NVIC Vaccine E-NewsletterFebruary 12, 2009



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

(http://rs6.net/tn.jsp?et=1102456317043&e=001eufqKJagJjS-B6KAAgchffhLJdhCbmmPecC\
m9XP3DG3c8Zx41eMOMD1pH1JHCFm0J651lXFxFHRPV0GgK0w05SONlLIE_OWdqSjr1ounpJ1-2b_yJEA\
YTGjY0ut4zdfGFkZDNRLaLLggJEMXNHECRItnXfymYI4pgq3tuDCwgrExlmjyzfN6KLRbns1tDQd-11H\
DcInFKCaJlPcQ9CP7nDR-zb0J1zG5FiUbaxrb4Uw=)that gave them liability protection.
It is Pharmalobbyists, who bully the FDA into fasttracking vaccines like
Gardasil(http://rs6.net/tn.jsp?et=1102456317043&e=001eufqKJagJjRv2WlQePzwpgg-HfA\
a0QLb4dLZh6XM2l6jPUjEjOUm_N3KNPfkYN-AY31VqqxWfFc65YcaCzdKbbM8zC-rtnoPNgTrxe0w-_W\
-CNt7fmXr-mrmql9-AEZmPddNLc4Mne2CuAuC1Pg2JOze3CI4UUN-c566NNaLrnewLgWf7ssohg==)
and who sit at theCDC's policymaking tables urging that new vaccinesbe
recommended for use by all children so they canpersuade state legislators to
mandate vaccines likeinfluenza
vaccine(http://rs6.net/tn.jsp?et=1102456317043&e=001eufqKJagJjQcAzLGPd1taqGyolkS\
9pP-oW-JZKPfoEh2w170ybmB2K4oCv7-YfTxnOwWWz5_VWVXKuqBqcXqF7AAHeE4E1G41IQAph1qDShn\
23HO9HWEnMkJ-QJfpM-EUVg_zo-9NcysS-eQLpJ5WQ==).Today, a
study(http://rs6.net/tn.jsp?et=1102456317043&e=001eufqKJagJjQSI-upOSB5catu3UL-FK\
X1a6fYbXh3iGYlfGwpm60HMnMHbeXdGODbwWy1X9noqbGyiH59zXzaMa1a_N6W-7TzZ-0rQfCPMwEAUK\
NF2V2PslfOVI0SSrAQ4DsH-A5O-_SLC2-bWHjf7uYB57LHjYX-XyNHdeFUQJ3OGup5itjnSOGWwECGUf\
WpgQDs_ON65QZTAlCRzdJqz5h5uOc5929Vu7kvWqtzcfRdFq1WTI1xoA==) published in the
British Medical Journal
(http://rs6.net/tn.jsp?et=1102456317043&e=001eufqKJagJjTO8qzbLenNxqj2jEO_pfUBBK-\
CJq99M0IQRZt0xZrGv9Fyja_H1KFDanlRamfDpI5e7xpFtraipZ6_bQoLHAFC2mogyOvQ4qM=)reveal\
s the clout that Big Pharma hasin the world of medicine journal
publishing,specifically the publishing of scientific articles aboutvaccines. In
a Cochrane Collaboration review andanalysis of published influenza vaccine
studiesconducted by Tom Jefferson, M.D., Ph.D. and hiscolleagues, they found
that influenza vaccine studiessponsored by industry are treated more favorably
bymedical journals even when the studies are of poorquality.Click
here(http://rs6.net/tn.jsp?et=1102456317043&e=001eufqKJagJjSSqQzMcSesBmclYBE0bRt\
TDGwS-hJvg4J8Zno4OyG5yk2mBtpjhOE7n83pAG9FPU__vG_FdO0uUJLGkWPx04CQeHlgB17kaEBke6Q\
K5Szy1OSdJKjCml7CCa8xUeWoRYzG3wWCfWcMA2NNiGDFDXYk)to view the BMJ
study:Jefferson's analysis confirms that drugcompaniesmarketing vaccines have a
major influence on whatgets published and is said about vaccines in
medicaljournals. It is no wonder that there are almost nostudies published in
the medical literature that callinto question vaccine safety. The preferential
treatmentof Pharma-funded studies also explains why the risksof an
inappropriately fast-tracked vaccine like Gardasilare underplayed in the medical
literature and why aphysician like Andrew Wakefield, M.D., who dared topublish a
study in
1998(http://rs6.net/tn.jsp?et=1102456317043&e=001eufqKJagJjRVVtx2UY4LgVMsdiUahqj\
vTAB5Jeox1qZHh94b4KSMpxbZ-WaKtPmKXChDwOTki2CP9zUXgfLot4F3scE_T7OG1UJtbLljURSHOoC\
Aa-0Kr8IUzHgT5khjnUkA_2NEVgQuhKAdSZJ5-1NxYGLqu2i2M3qt3Lv37W8=)in a medical
journal (The Lancet) calling for morescientific investigation into the possible
link betweenMMR vaccine and regressive autism, has beenmercilessly
persecuted(http://rs6.net/tn.jsp?et=1102456317043&e=001eufqKJagJjTkdJul7boXBtkBl\
CUM5xHsQLdiaepptiELykkytd2cVI9C4vWm6gaD-ToEPiu2YgKo9uagfyHNIukTFj88WOYItiXoS41zZ\
yIvZATNOge6U5lYaFy9f_6LxQLLQrMpYjkLU6DZzkxc_5WRIB-gJVgS9l5QVjLb5yrsK5cFbGH-DVXh1\
XZbx8HUBL4DQf0SoBr7uaWy0PQDzA==) for morethan a decade by both Pharma-funded
special interestgroups as well as public health officials maintainingclose
relationships with vaccine manufacturers. Jefferson and his colleagues
identified andassessed 274 published studies on influenzavaccines for their
methodological quality and found norelationship between study quality,
publication inprestige journals or their subsequent citation in otherarticles.
