InfoMail for March 14, 2002

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News Stories on Human ResearchProtection and
Commentary by Vera Hassner Sharav


March 14, 2002
Whistle-Blower SaysMarketers Broke the Rules to Push a Drug (Neurontin)

FYI

The New York Times reports that court papers in a civillawsuit "may provide a rare glimpse into how drug marketing executives atone company created a blockbuster medicine by trying to influence physicians,practices that have come under increasing scrutiny by Congress and by federaland state health care investigators."

Dr. David Franklin, a whistle blower, says he was hired in1996 "to take part in a nationwide drug-marketing campaign that he believedwas not only illegal, but was also possibly putting patients in danger."The case involves Warner Lambert’s marketing of Neurontin, a drug approved onlyfor the treatment of epilepsy that went on to become a billion dollar drug, Dr.Franklin alleges, thanks to the company’s marketing strategy.

According to Dr. Franklin’s lawsuit, the company paiddoctors "to appear as authors of journal articles on off-label uses ofNeurontin, articles that were actually written by non-physicians working underthe direction of the company’s marketers."

The FDA’s failure to exercise its oversight responsibilityby enforcing standards of practice in the drug development and marketingindustry, is undermining the health of the public and the integrity of themedical literature.

The United States attorney’s office in Boston isconducting both criminal and civil investigations into the marketing ofNeurontin, according to statements made by federal prosecutors in court.~~~~~~~~~~~~~~~~~~~~~

http://www.nytimes.com/2002/03/14/business/14DRUG.html?pagewanted=print

March 14, 2002

Whistle-Blower Says Marketers Broke the Rules to Push aDrug
by Melody Petersen

In 1996, Dr. David P. Franklin, a former research fellowat the Harvard Medical School, took a job as a medical liaison withWarner-Lambert, a large drug company, believing that he would be helping doctorsunderstand the intricacies of the company’s medicines.

But Dr. Franklin soon decided, according to court papersjust unsealed, that the company had instead hired him to take part in anationwide drug-marketing campaign that he believed was not only illegal, butwas also possibly putting patients in danger.

Dr. Franklin contends in a whistle-blower case, filedafter he resigned from the company later in 1996, that Warner-Lambert was notsatisfied with the limited sales potential of the drug Neurontin, approved onlyto treat epilepsy in certain cases. To increase sales, he said, the companyaggressively marketed Neurontin to doctors for more than a dozen medicalconditions for which it was not approved, conditions like attention deficitdisorder in children, neurological pain and bipolar disorder.

Under federal law, doctors can prescribe drugs in any waysthey believe best for their patients. But it is illegal for a drug manufacturerto promote a medicine actively for indications that are not approved by the Foodand Drug Administration, which requires detailed clinical trials showing itssafety and effectiveness.

The United States attorney’s office in Boston isconducting both criminal and civil investigations into the marketing ofNeurontin, according to statements made by federal prosecutors in court.

A spokeswoman for Pfizer (news/quote), which acquiredWarner-Lambert in 2000, said the lawsuit related to business activities thatwere said to have taken place before the acquisition. "We are not aware ofany credible evidence that Warner-Lambert employees made false claims aboutNeurontin," said the spokeswoman, Mariann Caprino.

In financial statements, Pfizer has said that it iscooperating with federal investigators and contesting the suit, which it says isunlikely to affect its finances significantly.

Regardless of whether Dr. Franklin’s case succeeds, hislawsuit — based on telephone conversations he recorded, internal documents andhis experiences — may provide a rare glimpse into how drug marketingexecutives at one company created a blockbuster medicine by trying to influencephysicians, practices that have come under increasing scrutiny by Congress andby federal and state health care investigators.

The company’s strategy, according to Dr. Franklin’slawsuit, included paying doctors to appear as authors of journal articles onoff-label uses of Neurontin, articles that were actually written bynon-physicians working under the direction of the company’s marketers. Thecompany then paid hundreds of doctors to attend expensive dinners and weekendretreats, where they were urged to prescribe Neurontin.

Other doctors, often frequent prescribers of Neurontin,were paid to speak to other physicians about Neurontin’s benefits. Finally, thecompany paid doctors to prescribe Neurontin and include those patients inclinical trials, which Dr. Franklin contends were designed mainly for marketingpurposes.

