FDA Panel Split On Vote To Remove Avandia From Shelves

Today, an advisory panel met to discuss and vote on whether or not to recommend if the FDA should pull diabetes drug Avandia from the market over a possible link to increased risk of heart attacks. In the end, the voting leaves no definite direction for how the FDA will ultimately come down on the issue.

In the final vote on whether or not to recommend pulling Avandia, a product of pharma biggie GlaxoSmithKline, 12 panel members said it should be taken off the market; 10 said it should still be sold, but only with serious revisions to its labeling and possible restrictions on its sale; 7 members were fine with just adding some more warnings to the drug’s labeling; 3 said it should continue to be sold as is.

Writes the NY Times, who spent the day live-blogging the various votes:

The vote is an enormous blow to Avandia and GlaxoSmithKline. The vast majority of panel members voted either to withdraw the drug or to allow continued sales only if strict controls are added.

Now the FDA takes the panel’s suggestions into account before making its final decision.

Earlier this year, the Senate Finance Committee took the FDA to task, alleging that the agency’s drug-approval system held too much sway over its post-market investigation department, causing a conflict of interest.

Blogging the F.D.A. Vote on Avandia [NY Times]


Edit Your Comment

  1. Engine-B says:

    I am not for the FDA banning any drug outright, as long as it can show that it can do some good. I believe it should be up to individual doctors to decide which medication is right for their patients. Yes, there is an increased risk of heart attacks, but is that risk for everyone? Maybe it’s just for a certain subset of people. Or, maybe there are those whose diabetes is so bad, and this drug works so well for them that the increased risk of heart attack is a risk they are willing to take. I believe that patients should be made aware of possible side effects of a drug and they should be able to make that choice with their doctor. Maybe they could have the patients sign an extra form stating that they know of the risks and are still willing to take the medication.

    • kujospam says:

      If you read the article they talk about that stuff when it comes to banning a drug. If it is outright banned, yes it is because it is bad for everyone. Otherwise they put restrictions on it, like not to be used with people who are pregnant, or low blood pressure,or w/e.

  2. RxDude says:

    There are other drugs available in this class that have not shown to make patients’ hearts explode. GSK is alleged to have concealed study data that would have jeopardized the attempt to discredit the study that revealed the link.

    Pull the drug, and slap a couple billion $ fine on GSK.

    • jojostix says:

      Agreed. My husband was on Advandia back in ’06. The doctor prescribed it to him specifically to help protect his heart from diabetes. Whenever he took it, he had really bad chest pains. He finally stopped taking the medicine against his doctor’s wishes and has not had chest pains since. The reason the doctor wanted him to continue taking it, the FDA said it was okay. >

  3. Bizdady says:

    As a diabetic that refuses to take care of himself. Sure glad I didnt listen to my doctors and hardly take my meds!! Suuure I’ll lose a leg sooner or later but now I wont get a heart attack!!

    • 47ka says:

      Actually, the leading cause of mortality in diabetics is CV events, so if you do have a heart attack you won’t be able to blame the pills that you don’t take (assuming, of course, that your doc recommended a glitazone).

  4. H3ion says:

    Every drug has some side effects and may react differently depending on the patient and drug interaction. I would much prefer to have my doctor be the one who decides what is indicated in my case. The availability of drugs such as Avandia doesn’t mean that every doctor will prescribe it for every diabetic patient, but it’s nice to know that it’s available if the benefits would outweigh the (fully disclosed) detriments.

    • Conformist138 says:

      Theoretically, this works. Problem is reality gets in the way- drug companies push their products, give deals, sales reps offer promos… Doctors face way too much pressure to prescribe more pills from company XYZ and can be paid well for doing so. It’s not right and not always legal, but it happens a lot more than it should. Personal accountability between me and my doctor (ha, typing that made me snort, like i have a doctor) would be great… if I knew just how accountable the doc was also being to his local sales guy.

      In the end, it’s about money and not about health. Profit driven, they want to sell whatever product will bring it in. Problem is, they never want to admit they were wrong, since in the PR game you tend to be reported as either making people better or killing them. There’s only one good side to be on, so even if people DO die, you never want to admit it.

      I wish things were always as transparent as they seem, where me sitting and talking with a doctor is just me and a doctor deciding my best interests. Unfortunately, insurance companies, drug companies, the government, etc are all working behind the scenes.

  5. SharkD says:

    In entirely unrelated news, Bob Ingram, GSK’s former Vice Chairman for Pharmaceuticals, currently serving as the Strategic Advisor to CEO Andrew Witty, placed an order for 20 new Porsche 997s:

    3 fully loaded GT3s,
    7 Turbo Cabriolets and
    10 standard 911s

    Source: http://www.bullcityrising.com/2008/01/pretty-precious.html

  6. Not Given says:

    The stuff take your osteoblasts from your thighs and hips, the cells that make new bone, and turns them into fat cells on your ass, and stuffs them full of triglycerides made from the glucose in your blood. Just eat less carb so you have less glucose in your blood and save your bones. Plus the drug really doesn’t lower A1c very much at all.

  7. hmmhmm says:

    why not just black label it

  8. Broke says:

    The panel was split over this. Wow! If ever there was a case for follow the money.