In all of the vitriol being spewed over a national health care plan, little attention is being directed at the pharmaceutical companies and the potential conflicts of interest involving the doctors doing their research.
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In all of the white-hot vitriol being spewed over a national health care plan, very little attention is being directed at the pharmaceutical companies and the potential conflicts of interest involving the doctors doing their research. In America, we are generally of the belief that by the time a drug or vaccine has made it into the marketplace there has been enough testing conducted by the FDA and objective physicians and researchers that we can trust its safety. Frequently, we are wrong. Great profit tempts drug manufacturers to deceive or cut corners to get more quickly to the market. Pfizer recently agreed to pay $2.3 billion in fines as a penalty for marketing drugs "off label," which means for other than their prescribed purpose. Merck, too, has a $4.85 billion legal settlement for Vioxx, a painkiller that doubled the risk of stroke and heart attack, and Eli Lilly agreed to almost $1.5 billion in penalties for illegal marketing of its top-selling anti-psychotic drug. .

Those numbers may look big but they are nothing compared to revenues. Pfizer earned $44.2 billion last year and can handily absorb the penalty. Industry experts don't expect the off label marketing to end because the profitability is so great. With this kind of money at stake, willful deception with off label marketing, and a public record of failure, why are we so inclined to readily accept drugs and vaccines from these manufacturers?

As autumn approaches, we are once more being whipped into a frenzy about H1N1 and a need for another vaccination. Imagine the profits if only it were government mandated. I am not anti-vaccine. I am, however, pro-full disclosure. Vaccinations are one of the most important advancements in medical history. Nonetheless, when they became huge profit centers, the numbers of vaccines on the schedule for our children rose to the point where there are now 42 recommended and, in many cases, most are required for admission to public school facilities. Because we are inclined to trust our physicians and federal regulators, we generally take the needle.

But we need to look more closely. The internecine relationships between drug companies and researchers and their institutions deserve constant scrutiny. As an example, the highest-profile proponent of vaccines like the MMR for children, Dr. Paul Offit has been made a wealthy man by Merck, the pharmaceutical giant that manufactures MMR. Offit did not conduct the research on the MMR (Measles-Mumps-Rubella) vaccine but sold a patent to Merck for a vaccine against rotavirus, which causes diarrhea in children. Children's Hospital of Philadelphia (CHOP), where Offit works, sold its royalty rights on the vaccine, which, according to a financial analyst firm's filing, netted the hospital $153 million. Based on hospital distribution guidelines, Offit, as the inventor, appears to have earned as much as $45 million for his 30 percent share.

The details of Dr. Offit's fiduciary interest in Merck are never disclosed when he is out pushing the safety of MMR, one of the company's biggest profit centers. Although the hospital appears to have taken its royalty in a lump payment from a company that purchases long term drug royalties and Offit is not known to be in the midst of a Merck revenue stream, his opinion can hardly be considered unbiased when speaking about the company's MMR product. None of this is ever disclosed when the media frequently run to interview Offit as a vaccine expert on MMR. In fact, during a recent broadcast on NBC Dateline, "A Dose of Controversy," it was the first time Offit was asked in an interview about the millions he had earned on his rotavirus vaccine royalty. However, no mention was made of Merck by either NBC's Matt Lauer or Offit.

Offit readily agreed to do the interview with Lauer because the program was centered on Dr. Andrew Wakefield's research regarding a possible link between MMR and the onset of autism in some children. He had refused, however, to sit for an interview with CBS News when Sharyll Attkisson was preparing a report about the relationships between pharmaceutical firms and researchers. (Offit said publicly that his email correspondences with Attkisson convinced him she was not going to do a balanced story. Later, on a friendly web site, he called her a liar.) As chief of infectious diseases at CHOP and a professor of pediatrics at University of Pennsylvania's medical school, Offit has credibility but rarely is anyone aware of the financial role Merck has played in his life. In fact, even the $1.5 million Paul Offit research chair at the Children's Hospital of Philadelphia is funded by Merck. In other words, he is entirely beholden to the company.

