This is a story about how the pharmaceutical industry pollutes the safety and efficacy regulatory process by the use of kickbacks and aggressive consumer marketing, including celebrity spokespersons. The story is getting more play because it has ensnared a celebrity. Radio and television personality, Dr. Drew Pinsky, is facing allegations that he accepted $275,000 to talk up the drug Wellbutrin SR while hosting this radio and television show, Loveline.
The revelations emerged during the Justice Department's case against drug company GlaxoSmithKline, which has agreed to plead guilty to misdemeanor criminal charges and pay $3 billion for committing healthcare fraud. This is reportedly the largest such case in U.S. history.
Pinsky reportedly accepted the six-figure sum over the course of two months in 1999 for extolling the virtues of the antidepressant “in settings where it did not appear that [he] was speaking for GSK,” according to the Justice Department.
Pinsky, who would later go on to host “Celebrity Rehab with Dr. Drew" and "Sober House" touted Wellbutrin SR for its ability to “increase libido” in depressed patients.
GSK did not have FDA approval to promote its drug as having fewer sexual side-effects.
A PR firm confirmed that Pinsky had “communicated key campaign messages” to his audience, when he talked up the off-label benefits of the drug.
In an email sent from his publicist, Pinsky denied any wrongdoing.
"In the late 90s I was hired to participate in a 2-year initiative discussing intimacy and depression which was funded by an educational grant by Glaxo Wellcome. Services for the non branded campaign included town hall meetings, writings and multi media activities in conjunction with the patient advocacy group the National Depresive and Manic Depressive Association (NDMDA)," he said in his statement. "My comments were consistent with my clinical experience."
Prosecutors said that GSK’s relationship with Pinsky was just a small part of their agenda of promoting drugs for unnapproved uses.
GSK also encouraged doctors and medical health-experts to prescribe Wellbutrin for non-FDA approved treatment for weight loss, ADHD and drug addiction.
GSK has also admitted wrongding for pushing Paxil to treat depression in children, even though it was not approved for those under the age of 18. It was critcized for making unproven claims about the safety and/or efficacy of the diabetes drug Avandia and the asthma drug Advair. And, it has been found guilty of paying kickbacks to doctors.
"The sales force bribed physicians to prescribe GSK products using every imaginable form of high-priced entertainment, from Hawaiian vacations [and] paying doctors millions of dollars to go on speaking tours, to tickets to Madonna concerts," said US attorney Carmin Ortiz.
GSK employees who objected to the scheme of doctor kickbacks were penalized or put on leave.
Although this is the largest settlement in U.S. history involving a drug company case, it is not unique.
In 2009, Pfizer paid the government $2.3 billion in fines for improperly marketing 13 different drugs, including erectile-dysfunction drug Viagra and cholesterol drug Lipitor. Pfizer paid for golf trips and luxurious resort vacations to doctors in "hopes" that the doctors would promote its drugs. I've heard stories from doctors that they knew of colleagues who quit their country clubs because they were getting so many free golf trips from drug companies.
Government prosecution of drug companies for unlawful bribes and kickbacks don't seem to have stopped the practice. The Justice Department hopes that the size of this settlement will get the industry's attention.
"For far too long, we have heard that the pharmaceutical industry views these settlements merely as the cost of doing business," said Acting Assistant Attorney General Stuart F. Delery, head of Justice's civil division. "Today's resolution seeks not only to punish wrongdoing and recover taxpayer dollars, but to ensure GSK's future compliance with the law."
Don't hold your breath.