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By Ed Silverman
Lilly says
Sarafem will help ease a severe premenstrual ailment. Critics
call the drug -- Prozac by another name -- a profit ploy
The women in the magazine ads are all
aglow. Sporting big smiles and carefree demeanors, they are
poster children for happiness and serenity.
These are the qualities Sarafem,
a new name among prescription drugs, is supposed to create
in women who suffer from a little-known ailment called PMDD,
or premenstrual dysphoric
disorder, a variant of premenstrual syndrome.
The medicine, approved by regulators last
year, is being widely promoted by its manufacturer, Eli Lilly
& Co., as a godsend to menstruating women who otherwise
would experience severe mood changes, sadness and irritability.
If only it
were that simple.
A chorus of doctors and insurers say Sarafem
is little more than a cleverly timed marketing ploy, because
the drug is really a renamed
version of Prozac.
The patent on the blockbuster depression
medicine expires this summer, and Lilly is scrambling to compensate
for sales that will be lost to cheaper generics.
Fueling the debate is a controversy over
PMDD itself. Only
5 percent of women may experience
PMDD, which some psychiatrists believe is
questionable ailment. As a result, critics say Lilly is stigmatizing
women by suggesting they suffer from a mental illness each
month. Rather than demonstrating a genuine interest in women's
health, they charge Lilly's move underscores the lengths to
which drug makers will go to protect profits.
"Lilly has done the wrong thing.
Calling it Sarafem is deceptive. It's sort of like a little
white lie," said Mickey Smith, director of the Center
for Pharmaceutical Management and Marketing at the University
of Mississippi. "There's an insidious element in this.
"They ought to just say they've found a new way to use
Prozac."
For its part, the Indianapolis-based drug
maker maintains it has done nothing wrong. Sarafem was designed
in response to requests from women and their doctors who were
seeking assistance in treating a little-understood ailment,
according to Laura Miller, a Lilly spokeswoman.
"PMDD is an underrecognized and undertreated
disorder. Women have told us for years that they've been told
it's something they have to live with or it's all in their
heads," she said. Miller also noted that there are other
instances in which more than one trademark exists for the
same drug being used to treat different ailments.
Nonetheless, Lilly faces a huge dilemma
when it comes to Prozac, which generated $2.6 billion in sales
last year. Unless Lilly wins a court battle over patents,
which Wall Street seems to think is unlikely, Prozac
sales are forecast to drop by one-third next year,
according to Hemant Shah, a securities analyst who follows
the drug industry.
By recasting Prozac as a new drug, though,
Lilly stands to gain if doctors write prescriptions specifically
for Sarafem. Right now, each
drug costs nearly $3 a day for
a month's supply.
But as soon as a generic is available,
the cost of Prozac is likely to drop by as much as 70 percent,
according to the drug industry's usual rule of thumb.
However, thanks to quirks in insurance
coverage, Sarafem would continue to command a higher price
that will be paid by insurers, at least those insurers that
agree to underwrite the medication. Under this scenario, Lilly
may be able to generate more revenue than the Indianapolis
drug maker might otherwise if it hadn't conceived Sarafem.
"The whole reason they did this is
to keep sales up," said Terry Leach, director of pharmacy
services at Horizon Blue Cross and Blue Shield of New Jersey.
If a doctor writes a prescription for
Sarafem, the pharmacist can't fill it with a generic Prozac
unless they call the doctor and get permission to switch,
he said. For that reason, Leach said, Lilly has incentive
to price Sarafem as a branded product.
Of course, not every insurer plans to
go along. WellPoint Health Networks, a large health-maintenance
organization based in Thousands Oaks, Calif., doesn't plan
to cover the cost of either Sarafem or Prozac once the generic
version becomes available this summer, according to Rob Siedman,
the company's chief pharmacy officer.
Coverage is
an issue for others, too. The Health Care Payers Coalition
of New Jersey, a nonprofit buyers consortium that represents
self-funded businesses and labor health plans, recently denounced
Lilly for aggressively promoting Sarafem. The group's officials
worry that a high-priced drug will be too readily prescribed
for women who do not need it.
"This
is going to get a lot of women taking Prozac, a psychotropic
drug that effects the brain and has side effects,"
said David Knowlton, a former New Jersey health commissioner
and coalition lobbyist. "I'm not saying price isn't an
issue, but we're seeing an escalation in their marketing,
which tends to drive people to a drug."
Indeed, Lilly's marketing has been aggressive.
From August, when the Food and Drug Administration
approved this new use of Prozac, through January, the drug
maker spent $17 million to promote it to consumers, according
to Competitive Media Reporting. During the same period, an
additional $16 million was spent to promote it to doctors
and in medical journals, according to IMS Health, a market-research
firm.
Within a few months of launching Sarafem,
Lilly's advertising ran afoul of regulators. The
FDA cited the drug maker for running a television ad that
was "misleading,
lacking in fair balance and in violation" of federal
law, according to a letter sent last November by
the agency to Lilly officials.
The 60-second ad showed a frustrated woman
trying to pull a shopping cart out of a tangled group of carts
in front of a supermarket. The ad then said: "Think it's
PMS? It could be PMDD," but it never distinguished between
the two illnesses or specifically defined PMDD. The FDA complained
the ad "trivializes the seriousness of PMDD."
The ad campaign, which has been prominent
in women's magazines, already has had an effect. Between September
and February, the number of prescriptions written by doctors
for Sarafem increased sevenfold, while the number of prescriptions
written for Prozac declined, according to IMS Health.
This trend worries Althea O'Shaughnessy,
a Princeton gynecologist and reproductive endocrinologist.
She believes too many women may react to the Sarafem ads by
asking their doctors to write prescriptions. But she worries
that such requests may be inappropriate because most
women never experience PMDD.
"The ads make it seem that you just
take the drug and all the problems go away," O'Shaughnessy
said. "I worry that physicians will prescribe it because
of patient demand. But it's not a wonder drug or a cure-all.
And only a very small percentage of women even suffer from
PMDD. Even PMS is a very loose term for symptoms."
The controversy over PMDD was never fully
settled by the American Psychiatric Association. The organization,
which oversees diagnoses, lists the ailment in both the appendix
and the main section of a widely cited compendium of disorders
called the Diagnostic and Standards Manual IV, which is the
equivalent of the Bible among mental-health specialists.
But a listing in the appendix is reserved
for a diagnosis lacking sufficient evidence for validity,
said Sally Severino, a former professor of psychiatry at the
University of New Mexico School of Medicine and a member of
a specially convened APA round table that, in 1998, was held
to settle the PMDD debate.
"The real question is whether PMDD
is a valid diagnosis. If it is, you should be able to prove
it in some way," she said. "But we can't ever seem
to get any consistency about what symptoms should qualify
for this diagnosis.
"It's all very confusing. And by
listing it in both places, the APA is talking out both sides
of its mouth."
Ed Silverman covers the drug industry
and can be reached at (973) 392-1542 or esilverman@starledger.com.
New
Jersey Star Ledger June
6, 2001
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