==================================================== Just Say No? When Drug Companies Make Offers Doctors Can't Refuse ==================================================== by Carla Atkinson and John Geiger _Public Citizen_ magazine, March/April 1991 ==================================================== Transcribed by Joe Woodard Reformatted and arranged by Harel Barzilai Doctors didn't have to be frequent flyers to get free airline mileage in the mid-1980s. They just had to prescribe a lot of one of the latest drugs on the market. The "Travel for Knowledge" program, sponsored by the Wyeth-Ayerst pharmaceutical company, gave doctors 1,000 points every time they prescribed the company's new heart drug and sent in information on their patients. When doctors worked their way up to 50,000 points -- put 50 patients on the drug -- they hit the jackpot: free American Airlines tickets. Glitzy promotions like these have prompted a congressional investigation and sent medical and pharmaceutical groups hustling to address the ethical questions involved. The pharmaceutical industry spends more than $8 billion a year on new research and development, and spends almost as much marketing its new drugs -- more than $5 billion last year in the United States alone. Some say this expense is passed on to the consumer. "I don't think physicians should be educated about drugs by drug representatives who have an obvious vested interest in selling pharmaceutical products," says one doctor. This situation leads to overuse of drugs, drugs prescribed for the wrong reason and inflated drug prices." Critics say drug marketing practices have evolved into slick, thinly-veiled forms of bribery - fancy gifts, money or other compensation in return for pushing new drugs. Questions about the ethics of drug promotions are not new. The same Senate Labor and Human Resources Committee that called for hearings in December on the industry's promotional practices held similar hearings back in 1974. Since then, the market has gone wild and so have the promotions. The pharmaceutical industry's staunch defense is that doctors need to have detailed, reliable information about the drugs they prescribe, and drug companies are best equipped to give them that information. Patients suffer if their doctors aren't up-to-date on new drug therapies, Gerald J. Mossinghoff, president of the Pharmaceutical Manufacturers Association, told the Senate committee in December. "Physicians today must be far better educated and informed as to new drugs," he said. "Since the 1970s, whole new categories of drugs have been introduced." He warned that if the industry is to continue as a world leader in new drug research and development, its products have to find prompt, widespread acceptance [sic; not "understanding" but "acceptance" --Harel Barzilai] among doctors. "Responsible marketing and promotion are essential to such acceptance," Mossinghoff said. But more than a few witnesses appeared at the Senate hearing to say that companies aren't sticking to responsible marketing methods. ************************************************************** The network, funded by pharmaceutical companies, began offering doctors a $35,000 office computer system, free of charge .. to receive the free system, doctors just [sic] had to listen to several promotional messages each month, then punch responses into the computer - providing more marketing information for drug companies. ************************************************************** "Doctors frequently don't know the intent of the drug companies," Jones told Public Citizen. They think they are doing honest research, but often they are just gathering marketing information." ************************************************************** "Many patients are harmed by the pharmaceutical companies' practices," says David Jones, a former pharmaceutical executive who testified at the hearings. "The companies entice doctors into prescribing drugs that are of no use to the patient." According to Jones and others, companies often ask doctors to keep records for them on patients taking new drugs. They then compensate physicians for this "research," much as Wyeth-Ayerst did with its "Travel for Knowledge" promotion. "Doctors frequently don't know the intent of the drug companies," Jones told Public Citizen. They think they are doing honest research, but often they are just gathering marketing information." Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, came to the hearings armed with examples of doctor bribery - most of them taken from a "Doctor Bribery Hotline" he set up in 1990. Wolfe told the committee he set up the hotline to encourage doctors, their office staff, drug industry employees and others to give documented examples of what he considers unethical activity. The Physicians' Computer Network, Inc., is just one of those examples. The network, funded by pharmaceutical companies, began offering doctors a $35,000 office computer system, free of charge, in 1988, Wolfe told the committee. To receive the free system, doctors just had to listen to several promotional messages each month, then punch responses into the computer - providing more marketing information for drug companies. Wolfe also testified about the Wyeth-Ayerst/American Airlines promotion, which was called to a halt after the Massachusetts Attorney General's office investigated the program for possible violations of the Medicaid False Claims Act. If any doctor compensated by this kind of promotion prescribes drugs for Medicaid or Medicare patients, the company involved may be violating a federal anti-kickback statute. Wolfe says there are too many identical drugs on the market to treat the same disease. In order to survive the competition, a company is often driven to outlandish lengths to present its product as superior to the other drugs in that market when price may be the only difference, Wolfe says. But the American Medical Association assured the committee that doctors are unlikely to compromise their objectivity. Doctors