Healthy Skepticism Library item: 12213

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Hensley S.
Stop the Government’s War on Drug Companies
The Wall Street Journal 2007 Dec 17
http://blogs.wsj.com/health/2007/12/17/stop-the-other-war-on-drugs/

Full text:

Former FDA big shot and perennial defender of the free market Scott Gottlieb makes the case in the WSJ that drug makers are being persecuted by Washington.

Exhibit A: Eli Lilly’s guilty plea to a criminal indictment from the Bush Justice Department in 2005 over the off-label promotion of the company’s osteoporosis pill Evista to reduce the risk of breast cancer in post-menopausal women.

Lilly paid $36 million in fines and disgorged its ill-gotten gains, he notes. But, Gottlieb asks, what was the crime? Lilly’s campaign to get the word out relied on findings “from a series of landmark national studies, some eventually touted by government research,” he writes. He goes on to cite another example involving the government’s investigation of Genentech for alleged promotion of Rituxan for unapproved uses in cancer.

There was the problem that Lilly only got FDA approval of Evista’s cancer indication this September.

But in Gottlieb’s view, ” ‘Off label’ are now dirty words in (the) conventional lexicon, made synonymous with lawbreaking as a result of these prosecutions, even though these words describe the way more than half of cancer medicine is practiced. It is true that some off-label drug use is based on very unsettled science and has more risks. But medicine – and not just cancer care – involves lots of hard choices.”

Off the top of our heads, we can think of more than a few cases not dealt with in Gottlieb’s brief. What about those allegations that stemmed from drug industry insiders blowing the whistle on promotion that they thought went far over the line? Remember the guilty plea of Pfizer’s Warner-Lambert unit and $430 million payment over promotion of epilepsy pill Neurontin for unapproved uses ranging from Lou Gehrig’s disease to treatment of alcohol withdrawal?

It’s no sure thing that initial studies on the far-out uses of drugs – even when published in peer-reviewed journals – will pass the tests of time or FDA review. And sometimes the research promoted by drug makers is cherry-picked from a field that includes stronger evidence pointing the other way.

Health Blog Questions of the Day: Is Gottlieb right? Have the prosecutions of drug makers for promotion of drugs beyond their approvals gone too far? Or is Gottlieb defining down the deviancy of drug makers from FDA regulation as acceptable behavior?