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Jurdys Blog Monheit Law : Blog Home : March 2005 : 2005-03-12

Should drug manufacturers be required to reveal drug trial data to the public?

It should be mandatory, so that the public, and those willing to interpret the data on behalf of consumers, can independently review the drug trial data to determine drug safety.This information should be open to the public so that there are independent people... (Read Article)


Will drug trial data be in a form that a consumer could understand?

It might not be directly useful to the average consumer, however, this information would be available by proxy to those consumers, through sophistaicated consumer groups and doctors.


Will disclosing drug trial information hurt competitiveness of the drug company?

Yes. And No!


It is not as bad as it may seem. Pharmaceutical manufacturers are very sophisticated about the studies being done by their competition. Remember, the studies are in the public eye, just not readily available. But since doctors are giving these drugs to their patients, and reporting back results, the data is "out there" and with the resources that a competitor has, they can have a pretty good idea of what is out there. The problem is that this information is not reaching the general medical community nor is it reaching consumers.


Open access will let competitors know whether they are on the right track... but that is a small price to pay for allowing the public to be kept safe.


How else can drug trial safety data be provided to the public?

Medical publications like JAMA and NEJM are requiring that clinical trials be public accessible data in order to qualify for publication in their journals. If the FDA won't require it, and if the drug companies won't do it voluntarily, at least we can be thankful to groups like the International Committee of Medical Journal Editors for announcing this policy. It is a step in the right direction.


How can we improve the clinical trial process?

(1) Make clinical trials more open.

(2) Create a review process at a local level. Review boards should have many people from outside the institutional setting.

(3) Remove bias. Choose investigators who are not paid for by private industry with a profit motive to see a specific result

(4) Create a national instititute to evaulate drugs.


Are Vioxx and Celebrex better than Aspirin or Ibuprofen?

The public might think yes... but studies show otherwise. The drug companies do not claim that these drugs are better at preventing pain. Rather, their claims are that they have fewer side effects -- in particular, less stomach bleeding/ulcers.


2005-03-11 «  » 2005-03-13