Doctors Challenge the FDA Over the Public’s Misunderstanding of
What FDA-Approved Means
by Bill Sardi: The
Federal Government Wants a Million More Hearts To Keep Beating To
Gain Votes, Not Save Lives
are challenging the Food & Drug Administration to improve consumer
information about prescription drugs following an online survey
of nearly 3000 Americans showing many Americans mistakenly believe
"FDA approved" means drugs are extremely effective and
without serious side effects, and that newer drugs are superior
to older ones.
Lisa M. Schwartz,
MD, MS; Steven Woloshin, MD, MS, affiliated with the Veterans Administration
Outcomes Group, White River Junction VA Medical Center, White River
Junction, Vermont, and Dartmouth Institute for Health Policy and
Clinical Practice, Hanover, New Hampshire, say the FDA "needs
to do a better job of routinely communicating what it knows – and
does not know – about how well drugs work."
and Woloshin say "Many Americans misunderstand what FDA drug
approval means. A substantial proportion mistakenly believes that
the FDA only approves – and only permits advertising of – drugs
that are extremely effective and without serious side effects. Furthermore,
many also fail to recognize fundamental uncertainties about the
benefits and harms of newer drugs."
of those surveyed chose a drug that was shown only to reduce cholesterol
levels over a drug known to actually reduce heart attacks, and almost
two-thirds chose a newly approved drug over an equally effective
one approved 8 years earlier. Their survey was recently published
in a recent
edition of the Archives of Internal Medicine.
and Woloshin say: "Ironically, trust in the FDA and the prevalent
misconceptions about what FDA approval means may undermine efforts
to promote skepticism about markers of disease and new drugs."
and Woloshin were prompted to conduct the survey in the wake of
the Vioxx scandal where the FDA approved a drug on limited evidence
provided by the drug manufacturer and then allowed Vioxx to be widely
advertised on television as if it were a breakthrough. It ended
up being a killer of thousands.
are in the dark about is that the imprimatur of the FDA misleads
many to falsely believe drugs are safe. In fact, the safety profile
of new drugs is not known possibly for years from the date of their
and Woloshin criticize the FDA for approval markers of disease rather
than disease itself. The best example is cholesterol-lower drugs
which lower circulating levels of cholesterol (a marker) but do
not significantly reduce the risk of death for coronary heart disease.
Actually, statin cholesterol-lowering drugs that were first approved
(example: Mevacor) did not significantly reduce cholesterol, but
the FDA continued to allow the drugs to be marketed under the guise
they saved lives. Later on more powerful statin drugs were approved
but to be effective they have to interfere with the natural production
of cholesterol in the liver, thus making them liver toxins.
There is a
call for FDA to place a new drug warning on labels and the FDA did
implement such a warning for Vioxx six years after the drug was
on the market, but Drs. Schwartz and Woloshin point out that "there
are no FDA requirements to do so for other new drugs."
of Medicine called for a new drug warning in 2006, something that
the Great Britain has already adopted. A black triangle is added
next to the name of all drugs for at least the first 2 years they
are on the market.
and Woloshin go on to say that: "the US FOOD AND DRUG Administration
approves drugs when it believes that benefits outweigh harms. But
approval does not mean that the FDA believes benefits are large
(or important) or that all serious side effects are known. The typically
small size (a few hundred to a few thousand participants), short
duration (less than a year), and limited end points of pre-approval
studies ensure that important uncertainties remain. Uncertainties
are greatest in the first few years after approval and for drugs
approved solely on the basis of a surrogate (marker of disease)
and Woloshin continue: "Despite uncertainties about benefits
and harms, many new drugs are aggressively promoted to the US public
in no uncertain terms. For example, direct-to consumer (DTC) advertising
for Zetia and Vytorin (approved only on the basis of improving lipid
profiles) reached $200 million (sales reached $1.8 billion) in 2007,
the year before a randomized trial reported in the New England Journal
of Medicine failed to detect any clinical benefit. Advertisements
only included a statement acknowledging that the clinical benefit
was unknown after publication of this trial."
in the Archives of Internal Medicine says: "In 2000, a year
after it was approved by the FDA, direct-to-consumer advertising
for Vioxx surpassed all other drugs, reaching $500million (sales
reached $2.4 billion) by 2003, the year before it was withdrawn
from the market because it caused myocardial infarction and strokes.
The FDA has never required advertisements to acknowledge uncertainties
inherent in all new drugs."
statements printed on labels do help consumers better understand
risks, the improvement is modest. A 23-word explanation resulted
in 12% more people correctly choosing a drug that reduced heart
attacks over one only known to improve cholesterol levels. A 37-word
explanation resulted in 19% more people correctly choosing the drug
with a longer track record. This assumes consumers actually read
drug labels. Many don’t. And even with the inclusion of these precautionary
statements, one-third of participants still chose a drug with an
and Woloshin add that "even with our most effective explanation,
almost one-third of participants still chose a drug with only a
surrogate benefit over one with a patient benefit, and nearly half
still chose a new drug over an equally effective older drug. Because
these ideas may challenge intuitive assumptions (that is, new is
better) and be unfamiliar (that is, markers of disease do not reliably
translate into patient benefit), it may take time – and reinforcement
by trusted sources – for more patients to accept them."
him mail] is a frequent writer on health and political
topics. His health writings can be found at www.naturalhealthlibrarian.com.
latest book is Downsizing
© 2011 Bill Sardi Word of Knowledge Agency, San Dimas, California.
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