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News Stories on Human ResearchProtection and April 7, 2002 Lancet: Just How Tainted Has Medicine Become? FYI The prestigious British journal, The Lancet,reports that "Total retail spending on prescription drugs was US $155billion in 2001, almost double what it was in 1997." The escalating corrosive influence of big pharmaceuticalcompanies in medicine is bankrupting healthcare budgets and undermining theintegrity of medical research institutions. Lancet reports that "supposedlyindependent medical journals" have been caught in publishing biasedarticles. For example, the Journal of American Medical Associationreported in February that 90% of authors of clinical practice guidelinesreceived research funding from or acted as consultants for a drug company. And, Lancet reports, the editor of the BritishJournal of Psychiatry was a member of a drug-company sponsored"educational organization", for which he received £2000 annually. Theeditor published a favorable review of the drug manufactured by that company. "Only after receiving the letter questioning hisbehaviour did the editor change his journal’s procedure, excluding himself fromdecisions about work sponsored by that same company." Industry’s ubiquitous influence has corrupted theintegrity of medical research and the scientific literature upon whichscientific research is built. Indeed, research on human subjects cannotethically be conducted without a trustworthy body of scientific knowledge. [See,The Nuremberg Code, The Declaration of Helsinki, and the Belmont Report] Industry may have delivered a fatal blow to a laudableenterprise: the bias that industry has injected effectively demolished thefoundation upon which public and professional trust had been built. The Lancet Editorial JUST HOW TAINTED HAS MEDICINE BECOME? Chief executives of multinational pharmaceutical companieshave much to celebrate this week. They saw spending on prescription drugs in theUSA soar by a remarkable 17% in 2001, according to figures recently released bythe National Institute for Health Care Management Foundation. As bonuses forcorporate leaders ratchet upwards, so does the unalleviated financial pressureon the elderly, the largest users of these drugs. Direct-to-consumer advertising campaigns forcholesterol-lowering agents, anti-ulcer medications, anti-arthritics, andantidepressants have been strikingly successful. Total retail spending onprescription drugs was US$155 billion in 2001, almost double what it was in1997. The escalating influence of big pharma in medicinepersuaded editors of medical journals to come together last year and agreestrict rules on reporting sponsorship and conflicts of interest (see Lancet2001; 358: 854-56). While this consensus sets the highest standards yet fordisclosing commercial influences in medical research, there are signs that itdoes not go far enough–or, at the very least, that this guidance is not beingfully heeded. A study of the interactions between authors of clinicalpractice guidelines and the pharmaceutical industry, published in JAMA inFebruary, found serious omissions in declarations of conflicts of interest.Almost 90% of authors received research funding from or acted as consultants fora drug company. Over half had connections with companies whose drugs were beingreviewed in the guideline, and the same proportion indicated that there was noformal procedure for reporting these interactions. The guidelines studiedcovered all fields where prescription drug use has seen the greatest increases. An especially corrosive example of such a commercialinfluence, involving one of the most respected US specialist societies–theAmerican Heart Association–was described in the BMJ last month. Was the AHAsensible to accept US$11 million in donations from Genentech while at the sametime producing guidelines about thrombolytics in stroke? Genentech is the USproducer of one such thrombolytic, which was recommended for use in the AHA 2000guidance on stroke management. Prestigious institutions are also not averse from mixingresearch with commercial gain from industry partnerships. The Seattle Times hasconducted one of the most thorough investigations of how such relations threatento poison patient care. In a series of articles published last year, staffreporters Duff Wilson and David Heath claimed to reveal how investigators at theFred Hutchinson Cancer Research Center completed experiments with biotechnologyproducts in which they had a direct financial interest. The journalists allegethat doctors did not tell patients that others had died using these products andthat there were safer alternatives available. The Center denies theseallegations but admits that it "could have handled better" perceptionsof conflict of interest. These concerns extend to journal editors, especially thosewho edit part-time while continuing to work in clinical practice and research.The rules issued by the International Committee of Medical Journal Editors statethat, "Editors who make final decisions about manuscripts must have nopersonal, professional, or financial involvement in any of the issues they mightjudge". However, the editor of the British Journal ofPsychiatry was recently questioned about his membership of adrug-company sponsored "educational organisation", for which hereceived £2000 annually, together with his decision to publish a paperfavouring a drug manufactured by the same company. Only after receiving theletter questioning his behaviour did the editor change his journal’s procedure,excluding himself from decisions about work sponsored by that same company. Heavoided the issue about whether he should have any commercial liaisons whileacting as editor of a supposedly independent medical journal. The Lancet’s policy is that editors should divestthemselves of all such links upon assuming their new duties. To return to our first question: how tainted by commercialconflicts has medicine become? Heavily, and damagingly so, is the answer. A moreimportant question arises: do those doctors who support this culture for thebest of intentions–e.g., to undertake important research that would otherwiseremain unfunded–have the courage to oppose practices that bring the whole ofmedicine into disrepute? FAIR USE NOTICE: This may contain copyrighted (© )material the use of which has not always been specifically authorized by thecopyright owner. 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