consumer group petitioned the federal government yesterday to take the
popular weight-loss drug Meridia off the market after 19 deaths were
reported as possibly related to the prescription medication.
The drug's manufacturer, Abbott Laboratories,
disputed the figures, saying that the deaths had not been proved to be
related to the drug and that in any case the number would represent a very
small percentage of the nine million people who have taken the drug
worldwide since it went on the market in 1998.
Melissa Brotz, a spokeswoman for Abbott, said the drug was important
because obesity is a major cause of sickness and death, and even modest
weight changes can reduce the risk. Studies have shown that obese people
taking the drug have lost an average of 6 to 11 pounds in the first year of
treatment, depending on the dose.
Public Citizen, the consumer group found by Ralph Nader, submitted its
petition to Secretary Tommy G. Thompson of the Department of Health and
Human Services, saying the drug's benefits were minimal the loss of a few
pounds over a relatively short period and the risks had proved
substantial.
More generally, the petition challenged the Food and Drug
Administration's approval of weight-loss drugs, suggesting that obesity is a
chronic disease but the drugs approved to treat it give only small benefits
over a year or two at most.
"No drug ever approved for weight loss has been shown to benefit patients
years later," said Dr. Sidney Wolfe, director of the Health Research Group
at Public Citizen.
From the time it was first marketed, Meridia, whose scientific name is
sibutramine, has been known to cause a sharp rise in blood pressure and
pulse rate in some people. An advisory committee to the drug agency voted
against approval of the drug, as did the agency's officer in charge of its
review for the market, the petition said.
When approval was granted, the drug agency required a warning on the
label, along with a recommendation that doctors give patients blood-
pressure tests before prescribing the drug. It is unclear whether doctors
are following the suggestions.
In the petition, Dr. Wolfe noted that the Food and Drug Administration
had reports, as of September 2001, of 357 serious adverse reactions possibly
linked to the drug, including 152 hospitalizations and 29 deaths. Of the
deaths, 19 listed the cause as cardiovascular disease like high blood
pressure or stroke.
The deaths and adverse reaction reports are collected by the drug agency
from voluntary reports, and the number of actual incidents is usually
estimated to be tenfold higher. The listing of a death in the agency's files
means that the drug is a suspect in the case, but that an investigation of
the link has not been done.
"Taking only those deaths with cardiovascular causes, the risk is still
far too high to allow a drug with such minimal value to be on the market,"
Dr. Wolfe said.
Italy has suspended sales of Meridia after two deaths were reported in
recent weeks, Ms. Brotz said, but Italy is now reconsidering.
Dr. Louis Aronne, assistant professor at Weill-Cornell Medical Center in
New York, a researcher who has worked with Abbott, said it was difficult to
separate the effects of severe obesity from the side effects of the drug,
because both can lead to cardiovascular damage.
On the question of small amounts of weight loss, Dr. Aronne said he
suspected that the first 5 percent to 10 percent loss might be the most
important. Although the data is unclear now, he added, "we are eventually
going to see long-term benefits."