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AUGUST 18, 2004
Drugmakers "Blackmail the Public" [Page 2 of 2] Q: What about medical journals? Are enough safeguards in place to make sure that the right research is published? A: There are two issues in that question. One, is the research valid, and can we trust it? And I'm concerned that increasingly, we can't -- that the sponsors introduce all kinds of bias in the designs and analyses of the study and that some of the more interesting data are suppressed. The second issue is whether journals are publishing the most medically and scientifically important research or whether they're publishing studies that are preferentially favorable to the industry. The answer depends a lot on the journal. I don't think the big distinguished journals, the reputable journals, like the New England Journal of Medicine or the Journal of the American Medical Assn. are selecting papers to publish because they're favorable to sponsors. Not at all. [But] I think many journals are publishing papers that are favorable to the industry because they're totally dependent on the industry for advertising revenues. Q: We're seeing many individuals -- even whole states -- buying drugs from abroad. What will be the impact of this? A: I think the industry is going to use trade agreements to force other countries to let their prices rise. This is something that Mark McClellan, former FDA commissioner, talked about last year. Already, a recent trade agreement with Australia was designed to do that, and it gives the drug companies the right to prevent importing drugs from Australia. I think the intention is for other bilateral trade agreements do the same thing. The real answer is to regulate prices here in some way, not to require them to go up [elsewhere]. Q: Is that a possibility? A: Not as long as the pharmaceutical industry has the largest lobby in Washington and contributes so generously to political campaigns. Q: What about legislative solutions? A: The most important and most doable solution in many ways is to require that companies, to get FDA approval, have to compare [the new product] with older drugs already in the market, not just with placebos. The new drug should be shown to be superior in some way to existing treatments -- more effective, safer, or substantially more convenient. This would pull the rug out from the me-too industry. Q: What about the recent talk of clinical-trial registries. Is that a solution? A: All clinical trials should be registered in one central place. It should be a condition of enrolling human subjects. After all, human subjects don't sign onto clinical trials just for fun. They are hoping that this will yield knowledge. If that knowledge is suppressed, then they've been used in a misleading way. Research must be registered, and it should be done so at the inception of the study. The reason for registering it at the beginning is that it doesn't allow companies to shift the goal post as the trial goes on. Q: What can individuals do to fight back? A: One recommendation is to be aware that this industry speaks through many voices, and whenever anyone makes a pronouncement about drug prices or anything else dealing with prescription drugs, people ought to ask themselves if there is a conflict of interest. Often there is. Patients have to become much more skeptical about claims that drugs will cure whatever ails them. There's reason to believe that some new drugs are not nearly as good as they're claimed to be, that doctors believe the claims as much as their patients do, and we have to remember that almost any drug has a risk of side effects. This isn't to say that there aren't important drugs on the market. They can be very helpful and even lifesaving. I'm not trying to say never take a drug -- but I'm saying that people should be reluctant to take drugs unless they're pretty sure that they're needed.
 Edited by Thane Peterson
BW MALL
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