Posted: 06-13-10 Categories:
Avandia FDA
Avandia News
Avandia Safety

Avandia study blocked: Dr. David Graham’s email to FDA Com. Margaret Hamburg

From: Graham, David J []

Sent: Friday, May 28, 2010 3:31 PM

To: Hamburg, Margaret; Sharfstein, JM

Cc: Graham, David J

Subject: TZD study update

Dear Drs. Hamburg and Sharfstein,

Except for a few minor details, we have completed our study comparing
the cardiovascular risks of rosiglitazone vs. pioglitazone in Medicare elderly.

With over 227,000 exposed patients, we found that 
rosiglitazone increases the risk of stroke by 27% (11-44), heart
failure by 25% (16-34), death by 13% (4-23), AMI or death by 11%
 (3-18), AMI, stroke, or death by 14% (7-21), and AMI, stroke, heart
 failure or death by 17% (12-23). The risk of AMI surviving to
 hospitalization was increased by 6% (-5 to +17), but not statistically
 significantly so. We suspect that fewer elderly patients survive 
their AMI long enough to reach hospital so that AMI/death is a better 

The number needed to harm was 59 patients treated with rosiglitazone 
for one year to produce one excess case of any of our outcomes. This
 translates to 48,000 excess events attributable to rosiglitazone among
patients age 65 years or older between 1999 and June 2009. Given that
62% of rosiglitazone use has been in patients below age 65, the actual
national impact is probably 100,000 or more.

JAMA is very interested in our manuscript and we would like to submit
 it before next Friday, June 4. Gerald Dal Pan, my supervisor is
prepared to sign the clearance form (the paper has a disclaimer and
does not represent an official FDA position) but won’t unless Dr.
 Woodcock and Dr. Jenkins approve. He is afraid to act, even though he
is the “clearing official.”

My CMS co-authors are also anxious to submit the manuscript and feel 
that they have a duty to their customers, Medicare patients, to bring
 these results to public notice in a scientific journal as soon as
possible. The idea of being blocked from doing this by a sister
 Agency is a source of concern to them and to me.

In late 2004, CDER management suppressed the publication of a study I
conducted using data from Kaiser California that showed increased AMI 
risk with rofecoxib. This was done in an effort to downplay the
seriousness of their prior poor decision-making in leaving rofecoxib
on the market. So you can understand that I am very sensitive to
anything that remotely smells like suppression or censorship. 
I am asking for your assistance in ensuring that we are able to submit 
our manuscript to JAMA before June 4.

Best regards,


Recent Comments
  • SEABEECH: Peace be with you. My dad died at 11:22 on December 21, 201...
  • vertee jackson jr: The company hired to save (GSK) money is using a point syste...
  • E. Tan: I am from the Philippines and my mother, a diabetic for more...
  • A. Held: "Documents released earlier this year by the Senate Finance ...
  • Robert: I was 37 and had to have Quadruple bypass in Oct 2005. I was...