Header graphic for print
Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Did GlaxoSmithKline Hide Information from the FDA About Avandia?

Posted in Misc. Drugs

If it weren’t for the Avandia lawyers who are suing GSK, this deposition would have never been taken.  That’s because, surprisingly, the FDA can’t subpoena GSK employees and records while any Avandia lawyer can.

WASHINGTON—A former Food and Drug Administration official said the maker of diabetes drug Avandia withheld from regulators information suggesting the drug posed an increased risk for serious heart problems, according to people familiar with her statements.

* * * *

The statements by the ex-FDA official, made in a deposition for lawsuits filed against Glaxo, are included in a letter received Monday by the agency from Sen. Charles Grassley (R., Iowa), the top Republican on the Senate Finance Committee, which has been investigating Glaxo and Avandia. His letter, co-signed by committee chairman Sen. Max Baucus (D., Mont.), includes additional information detailing internal company records about Avandia, according to people familiar with the letter.

Source: Glaxo Withheld Avandia Risk Data, Says Sen. Grassley – WSJ.com

One of the things I like best about the work I do is the opportunity to read depositions like these.  I get to learn about the things major pharmaceutical companies try and hide from the FDA and the general public.  I wish I could write about all of them here, but in most pharmaceutical lawsuits, pharmaceutical companies obtain BS protective orders.  (And BS is NOT a legal term of art.)

You see, a pharmaceutical company will have a document in their possession that says something like, “This data is really bad.  We need to hide it from the FDA so they don’t make us put a new warning on our drug.”  A lawyer will get his hands on that document, but the pharmaceutical company asks a court to place the document under seal so the lawyer can’t disclose it.  The pharmaceutical company argues that the document is a trade secret and that it will hurt them if their competitors get a hold of it.  Sure.  The truth is that it will hurt the product’s sales and may subject the company to FDA scrutiny if the document gets released.

I haven’t yet had a chance to read any depositions from Avandia lawsuits, but I’m looking forward to it.  If you or someone you know had a heart attack while taking Avandia, contact me.