA is basically unnecessary or that its role should be vastly constrained. You can see it all there: Minimal requirements for safety testing (phase I), no ethical oversight, the decision entirely up to the company and patient, and, of course, the patient is totally on his or her own. People with such views were even in consideration for the post of FDA Commissioner, for example, two cronies of the aforementioned Peter Thiel, both of whom believe that the FDA stifles their holy grail of “innovation.” The first was Jim O’Neill, who has advocated that the FDA test new drugs only for safety, not efficacy, thus returning the FDA to its pre-1962, pre-thalidomide role. The second was Balaji Srinivasan, a Silicon Valley entrepreneur who advocated basically doing away with the current system of FDA regulation and replacing it with online reviews, basically a Yelp or Über for drugs and medical devices. When asked “How do you prevent quacks?” Srinivasan replied, “Scaled Internet reputation systems. Works at massive scale in other areas.” So clueless were both of these men that it was a relief when a relatively normal Republican pharma shill named Scott Gottlieb was ultimately appointed. He was the “least bad,” most conventional choice, someone any conservative Republican administration might have appointed. Yes, he wants to “streamline” the process by which, for example, vaccines are approved, but he’s actually pretty conventional. He’s even decided to http://www.npr.org/sections/health-shots/2017/08/28/546719842/fda-cracks-down-on-stem-cell-clinics-selling-unapproved-treatments.

Stymied at the FDA, apparently Peter Thiel is now waging his war on the FDA by other means:

Defying U.S. safety protections for human trials, an American university and a group of wealthy libertarians, including a prominent Donald Trump supporter, are backing the offshore testing of an experimental herpes vaccine.

The American businessmen, including Trump adviser Peter Thiel, invested $7 million in the ongoing vaccine research, according to the U.S. company behind it. Southern Illinois University also trumpeted the research and the study’s lead researcher, even though he did not rely on traditional U.S. safety oversight in the first trial, held on the Caribbean island of St. Kitts.

Neither the Food and Drug Administration nor a safety panel known as an institutional review board, or an “IRB,” monitored the testing of a vaccine its creators say prevents herpes outbreaks. Most of the 20 participants were Americans with herpes who were flown to the island several times to be vaccinated, according to Rational Vaccines, the company that oversaw the trial.

“What they’re doing is patently unethical,” said Jonathan Zenilman, chief of Johns Hopkins Bayview Medical Center’s Infectious Diseases Division. “There’s a reason why researchers rely on these protections. People can die.”

Indeed it is. What Peter Thiel and Rational Vaccines, a company founded by Agustín Fernández III and William Halford (formerly of Southern Illinois University who died recently of cancer) did and are doing is patently unethical—shockingly, horrifyingly so. The very function of the IRB is to protect human subjects in clinical trials. Usually, when a clinical trial is proposed, it goes through two committees, first the scientific review board, or SRB, which determines whether the trial is scientifically justified and soundly designed. The second is the IRB, which is charged with protecting the human subjects. Its function is to examine the clinical trial design and to determine whether it is ethical and whether the risks to human subjects do not outweigh the potential benefits; e.g., that there is clinical equipoise. Once it approves the trial, the IRB continues to monitor the trial, examining reports of adverse events, both serious and minor, and sometimes demanding changes in the trial or even canceling it if it judges that there are too many adverse events or that one group is doing so much better than the other group that it would be unethical to continue the trial. These protections for human subjects flow from the Belmont Report and the Common Rule, both of which were designed to prevent the abuse of human research subjects like what the Nazis did and underlie all the federal regulation regarding human research protection. Unfortunately, these protections are not universal, as they only apply to organizations with federal funding (such as universities) or entities applying for FDA approval for one of its investigational drugs or devices.

Like right-to-try, Peter Thiel’s and Rational Vaccines’ offshore clinical trial of a new herpes vaccine is an attack on the FDA. Libertarians and free market fundamentalists even admit as much:

The push behind the vaccine is as much political as medical. President Trump has vowed to speed up the FDA’s approval of some medicines. FDA Commissioner Scott Gottlieb, who had deep financial ties to the pharmaceutical industry, slammed the FDA before his confirmation for over-prioritizing consumer protection to the detriment of medical innovations.

“This is a test case,” said Bartley Madden, a retired Credit Suisse banker and policy adviser to the conservative Heartland Institute, who is another investor in the vaccine. “The FDA is standing in the way, and Americans are going to hear about this and demand action.”

