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Junk Science and the Anti-Vaccine Fraud

Tuesday, January 11, 2011

The campaign against the most valuable medical technologies ever invented is based on junk science.

Vaccines occupy an odd place in medical history. They are almost universally recognized as among the most valuable and cost-effective medical tools ever developed. The very first vaccine—for smallpox—curtailed and finally eradicated the most devastating infectious disease ever to strike humanity. The list of lifesaving vaccines developed in the past century or so is long. Most of them are especially protective for diseases that hit children the hardest, such as polio, measles, mumps, whooping cough, and diphtheria.

Yet vaccines have also been controversial, starting with the smallpox vaccine. Paul Offit, a noted vaccine researcher at the Children’s Hospital of Philadelphia and the University of Pennsylvania, just published a book recounting the history of vaccine controversies and anti-vaccine movements in the United States and England. Partly history and partly a critical assessment of science and policy, it supplies essential guideposts for recent events.

Vaccine debates are sometimes about mandates, such as the requirement that children be vaccinated before starting school. But usually the issue is safety. At first glance, this makes little sense. Vaccines are tested on thousands or tens of thousands of patients, and because they are typically given to healthy persons, dangerous side effects are easy to spot, even when they are quite rare. Safety controversies usually focus on children, however, because millions of children are vaccinated every year at ages when several worrisome illnesses tend to arrive.

Vaccines are still probably the most valuable medical tool ever invented, and the failure to use them would be a disaster of epic proportions.

Occasionally, a new vaccine causes problems. This happened a decade or so ago with a vaccine for rotavirus. The vaccine kept children from being infected by a common virus that sometimes causes life-threatening dehydration, but the vaccine turned out to have a rare and dangerous side effect (a vaccine without that side effect has since received approval). Almost always, though, careful examination of huge databases makes clear that when an illness strikes soon after vaccination, it is almost always a coincidence.

In recent years, the biggest vaccine controversy by far has been over autism, which, yes, typically reveals itself in children at an age when vaccination is common. Offit wrote a book on this, too.

But some news this month requires a bit of background information.

A seminal event in the vaccine-autism controversy was the 1998 publication of an article in The Lancet, an old and prestigious medical journal in Britain. Coauthored by Andrew Wakefield and 12 others, the article reported on an examination of 12 children who had developed both gastro-intestinal problems and severe behavioral problems after receiving the measles, mumps, and rubella (MMR) vaccine. Nine of the children had become autistic. The authors concluded that they had identified a new syndrome involving “colitis and pervasive developmental disorder,” which they surmised but had yet to demonstrate was caused by the MMR vaccine.

Although immediately criticized as scientifically implausible, the article nevertheless created a firestorm—as did its flamboyant lead author. Ever since, the Wakefield Lancet article has been the single most prominent weapon in attacks on vaccines as a cause of autism. Among its consequences was that MMR vaccination in England dropped to dangerously low levels.

The Wakefield article cried out for close scrutiny, which it eventually received. Investigative reporting by Brian Deer, a British journalist, has played a crucial role. Starting in early 2004, Deer’s reports for the Sunday Times (of London) and a television network revealed numerous troubling details about the Wakefield study, including that Wakefield, some of his coauthors, and some patients in the study were involved in liability litigation against vaccine firms, that some of Wakefield’s research was funded via the plaintiff bar, and that subjects were recruited in a non-scientific manner. (One source for these and other details is the excellent Medscape medical news service.)

Careful examination of huge databases makes clear that when an illness strikes soon after vaccination, it is almost always a coincidence.

In its response to the first wave of Deer’s reporting, The Lancet issued a statement on February 23, 2004, that reaffirmed the article’s methods and conclusions but expressed regret that the editors had not been informed of an obvious conflict of interest. More telling, ten of Wakefield’s coauthors published a brief “retraction of an interpretation” in The Lancet on March 6, 2004, in which they disavowed any conclusion that the MMR vaccine had been shown by their study to cause autism.

In the meantime, Deer continued his own investigation, publishing and otherwise communicating his findings to interested parties. In due course, the U.K.’s General Medical Council (GMC) conducted lengthy hearings into the study and the actions of Wakefield and his coauthors. These revealed, among other things, that the children in the study had been put through painful and dangerous procedures with scant notice, warning, or scientific justification.

