The hastings center - essay - pharma goes to the laundry: public relations and the business of medical education

6. See the discussion in S. Brownlee, “Doctors without Borders,” 13. D. Healy, letter to Peter J. Pitts, Associate Commissioner for Ex- Washington Monthly, April 2004.
ternal Relations at the Food and Drug Administration, February 19, 7. See J.M. Drazen and G.D. Curfman, “Financial Associations of Authors,” NEJM 346 (2002): 1901-1902.
14. “Depressing Research,” Lancet 363 (2004): 1335. 8. D. Healy and D. Cattell, “Interface between Authorship, Industry 15. Krimsky, Science in the Private Interest, at 229.
and Science in the Domain of Therapeutics,” British Journal of Psychia- 16. Institute of Medicine, Responsible Research: A Systems Approach to try 183 (2003): 22-27; T. Bodenheimer, “Uneasy Alliance: Clinician In- Protecting Research Participants (Washington, D.C.: National Academy vestigators and the Pharmaceutical Industry,” NEJM 342, no.20 (2000): of Sciences, 2003), at 200-204; R. Steinbrook, “Public Registry of Clin- 1539-44, at 1539; and W.T. Carpenter, “From Clinical Trial to Prescrip- ical Trials,” NEJM 351 (2004): 315-17.
tion,” Archives of General Psychiatry 59 (2002): 282-85.
17. F. Fleck, “WHO and Science Publishers Team Up on Online Reg- 9. M. Baram, “Making Clinical Trials Safer for Human Subjects,” ister of Trials,” British Medical Journal 328 (2004): 854.
American Journal of Law and Medicine 27 (2001): 253-282, at 262.
18. Council on Scientific Affairs, American Medical Association, 10. E.J. Garland, “Facing the Evidence: Anti-Depressant Treatment in “Featured CSA Report: Influence of Funding Source on Outcome, Va- Children and Adolescents,” Canadian Medical Association Journal 170, lidity, and Reliability of Pharmaceutical Research (A-04),” June 2004, at http://www.ama-assn.org/ama/publ/article/print/2036-8608.html.
11. C.J. Whittington et al., “Selective Serotonin Reuptake Inhibitors 19. C. De Angelis et al., “Clinical Trial Registration: A Statement in Childhood Depression: Systematic Review of Published versus Un- from the International Committee of Medical Journal Editors,” NEJM published Data,” Lancet 363 (2004): 1341-45.
12. “Seroxat/Paxil—Adolescent Depression: Position Piece on the Phase III Clinical Studies,” October 1998. Document obtained fromDavid Healy.
Pharma Goes to the Laundry: Public Relations and the Business of Medical Education What’s the difference between medical educa- PR than that Kendle cannot even say for certain which tion and pharmaceutical public relations? business he is in. “Sometimes I describe Lowe Fusion as a ‘PR consultancy’, sometimes as a ‘healthcare communi- it. “(T)he broad distinction between healthcare PR and cations agency’. Sometimes I just cop out and list the medical education is becoming obsolete,” writes Neil Kendle, chief executive officer of Lowe Fusion Health- Here’s how the business works. The pharmaceutical care, in a recent issue of Pharmaceutical Marketing maga- industry puts up the money, usually in the form of an zine. So slender is the difference between education and “unrestricted educational grant.” The grant goes to a for-profit medical education and/or communications com-pany (MECC), which, in consultation with its pharma Carl Elliott, “Pharma Goes to the Laundry: Public Relations and the Busi- sponsor, puts together an “educational program.”2 The ness of Medical Education,” Hastings Center Report 34, no. 5 (2004): 18-23.
company and the MECC recruit academic physicians to 18 H A S T I N G S C E N T E R R E P O RT deliver the program in return for a small cut of the grant. If and Dinah Cattell in the British Journal of Psychiatry, it may the MECC is accredited by the Accreditation Council for Continuing Medical Education, it can offer the educational As Healy and Cattell explain, a lawsuit brought against program on its own. If not, it must go through the CME of- Pfizer in 1999 turned up documents produced by a medical fice of a medical school, which—again for a cut of the communications company called Current Medical Direc- grant—accredits the program and certifies it free of commer- tions. Current Medical Directions was working on a publica- cial bias. Then doctors, nurses and other health care workers tions strategy for Pfizer’s antidepressant, Zoloft (sertraline).
attend the “educational program” that pharma has funded in These documents listed all the Zoloft studies that Current order to satisfy the CME requirements of their professional Medical Directions was preparing for publication in 1999.
