E-DRUG: BMJ: Say no to the free lunch -------------------------------- [The BMJ has again devoted a large part of an issue to the question of the relationship between medicine and the pharmaceutical industry - below are the editor's comments, an editorial and a film review. Thanks to Andy for spotting. Copied as fair use. WB]
http://bmj.bmjjournals.com/cgi/content/full/330/7496/0-g BMJ 2005;330 (16 April), doi:10.1136/bmj.330.7496.0-g Editor's choice Say no to the free lunch Are you a pig or a weasel? Or do you consider yourself above all that? When the BMJ published a special issue on the links between doctors and drug companies in 2003, the cover showed pigs in white coats lunching and golfing with weasel drug reps. At the time this seemed strong stuff even to those involved in editing the issue. But little has happened since to suggest that the image was wrong. In fact, every day new revelations suggest that the reality is worse. The power of drug companies to buy influence over every key group in health care-doctors, charities, patient groups, journalists, politicians-has clearly shocked a UK parliamentary committee (p 855). It should shock us all. Can we console ourselves that companies' lavish spending on research and marketing, which far outstrips spending on independent research and drug information, leads to truly innovative treatments? No, says the committee's report. Can we rely on regulatory bodies to keep the industry in check? No, again. What we can rely on, says Slattery-Moschkau, a former drug rep and creator of a hard hitting new film on the industry (p 911), is that drug reps are "armed and dangerous," selected for their ability to seduce and persuade rather than their scientific skills, and armed with, among other things, details of your prescribing behaviour. All of this might encourage new resolve to step away from the trough and stand with the good guys. So it's interesting that the American College of Physicians has refused a booth at its annual meeting to the not-for-profit group No Free Lunch, which works to reduce conflicts of interest (p 862). Interesting, too, that the US National Institutes of Health may be forced to relax its policy on conflict of interest in response to protests from staff that it is too restrictive (p 864). The BMJ, like most academic medical journals that carry pharmaceutical advertising, is perhaps somewhere between a pig and a weasel. And those of you alert to competing interests will see that Gauthier (p 857), in line with our policy on disclosure, lists at the end of his editorial several companies he has received funding from. We take the pragmatic view that competing interests cannot be removed altogether, since few clinical experts do not have some links to industry. But this is a hard balance to keep, and perhaps we delude ourselves that we have got it right. Ferner (p 855) indicates that "professional self delusion"-doctors' view that they are not influenced by marketing-may force external regulation. The committee recommends, for example, requiring clinicians to register all substantial gifts from industry. It also recommends limits to promotion aimed at inexperienced prescribers and more training for medical students about marketing by drug companies. So when the drug reps call for a chat, or offer to throw a sponsored lunch, make sure you are armed with cynicism, or information, or both. Better still - however seductive they are, just say no. Fiona Godlee, editor ([EMAIL PROTECTED]) ~~~ http://bmj.bmjjournals.com/cgi/content/full/330/7496/855 BMJ 2005;330:855-856 (16 April), doi:10.1136/bmj.330.7496.855 Editorial The influence of big pharma Wide ranging report identifies many areas of influence and distortion ...he would have us believe that his drug has been discovered by chemical research of alchemical profundity, and is produced by a process so costly and elaborate that it can only be sold at a very high price.1 A report published last week on "the influence of the pharmaceutical industry" describes a strong United Kingdom pharmaceutical industry, whose net exports are worth over #3bn ($5.6bn; 4.3bn) annually.2 The industry's declared goal is "to bring patients life-enhancing medicines," a goal "not only necessary but noble." The House of Commons health committee examined the means used to achieve this noble end. They found an industry that buys influence over doctors, charities, patient groups, journalists, and politicians, and whose regulation is sometimes weak or ambiguous. For example, the Department of Health, responsible for a national health service that spends #7.5bn on drugs annually, is also responsible for representing the interests of the pharmaceutical industry. The committee described how the industry taints doctors. Over half of all postgraduate medical education in the UK, and much education of nurses, is funded by the pharmaceutical industry from its annual marketing budget of #1.65bn. The Department of Health spends just 0.3% of this on publishing independent information on drugs. "Key opinion leaders" may receive #5000 for giving an hour's lecture. The committee found this surprising. Their report recommends that the General Medical Council maintain a register of "all substantial gifts, hospitality, and honoraria received by members." In this way, professional self delusion that "marketing does not influence us" may bring outside regulation. The industry spends #3.3bn annually on research in the UK, financing about 90% of all clinical drug trials, but develops few truly innovative drugs. It influences the interpretation and reporting of results of trials. Negative results can be dismissed as erroneous ("failed trials"), whereas positive ones can be published repeatedly in different guises.3 The committee report recommends establishing an independent register of clinical trials, containing full information and available at the time of product launch, as a condition of authorisation for marketing. Registering all trials at their inception might be better