The bloviating Peter Doshi, who loves all things anti-vaccine, filed a lawsuit against Health Canada, essentially, the Ministry of Health for the country and the ministry that regulates medications and vaccines for Canada, to retrieve all of the clinical trial data for HPV vaccines that was used to get approval for the vaccines in the country (see Note 1). He recently won that lawsuit, and, unless Health Canada appeals the ruling, so we can assume he will receive mountains of data to “analyze.”
According to an article in the CBC, the ruling gives Doshi access to clinical trial data submitted to Health Canada by the manufacturers of HPV vaccines, Gardasil, Gardasil9, and Cervarix, and of anti-viral flu medications. Doshi wants to do a “systematic review” of the findings, although I don’t think that’s what a systematic review is, we’ll discuss that below. Health Canada argued that the data was confidential, and they would only hand over the data if he signed a non-disclosure agreement. Doshi refused, and he prevailed in the lawsuit.
You may have read all of this and wondered who is this Peter Doshi and why do I dislike him so. Well, most of you know of Doshi. And then you wonder why I care at all that he gets this data. I actually don’t care, but I should talk about it anyway.
So, let’s talk about the false authority, Peter Doshi, and why it matters or not that he gets this data. Spoiler alert – it doesn’t matter, but we should be prepared.
All about HPV vaccines
Genital and oral human papillomavirus (HPV) infections are the most common sexually transmitted infections (STI) in the USA. HPV is generally transmitted from personal contact during vaginal, anal or oral sex.
It’s important to note that there are more than 150 strains or subtypes of HPV that can infect humans – however, only 40 of these strains are linked to one or more different cancers. Of those 40 strain, most are fairly rare.
Although the early symptoms of HPV infections aren’t serious and many HPV infections resolve themselves without long-term harm, HPV infections are causally linked to many types of cancers in men and women. According to current medical research, here are some of the cancers that are linked to HPV:
In addition, there is some evidence that HPV infections are causally linked to skin and prostate cancers. The link to skin cancer is still preliminary, but there is much stronger evidence that HPV is linked to many prostate cancers.
HPV is believed to cause nearly 5% of all new cancers across the world, making it almost as dangerous as tobacco in that respect. According to the CDC, roughly 79 million Americans are infected with HPV – approximately 14 million Americans contract a new HPV every year. Most individuals don’t even know they have the infection until the onset of cancer. The CDC also states that over 41,000 HPV-related cancers are diagnosed in the USA every year.
There were two HPV vaccines on the world market before 2014. GSK, also known as GlaxoSmithKline, produced Cervarix, a bivalent (protects against two HPV strains) vaccine. It has been withdrawn from the US market (although available in many other markets), because of the competition from the quadrivalent (immunizes against four different HPV strains) and 9-valent (against nine HPV strains) Gardasil vaccines.
Merck manufactures Gardasil, probably the most popular HPV vaccine in the world. The first version of the vaccine, quadrivalent Gardasil, targets the two HPV genotypes known to cause about 70% of cervical cancer and two other HPV genotypes that cause genital warts. In Europe and other markets, Gardasil is known as Silgard.
The newer Gardasil 9, approved by the FDA in 2014, is a 9-valent vaccine, protecting against HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. It targets the four HPV strains found in the quadrivalent version, along with five additional ones that are linked to cervical and other HPV-related cancers. Both versions of Gardasil are prophylactic, meant to be given to females or males before they become exposed to possible HPV infection through intimate contact.
Gardasil is one of the easiest and best ways to prevent a few dangerous and, to abuse the definition slightly, common cancers that afflict men and women. Without a doubt, the HPV vaccine prevents cancer.
Currently, in the United States, the Advisory Committee on Immunization Practices (ACIP) recommends that preteen girls and boys aged 11 or 12 are vaccinated against HPV. The immunization is also recommended for teenage girls and young women up to the age of 26 who did not receive it when they were younger, and teenage boys and young men up to the age of 21.
Let me sum this all up so that if you come away from this section with nothing else, you get this summary. HPV is a sexually transmitted disease. HPV causes 41,000 cancers a year in the USA alone. The HPV vaccine prevents becoming infected by HPV, which means you are protected from these cancers.
All about Peter Doshi
I think the first thing we to review is who is Peter Doshi? And why is he so insistent on getting this data?
Peter Doshi received his BA in anthropology from Brown University, MA in East Asian studies from Harvard University, and Ph.D. in history, anthropology, and science, technology and society from the Massachusetts Institute of Technology. Those would be fine credentials for someone who is going to teach history or anthropology.
But does it make one a vaccine expert? Absolutely not. For most of us, an authority in vaccines requires actual studies in those biomedical science fields like virology, microbiology, epidemiology, immunology, cell biology, and a few others. Even then, there are fake authorities, like Tetyana Obukhanych, who actually have some credentials, but deny basic scientific knowledge.
On the other hand, I keep making a big point – credentials actually don’t matter, what does matter is evidence. And we want quantity and quality of said evidence.
However, there are substantial reasons why credentials can matter. They imply many things – a broad education in the science of the subject matter, hard work in the minutiae of that field of science, and approval by one’s peers. Getting a Ph.D. in epidemiology is not simply taking classes, but it’s actually doing research in the laboratory and field with a published thesis that is reviewed by numerous scientists, some of whom may not be in the specific field (to give some unbiased eyes to the research).
Clearly, Doshi lacks a broad research and publication record in any of those areas, save for his critique of the flu vaccines, which included a statement that claims that “influenza” (disease caused by influenza viruses) is different than “flu” (a syndrome with many causes, of which influenza viruses appear to be a minor contributor).” That makes me conclude that Doshi actually fails to understand the basic principles of diseases.