The documents listed the journals where their papers had It is, as the corporate manuals like to say, a win-win situa- been submitted, the conferences where the papers had been tion. The doctors and nurses get CME credits; universities get presented, the authors of the articles, and so on. It was this a new revenue stream; academic physicians get some extra last category—authorship—that was the most revealing. On a pocket money; MECCs get a lucrative market niche (over a number of articles, the authors were listed as “TBD,” or “to billion dollars a year, according to The Lancet), and the phar- be determined.” Apparently, Current Medical Directions had maceutical industry gets to shape the minds of medical Amer- written the articles but was still searching for an academic to ica.3 By laundering its message through the MECCS, pharma gives up some control, but the pay-off is even better: adver- Healy and Cattell decided to track down the articles on tisements with the appearance of objectivity. PR practitioners Zoloft that Current Medical Directions was working on in call this a “third-party” strategy. As Kendle puts it, “Third 1999 and see what had happened to them. They picked three party sources of information, as long as they are perceived to years—1998, 1999, and 2000—and scanned the medical lit- have expertise in the area they are talking about, are much erature for all articles published on Zoloft during that time.
more credible sources of information than the pharmaceutical What they found was stunning. First, the ghostwritten and company itself.” Pharma now funds over 60 percent of con- agency-prepared articles outnumbered the articles written in tinuing medical education in the United States.4 the traditional way. Forty-one “traditionally authored” articles Not bothered that your doctor’s education comes from on Zoloft had been published, while fifty-five articles had pharma? Have a look, then, at the “communications” arm of come from Current Medical Directions. Second, the articles this lucrative business. Here the results are scientific articles, that came from Current Medical Directions had been pub- often in peer-reviewed medical journals. The money is laun- lished in far more prestigious journals than the traditionally dered in much the same way. Pharma pays the MECC; the authored articles (ranging from JAMA through Archives of MECC puts together the articles; academic physicians are General Psychiatry and the American Journal of Psychiatry.) In paid to sign onto the articles, and the MECC places the arti- fact, the citation rate for the Current Medical Directions arti- cles in medical journals. Some academics simply sign ghost- cles was over five times higher than the citation rate for the written articles, while others work from a draft supplied by traditionally authored articles. Finally, the Current Medical the company. Sticklers for honesty merely take the money Directions articles painted a much happier profile of Zoloft and write the articles themselves. Fees vary. Some academics than did the traditionally authored articles. For example, the have signed on for as little as $1,000 or $1,500 per article, in- articles prepared by Current Medical Directions on pediatric cluding the two faculty members at the Medical University of psychopharmacology failed to mention five of the six children South Carolina who recently “authored” a ghostwritten article taking Zoloft who took action towards committing suicide.
on Ritalin for Novartis.5 Others command much higher fees.
