Ethical Dilemma
In my second post ever on this site, I wrote about the FDA Fast Track program called Pay-For-Review, and I questioned whether drug companies who took advantage of this program were being given enough scrutiny for the products they were putting to market. Interestingly, in a Boston Globe article yesterday called “Burden of Proof,” the author, Diedtra Henderson, explored a similar argument that was being made by Dr. Clifford J. Rosen, a prominent New England researcher and director of the Main Center for Osteoporosis Research and Education. He specifically targets drugs that are being used to treat type 2 diabetes, such as GlaxoSmithKline’s Avandia which recently earned the black box warning from the Food and Drug Administration (FDA). You can read more about Avandia and the black box warning here, in another of my previous articles.
Dr. Rosen sat on the FDA panel that recommended that the new warning label should be issued, and it seems his participation was a catalyst for his deeper analysis of the process that brings these drugs to market. What Dr. Rosen claims is at issue is the methodology the FDA employs in testing medications for public use. Currently, clinical trials are set up to test a medicine’s efficacy against the disease or affliction it’s intended to treat, but there is no study as to whether the drug increases lifespan or improves quality of life. Such an effort would require substantially longer clinical trials, sometimes taking years to complete, but Dr. Rosen claims that by making this effort patients would benefit from the better understanding of the long-term effects of the drug.
Dr. Robert Temple, who is one of the top clinical trial designers for the FDA, argues against Dr. Rosen’s approach because he claims it could have the unintended consequence of slowing the approval process and increasing the cost for life-saving drugs. The push for speedy approvals came in the early 1990s, during attempts to get HIV and cancer treatments to patients more quickly, and the agency asserted that it was willing to pull drugs from the market if the early predictions ascertained from the trials proved wrong.
But the FDA may not have much of a choice in the matter. Today’s Boston Globe reports that incidences of drug reactions nearly tripled between 1998 and 2005, further evidence that the FDA’s current methodology for reviewing drug safety isn’t working and needs some evaluation. Thomas Moore and Michael Cohen of the Institute for Safe Medication Practices, a nonprofit educational group that analyzes drug safety issues, published their findings in the Archives of Internal Medicine. They say that the number of deaths and serious side effects from 1998 to 2005 grew from 34,966 to 89,842.
Conditional approval of drugs could be one way that the FDA could avoid controversy and keep current practices in place, says Harvard Medical School professor of medicine Dr. Jerry Avorn. If the speedier tests prove the drugs effective for treatment of an ailment, then they could be released on that criteria alone. At regular intervals, the FDA could analyze statistical data on a new drug to ensure that its proposed overall effect, an improvement in the quality of life, was the true result of its use. In absence of this proof, the drug would be pulled from the market. In this way, no delays to get drugs to market are necessary, and life-saving drugs are delivered to those who need them.
Which is the right move? Would it be better to create a more thorough, if laborious and costly process to get a broader picture of a drugs effects on a patient’s life and overall health? Would better tracking of patients living with the treatment give a better understanding of the effects and appropriate actions for drugs that might be dangerous? Or do you feel that the current system works fine the way it is, and doesn’t require any kind of serious change?
I would contend that the current system is broken, and a hybrid of the ideas above is necessary. If people are dying, drugs that could help aren’t likely to make them any worse off. Obviously, the choice is ultimately the patient’s, but I believe the wise choice would be to continue to bring oncology and HIV treatments to market more quickly. Drugs that deal with pain are a little more difficult. In reality, pain shouldn’t kill you, but to live with it every day is not something I’d wish even on an enemy. Other drugs should probably have the highest level of scrutiny, because it’s possible the cure is worse than the disease.
What do you think?
