The FDA is currently rethinking its guidelines for corporations
that advertise their prescription drugs and medical devices
to consumers. Don't think that the regulatory agency has
your best interests at heart. For one thing, the FDA cannot
screen the ads for accuracy before they are unleashed
upon the public, nor does it have the staff to track all
the print and broadcast ads after the fact. The new guidelines
currently under consideration by the FDA are just as wimpy
as the old ones. The FDA can only provide guidance
to the drug and device industries thereby living
up to its reputation as a toothless tiger.
In
a perfect world, one where the FDA actually served the
public's interest, these ads would be abolished altogether.
That's never going to happen. Here's the Center for Medical
Consumers' pie-in-the-sky recommendations that the FDA
is unlikely to follow:
-Make
those entrepreneurial radiologists hawking whole-body
scans and heart scans reveal the risks in their ads. They
should be made to identify the radiation doses involved,
as well as the high likelihood that scans will lead to
unnecessary biopsies and detection of a type of cancer
that would have remained dormant. As things stand now,
a company can advertise any outrageous claim about, say,
its digital mammography or scans with impunity as long
as the brand name of the equipment is not revealed in
the ad.
-Include
the rate of effectiveness in all ads. Only about 10% of
all drug ads currently address this important issue; the
rest give the impression that everyone benefits from the
product. To get FDA approval, a drug must prove to be
better than nothing (i.e., a placebo). Let the public
know how much better.
-Stop
telling us that drug advertising is a good form of consumer
education. Ads are designed to sell a product, not to
provide balanced information. That's why you see so many
ads devoted to new, i.e., expensive, “me-too” drugs (think:
Celebrex and Vioxx, Prilosec and Nexium, Lipitor and Zocor).
That's why you see little in the way of education— just
a few promising words in the headlines like power
and strength.
-Abolish
all “disease awareness” ads. They masquerade as public
service announcements because no drug is named. This type
of ad is all about selling fear of a disease, the need
for testing, and drumming up customers for lifelong drug
therapy. Merck, maker of the osteoporosis drug, Fosamax,
provides a classic example: “Osteoporosis—could you be
at risk…. ask your doctor whether a bone density test
is right for you.”
-Don't
allow companies to advertise diagnostic or screening tests
to the public without proof that the new technologies
are better than the old. Ads touting the expensive Pap
screening technology called ThinPrep are a case in point.
Such promotional activities have raised the cost of Pap
testing without improving the accuracy of finding cervical
cancer. To gain FDA approval, the maker of ThinPrep (and
any other screening technology) has to prove only that
it could find cancer, not that it is any better at finding
cancer than the standard Pap test.
-Be
straight with the public about the limits of FDA testing
requirements. Each ad should have a disclaimer, such as:
To be approved by the FDA, a drug has only to be proven
safe and more effective than a placebo, not better than
older drugs prescribed for the same condition. The drug
trials required for FDA approval typically last eight
to 12 weeks.
-Require
the drug companies to list a few of the most common and
most serious side effects in the body of the ad. Print
ads are currently mandated to include the misnamed “brief
summary” in tiny type on the reverse side of the ad. Anyone
who reads the entire brief summary—and not many people
do—will appreciate the concept of befuddling the public
with too much information.
-Speed
up the process for pulling a misleading ad. The FDA usually
waits for someone to complain about a misleading ad. Then
the agency takes too long to remove it, according to a
report from the U.S. General Accounting Office. What's
more, there is no penalty. Corrective ads are rare, though
deception is not. We were cheered to see the recent corrective
ad for Pravachol, the cholesterol-lowering drug. Its maker,
Bristol-Myers Squibb, had to run full-page ads in such
publications as The New York Times and Parade, stating
that Pravachol “has not been proven to help prevent
stroke in people without heart disease. Pravachol
is proven to help prevent stroke only in people with coronary
heart disease.” [Note: Though most ad complaints come
from a competing drug maker, according to an FDA spokesman,
the Bristol-Myers Squibb lie was found by FDA staff.]
Our
suggestions to the FDA were made last month in a letter
written in response to the agency's request for comments
on its guidance to industry. We do not have high hopes
that they will be taken seriously given the current political
climate. (Political contributions from the drug industry
totaled $29 million in 2002.) The FDA's hands are tied
by a Congress unwilling to release the necessary funds
or rein in the pharmaceutical industry. Meanwhile, drug
costs continue to rise, much of it because advertising
promotes the most expensive new drugs, not necessarily
the safest or best drugs.
Maryann
Napoli May 2004