Still not worried? Have a look at another piece of litiga- When the debate over second-hand smoke was heating up in tion. Readers of the business pages are becoming familiar with the early 1990s, the tobacco industry paid a biostatistician headlines like this one: “The cost of Wyeth’s diet-drug disas- $10,000 to write a single letter to the Journal of the American ter: $16.6 billion. And the claims keep coming.”10 That $16.6 Medical Association.6 Warner Lambert, the maker of Neuron- billion is the latest price tag for litigation over Fen-Phen, the tin, a seizure drug, gave a professor at the University of Min- diet drug combination produced by Wyeth. Fen-Phen is a nesota over $300,000 to write a textbook on epilepsy.7 combination of fenfluramine and phentermine that was pro- None of this is exactly new. What is new is the magnitude moted as a weight loss drug in the mid-90s. Wyeth produced of the phenomenon, which has only become evident through two versions of fenfluramine: Pondimin and a newer chemi- recent litigation. For years, nobody really knew how much of cal cousin, Redux, or dexfenfluramine. The FDA approved the medical literature was ghostwritten, or even how much Redux in 1996 despite worries that it might cause primary had originated from pharma. (Ghosts take care to remain in- pulmonary hypertension. As many as seven million people visible.) The most widely cited article on ghostwriting, pub- used the drugs. In 1997, Fen-Phen was withdrawn from the lished in JAMA in 1998, found evidence of ghostwriting in market after being linked to valvular heart disease. By some 11 percent of articles published in six major American med- estimates as many as 30 percent of the seven million users ical journals.8 To the uninitiated that figure may sound alarm- would contract valvular disease.11 Soon the link to primary ingly high. But according to a recent study by David Healy pulmonary hypertension became even clearer. By 2001, at least 365,000 users had joined a mass federal settlement and was being considered for approval by the FDA, Wyeth also Wyeth had acknowledged that at least 45,000 patients had be- sent another KOL to testify on its behalf: Tufts University’s come ill as a result of using the drug. No uncontroversial fig- Louis Lasagna, the noted expert on clinical trial methodology ures exist as to how many Fen-Phen users have died, but it is whose essays on research ethics appear in many standard safe to say that they number in the many hundreds.12 bioethics textbooks, and whose revised version of the Hippo- As Alicia Mundy has documented in her alarming book, cratic Oath is repeated every year by students at many Amer- Dispensing with the Truth, the behavior of Wyeth officials dur- ing the safety crisis was not exactly a model of corporate re- One of the most ingenious pieces of the Fen-Phen public sponsibility. In 1997, clinicians in Fargo, North Dakota, and relations strategy was its ghostwriting scheme. In 1996 Wyeth the Mayo Clinic notified Wyeth that they had seen thirteen hired Excerpta Medica Inc, a New Jersey-based medical com- patients on Fen-Phen who had developed valvular disease.
munications firm, to write ten articles for medical journals How did Wyeth respond? Their safety officer destroyed the promoting obesity treatment. Wyeth paid Excerpta Medica data. She went to the files and “overwrote” them to avoid any $20,000 per article. In turn, Excerpta Medica paid prominent mention of valvular disease.13 Wyeth then sat on the informa- university researchers $1,000 to $1,500 to edit drafts of their tion about valvular disease for several more months before no- articles and put their names on the published product. Wyeth tifying the FDA. Wyeth’s approach to the worries about pri- kept each article under tight control, scrubbing drafts of any mary pulmonary hypertension was hardly better. Typical of its material that could damage sales. One draft article included attitude was a memo from a company bureaucrat, later un- sentences that read: “Individual case reports also suggest a link earthed in litigation, that read, “Can I look forward to my between dexfenfluramine and primary pulmonary hyperten- waning years signing checks for fat people who are a little What made Excerpta Medica such an inspired choice is The irony is that Fen-Phen was never an especially effective that it is a branch of the academic publisher, Reed Elsevier drug. Wyeth’s own data showed only a 3 percent difference Plc., which publishes many of the world’s most prestigious between Fen-Phen and placebo.15 The average weight loss on science journals. Excerpta Medica manages two journals itself: the drug was less than 5 percent.16 For this very reason, the Clinical Therapeutics and Current Therapeutic Research. Ac- success of Fen-Phen was enormously dependent on PR. At cording to court documents, Excerpta Medica planned to the center of Wyeth’s PR campaign was the message that submit most of the articles it produced to Elsevier journals. In being overweight is not merely a matter of personal aesthetics.
