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Death knell for “poison in a pill” finally being sounded?

Posted Jul 06 2010 5:55am

What exactly does it take for a drug to be pulled from the market? How many people have to be made sick? How many people have to die?

 

Whatever those numbers are the FDA sure isn’t revealing them and apparently GlaxoSmithKline’s dangerous diabetes drug, Avandia, somehow still hasn’t reached them.

 

But at an estimated 100,000 extra “complications”…including heart attacks, strokes and deaths… from the drug a year and thousands of pending liability cases it’s certainly not from lack of trying.

 

It’s been three years since the red flag was first raised -- and frantically started waving -- on Avandia users’ increased cardiovascular risks. Yet unbelievably a doctor can still, to this day, pull out his pad and write you a prescription for this poison.

 

Now a new study by Dr. David Graham, the same researcher who blew the whistle on the death drug Vioxx, has once again brought to light some numbers that will be tough for the FDA to continue to ignore. And that might finally help signal the death knell for this killer.

 

Looking at data from almost 230,000 Medicare patients Graham and his colleagues found that Avandia raised a user’s risk of heart attack by 25 percent and risk of stroke by 27 percent. And scariest of all was that Avandia users risk of death was increased by as much as 17 percent.

 

After some serious toe-dragging, the FDA reluctantly gave Graham permission to release his paper for publication. But only after he made some noise last month when he feared his findings were being suppressed from the public.

 

The FDA is finally set to review the safety risks of Avandia in a public meeting this month. However, don’t expect them to support Graham’s findings. In their scramble to stay in the good graces of Glaxo they’ve already distanced themselves from the study by forcing Graham to add a disclaimer that his conclusions were not those of the agency.

 

But really, no disclaimer was necessary. His report clearly puts the health of the public ahead of the needs of the drug company. We KNOW those are not the conclusions of the FDA.

 

Giving thanks for whistleblowers,

Alice Wessendorf

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