so that "failed" trials can also be scrutinised. The committee noted that drug advertising deliberately associates brands with attributes that satisfy the emotional needs of the professionals-the "strategy of desire."4 The report recommends closer scrutiny of advertisements and limits to promotion aimed at inexperienced prescribers. It also recommends that medical undergraduates learn more about clinical trials, adverse drug reactions, and marketing by drug companies. Unfortunately, clinical pharmacology has disappeared from many medical school curriculums and will need active resuscitation.5 The report also suggests that marketing and prescribing be limited when a product is first licensed, to allow experience to accrue. The idea of a probationary period is attractive, but formal trials of relative efficacy within the NHS would be better.6 Companies can only market products if they have authorisation to do so from the Licensing Authority. The Medicines and Healthcare Products Regulatory Agency (MHRA) is its executive arm, with an annual income of #65m derived entirely from licensing fees. The committee thought that the need to attract pharmaceutical business could conflict with the MHRA's primary task of protecting the public. They also questioned the thoroughness with which the MHRA reviewed data submitted for licensing, and its ability, after licensing, to detect adverse drug reactions and act on them. As evidence, the report cites the fact that "only 19 drugs have been withdrawn between 1993 and 2004," but "medicines can be licensed in the absence of adequate data or investigation into possible adverse reactions..." The MHRA cannot win with this analysis: if it withdraws drugs, it has failed in the first place to obtain adequate information to predict adverse reactions; and if it does not, then it has failed to detect adverse reactions. The committee chose rofecoxib as an example. We now know from a large randomised trial that this coxib probably increases the risk of thromboembolism by 1:140 patient years, less than twice the background incidence.7 To confirm such small increases is notoriously difficult.8 9 The spontaneous adverse drug reaction reporting scheme using yellow cards is also criticised. Many reactions go unreported, and increasing their reporting rates would be good.10 However, spontaneous reports describe association, not causation, and rarely provide sufficient evidence for regulatory action. Even with good data on benefit and harm, pharmacovigilance is rarely straightforward - the US Food and Drug Administration may yet agree to re-licence rofecoxib.11 The report urges greater efforts to investigate signals of possible problems, but does not suggest how to command the necessary resources. Matters would improve if the MHRA could require companies to undertake specific studies as a condition of renewal of a marketing authorisation. The last health select committee report on the pharmaceutical industry was published on the day World War I was declared,12 and its far sighted recommendations such as the registration of all manufacturers, remedies, and therapeutic claims, were ignored in the aftermath. The current wide ranging report correctly identifies many areas of pharmaceutical influence, and the distortions they introduce. The report does not identify the resources to assure that an independent David triumphs over the pharmaceutical Goliath. Unbiased clinical trials, objective drug data, and perfect pharmacovigilance are desirable but probably illusory and certainly expensive. R E Ferner, director West Midlands Centre for Adverse Drug Reaction Reporting, City Hospital, Birmingham B18 7QH ([EMAIL PROTECTED]) -------------------------------------------------------------------------------- Competing interests: RF is director of the West Midlands Regional Monitoring Centre of the Committee on Safety of Medicines (CSM), and a member of the CSM sub-committee on pharmacovigilance, and CSM working groups. The views expressed here are personal and do not represent the views of the committee or subcommittee. References 1. British Medical Association. Secret remedies: what they cost and what they contain. London: British Medical Association, 1909. 2. House of Commons Health Committee. The influence of the pharmaceutical industry. http://www.parliament.the-stationery-office.co.uk/pa/cm200405/cmselect/cmhealth/42/42 pdf (accessed 5 Apr 2005). 3. Melander H, Ahlqvist RJ, Meijer G, Beermann B. Evidence b(i)ased medicine-selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ 2003;326: 1171-3. 4. Ferner RE, Scott DK. Whatalotwegot-the messages in drug advertisements. BMJ 1994;309: 1734-6. 5. Maxwell S, Walley T. Teaching safe and effective prescribing in UK medical schools: a core curriculum for tomorrow's doctors. Br J Clin Pharmacol 2003;55: 496-503. 6. Ferner RE. Newly licensed drugs. BMJ 1996;313: 1157-8. 7. Bresalier RS, Sandler RS, Quan H, Bolognese JA, Oxenius B, Horgan K, et al. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med 2005;352: 1092-102. 8. Jick H. The discovery of drug induced illness. N Engl J Med 1977;296: 481-5. 9. Clark DWJ, Layton D, Shakir SAW. Do some inhibitors of COX-2 increase the risk of thromboembolic events? Linking pharmacology with pharmacoepidemiology. Drug Safety 2004;27: 427-56. 10. Smith CC, Bennett PM, Pearce HM, Harrison PI, Reynolds DJM, Aronson JK, et al. Adverse drug reactions in a hospital general medical unit meriting notification to the Committee on Safety of Medicines. Br J Clin Pharmacol 1996;42: 423-9. 11. Tomlinson H. Pfizer drug withdrawn over fears of side-effects. Guardian Apr 8 2005; 18. 