Offit was also in the enviable position of voting himself wealthy while serving on the government's Advisory Committee on Vaccine Practices (ACVP). He voted to approve the inclusion of his rotavirus vaccine in the Vaccines for Children Program, which, ultimately led to the widespread distribution of the Rotateq patent he developed at CHOP. When the big royalty check arrived Offit was quoted as saying, "It felt like winning the lottery." While dehydration through diarrhea is undoubtedly a big problem in developing countries, how essential is it that such a vaccine be included for every single child in the US schedule and millions spent on its administration?

Technically, Offit appears to meet the letter of the law and basic ethical standards with his disclosures. Before the ACVP meetings, he acknowledged a $350,000 grant from Merck to conduct the rotavirus research and that he was working "as a consultant to Merck." The compounding failure belongs to the media, which runs to Offit as the consistent pro-vaccine voice without ever acknowledging or writing about his Merck-generated wealth. Offit is allowed to call other researchers ethically conflicted without being confronted over his own relationships with the manufacturer of MMR.

On Dateline and in his lectures and publications, Offit dismissed Dr. Andrew Wakefield's Lancet paper on potential links between autism and bowel issues (possibly prompted by MMR) because he said Wakefield was conflicted by being a medical expert for a law firm looking at the issue for potential litigation. Physicians are constantly retained to provide medical expertise for law firms and the only ethical question is disclosure. Wakefield has documentation showing his relationship with the law firm was disclosed to the Lancet well before publication as well as in communications with the Royal Free Hospital where he worked, and in articles in the news media

The Lancet paper that Offit has vilified was nothing more than an analysis of a collection of data from children being admitted to Royal Free with bowel problems. Drs. John Walker-Smith and Simon Murch, some of the pre-eminent gastroenterologists in the world, were encountering children whose bowel inflammation occurred weeks after their MMR vaccinations and were then followed by regression into autism. Their data was provided to Wakefield and led to the 1998 Lancet paper. Wakefield had the temerity to suggest that there might be an association between bowel disease, autism, and MMR and called for further studies, a logical rather than audacious proposition.

In "A Dose of Controversy," Lauer said Wakefield's research had never been duplicated and that epidemiological studies had proved there was no association between the MMR vaccine and autism. Both statements are incorrect. Because I am involved as an advocate of research and Wakefield's point of view, I was present when NBC's producer was provided five papers from researchers and institutions in Canada, Italy, the US, and Venezuela where the bowel disease-autism link was confirmed and there was further description of the disease's pattern. NBC failed to cite that research while giving complete credibility to Offit and the epidemiologic research, which has endured significant criticism. Dr. Bernadine Healy, former head of the National Institutes of Health and member of the Institute of Medicine, acknowledged on the program that it was possible the population samples were too small in the epidemiological studies Offit and others are using to dismiss Wakefield's work.

Mainstream medicine, of course, can be wrong, as Merck and Pfizer and Eli Lilly have proved. Wakefield's outrageous act is to demand safety studies on MMR and other vaccines. Most Americans are undoubtedly unaware that there has never been a long-term study conducted on MMR to compare a vaccinated population of children with an unvaccinated population. If Offit is a researcher of the most rigorous discipline, he would be leading the call for such a study using his rather large media megaphone. However, he told Jim Moody, legal counsel for the National Autism Associations that such a study is "impossible prospectively and unethical retrospectively." Actually, it seems unethical not to do such a study to prove conclusively a vaccine like MMR is safe to give to our children and our government clearly is aware of this failing. A media strategy document from the Center for Disease Control makes the sad confession that the government does not actually have the science to prove that vaccines are safe. Undoubtedly, that has much to do with why anyone who questions MMR or other vaccines is dismissed as an "anti-vaccine nut." Research costs money and takes time and is likely to make people question the shots being given to their children.

Nothing, of course, matters but the science. Unfortunately, when it is finally done, the truth it provides will arrive many years too late for millions of families. They erroneously placed their trust in our government's policies and the physicians and researchers that were supposed to "first do no harm.".

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