These are exactly the sort of arguments made by right-to-try advocates. Indeed, as I’ve often pointed out, state-level right-to-try laws are completely toothless because federal law supersedes state law and the FDA regulates drug approval. The real reason for their existence is to put pressure on the FDA and to pressure federal legislators to pass a federal law. Sadly, it appears to have worked, as I doubt that the House will block the right-to-try bill passed by the Senate earlier this month. It will very likely become law next month.

There’s also the same sort of snake oil being used to push this approach to Rational Vaccines’ approach, which before this trial had resulted in a previous small preliminary trial:

For the initial trial, Halford and Rational Vaccines co-founder Fernández were unable to get federal funding or IRB approval, which oversees human safety. After testing out the vaccine on themselves for safety, they moved the trial to the Caribbean island. They flew 17 patients with pre-existing genital herpes cases there to get three shots of the vaccine. Halford reported that they experienced on average a three-fold reduction in days with symptoms on followup at four to six months after vaccination. Overall, the pair claimed that the trial and self-tests proved the safety and promise of the vaccine.

But when Halford attempted to publish the results, scientific reviewers were ruthlessly critical of the data and lack of safety precautions. One reviewer concluded: “This manuscript is partly a vision, partly science, and partly wishful thinking.”

I read the reviews of the manuscript, and I’ve rarely seen such critical comments from reviewers, ever. Interestingly, the authors apparently tried to slip their clinical trial data into a Perspectives article, rather than as a scientific or clinical report, and they inserted all sorts of extraneous rants and proselytizing into the manuscript, such that Reviewer 2 proclaimed it “part autobiography, part criticism of the herpes vaccine field, part description of autoinoculation studies with the author’s herpes vaccine candidate vaccine, part advertisement for the author’s vaccine company, and part description of preliminary results of a phase I trial.” One reviewer explicitly wondered if this was “an end run around the FDA.”

Why, yes. Yes it was and is. Very obviously so. So is the current trial. Even so, it’s hard to see how this works. Both Both Office for Human Research Protections (OHRP) and FDA regulations explicitly require that clinical trials used in support for an application to approve an investigational new drug (IND) be approved and monitored by an IRB. Even Dr. Gottleib can’t change that without changing the regulations (a long and onerous process), and I doubt that even he would want to try, his prior advocacy of “streamlining” the drug approval process notwithstanding. Thus, like state-level right-to-try laws, this stunt by Thiel and Fernández is designed to put pressure on the FDA and lawmakers.

If you don’t believe me, listen to Fernández, a former Hollywood filmmaker, himself:

Even so, Fernández, a former Hollywood filmmaker, said he and his investors plan to submit the trial data to the FDA in hopes of getting the vaccine approved for treatment. If the FDA does not respond favorably, he said, the company will continue its trials in Mexico and Australia. Fernández said he hopes to set up an IRB for these next trials. No matter what, he plans to manufacture the vaccine offshore. However, without U.S. approval, the challenges to market such a vaccine in the United States remain significant.

Manufacture and sell the vaccine offshore no matter what the FDA says? This is what quacks do.

Perhaps the worst thing about this is the involvement of the Southern Illinois University. Not only does SIU make excuses, it basically tries to wash its hands of the whole thing, even after having published a glowing press release about the research, promoting it despite how utterly unethical the research was. Now, here’s what SIU says:

Nonetheless, Southern Illinois University officials said they had no legal responsibility to ensure safety measures were in place because the university has an arms-length relationship with Rational Vaccines. Fernández said the company licensed two patents related to the vaccine from the university.

“SIU School of Medicine did not have any involvement in Rational Vaccines’ clinical trial,” said Karen Carlson, the university’s spokeswoman. “But we are confident that as the chief scientific officer of Rational Vaccines, Dr. Halford followed safety protocols appropriate to the clinical trial.”

But other researchers said they were appalled by what they described as the university’s complicity in ignoring more than 70 years of safety protocols.

As am I. For shame, SIU:

One can only wonder whether the feds can do something about SIU’s involvement in this, given that the university receives federal funding. Of course, in the anti-regulation governmental era that President Donald Trump has ushered in, I doubt that the FDA or the OHRP will do anything at all, even though SIU richly deserves it for its lack of ethics and disingenuousness. For example:

However, after questions about the lack of IRB approval (a federal requirement), the spokesperson said that the university would “take this opportunity to review our internal processes to ensure we are following best practices.”