don't "knowingly or intentionally compromise their patients' care as a result of gifts from industry," [anymore than, say, a judge in a court house, and others who are above mere Human trivialities like wealth --HB] AMA representative Daniel H. Johnson, Jr., told the committee. Gifts may make doctors more likely to listen to sales presentations and use a new drug on a trial basis, but most won't continue to prescribe a drug that doesn't work, added Johnson, a radiologist [Again, imagine anyone saying such nonsense about a court judge. --HB] But some doctors clearly see big dollar signs beneath drug company education and research programs. "There's definitely a conflict in the pharmaceutical companies between the scientists and the marketers," says Dr. Charles van der Horst, a professor in the Department of Medicine at the University of North Carolina at Chapel Hill. "The scientists are out to better humanity and the marketers want to make money." ************************************************************** Their survey of medical faculty .. from 1977 to 1988 found strong statistical associations between conversations with drug reps, honoraria, travel and research grants "and whether a drug was recommended for formulary addition," ************************************************************** Some studies are "purely devices the companies use to get patients on their drugs," says Jones, formerly a vice-president at Abbott Laboratories ************************************************************** Drug companies are particularly interested, for example, in hospitals' formularies, or the lists of drugs authorized to be used there, says van der Horst. The physician committees that help select the drugs for these lists are prime targets for companies' influence, he says. Medical residents are also regularly bombarded by sales reps, Dr. Nicole Lurie, who instructs residents and medical students in a teaching hospital, told the Senate committee. She described "donut rounds," twice-a-week sessions in which drug companies provide coffee and donuts while their sales reps talk to residents. [Next: direct-marketing to grade-school teachers about which brands of notebooks are the best for the children they teach, including "bonus systems" --HB] Lurie and two colleagues investigated the industry-physician relationship. Their survey of medical faculty at a number of university-affiliated institutions from 1977 to 1988 found strong statistical associations between conversations with drug reps, honoraria, travel and research grants "and whether a drug was recommended for formulary addition," Lurie told the committee. The study led her to believe that marketing efforts are so effective "that most physicians are unaware of the fact that they are being compromised." David Jones, the industry defector who gave an insider's view of pharmaceutical marketing at the hearings, says companies are more than aware of the means they are using and the end they want to achieve. Some studies are "purely devices the companies use to get patients on their drugs," says Jones, formerly a vice-president at Abbott Laboratories and executive director of public affairs at Ciba Geigy. This is particularly true, he says, of maintenance drugs - those that chronically-ill patients depend on to stay alive. A cardiologist in New Jersey said in a recent interview that he shunned an offer from a pharmaceutical company to do a drug study. "A new blood pressure drug came out and they offered me money to do some research on it," says the doctor, who preferred anonymity. "I had to get five people to do the project." Less than five patients, and the deal was off, the cardiologist says. "It seemed fishy to me, so I didn't do the study." When a doctor is told to send back only some information, Jones says, "like age, sex, test results, it's not research, it's pure marketing. Real research involves reams of information. "I was proposing programs of this nature when I worked for the industry," says Jones, who is now a volunteer lobbyist in the North Carolina state legislature for grassroots AIDS groups. "This stuff is routine with pharmaceutical companies." "Human beings and diseases become abstract concepts. This system contributes to that and it has to be rectified." That point has been driven home to several professional organizations in the past year. The AMA, the Board of Regents of the American College of Physicians and the Pharmaceutical Manufacturers Association have all adopted ethical guidelines for relationships between physicians and drug companies. The PMA's "Code of Pharmaceutical Marketing Practices" says the industry must use "complete candor" in dealings with health professionals, provide scientific information with "objectivity and good taste... and with scrupulous regard for truth," and comply with federal policies and procedures. "The pharmaceutical companies are marketing in a very responsible way," says Mark Grayson, PMA assistant vice-president. "In any industry you can find isolated abuses, but damning a whole industry just isn't justified." [How about damning a profit-based instead of human-needs-based system?] The PMA code also endorses the AMA and American College of Physicians' guidelines. For its part, the AMA says textbooks, modest meals and other gifts are appropriate if they serve "a genuine function.. and are not of substantial value." [no doubt meals and other "gifts" *do* serve a "function" as far as the Pharmaceutical industry making them is concerned. --HB] Payments to defray the cost of attending conferences, cash or "gifts with strings attached" shouldn't be accepted. It does allow for "reasonable honoraria" and reimbursement for "reasonable travel lodging and meal expenses" while attending symposia or conferences. "We believe there are two parts to enforcement of the guidelines -- education and grievance," says an AMA spokesman. "The first is to inform the physicians of the guidelines. There were never any rules [what does this say about the *system*? which is now still in place despite cosmetic reforms?