the actual event, Excerpta managed to publish only two arti- It is a health issue—and thus a matter that doctors need to cles before Fen-Phen was withdrawn from the market in take very seriously. To a background chorus of slogans such as 1997. One appeared in Clinical Therapeutics, the other in the “Obesity—The Public Health Crisis” and “Obesity—A American Journal of Medicine (another Elsevier journal). In Chronic Disease,” Wyeth pounded out a dubious statistical neither case did the authors of the articles disclose that they message: obesity causes 300,000 deaths a year.17 Wyeth need- were paid by Excerpta Medica. So clean was the laundering ed to cast obesity as a dangerous medical problem in order to operation, in fact, that many of the authors did not even real- justify the potential risks of Fen-Phen.
ize that Wyeth was involved. Richard Atkinson of the Univer- Wyeth’s “medical education” campaign for Fen-Phen was a sity of Wisconsin wrote a letter to Excerpta Medica congratu- model of the genre. It included pay-outs to academic physi- lating them on the thoroughness and clarity of their article.
cians, lavish conferences, and generous grants to professional “Perhaps I can get you to write all my papers for me!” he medical societies. The $54 million set aside by Wyeth to wrote. He did have one reservation about the piece he was launch the drug included grants to the American Academy of signing: “My only general comment is that this piece may Family Physicians, the American Diabetes Association, the make dexfenfluramine sound better than it really is.”22 North American Society for the Study of Obesity, and the It wasn’t until evidence had mounted that Fen-Phen was American Society of Bariatric Physicians. Wyeth budgeted actually causing people to die that Wyeth put its PR machine $700,000 for C. Everett Koop’s advocacy group, Shape Up into high gear. After Fen-Phen had been withdrawn from the America, $275,000 for a “State of Weight” teleseminar, market, Wyeth spent $100 million on public relations to con- $179,000 for “Dear Doctor” letters, and $50,000 for a vince the public that the response had been overblown.23 It Women’s Health seminar.18 Wyeth also maintained a stable of convened an “Expert Panel” of cardiologists and gave Arthur high-profile academic consultants—known in the business as Weyman of Harvard an honorarium of $5,000 per day to Key Opinion Leaders (KOLs) and “advisory board” members.
chair it.24 It put together a “Very Important Visiting Profes- These KOLs included JoAnn Manson of Harvard and Gerald sor” (VIVP) program and flew the VIVPs to CME events at Faich of the University of Pennsylvania, who wrote a compli- exotic resorts.25 Most critically, Wyeth funded studies to dis- mentary editorial on Fen-Phen for the New England Journal of cover evidence that would minimize the safety worries about Medicine (without disclosing their corporate ties) and George Fen-Phen, and if the studies were favorable, it publicized Blackburn, the chair of the Committee on Nutrition for the those studies heavily. For example, Wyeth spent over $18 mil- Massachussetts Medical Society, who was instrumental in get- lion on a study by Neil Weissman at Georgetown University ting Massachussetts to lift a ban on Fen-Phen.19 When Redux examining valvular damage. When a preliminary analysis of 20 H A S T I N G S C E N T E R R E P O RT the unpublished data looked somewhat favorable, it was pre- themselves against ghostwriting charges by pointing out just sented at a conference, promoted by press release, and fea- how widespread the practice was. “This is a common practice tured on the front page of USA Today with the headline, in the industry,” said Wyeth spokesman Doug Petkus. “It’s “Study: No Heart Damage from Diet Drug.” (That analysis Why is it so hard to bring about change? Partly because Of all the depressing features of the Fen-Phen saga, per- change is in nobody’s financial interest. In the case of medical haps the most depressing is just how little positive change it education, the funding operation is seamless. Not only does has produced. Wyeth has been punished, but academic physi- pharma fund the MECCS who organize the CME, the acad- cians are still taking paychecks from pharma to sign onto emics who deliver the CME, and the offices that certify the ghostwritten articles; medical schools are still bringing in CME, it also funds the professional societies that require the pharma-funded speakers to deliver lectures and Grand CME. Specialty groups like the American Psychiatric Associa- Rounds; and peer-reviewed medical journals are still publish- tion and the American Academy of Family Physicians are ing pharma-funded editorials, review articles, and journal heavily dependent on industry funds.33 Pharma even helps supplements. What little action the professional bodies have write the accreditation guidelines. Nearly half of the member- taken has been purely cosmetic. Although the AMA devel- ship of the task force which produced the original ACCME oped clear, well-publicized guidelines governing gifts to physi- standards governing industry support of CME came from in- cians many years ago, the guidelines have been widely ig- nored, perhaps because the pharmaceutical industry funds the Another reason is that responsibility for the harm is so dif- AMA itself. When the AMA’s Council on Ethical and Judicial fuse. Most of the people involved in these operations do not We have known for many years that pharma funding influences behavior. Individually,
the influence may be slight or even nonexistent; statistically, the result is a clinical
and research agenda overwhelmingly shaped by pharma money. Still, we cling to the vast
collective delusion that because we cannot see a provable causal link between funding
and our own individual behavior, no real influence has been exerted.
