Pfizer Probes Deaths Amid Gripes
Over Lack of Viagra Guidance
By NANCY ANN JEFFREY and ANDREA PETERSEN
Staff Reporters of THE WALL STREET JOURNAL
NEW YORK -- Pfizer Inc. is moving aggressively to investigate the cases
of six people who died in recent weeks while taking Viagra, the drug
maker's blockbuster impotence medicine.
Last week, Pfizer and the Food and Drug Administration confirmed that
the company had reported six deaths of Viagra users to the FDA under
rules that require the company to report serious or unexpected adverse
effects to the agency. Both Pfizer and the FDA said they aren't certain
what, if any, role Viagra played in the deaths. Moreover, Pfizer and the
FDA maintained that the drug is considered very safe. At this time there is
no evidence that any further restrictions are needed beyond those that
already are in the drug's label, the FDA and Pfizer said.
Still, some doctors are complaining that despite a flood of requests for the
drug driven by a storm of media reports, they have yet to receive
educational materials from Pfizer on how to use the drug or how to avoid
interactions with other medicines.
Alerting Emergency-Room Doctors
In an interview Tuesday, Joseph Feczko, senior vice president for medical
and regulatory operations for Pfizer, said the company has taken steps to
stress to physicians and the public that the drug's label warns against
combining Viagra with commonly used heart-disease medicines containing
nitrate-type chemicals such as nitroglycerin. Last week, the company
mailed out 21,000 letters to the country's emergency-room doctors
alerting them that men complaining of chest pains, perhaps due to heart
disease, should be asked if they are taking Viagra before being given
nitrate-type drugs that often are prescribed to treat angina, severe chest
pains often accompanying heart disease. Dr. Feczko also said Pfizer has
been calling officials at medical associations representing emergency-care
workers across the country to get the word out about the interaction
warning.
But Pfizer reiterated that its action, while occurring in the wake of reports
of the six deaths, is not a direct result of those disclosures. Instead, the
company said it felt the additional alert was prudent given the drug's
exceptionally high use and inquiries Pfizer sales representatives received
from doctors. Since the first marketing of the drug in early April, more than
one million men have filled Viagra prescriptions, making the drug one of
the fastest-growing new drugs ever. Pfizer shares, which moved up sharply
in recent weeks, fell 3.4% Friday on news of the deaths. In composite
New York Stock Exchange trading, Pfizer shares Tuesday fell 2.1%,
down $2.25 to $103.1875, in volume slightly above average.
Death Investigation
Pfizer said it is investigating the deaths by calling physicians who treated
those patients to find out if the Viagra users had underlying medical
conditions, such as heart disease or diabetes, or were taking other
medications, including nitrates. Dr. Feczko said Pfizer has learned nothing
so far that would change the drug's safety profile or necessitate further
warnings on its label.
He added that the number of deaths were not higher than might be
expected in the age group of men who primarily might take the drug for
impotence. The company said about 85% of Viagra users are older than
age 50. That is an age when many men have heart conditions or diabetes,
which increase their risk of death.
The FDA said it also was investigating the six cases, but said nothing it has
seen yet suggests it should strengthen the warning against nitrate use that
Pfizer provides to doctors. The FDA also noted that in clinical trials of
3,000 men studied to test the drug's safety and effectiveness, there were
eight deaths among those taking Viagra, compared with one death among
a similar group taking a placebo. But the agency said none of the eight
deaths were attributed to Viagra. Moreover, because many more patients
were taking Viagra than were taking the placebo -- and were on the
medication longer than the placebo patients -- the death rates were
comparable when adjusted for those factors, Pfizer said.
Pfizer said it received reports of the six deaths during a period of weeks
since the drug became widely available. The company said it received the
reports from doctors, hospitals or its sales representatives who interact
with doctors, and that it passed along the reports to the FDA within 15
days of receiving them, as required by law.
Label Warns Against Nitrates
The warning against combining Viagra with nitrates, which can lead to
dangerous plunges in blood pressure, has appeared on Viagra's label since
the drug was approved March 27 and was widely reported in news
accounts of the drug's approval. But some physicians have expressed
concerns that some patients were taking Viagra and nitrates unaware of
those risks or that Viagra patients were being given nitrates by
emergency-room doctors or paramedics who didn't know a patient was
on the impotence pill.
Pfizer says its efforts to alert emergency-room doctors, nurses and
paramedics arose out of concerns within the company that such
health-care workers were not part of the Viagra educational campaign
initially aimed at urologists and primary-care doctors, the main prescribers
of the drug. Such health-care professionals "may be seeing patients who
are on Viagra who may be having complications if they were on nitrates,"
Dr. Feczko said.
The latest efforts are part of the company's educational campaign of the
medical community, Dr. Feczko said. Such efforts began with putting the
drug's package insert up on the company's Web site shortly after
approval, faxing copies of the package insert to pharmacists when the drug
was first being stocked and sending a few thousand Pfizer sales
representatives into the offices of primary-care doctors and urologists.
Some Physicians Complain
But some doctors say that, for a drug of such enormous popularity,
Pfizer's educational efforts have fallen short. Richard Roberts, a family
doctor in Madison, Wis., has been prescribing Viagra for more than a
month now, but said he still hasn't received any prescribing guidance from
Pfizer -- no package inserts and no calls from Pfizer sales representatives.
He has resorted to downloading Viagra information from the World Wide
Web and searching through medical publications. "I've had to go dig stuff
up about it," Dr. Roberts says.
Neil Brooks, a family physician in Rockville, Conn., said his patients had
been clamoring for Viagra for about two weeks before a Pfizer sales
representative showed up with a package insert. "They knew what the
market interest was," Dr. Brooks says. "I think they were slow to do their
education."
Dr. Brooks said he fears that most men are unaware of the dangers of
combining Viagra and nitrates. He said a patient who was taking a nitrate
drug and other heart medications asked for the drug this week. He said
most patients aren't aware of drug interactions.
'Read the Package Insert'
Dr. Feczko said a few thousand Pfizer representatives couldn't
immediately visit every one of the hundreds of thousands of doctors in the
country, but that any doctor uncertain about the drug's usage should have
contacted the company. "We felt we were very aggressive in getting
information out," he says. "Physicians should read the package insert. If
they have any questions, they should have called Pfizer ... . If a physician
doesn't understand the drug, they probably shouldn't be prescribing it."
Pfizer has been especially active, however, in warning the gay community
that Viagra shouldn't be combined with amyl nitrate or nitrite, a
recreational drug known as "poppers" that some men use to enhance
sexual pleasure. In April, Pfizer organized a meeting with the Gay and
Lesbian Medical Association. The association has warned that men
infected with the AIDS virus who are taking protease drugs should know
that Pfizer hasn't studied the combination for potential problems. |
