2009 Feb
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.
...
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