Affairs decided to launch a campaign to educate doctors on see any harm in taking a piece of the industry money for the ethics of industry gifts in 2000, it made the stunningly themselves. The academic researcher says: what’s the harm if I inept decision to have pharma fund the campaign.27 In June take money for signing onto a MECC-produced editorial as 2004 the ACCME published its new guidelines for commer- long as I agree with everything that is in it? The doctor says: cial support of medical education, but the guidelines are what’s the harm in attending an industry-funded symposium vague and toothless.28 They do little to punish offenders, in Boca Raton as long as I look at the presentations with a much less to cut off the flow of money from pharma.
skeptical eye? The department head says: what’s wrong with The Fen-Phen case is by no means unique. A similar pat- taking money from Janssen or Merck to fund our Grand tern of deception is emerging in the story of SSRIs and sui- Rounds program if it means we can bring in more high-pro- cide.29 Warner Lambert’s off-label promotion of Neurontin file speakers? The journal editor says: what’s wrong with pub- has been, if anything, even more deceptive than Wyeth’s Fen- lishing an industry-funded editorial or review article as long as Phen campaign—and despite fraud sanctions, Neurontin is it gets appropriate peer review? The ethicist says: what’s wrong still a wildly profitable drug.30 Many (if not most) MECCs are with funding our centers with industry money as long as the owned by advertising and marketing firms, some of which gifts are unrestricted and the funders are not issuing any or- have begun conducting clinical research themselves.31 What is ders? But it is only when all these cogs click together that the especially striking about the testimony of the people involved in these promotions is just how matter-of-fact they are about We have known for many years that pharma funding in- their marketing practices. When asked about the way the in- fluences behavior. We know that when research is funded by dustry cultivates “key opinion leaders” and “advisory board pharma, it tends to favor pharma.35 We know that when doc- members” to lecture on behalf of pharma, Hugh Gosling, the tors take gifts and fees from pharma, they are much more like- editor of Pharmaceutical Marketing, replied that it was the in- ly to prescribe the drugs produced by the company that has dustry norm. “I think it’s exactly the same as it always has given them the gift.36 We know that researchers don’t disclose been,” he said. “I don’t feel that there has been a turning point their financial ties even when they are asked—and usually, in any way.”32 In the Fen-Phen case, Wyeth officials defended they are not asked.37 Individually, the influence may be slight H A S T I N G S C E N T E R R E P O R T 21 or even nonexistent; statistically, the result is a clinical and Zoloft articles, fighting a lawsuit by parents of children research agenda overwhelmingly shaped by pharma who died in its Nigerian Trovan trials, and paying off a money. Still, we cling to the vast collective delusion that $430 million fraud penalty, but you can still hear ethics because we cannot see a provable causal link between lectures in the Pfizer Hall for Medical Humanities at New funding and our own individual behavior, no real influ- York University medical school, attend classes taught by ence has been exerted. Nobody is willing to give up the Pfizer Lecturer in Medical Humanities at Royal Free money or perks in order to combat a statistical problem.
