Field of Science

PBS blunders on vaccines and autism

Earlier this week, the NewsHour on PBS – usually one of the best news shows on TV – featured a segment on “Parents’ fear of vaccines.” The transcript of the May 22 show, available here, illustrates how badly the news media tends to report science. One reason for this flawed reporting is the media’s belief – probably stemming from training in journalism schools – that they need to present “both sides” of a story.

The story opens well, with a tale of a child in San Diego, California, who had to be quarantined because she was exposed to measles. The source was a 7-year-old boy who’d been exposed to the measles in Switzerland, and who hadn’t been vaccinated. The mother was shocked and upset that her daughter had to be quarantined. The un-vaccinated boy caused 70 children to be quarantined, 11 to come down with measles, and 1 to be hospitalized. Fortunately, all the children recovered.

Then the story goes off the rails: the reporter interviewed a mother – with no medical or scientific training – who read on the Internet “that the information I was getting from the mainstream medical community wasn't necessarily accurate. Nobody told me about possible reactions, such as increased chances of allergies, increased chances of asthma, increased chances of autoimmune disease. Nobody told me any of that.”

Well, nobody told her that because it isn’t true. However, the intrepid PBS reporter, Betty Ann Bowser, said it this way: “nobody told her that vaccines trigger autism in children, as she read on the Internet, because most doctors don't believe that's true.”

Here we have error number one: by saying “most doctors,” Bowser instantly implies that some doctors think otherwise. How is the viewer to know who is right? Bowser then goes on to report on the fraudulent 1998 study linking vaccines to autism (see my earlier blog post for much more on this), which she correct said “has since been discredited.” But then Bowser reported that “At the time, many vaccines contained a mercury-based preservative called thimerosal, and some research linked it to autism. By 2002, thimerosal had been removed from most vaccines. And since then, study after study has found no connection between vaccines and autism.”

Error number two: research did NOT link thimerosal to autism. This was one of the bogus claims – also discredited – made by Andrew Wakefield and others in their attempts to link vaccines to autism. As I reported earlier, Wakefield’s original study was discredited and his own co-authors repudiated it, after they learned (among other things) that he was being paid huge fees by a lawyers’ group that was attempting to sue vaccine makers. Multiple studies have failed to show any link between thimerosal and autism. And that’s the best science can do: if there isn’t a link, we can never prove a negative, we can only show that the evidence doesn’t support a link.

The PBS story then righted itself a bit, quoting a medical researcher (Dr. Anne Schuchat) on the enormous benefits that childhood vaccines have produced:
“The vaccines that babies get today are preventing about 33,000 deaths over the course of those babies' lives, preventing 14 million infections, and also saving about $43 billion.”
But Bowser (the reporter) didn’t stop there – she had to report (error number three) “the other side.” So she quoted Jay Gordon, a pediatrician who is in the Wakefield camp – he thinks vaccines cause autism, despite the lack of evidence. Bowser reports that “not one of his 3,000 patients has been vaccinated against all the diseases recommended by the government; 50 percent of them haven't been vaccinated at all.” And she quotes Gordon saying
“I think the children who receive no vaccines at all are statistically safe…. Vaccines are causing an increase in the incidence of everything from diabetes to multiple sclerosis to other autoimmune diseases. And these are extremely rare occurrences, OK -- overstating it, OK, isn't honest, but it's happening.”
Wow, this is really damaging stuff. How many parents will withhold vaccines from their kids after hearing this? There is no scientific evidence to support Gordon’s position, and a great deal of evidence contradicting it. And his phrase “statistically safe” is tragically wrong – individually, some of these children will likely be fine, but statistically speaking, they are clearly in danger, and furthermore they are endangering their communities.

Jay Gordon is a charlatan. He is a well-known pediatrician who has appeared on countless news shows, and he clearly enjoys the publicity – and the money – he gets from being a public figure. For some interesting rebuttals of Gordon’s mistaken claims about autism, see this Skeptico blog from 2005 and the detailed rebuttal by Orac, who points out that Gordon is a big fan of David and Mark Geier, two frauds who are little more than professional expert witnesses and consultants for people suing vaccine makers.

Unfortunately, Bowser (the reporter) didn’t bother to look for skeptical views about Gordon, but apparently was happy to have someone to present “the other side.” By giving a platform on a widely respected news show to these anti-vaccine charlatans, the NewsHour and PBS are doing more harm than they realize.

