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March 12, 2003, Wednesday


Doctor Explains Why He Blew the Whistle

BOSTON, March 11 -- Dr. David P. Franklin decided within weeks of accepting a job with the drug maker Warner-Lambert that he had become a crucial component in an apparent corporate plan to illegally market an epilepsy drug called Neurontin, he said today.

In his first extensive interview since filing a federal lawsuit against the company in 1996, Dr. Franklin said he thought he had little choice but to blow the whistle on what he says was a scheme to ignore federal regulations and market Neurontin for more than a dozen uses it was not approved to treat.

''We were truly experimenting on patients, which put them at risk,'' said Dr. Franklin, 41, a microbiologist and a former fellow at Harvard Medical School who worked as a medical liaison for Warner-Lambert. ''I was involved in this, trained and asked to deceive physicians and take advantage of their trust, and I'm embarrassed by that.''

''When you put profits above patients,'' he said, ''aberrations like this happen.''

Nearly seven years after Dr. Franklin filed the whistle-blower suit, the case appears to be moving closer to resolution. Pfizer, which acquired Warner-Lambert in 2000, is now negotiating a settlement with government prosecutors, according to court papers.

The issue involves hundreds of millions of dollars that Medicaid and other government programs paid for Neurontin because of what Dr. Franklin contends was a fraudulent marketing scheme. Under the law, Dr. Franklin and his lawyers would receive a portion of any settlement, which could amount to millions of dollars.

Pfizer has said that the actions Dr. Franklin claims to have seen would have occurred well before it acquired Warner-Lambert and that it is not aware of any credible evidence that Warner-Lambert employees made false claims about Neurontin.

Mariann Caprino, a spokeswoman for Pfizer, said company policy did not allow sales representatives to make inappropriate claims or encourage the use of Pfizer products in treating medical conditions they are not approved for. She declined to comment further because of the pending litigation.

Neurontin accounted for $2.3 billion of Pfizer's sales last year and was one of the company's top-selling drugs. Pfizer said in court papers that more than 78 percent of Neurontin prescriptions in 2000 were written for unapproved uses.

While doctors are allowed to prescribe drugs for uses not specifically approved by the Food and Drug Administration, it is illegal for a company to promote a medicine for so-called off-label uses, those not described on the medicine's label.

When Dr. Franklin joined Warner-Lambert in April 1996, executives there were unhappy with the limited sales potential of Neurontin, he said. The drug was originally approved only to treat epilepsy patients who were already taking a seizure medicine.

To compensate, he said, Warner-Lambert executives created a plan to sell Neurontin for conditions ranging from migraines to manic-depression to attention deficit disorder -- even though such uses were not supported by proper clinical studies.

Warner-Lambert hired Dr. Franklin as a medical liaison to help with that effort, he said. Many drug companies use medical liaisons, who often have medical or science degrees, to answer doctors' technical questions. Usually, they are not considered sales representatives, and they are forbidden to talk to doctors about off-label uses unless the doctor has a specific question.

But Dr. Franklin said that as a Warner-Lambert medical liaison, his primary job was to sell. He was trained to earn doctors' trust, he said, and then provide them information. Some of it, he said, was not scientifically valid.

''We tainted the environment in which physicians collect information,'' he said. ''It put the whole system at risk.''

Dr. Franklin said he realized that what he was doing was illegal at a training session for the liaisons a couple of weeks after he was hired. The company videotaped the liaisons listening to a corporate lawyer and former federal regulator telling them that they could not urge physicians to prescribe drugs for unapproved uses. The videotape was then turned off, he said, and the liaisons were told how they could get around the rules and were told they must stay focused on increasing sales.

At first, he said, he thought that what he was being asked to do fell into a legal gray area that could not cause harm. But he soon changed his mind. He said he was trained to exaggerate the results of studies that were too small to prove anything and to hide reports of side effects or trials that showed Neurontin did not work for various conditions.''We weren't driving 60 in a 55-mile-per-hour zone,'' he said. ''We were reckless driving.''

One day, Dr. Franklin said, a doctor showed him an article stating that Neurontin had worsened the behavior of a child with attention deficit disorder. ''He said, 'You keep telling me it's a benign drug and it's not,' '' Dr. Franklin related.

Dr. Franklin said he later showed the article to his boss, who dismissed it as an isolated case. He said his boss then laughed and said, ''Well, the doctor should not have been using the stuff off label anyway.''

To persuade doctors to prescribe Neurontin, Dr. Franklin said, the company also offered them a variety of financial incentives.

According to Dr. Franklin and to thousands of pages of company documents that became public in the lawsuit, Warner-Lambert paid some doctors tens of thousands of dollars to speak about Neurontin to other physicians at dinners and meetings. Other doctors were paid to serve as the named authors of medical journal articles that were actually written by medical marketing firms, according to court papers. Still other doctors were paid to enter patients into clinical trials that were too small to have any scientific value, Dr. Franklin said.

Warner-Lambert also paid doctors for what the company called record reviews, Dr. Franklin said. In such cases, doctors were paid to let drug company representatives review the confidential records of patients taking Neurontin so that the representatives could develop a written report to be shared with other doctors.

After only four months at Warner-Lambert, Dr. Franklin decided to resign. Medical liaisons were beginning to complain to their superiors about what they were being asked to do, he said. Dr. Franklin remembers one of his supervisors telling the group that anyone who was not comfortable with aggressively selling Neurontin should leave, he said.

He said he felt threatened when at least one executive told him that if he talked publicly about the company's marketing he would be made a scapegoat and be described as a rogue employee in a company that played by the rules.

That is when he went to talk to Thomas M. Greene, a lawyer in Boston, and soon filed the lawsuit.

Dr. Franklin, who now works as director of market research at Boston Scientific, a medical device company, said he was sorry he had pushed doctors to prescribe a drug that did not work for many conditions. ''Patients walked away thinking they had something that could help them,'' he said. ''They didn't.''

CAPTIONS: Photo: Dr. David P. Franklin, who has sued Pfizer, making a point in an interview in Boston yesterday. He contends a company acquired by Pfizer promoted off-label drug use. (Michael Dwyer for The New York Times)

Copyright 2003 The New York Times Company