Yeah, I hope so. Because clearly SIU wasn’t following “best practices” before. Remember OHRP and FDA regulations apply to any faculty of any university receiving federal funds, regardless if the faculty member used federal funds to carry out a clinical trial. SIU dropped the ball here, big time.

There is a multi-pronged war being waged on the FDA by ideological and business interests whose belief in the free market (and profit) as the adjudicator of the value of all things has deluded them into believing that all federal regulation is harmful and represents an undue brake on “innovation,” which basically seems to mean whatever people like Peter Thiel want to do to make money, regardless of scientific plausibility and ethics. (The passage of the 21st Century Cures Act is a less egregious example of another front in this war.) If Thiel and Fernández get away with not just taking their clinical trials offshore (which many drug companies do) but of so blatantly flouting FDA and OHRP regulations by not forming an IRB for these trials (which basically no drug company seeking to market a drug in the US does) and manage to win FDA approval for their vaccine, it will be a stake in the heart of the FDA, which is exactly what Thiel wants.

[Next time, to conclude this two-part series: If a federal right-to-try law passes, here’s what’s likely to be next.]

Comments

  1. #1 Mary Mangan (mem_somerville)
    August 29, 2017

    This is so dangerous in so many ways. First to the participants, of course. But more broadly to the feeding of anti-vax drama as well. Cranks can claim that this stuff is poorly tested, on vulnerable people, and they’ll be right.

    And if it doesn’t work or causes later problems? It will only be more reason to inflame anti-vax sentiment. Which will harm the perception of the whole field too.

    I understand that people who are desperate want hope. But we created a lot of ring-fences around these things for real and legit reasons.

  2. #2 Dorit Reiss
    August 29, 2017

    I agree that this is extremely bad. A herpes vaccine would be good to have, but the way this is done is so bad, long and short term.

    If an IRB didn’t approve it, there was likely a good reason.

    I hope the FDA stands firm on this.

    And can anyone explain why it’s being tested on patients that already have herpes? Aren’t vaccines preventive?

  3. #3 Eric Lund
    August 29, 2017

    Both Office for Human Research Protections (OHRP) and FDA regulations explicitly require that clinical trials used in support for an application to approve an investigational new drug (IND) be approved and monitored by an IRB. Even Dr. Gottleib can’t change that without changing the regulations (a long and onerous process), and I doubt that even he would want to try, his prior advocacy of “streamlining” the drug approval process notwithstanding.

    Unfortunately, Congress can change the rules, and I don’t see anything preventing them from doing that. There are too many on Capitol Hill who have drunk the libertarian Kool-Aid.

    Since the guy I infer was PI of this misbegotten study is dead, there is no way to punish him directly. But as long as the regulations allow them, the FDA should indeed stand firm, and mete out the maximum institutional penalty on SIU that the regulations allow. Cutting off the flow of facilities and administrative costs should get the attention of the SIU administration.

  4. #4 Concerned
    August 29, 2017

    Halford’s manuscript and cover letter are also posted on that site.

  5. #5 Narad
    August 29, 2017

    Um, “Patient CE‐27 shows a ’60 cm2 area of inflamed epithelium'”? Yikes.

  6. #6 MI Dawn
    August 29, 2017

    @Dorit: from the reviewer’s comments, it appears this vaccine is to prevent future outbreaks of herpes, and also “cure” the person of having the virus, therefore eliminating the risk of outbreaks.

    • #7 Dorit Reiss
      August 29, 2017

      Thank you, Dawn.

  7. #8 jrkrideau
    At the bottom of the lake (the bottom end, that is)
    August 29, 2017

    A stray thought crossed my mind as I read that the “trial” was carried out by ferrying 17 Americans to St. Kitts and shooting them up. Did the Government of St. Kitts have any idea that a “clinical trial” was being carried out?

    Would any of the medical team be licensed to practice there?

    Did the St. Kitts Gov’t just think it was another US vacation tour group?

