Prescription for reform? Power of Drugmakers Challenged by Government, Researchers

Prescription for reform? Power of Drugmakers Challenged by Government, Researchers

USA TODAY - September 14, 2004

Against a backdrop of spiraling prescription drug costs, questions are mounting about whether drugmakers -- and the doctors who test and prescribe their products -- always have patients' best interests in mind. Increasingly, critics say, money, not medicine, drives drug development and use.

But recently, there have been signs of a backlash:

* A Food and Drug Administration advisory committee began a meeting on Monday to discuss whether to require stronger labels warning about antidepressant use in children. The FDA meeting follows allegations that drugmakers suppressed unfavorable studies. The Pharmaceutical Research and Manufacturers Association, or PhRMA, a trade group, announced last week that it will launch an online, voluntary registry of clinical trials Oct. 1, but others say it should be mandatory.

* New York Attorney General Eliot Spitzer sued GlaxoSmithKline in June, alleging that the company withheld studies that showed its antidepressant Paxil was not effective in children and adolescents and actually raised the risk of suicidal thoughts and behavior in young patients. Spitzer dropped the lawsuit last month after Glaxo agreed to post online the results of all clinical trials of its drugs, not just those that were favorable.

* At a House Commerce subcommittee hearing last Thursday, an American Medical Association trustee outlined his group's criteria for a mandatory national registry that would list the results of all clinical trials. ''Physicians need complete and unbiased information about the safety and effectiveness of the treatments they prescribe for their patients,'' Ronald Davis told the panel. The hearing had been postponed from July because then-subcommittee chairman Rep. James Greenwood, R-Pa., who had spearheaded it, announced that he will become head of a biotechnology trade group -- whose members include drug companies -- when his term expires.

* The International Committee of Medical Journal Editors on Wednesday announced that its 11 journals will publish only studies that had been entered into a public registry of trials. ''Honest reporting begins with revealing the existence of all clinical studies, even those that reflect unfavorably on a research sponsor's product,'' according to the group's statement.

* Four new books -- two by former editors of The New England Journal of Medicine and two by Harvard-affiliated doctors -- slam the drug industry and doctors who accept its largess for profiting at the expense of Americans' health.

Focus on profits

PhRMA president Alan Holmer blames the intense scrutiny on the fact that patients have to pay a bigger chunk out-of-pocket for prescription drugs than they do for doctor visits or hospital care.

''That's why people are writing these books, and that's why politicians are beating up on the pharmaceutical industry, because we have a lack of insurance for these medicines that are becoming an increasingly important part of our medical system,'' Holmer says.

PhRMA wrote a 28-page rebuttal to The Truth About Drug Companies: How They Deceive Us and What to Do About It by former New England Journal editor Marcia Angell, the only book it obtained before publication.

Angell and her colleagues say the problem is as big as the drug companies' pockets are deep. Pharmaceutical firms now fund the majority of U.S. clinical trials. On top of that, it's hard to find a high-profile researcher who doesn't pad his pay with speaking or consulting fees from the makers of relevant drugs. Lesser lights accept meals and other freebies from drug sales reps in exchange for listening to their spiels.

Harvard clinical professor John Abramson, author of Overdosed America: The Broken Promise of American Medicine, bluntly assesses the situation this way: ''I've written this book because I want my colleagues to understand that much of what they believe to be true about the best way to practice medicine is distorted by commercial interests and has no more integrity than commercially sponsored infomercials on TV.''

Drug companies have funded studies of their own products for years, Angell notes. ''But it used to be they gave grants at arm's length,'' she says. ''They had nothing to do with the way the study was done or whether it was published. Now they are intimately involved in every detail of the study.''

Because the companies decide what gets studied, Angell says, there are too many ''me-too'' drugs that are quite similar to six or seven already on the market. ''What I'm most concerned about is the opportunity costs of all the me-too drugs,'' she says. ''We do have shortages of some drugs. Too few antibiotics. We have way too few drugs for tropical diseases and other non-paying customers.''

Holmer counters that so-called me-too drugs are usually cheaper and some patients tolerate them better than older drugs on the market. Besides, he says, ''the government does a lot of good things, but discovering and, particularly, developing new medicines is not one of them.''

Surprisingly, Peter Rost, a vice president at drug giant Pfizer, sides with Angell. He posted a 5-star review of her book on Amazon.com.

''It's really hard to find new drugs, and it's getting harder and harder,'' Rost, representing himself, not Pfizer, said in an interview. ''There is a lot of low-hanging fruit out there that has been picked off. It is very, very difficult to really find a breakthrough.'' Instead, Rost says, drugmakers focus on tweaking existing drugs to make money, not to advance science.

Changing principles

Critics say the medical profession deserves part of the blame for drug companies' ascendancy.

''Gee, journals are not interested in publishing negative studies?'' says Jerome Kassirer, former New England Journal of Medicine editor and author of Bad Medicine, which will hit bookstores early next month. ''Doctors were involved in those studies. Why weren't they out there screaming that these studies were no good?''

Editorial writers sharpened their pencils after learning that all but one author of a July report calling for more aggressive treatment of high cholesterol have financial ties to companies that make cholesterol-lowering drugs. While the co-authors might well have based their advice solely on the science, critics say their industry connections can't help but raise doubts.

''The problem, of course, is that many of the people with true expertise in an area are called upon by the pharmaceutical industry to help with the design of clinical trials and the evaluation of data,'' says update co-author Sidney Smith, a University of North Carolina-Chapel Hill cardiologist.

Smith rejects Angell's suggestion that experts be excluded from writing practice guidelines because of their conflicts of interest. ''If all this amounted to was analyzing drug trials, then you could have a biostatistician doing it,'' he says. But expertise in treating patients and conducting trials is important, too, Smith says.

Times have certainly changed, Kassirer says. ''When I was a fledgling researcher in the '60s and '70s, if you were taking money from a drug company to do research, people would look down their nose at you,'' he says. ''Now . . . there's prestige associated with the fact that you've become a consultant for various companies.''

Doctors' role

The drug industry and doctors go way back, notes Catherine DeAngelis, editor of The Journal of the American Medical Association. To this day, DeAngelis says, she still feels ashamed about accepting a doctor's black bag from Eli Lilly at the end of her first year of medical school. Now, when she unexpectedly finds that a professional dinner to which she has been invited is being paid for by a drug company, DeAngelis either pays for the meal herself or only drinks water.

Can gifts and free meals persuade doctors to prescribe a particular drug? ''Probably. To what degree? I don't know. It should be zero,'' DeAngelis says. ''To me, it would be a problem if only one physician were involved. Of course, I know there are many more than one.''

No doctor can escape drug companies' attempts to shape prescribing habits, says Harvard doctor Jerry Avorn, author of Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs.

''We simply can't keep going on the way we have been with the industry being the main source of information for doctors about the appropriateness of drugs and the choice of drugs,'' Avorn says.

That's all going to change this fall in Pennsylvania and Kentucky, when those states begin sending out their own sales reps to doctors' offices, Avorn says.

They'll be taking a page from the drug companies' marketing manuals, he says. For example, if doctors say they don't have time to meet, the pharmacists will offer to buy them lunch. But, Avorn says, these reps, mainly pharmacy professors, will be promoting only the most cost-effective treatments.

''We as prescribers are starved for neutral information,'' says Avorn, whose research serves as a basis for the state programs. ''I think the trouble is not that doctors are easy marks, but that there ain't no alternative.''

Source: USA Today

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