They also found that most influenza vaccinestudies are of poor quality but those
with conclusionsfavorable to influenza vaccinations are of significantlylower
methodological quality. The single mostimportant factor determining where the
studies werepublished or how much they were cited wassponsorship, with those
partially or wholly funded bythe pharmaceutical industry having
highervisibility.Dr. Jefferson commented, "The study showsthatone of the levers
for accessing prestige journals is thefinancial size of your sponsor. Pharma
sponsors ordermany 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 ontheir website. It
is time journals made a full disclosureof their sources of funding. Earlier this
week the National VaccineInformationCenter
(www.NVIC.org(http://rs6.net/tn.jsp?et=1102456317043&e=001eufqKJagJjRj1oLn1f4jda\
YzqmpCkQw5LTreYWhA6mqsNXceXee4ywC5MM2N_t-KujGVJRrQex59RCC0YWPHtQ8T5O_h4ps_LfD-wU\
hXX_U=))called on the Obama Administrationand
Congress(http://rs6.net/tn.jsp?et=1102456317043&e=001eufqKJagJjSEayFHSKJt8dYbriH\
EiS_kUyy2FJeYNRwMpfUhzFxFKc3KamA0vYTH0-_9REpK_i_ibRN11ww56izrqcW04-aMMaqYP5EIchR\
BhbrrVGhTBCzWxuOwC2HLtrW5q8NnbMuCYk25nuLejPseqrJ1-R3K0U58oPRXG07RypeuxwEJpA==)to
investigate Gardasil vaccine risks. NVIC has longquestioned the inappropriate
influence of vaccinemanufacturers in federal vaccine licensing andpolicymaking
and state vaccine mandates. In 2006,Merck's Gardasil vaccine was fast tracked by
the FDAat Merck's request and in 2007 Merck lobbyistsmounted anaggressive
lobbying
campaign(http://rs6.net/tn.jsp?et=1102456317043&e=001eufqKJagJjTkKQ6zzhKvMaLlK_L\
ywfoz20C2g88ILGZA2Sw4th3ARKcxlPlP3qbxTpJr9z-iWJ7QAW5TqRyH-QeYXUzIEArCOp-X7w6-IE1\
BM_RNbICVs6u8Kk1rHQ8gZc31UHk8uoyqPp9HVH5RNrOW09WZxPex2vKPl5GsFY4wssFjmDP6M-Hcbkm\
couxUQKpxaRtJbCc=) to getGardasil mandated by state legislators for all
sixthgrade girls, which would have assured the big drugcompany a predictable
market. The Pharma lobbying effort in 2007 to get allstates tomandate Gardasil
failed but every other vaccineproduced by drug companies and licensed by the
FDAin the past quarter century has been mandated. Thosenew mandates were added
to state vaccine laws bylegislators and public health officials at the urging
ofvaccine manufacturer lobbyists and Pharma fundedorganizations touting vaccine
studies published in themedical literature.In the past three decades, the
numbers of dosesofgovernment recommended vaccines for children andmedical
organizations like the American Academy ofPediatrics has tripled to 69 doses of
16 vaccines, with48 doses of 14
vaccines(http://rs6.net/tn.jsp?et=1102456317043&e=001eufqKJagJjQRArd3j37qO-E9f2W\
kn0VjzlUdf_rUiKMV-4jo3owUfvZQiVfpB4Jj5kF7E1V7_592ti-VNIQKkSAI6rQayNJTUD_-WJYedz7\
er9nXFAG_3Mgcd8Xi1Xc2UOvbVZONfutJmDBdgQ4Ut044BkdICzPV) targeted to children
under age six. Pharmalobbyists have persuaded most states to pass lawsrequiring
two to three dozen doses of most of the 16government recommended vaccines. Last
year NewJersey became the first state to mandate influenza
vaccine(http://rs6.net/tn.jsp?et=1102456317043&e=001eufqKJagJjQcAzLGPd1taqGyolkS\
9pP-oW-JZKPfoEh2w170ybmB2K4oCv7-YfTxnOwWWz5_VWVXKuqBqcXqF7AAHeE4E1G41IQAph1qDShn\
23HO9HWEnMkJ-QJfpM-EUVg_zo-9NcysS-eQLpJ5WQ==)for children attending daycare
andschool.In the past few years, Dr. Jefferson hasauthoredseveral independent
reviews of influenza studiespublished in the medical literature for the
CochraneCollaboration, which have been published in theBritish Medical
Journal(http://rs6.net/tn.jsp?et=1102456317043&e=001eufqKJagJjSTamDrY-KtzbcVSJQQ\
zArHoo62jPrE4aLB4yjKnG5vGRpnIz9GSsOvR6DegD_sqVhXr60ivRO8Om_6cT8NeM-j7TibNDw2RUXc\
