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Vaccine Whistleblower: BS Hooker and William Thompson try to talk about epidemiology

Vaccine Whistleblower – a highly edited misrepresentation of the facts

Vaccine Whistleblower” – a highly edited misrepresentation of the facts.

Here we go again with the whole “CDC Whistleblower” thing, this time with a book about the recorded conversations between Brian J. Hooker and William Thompson. Well, not the whole conversations, of course. If they were to release the whole conversations, we might get the truth, and the truth always gets in the way of the antivax crowd. Instead, we get an edited transcript of the conversations between those two in which, according to them and the book’s editors and authors, there is some sort of massive cover-up at all levels of science, government, and public health. What’s the cover-up? As usual, vaccines are evil and whatnot.

I’m not going to review the whole book for you because Dr. Gorski has already done so, and Dorit Reiss has discussed the legal aspects of what is discussed in the book. You can go read his review and/or Prof. Reiss’ analysis and then come back, or stay here and read what I have to say about the failed attempts at epidemiology from both BS Hooker and Thompson.

Let’s start by reviewing BS Hooker’s credentials. He is a bioengineer and chemical engineer, not an epidemiologist, despite what the author of the book wants you to believe:

With the publication of Kevin Barry’s Vaccine Whistleblower: Exposing Autism Research Fraud at the CDC, any claims of credibility for the CDC’s science has collapsed. Barry built his book upon four legally taped conversations between CDC senior vaccine safety scientist Dr. William Thompson and Simpson College professor and epidemiologist, Dr. Brian Hooker.

Later in the book, in the transcript of one of the conversations between BS Hooker and Thompson, BS gets a list of things he needs to do to earn an “honorary” degree in epidemiology. Among those things was to look at some of the earlier studies that Thompson had coauthored. And BS did. He would go on to write a flawed paper that I critiqued here and ended up being retracted, as I told you about here. That paper alone should tell you everything you need to know about BS Hooker’s epidemiological understanding, but the transcripts given to us by his camp in the form of the book really reveal his ignorance.

So let’s go through the calls we have transcripts for and pick at the epidemiological and biostatistical missteps that Thompson suggests for BS Hooker. (more…)

Posted in: Politics and Regulation, Public Health, Vaccines

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Vaccine Whistleblower: An antivaccine “exposé” full of sound and fury, signifying nothing

Life’s but a walking shadow, a poor player
That struts and frets his hour upon the stage
And then is heard no more: it is a tale
Told by an idiot, full of sound and fury,
Signifying nothing.

– Shakespeare’s Macbeth, Act 5, Scene 5

 

"Vaccine Whistleblower"? More like the next Andrew Wakefield in the making.

“Vaccine Whistleblower”? More like the next Andrew Wakefield in the making, albeit a shy, really pissed off Andrew Wakefield.

I don’t review books that often. The reason is simple. My posts for this blog sometimes take as much as a several hours to write (particularly my more “epic” ones that surpass 5,000 words), and I usually don’t have the time to add several more hours to the task by reading an entire book. Also, by the time I’ve read a book I might want to review, weeks—or even months—have often passed, and a review is no longer of much interest to our readers anyway. Fortunately, Harriet does an admirable job of reviewing books for us.

Today, I’m making an exception for a book hot off the presses. The main reason is curiosity, because the book is about a topic that I’ve blogged about three times here and several times more for my not-so-super-secret other blog, and I really wanted to find out more about what was going on. I didn’t expect to find out what really happened, because I knew from the beginning that the book, Vaccine Whistleblower: Exposing Research Fraud at the CDC by an antivaccine lawyer named Kevin Barry, would be highly biased. However, as I found out a few weeks ago, the book promised four complete transcripts of telephone conversations between the “CDC whistleblower,” a Centers for Disease Control and Prevention (CDC) psychologist named William W. Thompson who has been a co-investigator on important CDC studies since the late 1990s.

Given my rather public skepticism about the particulars of Thompson’s story, I was quite surprised when my request to Barry’s publicist for a review copy of Vaccine Whistleblower was enthusiastically answered in the affirmative, thus giving me time to read the e-book before it was released. I also sent a copy of the book to a law professor familiar with the saga, Dorit Reiss, to write a legal perspective (also being published on SBM today) which is why I will say little about this aspect of the book in my discussion. In addition, René Najera has examined the book from a statisticians’ standpoint.
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Posted in: Book & movie reviews, Politics and Regulation, Public Health, Vaccines

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Review of Vaccine Whistleblower: A Legal Perspective 

"Vaccine Whistleblower"? More like the next Andrew Wakefield in the making.

“Vaccine Whistleblower”? More like the next Andrew Wakefield in the making.

