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So, is caution a bad idea?

Doris' Blog
By: dorisjdickson

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Posted: Jan 12, 2009 13:36
  • So, is caution a bad idea?

    The FDA wants drug manufacturers to be more cautious in the approval process of type 2 drugs as noted in this Healthday News article.  They want to know about cardiovascular risk which in and of itself is not a bad thing.

    It means that more information will have to be provided to the FDA before approval is granted and that studies will have to be longer and larger, especially on older at risk patients.  This obviously means it will take longer for new drugs to reach market.  That will also mean more cost to pharmaceutical companies and a longer period before they see any return on their investment.

    Now ... one question I have is are these people really at more risk by taking the drugs?  Or is the higher risk actually caused by the non-normalized targets and attainment and years at damage levels?  Are they just in really crappy condition anyway?  Or is the problem an aging population with poor eating habits, huge percentages of overweight or obese people and total inactivity? 

    The bottom line is there is only one way to know ... properly geared studies of appropriate populations, not studies gear to prove the meds won't hurt people in totally out of control populations.  I'm not sure we'll ever see "proper" studies because of where most study funding seems to originate. 

    Take a look at clinical trial detail ... who is paying, the target population, the goal of the trial, what they do to steer the trials/studies in the desired direction.  It's quite appalling.

    Doris J. Dickson

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