Rita Rubin On the Nissen Trial

  • by: |
  • 06/07/2007
Here's Rita Rubin about the chain of events leading up to the black box warning about congestive heart failure and PPARs at the FDA:

"Grassley, whose office released the letter Wednesday, asked von Eschenbach to respond to allegations that Johann-Liang had been reprimanded for agreeing with her staff's recommendation that Avandia needed a black-box warning about congestive heart failure and stronger warnings about macular edema, a serious eye condition."

Let's be clear about who Johann-Liang is and her history. She is the same person who was selectively leaking stuff to Grassley on Ketek and recommended pulling the drug altogether. Her actions and dalliance with Grassley's staff have led delays and increased costs in antibiotic research. Her demand for a black box was in advance of both the Glaxo meta analysis, the DREAM results and the RECORD study. And both Takeda and Actos had previously sent out letters to prescribers warning about the elevated risks of their drugs to patients with a history of heart failure.

"The FDA, which had received data from Glaxo last August suggesting a 30% increased risk of heart attacks in Avandia users, did not alert patients and doctors about that possibility until Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, reported a similar finding, posted May 21 on The New England Journal of Medicine's website."

The facts are that the FDA had been working on this issue well in advance of the NIssen article -- as Nissen himself admitted in his testimony. Nissen's article was timed to pre-empt a pending FDA decision.

Rita again: " Glaxo should have begun enrolling high-risk diabetes patients in a large, long-term study when Avandia was approved in 1999. By now, Nissen said, the results would be in."

In fact, Glaxo did begin enrolling "high-risk diabetes patients in large long term study when Avandia was approved in 1999." It was called the DREAM study. It looked at heart problems as a secondary endpoint and was expected to have it's data blended with other studies looking at heart safety since the sample size alone was considered to be underpowered to determine RARE risks.

That's how safety signals are validated today in the absence of new IT and genomic tools. We could do it faster, better, more personalized and predictive.

Which is why Andy Von E kept on calling for more resources, not more authority to improve post market surveillance.

That's the rest of the story.
CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
AHRP
Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog