Conflicts of Interest
It should go without saying that no one making public health decisions that will directly affect the lives of millions of United States children and indirectly affect the lives of millions of international children through our global influence should have any ties to the pharmaceutical industry. But sadly, this is not the case. Policies that do exist are either completely ignored or enforcement has been lax. The CDC, especially, has a lengthy history of corruption and deceit and has routinely turned a blind eye to vaccine conflicts of interest while it works to protect the private good. And, the problem goes all the way to the top with one previous CDC director working for Merck while another resigned in disgrace after allegations of owning stock in companies working with the CDC.
The US urgently needs, and taxpayers firmly deserve, ethical leadership in government, industry and media who are free from conflicts both before and after taking the job. The far-reaching health decisions made need to be driven by solid and truly independent science, not personal back accounts. Private, corporate and government reports and studies have called into question the rampant conflicts of interest currently occurring in our government regulatory agencies and in Congress. Here are some below.
The Rotavirus Vaccine: A Case Study in Government Corruption and Malfeasance
The major media dismiss public vaccine policy critics as “conspiracy theorists”, but no conspiracy is required to explain how it can be true that the CDC deceives about vaccines.
By Jeremy R. Hammond, Children’s Health Defense Contributing Writer
In a previous article for Children’s Health Defense, titled “Why You Can’t Trust the CDC on Vaccines”, we looked at how it can be true that government agencies are misinforming the public about the safety and effectiveness of vaccines. The very prospect is treated by the mainstream corporate media as a “conspiracy theory”, but no such theory is required to explain it. On the contrary, the existence of institutionalized biases within the medical establishment and scientific community are well recognized in the scientific literature, and the Congress itself has criticized the endemic corruption within the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA).
For example, we saw how both agencies were criticized by the June 2000 report of an investigation initiated by the Committee on Government Reform within the House of Representatives. That investigation touched on a particularly salient example of government corruption and malfeasance: the case of the rotavirus vaccine.
Among the Congressional investigation’s findings were that three out of five members of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) “who voted to approve the rotavirus vaccine in December 1997 had financial ties to pharmaceutical companies that were developing different versions of the vaccine”, while four out of eight members of the CDC’s Advisory Committee on Immunization Practices (ACIP) “who voted to approve guidelines for the rotavirus vaccine in June 1998 had financial ties to pharmaceutical companies that were developing different versions of the vaccine”.
Included among the half of ACIP members who had financial ties to pharmaceutical companies while deliberating what CDC policy should be with respect to the rotavirus vaccine was one Dr. Paul Offit.
Corruption and Hypocrisy
Paul Offit is currently director of the Vaccine Education Center at the Children’s Hospital of Philadelphia (CHOP). He also holds the Maurice R. Hilleman Chair in Vaccinology, created in honor of the former senior vice president of Merck, which provided a $1.5 million endowment to the hospital and the University of Pennsylvania to “accelerate the pace of vaccine research”.
Offit joined the ACIP in October 1998 and three times voted in favor on decisions related to the use of the rotavirus vaccine, including a vote to add the vaccine to the CDC’s “Vaccines For Children” program—all while sharing ownership of a patent for a rotavirus vaccine being developed under a grant from Merck.
A member of the CDC’s advisory committee until June 2003, Offit’s vaccine was approved by the FDA in 2006 under the trademark “RotaTeq”. The Children’s Hospital of Philadelphia was listed alongside Offit as a patent owner on the filing certificate issued by the US Patent and Trademark Office, and the hospital sold its stake in RotaTeq in 2008 under a deal in which Offit profited handsomely; he has acknowledged that he made “several million dollars, a lot of money”.
Offit also happens to be a routinely cited go-to “expert” on vaccines for the mainstream media. He once penned an op-ed for the New York Times accusing parents who choose not to vaccinate their children of child abuse on the grounds that Jesus, were he with us in the flesh today, would advocate forcibly vaccinating children against their parents’ will.
As it so happened, in October 1999, the first rotavirus vaccine licensed for use in the US, Wyeth’s RotaShield, was withdrawn from the market because it was found to be causing intussusception, an often excruciating and potentially fatal condition in which part of the intestine telescopes into itself.