and University College Medical School, and read Pfizer- One of the first ethicists to call attention to the prob- funded disquisitions on conflict of interest in the Ameri- lem of paid editorials was Troyan Brennan at Harvard, can Journal of Bioethics—which is housed at the Pfizer- who addressed the issue over ten years ago. Writing in the funded Center for Bioethics at the University of Pennsyl- New England Journal of Medicine, Brennan explained how vania, whose director has served as a Pfizer consultant.39 he was offered $2,500 by Edelmann Communications on What should we make of the fact that the Hastings Center behalf of a pharmaceutical company in exchange for writ- Report, which receives funding from Merck, one of many ing an editorial for a peer-reviewed journal. Brennan pharmaceutical companies undertaking clinical research turned down the money, but he was not willing to con- in the developing world, has recently published an essay demn paid editorials or pharma-funded CME. Instead, he on the ethics of research in the developing world whose called for transparency. “Rather than foreclose the partici- lead author is a paid speaker for Merck?40 pation of these physicians in such activities as editorial The degree of dissembling and rationalization here writing, we should consider improving disclosure,” wrote might be funny if the stakes were not so high. “I take the Brennan. “Conflicts will remain with us. They must be money but it doesn’t influence me.” “I take the money from many different sources in order to keep my objectiv- It is time to admit that as a remedy for conflict of in- ity.” “I take the money but I make sure that no more than terest, disclosure has been an utter failure. Disclosure is an forty percent of our center’s funding comes from corpo- empty ritual designed to ease the consciences of academics rate sources.” “I take the money but I always disclose.” “I unable to wean themselves from the industry payroll. Its take the money but I say what I want.” Or my favorite: “I only purpose is to serve as a warning signal, like a fire take the money but I use it to advocate for social justice.” alarm in a burning building. Disclosure does nothing to The rationalizations always begin with the phrase: “I take fix the underlying problem of pharma funding, which is the money.” No one will just say no. In fact, only a few not secrecy but power. It does patients no good to be told people in academic medicine will openly criticize those that doctors, researchers, and regulators are all in pharma’s who won’t say no. With the exception of a few watchdog pocket if there is nothing they can do about it.
groups and an outspoken group of critics, most of them If the right constituencies could be mobilized, the mess journal editors or ex-editors, academic medicine treats the would not be that hard to clean up. Universities and jour- issue as an embarrassing peccadillo, like an extramarital nals could treat ghostwritten articles as cases of scientific affair: an unavoidable temptation best handled with a fraud. Department heads could treat faculty who sign wink and a grin. At all costs we must avoid what ethicist onto paid editorials the same way they treat students who and drug industry consultant Thomas Donaldson calls a sign their names to papers they buy on the Internet. Med- ical organizations could hold conferences without drug But this is no peccadillo. It represents an enormous be- industry perks, just like other professional societies. Uni- trayal of public trust. We count on doctors to make deci- versities could pay their ethicists without the help of in- sions based on what’s best for us, we count on researchers dustry funds, in the same way that they pay their philoso- to publish impartial data, and we count on educators to phers and sociologists. Journal editors could refuse to tell us the truth—regardless of what the pharmaceutical publish editorials, review articles, and ethics essays written industry says. Nobody who makes even a token effort to by authors who are funded by the industry whose prod- find out where their checks are coming from could con- ucts they are addressing. Academic physicians could treat clude that consultancies, advisory board memberships, lectures and grand rounds as part of their duty as teachers, educational grants, and speaker’s bureaus are anything but rather than as a way to generate extra income. But nobody thinly disguised marketing tools.42 Pharma needs to make will take action because nobody sees the problem as their a profit; that is part of its mission. But to surrender our own responsibility. It is hard to see any change taking impartiality to that mission is a betrayal of everything that place in the current climate unless litigators start going universities are supposed to stand for. The cost of that be- after the people who accept this money as well as those trayal is being paid in human lives.
