Pharma manufacturer's failure to disclose endangers Swine Flu vaccination program

As autumn approaches and millions of Americans consider taking an H1N1 Swine Flu vaccination, the integrity of all vaccine developers has been called into question by the financial relationship of a leading vaccine advocate and a pharmaceutical manufacturer. Dr. Paul Offit of Children's Hospital of Philadelphia (CHOP), who was interviewed for a Dateline NBC television special, failed to tell millions of viewers that while he was promoting MMR as safe he had also made tens of millions of dollars from selling another vacdicine patent to Merck, which is the manufacturer of MMR. According to CHOP documents, Offit's share of a royalty sale for the Rotateq vaccine to Merck is a minimum of $29 million and may approach $50 million.

"When Dr. Offit went on Dateline he was probably disinclined to criticize the MMR vaccine since it is produced by the same pharmaceutical company that made him a wealthy man," said Jim Moody, attorney for the National Autism Association (NAA). "If people are to have confidence in the integrity of the Swine Flu vaccination program this fall then we need full disclosure of all financial relationships between proponents and manufacturers on every vaccine on the market. Who has an objective opinion about a company that has made them rich?"

Dateline NBC's broadcast was about the potential link between the MMR vaccine and the onset of autism. Offit has stated unequivocally that there is no connection and that he has no conflict of interest with Merck. However, he acknowledged in testimony to Congress in 2000 that "I have been in collaboration with Merck and Co. on the development of a rotavirus vaccine since 1992" and that "I am a consultant to Merck." Although the Rotateq vaccine that enriched Offit has no relationship to MMR, his close financial connections to Merck, if disclosed, are likely to affect the public's value of his opinions on the efficacy of the MMR vaccine.

"It is, at a minimum, disingenuous of Dr. Offit not to tell the public through the Dateline program what he told Congress in 2000," said Dr. Andrew Wakefield, Executive Director of Thoughtful House autism treatment center, who was also featured in the program. "Even if he is no longer a consultant to Merck, the fact the company made him wealthy by buying his rotavirus vaccine is certain to make him warmly view the company and its products, including MMR. Let us hope that all such relationships are disclosed prior to any Swine Flu vaccination program."

Offit has frequently accused Wakefield of being conflicted during his MMR research, claiming that Wakefield was being paid by a law firm for his expertise on MMR while also conducting his studies. Although physicians are frequently paid for their medical expertise in legal cases, Wakefield fully disclosed his relationship with the litigators in various UK media stories and publicly reported documents. Offit, however, has continued to back MMR as completely safe while failing to inform the public that the MMR manufacturer Merck has made him so wealthy he said "it was just like winning the lottery." As a member of the Advisory Committee on Immunization Practice, Offit also voted to include the rotavirus vaccine in the Vaccines for Children program, which ultimately made his Rotateq product worth hundreds of millions of dollars to Merck.

"Offit has zero credibility in matters of vaccine safety," said Wendy Fournier, President of the NAA. "Not only does he advance the absurd suggestion that children could safety get 100,000 vaccines at a time, he opposes any studies of the comparative health of unvaccinated children that could shed light on the extent and nature of vaccine-caused injuries, leading to their prevention.

Beyond Offit's financial conflicts, autism advocates are also dismayed about the physician's credibility on speaking about autism in general, as he does not treat patients with autism. "It's a mystery how such an inexperienced and financially conflicted man has become the go-to guy for information on autism," commented Ms. Fournier. "Here's a man with no real knowledge about autism that again and again appears in media coverage. Not only is he completely unqualified to address autism from a medical standpoint, his financial conflicts of interest disqualify him as a credible source for vaccine safety commentary as well."