Drug companies say the millions of dollars they pay physicians for speaking and consulting justly compensates them for the laudable work of educating their colleagues.
But a series of lawsuits brought by former employees of those companies allege the money often was used for illegal purposes — financially rewarding doctors for prescribing their brand-name medications.
In several instances, the ex-employees say, the physicians were told to push “off-label” uses of the drugs — those not approved by the U.S. regulators — a marketing tactic banned by federal law.
In the past three years alone, pharmaceutical companies have anteed up $7 billion for settlements in cases such as one filed by Angela Maher, a former drug sales rep for Ortho-McNeil Pharmaceutical.
Maher sued the company in Massachusetts federal court in 2003, alleging it pushed an anti-seizure drug for 27 off-label uses. She said company officials rigorously tracked whether their payments to physicians were worthwhile.
Maher said she would regularly hear commentary from her boss after a physician spoke at a dinner program: “‘After he talked last week, our sales went up 8 percent’ or ‘I listened to doc ABC and he barely mentioned’” the drug.
The company settled for $81 million earlier this year and pleaded guilty to a misdemeanor charge of misbranding a drug; Maher was awarded $3 million.
Allegations in other whistleblower lawsuits provide a rare glimpse into the inner workings of the drug marketers:
-- Allergan, the maker of Botox, created faux advisory boards solely “to reward hundreds of its top injectors,” federal prosecutors charged this month. More than 200 doctors, for example, were put up at an oceanfront resort in Newport Beach, Calif., in 2005 and 2006 and paid $1,500 to listen to presentations, according to their sentencing memorandum.
Allergan settled with the government for $600 million last month and pleaded guilty to a misdemeanor for misbranding Botox. Allergan said in a statement that it is “committed to conducting its business with the highest ethical standards and in compliance with all applicable laws.”
-- Forest Laboratories created “preceptorship” programs in which physicians were paid up to $1,000 each to allow a sales rep to spend time observing their practice. “In reality, Forest sales representatives used the preceptorships to induce physicians to prescribe [anti-depressants] Celexa and Lexapro,” according to a 2009 complaint filed by federal attorneys in Massachusetts.
The reps filled out “return on investment” forms to justify the payments from 1999 until 2003. One rep noted that a psychiatrist’s prescription “numbers were trending up,” and “we need to keep a good thing going as long as we are still getting this kind of growth,” the complaint said.
A Forest subsidiary pleaded guilty to one felony and two misdemeanors and the company paid $313 million in criminal and civil fines. In a statement, Forest’s CEO said the firm had improved its “compliance program since the events at issue in this investigation, which occurred a number of years ago.”
-- In a 2005 lawsuit pending in Pennsylvania , Wyeth Pharmaceuticals is accused of hiring speakers until 2003 based on how often they prescribed the kidney transplant rejection drug Rapamune. “Wyeth management was able to exclude speakers who did not promote Rapamune, and reward those who did so with repeated speaking engagements and resulting honoraria,” according to an amended complaint filed this year by two former sales reps.
Speakers who were “unfavorable or even unenthusiastic” about Rapamune were counseled by drug reps on the “ways in which the speaker might treat Rapamune more favorably,” the complaint said.
The federal government the lawsuit, which is pending in federal court in Pennsylvania. Pfizer, which owns Wyeth, said last month that the company is “committed to ensuring that information provided to physicians on the uses, benefits and risks for Rapamune is consistent with its FDA-approved label.”
Last year, Pfizer to settle allegations in other cases that it had illegally promoted its drugs.
-- Cephalon was accused of rewarding even poor speakers if they heavily prescribed its narcotic lollipop Actiq and other drugs, according an amended complaint filed in 2008 by a former sales manager. Physicians were paid to attend speaker training even though the company never intended them to speak. Some were paid even when no one showed up to hear them, said the complaint filed in federal court In Pennsylvania.
“Even good public speakers have been dropped by Cephalon,” the lawsuit said, “if experience later showed that they did not themselves write substantial off-label prescriptions.”
Cephalon in 2008 to a misdemeanor count of selling misbranded drugs and paid $425 million in penalties. In a statement, an official said the company had put a “strong compliance infrastructure” in place that has “improved the accountability of our employees and the transparency of our actions.”
One company continued to pay doctors to discuss its products even after it settled a lawsuit that singled out those speakers for alleged misconduct.
The case, filed against AstraZeneca, how California psychiatrist Rimal Bera discussed the antipsychotic Seroquel for “conduct disorders” in children even though it was not approved for that use.
AstraZeneca settled with the government for $520 million in April, and like the other firms, signed a corporate integrity agreement promising to follow federal rules.
AstraZeneca paid Bera at least $10,530 for speaking this year, company data show. It paid another doctor named in the case nearly $42,000. A company official would not discuss Bera but said speakers are terminated if they violate company standards. In an interview, Bera said he has become more conscious of when it is permissible to discuss off-label uses.
“We have done a better job certainly as speakers — and I think the industry really has hammered this home,” he said.