The drug industry spends $59 billion a year promoting drug sales, most of it aimed at physicians. Today's Wall Street Journal provides an eye-opening account of one of the seamier sides of that promotion effort: paying patients who offer testimonials about the drugs.
The story comes to light because one such celebrity patient had a falling out with his corporate sponsor, Bristol-Myers Squibb. Andy Behrman is bipolar, and he earned $10,000 a day or $400,000 in total singing the praises of Abilify (aripiprizole, an atypical antipsychotic drug) to Bristol-Myers' drug salesmen and physician-consultants. Behrman's presentations worked off talking points provided by a public relations firm:
Behrman now claims he suffered serious side effects while on the drug (to learn more about Abilify and akathisia or severe jitteriness, see this post on Dan Carlat's Psychiatry blog). Company officials claim Behrman tried to shake them down for a $7.5 million contract.
Is their no honor among thieves?
Behrman, whose 2002 book "Electroboy: Memoir of a Mania" made him an ideal spokesman for Bristol-Myers, is currently working on a new book because, he says, people need to know about the extensive marketing that went into promoting Abilify.
Do we need any more evidence that the tide has turned against direct-to-physician marketing? Behrman, whose disease apparently does not prevent him from making a very good living at being diseased, is the perfect weathervane.
While Congress should move quickly to pass the Physician Payments Sunshine Act, which will require that drug companies disclose their payments to doctors in a publicly available database, it is increasingly clear that the bill doesn't go far enough. It should also require disclosure of all payments to patient advocacy groups and other non-profits, and it should disclose all payments to patients who offer paid testimonials about the benefits of drugs (one is tempted to call it the Sally Fields Disclosure Amendment).
This story also raises some serious questions for the Food and Drug Administration. Physicians no less than patients are being influenced by paid advertising. Aren't patient-shills standing before groups of physicians while offering talking points written by a public relations firm engaged in an activity that should be regulated, just as direct-to-consumer advertising is regulated?
By law, DTC must adhere to certain standards. For instance, ads must disclose side effects. They also cannot make claims beyond those contained on the FDA-approved label. According to this story, Behrman was touting the benefits of Abilify to company salesmen in 2004. The drug wasn't approved for bipolar disorder until March 2005.
Comments
The paid patient spokesperson
The paid patient spokesperson is quite common with all big pharma (they were often present at the meetings I attended as a rep. with three of the top 10 drug companies).
All drugs have side effects. If a drug does not have a side effect, it is not a drug. spokespeople are obligated to state this fact, but do not.
Another seamier side of drug promotion is to hire doctors thoughout the country to attend meetings such as this. Their purpose is to listen to drug reps and their pitches during the meetings. I've seen over 100 doctors present at the meetings I attended of this nature during my career.
Abilify for Children and
Abilify for Children and Lyme Sufferers: Lyme disease patients are currently battling the Bristol-Myers marketing machine, which is trying to redefine chronic Lyme disease as a new psychological syndrome, called "Post Lyme Disease Syndrome," that requires ongoing blockbuster antidepressants like Abilify, rather than the cure, a finite course of inexpensive off-patent antibiotics.
In addition, Abilify was just approved for use in children with clinical trial help from Robert Woods Johnson Univ. Hospital, right around the time BMS donated $5 million to the university's children's hospital. (http://underourskin.com/blog/?p=137)
So, did that $5 million donation influence the university's clinical trials of Abilify in children? Did it motivate the BMS R&D director to write several journal articles saying that persistent Lyme disease is really due to a "maladaptive belief system" rather than a crafty bacteria?
It sure looks like a conflict of interest to me. As long as Big Pharma's paying off the university medical researchers, it'll be impossible to discern the truth in clinical trials and journal articles.