Towards the end of the piece, Bowser brings in another medical expert, Dr. James Cherry, a professor at UCLA who does research on vaccines. Cherry helps right the ship (which the reporter is determined to sink) in this exchange:
DR. JAMES CHERRY: I think it's terrible [Dr. Gordon's practices, that is]. Once those children start crawling around, they're going to need tetanus [vaccines]. They're exposed to tetanus and injury, and they're going to have to be treated, and the treatment is going to be far worse. And it's actually bad for these people.

BETTY ANN BOWSER: Is that irresponsible?

DR. JAMES CHERRY: Well, in my opinion, it is.

BETTY ANN BOWSER: Is he doing something dangerous?

Too bad Bowser didn’t end there. But instead, she ended with a quote from Bernadine Healy, a former Director of NIH. Astonishingly, Healy said “Vaccines are safe, but there may be the susceptible group. I think the public health officials have been too quick to dismiss the hypothesis as irrational without sufficient studies of causation.”

I don’t know what studies Healy has been reading – if any – but she’s out of her depth here. The NewsHour missed a great opportunity to educate the public and improve the health of our children. My fear is that they’ve contributed to a trend – withholding vaccines from children – that will lead to many needless illnesses, and deaths, in the years to come.

Candidates re-state their views on autism

After both John McCain and Barack Obama have recently made erroneous statements linking vaccines to autism, it appears that their campaigns have take steps to produce scientifically accurate positions on their websites. This is to be applauded – although we’ll wait and see what the candidates say if they are questioned about this again. Because I blogged on this recently, I thought it was worth posting this update showing the candidates’ responses to the criticism they received (deservedly so) from many quarters after their irresponsible remarks. I’m not entirely convinced that their websites represent their views – I’d rather hear it from their own mouths. Still, this is progress.

As of today, here is what both candidates’ websites say on the topic of autism:
Obama: at his website he has these two paragraphs describing the issue:
"More than one million Americans have autism, a complex neurobiological condition that has a range of impacts on thinking, feeling, language, and the ability to relate to others. As diagnostic criteria broaden and awareness increases, more cases of autism have been recognized across the country. Barack Obama believes that we can do more to help autistic Americans and their families understand and live with autism. He has been a strong supporter of more than $1 billion in federal funding for autism research on the root causes and treatments, and he believes that we should increase funding for the Individuals with Disabilities Education Act to truly ensure that no child is left behind.
More than anything, autism remains a profound mystery with a broad spectrum of effects on autistic individuals, their families, loved ones, the community, and education and health care systems. Obama believes that the government and our communities should work together to provide a helping hand to autistic individuals and their families."
After John McCain's strongly worded but inaccurate statement on the issue (“there’s strong evidence that indicates it’s [the rise of autism] got to do with a preservative in vaccines,” he said), his campaign had an even bigger error to correct, so they made a special web page on autism, here. (This page was created sometime after his comments.) I'll quote the entire content verbatim here:
John McCain is very concerned about the rising incidence of autism among America's children and has continually supported research into its causes and treatment. He has heard countless stories about families' hardships obtaining a diagnosis for their children's autism and accessing quality medical treatment. He believes that federal research efforts should support broad approaches to understanding the factors that may play a role in the incidence of autism, including factors in our environment, for both prevention and treatment purposes.
John McCain was proud to lend his support to the Combating Autism Act of 2006, which he cosponsored, and worked to ensure its enactment. This law is helping to increase public awareness and screening of autism spectrum disorder, promote the use of evidence-based interventions, and create autism Centers of Excellence for Autism Spectrum Disorder Research and Epidemiology. John McCain understands that despite the federal and scientific research efforts to date, the exact causes of autism are not yet known and greater research is needed to understand this disorder. That is why in November 2007, he joined with Senator Lieberman in requesting the leadership of the Senate Health, Education, Labor and Pensions Committee, which has jurisdiction over federal research into autism, to hold a hearing on federal research efforts regarding factors affecting incidence and treatment in order to help determine where research efforts can best be directed. As President, John McCain will work to advance federal research into autism, promote early screening, and identify better treatment options, while providing support for children with autism so that they may reach their full potential.
Both candidates have retreated to carefully worded statements supporting more research, and saying nothing about vaccines. Both websites say that the causes of autism are not yet known. I’d be much more impressed if they would come out and say explicitly that multiple scientific studies have failed to show any link between vaccines and autism – and even better yet, if they would say that they don’t want to pour more valuable research money into investigating a discredited hypothesis. But I expect that the carefully worded statements on their websites – designed not to offend anyone, including those who persist in their belief that vaccines cause autism – are the best we’re going to get. At least the websites don’t repeat the blunders the candidates themselves have made.

