Lilly Paid Doctors to Prescribe Zyprexa, Notes Show (Update2)

By Margaret Cronin Fisk and Jef Feeley

Sept. 8 (Bloomberg) -- Eli Lilly & Co. paid doctors in South Carolina for participating in a speakers’ program in exchange for prescribing the antipsychotic Zyprexa, and used golf bets to get more patients on the drug, according to notes by sales representatives.

During a golf game, one doctor agreed to start new patients on Zyprexa for each time a sales representative parred, or put the ball in a hole within a predetermined number of strokes, according to the notes.

“I got four pars out of nine holes,” Lilly salesman Vince Sullivan said in a February 2002 note. “I said I wanted my four new patients.”

The notes were made public for the first time in a court hearing today in South Carolina in the state’s lawsuit against Lilly over Zyprexa marketing practices. State officials contend Indianapolis-based Lilly marketed the drug for unapproved uses. A trial is set to begin Sept. 14.

South Carolina wants to recoup $200 million it contends it wrongfully spent on Zyprexa prescriptions as a result of Lilly’s push to get doctors to use the medicine, approved only for schizophrenia and bipolar disorder, for other ailments. The state also contends the drugmaker withheld information about Zyprexa’s side effects, such as weight gain.

“Call notes are jottings written by sales reps and most reps make hundreds of notes monthly. They are not literal recitations of interactions with physicians,” Marni Lemons, a Lilly spokeswoman, said in telephone interview.

‘Out Of Context’

Lemons said the state’s lawyers took the notes “out of context” and “not one physician employed by the state of South Carolina has testified Lilly promoted off-label to them.”

The notes became public at a hearing in Spartanburg, South Carolina, on Lilly’s motion to have the state’s case thrown out prior to trial.

The state also is seeking a $5,000 fine for each Zyprexa prescription dating back to 1997, according to court filings. That could result in billions of dollars in fines, South Carolina’s lawyers say.

Lilly resolved a marketing investigation over Zyprexa in January with the U.S. Justice Department, promising to pay $1.42 billion, including about $362 million to more than 30 states. South Carolina opted not to join that settlement.

Alaska Settlement

The only trial of a state’s lawsuit ended in March 2008 with an out-of-court settlement in which Lilly agreed to pay Alaska $15 million.

Zyprexa, part of a class of medications called atypical antipsychotics, has been linked to excessive weight gain and diabetes. The lawsuits also claim Lilly failed to properly warn of Zyprexa’s side effects.

Lilly officials have denied the drugmaker withheld information about Zyprexa’s side effects or improperly marketed the drug in South Carolina.

Lawyers for the state pointed to a sales note from Sullivan in which he tells another salesman to tie a doctor’s Zyprexa prescriptions to participation in a speakers’ program.

The company paid doctors and psychiatrists to address physician gatherings about the benefits of the antipsychotic. “If his numbers go up, maybe he can talk,” Sullivan said in the August 2001 note.

‘So Much Money’

A year later, Sullivan noted in sales records that he was pressing a doctor to write more Zyprexa prescriptions “because we’re paying him so much money” to participate in the speakers’ program, according to a call note made public today.

Lilly also offered other inducements to doctors who prescribed Zyprexa, such as deep-sea fishing trips and Palm- Pilot devices, said John Simmons, a Columbia, South Carolina- based lawyer representing the state.

The sales notes show that many of those prescriptions were for unapproved, or so-called off-label, uses, Simmons told Judge Roger Couch.

The U.S. Food and Drug Administration regulates what drugs can be used to treat specific ailments. Drugmakers can only promote their medicines for FDA-specified illnesses.

Faced with the loss of patent protection for its Prozac antidepressant, Lilly officials pushed salespeople to market Zyprexa for a host of ailments, including depression, agitation and anger, Simmons said. The FDA hadn’t approved the drug for any of those uses, he added.

‘Diamond’

Company officials said in a memo that they were “betting the farm on Zyprexa” to replace Prozac, Simmons said.

In internal memos, Lilly officials used the word “diamond” as a code for talking about their Zyprexa off-label marketing campaign, he said.

He cited notes from visits with doctors in 2000 and 2001 where sales reps reported talking about older patients being treated with Zyprexa for agitation and declining mental acuity.

Simmons noted the drugmaker already pleaded guilty to a criminal charge over its off-label promotion of Zyprexa for use with elderly patients.

In that plea, Lilly officials acknowledge that the company illegally pushed the drug’s off-label use by older patients from Sept. 1, 1999, to March 31, 2001.

The company also pushed primary-care physicians to use the antipsychotic medication on children, Simmons said. One of the notes indicated salespeople said the drug is ‘for kids whose parents have to shove the pills down their throat every day.”

‘In His Tea’

Another note shows that one doctor told Lilly he was prescribing Zyprexa for a 13-year-old, whose mother “puts it in his tea.”

Besides illegally marketing its drug, South Carolina officials contend Lilly violated the state’s unfair trade practices law by mishandling Zyprexa and unjustly enriched itself at the state’s expense.

Lilly’s lawyers have countered in court filings that the company didn’t engage in fraud in its handling of Zyprexa or misrepresent the drug’s strengths and weaknesses.

They contend South Carolina officials have no evidence of illegal marketing within the state, either from private doctors or those working with state agencies.

“At least 12 state officials, including state physicians who prescribe Zyprexa, testified that they were not misled by Lilly,” the lawyers said in the filings.

The state can’t produce a single South Carolina doctor who’ll testify they’ve received “communications from Lilly regarding off-label promotion of Zyprexa,” according to the filings.

The South Carolina case is State of South Carolina v. Eli Lilly & Co., 2007-CP-42-1855, Common Pleas Court for South Carolina’s Seventh Judicial Circuit (Spartanburg).

To contact the reporters on this story: Margaret Cronin Fisk in Southfield, Michigan, at mcfisk@bloomberg.net; Jef Feeley Spartanburg, South Carolina, at jfeeley@bloomberg.net.

Last Updated: September 8, 2009 14:56 EDT