JrTf-IeTWadwDOICOk-GUDFE4JwD9BfAIvCuPPpJjDn5P3H-_XQe), questioning
thequalityofpublished scientific evidence forinfluenza vaccine effectiveness
and safety for theelderly as well as children. Clearly, if the makers and
marketers ofvaccines can influence the quality and quantity of thescientific
evidence published in the medical literatureproving that vaccines are safe and
effective - evidencethat is used by states to mandate vaccines and by theU.S.
Court of Claims to deny compensation to vaccineinjured children - then Congress
was wrong in 1986 toprotect the makers and marketers of vaccines fromliability
for injuries and deaths caused by thosevaccines.Government vaccine
recommendations, U.S.Court of Claims vaccine injury compensation awardsand state
vaccine mandates are justified on thestrength of scientific published in medical
journals. Itis time for medical journals to disclose all financialties to the
pharmaceutical industry. It is time forstudies questioning the safety and
effectiveness ofvaccines to receive a fair hearing in scientific journalsrather
than editors confining themselves to primarilypublishing studies funded by the
pharmaceuticalindustry maintaining that every vaccine is totally safe,effective
and necessary.Kudos to the British Medical Journal for having theintegrity to
publish Jefferson's comprehensiveanalysis of pharmaceutical money influence
onvaccine studies published in the medical literature.Hopefully, this will be a
wake-up call for the scientificcommunity, Congress and the public to put an end
tothe undue influence the pharmaceutical industry hason the science and policy
of mass vaccination in theU.S..BMJRelation of study quality, concordance, take
homemessage,funding, and impact in studies of influenza vaccines:systematic
reviewT Jefferson, coordinator, C Di Pietrantonj, statistician,M G Debalini,
researcher, A Rivetti, researcher ,V Demicheli, director of health, Piemonte
regionCochrane Vaccines Field, ASL(Azienda Sanitaria Locale) AL 20,15100
Alessandria, ItalyCorrespondence to: T Jeffersonjefferson.tom@... this
as: BMJ 2009;338:b354doi:10.1136/bmj.b354ABSTRACTObjective To explore the
relationbetween studyconcordance, take home message, funding, anddissemination
of comparative studies assessing theeffects of influenza vaccines.Design
Systematic review withoutmeta-analysis.Data extraction Search of theCochrane
Library, PubMed,Embase, and the web, without language restriction, forany
studies comparing the effects of influenza vaccinesagainst placebo or no
intervention. Abstraction andassessment of quality of methods were
carriedout.Data synthesis We identified 259primary studies (274datasets). Higher
quality studies were significantlymorelikely to show concordance between data
presentedandconclusions (odds ratio 16.35, 95% confidence interval4.24 to 63.04)
and less likely to favour effectiveness ofvaccines (0.04, 0.02 to 0.09).
Government fundedstudieswere less likely to have conclusions favouring
thevaccines(0.45, 0.26 to 0.90). A higher mean journal impactfactorwas
associated with complete or partial industryfundingcompared with government or
private funding and nofunding (differences betweenmeans5.04). Studysizewasnot
associated with concordance, content of take homemessage, funding, and study
quality. Higher citationindexfactor was associated with partial or complete
industryfunding. This was sensitive to the exclusion from theanalysis of studies
with undeclared funding.Conclusion Publication in prestigiousjournals
isassociated with partial or total industry funding, andthisassociation is not
explained by study quality or size.* Make a difference SUPPORT
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