In addition to the conflicts of interest within the CDC, the FDA had approved RotaShield as “safe” despite clinical trials having shown an increased incidence of intussusception in vaccinated infants.
Since the increased risk did not reach statistical significance, this finding was dismissed as “probably due to chance” by the FDA’s advisory committee—which, again, included three out of five members having ties to pharmaceutical companies developing rotavirus vaccines.
Furthermore, while the FDA instructed Wyeth on specific areas it ought to focus its postmarketing safety studies, the risk of intussusception was not one of them.
Researchers monitoring publicly available postmarketing surveillance data nevertheless did pick up on the incoming reports of intussusception after vaccination, and studies were conducted that confirmed the association between vaccination and an increased risk of the intestinal disorder.
As the CDC spokesman John Livengood summarized the findings, “We feel there is a strong causal relationship between rotavirus vaccine and intussusception. It’s of high magnitude and it appears to be about one in every five thousand children who are vaccinated with the vaccine.” Estimates ranged from one in five thousand to one in ten thousand. Prior to being pulled from the market, the vaccine was administered to half a million children. Surveillance data showed that during its short time in use, there were 98 confirmed reports of vaccine-related intussusception, over half of which required surgery and one of which resulted in death.
When the CDC voted on October 22, 1999, to withdraw its recommendation for routine use of RotaShield in children, Paul Offit recused himself from the vote on the grounds that it would create a “perception” of a conflict of interest for him to participate in the vote while he was also serving as a consultant for Merck, which was developing a vaccine to compete with Wyeth’s RotaShield. Instructively, he considered his glaring conflict of interest as a reason only to abstain from voting against the use of the vaccine—not to abstain from voting in favor.
The Government Is the Vaccine Industry
As an additional twist to the story, the virus used in the manufacture of RotaShield was developed by the US government.
With development of a rotavirus vaccine having been considered a priority for researchers since the virus was discovered in the early 1970s, the National Institutes of Health (NIH) created a “live simian-human reassortant virus” for the purpose. (A reassortant virus is one containing two or more pieces of nucleic acid from different parent viruses, produced by coinfecting a cell with the parent strains. The simian virus in this case was from a rhesus monkey.)
The NIH then licensed Wyeth to use its patented vaccine technology for RotaShield.
Yes, the US government patents vaccine technology and licenses it for a fee to private corporations. As another example, the NIH licensed vaccine technology to Merck for development of its Human Papilloma Virus (HPV) vaccine, Gardasil.
As you can see, the government isn’t so much a “regulator” of the vaccine industry as an integral part of it.
The CDC itself maintains contracts with pharmaceutical companies and, excepting influenza vaccines, purchases more than half of the childhood vaccines distributed in the US. The CDC is essentially a marketing and distribution division of the vaccine industry.
With no lack of irony, the way the government tells the story of RotaShield, it is a shining example of how the bureaucracies charged with ensuring vaccine safety are highly effective at doing so.
But wait, there’s more!
Viral Contamination of the Rotavirus Vaccine
In March 2010, the FDA advised temporarily suspending the use of GlaxoSmithKline’s rotavirus vaccine, Rotarix, because it was found to be contaminated with a pig virus—porcine circovirus type 1 (PCV-1). It was therefore recommended that patients instead receive Merck’s product, RotaTeq.
RotaTeq was soon thereafter also found to be contaminated with both PCV-1 and porcine circovirus type 2 (PCV-2).
The FDA publicized this finding on May 6, 2010. But rather than advising that RotaTeq, too, be suspended from use until this contamination could be resolved and the threat evaluated, on May 14, the FDA recommended that health care professionals resume use of Rotarix alongside the continued use of RotaTeq on the grounds that there was no known risk to humans from these viruses.