This post addresses some legal issues raised in the Vaccine Whistleblower book. The first part explains whistleblower protections and how Dr. Thompson’s allegations fit into them. The second part addresses Dr. Thompson’s suggestion of an independent research agency. The third part explains why the book’s claim that school mandates violate international human rights is incorrect.

A note on the book: Chapters 1 is an executive summary of Chapters 2-5, the interview transcripts; Chapters 6-12 are the author Kevin Barry’s thoughts on what should be done. (Note that Dr. Gorski has also discussed this book from the perspective of the science.)

Prologue: to set the scene

The “Vaccine Whistleblower Book” has four transcripts of telephone conversations between William Thompson and Brian Hooker, recorded between May 1, 2014 and July 28, 2014.

Hooker has elsewhere stated that these conversations were only four of over thirty conversations between Thompson and Hooker. Hooker asserts these conversations began in November, 2013, and that Thompson initiated the conversations. It is not clear if these four recorded conversations were the only ones during that time frame, or what was discussed in the non-recorded conversations.

William Thompson was a co-author on a number of vaccine-safety studies published by the CDC. The most salient one for this discussion is (hereinafter DeStefano 2004):

DeStefano F, Bhasin TK, Thompson WW, Yeargin-Allsopp M, Boyle C. Age at first measles-mumps-rubella vaccination in children with autism and school-matched control subjects: a population-based study in metropolitan Atlanta. Pediatrics. 2004 Feb;113(2):259-66. PMID 14754936

It is not clear why Thompson became concerned enough to reach out in 2013 about a paper that had been published almost a decade previously.

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Posted in: Politics and Regulation, Public Health, Vaccines

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A homeopathic win for consumers

Homeopathy – not medicine

Do you believe in magic? It might surprise you to learn that some people believe sugar pills have healing properties. This belief system, called homeopathy, is a multi-billion dollar industry worldwide, and it’s growing. While there is no convincing evidence to demonstrate that homeopathic treatments are more effective than a placebo, many consumers and even some health professionals accept homeopathy as a legitimate health treatment, and its providers as legitimate health professionals. Responding to the perceived consumer demand for these products, government regulators have had a difficult decision to make: They could ignore homeopathy as a health practice, treating it like we might think of astrology: firmly outside of medicine. Or they could choose some form of regulation, targeting the providers (homeopaths) or the product (homeopathy), possibly with the goal of managing its use, or perhaps limiting harms to consumers. The risk of regulating nonsense, as has been described before, is the perceived legitimacy that recognition and regulation implies. Regrettably, regulation in many countries has had that exact effect. What’s worse, regulation often seems to have prioritized the commercial interests of homeopaths over the public interest, leaving consumers with little understanding that homeopathy lacks scientific credibility as a health practice. Consequently, homeopathy has attracted regular criticism from SBM’s bloggers, science and health journalists, and other science advocates over the years. It appears this advocacy is finally having an effect. Regular readers will recall several posts over the past few weeks, describing the possibility of new regulation of homeopathy by the US Food and Drug Administration (FDA). And just recently, Health Canada announced two important changes to its homeopathy regulation, which may signal a new direction. Are we witnessing the beginning of more sensible regulation of this prescientific practice? (more…)

Posted in: Homeopathy, Politics and Regulation, Science and Medicine, Vaccines

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The 21st Century Cures Act: The (Somewhat) Good, The (Mostly) Bad, and The (Very) Ugly

The 21st Century Cures Act: Unnecessary and misguided.

The 21st Century Cures Act: Unnecessary and misguided.

The approval of new drugs and medical devices is a process fraught with scientific, political, and ethical landmines. Inherent in any such process is an unavoidable conflict between rigorous science and safety on the one side, which tend to slow the process down by requiring large randomized clinical trials that can take years, versus forces that demand faster approval. For example, patients suffering from deadly diseases demand faster approval of drugs that might give them the hope of surviving their disease, or at least of surviving considerably longer. This is a powerful force for reform, as evidenced by HIV/AIDS activism in the 1980s and 1990s that led to the development of fast-track approval mechanisms for drugs for life-threatening conditions, a change whose effects have been mixed. It’s also a powerful force potentially for ill, as I’ve documented in my posts about the understandable but misguided “right-to-try” movement. After all, what politician can say no to a constituency representing desperately ill people who only want a shot at survival? It’s not all desperate patients, however. Also wanting more rapid drug approval are powerful business interests in the form of the pharmaceutical and medical device industries, for whom the time and expense of prolonged clinical trials eat into profits and make some drugs not worth developing from a business standpoint.

