Tom Ballard, ND's blog


Diabetes, the FDA, and your safety
September 30, 2010, 9:47 am
Filed under: Commentary, Medications, News | Tags: , , , , ,

Here’s the unfolding of a story that impacts millions of diabetics.

  • 1999: Avandia diabetes drug released and with massive advertising becomes the most popular drug for type 2 diabetes.
  • 2007: The prestigious Cleveland Clinic reports that Avandia increases heart attacks and stroke.
  • 2010, February: After pressure from Congress, the FDA finally takes another look at the safety of Avandia.
  • 2010: Avandia maker GlaxoSmithKline launches a study (TIDE) on safety of their drug (foxes watching the chicken coop).
  • 2010: In spite of internal FDA reports that GlaxoSmithKline study is “unethical and exploitative”, FDA allows study to proceed.
  • 2010, July: The FDA panel vote: 12 feel the research warrants removing Avandia from the market. 10 vote for keeping it on the market with restrictions. 7 vote to keep it on the market with increased warnings. Only 3 recommend keeping it on the market without any changes. Result: Avandia stays on the market.

Important fact: There is no reason for Avandia to stay on the market, even if you only believe in the drug treatment of disease. Several safer drugs exist (Not to mention the proven, safe results of diet and exercise).

[Update: Avandia diabetes drug placed under severe FDA restrictions]

Gotcha: The TIDE safety study will not be completed until 2020. The patent expires in 2012 at which time the profits will be fully milked and untold numbers of users may die needlessly.

Conclusions:

1.   FDA did an inadequate job of screening Avandia in the first place.

2.   FDA was painfully and potentially deadly slow in responding to studies demonstrating Avandia’s dangers.

3.   FDA action was precipitated by Congressional pressure as a result of citizen action.

4.   Drug safety is not a priority of the FDA. Avandia is an unnecessary drug. Why let it remain on the market?

5.   FDA allows pharmaceutical industry to conduct its own safety studies! (Do we allow bridge builders to inspect their own bridges? Was your home inspected by a reliable third party or by the builder?)

6.   Seriously flawed “scientific” studies are allowed by the FDA, even when their own scientists recommend against it.

7.   Money controls the science and safety of the pills millions of people have been led to believe are safe and effective.

Advertisements

Leave a Comment so far
Leave a comment



Leave a Reply

Please log in using one of these methods to post your comment:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s