Wednesday, October 29, 2008

Off Label meds are the REAL worry, not placebos

Art Caplan brings us all up to speed in his latest MSNBC column:

Last week, a newly released study showed that half of all American doctors who responded to a nationwide survey say they regularly prescribe placebos to patients. This news captured a lot of media attention and elicited a round of ethical hand-wringing with many experts wondering if systematically deceiving patients by giving them placebos without telling them was right. But ironically, there is a paper out this week in Public Library of Science Journal that is getting nowhere near the same attention as the placebo study, but raises a far more serious concern: Doctors prescribing off-label medicines that may not work.

In 2001, the last year for which data is available, American physicians wrote 150 million prescriptions off-label to treat conditions for reasons other than the ones for which the drugs were approved. This represents 21 percent of all prescriptions written for 160 of the most common medications used in the United States. About three-quarters of all off-label prescriptions were written for conditions for which there was little or no scientific support to show that they worked.

The manufacturers of these drugs apparently believe the practice is ethical. In the article, two physician researchers, Dr. Adriane Fugh-Berman and Dr. Douglas Melnick, say that despite the fact that it is illegal for pharmaceutical companies to promote drugs for off-label uses, drugmakers still find ways to do so — primarily because there is so much money to be made from the practice.

Drug companies sometimes seek approval from the U.S. Food and Drug Administration for an obscure use for a new drug knowing that it is likely it will be picked up for much wider use off-label. A “decoy” indication for a rare or unusual condition may get a drug approved quickly while the company gears up a subtle campaign to suggest off-label uses for which no data has been given to the FDA.

Doctors not bound by same rules
The key to encouraging off-label use is to make sure no one working for the company suggests any such thing. But if prominent, respected physicians can be recruited to give talks for the company concerning a drug, they are free to say what they want about possible off-label uses.

Flooding medical meetings with abstracts, posters and other additions to programs that are not obviously sponsored by industry creates more buzz for possible off-label uses. These practices are so lucrative that some drug companies pursue them even at the risk of huge fines. In the past few years, Schering Plough, Cell Therapeutics, Purdue-Pharma, Cephalon and many other companies have paid billions in fines even as the practice of surreptitiously promoting off-label uses flourishes.

What we now have is a huge amount of money being spent on what are often placebos. The system for regulating off-label use is not working and needs to be toughened. And it makes sense for the next presidential administration to consider creating an agency that can serve as an independent, publicly funded source of data on the safety and efficacy of off-label use of drugs.

Until changes are made, what you really need to know from your doctors is not whether they are using placebos but whether the drugs they prescribe for you are off-label and why.

1 comment:

Anonymous said...

I have been actively exposing Purdue Pharma (a $10 billion criminally convicted pharmaceutical company) and its 3 CEO's Michael Friedman, Howard Udell and Paul Goldenheim for criminally marketing OxyContin. I have worked on this for over 6 years. In July 2007, they were charged in Federal Court with marketing OxyContin to patients and physicians as less likely to be addictive or abused. They pled guilty and were sentenced. I testified against them in Federal Court and in front of the US Senate. Their actions have resulted in an epidemic of OxyContin addiction and death in every state in the country. My work now focuses on further action being taken against them and J. David Haddox, the gatekeeper of Purdue Pharma's involvement in the criminal marketing of OxyContin. I am working with government agencies and the FDA to accomplish this next goal. Purdue Pharma has recently begun marketing OxyContin to pregnant women for pain. I have notified all Attorney Generals of this latest marketing ploy which will cause an epidemic of addiction and death to pregnant women and unborn babies. Purdue Pharma is also marketing for the undertreatment of pain in infants and pediatric patients which I believe is criminal. I have filed a charge against Purdue Pharma with the FDA and FTC which they have advised me they are taking "very seriously".

Marianne Skolek
Activist for Victims of OxyContin and
Purdue Pharma - a criminally convicted pharmaceu
tical company
I testified against Purdue Pharma before the U.S. Senate