--HB] concerning the doctors and pharmaceutical companies. We believe once the doctors realize there are rules they will comply. [Just like once the corporations "realize" that human beings are human beings they will stop exploiting them in the interest of profits -- despite the fact that the profit-based system (and profit-based economy as a whole) rewards precisely that --HB] "The second, grievance, involves state and county medical societies in every state. When a violator is reported to the societies, (they) will take action. They can reprimand or expel the physicians, which would show up on the National Practitioners Data Bank." The data bank, mandated by a 1986 law and overseen by the Department of Health and Human Services, stores information on the conduct and competence of physicians nationwide. Consumer advocates have criticized the effectiveness of the data bank because CONSUMERS ARE NOT ALLOWED DIRECT ACCESS to its information. [emphasis added. --HB] ************************************************************** "The drug companies say drug prices are so high because of research and development costs. But they include most of the subtle bribes and marketing research in the R&D costs they submit to Congress in the hearings." ************************************************************** "For the FDA not to have criminally prosecuted a drug company for advertising and promotional violations for 20 years, in the face of a massive amount of violative activities, is an invitation to continued lawbreaking," [ -- and speaks loudly about who owns our "represetatives" --HB] ************************************************************** Increasing attention to the ethical and health implications of "doctor bribing" may lead to changes in a system that has had few checks and balances. Rep. Pete Stark, D Calif., plans to introduce legislation through the House Ways and Means Committee that would curb pharmaceutical companies' influence over doctors' prescribing practices. The legislation would disallow drug promotions as a business tax deduction, says a committee aide. CURRENTLY, COMPANIES CAN DEDUCT ALL PROMOTIONS -- from pens and journals to conferences in the Caribbean -- as business expenses. [Emphasis added --HB] Stark's legislation "would be a step in the process of stopping this practice of influence," the aide says. Dr. van der Horst says Congress has been ignoring the problem for too long. "Congress is putting on the blinders when it comes to this problem of promotions," he says. "The drug companies say drug prices are so high because of research and development costs. But they include most of the subtle bribes and marketing research in the R&D costs they submit to Congress in the hearings." Consistent demand will always support higher drug prices, van der Horst says, and taxpayers ultimately pay through inflated Medicare and Medicaid costs. Congress should demand a detailed breakdown of the drug companies' expenses to discern legitimate research and development from marketing bribes, he says. And pharmaceutical sales reps should be eliminated, says van der Horst. Public Citizen's Wolfe says HHS and the FDA need to enforce existing laws to curb the industry's growing influence. "For the FDA not to have criminally prosecuted a drug company for advertising and promotional violations for 20 years, in the face of a massive amount of violative activities, is an invitation to continued lawbreaking," he says [Again, *that* the FDA acted in this way speaks loudly about the system, still in place, our system of government and the corporate control over it. --HB] Wolfe also urged Congress to pass new laws to give HHS and the FDA more jurisdiction and prosecuting power. "Even if the FDA was to do a perfect job in deciding which drugs are safe and effective enough for which diseases to merit approval for marketing, Wolfe says, "the current criminal, unethical and immoral marketing practices of many drug companies seriously undermine this aspect of FDA regulation." Some say the new guidelines will gradually make doctors more aware of the ethical questions involved when drug companies come courting. And the recent round of hearings may inspire Congress to change the way the industry does business by making regulatory changes. Regardless of how it happens, critics say the rules of the promotion game have to be overhauled [How about eliminating any "promotion game"? --HB] "Unless these practices are forcefully and promptly stopped, they will play a major role in destroying American medicine," says Sidney Wolfe. "There's a point that you really see what your decisions are doing to people," David Jones says of the industry he left. "You don't see it from the corporate suite or the corporate jet flying from city to city. "The price of prescription drugs is determined by what the market will bear. Pain and suffering and desperation will support a high price indeed." ---- John Geiger is a regular contributor to Public Citizen ****************************************************************** Public Citizen 2000 P Street, N.W., Suite 605 Washington, D.C. 20036 Founded by Ralph Nader in 1971 (Possible) email: pcctw@igc.org Lori Wallach Washington DC USA 20003 (Public Citizen /Citizen Trade Watch) Keys: trade, harmonization Newsgroups: misc.activism.progressive,alt.activism From: harelb@math.cornell.edu (misc.activism.progressive co-moderator) Subject: FCUS/HEALTH: Just Say No? Private Greed, Bribed Doctors (I) Message-ID: <1993Aug21.210017.4988@mont.cs.missouri.edu> Date: Sat, 21 Aug 1993 21:00:17 GMT Subject: FCUS/HEALTH: Just Say No? Private Greed, Bribed Doctors (II) Message-ID: <1993Aug22.010026.7214@mont.cs.missouri.edu> Date: Sun, 22 Aug 1993 01:00:26 GMT Subject: FCUS/HEALTH: Just Say No? Private Greed, Bribed Doctors (III) Message-ID: <1993Aug22.131914.12743@mont.cs.missouri.edu> Date: Sun, 22 Aug 1993 13:19:14 GMT Subject: FCUS/HEALTH: Just Say No? (Conclusion) Message-ID: <1993Aug23.010016.19985@mont.cs.missouri.edu> Date: Mon, 23 Aug 1993 01:00:16 GMT