Drug Company Sued for Promoting Drugs in
Exam Rooms
By Melody
Petersen
Newly unsealed court documents
reveal that some physicians, in exchange for money, have allowed
pharmaceutical sales representatives into their examining rooms to meet with
patients, review medical charts and recommend what medicines to prescribe.
And some of those salespeople
tried to influence doctors to prescribe drugs for uses that were not
approved by the federal Food and Drug Administration, those documents show.
This so-called shadowing
program, apparently involving hundreds of patients, is just one way that
Warner-Lambert tried to increase sales of a drug called Neurontin, not just
for epilepsy, for which it was approved, but also for more than a dozen
medical conditions it was never approved to treat, according to a federal
whistle-blower case that is now the subject of a criminal and civil
investigation by the United States attorney's office in Boston.
The case details marketing
practices that experts say have become standard practice for many
pharmaceutical companies as they spend billions of dollars trying to
persuade physicians to prescribe their drugs. A recent survey of physicians
in Maryland, for example, found that 37 percent said they had accepted some
kind of compensation from pharmaceutical companies.
According to court documents,
Warner-Lambert, which has since been acquired by Pfizer, tracked whether
doctors prescribed Neurontin, rewarding those who were considered
high-volume prescribers by paying them as speakers and consultants and also
paying them to enter patients in clinical trials.
Warner-Lambert also tried to
influence doctors who wrote medical journal articles about Neurontin by
paying them, sometimes secretly, and even hiring a marketing company to
write first drafts. The drug is expected
to reach $2 billion in sales this year.
Dr. Marcia Angell, the former
editor of The New England Journal of Medicine, said having sales
representatives tell doctors what to prescribe while examining patients was
"inexcusable."
"Drug companies have no
business being involved in education or clinical care," she said.
In the case of Warner-Lambert,
one sales representative boasted that he had persuaded a doctor to prescribe
Neurontin for unapproved uses, according to a voice-mail message obtained by
the whistle-blower. "While the patient was dressing, the doctor and I
one-on-one would discuss the patient and therapeutic options," the sales
representative said. "I felt I had influenced her."
The lawsuit, brought by Dr.
David P. Franklin, a former Warner-Lambert employee, is based on thousands
of pages of internal company documents. The documents do not reveal whether
doctors told their patients who the third person was in the examining room.
Dr. Franklin accuses
Warner-Lambert's sales representatives of encouraging doctors to experiment
by prescribing Neurontin for unapproved uses including pain, bipolar
disorder and attention deficit disorder in children.
It is illegal for a drug
company to promote a medicine for uses not approved by the government,
though it is not illegal for doctors to prescribe medicines for so-called
off-label uses.
Warner-Lambert's shadowing
program involved an estimated 75 to 100 doctors in several Northeast states,
Dr. Franklin estimated in court documents. Each doctor was paid $350 or more
for each day they let sales representatives watch as they examined patients,
according to court documents.
Other companies also pay
doctors to open their doors to sales people.
The federal investigation,
which stems from the whistle-blower lawsuit, centers on marketing activities
that took place in the mid- to late-1990's, before Pfizer bought
Warner-Lambert in 2000. The lawsuit argues that Medicaid paid tens of
millions of dollars it should not have for Neurontin prescriptions written
for unapproved uses.
Pfizer said that in 2000 more
than 78 percent of Neurontin prescriptions were written for unapproved uses.
Sales of the drug are growing at a rate of 50 percent a year - fueled mostly
by those off-label uses.
Neurontin has been approved by
the F.D.A. for a very narrow use: controlling seizures in epileptics who
already take another drug. But one marketing executive at Warner-Lambert, in
a recorded voice-mail message that is part of the lawsuit, told sales
representatives: "If we are going to market Neurontin effectively, we have
to do it for monotherapy, for epilepsy, also for pain and bipolar and other
psychiatric uses." (Monotherapy refers to using a single drug to treat a
condition, which is not an approved use of Neurontin.)
But researchers working
independently from the company say they are finding that Neurontin does not
work for some of those unapproved uses cited in the lawsuit. In a few cases,
these researchers say, Neurontin may make patients worse.
Dr. Jessica Wehner Lea and
other doctors at the Northwest Missouri Psychiatric Rehabilitation Center
said they recently had found that some patients taking Neurontin for
schizophrenia or bipolar disorder appeared to become more aggressive after
starting on the drug.
"Neurontin
is being used like water for disorders where there is not much evidence it
is effective," said Dr.
Jonathan Sporn, clinical fellow in the mood and anxiety program at the
National Institute of Mental Health. Dr. Sporn led a clinical trial funded
by the government that showed that
Neurontin worked no better than a sugar pill for patients with
obsessive-compulsive disorder.
Many doctors, however, say that
Neurontin appears to help some patients with pain. Last year, eight years
after Neurontin was put on the market, Pfizer filed data with the Food and
Drug Administration from clinical studies to try to gain approval for the
medicine's use for pain.
In his first public interview
since filing the whistle-blower case, Dr. Franklin, a 40-year-old former
research fellow at Harvard Medical School, said that soon after joining the
company in 1996 he was asked to participate in what he now says was an
illegal marketing scheme that put patients at risk.
Dr. Franklin said he was most
troubled by the company's insistence that he press doctors to prescribe
Neurontin in much higher doses than had been approved. "It was untried
ground," Dr. Franklin said. "We were not sure what would happen at these
high doses. I recognized that my actions may be putting people in harm's
way."
Dr. Franklin said several
Warner-Lambert marketing executives had told him that because Neurontin
appeared to be safe in high doses it was reasonable to encourage doctors to
try it for almost any neurological condition "just to see what happens."
Dr. Franklin's lawsuit also
accuses the company of paying dozens of doctors to speak about Neurontin to
their peers - some earning tens of thousands of dollars a year. One internal
memo listed doctors the company considered to be "movers and shakers,"
including some at prestigious medical schools such as Harvard, Cornell and
Columbia.
Warner-Lambert also hired two
marketing firms to write articles about the unapproved uses of Neurontin and
find doctors willing to sign their names to them as authors. According to an
invoice from one of the marketing firms, Warner-Lambert agreed to pay the
firm $12,000 to write each article and $1,000 to each doctor willing to
serve as author.
Internal memos filed in court
detail how the marketing firm often wrote a first draft of an article, but
sometimes had problems finding an author. The articles were then reviewed
and approved by Warner-Lambert before they were sent to journals for
publication, records show.
Other drug companies also use
marketing firms to help them "ghost write" medical studies, a practice that
angers editors of the leading medical journals.
"It is a form of marketing,
although it is disguised not to look like marketing," said Dr. Frank
Davidoff, the former editor of the Annals of Internal Medicine. "Authors
should be authors and should not be signing on to work by someone else,
particularly not for money."
Dr. Franklin, the
whistle-blower, now works as director of market research at Boston
Scientific, a developer and marketer of medical devices. He resigned from
Warner-Lambert only a few months after being hired, and said some company
executives had threatened to make him a scapegoat if he went public with his
concerns.
"I was terrified," said Dr.
Franklin, who sought help from Thomas M. Greene, a lawyer in Boston. Dr.
Franklin filed his suit several months later.
New York Times May 15, 2002
It is bad enough that the
drugs are being used in the first place, but to bribe physicians, as Dr.
Angell suggests, is inexcusable.
Folks, it stories like this
that make it crystal clear that the system is desperately broken.
It's time for a change where
the average patient will not have to reach out and rely on drug based
solutions, but will have ready and easy access to natural therapies that
will treat their systems while they improve their health.
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