    OT a bit but have you seen this controversy? It does not speak directly to the “right to try “ issue but it seems strange. http://blogs.discovermagazine.com/neuroskeptic/2017/08/25/eteplirsen-curious-controversy/#.WaV39heQxy0

  8. #9 Panacea
    August 29, 2017

    Dorit: yes, vaccines are supposed to be preventative, but sometimes they’re given when someone has been exposed with the hope of beating the disease to the punch. Immunoglobulins also serve this purpose. It’s why people who get the flu after getting a flu vaccine don’t typically get as sick as someone who wasn’t vaccinated for it.

    I find it hard to believe they got data showing a decrease in symptoms since herpes comes and goes out of remission. They’d have to vaccinate someone at the start of an outbreak to get that data. I call BS.

    I also call BS that the PI’s vaccinated themselves with an unproven herpes vaccine. I want to see the titer before I’ll believe it. They could just as easily have injected themselves with saline, and anyone so unethical to run a trial like this is not above lying about something like this.

  9. #10 Helianthus
    August 29, 2017

    @ Dorit

    And can anyone explain why it’s being tested on patients that already have herpes? Aren’t vaccines preventive?

    My guess would be a rationale similar to the one for the treatment for rabies – the vaccine is providing antigens which the immune system may have trouble to find otherwise, because it’s confronted to an aggressive virus (rabies) and time is of the essence.
    In the case of herpes, it would be more because it is an elusive virus. The vaccine may be supposed to strengthen/re-awaken the existing immune response and help keep the dormant virus in check.
    That’s would be my theory, anyway. But I’m not sure it’s even proven that a vaccine injection is helping a patient with rabies (it’s not like there have been many successful stories).
    There may be other illness where a curative treatment is tried by using a vaccine. There were some trials in Canada a few years ago with a vaccine for people with cat’s allergy. But again, I’m not up-to-date on this.

    tl;dr: there may be some legit theory behind the use of a vaccine as curative treatment, but I don’t feel that confident…

  10. #11 Chris Hickie
    August 29, 2017

    @ jrkrideau

    I suspect the government of St. Kiss could care less about unethical medical trials. St. Kitts is one of those islands that boasts at least 2 non-accredited “medical schools” (I use this term very loosely) for US students which are basically money making honey potts for crooks who try and convince people who couldn’t get into a US-accredited medical school to spend a lot of money on a shady medical degree with long odds of getting into a US residency.

  11. #12 Narad
    August 29, 2017

    It’s why people who get the flu after getting a flu vaccine don’t typically get as sick as someone who wasn’t vaccinated for it.

    That assertion may be bolder than is warranted:

    “Flu vaccination also may make your illness milder if you do get sick.”

    I think I’ve seen Vincent Racaniello completely dismiss the proposition, but I have to pack this machine up and head to an airport, so I can’t go digging.

  12. #13 Eric Lund
    August 29, 2017

    Did the Government of St. Kitts have any idea that a “clinical trial” was being carried out?

    Was there any reason for them to have suspected? If the participants looked like ordinary tourists from the US–especially if they arrived separately, which sounds perfectly plausible to me, the government need not have suspected anything was up until the manuscript became public. US citizens can visit for up to 90 days without a visa.

  13. #14 squirrelelite
    August 29, 2017

    There is also the example of herpes zoster or shingles. The vaccine is given to people who have already been infected with the chickenpox virus to prevent an outbreak of shingles later in life when their immunity is waning.

  14. #15 Roadstergal
    August 29, 2017

    Yes, the herpes viruses love to hide out in nervous system reservoirs and reactivate, and a vaccine can be useful in reducing those reactivations – as in shingles.

    Given the variability, I don’t know how a trial that small, with no control arm, can say anything about the vaccine’s effect…

  15. #16 JustaTech
    August 29, 2017

    Here’s a thing I’ve noticed about these libertarian approaches to business: so far they don’t seem to go after aerospace, and I have to wonder if that is because aerospace and airlines are at least as heavily regulated as pharma.

    These libertarians genuinely don’t seem to understand that there is a *reason* why Pharma and biomedical research are highly regulated. And I think it’s because they’re coming from very lightly regulated industries.

    If you mess up your code for eBay or PayPal? Somebody doesn’t get their 1978 Matchbox car, or doesn’t get paid. If you mess up the manufacture of your drug? People could die. You mess up the design of your airplane? People could die. Often a regulation is also a tombstone.

    Either they don’t know or they don’t care, but either way they have to be stopped before they kill a whole bunch of people.

