Gilead Whistleblower Suit: A Bullet Dodged

The Department of Justice recently said it would not intervene in a whistleblower lawsuit filed against Gilead. BNET learned that the suit itself has now been dropped by the plaintiffs.

As such, Gilead has dodged a bullet. The DOJ tends to decline suits where government reimbursement money is not at stake; and without that carrot the plaintiff appears to have thrown in the towel. One must also assume that case was not that strong or was otherwise flawed — in other words, when reading it, it’s wise to give Gilead all the benefits of the doubt.

But let’s read it anyway, to see if it contains anything interesting about the inner workings of the country’s premier supplier of HIV drugs.

The suit describes Gilead’s drug marketing, beginning with Gilead’s 2004 plan to encourage doctors to switch their patients from GlaxoSmithKline’s Combivir to Gilead’s Truvada. Switches were encouraged, the suit alleged, whether patients were doing well on Combivir or not, and:

… despite substantial resistance from treating physicians, the misgvings of its own Medical Affairs department, and the fact that its own top physician-advisors did not think Gilead’s data supported such switches.

Each switch was more expensive by $900 per patient and required additional physician visits.

Gilead created COMET, a “switch study,” in which physicians were paid $2000 - $3500 for each patient switched from Combivir to Truvada. It didn’t go completely smoothly, the suit alleged, citing a memo from David Johnson, Gilead’s senior marketing director:

COMET is the key to the switches we need in 2005 … We are paying them [doctors] to switch patients … why is this not happening?

So Gilead offered physicians trips to Chicago for “speaker training,” “all-expenses paid travel and luxury accommodations as well as a cash payment of approximately $1500.”

Docs were also given “teleweb updates” at $300 a pop. “They are not required to perform any work to receive the payment; they may simply dial in and listen,” the suit claims.

COMET recruited 411 patients at a cost to the company of over $1 million, the suit claimed.

Gilead also maintains a speaker’s bureau of HIV docs. There are 360 doctors in the bureau, the suit claims,

many more than it legitimately requires or can even be put to use.

To qualify, speakers must speak twice a year, but the majority of Gilead speakers do not meet the requirements, the suit alleged. About half give no talks at all and two-thirds give only one, the suit states. Of 467 speaking engagements in 2005, half were performed by just 38 docs, the suit claims. Yet:

Gilead continues to permit trainees to remain on the Speakers Bureau despite their failures to speak, and continues to train and retrain these no-speaking speakers (and repeatedly pay them the appurtenant cash and no-cash remuneration).

The suit also quotes the PhRMA code on the use of consultants. The PhRMA code says 15 consultants is a “reasonably small” number, but the suit claims Gilead employs 400.

The suit also describes Gilead’s financial relationships with high-prescribing HIV docs, such as Dr. Peter Ruane of Los Angeles. It describes an email exchange between Gilead’s director of medical education Bill Guyer, and Ruane:

Dr Ruane’s relationship with Gilead is epitomized in an email from January 2004, in which Bill Guyer told Dr. Ruane that he had better start sucking up to Gilead if he wanted to participate in a major upcoming study. Dr. Ruane responded that he was already sucking up to Gilead every time he writes a prescription for one of Gilead’s drugs.

• See BNET’s previous coverage of Gilead:
• With New CV Drugs, Gilead Tests Its Commitment to Efficiency
• Gilead Executive Pay: Modest Raises for Outstanding Performance
• Gilead Deal Gives CV Therapeutics CEO $8.4 Million Payday Despite Lack of Profits
• Gilead’s FDA Warning Letter Contains Lesson About the Internet
• Ranking of 20 Drug Companies’ Sales Forces Shows Productivity Flat or Declining
• Gilead Earnings Sound Death Knell (Again) for Large Sales Forces
• It’s Good News, Bad News for Gilead’s HIV Pill