<a href="http://www.justice.gov/usao/ma/news/GlaxoSmithKline/2011.10.26%2011-10398%20US%20Exhibits/EX.28A.wmv">Department of Justice
Four pharmaceutical executives stand with their backs to a darkened Las Vegas auditorium. Smoke machine fog billows at their heels while a platform slowly rotates them to face thousands in the audience. A song from the Space Jam soundtrack plays, stage lights brighten, and suddenly a giant model pill dispenser is revealed on stage. Cue sparklers.
Y’all ready for this?
This is not a parody of corporate conduct. It’s Exhibit 28A, a video (above) uploaded by the Department of Justice last week from court documents pertaining to the “largest health care fraud settlement in U.S. history.” The scene itself is from the real and not-so-distant past, at GlaxoSmithKline’s 2001 sales launch for its asthma medication Advair, which the company promoted as first-line therapy for mild asthma patients. The study that conclusion came from, however, had been flatly rejected by the FDA, and later received a black box warning as the result of deaths in halted clinical trials. The US complaint alleged that GSK continued to market the product as such anyway—as recently as 2010—while providing kickbacks for high-prescribing physicians to boot.
Last week, GlaxoSmithKline agreed to plead guilty to criminal charges and pay a total of $3 billion to resolve allegations pertaining to several other drugs, the illegal marketing of them, and the obscuring of clinical data from the FDA. “Today’s multibillion dollar settlement is unprecedented in both size and scope,” Deputy Attorney General James M. Cole said in a press conference.
The investigation unearthed at least a decade’s worth of physician kickbacks, fraudulent marketing, and various other kinds of legal (and ethical) boundaries breached, though this kind of behavior seems par for the course across the industry: Last year, Johnson & Johnson, pleading guilty to bribing foreign doctors, agreed to fork up $70 million in fines. As of April, Bristol-Myers Squibb has been subpoenaed by the SEC (likely for something similar), and Merck, Eli Lilly, GlaxoSmithKline, and AstraZeneca have said they are also cooperating with investigations, according to the New York Times.
Meanwhile, as Forbes highlighted, the market hasn’t blinked—GSK’s stock prices are dandy. Still, the evidence is up and available on the web for anyone to peruse: emails detailing how physicians are to be plied with basketball tickets, a flier for a GSK-sponsored yacht trip, payments made to Dr. Drew Pinsky (yes, the Dr. Drew) as he marketed off-label uses of anti-depressant Wellbutrin, and a physician assistant’s request for a deep tissue massage. Deep-sea fishing, kayaking, snorkeling, sailing, horseback riding, and balloon rides were just a few of the recreational activities offered to physicians at “Paxil Forum” events held at resorts in Puerto Rico, Hawaii, and California in 2000 and 2001.
So, see for yourself: A compilation of some of the most gagworthy snippets from one of Big Pharma’s biggest frauds.
1) What happens in Vegas…
Looking to self-inflict some lasting psychological damage? Watch this video from Advair’s Las Vegas product launch on repeat. Alternately, you can fast-forward to minute three, when Advair’s product manager, Jim Daly, asks the crowd, “Who wants to be a millionaire?” or minute nine, when Pink Floyd’s “Money” plays as CEO J.P. Garnier steps on stage. “There are people in this room who are going to make an ungodly sum of money selling Advair,” Daly tells the crowd. “And that’s the way it should be.”
2) “Welcome aboard!…Experience the Tranquility.”
In the summer of 2000, GSK coordinated its speaker program to support anti-depressant Wellbutrin with a cruise on a Boston yacht, the Tranquility. Known as PRIDE (Peer Review of Intimacy, Depression, and Efficacy), the program invited specially targeted physicians and presented them with speakers touting off-label uses on the boat. Doctors—some paid more than $1.5 million between 2000 and 2003 by GSK—often talked up the benefits of Wellbutrin to include easing the symptoms of ADD and ADHD, among other disorders. On the Tranquility, a child psychiatrist presented on the “effectiveness” of Wellbutrin. The FDA has only approved Wellbutrin for adults over the age of 18: In 2004, the FDA also required that a black box warning stating increased risk of suicide and suicidal thoughts in children and adolescents be included on the drug.
3) I’ll take a deep tissue massage with that.
In 2001, Greg Thorpe, a sales rep who had been working with GSK for more than 23 years, emailed higher ups with a complaint about these kinds of off-label promotions. He wrote:
We have been told that “public perception” is everything now. Well just imagine the call I received ten minutes ago from a physicians assistant, not a physician, ordering a 1) 65 minute deep tissue massage 2) a 60 minute Colorado cleansing facial 3) a 30 minute foot reflexology and 4) a pedicure and a French manicure. This would be after her “lunch at the Broadmoor” and 30 minute lecture by Brendan Montano, MD who flew in from Connecticut for several thousand dollars to talk about weight loss and the benefits of Wellbutrin SR!!!! I want to promote the benefits of my products, but this even sickens me.
4) “God save political donations.”
In 2006, Arkansas Medicaid restricted its coverage in off-label use of Advair by requiring that patients try another medication first. “Arkansas Medicaid determined that this restriction increased appropriate use of Advair and decreased Advair utilization by 25% without adverse impact on patient care,” the US complaint reads. GSK then allegedly gave an untold sum of campaign donation dollars to an Arkansas lawmaker who introduced legislation to get rid of the restriction. “God save political donations,” wrote one GSK employee to senior VP Stan Hull in an internal email.
5) Playing the game
In 2000, GSK bought a set of tickets to Celtics and Bruins games (at roughly $350 per seat) for certain high-prescribing physicians. “For ROI it’s imperative only KEY Customers attend these valuable venues,” wrote a GSK employee to his sales reps. “ROI” meant “Return on Investment” and “Customers” referred to the physicians. Other goodies mentioned in the court documents: Crosby, Stills, and Nash tickets, NASCAR races, Knicks games, tennis lessons, and pheasant hunting. Yes, pheasant hunting.
