I found a disturbing common thread emerge this week from news coverage of the medical-pharmaceutical industry, a thread that can be summed in these words: If you can’t buy them, bully them.
First off, we have reports in The New York Times and Pharmalot that an FDA advisory panel concluded that powerful anti-psychotic drugs are being prescribed much too readily to children; the panel called on the FDA to do more to discourage the use of these drugs in children diagnosed with bipolar disorder. As Gardiner Harris of The New York Times notes, “the leading advocate for the bipolar diagnosis is Dr. Joseph Biederman, a child psychiatrist at Harvard University whose work is under a cloud after a Congressional investigation revealed he had failed to report at least $1.4 million in outside income from the makers of antipsychotic medicines.”
Biederman, as this and many other blogs have noted, is just one of many doctors who failed to fully disclose the extent of their earnings from the makers of drugs whom they were, at the same time, studying and touting to colleagues. As I reveal in Side Effects, this is simply the way the drug industry does business: they recruit prominent doctors, called key opinion leaders (KOLs), and pay them lots of money to promote new drugs to other doctors. Such blatant conflicts of interest are only now being widely publicized due to the diligence of Sen. Chuck Grassley’s Finance Committee. That’s the carrot side of the equation.
Now, we find that the drug industry also used the stick to intimidate doctors who spoke up about the worrisome side effects of some drugs. The Wall Street Journal and Pharmalot today reported that GlaxoSmithKline attempted to intimidate a physician at a Maryland hospital to stop her from voicing concerns about its antidiabetes drug, Avandia. In 2000, Dr. Mary Money and several colleagues at Washington County Hospital in Hagerstown raised concerns with both the company and the FDA that Avandia increased the risk of heart failure. GlaxoSmithKline dismissed their concerns and then wrote a letter to the hospital’s chief of staff demanding he take immediate steps to “stop the dissemination of unsubstantiated information by your medical staff.”
We also learn that another physician from Duke University testified before Congress that he too had been attacked as a liar and threatened with a lawsuit by the drug company when he raised concerns about Avandia. It was not until 2007, after The New England Journal of Medicine published a meta-analysis showing an increased risk of heart failure among patients taking Avandia, that the FDA put black box warnings on the drug. (It’s worth noting that researchers would never have been able to do this meta-analysis if not for the New York State Attorney General’s lawsuit against GlaxoSmithKline for deceiving physicians and consumers about another of its drugs, the antidepressant Paxil; as part of settling that lawsuit, Glaxo agreed to post the findings of all its clinical trials, including those about Avandia).
So what’s the common theme in all of this? If the drug industry can’t buy doctors to promote their new drugs, then they will do what they can to bully them into silence. For shame.