In 1962, after Frances O. Kelsey, MD, PhD (who died on Friday at the age of 101) successfully prevented the approval of the drug thalidomide in the US, a drug found to cause serious birth defects, Congress passed the Kefauver-Harris Drug Amendments to the Federal Food, Drug, and Cosmetic Act. These amendments required that drug companies not just show safety before their drugs could be FDA-approved, as had been the case prior to the amendments, but also to provide substantial evidence of effectiveness for the product’s intended use. That evidence had to be in the form of adequate and well-controlled clinical trials, which at the time was considered a revolutionary requirement. (Believe it or not, no requirement for high quality clinical trials existed before 1962.) This led to the current system of phase I, II, III, and IV clinical trials in force in the United States today. The amendments also included a requirement for informed consent of study subjects and codified good manufacturing processes, as well as the requirement that adverse events be reported. This has been, with some tweaking over the years, the law of the land regarding how the FDA approves drugs for specific indications

Medicine is a lot more complex now than it was in the 1960s however, and there has been a growing sentiment that the system is, if not broken, at least functioning in a way that is behind the times, a manner that was acceptable and appropriate 40 years ago but is no longer so in this era of genomics, precision medicine (formerly known as “personalized medicine”), and targeted therapies. The new drug approval process, which can take up to a decade and cost a billion dollars, it is argued, is too rigid, cumbersome, and slow for the 21st century. (Why it wasn’t too rigid, cumbersome, and slow in the 20th century, no one seems to say. I guess that “21st century” sounds way cooler.)

Into this ongoing controversy have marched Rep. Fred Upton (R-Mich.) and Rep. Diana DeGette (D-Colo.), who have sponsored a bill passed by the House of Representatives in a rare display of bipartisanship in July. The bill, H.R.6, is entitled the “21st Century Cures Act“. Given how it passed the House by a vote of 344-77, one would think that it should glide through the Senate easily. Certainly, its sponsors and supporters have mounted a mighty PR effort. That might not be the case, given that in the Senate a single senator can hold up or even kill a bill through a filibuster, and to shut down a filibuster or prevent a threatened filibuster requires 60 votes. Be that as it may, I’m not so much interested in the politics of this bill, which, if it survives the Senate, will almost certainly be significantly amended, but rather what the bill does.
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Posted in: Basic Science, Clinical Trials, Politics and Regulation

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Society for Science-Based Medicine: Comment to FDA on homeopathic drug regulation

Sisyphus

Author’s note: The FDA has asked for public comments on the regulation of homeopathic products. The Society for Science-Based Medicine’s Comment follows, modified for this format. The Comment is based in part on two previous posts, “How should the FDA regulate homeopathic remedies?” and “Homeopathic industry and its acolytes make poor showing before the FDA.” The comment period closes August 21, 2015.

Society for Science-Based Medicine

Comment: Homeopathic Product Regulation: Evaluating the Food and Drug Administration’s Regulatory Framework After a Quarter-Century

All homeopathic products on the U.S. market today, whether over-the-counter (OTC) or prescription, fall within the definition of “drug” in the Food, Drug & Cosmetic Act of 1938. The overwhelming scientific consensus is that homeopathy is highly implausible, unsupported by scientific evidence, ineffective in treating illness and, when relied upon instead of actual medicine, dangerous and even deadly. Yet the FDA has, without statutory authority, exempted homeopathic drugs from the regulatory scheme mandated by federal law. In accordance with its consumer protection mandate, the FDA should take immediate action to remedy this by requiring that all homeopathic drugs comply with the same statutes and regulations as all other OTC and prescription drugs. (more…)

Posted in: Announcements, Health Fraud, Homeopathy, Legal, Politics and Regulation

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Medical marijuana as the new herbalism, part 4: Cannabis for autism

Medical marijuana as the new herbalism, part 4: Cannabis for autism

When I first started writing about the claims made for medical marijuana and the cannabis oil derived from it, it didn’t take long for me to characterize medical claims for cannabis as the “new herbalism,” as opposed to pharmacognosy, the branch of pharmacology devoted to the study of natural products. The reason is simple. Although I support legalization of marijuana for recreational use, when I look at how medical marijuana has been promoted as a “foot-in-the-door” prelude to legalization, I see testimonials and flimsy evidence ruling over all. I see all the hallmarks of alternative medicine herbalism and none of the hallmarks of pharmacology. Here’s what I mean. Pharmacognosy examines an herb, plant, or other natural product and seeks to identify the chemicals within it that have pharmacological activity against a condition or a disease, the better to purify and isolate those chemicals and turn them into drugs. Herbalism, on the other hand, emphasizes the use of whole plants or extracts from plants, rather than the isolation of the most active compounds. Thus, herbal remedies often contain hundreds, or even thousands, of different compounds, of which only one or a few are active. Even extracts, such as cannabis oil, contain many compounds.

