Whistle-Blower Says Marketers Broke the Rules to Push a DrugMar 14, 2002
In 1996, Dr. David P. Franklin, a former research fellow at the Harvard Medical School, took a job as a medical liaison with Warner-Lambert, a large drug company, believing that he would be helping doctors understand the intricacies of the company's medicines.
But Dr. Franklin soon decided, according to court papers just unsealed, that the company had instead hired him to take part in a nationwide drug-marketing campaign that he believed was not only illegal, but was also possibly putting patients in danger.
Dr. Franklin contends in a whistle-blower case, filed after he resigned from the company later in 1996, that Warner-Lambert was not satisfied with the limited sales potential of the drug Neurontin, approved only to treat epilepsy in certain cases. To increase sales, he said, the company aggressively marketed Neurontin to doctors for more than a dozen medical conditions for which it was not approved, conditions like attention deficit disorder in children, neurological pain and bipolar disorder.
Under federal law, doctors can prescribe drugs in any ways they believe best for their patients. But it is illegal for a drug manufacturer to promote a medicine actively for indications that are not approved by the Food and Drug Administration, which requires detailed clinical trials showing its safety and effectiveness.
The United States attorney's office in Boston is conducting both criminal and civil investigations into the marketing of Neurontin, according to statements made by federal prosecutors in court.
A spokeswoman for Pfizer (news/quote), which acquired Warner-Lambert in 2000, said the lawsuit related to business activities that were said to have taken place before the acquisition. "We are not aware of any credible evidence that Warner-Lambert employees made false claims about Neurontin," said the spokeswoman, Mariann Caprino.
In financial statements, Pfizer has said that it is cooperating with federal investigators and contesting the suit, which it says is unlikely to affect its finances significantly.
Regardless of whether Dr. Franklin's case succeeds, his lawsuit — based on telephone conversations he recorded, internal documents and his experiences — may provide a rare glimpse into how drug marketing executives at one company created a blockbuster medicine by trying to influence physicians, practices that have come under increasing scrutiny by Congress and by federal and state health care investigators.
The company's strategy, according to Dr. Franklin's lawsuit, included paying doctors to appear as authors of journal articles on off-label uses of Neurontin, articles that were actually written by nonphysicians working under the direction of the company's marketers. The company then paid hundreds of doctors to attend expensive dinners and weekend retreats, 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, the company paid doctors to prescribe Neurontin and include those patients in clinical trials, which Dr. Franklin contends were designed mainly for marketing purposes.
The company adopted the marketing strategy, according to the lawsuit, after deciding not to perform the clinical trials needed to gain approval of new uses for Neurontin because it believed that the drug would soon lose patent protection.
Whatever strategy the company used appears to have been a great success. In 2000, Warner-Lambert said that more than 78 percent of Neurontin prescriptions had been written for indications other than epilepsy. Sales of Neurontin that year were $1.3 billion, and they rose to $1.7 billion last year, according to IMS Health (news/quote), a health care information company.
Dr. Franklin argues that the federal government paid hundreds of millions of dollars for prescriptions for off-label uses of Neurontin as a result of Warner-Lambert's marketing.
Thomas M. Greene, a lawyer in Boston who represents Dr. Franklin, said his client was not available for comment. Dr. Franklin, who has a doctorate in biology, now works as a global forecast manager at Boston Scientific, a medical device company in Natick, Mass.
Neurologists say doctors prescribe Neurontin because it has fewer side effects than similar medicines.
"People are using Neurontin because it works," said Dr. Ronald P. Lesser, a professor of neurology at Johns Hopkins University who specializes in treating epilepsy and who has also prescribed Neurontin to treat pain. "The question is whether Pfizer or Warner-Lambert should be able to say" it works for unapproved, or off-label, uses, he added.
"You don't want companies selling drugs like snake oil," Dr. Lesser said.
Many drug companies hire specialists like Dr. Franklin to answer doctors' technical questions about their medicines. At most companies, the specialists, or medical liaisons, do not promote medicines.
But Warner-Lambert trained Dr. Franklin and its other medical liaisons in sales techniques, he contends. According to court papers, the medical liaisons were sent to tell doctors how Neurontin could be used to treat numerous conditions in addition 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, told the medical liaisons that he wanted them "out there every day selling Neurontin." According to Dr. Franklin's recollections, Mr. Ford told the liaisons that "we need to be holding their hand and whispering in their ear, `Neurontin for pain, Neurontin for monotherapy, Neurontin for bipolar, Neurontin for everything."
Dr. Franklin contends that the company told him to tell doctors that "early results" from clinical trials had shown that Neurontin was highly effective for many off-label uses, although, the lawsuit says, no data supported those statements.
In addition, Dr. Franklin reported, when he did research on his own and found medical articles that reported side effects in some children taking Neurontin, his managers told him not to tell doctors.
Another element of the company's marketing strategy was having journal articles published on Neurontin's off-label uses.
In 1996, Warner-Lambert retained an outside firm, Medical Education Systems, to prepare at least 20 articles for publication in various journals, Dr. Franklin's lawsuit said. The articles were actually written, the lawsuit said, by writers retained by Warner-Lambert, which had the right to control the articles' content.
Warner-Lambert then paid doctors, often frequent Neurontin prescribers, for the use of their names as authors, Dr. Franklin said. But Warner-Lambert's role in creating and sponsoring the articles was hidden, according to the lawsuit.
Dr. Franklin said another key to Warner-Lambert's strategy had been to make "tens of thousands" of payments to physicians.
For example, Warner-Lambert recruited doctors to become its consultants — a practice used by many pharmaceutical companies. The consultants attend dinners or weekend retreats and are told that they are being paid for their expert advice.
Dr. Franklin contends that in many cases, Warner-Lambert did not even record advice from its consultants. Instead, doctors attending the meetings, many in vacation destinations like Aspen, Colo., were given lengthy presentations on Neurontin, especially on its off-label uses, according to Dr. Franklin.
The lawsuit also says that Warner- Lambert paid doctors out of its marketing budget to take part in clinical studies. One large trial, Dr. Franklin claims, was intended to persuade neurologists to prescribe Neurontin in higher doses than those with federal approval. In that trial, 1,200 doctors were paid both for their participation and for every patient enrolled.