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Drug Trial Studies and FDA Approvals
Jul 04, 2008 09:48AM
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In the July 2008 edition of Discover Magazine there is an interesting article entitled "Medicine's Magic Bullets". It describes how many drug companies skew test study results on new drugs in order to get FDA approval. In many cases this results in drugs that can be ineffective or dangerous to patients and are eventually discredited. Doctors do not have time to review a study before writing a prescription.
Here are some of the highlights:
- In many cases if people stop taking the drug during the trial due to side effects they are dropped from the study and the side effects are not reflected in the results
- The size of the study plays a huge factor in the success. A too small study (like 200 or 2,000 patients) can often not reveal potentially serious side effects.
- Journals of medicine are often searching for items to publish and will publish worthless studies which then result in doctors prescribing based upon those studies.
- In many cases only positive studies get published even when there are more negative studies against the same drug.
- A placebo effect can influence the study and the benefit would have happened naturally.
- They will combine more than one end point when really only point A was a benefit they will combine point A and B together for reporting (i.e. say it reduces death and disability but really there was no reduction of deaths, just a bit of disability but they will say both).
- Many doctors are being paid by the drug companies to review positively.
When your health is lying in the balance this is quite a scary scenario. If there is something new and untried push your doctor for info and do the research as much as it is possible.
Here is a link to the on-line article http://discovermagazine.com/2008/jul/20-wonder-drugs-that-can-kill. I found this most interesting.
Here are some of the highlights:
- In many cases if people stop taking the drug during the trial due to side effects they are dropped from the study and the side effects are not reflected in the results
- The size of the study plays a huge factor in the success. A too small study (like 200 or 2,000 patients) can often not reveal potentially serious side effects.
- Journals of medicine are often searching for items to publish and will publish worthless studies which then result in doctors prescribing based upon those studies.
- In many cases only positive studies get published even when there are more negative studies against the same drug.
- A placebo effect can influence the study and the benefit would have happened naturally.
- They will combine more than one end point when really only point A was a benefit they will combine point A and B together for reporting (i.e. say it reduces death and disability but really there was no reduction of deaths, just a bit of disability but they will say both).
- Many doctors are being paid by the drug companies to review positively.
When your health is lying in the balance this is quite a scary scenario. If there is something new and untried push your doctor for info and do the research as much as it is possible.
Here is a link to the on-line article http://discovermagazine.com/2008/jul/20-wonder-drugs-that-can-kill. I found this most interesting.