Vaccine Studies: Under the Influence of Pharma

by Barbara Loe Fisher

If you take more than a casual look at the way the mass vaccination system in the U.S. works, you see that pharmaceutical companies marketing vaccines have a lot of clout. It was the pharmaceutical industry that told Congress in 1982 that they were going to leave the nation without vaccines if they didn't get liability protection but have opposed making it less difficult for vaccine victims to obtain federal compensation in the U.S. Court of Claims under a 1986 law that gave them liability protection. It is Pharma lobbyists, who bully the FDA into fast tracking vaccines like Gardasil and who sit at the CDC's policymaking tables urging that new vaccines be recommended for use by all children so they can persuade state legislators to mandate vaccines like influenza vaccine.

Today, a study published in the British Medical Journal reveals the clout that Big Pharma has in the world of medicine journal publishing, specifically the publishing of scientific articles about vaccines. In a Cochrane Collaboration review and analysis of published influenza vaccine studies conducted by Tom Jefferson, M.D., Ph.D. and his colleagues, they found that influenza vaccine studies sponsored by industry are treated more favorably by medical journals even when the studies are of poor quality.

Click here to view the BMJ study:

Jefferson's analysis confirms that drug companies marketing vaccines have a major influence on what gets published and is said about vaccines in medical journals. It is no wonder that there are almost no studies published in the medical literature that call into question vaccine safety. The preferential treatment of Pharma-funded studies also explains why the risks of an inappropriately fast-tracked vaccine like Gardasil are underplayed in the medical literature and why a physician like Andrew Wakefield, M.D., who dared to publish a study in 1998 in a medical journal (The Lancet) calling for more scientific investigation into the possible link between MMR vaccine and regressive autism, has been mercilessly persecuted for more than a decade by both Pharma-funded special interest groups as well as public health officials maintaining close relationships with vaccine manufacturers.

Jefferson and his colleagues identified and assessed 274 published studies on influenza vaccines for their methodological quality and found no relationship between study quality, publication in prestige journals or their subsequent citation in other articles. They also found that most influenza vaccine studies are of poor quality but those with conclusions favorable to influenza vaccinations are of significantly lower methodological quality. The single most important factor determining where the studies were published or how much they were cited was sponsorship, with those partially or wholly funded by the pharmaceutical industry having higher visibility.

Dr. Jefferson commented, "The study shows that one of the levers for accessing prestige journals is the financial size of your sponsor. Pharma sponsors order many reprints of studies supporting their products, often with in house translations into many languages. They also purchase advertising space in the journal. Many publishers openly advertise these services on their website. It is time journals made a full disclosure of their sources of funding.

Earlier this week the National Vaccine Information Center (www.NVIC.org) called on the Obama Administration and Congress to investigate Gardasil vaccine risks. NVIC has long questioned the inappropriate influence of vaccine manufacturers in federal vaccine licensing and policymaking and state vaccine mandates. In 2006, Merck's Gardasil vaccine was fast tracked by the FDA at Merck's request and in 2007 Merck lobbyists mounted an aggressive lobbying campaign to get Gardasil mandated by state legislators for all sixth grade girls, which would have assured the big drug company a predictable market.

The Pharma lobbying effort in 2007 to get all states to mandate Gardasil failed but every other vaccine produced by drug companies and licensed by the FDA in the past quarter century has been mandated. Those new mandates were added to state vaccine laws by legislators and public health officials at the urging of vaccine manufacturer lobbyists and Pharma funded organizations touting vaccine studies published in the medical literature.

In the past three decades, the numbers of doses of government recommended vaccines for children and medical organizations like the American Academy of Pediatrics has tripled to 69 doses of 16 vaccines, with 48 doses of 14 vaccines targeted to children under age six. Pharma lobbyists have persuaded most states to pass laws requiring two to three dozen doses of most of the 16 government recommended vaccines. Last year New Jersey became the first state to mandate influenza vaccine for children attending daycare and school.

In the past few years, Dr. Jefferson has authored several independent reviews of influenza studies published in the medical literature for the Cochrane Collaboration, which have been published in the British Medical Journal, questioning the quality of published scientific evidence for influenza vaccine effectiveness and safety for the elderly as well as children.

Clearly, if the makers and marketers of vaccines can influence the quality and quantity of the scientific evidence published in the medical literature proving that vaccines are safe and effective - evidence that is used by states to mandate vaccines and by the U.S. Court of Claims to deny compensation to vaccine injured children - then Congress was wrong in 1986 to protect the makers and marketers of vaccines from liability for injuries and deaths caused by those vaccines.

Government vaccine recommendations, U.S. Court of Claims vaccine injury compensation awards and state vaccine mandates are justified on the strength of scientific published in medical journals. It is time for medical journals to disclose all financial ties to the pharmaceutical industry. It is time for studies questioning the safety and effectiveness of vaccines to receive a fair hearing in scientific journals rather than editors confining themselves to primarily publishing studies funded by the pharmaceutical industry maintaining that every vaccine is totally safe, effective and necessary.

Kudos to the British Medical Journal for having the integrity to publish Jefferson's comprehensive analysis of pharmaceutical money influence on vaccine studies published in the medical literature. Hopefully, this will be a wake-up call for the scientific community, Congress and the public to put an end to the undue influence the pharmaceutical industry has on the science and policy of mass vaccination in the U.S..


BMJ

Relation of study quality, concordance, take home message, funding, and impact in studies of influenza vaccines: systematic review


T Jefferson, coordinator, C Di Pietrantonj, statistician, M G Debalini, researcher, A Rivetti, researcher , V Demicheli, director of health, Piemonte region

Cochrane Vaccines Field, ASL(Azienda Sanitaria Locale) AL 20,15100 Alessandria, Italy
Correspondence to: T Jefferson jefferson.tom@gmail.com
Cite this as: BMJ 2009;338:b354 doi:10.1136/bmj.b354


ABSTRACT

Objective To explore the relation between study concordance, take home message, funding, and dissemination of comparative studies assessing the effects of influenza vaccines.

Design Systematic review without meta-analysis.

Data extraction Search of the Cochrane Library, PubMed, Embase, and the web, without language restriction, for any studies comparing the effects of influenza vaccines against placebo or no intervention. Abstraction and assessment of quality of methods were carried out.

Data synthesis We identified 259 primary studies (274 datasets). Higher quality studies were significantly more likely to show concordance between data presented and conclusions (odds ratio 16.35, 95% confidence interval 4.24 to 63.04) and less likely to favour effectiveness of vaccines (0.04, 0.02 to 0.09). Government funded studies were less likely to have conclusions favouring the vaccines (0.45, 0.26 to 0.90). A higher mean journal impact factor was associated with complete or partial industry funding compared with government or private funding and no funding (differences betweenmeans5.04). Study sizewas not associated with concordance, content of take home message, funding, and study quality. Higher citation index factor was associated with partial or complete industry funding. This was sensitive to the exclusion from the analysis of studies with undeclared funding.

Conclusion Publication in prestigious journals is associated with partial or total industry funding, and this association is not explained by study quality or size.