  16. #17 herr doktor bimler
    August 29, 2017

    These libertarians genuinely don’t seem to understand that there is a *reason* why Pharma and biomedical research are highly regulated.

    They understand perfectly well that the FDA is there to protect consumers. They just see that as a problem.

    Meanwhile:

    Federal authorities raided a California stem cell clinic and seized a smallpox vaccine that is reserved only for the military and high-risk populations, as the Food and Drug Administration expressed “serious concerns” about how the clinic obtained access to the vaccine at all.

    The U.S. Marshals Service seized five vials of the smallpox vaccine, which is not commercially available, the FDA announced Monday. Four of the vials — which each hold 100 vaccine doses — were unused, but a portion of the fifth vial had been used.

    The treatment mixed some of the vaccine with stem cells taken from a patient to create an injectable — and unproven and unregulated — cancer treatment that was targeted directly at the patient’s tumors, the FDA said. The FDA, which learned of the treatment after inspections, said the injection could have caused inflammation and swelling of the heart.

    The treatment belonged to San Diego-based company StemImmune Inc., and was given at California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills. U.S. marshals seized the product on Friday.

  17. #18 Graham
    August 30, 2017

    The process you are describing in that ‘clinical trial’ are quite literally the ones that Quacks have been using for decades in the Third World to foist homeopathy, acupuncture, Miracle Mineral Solution and other nostrums to people who are desperate for effective healthcare. Why, because the bogus trial results make great advertising in the West.

    At least this time it’s happening in the US’s backyard and it seems that the people behind it made the mistake of sending their paper to a real journal.

  18. #19 jrkrideau
    At the bottom of the lake (the bottom end, that is)
    August 30, 2017

    # 11 Chris Hickie

    Does that mean that my degree from the Ross University School of Veterinary Medicine may not be a valuable as I thought? Oh dear.

    On the other hand, a rogue medical trial pays no taxes and , if anything goes wrong probably leaves the St Kitts’ Gov’t to clean up the mess.

    # 13 Eric Lund

    Was there any reason for them to have suspected?

    Exactly, if I was the St Kitts’ Gov’t I’d be a bit annoyed for several reasons— including American arrogance, and see above re tax, etc.

  19. #20 David Foster
    San Diego
    August 30, 2017

    I am going to put this date on my calendar, as I believe this is the first time I have agreed with any post from this blogger on the subject of vaccines. I commend the thoughtful criticisms of this so-called “clinical trial” and all of its ethical failings.

    What amazes me though is the completely myopic perspective demonstrated here. If what is being done with this herpes vaccine is wrong, then you also need to appreciate that this type of thing has been happening all the time throughout the history of vaccines. Are you open-minded enough, and brave enough, to direct the same criticisms to very similar episodes which occurred during the development of many of the vaccines which are in use today?

    There are new stories about unethical clinical trials throughout the developing world, many of them sponsored by the Bill and Melinda Gates Foundation, coming almost weekly.

    Many vaccines have been fast-tracked, much of the so-called “safety studies” are completely bogus, and the notion of informed consent has been completely dispensed with for many of these trials.

    Look up the history of the anthrax vaccine. The development of the polio vaccine was the beginning of everything that was to become totally wrong about vaccine development, vaccine policy and vaccine politics (we call it Political Immunology). Look at the history of the MMR vaccine, where earlier versions caused meningitis outbreaks but the vaccine was still licensed for use, and in some countries like the UK it became licensed even *after* the meningitis risk was known. Even after it was pulled from use in the UK it was then sent to developing countries…no reason to waste perfectly good product! Even our current MMR vaccine is under scrutiny as Merck is fighting a lawsuit from two whistleblowers who are claiming that they were asked to falsify clinical trials data in order to make the mumps portion of the vaccine appear to be more effective.

    The story of the development and licensing of Gardasil is a perfect example of fraudulent testing which left us with a vaccine which is killing and injuring children all over the world:

    http://www.ageofautism.com/2012/10/spotlight-on-gardasil.html

    I know that the majority of you will simply see Age of Autism and dismiss this, but if you actually take the time to read it, you will see that Mark and Dan uncovered many of the same ethical problems that Orac discusses here.

  20. #21 Chris
    August 30, 2017

    Mr. Foster: “Look at the history of the MMR vaccine, where earlier versions caused meningitis outbreaks but the vaccine was still licensed for use, ….”