When Brennan was writing, bioethicists could have stepped into this debate. But we forfeited any credibility I am grateful to Arnold Relman and Alicia Mundy for we may have had when we started taking pharma money ourselves. Pfizer may be commissioning ghostwritten 1. N. Kendle, “Life Without a Label,” Pharmaceutical Marketing, 30. J. Lenzer, “Pfizer Pleads Guilty but Drug Sales Continue to Soar,” BMJ 328 (2004): 1217.
2. A.S. Relman, “Separating Continuing Medical Education 31. Petersen, “Madison Ave. Has Growing Role in Business of from Pharmaceutical Marketing,” JAMA 285 (2001): 2009-2012.
3. “Drug Company Influence on Medical Education in USA,” 32. T. Jackson, “Are You Being Duped? How Drug Companies Use Opinion Leaders,” BMJ 322 (2001): 1312.
4. S. Hensley, “Drug Firms Shown Classroom Door: Continu- 33. The Center for Science in the Public Interest maintains a ing-Ed Programs For Doctors Aim to Reduce Influence of Big searchable database on the financial ties of non-profit groups and Companies,” Wall Street Journal, January 14, 2003.
scientists to corporate sources. It can be found at 5. M. Petersen, “Madison Ave. Has Growing Role In the Busi- http://cspinet.org/integrity/nonprofits/.
ness of Drug Research,” New York Times, November 22, 2002.
34. Relman, “Separating Continuing Medical Education from 6. D. Hanners, “Documents Indicate Tobacco Industry Paid Sci- entists to Write to Editors,” St. Paul Pioneer Press, August 5, 1998.
35. B. Als-Nielsen et al., “Association of Funding and Conclu- 7. M. Petersen, “Court Papers Suggest Scale of Drug’s Use,” New sions in Randomized Drug Trials,” JAMA 290 (2003): 921-28; R.A. Davidson, “Source of Funding and Outcome of Clinical Tri- 8. A. Flanagin et al., “Honorary Authors and Ghost Authors in als,” Journal of General Internal Medicine 1, no. 3 (1986): 155-58.
Peer-Reviewed Medical Journals,” JAMA 280 (1998): 222-24.
36. See A. Wazana, “Physicians and the Pharmaceutical Industry: 9. D. Healy and D. Cattell, “Interface between Authorship, In- Is a Gift Ever Just a Gift?” JAMA 283 (2000): 373-80; M.M. Chren dustry and Science in the Domain of Therapeutics,” British Journal and C.S. Landefeld, “Physicians’ Behavior and Their Interaction of Psychiatry 183 (2003): 22-27.
with Drug Companies,” JAMA 271 (1994): 684-89; J.P. Orlowskiand L. Wateska, “The Effects of Pharmaceutical Firm Enticements 10. A. Barrett, “The Class Action That Wouldn’t Quit: The Cost on Physician Prescribing Patterns,” Chest 102 (1992): 270-73.
of Wyeth’s Diet-Drug Disaster: $16.6 Billion. And the Claims KeepComing,” Business Week, May 24, 2004.
37. S. Krimsky and L. Rothenberg, “Conflict of Interest Policies in Science and Medical Journals: Editorial Practices and Author 11. Morbidity and Mortality Weekly Report 46, no. 45, November Disclosures,” Science and Engineering Ethics 7, no. 2 (2001): 205- 12. The FDSA linked Redux, which was only on the market for 38. T. Brennan, “Buying Editorials,” NEJM 331 (1994): 673-75.