The company adopted the marketing strategy, according tothe lawsuit, after deciding not to perform the clinical trials needed to gainapproval of new uses for Neurontin because it believed that the drug would soonlose patent protection.

Whatever strategy the company used appears to have been agreat success. In 2000, Warner-Lambert said that more than 78 percent ofNeurontin prescriptions had been written for indications other than epilepsy.Sales of Neurontin that year were $1.3 billion, and they rose to $1.7 billionlast year, according to IMS Health (news/quote), a health care informationcompany.

Dr. Franklin argues that the federal government paidhundreds of millions of dollars for prescriptions for off-label uses ofNeurontin as a result of Warner-Lambert’s marketing. Thomas M. Greene, a lawyerin Boston who represents Dr. Franklin, said his client was not available forcomment. Dr. Franklin, who has a doctorate in biology, now works as a globalforecast manager at Boston Scientific, a medical device company in Natick, Mass.Neurologists say doctors prescribe Neurontin because it has fewer side effectsthan similar medicines. "People are using Neurontin because it works,"said Dr. Ronald P. Lesser, a professor of neurology at Johns Hopkins Universitywho specializes in treating epilepsy and who has also prescribed Neurontin totreat pain. "The question is whether Pfizer or Warner-Lambert should beable to say" it works for unapproved, or off-label, uses, he added."You don’t want companies selling drugs like snake oil," Dr. Lessersaid. 

Many drug companies hire specialists like Dr. Franklin toanswer doctors’ technical questions about their medicines. At most companies,the specialists, or medical liaisons, do not promote medicines. ButWarner-Lambert trained Dr. Franklin and its other medical liaisons in salestechniques, he contends. According to court papers, the medical liaisons weresent to tell doctors how Neurontin could be used to treat numerous conditions inaddition to epilepsy, including migraines, drug and alcohol withdrawal seizures,and restless leg syndrome. At one company meeting, as described by Dr. Franklin,John Ford, a senior marketing executive at Warner-Lambert’s headquarters, toldthe medical liaisons that he wanted them "out there every day sellingNeurontin." According to Dr. Franklin’s recollections, Mr. Ford told theliaisons that "we need to be holding their hand and whispering in theirear, `Neurontin for pain, Neurontin for monotherapy, Neurontin for bipolar,Neurontin for everything." 

Dr. Franklin contends that the company told him to telldoctors that "early results" from clinical trials had shown thatNeurontin was highly effective for many off-label uses, although, the lawsuitsays, no data supported those statements. In addition, Dr. Franklin reported,when he did research on his own and found medical articles that reported sideeffects in some children taking Neurontin, his managers told him not to telldoctors. 

Another element of the company’s marketing strategy washaving journal articles published on Neurontin’s off-label uses. In 1996,Warner-Lambert retained an outside firm, Medical Education Systems, to prepareat least 20 articles for publication in various journals, Dr. Franklin’s lawsuitsaid. The articles were actually written, the lawsuit said, by writers retainedby Warner-Lambert, which had the right to control the articles’ content.Warner-Lambert then paid doctors, often frequent Neurontin prescribers, for theuse of their names as authors, Dr. Franklin said. But Warner-Lambert’s role increating and sponsoring the articles was hidden, according to the lawsuit.

 Dr. Franklin said another key to Warner-Lambert’sstrategy had been to make "tens of thousands" of payments tophysicians. For example, Warner-Lambert recruited doctors to become itsconsultants — a practice used by many pharmaceutical companies. Theconsultants attend dinners or weekend retreats and are told that they are beingpaid for their expert advice. Dr. Franklin contends that in many cases,Warner-Lambert did not even record advice from its consultants. Instead, doctorsattending the meetings, many in vacation destinations like Aspen, Colo., weregiven lengthy presentations on Neurontin, especially on its off-label uses,according to Dr. Franklin. The lawsuit also says that Warner- Lambert paiddoctors out of its marketing budget to take part in clinical studies. One largetrial, Dr. Franklin claims, was intended to persuade neurologists to prescribeNeurontin in higher doses than those with federal approval. In that trial, 1,200doctors were paid both for their participation and for every patient enrolled.

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