Peter Doshi is currently an assistant professor (non-tenured) of pharmaceutical health services research in the School of Pharmacy at the University of Maryland. This field of study is not basic pharmacological and clinical research of pharmaceuticals – it is an economic-based study for drug utilization and other areas. These fields might be interesting if I was writing about pharmaceutical economics, but is nearly irrelevant to understanding vaccines.
Doshi is also an editor at BMJ, a leading medical journal. Why he is at that journal, which published Brian Deer’s investigations of Andrew Wakefield’s fraud, is not clear to me. Lucky for us, I haven’t seen any trend of anti-vaccine nonsense flowing from that journal.
Finally, and I hate belaboring a point, but the only thing that matters is evidence. And has Doshi led clinical research into any aspect of vaccines? No, his scientific credentials in that area are totally lacking.
Peter Doshi is a False Authority
We need to examine how the anti-vaccine crowd depends on false authorities. Vaccine deniers often rely upon the argument from false authority, a logical fallacy which is an argument from an authority, but on a topic outside of the authority’s expertise or on a topic on which the authority is not disinterested. Furthermore, the works of authorities, no matter how eminent or influential, is always judged by the quality of their evidence and reasoning, not by their authority alone.
For example, Peter Duesberg, a professor of molecular and cell biology at the University of California, Berkeley, has incredible credentials and would probably be considered an authority based on his academic credentials alone. Sadly, Duesberg claims that HIV is not the cause of AIDS and that recreational drug use is more to blame for the prevalence of AIDS amongst the homosexual community.
Duesberg has also claimed that AIDS in Africa is largely misdiagnosed, and is not really AIDS but merely the accumulated effects of malnutrition and disease. AIDS deniers, like Duesberg, have little or no scientific evidence for their disputing that HIV causes AIDS, they are considered crackpots at best and harmful to the research to treat and prevent AIDS. A true scientific skeptic does not accept the statements of an authority figure just because they are an authority, but on the body of evidence, along with the qualifications, of said authority.
Science deniers attempt to create a false equivalence, or even this false democracy of science, by cherry picking some “authority” that supports their point of view. Of course, they ignore the vast majority of “authority” figures who are on the other side of the fence. Once again, one authority person does not outweigh the vast numbers that are usually on the other side of the argument.
Big Pharma clinical data
Don’t be shocked, but on one small point, I actually agree with Peter Doshi – this data should be available to researchers to follow up. I don’t happen to think that this data, or most Big Pharma data, is hiding data. That would be a criminal act, and the FDA (and other international drug regulatory agencies) would be very unhappy if they did not receive all of the data before granting approval.
I think clinical trials should be utterly transparent. Dr. Ben Goldacre, in his book, “Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients,” he writes:
Sometimes drug companies conduct lots of trials, and when they see that the results are unflattering, they simply fail to publish them. This is not a new problem, and it’s not limited to medicine. In fact, this issue of negative results that go missing in action cuts into almost every corner of science. It distorts findings in fields as diverse as brain imaging and economics, it makes a mockery of all our efforts to exclude bias from our studies, and despite everything that regulators, drug companies and even some academics will tell you, it is a problem that has been left unfixed for decades.
Certain information should be kept confidential. Formulation, production costs, or anything else that could be used by a competitor. But I’m having a difficult time seeing any good reason to keep clinical data from being shared.
How Peter Doshi will use this data
I know Doshi was celebrating with this anti-vaccine buddies over this win. They probably think they’ll find some smoking gun that will “prove” the HPV vaccines are dangerous to mankind. I wouldn’t hold my breath there false authority Peter Doshi. Are you so arrogant that you think you’ll find something that regulatory authorities across the world missed?
Doshi claims he’ll write a “systematic review” of the data. As I’ve written before, it is considered the pinnacle of biomedical research. The very top. Maybe the CBC article got it wrong, but I don’t think that systematic review means what Peter Doshi thinks it means.
A systematic review examines the quality of research in each of the papers, describe the results qualitatively, and find bias and errors. A published systematic review usually includes a description of the findings of the collection of research studies. Many systematic reviews also include a quantitative pooling of data, which is called a meta-analysis.
What Doshi is doing is a primary analysis of the data – he’s looking at original data. Moreover, I’m getting the impression that Peter Doshi has a pre-conceived conclusion, and he will examine the data to support that conclusion!
Furthermore, I’m not even sure what will be the value of this data. The original clinical trials have long been superseded by extremely large Phase IV studies (which are still monitored for safety and efficacy signals by the FDA and other regulatory authorities) that have shown us two things – the HPV vaccine is extremely safe and very effective in preventing HPV and cancer.
Peter Doshi ignores all of that in his quest for pure vaccine denial. But what can you expect from a vaccine denier?
Summary
Yes, HPV vaccine manufacturers ought to make all of their data public. But there’s not going to be anything there. I strongly doubt that there’s anything in that data that will show us anything new. Moreover, we have much better data since the original clinical trials that give us powerful evidence that the HPV vaccines are safe and effective. Peter Doshi just ignores that evidence in his quest to be some sort of hero for the anti-vaccine religion.
But the vaccine deniers will hang on to their false authorities no matter what real evidence has shown us.
Notes
- Most clinical trials are done across borders. So, Health Canada probably reviewed data from HPV vaccine clinical trials done in the USA and Europe, along with any that were done in Canada. This is typical of all drug applications, even those in the USA and EU – clinical trials could be done anywhere, as long as the trial followed the protocols approved by the regulatory authority prior to the commencement of the study.
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