a year, to 123 deaths when it was withdrawn in 1997. Pondiminwas marketed for a longer period, Mundy estimates the total num- 39. B. Tansey, “Huge Penalty in Drug Fraud; Pfizer Settles ber of deaths to be close to 1,000. See David Willmon, “The New Felony Case in Neurontin Off-label Promotion,” San Francisco FDA,” Los Angeles Times, Dec 20, 2000, and Alica Mundy, person- Chronicle, May 14, 2004. For information about the Pfizer Foun- dation Hall for Humanism in Medicine, see R. Moynihan, “TheMaking of a Disease: Female Sexual Dysfunction,” BMJ 326 13. A. Mundy, Dispensing with the Truth (New York: St. Martin’s (2003): 45-47. Information about Pfizer’s New York University School of Medicine Master Scholars Program is available at h t t p : / / t u t o r i a l s p u b . m e d . n y u . e d u / C o n t e n t / M S P / 15. J. Brown, “The Poison Pill,” Salon, May 16, 2001.
MSPBrochure.pdf. An announcement of the Pfizer Lecturer in 16. M. Kaufman and A. Julien, “Scientists Helped Industry to Medical Humanities is reported in the Journal of Medical Ethics: Push Diet Drug,” Hartford Courant, April 10, 2000.
Medical Humanities 27 (2001): 69. For the Nigerian Trovan trials, 17. Mundy, Dispensing with the Truth, 41.
see A. Raufu, “Nigerians in Drug Trial Take Their Case to U.S.
Court,” BMJ 326 (2003): 899. The University of Pennsylvania Center for Bioethics discloses its funding sources at 19. J.E. Manson and G.A. Faich, “Pharmacotherapy for Obesity: http://www.bioethics.upenn.edu/resources/. For the Pfizer-funded Do the Benefits Outweigh the Risks?” NEJM 335 (1996): 659-60; article on conflict of interest, see D. Katz, A. Caplan, and J. Merz, M. Angell and J. Kassirer, “Editorials and Conflicts of Interest,” “All Gifts Large and Small: Toward an Understanding of the Ethics NEJM 335 (1996): 1055-1056; Mundy, Dispensing with the Truth, of Pharmaceutical Industry Gift-Giving,” American Journal of Bioethics 3, no. 3 (2003): 39-46. On the director’s Pfizer consultan- 20. Kauffman and Julien, “Scientists Helped Industry to Push cy, see L. Weeks, “Viagra Debate Vigorous; Drug Sparks Questions of Sexual Politics,” Washington Post, April 26, 1998.
21. C. Ornstein, “Maker of Diet-Drug Combo Accused to 40. The participants in the 2001 Conference on Ethical Aspects Funding Journal Articles,” Dallas Morning News, May 23, 1999.
of Research in Developing Countries, “Moral Standards for Re- 22. Ibid.; see also Mundy, Dispensing with the Truth, 164.
search in Developing Countries: From ‘Reasonable Availability’ to ‘Fair Benefits,’” Hastings Center Report 34, no. 3 (2004):17-27. 41. T. Donaldson, “The Business Ethics of Bioethics Consult- ing,” Hastings Center Report 31, no. 2 (2001): 13.
42. Petersen, “Madison Ave. Has Growing Role In the Business of Drug Research.” See also the revealing account of a former drug 27. S. Okie, “AMA Criticized for Letting Drug Firms Pay for representative: M.J. Oldani, “Tales from the ‘Script’: An Ethics Campaign,” Washington Post, August 30, 2001.
Insider/Outside View of Pharmaceutical Sales Practices,” Krober 28. A. Relman, “Defending Professional Independence: Anthropological Society 87 (2002): 146-76.
ACCME’s Prposed New Guidelines for Commerical Support ofCME,” JAMA 289 (2003): 2418-2420.
29. See C. Medawar and A. Hardon, Medicines Out of Control? Antidepressants and the Conspiracy of Goodwill (Amsterdam: Trans-action Publishers, 2004); and David Healy, Let Them Eat Prozac(New York: New York University Press, 2004).

Source: http://www.thehastingscenter.org/pdf/publications/hcr_sep_oct_2004_essay.pdf