In contrast to pharmacognosy, herbalists make the claim that whole herbs and plant components possess a synergy that is missing from the purified active constituents and/or that the mixture is safer than the pure components because one compound can reduce the side effects of another without reducing therapeutic efficacy. When looked at closely neither claim stands up to scrutiny. Synergism between plant constituents is rare and very difficult to demonstrate, for example. In essence, herbalism turns back the clock 200 years to a time before scientists had developed the techniques and abilities to isolate active ingredients with pharmaceutical activity. Moreover, herbalism, in contrast to pharmacognosy, emphasizes anecdotes over scientific evidence.

Indeed, in my previous posts in this series on medical marijuana, one theme has emerged, which is that cannabis—specifically, a class of active chemicals in marijuana known as cannabinoids—has potential for some diseases but is not the panacea claimed by its proponents. It does not cure cancer, for instance, contrary to glowing testimonials promoted by people like Rick Simpson. For other conditions, the evidence is either not particularly compelling or only mildly promising.

So I reacted with considerable dismay on Friday night when I saw this news report on the 11 o’clock news, “Michigan panel recommends allowing marijuana for autism“:
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Posted in: Herbs & Supplements, Politics and Regulation

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Naturopathic Medical Magic in the NW

Me and my lovely wife Phyllis Schlafly, amazed at what naturopaths will believe. From the Wikimedia Commons, because we're that famous.

Me and my lovely wife Phyllis Schlafly, amazed at what naturopaths will believe.
From the Wikimedia Commons, because we’re that famous.

As regular readers know, I live in the great Pacific Northwest, specifically Portland, Oregon. I am at home in the organic/hippy/environmental mind-set. It is what I grew up with. It is a relaxed, informal place to live. It is not much of an exaggeration to say that formal attire is tucking your tee shirt into your jeans. At least the metro area, and perhaps much of the state, is relatively tolerant of the actions of others. A real what’s the harm/shruggie approach to life, the universe and everything.

I will admit that the irrational/shruggie/emotional/Oregonian/goateed part of my brain is often at odds with my more rational brain, which wants me to give a rat’s ass about issues I think are just wrong. It showed up strongly with fluoridation in Portland, where my rational brain knew adding fluoride to the water was a great idea and my Oregonian nature said water should be pure, man, like nature intended. I keep my inner Oregonian under tight control as his approach often sounds good until you carefully examine how his ideas are implemented. Except at the pub of course. Bring on the hops, man, like nature intended beer to be.

Naturopathy is well tolerated in Oregon, with two schools in the NW producing NDs. We have a Board of Naturopathic Medicine, whose vision is to:

To protect the health, safety and welfare of the public in the matters of care provided by Naturopathic physicians in Oregon.

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Posted in: Legal, Naturopathy, Politics and Regulation

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The evolving story of the harms of anti-inflammatory drugs

Advil (ibuprofen)

Owing to summer vacation, today’s post updates a 2011 post and a 2013 post with some new information.

Anti-inflammatory drugs are among the most well-loved products in the modern medicine cabinet. They can provide good pain control, reduce inflammation, and eliminate fever. We give non-steroidal anti-inflammatory drugs (NSAIDs) in infancy, continuing through childhood and then adulthood for the aches and pains of modern living. It’s the later stages of life where NSAIDs are used most frequently, usually in the treatment of joint disease like osteoarthritis, which eventually affects pretty much everyone. Over 17 million Americans use NSAIDs on a daily basis, and this number will grow as the population ages. While they’re widely used, they also have a long list of side effects. Not only can they cause stomach ulcers and bleeding by damaging the lining of the gastrointestinal tract, cardiovascular risks are also significant.

It was the arrival (and withdrawal) of the drugs Bextra (valdecoxib) and Vioxx (rofecoxib) that led to a much better understanding of the potential for these drugs to increase the risks of heart attacks and strokes. And it’s now well-documented that these effects are not limited to the “COX-2″ drugs – almost all NSAIDs, including the old standbys we have used for years, raise the risk of heart attacks and strokes. (more…)

Posted in: Clinical Trials, Politics and Regulation, Science and the Media

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It’s time for pharmacies to stop selling sugar pills

Some of these products contain no medicine at all.

Some of these products contain no medicine at all.

Retail pharmacies have a sugar pill problem. Homeopathic “remedies” may look like conventional medicine when they’re stocked on pharmacy shelves, like the photo above. But unlike conventional medicine, homeopathic products don’t contain any “medicine” at all. They are effectively sugar pills – placebos. Not surprisingly, there is convincing evidence to show that homeopathy is useless as a medical treatment, and fundamentally incompatible with a scientific understanding of medicine, biochemistry and even physics. Questions have been raised about the ethics of selling homeopathy in pharmacies to consumers who may not realize what they’re buying. This growing practice is attracting sharp criticism from other health professions. So why do pharmacies sell them? And what will it take for pharmacies to change? (more…)

Posted in: Ethics, Homeopathy, Politics and Regulation, Public Health

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