The Vioxx Wall of Shame

The April 16 issue of Journal of the American Medical Association (JAMA) has an astonishing account of medical and research fraud, perpetrated primarily by Merck with the willing assistance of a number of biomedical researchers. What’s astonishing is not only that it happened, but that apparently this sort of thing goes on all the time, according to the accompanying editorial in JAMA.

The details reveal an extensive, systematic effort by Merck to shape and distort the research around its blockbuster drug Vioxx (rofecoxib). Merck ran its own trials of Vioxx, prepared the results for publication, and then recruited outside authors to be the lead authors, because (obviously) that would give the studies more credibility. We can assume they (Merck) intended to then describe each paper as “a study led by independent unversity researchers....” In many cases the authors had little or nothing to do with the study – they merely attached their name to the paper after the study was completed. In some cases, Merck paid the authors a consulting fee. Perhaps these scientists were simply padding their resumes, or perhaps they really believed that the studies were good science – but by allowing Merck to use their names in this fraudulent manner, these scientists undermined the integrity of the scientific literature. They deserve to be called out, so I’ve decided to create a Vioxx Wall of Shame and list their names in this post. All of these names can also be found in the article in JAMA by Ross et al., JAMA 299(15):1800-12.

The details only came to light because of the ongoing lawsuits against Merck on behalf of patients who might have been harmed by Vioxx. [Aside: for those who don’t know, Vioxx is a painkiller much like ibuprofen/Advil or aspirin.] The scientists who wrote the exposes in JAMA had access to numerous internal documents that normally would never see the light of day. So for example, Ross et al. found internal versions of a paper listing 9 Merck authors, with the first author left unspecified as “External author?” When the paper appeared, not one but three academic authors appeared as the first three authors, followed by 8 of the 9 Merck authors (one was removed for an unknown reason) – despite the fact that the final version was almost unchanged from the draft. This is just one of the smoking guns that show not only Merck’s deception, but also the unethical behavior of these scientists. These three authors are the first three names on the Vioxx Wall of Shame.

The Ross et al. study found 20 articles published on Vioxx by Merck, and in 16 out of 20, the first author is an external academic scientist. This despite the fact that for all the studies, a Merck employee was the author of the first draft of the manuscript. On those 16 articles, external authors were usually first, second, and third authors (sometimes all three) on the published version. This illustrates that the academic authors were likely motivated by academic “credit” they gain by appearing to lead these studies: the first author, and to a lesser extent the second and third authors, are generally regarded as the intellectual and scientific leaders of a study, and the first author gets the most credit for the publication. The problem is that they took credit for work they did not do.

Perhaps even more egregious is the practice of hiring outside companies to write the papers. Merck did this multiple times for Vioxx. The fact that such companies exist, and make a profit, is strong evidence that this happens all the time. For example, one company (Scientific Therapeutics Information, STI) wrote a paper and sent it to Merck with an email message in which they say that Merck needed to "invite" an author. In another case, STI describes an “independent” author who was “too busy” to make revisions to “his” article. STI wrote to Merck because they wanted to be paid more money for handing the revisions. Another company, Health Science Communications, sent a contract to Merck for $23,841 to write a manuscript including figures and tables, “journal-ready for author submission to journal”. One particularly damning STI document discloses their progress (in 1999) on writing 8 studies on Vioxx targeted at different journals: 7 of the 8 studies eventually appeared, all in the intended journals, and all of them with academics as sole author. Those authors appear in the Wall of Shame.

Vioxx Wall of Shame
Leon J. Thal, UC San Diego
Steven H. Ferris, NYU School of Medicine
Louis Kirby, Pivotal Reearch Centers
These three listed their names as the first 3 authors on a paper in Neuropsychopharmacology (2005;30(6):1204-15) despite having made few or no contributions to the paper.

