Given the extent of our medical knowledge these days it is difficult to imagine a scenario in which someone takes a drug thinking that it will prevent a serious medical problem, only to find out later that the drug has in fact been endangering his or her health all along.
However, in the past month, this very scenario arose twice: a study by the Food and Drug Administration showed that two types of drugs on the popular market in fact can have very negative effects on the health of those who take them.
In the first case, they found that bisphosphonates, widely prescribed to prevent fractures as a result osteoporosis, can lead to a rare degeneration of the jawbone that was previously unheard of. In the second case, Avandia, used to try to prevent heart problems in diabetics, has in fact been causing the heart problems that it was meant to be shielding patients from.
The question thus arises, how could laws, drug manufacturers and food testing authorities have ever allowed there to be such risks to the general population? The answer arises can be found in the disconnect between trials of new drugs, and the way they are used by patients once they are put on the market. Due to the race for innovative new drugs and thus profit margins, companies have been putting too much emphasis on premarket testing as opposed to post-market testing. Typically, the length of time that a drug is tested for before release to the market is at most a few years. However, the drugs are advertised for “lifetime use” and patients have been using them for far longer than just a few years, thus revealing new side effects that were previously unknown.
While it seems completely logical that drugs should be tested for longer in order to determine all of the risks associated with them, it would be completely impractical for all “lifetime” drugs were to be tested for an entire lifetime before their release to the market. Drugs that could be improving the quality of life would be withheld to the point that they may not even help the current generation, and also the pace of innovation and development in the drug industry would be significantly hindered, thus preventing us from coming up with better drugs more quickly in order to maximize our improvement of people’s well being.
Clearly, we need to seek a better balance between safety and practicality. Perhaps the implementation of better and more thorough post-market testing would eliminate the possibility that the population would be unknowingly exposing themselves to great risk with little benefit. And premarket testing should also perhaps be lengthened – if not to the actual extent of an entire lifetime, perhaps more than just a couple of years. After all, what on earth is the point of a drug that does the opposite of what it is supposed to do?
Source: http://www.nytimes.com/2010/10/17/health/policy/17drug.html?_r=1&ref=health
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Another way to protect patients from newly discovered side effects is to require drug companies to publish all of the results of all of the clinical trials. The side effects from Avandia were discovered when doctors looked at the results of clinical trials that were not published until the company which makes Avandia, GlaxcoSmithKline, was forced to do so as part of a lawsuit. Drug companies may suppress or downplay the risks and side effects of drugs and exaggerate their benefits so that they will be approved, especially for drugs that have the potential to be extremely profitable, such as drugs to aid in weight loss or to prevent heart disease. When drug companies are allowed to distort the risks and benefits of their drugs, they are the only ones who benefit.
www.nytimes.com/2010/10/03/business/03psych.html=3fref=3dfood_and_drug_administration
www.nytimes.com/2010/09/24/health/policy/24avandia.html=3fref=3dfood_and_drug_administration
Scientific development has closely followed a simple mathematical model for thousands of years which predicts increasingly frequent breakthroughs, or "paradigm shifts", in any discipline, as time increases. The statisticians who analyze these shifts predict a singularity in our near future - a "technological singularity" at which point science will advance at a nearly instantaneous rate. Whether or not one believes that instantaneous paradigm shifts will ever occur, though, the data that led to this hypothesis is clearly factual; science today is progressing at an exponential rate. What right do scientists have, then, in keeping the fruits of their studies from those who need them most? Clearly, in light of recent issues, research pharmacologists do have a greater moral obligation than they do legally to publish their research, and postmarket trials should be given more attention, but the only thing that greater time devoted to premarket trials across the board will yield is public frustration and wasted time, as seen in the case of Brandon Ryan. (http://www.nytimes.com/2010/09/19/health/research/19trial.html) As our knowledge of the universe continues to increase progressively faster, the world doesn't need a bulky bureaucratic system of regulations to interfere with this promising scientific growth. We do need information and medication to be available for those who need it as quickly as possible, but with constant monitoring, as mentioned, to prevent disasters like this from happening again.
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