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The pharmaceutical industry has come under fire for allegedly keeping information about the risks of its products from the public. The safety of a number of drugs has been questioned, most recently COX-2 inhibitors such as valdecoxib (Bextra, Pfizer) and rofecoxib (Vioxx, Merck).
Other drugs that have attracted attention include sibutramine (Meridia, Abbott), troglitazone (Rezulin, Parke-Davis), isotretinoin (Accutane, Roche), and salmeterol (Serevent, GlaxoSmithKline).
Some in the industry—including acting Food and Drug Administration (FDA) Commissioner Lester M. Crawford, DVM, PhD—have proposed making more clinical data available to the public. Several drug companies and trade groups have said they will voluntarily publish more data about clinical drug trials on the Web. The American Medical Association says a mandatory, centralized registry is needed to fully inform patients, physicians, and researchers.
Should clinical drug safety data be made available to the public?
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It's a good idea to protect the safety of the patient. Some of the clinical trials don't get published. So all clinical trials should be available to physicians and also to the public.
I don't know the extent to which it could cause damage, but it might cause some fear and unnecessary tests and other workups. I don't know whether the average person will understand it, but the physicians will.
What happens is, if the [trials] show negative results, they don't end up in journals, and most physicians don't hear about what the negative outcome of that drug is. So I think all trials should be available to physicians.
Habte A. Yimer, MD Internal Medicine Resident Palos Hills, Ill.
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Openness is a great thing. I understand there are proprietary reasons why people are resistant to this—you know the money that's involved in these things is astronomical.
I would say with respect to the COX-2s, though, there was a lot of information out there. So I don't know how much more information resides in some data books that the pharmaceutical companies or the FDA have.
The other thing that gets lost in some of this discussion is that all medicines, certainly prescription medicines, come with some risk. Hopefully, they come with some benefit and are only used when the benefits far outweigh the risks. But there isn't any free lunch, and we, as a public, take medicines quite willingly that have risks.
If you look at the COX-2s, the lives of some of the people who were taking those drugs were really immensely helped. I don't know if I can make the judgment that a person might not really be a good candidate. And who makes that judgment? To what extent do the public and physicians understand these risks and benefits? As a society, we have to come to grips with a more realistic weighting of these kinds of things.
Jeffrey Glassroth, MD Vice Dean for Academic and Clinical Affairs Tufts University School of Medicine Boston, Mass.
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The registration of trials is a good idea. The logic is, if a drug company does 10 studies and one is positive and nine are negative and they only publish the one that's positive, that obviously would be a problem. And if they're not registered, how would you know?
At the very least, registering would give people a better sense of trust in the whole evidence-based process.
There's already so much information overload that most people are overwhelmed just by what's on the Web, so I'd be very surprised if it had any direct effect on my patients. However, if it were publicly available, there would be people who are interested in the topic who would take the trouble to interpret it, so at least you'd have the opportunity for people to independently look at it.
I think it would, depending on how it's done, generally improve the atmosphere. Pharmaceutical companies are trying to create good products, and we want good products, and we don't want to mistrust the people who are trying to develop a good product. It would just improve the transparency of the process.
Some sort of consortium of people who do studies would be a good format, maybe coordinated by the [National Institutes of Health], since they approve studies, rather than the FDA. I think the issue is trust and transparency. They're both important, and they're both related.
Michael Hattwick, MD Internal Medicine, Private Practice Fairfax, Va.
TALK BACK: STEM-CELL RESEARCH
Stem cells offer tremendous potential for regenerative medicine. The great hope is they may one day provide cures for diabetes, Parkinson's disease, stroke, spinal cord injury, cancer, and Alzheimer's disease, among many other conditions.
Human embryos would be an ideal stem-cell source were they not a moral and ethical minefield. Experts say embryonic stem cells are more plentiful, are immunologically "naïve," and can produce a wider range of tissues than other sources.
The American Diabetes Association supports stem-cell research, including research using stem cells derived from human embryos, provided that it is consistent with federal guidelines.
In 2000, President George W. Bush issued an order placing strict limits on federal funding of embryonic stem-cell research. Since then, some states have adopted their own stem-cell research initiatives. Similar efforts are gathering momentum in others. In May, the U.S. House of Representatives voted to increase government funding for embryonic stem-cell research. Bush has vowed to veto the bill if it passes the Senate.
In April 2005, the National Academies released guidelines for human embryonic stem-cell research, including a ban on payments to embryo donors, rules for informed consent, and a ban on cross-species transplantation. This step may help propel research toward a cure for diabetes and other diseases affecting millions of Americans.
What do you think? Should the federal government step up support and ease restrictions on embryonic stem-cell research?
Send your comments to docnews{at}diabetes.org.
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