If only some Glaxo officials had listened to Greg Thorpe in 2001, perhaps the big drugmaker would not be doling out $3 billion to settle a raft of criminal and civil charges for off-label marketing, failing to disclose safety data and reporting false prices (back story). But Glaxo officials failed to heed the warnings that Thorpe, a former sales rep and a Glaxo whistleblower, repeatedly made more than a decade ago, according to court documents.
"Regardless of what company policy may be, my letters to human resources and my previous complaints of misconduct have been quashed. My 23-plus year career with this company has been trashed, and it is obvious I can no longer work with my district manager and friends/counterparts just because I have come forward with the truth, which could save the reputation of GSK and millions of dollars in fines," wrote Thorpe, one of the whistleblowers on whose claims the feds based their allegations, in a January 2002 note to Glaxo officials (here is the complaint).
In fact, some of his documentation had allegedly been discussed at a meeting that month at which several high-ranking Glaxo officials were present, including Robert Ingram, who was then the Glaxo chief operating officer, and David Stout, who headed the US pharma business, according to a Glaxo regional human resources director who was cited in court documents. The suggestion? Senior management was aware of violations.
Instead, though, Glaxo officials issued their own warnings to Thorpe about his willingness to be a team player and refused to address various violations of the False Claims Act, which he referred to specifically and repeatedly in numerous communications. His missives were sent not only to his direct supervisors, but also to Arjun Rajaratnam, who was chief compliance officer for global pharmaceuticals, and the human resources director, among others (read all this).
Thorpe, who had spent 23 years with Glaxo and its predecessor companies, had refused to participate in various efforts to undertake off-label promotion. For instance, there was a lecture program in which a pediatric psychiatrist was paid by Glaxo to lecture about off-label uses of the Wellbutrin SR antidepressant, including treatment of ADHD in children, before a group of approximately 60 physicians. This earned him a rebuke.
He also refused to participate in organizing and attending a lecture and dinner program on May 23, 2001 in Colorado Springs, Colorado, by a physician, who Glaxo had flown to lecture local physicians on Wellbutrin effectiveness in treating adult and pediatric ADHD. Thorpe also refused to participate in organizing special events, such as a spa weekend at a local luxury hotel for a number of physicians, which was initiated by a Glaxo sales rep, as well as an ski trip that the drugmaker sponsored for physicians. Thorpe then received a verbal warning from his supervisors (see here).
At the same meeting where he was warned, Thorpe mentioned a Glaxo payment to the chief psychiatrist at the Pikes Peak Community Health Center for addressing a group of doctors on the advantages of using Wellbutrin SR to treat ADD in adults and ADHD in children. There was no indication or a pending NDA for either of these uses. At the time, this center had a patient population that was overwhelmingly enrolled in the Medicaid program, according to the documents.
There was more. Thorpe also indicated that he objected to sending a Glaxo check to a nurse practitioner so that she would deliver a lecture in Keystone, Colorado, to a nationwide group of health care practitioners on the benefits of Amerge to treat pediatric migraines. This was an off-label use for which Glaxo had never submitted an NDA to the FDA. And he told them that he had been asked to recruit a local physician to lecture other doctors about off-label prescribing for using Lamictal to treat bi-polar disorder.
By March 2002, Thorpe believed he could no longer work at Glaxo after Rajaratnam, who struggled to find a way to show that Glaxo conducted due diligence in response to the issues Thorpe had raised (see this), allegedly told the former sales rep that his concerns had been investigated and the verbal warning would remain intact.
And so, Thorpe accepted an offer: in exchange for executing a waiver and releasing Glaxo from all legal claims, he would receive from $11,000 towards the purchase of his company car, $80,000 to cover relocation costs to Arkansas, and his Cash Balance Plan Enhancement and the value of his Enhanced Separation Program, which consisted of unused vacation, two months’ compensation, and family medical and dental. But Glaxo allegedly reneged on some of these items, setting in motion the announcement from the feds.
Glaxo "could have saved hundreds of millions, perhaps a billion or more dollars of the $3 billion it paid today by following through on the combined Human Resources /Corporate Compliance investigation they launched," says Brian Kenney, who is Thorpe's attorney. "Instead, they ignored evidence of improper marketing and physician kickbacks. When you look at the detail and accuracy of Greg Thorpe’s written complaints distributed to the highest levels of Glaxo, it’s almost surreal that the company took no corrective action. Now, more than a decade later, Glaxo is, essentially, admitting that Thorpe had been right in 2001.”