    The Urabe mumps strain has never ever been used in the USA. The Jeryl Lynn mumps strain was in the original American version licensed in 1971. The new improved version was introduced in 1978 with a better rubella strain.

    Your version of history is very flawed. In fact, the UK removed both Urabe mumps strain MMR versions in 1992. In fact the effect of Wakefield’s stupid evidence free video press recommendation in 1998 to use separate caused this issue:
    MEDICINES CONTROL AGENCY TO OBJECT TO IMPORTATION OF UNLICENSED SINGLE URABE STRAIN MUMPS VACCINE

    This alone is enough to ignore anything by you and the other idiots at AoA.

  21. #22 Narad
    August 30, 2017

    we call it Political Immunology

    “We”?

  22. #23 Narad
    August 30, 2017

    I didn’t realize that it was possible to have “outbreaks” of aseptic meningitis.

  23. #24 Rich Bly
    Ocean Shores
    August 30, 2017

    David Foster,

    Please provide creditable citations for some these unethical trials being sponsored by the Bill and Melinda Gates Foundation. Age of Autism is not a creditable source. Remember you are making the claims of unethical trials, so must provide the creditable references.

    I have my doubts that you can actually provide the source material but as they say the horse may be able to sing.

  24. #25 Lawrence
    August 30, 2017

    Well, at least in one respect, he’s right. Clinical trials do take place all over the world – because many countries require their own approvals and oversight of vaccines used within their borders.

    Not to mention (though I will), that countries like India have their own domestic vaccine manufacturers, who are required to perform clinical trials and receive approval from the relevant government regulatory agencies as well.

  25. #26 Julian Frost
    Gauteng East Rand
    August 30, 2017

    @David Foster:

    Mark and Dan uncovered many of the same ethical problems that Orac discusses here.

    Ha.
    Ha, ha!
    Ha, ha, ha, ha!
    HAHAHAHAHAHAHA!!!!
    Dan Olmsted once claimed that there were no autistic Amish. His “research” and “journalism” skills were so weak he failed to learn about the “Clinic for Special Children”, which catered to the Amish, and which had autistic residents.
    That you view him as reliable tells me all I need to know.

  26. #27 Chris Hickie
    August 30, 2017

    David Foster is AWAK3 and thinks we are SHEEPL3.

    (yawn)

  27. #28 Chris
    August 31, 2017

    Dr. Hickie, he is just a clueless fool.

    Being a Brit he does not realize there was an MMR in use for seventeen years before the UK licensed three versions in 1988.. and then removed two in 1992.

    It is like his view of medical history does not extend west or east of the UK.

  28. #29 David Foster
    August 31, 2017

    @Chris:
    Are you denying that a version of MMR which was already known to cause meningitis was in fact licensed in the UK before being pulled? That was my only point, that they knew there were issues with the vaccine yet still licensed it and used it for years before pulling it.

    @Narad:
    We.
    An “outbreak” does not necessarily need to be an infectious disease, though my use of the word was not very precise. I should have used “epidemic”.

    @Rich Bly
    I am not going to write an entire essay on this just to convince those of you who will likely never decide to investigate this for yourselves…it would be a waste of my time. The Bill and Melinda Gates Foundation has found itself in trouble many times due to its clinical trials, in fact it is currently involved in lawsuits in India. I bring this all up in the hopes that perhaps some of you will look into this for yourselves. I already have.

    @Chris Hickie
    My point was that while I agree with Orac’s post regarding this particular vaccine trial, the very same problems he brings up occur quite often with regard to previous and current clinical trials, especially those conducted in other countries. The history of vaccines is replete with ethical failures like this.

    @Julian Frost
    You seem to be one big walking talking logical failure. Dan Olmsted’s investigation into the Amish was preliminary, he did not fool himself into believing he was doing an epidemiological study. But what he found was very interesting, though not absolute. Your assumption that what he found is meaningless simply because there are some autistic Amish children is silly, but it is amusing to see how easily the pseudo-skeptics can convince themselves of a fallacy.

  29. #30 Chris
    August 31, 2017

    Mr. Foster: “Are you denying that a version of MMR which was already known to cause meningitis was in fact licensed in the UK before being pulled?”

