081800Wyeth-Ayerst Asks Doctors to Stop
Inserting Norplant Contraceptives
Warning on Lots Sent After November
Says Dosage Might Not Last as Long
By LAURIE P. COHEN and SCOTT HENSLEY
Staff Reporters of THE WALL STREET JOURNAL In the latest public-relations blow to American Home Products Corp.,
its Wyeth-Ayerst Pharmaceuticals unit asked doctors to stop
inserting Norplant contraceptives shipped since October 1999.
Norplant consists of six matchstick-sized capsules, which are
inserted in a woman's upper arm and release a synthetic hormone into
the bloodstream that prevents pregnancy for as long as five years.
But in an Aug. 10 letter sent to physicians and wholesalers across
the country, Wyeth-Ayerst cautioned that its own testing of these
eight lots of Norplant suggested that the contraceptive might not be
able to provide women protection from pregnancy through 2004, the
full five-year term.
A company's letter stressed that "at this time we do not believe
there is an incremental risk of pregnancy with these lots." But as a
precaution, the company in its letter nonetheless urged doctors to
tell women for whom avoiding pregnancy is of "great importance" to
use diaphragms or condoms in addition to Norplant.
In an interview, Phillip J. de Vane, Wyeth-Ayerst's vice president
of clinical affairs, stressed that the company had received no
reports of unintended pregnancies, but said: "We don't have any
evidence that efficacy is affected, but we thought it was prudent to
advise people."
American Home officials also said that after discovering the problem
with Norplant in the course of routine quality testing, the company
voluntarily notified the Food and Drug Administration. The company
said it is now conducting tests, which are expected to be completed
in September or October, to determine if there is any clinical
relevance to the apparent reduced potency of the Norplant in
question. In the meantime, the company said it has suspended all
shipments of Norplant. American Home said the maximum number of
affected patients was 22,000.
The possible failure of Norplant to prevent pregnancies, earlier
reported in the Milwaukee Journal Sentinel, is the latest setback
for American Home. Late last year, the company's RotaShield vaccine
for infants was recalled amid concerns that it caused a potentially
fatal condition. American Home was also forced to recall Duract, a
painkiller that may have killed some patients who took it for longer
than they were supposed to.
American Home was also tarred in the debacle over the obesity-drug
cocktail fen-phen, which was alleged to have played a role in some
heart problems. American Home recalled fenfluramine -- the "fen"
part of the cocktail -- as well as a chemical cousin, Redux, in
1997. The company is nearing a $4.83 billion settlement of
fen-phen-related class-action suits.
In 4 p.m. New York Stock Exchange composite trading Thursday,
American Home shares fell $1.38 to $56.31.
Ever since its introduction in 1991, Norplant, which is primarily
used by low-income, inner-city women, has itself been dogged by
image and liability problems. In August 1999, the company agreed to
pay about $50 million to settle injury suits over its alleged
failure to adequately disclose side effects such as menstrual
bleeding and severe depression associated with the contraceptive
device. In settling the suits, American Home didn't admit any
wrongdoing -- it had already won three jury verdicts and more than
20 summary judgments in these cases -- but said it did so "purely as
a business decision."
Some providers had been expressing doubts about the prospects for
the contraceptive even before the latest move. Norplant's sales have
dwindled from a 1992 peak of $140.9 million to $13.3 million in
1999. "Norplants have hardly been in great demand over the last
couple of years," said Dorothy Mann, executive director of the
Family Planning Council in Philadelphia, who said that in the past
year, clinics affiliated with her agency have administered half as
many Norplants as four years ago. The current problem won't "help
Norplant's marketability" with users, Ms. Mann said.
Providers were moving quickly to determine how many patients had
received the affected Norplant and what to tell them. Kate Thomsen,
medical director of Planned Parenthood Federation of America, said
that the nation's largest contraception provider received the
Wyeth-Ayerst letter Tuesday and then spoke with both Wyeth-Ayerst
and the FDA. While Planned Parenthood, which serves more than five
million people annually, still hasn't determined how many patients
it will need to contact, Dr. Thomsen said, "We're advising our
patients to remain calm and cautious and to use an additional
barrier method of contraception."
Some other providers, however, speculated that Wyeth-Ayerst may not
have wanted to encourage Norplant's removal for business reasons --
and said that they would give women that option.
At the Family Planning Council in Philadelphia, Ms. Mann said that
60 women in her network of 85 clinic sites received the Norplant
that is potentially problematic. The network intends to give
patients a choice "of using other birth control or having their
Norplant removed," she said. But Wyeth-Ayerst's Dr. de Vane said it
is "probably premature to remove them."
Anita Nelson, a professor of obstetrics and gynecology at UCLA
Medical Center, said that the potential problem with Norplant's
potency would likely not affect women until the end of Norplant's
life span. That is because its initial delivery of hormones to
prevent ovulation drifts down over time. That may explain why there
hasn't been a higher-than-normal rate of unintended pregnancies with
the affected Norplant batches, she said. Norplant's failure rate is
3.9% over five years, American Home said.
In relaying its concerns soon after contacting the FDA, Wyeth-Ayerst
seems to have precluded a new round of lawsuits against Norplant, at
least for now.
"By saying this Norplant shouldn't be used, American Home is nipping
the problem in the bud," said Turner Branch, an Albuquerque, N.M.,
attorney who led the earlier Norplant suits on behalf of plaintiffs.
--Lolly Bowean contributed to this article.
Write to Laurie P. Cohen at laurie.cohen@wsj.com and Scott Hensley
at scott.hensley@wsj.com
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