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Dec 13, 2007 6:05 pm US/Central
FDA Rejects Over-The-Counter Cholesterol Drug
WASHINGTON (AP) ―
Government advisers on Thursday rejected Merck & Co.'s bid for
over-the-counter sales of Mevacor, the granddaddy of the famed
cholesterol-lowering drugs.
Too many of the wrong people would use the drug if it no longer
required a prescription, advisers to the Food and Drug Administration
concluded in a 10-2 vote against nonprescription sales of the
medication.
"The patients couldn't figure out whether the drug was for them,"
said one FDA adviser, Dr. William Shrank of Harvard Medical School.
Merck argued that offering a low dose of Mevacor on open drugstore
shelves, next to the aspirin, would persuade millions of people with
moderately high cholesterol levels to take a pill that might prevent a
first heart attack.
"This is a real opportunity," said Edwin Hemwall, executive director
of Merck's worldwide OTC regulatory and scientific affairs. After the
meeting, Hemwall said, "We are disappointed. We felt we presented a
compelling case."
The FDA's advisers, however, were struck by how many people, in a
study of almost 1,500 potential customers, wanted to buy the drug even
though they were bad candidates.
One-quarter of people who wanted the pill did not have a high enough
risk of heart disease to qualify, meaning they would face unnecessary
side effects.
Worse still, 30 percent of very high-risk people — those who have
heart disease or diabetes or had survived a stroke — wanted Mevacor;
these are people who should be under a doctor's care. Merck says many
of them are not seeing a doctor and that a little treatment is better
than none.
Yet more than 30 percent of patients already taking prescription
cholesterol-lowering drugs said they wanted the over-the-counter
version. One-half said they would drop the more potent drug in favor of
low-dose Mevacor. To the FDA advisers, that raises big questions about
previously protected people setting themselves up for a heart attack.
"That's not good," said Dr. Kenneth Burman of Washington Hospital
Center. "They're not getting monitored, they're not getting other
medications and they're not getting counseling."
Arthur Levin, director of the Center for Medical Consumers in New
York, told Merck: "What I keep hearing from you is, 'It's good to be on
a statin, it's good to be on a statin.' Don't you think that's a risk,
that they may misdiagnose themselves and take too low a dose?"
The FDA is not bound by its advisers' recommendations, but usually
follows them. Twice since 2000 the FDA has said no to over-the-counter
Mevacor.
Britain allows nonprescription sale of the cholesterol-lowering
statin Zocor, but only if customers get it directly from a pharmacist —
meaning behind-the-counter sales.
Merck wants Mevacor to be sold over-the-counter, arguing that with
heart disease still the nation's No. 1 killer, people have become
sophisticated enough about artery-clogging cholesterol to try.
If such sales were allowed, Mevacor might become the most complex over-the-counter drug available.
Unlike OTC remedies for headaches or allergies, high cholesterol
causes no outward symptoms. People would need a laboratory blood test
to know if their cholesterol was high enough to qualify and follow-up
tests to make sure the pills were working.
The FDA advisers questioned if people would do that. They also noted
that at $1 to $1.50 a day, an over-the-counter version would cost more
for the insured than the typical $4 to $15 for a month's supply of
numerous statins.
Doctors are divided about the request. The American Heart
Association is remaining neutral, while the American College of
Cardiology opposes OTC Mevacor, for the same reasons the FDA panel
cited.
But others told the advisers that a drug known to have few
serious side effects should have a shot at reaching the millions of
people now getting no treatment for high cholesterol.
"We're still failing to prevent this epidemic. It's time to
take bolder action, to try new approaches," said Dr. Valentine
Burroughs of New York's Mount Sinai Medical School, a Merck consultant.
"You should put this drug in the drinking water," said Dr. David Nash of Philadelphia's Thomas Jefferson Medical College.
(© 2009 The Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.)
