June 2, 2007

How Glaxo Tried to Silence Concerns about Avandia: NYTimes

Today's New York Times reports that John B. Buse will testify to Congress about the attempts made by Glaxo, the company that sells Avandia, to silence his criticism of the drug. Buse is keeping the details close to his chest before his testimony, but reading between the lines in the article, it looks like Glaxo, a huge contributor of research funds to his university, may have threatened they'd cut those funds if he didn't shut up.

Buse will be the next head of the ADA, which makes it pretty sure he isn't a rogue, rabble-rousing extremist. So whatever Glaxo did to inspire him to bite the hand that paid for his research must have been pretty bad.

Doctor Says Drug Maker Tried to Quash His Criticism of Avandia

Note that Dr. Buse was already expressing his concern about Avandia in 2000, seven years ago. Even more troubling is this information taken from the same article. "The following year [2001], after demanding that Glaxo strengthen the language on Avandia’s label describing its potential heart risks, the F.D.A. sent Glaxo a letter reprimanding the company for playing down those risks in discussions between sales representatives and undercover investigators at a medical conference."

That was 6 years ago. The company was given a meaningless slap on the wrist, went on to sell 7 million more prescriptions of the drug worth many billions of dollars, and the FDA ignored the evidence its own investigators found that Glaxo was lying to doctors about a drug that they already knew was causing unnecessary heart deaths.

The issue goes way beyond Avandia. Every drug you are taking that is still under patent may be the subject of the same kind of strong arm tactics and fraud that you see revealed here. If it took 7 years and untold numbers of unnecessary deaths (I've seen numbers like 10,000 and 20,000 bandied about in the medical press) to get anyone to go to the media about the safety of Avandia, you can be sure that there are other equally dangerous drugs being promoted heavily to your doctor.

More importantly, since your doctor, like most, probably gets his or her information about drug safety from the drug companies who sell the drugs, and since these companies do lie about safety issues, you cannot trust your doctor's assurance that a drug is safe.

So what can you do?

1. Before you take ANY new drug, download the "Prescribing Information" for that drug. This is a legal document. It has to be kept up-to-date. It is the "label" you see mentioned in articles about the drug. Unfortunately, years ago the drug companies got the FDA to remove the requirement that a copy of this information be given to consumers when they purchased the drug at a pharmacy, and many people do not even know this important document exists.

The Prescribing Information will list all the known serious side effects of a drug. When the FDA issues a slap on the wrist, it makes the drug company mention the side effect in the Prescribing Information. The Avandia Prescribing information has listed heart failure as a concern for years and last year it added macular edema (swelling in the retinal area that can cause blindness.)

2. Make sure you understand the Prescribing Information. If your medical knowledge isn't good enough to understand the wording, do not be shy about calling up your doctor and asking him to interpret it to you. The information may be as big a surprise to your doctor as it is to you. When I have asked doctors about information in the Prescribing Information, including black box warnings, they have often not known it was there.

3. If there are serious side effects, ask your doctor whether there is testing that can spot these side effects early enough to prevent permanent damage and make sure your doctor does those tests. Even here, there is the concern that the drug company may have told your doctor that certain tests can guarantee safety when this is not true.

For example, with some drugs, including Rezulin, by the time your liver function tests came in abnormal, the damage was already done and you might not recover. With Zyprexa, by the time your blood sugar is abnormal, you may have sustained irreversible damage, too. Since we learned that the drug companies selling these dangerous drugs may offer insurance to your doctor to cover claims if you sue him after experiencing kind of permanent damage as an incentive to get him to keep prescribing a dangerous drug, as was done with both Vioxx and Zyprexa, you can't trust your doctor's assurances 100%.

4. Ask if there is an older, better understood drug or other healing strategy (like exercise and diet) that could be used instead of the newer drug. In the case of Avandia, diet and exercise provided much better outcomes for people with diabetes and prediabetes than did the drug. The alternative drugs or strategies are usually much cheaper, too.

5. If a doctor makes a claim that a new drug does something really important no other drug does and that is why you should take it, investigate the data on which that claim rests.

Many people with diabetes were told that Avandia would rejuvenate their beta cells, and that was why they should take it even if they were gaining tens of pounds and swelling up like ticks. This turns out to have been a claim based on the most flimsy of evidence--much of it derived from the study of another, more dangerous drug no longer on the market--that was recently completely disproved by the DREAM study.

Vioxx was sold with the promise that it didn't cause the stomach bleeding other NSAIDS cause, which was also false. (My mom ended up in the ER thanks to stomach bleeding from Vioxx.) More recent data shows that Vioxx and related expensive, dangerous, new drugs are no more effective than Ibuprofen.

Right now, people taking incretin drugs like Byetta are being told that this drug will rejuvenate their beta cells, but the evidence for this is also weak and is derived from mouse studies. One fact everyone with diabetes must memorize is this: Rodents have very different pancreas function from humans and many drugs have effects on rodents that they do not show in humans.

All this sounds like a lot of work, and it is. But since your doctor is too busy to do it, you will have to. It is YOUR body that will pay the price if you take a toxic drug.