    Do you have reading comprehension problems? Please directly quote where the denial occurred. Especially since I actually explained to you the entire history and included this little issue caused by Wakefield:
    MEDICINES CONTROL AGENCY TO OBJECT TO IMPORTATION OF UNLICENSED SINGLE URABE STRAIN MUMPS VACCINE

    By the way, the above article has to do with laws in the United States of American, not the United Kingdom. So I will repeat again that the only mumps vaccine strain used in any American MMR is the Jeryl Lynn strain going back to 1971.

    Okay, deer Davey, some simple arithmetic: 1988 – 1971 = 17 …

    Which is the number of years the MMR vaccine was used in the USA before the UK. And since you have trouble retaining information: The USA has only used the Jeryl Lynn vaccine strain.

    Some more simple arithmetic: 1998 – 1992 = 6 ….

    Which is the number of years between the UK pulling the two MMR vaccines with Urabe and Wakefield’s fraudulent lying Lancet paper.

  30. #31 squirrelelite
    August 31, 2017

    Since an epidemic is

    a widespread occurrence of an infectious disease in a community at a particular time.

    and aseptic meningitis
    http://emedicine.medscape.com/article/1169489-overview

    Aseptic meningitis syndrome … has a number of other etiologies as well, both infectious and noninfectious.

    I suggest you stick to the term outbreak.

    The WHO has a good list of references on Mumps and vaccines.
    http://www.who.int/immunization/Refs_Mumps_25_Jan_2007.pdf

    If you scroll down and read Nokes et all from 1991, you’ll find that

    In communitybased
    programmes, the greater apparent safety of the Jeryl Lynn vaccine (fewer vaccineinduced
    complications) is offset by the greater apparent efficacy of the Urabe Am 9 vaccine
    (fewer complications due to natural infection). The findings suggest that it may not always be
    in the interests of the community to use the vaccine with the lowest complication rate.

    so there was a tradeoff made and the UK chose the vaccine with greater efficacy against the primary cause of aseptic meningitis, mumps itself.

    As I recall, there was also an availability issue as well, but perhaps Chris can clarify that. As the side effect concerns became clearer and the Jeryl Lynn strain became available in the quantities needed, the UK switched vaccines.

    Perhaps, David, you could clarify for us.

    An unethical trial that only had 20 participants and probably couldn’t have demonstrated much of anything was snuck overseas to avoid the restrictions and requirements that have been put in place in the US and many other countries to protect patients because of mistakes that were made 30 to 50 years ago, therefore what?

  31. #32 Julian Frost
    Gauteng East Rand
    August 31, 2017

    @David Foster, responding to me:

    Your assumption that what he found is meaningless simply because there are some autistic Amish children is silly

    Way to miss the point. Dan Olmsted loudly proclaimed that the Amish did not vaccinate, and did not have autistic children. He was wrong with both arms of his claim.
    My point was, if he made such an easily provably wrong claim, then he can’t be trusted to get things right.

  32. #33 Narad
    August 31, 2017

    @Narad:
    We.

    Who would yall be?

    An “outbreak” does not necessarily need to be an infectious disease, though my use of the word was not very precise. I should have used “epidemic”.

    No, you should have used “cluster in Nottingham.”

  33. #34 Chris
    August 31, 2017

    squirrelelite: “As I recall, there was also an availability issue as well, but perhaps Chris can clarify that. As the side effect concerns became clearer and the Jeryl Lynn strain became available in the quantities needed, the UK switched vaccine”

    Some of has to do with costs. Though from my reading after Japan developed the Urabe mumps vaccine, it was about the time mumps vaccination was coming to Europe, in the 1980s. Especially since the Rubini mumps strain was deemed ineffective.

    I think it may have been more of a cost issue than an availability issue: Mumps Outbreaks in Canada and the United States: Time for New Thinking on Mumps Vaccines

    Which says:

    Money should not be the only decisive factor, but it allows one to rank vaccines in certain order: a single-dose vial (according to the price for the US-manufactured vaccine) costs $.90, $1.20, and $2.50 for MMR vaccine containing L-Zagreb, Urabe, and Jeryl Lynn strains, respectively [96, 97].

    You can see that the Jeryl Lynn strain costs slightly more than double of the Urabe strain.