12. Select Committee on Patent Medicines. Report from the Select Committee on Patent Medicines: ordered, by the House of Commons, to be printed, 4th August, 1914. London: Printed under the authority of His Majesty's Stationery Office by Darling and Son, 1914. ~~~ http://bmj.bmjjournals.com/cgi/content/full/330/7496/911 BMJ 2005;330:911 (16 April), doi:10.1136/bmj.330.7496.911 reviews FILM Confessions of a drug rep A forthcoming movie claims to spill the beans on Big Pharma Think big. Think money. Think drugs. And then think of all the sly, silly, ethically impaired things that people will do to sell drugs, and you'll have a taste of Kathleen Slattery-Moschkau's film, Side Effects. Slattery-Moschkau (pronounced Moscow, "like the city") sold drugs for a living for Bristol-Myers Squibb and Johnson & Johnson, until she found it increasingly difficult to "look myself in the mirror," and left her job after 10 years in the industry. An aspiring screenwriter since her college years, Slattery-Moschkau, wrote, directed, and produced Side Effects, a satirical film about the dilemma of Karly Hert (Katherine Heigl), a drug representative torn between her conscience and some really good perks. Hert's company plans to roll out "the biggest drug launch of the 21st century" for its new antidepressant, Vivexx, which they enthusiastically promote as "absolutely the most efficacious drug your patients can use!" while cheerfully predicting that "Vivexx will make Prozac look like penny candy." Hert, who suffers pangs of conscience about some of the promotional techniques encouraged by her managers, launches a campaign of her own-to tell doctors the truth about drug side effects. She's surprised when her honesty pays off-with increased sales. With increased sales comes a meteoric rise on the corporate ladder, making her even more beholden to her company - a company that is hiding some dirty secrets about Vivexx. Enter Hert's new boyfriend, Zach Danner (Lucian McAfee), a former drug representative who challenges Hert about her values. When corporate shenanigans turn ugly, the action goes from amusing to savagely funny. In one scene, likely to resonate with doctors who are frequently presented with wildly conflicting information about drugs, a manager grills one of his drug reps during a group meeting: "Where is Dr Schmidt in terms of Festril prescriptions?" "He's at 2%." "Why isn't he on board yet?" "He likes to wait at least one year before prescribing any new drugs. It's a safety issue and he likes to reserve quinolones for compromised patients." "What kind of idiot would reserve the most effective drug on the market? What's his reason?" "Well, because last year, you know, when we didn't have our own quinolones to sell, we were calling him an idiot for using such a big gun when it wasn't absolutely necessary." "Oh, it looks like you did your job a little too well last year. Have you invited him out to corporate yet?" "No, but..." "OK. I want him flown out to corporate. Also make sure he is signed up for the upcoming webcast with Dr Sing. I want you in his office twice a week for the next three. Got it?" Slattery-Moschkau told the BMJ that when sales reps went into doctors' offices, they were "armed and dangerous" with prescribing information on each doctor. "They know what percentage of Prozac or Paxil a doctor prescribes," she said. "The doctor often doesn't know this and it gives [reps] an incredible advantage over the doctor." When doctors do find out that every single drug they prescribe has been tracked and sold "for millions of dollars" to drug companies, they can "go ballistic," said one drug company insider who asked to remain anonymous. Telling a doctor about the existence of these prescription tracking lists, he said, was "not a good career move." "This story is actually my story," said Slattery-Moschkau, adding that the tactics employed by the industry in its "dangerous pursuit" of profits sometimes came "at the expense of patients' lives." One widespread corporate tactic is hiring reps who are undeniably alluring and always charming. And when it comes to experience, sales, rather than science, is the hands-down winner. Slattery-Moschkau, like her alter ego Hert, was stunned when she found that her experience selling cellphones and her political science degree from the University of Wisconsin-Madison were all she needed to get started in an exciting career of "educating doctors." Her science background? A course in geology. Slattery-Moschkau: industry tactics sometimes come "at the expense of people's lives" Jeff Trewhitt, spokesperson for the Pharmaceutical Research and Manufacturers of America, was quoted in USA Today on 15 March saying that Slattery-Moschkau's film "really does sound like fiction considering that all sales representatives undergo extensive technical training and are prepared to answer questions about new medicines and their characteristics." Mr Trewhitt also said that drug companies often hired nurses and pharmacists for their sales force, according to the article. But Slattery-Moschkau told the BMJ, "Most of the people I worked with majored in history or drama or music." She added, "Drug reps are pawns. They are encouraged to believe they are doing the right thing. But there are clues and when it gets a little dangerous, it's made clear to them that you toe the line." The rewards for "toeing the line" can be substantial. Slattery-Moschkau was pulling in $100 000 (#53 000; 77 000) annually when she left her job, her company car, and expense account behind. Side Effects premiered at the Cinequest Film festival in San Jose, California, in March and Slattery-Moschkau expects the film to be in cinemas by early summer. She decided to produce the film herself after a Hollywood agent wanted to "water down" the script to be more appealing to the studios. So she raised $190 000 and shot the film over 18 days last summer. Since the film's debut, the writer has been contacted by other drug representatives whose response, she said, had largely been, "Amen, sister." -------------------------------------------------------------------------------- Jeanne Lenzer, medical investigative journalist Kingston, New York state, USA [EMAIL PROTECTED] ------------------------ Yahoo! Groups Sponsor --------------------~--> In low income neighborhoods, 84% do not own computers. 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