n
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.