Last May, the GMC revoked Wakefield’s medical license. He has since moved to Texas, where he operates an autism clinic that, according to Offit’s autism book, offers treatments that involve substantial risks to patients but no prospect of benefit.

Last February, The Lancet finally retracted the article, not on scientific grounds but because of inadequate handling of the subjects in the study. This half-hearted retraction essentially left the study’s conclusions in place. Long before, however, a series of studies (summarized in Offit’s two books) had failed to replicate Wakefield’s results and in fact had ruled out any connection between autism and any vaccine, including the MMR vaccine.

And, now, the final chapter.

On January 5, another U.K. medical journal—BMJ, formerly known as the British Medical Journal—posted the first of a series of articles by Deer in which Wakefield’s article was revealed as being not merely sloppy or deceptively presented, but fraudulent. In combing through voluminous records in the Wakefield hearings plus other sources, Deer had found pervasive manipulation of basic data. For example, some of the subjects had behavioral symptoms before vaccination, post-vaccination data were misrepresented, and only one subject had regressive autism, the main condition at issue. Data for all 12 subjects had been manipulated in one way or another, always in a manner that favored the autism hypothesis.

In an accompanying editorial, the journal’s editor-in-chief and two other editors endorsed these conclusions while also asking probing questions about, among other things, editorial oversight at The Lancet, a topic that BMJ will address in articles to be published shortly.

Ten of Wakefield’s coauthors disavowed any conclusion that the MMR vaccine had been shown by their study to cause autism.

The denouement of the Wakefield scandal held few, if any, surprises for the scientists who have followed it most closely. But for the rest of us, a few remarks are in order on the entire vaccine controversy.

As Offit has pointed out in interviews, this latest finding will do little to deter those who think vaccines cause autism. They will always find plausible arguments for their cause and will receive support from a small coterie of physicians.

One has to wonder about The Lancet, however. One would have expected the editors to have fully retracted the article when its dubious provenance was first revealed. When a complete retraction finally came in February 2010, its tortured wording mainly suggested embarrassment, as if the editors already knew that the article was disreputable but did not want to let it go until they had some new facts to lean on, which happened to be fresh information (from Deer) about the manner in which the subjects were recruited.

More fundamentally, we can hope that these events will reinforce certain truths about the childhood vaccine market.

First, checks and balances are potent. Naturally overcautious, the Food and Drug Administration is a nearly insurmountable barrier between children and bad vaccines.

Second, there is such a thing as junk science, and it has been at the middle of the anti-vaccine movement since its inception.

Third, vaccines are not perfect, and they do sometimes have serious side effects. The National Vaccine Injury Compensation Program is designed to deal with that. If anything, it is too generous in the sense of assigning blame to vaccines for harms for which even a biological plausibility is weak at best.

Fourth, liability litigation is a terrible way to deal with vaccine safety. Indeed, the failure of the liability system in the childhood vaccine market in the mid-1980s is the reason the system was replaced by the National Vaccine Injury Compensation Program in 1986. The simple fact is that it is usually impossible for a jury to know whether a vaccine caused the harm at issue. That leaves sympathy for the victim as the dominant force. That arrangement nearly destroyed the childhood vaccine market in the 1980s.

Fifth, yes, there are good arguments to be made about vaccination mandates and the importance of “herd immunity,” which provides protection to the unvaccinated if, and only if, enough people are vaccinated.

And finally, the most important truth by far: vaccines are still probably the most valuable medical tool ever invented, and the failure to use them would be a disaster of epic proportions.

John E. Calfee is a resident scholar at the American Enterprise Institute.

FURTHER READING: Calfee earlier showed how “The Invisible Hand Works for Women,” said, “Don’t Give Trial Lawyers This Booster Shot,” explained “How Washington Just Worsened the Gulf Oil Spill,” and discussed “Progressives, Jim Crow, and Selective Amnesia.” His scholarly work details “Why the AARP Drug Price Reports Are Misleading or Worse” and explores “Soda Tax, Will It Actually Help Lower Obesity Rates?”

Image by Darren Wamboldt/Bergman Group.

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