FDA incompetence a hard pill to swallow

Many people don’t trust the government, and after close
examination, it’s not difficult to tell why.

It’s always in trouble on the news for a
“cover-up” that hid something important from the
public. It docks enormous amounts of money from our paychecks for
reasons explained only by mysterious abbreviations. And it employs
an army of men who dress like characters from the Matrix and work
for an agency with a name that begins with the word
“secret.”

The most recent reason for being suspicious of the government is
one that has not been kept secret, however. The news has been
flooded with stories about the various flubs made by the Food and
Drug Administration.

The agency that controls nearly everything we put in our mouths
and our bodies, from food to injections, has not been proving
itself to be very trustworthy of late.

First there was the Vioxx incident. The FDA approved the drug,
only to find that it causes heart attacks and strokes. This
discovery wasn’t made public, however, until after the
estimated number of victims ““ 100,000 ““ grew too large
to ignore. Yes, the FDA knew about the risk for an extended period
of time before warning consumers.

How could such a gross act of negligence occur? Drug companies
are supposed to be required by the FDA to conduct studies on their
medications after they are released on the market, but according to
the Boston Globe, only two out every three studies drug companies
promised have actually been done.

This means that the prescription you get after visiting the
doctor may have serious consequences you know nothing about, and
those consequences could be life-threatening. All because the FDA
doesn’t have enough muscle to force drug companies to observe
their own products.

The approval process at the FDA does not seem to be in any
better shape. The organization was recently sued by the New
York-based Center for Reproductive Rights for waiting so long to
decide if the morning-after pill should be available without a
prescription.

The Los Angeles Times reported from court transcripts that the
former commissioner of the FDA, Lester M. Crawford, had ignored his
top subordinates’ advice to make the pill available without a
prescription, personally overruling the recommendations of medical
reviewers.

Conservatives believe easy access to the pill would encourage
promiscuity in young people, and Crawford bowed to the pressure in
spite of his staff’s opinions.

Accusations flew that Crawford was playing politics with
America’s health, and the FDA’s women’s health
chief resigned in protest. Crawford suddenly resigned shortly after
““ without mentioning the pill in his farewell address, of
course.

These incidents have been mostly underplayed by the press, but
if you look hard enough, the turmoil is not difficult to see. The
FDA is not only struggling with its current image, but also the
nature of its organization as a whole.

Although issues like the war in Iraq or the state of the economy
may seem more important and immediate, the FDA personally affects
every single American every day.

Does your soft drink contain too much of a chemical that causes
cancer? Are the pain killers you take after surgery really safe?
Simply giving products a nod from the FDA and a thumbs-up does not
provide the information necessary to answer these questions.

When the FDA’s panel of medical experts discusses the pros
and cons of a new drug, it should do so in public.

Its talks could be broadcast on a medical version of C-SPAN.
Although, like C-SPAN, the station would have fairly low ratings
and be used mostly to induce afternoon naps, interested parties,
such as doctors, pharmacists and potential consumers of the product
being debated would have full access to information about all of
the costs, benefits and uncertainties of the new product.

This open way of conducting business would also put a spotlight
on the drug companies that neglect to conduct follow-up studies. In
order to stay in business, companies would need to maintain a good
public image. As evidenced by Crawford’s behavior, political
pressure is a very effective motivator.

This kind of transparency would also prevent a single individual
from making a decision for the entire nation, such as
Crawford’s rejection of the morning-after pill.

It might also finally answer other important questions, such as
why the FDA is so concerned with preventing cheap prescription
drugs from overseas from reaching consumers in the U.S. and whether
Oreo cookies are really all that bad for us.

The FDA is an enormous organization that holds our lives in its
hands and is fueled by tax dollars that we pay. It’s time we
demanded to be in the know. Secrets don’t make friends,
healthy food or safe drugs.

Leave a comment

Your email address will not be published. Required fields are marked *