Incidentally, one of the scientific contributions of Maurice R. Hilleman—the former Merck vice president in honor of whom the chair held by Paul Offit was created—was his discovery in 1960 that both the live-virus and inactivated polio vaccines in use in the US were contaminated with a monkey virus known as simian virus 40 (SV40). In May the following year, the National Institutes of Health (NIH) convened to discuss the issue, recommending that the vaccines not be withdrawn from use on the grounds that there was no known risk to humans from the virus.
The way the government tells the story of the rotavirus vaccine, it’s a shining example of how agencies tasked with safeguarding public health responded quickly to the discover of potential harms from a vaccine on the market.
The reality is that the government approved the first rotavirus vaccine and added it to its list of vaccines children are typically required to get to attend public school despite clinical safety trials having indicated that it might cause intussusception.
That fact that the FDA didn’t require further studies with greater statistical power to determine whether the increased risk was “due to chance” or real, but contented itself with the wrong conclusion that the vaccine would “probably” not cause this painful and potentially deadly condition in children, is a clear example of how the government places the interests of the pharmaceutical industry above the interests of the public.
And this should not be surprising, given also the fact that three out of five members of the FDA’s vaccine advisory committee who voted to approve the vaccine had financial ties to the industry.
It should also come as no surprise, then, that after the withdrawal of that first rotavirus vaccine, the FDA approved two more despite both being contaminated with one or more pig viruses.
Also unsurprising is the fact that the CDC pushed the vaccine on the public, given how members of the CDC vaccine advisory committee had financial ties to pharmaceutical companies that were developing rotavirus vaccines.
The perception of government agencies like the FDA and CDC as acting in the best interests of public health and “regulating” the industry is illusory. The reality is that the government to a very large extent is the vaccine industry. Both the government and industry powerfully influence the direction of science, resulting in an institutionalized bias favoring public vaccine policy and treating vaccination as the solution for an increasing number of communicable diseases, at the opportunity cost of researching alternatives and simply educating people how to strengthen their immune systems naturally, including through proper nutrition, exercise, and avoidance of toxic exposures.
The government also misleads the public about what science tells us about the safety and effectiveness of its recommended vaccines, which can be explained not only by the institutionalized bias, but also by the endemic corruption within the agencies. This problem is compounded by fact that the mainstream corporate media do public policy advocacy on this issue rather than journalism, attacking rather than substantively addressing the arguments and legitimate concerns of anyone who dares criticize or dissent from the CDC’s routine childhood vaccine recommendations and the state laws that infringe on the parental right to informed consent by making these vaccines mandatory for children to receive a public education.
Jeremy R. Hammond is an independent journalist and analyst, publisher and editor of Foreign Policy Journal, author of several books, and father. Read more of his writings at JeremyRHammond.com. To stay updated with his work on vaccines and download his report “5 Horrifying Facts about the FDA Vaccine Approval Process”, subscribe to his free newsletter.
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In examining compensation records from drug companies to physicians who advised FDA on whether to approve 28 psychopharmacologic, arthritis, and cardiac or renal drugs between 2008 and 2014, Science found widespread after-the-fact payments or research support to panel members. The agency’s safeguards against potential conflicts of interest are not designed to prevent such future financial ties.
Conflicts of Interest at Medical Journals: The Influence of Industry-Supported Randomised Trials on Journal Impact Factors and Revenue – Cohort Study
Transparency in reporting of conflict of interest is an increasingly important aspect of publication in medical journals. Publication of large industry-supported trials may generate many citations and journal income through reprint sales and thereby be a source of conflicts of interest for journals. The authors of this study investigated industry-supported trials’ influence on journal impact factors and revenue.
Conflicts of Interest in Vaccine Safety Research
By Gayle DeLong
How safe are vaccines? Health officials caution that no vaccine is 100% safe, but they sponsor studies that conclude the benefits of vaccines far outweigh the risks. Yet conflicts of interest (COls) cloud the study of adverse effects of vaccines, and public skepticism about vaccine safety information is widespread Investigation into the possible link between childhood vaccines and autism provides an illustration of the competing interests that sponsors of vaccine safety research face that could affect their objectivity in choosing which studies to support.
Using the investigation into the possible link between childhood vaccines and autism as an illustration, this article discusses the current state of vaccine safety research.