On Friday, Sen. Charles Grassley (R-IA) wrote to a pharmaceutical consulting company asking it to clarify the service it offered clients on its (recently changed) website.
On that now-extinct webpage, Best Practices LLC described itself as “a network of distinguished clinical investigators and opinion leaders serving as a bridge between drug companies’ preclinical scientists, clinical scientists, and marketing specialists.”
One of Best Practices’ founding consultants is Dr. Frederick Goodwin, a psychiatrist and host of an NPR radio show, “The Infinite Mind,” under investigation by Sen. Grassley for not disclosing $1.3 million in drug company pay between 2000-2007 to the producers or listeners of his show, on which he discussed often the safety and efficacy of psychiatric drugs.
Under the heading Evaluating Regulatory Environment, the Best Practices website listed assistance in dissemination of new “off label” information.
In his letter to the Bethesda-based group, Sen. Grassley points out that marketing, or “information dissemination,” of drugs for indications not approved by the FDA – known as off-label – is illegal. Doctors can prescribe drugs off-label, but companies can’t peddle them that way, a margin that some marketing teams have mined for profit at their peril [see Neurontin]. But Best Practices did not seem to be particularly covert about its helpfulness around off-label marketing, unless you count scare quotes as covert.
Of course, those “scare quotes” around off-label may be important, and not fall into the growing collection of “unnecessary quotation marks” popping up on web pages, restaurant menus, and advertisements everywhere. But not even proper quotes can change the meaning of a word. And if “off-label” is anything like the off-label we know of, then an explanation from Best Practices is more than necessary.