William Garnett, Department of Pharmacy Virginia Commonwealth University, Medical College of Virginia. Listed as sole author on a paper about Vioxx that was paid for by Merck and written by a private company, Scientific Therapeutics Information. The paper was: Clinical implications of drug interactions with coxibs. Pharmacotherapy 2001;21(10):1223-32.

Noor Gajraj, Dept. of Anesthesiology, UT Southwester Medical Center. Listed as sole author on a paper about Vioxx that was paid for by Merck and written by a private company, Scientific Therapeutics Information. The paper was: Cyclooxygenase-2 inhibitors. Anesth Analg. 2003 Jun;96(6):1720-38.

Arthur Weaver, Arthritis Center of Nebraska. Listed as sole author on a paper about Vioxx that was paid for by Merck and written by a private company, Scientific Therapeutics Information. The paper was: Rofecoxib: clinical pharmacology and clinical experience. Clin Ther. 2001 Sep;23(9):1323-38.

Mark C. Hochberg, School of Medicine, University of Maryland. Listed as sole author on a paper about Vioxx that was paid for by Merck and written by a private company, Scientific Therapeutics Information. Paper: Treatment of rheumatoid arthritis and osteoarthritis with COX-2-selective inhibitors: a managed care perspective. Am J Manag Care. 2002 Nov;8(17 Suppl):S502-17. Dr. Hochberg gets extra credit for a later article titled “COX-2: Where are we in 2003? - Be strong and resolute: continue to use COX-2 selective inhibitors at recommended dosages in appropriate patients.” (Arthritis Res Ther. 2003;5(1):28-31.) I have to wonder if he wrote that one himself.

F. Michael Gloth III, Victory Springs Senior Health Associates and Johns Hopkins University School of Medicine. Listed as sole author on a paper about Vioxx that was paid for by Merck and written by a private company, Scientific Therapeutics Information. Paper: Pain management in older adults: prevention and treatment. J Am Geriatr Soc. 2001 Feb;49(2):188-99.

Thomas Schnitzer, Northwestern University Medical School.
Listed as sole author on a paper about Vioxx that was paid for by Merck and written by a private company, Scientific Therapeutics Information. Paper:
Osteoarthritis management: the role of cyclooxygenase-2-selective inhibitors.
Clin Ther. 2001 Mar;23(3):313-326;

A. Mark Fendrick, Department of Internal Medicine, University of Michigan. Listed as sole author on a paper about Vioxx that was paid for by Merck and written by a private company, Scientific Therapeutics Information. Paper: Cost-effective use of NSAIDs: issues pertinent to coxib use in managed care. Am J Manag Care. 2002 Nov;8(17 Suppl):S529-41.

So that's the list. These scientists have authored many other publications besides their Vioxx work, and I have to wonder about their other studies. A scientist who will put his name on a paper at the behest of a drug company cannot be trusted to conduct objective science. The editors of JAMA (DeAngelis and Fontanarosa) called for these scientists and others like them to be “banned from publishing articles in that journal" and to be “reported to the appropriate authority (ie, medical school dean or department chair)” - a good idea, so I wonder if JAMA has reported the authors described in their own journal?

The JAMA editors also call for sanctions against the scientists who participate in these schemes. As the JAMA editors say in their editorial:
“Individuals, particularly physicians, who allow themselves to be used in this way, especially for financial gain, manifest a behavior that is unprofessional and demeaning to the medical profession and to scientific research.”
To some scientists, the JAMA revelations may come as no surprise. But to most of us, the behavior of Merck and of the scientists who colluded with Merck is shocking and reprehensible. Medical journals need to tighten their oversight, as do the employers (mostly medical schools and universities) of these authors. Quoting the JAMA editorial again: “When integrity in medical science ... is impugned or threatened ... patients, clinicians, and reearchers are all at risk for harm, and public trust in research is jeopardized.”

Finally, all of this is made worse by the fact that Vioxx does kill people, and Merck knew it, and they kept their own findings from the public. This is revealed in the other JAMA paper by Psaty and Kronmal from the same issue. Their investigation revealed that Merck's own internal analysis, in April 2001, "identified a significant increase in total mortality" among patients taking Vioxx versus placebo. Psaty and Kronmal show how selective reporting of results made Vioxx appear safe when it really isn't. They call for greater oversight of clinical trials and much greater scrutiny by journal editors and reviewers. We can start by calling out scientists such as those in the Vioxx Wall of Shame.