  34. #35 Chris
    August 31, 2017

    Okay, another one of my comments has gone into the ether. I had just put in this quote: “Money should not be the only decisive factor, but it allows one to rank vaccines in certain order: a single-dose vial (according to the price for the US-manufactured vaccine) costs $.90, $1.20, and $2.50 for MMR vaccine containing L-Zagreb, Urabe, and Jeryl Lynn strains, respectively [96, 97].”

    From a paper titled: “Mumps Outbreaks in Canada and the United States: Time for New Thinking on Mumps Vaccines”

    Published on 15 August, 2007 in Clinical Infectious Diseases

  35. #36 Chris
    August 31, 2017

    Okay, try for the reason why I used that quote… Europe started to vaccinate for mumps in the 1980s, after the Urabe mumps vaccine strain was developed in Japan. Especially since the Rubini mumps vaccine strain was not terribly effective.

    As you can see from the quote, the Jeryl Lynn strain costs slightly more than twice that of the Urabe strain.

  36. #37 herr doktor bimler
    August 31, 2017

    @Rich Bly
    I am not going to write an entire essay on this just to convince those of you who will likely never decide to investigate this for yourselves…it would be a waste of my time. The Bill and Melinda Gates Foundation has found itself in trouble many times due to its clinical trials, in fact it is currently involved in lawsuits in India. I bring this all up in the hopes that perhaps some of you will look into this for yourselves. I already have.

    If proof of the Gates Foundation naughtiness existed, It would have been easy to link to it. Instead you spent time writing an entire essay on why you were not writing an entire essay, and instead Leaving it as an Exercise For the Reader.

  37. #38 Chris
    August 31, 2017

    The last couple of hours have been crazy making. At least four of my comments to this blog have been sucked into void, we lost power for over an hour, and now I am gritting my teeth listening to Michael Marshall interview a crackpot on Be Reasonable (very similar to the NWO Troll). At this point of the podcast she is promoting MMS.

  38. #39 Lawrence
    August 31, 2017

    “Go look yourself.” The constant idiotic refrain from the typical anti-vaxer.

    It just so happens that I have looked – and you’re full of crap.

  39. #40 Narad
    August 31, 2017

    Forgot about this:

    Even after it was pulled from use in the UK it was then sent to developing countries…no reason to waste perfectly good product!

    Viral meningitis “occurs in about one in seven cases of mumps.” Compare this with “1 in 10,000–15,000 doses,” from the American Journal of Epidemiology paper linked above.

    Of course, this assertion is once again quite vague, so there’s no telling which countries it was “sent to” (the assertion may be that UNICEF had Urabe availability until 2014 [PDF], for all I know).

  40. #41 Narad
    August 31, 2017

    Dan Olmsted’s investigation into the Amish was preliminary, he did not fool himself into believing he was doing an epidemiological study.

    *blink*

  41. #42 Rich Bly
    Ocean Shores
    August 31, 2017

    HDB,

    Thanks, I wrote a short rebuttal but it got sucked into the void. All I can say is at best Foster is just an over inflated hot air bag and will not lower myself to call him what most probably he is.

  42. #43 squirrelelite
    August 31, 2017

    @Narad,

    There was also the 1997 cluster in Salvador, Brazil with an estimated risk of 1 in 14,000 for Urabe MMR.

  43. #44 Rich Bly
    Ocean Shores
    August 31, 2017

    Just for the hell of it, I looked up the Gates Foundation being sued in India. The article was from Vaccine This (appears to be an anti-vax site). The law suit was really against Merck over guardasil. The Gates Foundation was involved because they provided grant monies. Of course this article was fro 2014, so is way out of date.

  44. #45 Narad
    August 31, 2017

    There was also the 1997 cluster in Salvador, Brazil with an estimated risk of 1 in 14,000 for Urabe MMR.

    Yes, I saw that (PDF), but the question of comparative risk hinges on incidence, and I just wasn’t up to trying to calculate something.

  45. #46 Rich Bly
    Ocean Shores
    August 31, 2017

    Just for the heck of it I looked up the law suit against the Gates foundation in India. It actually was Merck being sued about Guardasil and the Gates Foundation was involved because they provided grant monies. The article was from a group called Vaccine This, which appears to be an anti-vax group. The article was dated 2014.

  46. #47 MSud
    September 6, 2017

    There is a legit therapeutic herpes vaccine in the clinical trial pipeline, about to enter P3 at the end of this year. Check out geneocea biosciences…

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