I have created a new category in honor of Scott Gottlieb's latest and greatest oped in the Wall Street Journal. (See Peter's post below) This will catalog the various efforts of Washington types to politicize science or regulate the practice of medicine according to a specific ideological agenda without debate or transparency or regard to science. The gold standard for such meddling or micromanagement will likely be a battle between Waxman and David Graham now that Senator Grassley is in the minority.
Here's the first entry of the spring training season for this :
Congressional Panel to Study
Off-Label Use of Stents, Drugs
By KEITH J. WINSTEIN
March 6, 2007; Page A12
A congressional committee is looking into the "off label" use of drugs and heart stents, examining the widespread practice in which doctors prescribe medical products to patients outside the boundaries approved by the Food and Drug Administration.
Boston Scientific Corp. and Johnson & Johnson's Cordis unit, the only makers of drug-coated stents sold in the U.S., were asked to submit marketing materials and clinical data to the House Committee on Oversight and Government Reform on Wednesday. About 60% of drug-coated stents, which prop open clogged arteries, are used off-label. For example, manufacturers haven't rigorously tested their stents in patients who have had heart attacks, but stents are commonly given to such patients. Doctors are allowed to prescribe stents to off-label patients, but manufacturers can't encourage off-label use.
The committee's chairman, California Democrat Henry Waxman, also asked for marketing materials from three drug companies that have come under scrutiny over whether they promoted their products for unapproved uses: Eli Lilly & Co., whose antipsychotic drug Zyprexa had $4.36 billion in sales last year and was the company's best seller; AstraZeneca PLC, which makes another depression drug, Seroquel; and Cephalon Inc., whose marketing of painkillers has been under investigation by the Connecticut attorney general.
Here's the first entry of the spring training season for this :
Congressional Panel to Study
Off-Label Use of Stents, Drugs
By KEITH J. WINSTEIN
March 6, 2007; Page A12
A congressional committee is looking into the "off label" use of drugs and heart stents, examining the widespread practice in which doctors prescribe medical products to patients outside the boundaries approved by the Food and Drug Administration.
Boston Scientific Corp. and Johnson & Johnson's Cordis unit, the only makers of drug-coated stents sold in the U.S., were asked to submit marketing materials and clinical data to the House Committee on Oversight and Government Reform on Wednesday. About 60% of drug-coated stents, which prop open clogged arteries, are used off-label. For example, manufacturers haven't rigorously tested their stents in patients who have had heart attacks, but stents are commonly given to such patients. Doctors are allowed to prescribe stents to off-label patients, but manufacturers can't encourage off-label use.
The committee's chairman, California Democrat Henry Waxman, also asked for marketing materials from three drug companies that have come under scrutiny over whether they promoted their products for unapproved uses: Eli Lilly & Co., whose antipsychotic drug Zyprexa had $4.36 billion in sales last year and was the company's best seller; AstraZeneca PLC, which makes another depression drug, Seroquel; and Cephalon Inc., whose marketing of painkillers has been under investigation by the Connecticut attorney general.
