• Supplement does not prevent bone loss; raises safety concerns
• Drug giant's spin may obscure risk
• San Francisco targets ads for AIDS drugs; ban on 'unrealistic' messages
proposed
• Drug reports too positive; media reports on medicines often lack accuracy
• Flu drug marketing may be increasing media coverage
• Flu drugs sharpen debate on ads; what some see as informative others regard
as troublesome
• Direct-to-consumer prescription drug ads get poor grades for educating
consumers
• A pill turned bitter: How a quest for a blockbuster drug went fatally wrong
• Drug firms step up celebrity pitches
• The FDA, arguing that TV commercials exaggerate pain reliever's benefits,
makes manufacturer tone down its ads
• 'Emotional' ad campaign has parents asking M.D.s for costly drug
• Is TV advertising of prescription medicine hooking Americans on expensive
and unneeded drugs?
• Risk was known as FDA OK'd fatal drug
An
FDA commissioner's job description, in a nutshell, is to deal with these
issues.
Even though I was in a spring-cleaning frame of mind, I couldn't get past
the recurring theme in this random collection of clippings. Safety issues,
drug company "spin" or unrealistic promotional messages, the impact
of
direct-to-consumer (DTC) drug advertising, cost concerns and, over and over
again, more safety concerns. I was conscious of each of these issues, but
I
had lost track of how often they had arisen in just a few months' time.
The public debate over the role of the FDA has swung in wildly different
directions in just the past few decades. After tragedies such as those
involving the drug thalidomide, public sentiment swung toward support for
a
powerful watchdog role for the FDA. Better safe and slow and scientifically
sound than sorry. But is that the theme of today? In recent years, some
vocal patient advocacy groups charged that the U.S. drug approval process
is
slower than in other countries. Some business and political interests pushed
an anti-regulatory, anti-government-intervention theme. In recent years, the
FDA has been encouraged to adopt a more streamlined, "fast track"
drug
approval process.
What can consumers do about this? It would be easy to say, "Not much."
This
is a complicated issue that is difficult for news consumers and health care
consumers to evaluate. It's big business and big government at work.
But consumers can act with greater caution, with better information and with
more skepticism in the face of some of the incidents of questionable
disclosure — if not downright deception — happening in the marketplace.
Here are some tips for evaluating drug-related news stories and advertising:
1. Get your doctor's opinion before concluding that the new drug you just
read or heard about is for you. There's a good chance that he or she will
quickly tell you the limitations of the new drug, what the ads and the news
stories didn't tell you, and why there's something cheaper and more
effective you could be using. It may even involve not taking a pill. The
"pill for every problem" approach is an unhealthy one.
2. If you pay attention to DTC prescription drug advertising, you need to
know you're not getting the whole picture. In a study published in the
December 2000 issue of the Journal of Family Practice, researchers analyzed
320 print ads for 101 drug brands. Only 9 percent of the ads provided
consumers with estimated success rates of the drugs being advertised.
3. If you are influenced by what you hear or read in the traditional news
media, you need to know you're not getting the whole picture. In an analysis
in the June 1, 2000, New England Journal of Medicine (NEJM), researchers
reviewed 207 news reports of three popular drugs over a 5-year time span.
They found that 53 percent of those news reports failed to discuss drug
risks, 40 percent described benefits without numbers to back up those claims
and 70 percent didn't venture into cost-effectiveness discussions. If you
collected a year's worth of clippings, as I just happened to do, the other
side of these stories would be quite clear to any consumer.
4. Consider the source. In the NEJM study mentioned above, of 14 TV news
stories concerning researchers who had ties to the manufacturer of the drug
in question, none mentioned those ties.
Before she left the position of editor in chief of the New England Journal
of Medicine last year, Marcia Angell, M.D., wrote an editorial criticizing
the "large-scale breaching of the boundaries between academic medicine
and
for-profit (pharmaceutical) industry." She scolded researchers who "allow
themselves to be plied with expensive gifts and trips to luxurious
settings."
These are the kinds of things consumers may not know about, may not think
about, may not worry about when they see expensively produced television or
magazine drug ads showing smiling models basking in sunshine or running
through fields of flowers.
The pharmaceutical industry is a $100 billion a year industry.
The FDA commissioner helps set the tone for research standards, for what
drug companies must tell consumers and for what they may tell consumers and
for how drugs must be proved safe and effective before they are sold to the
first consumer, not after.
That's why this is one presidential appointment worth watching. I may have
not thought about it if I hadn't saved a year's worth of drug news
clippings.