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Whistleblower's lawsuit being closely watched by drug industry

THEO EMERY, Associated Press Writer Friday, August 8, 2003

(08-08) 10:36 PDT BOSTON (AP) --

When Dr. Edgar L. Ross wants information about anti-pain drugs, he
does need to look far: He can attend dinner meetings funded by drug
companies, fly to industry-sponsored conferences and seek out company
representatives eager to answer questions.

But none of that, he said, influences his decisions about
prescriptions. Only one source does: "peer-reviewed journals I read
and trust."

Ross, medical director of the Pain Management Center at Boston's
Brigham and Women's Hospital, said he began prescribing the
anti-seizure medication Neurontin after he read about it in a medical
journal in the mid-1990s, convincing him the drug worked for pain. He
said he doesn't remember whether he knew then that an author of the
paper was paid thousands of dollars by Neurontin's manufacturer in
what a federal whistleblower now alleges was part of an elaborate
scheme to skirt federal rules for promoting drugs.

The lawsuit in U.S. District Court in Boston charges that Neurontin's
manufacturer, Parke-Davis, and parent company, Warner Lambert, which
merged with Pfizer Inc. two years ago, flouted federal law in the
1990s with an illegal marketing plan intended to drive up Neurontin's
sales.

David Franklin's lawsuit is being closely watched by the drug industry
and its critics, who say pharmaceutical companies use subtle tactics
to increase sales of drugs for other uses than the Food and Drug
Administration has not yet approved -- a practice known as "off-label"
uses.

The federal government, 11 states and the District of Columbia have
joined Franklin's complaint, which has provided a rare look at the
tactics drug makers use to provide information about different uses of
new drugs to doctors.

Franklin, who worked as a Parke-Davis drug liaison for less than five
months in 1996, claims the company adopted a strategy to increase
publicity about Neurontin's effectiveness for unapproved uses such as
relieving pain, headaches and psychiatric illnesses -- defrauding the
government in the process by encouraging doctors to write
prescriptions and seek Medicaid reimbur*****t.

The strategy allegedly included paying doctors to put their names on


company wanted "Neurontin champions" at prestigious teaching hospitals
to spread the word about the drug and take part in phony studies, the
suit said.

Franklin alleges that he and other liaisons were instructed to lie
about Neurontin's effectiveness, and that a Parke-Davis medical
director told him that what the company was doing was "brazenly
criminal."

Franklin, who now works for the medical device maker Boston
Scientific, stands to claim a portion of any settlement if the lawsuit
is successful. His attorney, Thomas M. Green, refused repeated
requests for interviews with Franklin.

Today, about 80 percent of Neurontin prescriptions are for off-label
uses. The FDA has since approved the drug's use for one type of pain.

Pfizer has strongly disputed Franklin's claims in court do***ents,
saying "no evidence supports the allegations that false statements
were made."

"As a result, the allegations provided by (Franklin) that the
statements are false are unsupported, conclusory assertions made by
(Franklin), with no evidentiary support," Pfizer attorney David B.
Chaffin wrote.

A spokeswoman for U.S. Attorney Michael Sullivan, whose office has
joined Franklin in the lawsuit, declined to comment on the Neurontin
case.

Ahaviah Glaser, director of the Prescription Access Litigation Project
in Boston, which has brought a similar lawsuit against Pfizer and
Parke-Davis in California, said doctors often rely on biased drug
marketing information disguised as education.

"I think everyone's feet need to be held to the fire," she said. "I do
think that a few strong court opinions critiquing these practices will
be very helpful in discouraging these practices from being as widely
used as they are."

Once the FDA has approved a drug, the agency allows doctors to
prescribe it for other uses. But with few exceptions, it forbids
companies and their representatives from promoting such off-label
uses.

The FDA has purposefully left its definition of "promotion" vague,
according to former FDA associate commissioner Marc J. Scheineson, now
an attorney with Reed Smith in Washington.

"The courts have consistently said in the United States that they want
consumers and they want physicians to get as much information as they
can, as long as that information isn't false or misleading," he said.
"Keeping it ambiguous enough to create a penumbra around most
marketing pieces, you're never sure whether this will trigger FDA
enforcement action."

In the lawsuit, Franklin cites Ross as an example of how the scheme
increased Neurontin sales, saying the doctor began writing
prescriptions and asking for reimbur*****t from Medicaid right after
he attended a conference in Atlanta on pain medications in 1997. Ross
said the reason Medicaid has no records of his Neurontin prescriptions
in Massachusetts before that conference was because he only recently
moved to the state.

But when asked what has influenced his prescription writing, Ross
cited the 1995 article by Dr. Gary Mellick and his brother, Dr. Larry
Mellick, saying it first drew his attention to Neurontin's efficacy
for pain.

Franklin's lawsuit cites Gary Mellick's writing as part of the scheme,
saying he was paid at least $21,000 by Parke-Davis and didn't divulge
the income in his published articles.

Ross said he cannot remember whether he knew that Parke-Davis paid
Mellick, but he said he wants to know whether doctors are being paid
to write about drugs. "I definitely rely on accurate information, and
I look at the bottom of the article for who's funding it," he said.

Numerous calls placed to Gary Mellick's office in Ohio were met with
busy signals, and a message left at a residence for a Gary Mellick in
Grafton, Ohio, was not returned.

Other doctors allegedly received more money from Parke-Davis. A
neurologist at Beth Israel Deaconess Medical Center, received more
than $71,000 to speak about off-label uses; the highest-paid speaker
took almost $308,000 for speaking at conferences, according to the
lawsuit.

Dr. Robert Levine, who teaches medical ethics at the Yale University
School of Medicine, said there are good reasons for the FDA's rules on
off-label uses.

Without flexible rules to allow free-flowing information, medicine
wouldn't evolve as quickly and some common medical practices might be
out of bounds, he said. And long-standing practices that are common
today -- such as sponsoring meetings about drugs over dinner -- may
look unethical on their face, but actually improve medicine.

"If you just say, look, they're getting a lot of expenses or perks,
that can superficially look really bad, but you've got to look
underneath to find out," he said.

http://www.sfgate.com/cgi-bin/article.cgi?file=/news/archive/2003/08/08/financial1336EDT0118.DTL