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Drug Safety: Balance and Discretion Needed
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Most of us have had a bad reaction to a medication or at least an unexpected side effect. You may even know someone who died from a reaction to a drug. At least one report* claims the number of people killed from a drug reaction at more than 100,000 a year. And of course we are all familiar with drugs like Vioxx which were pulled off the market.
The July issue of Discover magazine has an article by Jeanne Lenzer titled “Medicine’s Magic Bullets?”. In it she discusses the issues of harm caused by medications. Some of the problems she points out include doctors not having the time to look up detailed information about drugs from the manufacturers and that doctors are not scientists and do not necessarily have well-honed critical thinking skills to be able to fully evaluate the science.
Other studies such as one published in JAMA found that “industry sponsored research was positive 87% of the time compared with 65% positive for research that was not industry sponsored”.
Balance
My personal opinion is that most likely pharmaceutical companies are skewing the results in their favor at times. On the other hand there is the issue of study sizes. Phase I and II trials for drugs only have a few hundred people in them and even the Phase III trials only have at most a few thousand. Side effects and other complications may not be apparent until many thousands or millions of people are taking a medication.
Experience in science and working for a company with a pharmaceutical division (although I did not work in the pharmaceutical division myself) tells me that these companies have put millions of dollars and many years into developing these drugs. And they have lots of well-educated scientists that have families to support who need to be paid each week (and who are already not getting paid as much as they should). Somehow the drug companies have to make a profit if we are to get any new medications for anything – unless it becomes publicly funded.
On one hand there is criticism for releasing drugs that may not have been fully or properly tested and on the other hand the push for approving drugs even faster – particularly for those for people who are dying or suffering greatly.
A balance needs to be achieved for making certain that new drugs are well tested with the more urgent needs of those who don’t have that kind of time to wait. Better public understanding of the costs of developing these medications also needs to be considered to understand the motives and pressures that companies have for exaggerating their safety and efficacy claims.
One possible solution would be an increase in the number of publicly funded studies to help offset the tendency of companies to skew and exaggerate their own studies.
Discretion
Doctors and patients need to use more discretion when considering new medications. In many cases lifestyle changes could eliminate or reduce the need for some drugs. Doctors need to educate their patients better about these changes and they need to do so before the problem is too severe and results in medication becoming a necessity as it does in some cases. It would also be helpful, when time and ability permit, for doctors to examine more carefully the claims of pharmaceutical companies.
Patients need to take more responsibility for their own health as well. Following their doctor’s advice for lifestyle change needs to be taken more seriously. A self evaluation of the severity of their symptoms should also be encouraged. The heart risks associated with a medication like Vioxx may be appropriate for someone who would otherwise be disabled by severe arthritis, but not for someone for whom weight loss and exercise may eliminate or sufficiently reduce their discomfort.
More Information
For more information you may want to read some other articles on this topic by Jeanne Lenzer such as Drug Secrets – What the FDA isn’t telling or her paper published in PLoS: What Can We Learn from Medical Whistleblowers?.
Also of possible interest is the blog Eye on FDA.
* according to an article in the Journal of the American Medical Association in 1998 and mentioned in the Discover Magazine article
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3 Responses to 'Drug Safety: Balance and Discretion Needed'
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on June 10th, 2008 at 8:42 pm
i agree completely with needing to educate the patients better, plus they need more discretion in how the meds are evaluated.
i remember being placed on neurontin for bipolar disorder a few years ago..it didnt work of course and we changed meds after a short time..but later, i saw television commercials about lawsuits that were being saught sa a direct result of promoting the drug for purposes it was not designed for or even useful for.
on June 11th, 2008 at 8:07 am
Even if, as you suggested there was more publicly funded studies to help offset the tendency of companies to skew and exaggerate their own studies I am sure the pharmaceutical companies would still find a way – its a multi billion dollar industry.
Currently in Australia we have a drug controversy over a sleeping tablet called Stilnox or Ambien in America. Interestingly, it was one of the drugs Heath Ledger had been prescribed when he died.
This drug has been linked to 14 deaths and a range of bizarre side effects, from hallucinations to sleep driving. Australia’s Therapeutic Goods Administration, has upgraded warnings on the drug but it is still believed that it is being over prescribed by doctors.
The makers of Stilnox have opposed the move calling instead for better education about the use of the drug. Does this surprise us?
on June 13th, 2008 at 4:16 pm
@spostareduro – yes, doctors need to explain more to their patients and not assume we won’t understand what they are talking about.
@Nicole – I heard lots of bad things about ambien too. Publicly funded studies wouldn’t solve the problem, but I think it would help balance it out a bit.