No drug is safe for everyone

As I write this, my life is in danger. There could be a fire in
my dorm, and living on the top floor, I might not make it out in
time. I could choke on the gum I’m chewing and not have the
breath to call for help. The pork chops I had for dinner could have
been contaminated with a strain of bacteria that might not kill me,
but could sure lead to some rather unpleasant gastrointestinal
issues tomorrow morning.

And that’s just while I sit quietly in my room! The
possibilities for death and destruction are virtually endless once
I step out onto campus.

I suppose I could just become a shut-in, although that too has
its potential hazards. What’s a paranoid guy to do?

In the wake of the scare over Vioxx, Celebrex and Bextra, three
arthritis pain relievers known as COX-2 inhibitors, even the good,
old-fashioned pill-popping route may not be so safe anymore.

Since Merck, the maker of Vioxx, withdrew it from the market for
fear that it increased the risk of heart attack or stroke, the Food
and Drug Administration has held hearings, convened panels, and
will finally rule later this month on whether to allow the drugs
back on the market.

Vioxx was designed for arthritis patients on faulty medications
found to have “the nasty side effect of creating gastric
ulcers,” said Dr. Stuart Schweitzer, a UCLA professor of
health economics. “Sixteen hundred patients a year were dying
from (intestinal) bleeding before the COX-2 drugs came to
market.”

That was the supposed miracle of Vioxx: It alleviated arthritis
pain without an increased risk of intestinal bleeding. But now that
harmful potential side effects are known, what should be the fate
of the drug?

That’s like asking what the correct car is to buy, given
all relevant crash-test data ““ there just isn’t an
answer. Just as the car you buy depends on your financial
situation, desire for certain safety features and lack of desire
for other features, the prescription drug you buy depends on what
you can afford and the benefits and harms it may pose.

In the case of Vioxx, patients at high risk for heart attack and
low risk of intestinal bleeding are not likely to benefit from the
drug as much as from an alternative like aspirin or Aleve, both of
which are associated with a risk of intestinal bleeding.

“Consumers need to realize that there are no absolutely
safe drugs,” Schweitzer said. “When the FDA approves a
drug as “˜safe and effective,’ that doesn’t mean
it is.”

Which is a large part of the problem with the FDA ““
consumers simply place too much confidence in its evaluations. The
agency actually thrives on failure. Following incidents like this,
there is always clamor for increased regulatory power. If the FDA
lets a drug be sold, then it must be safe, the common wisdom
goes.

But drugs are not inherently safe or unsafe. Rather, they carry
varying risks for different groups of patients. Simply because the
FDA has approved a drug for some people doesn’t mean it is
safe for all.

“No drug is safe for everyone,” said Dr. Mary
Ruwart, who spent 19 years as a pharmaceutical researcher for a
company that is now a part of Pfizer. “If a drug helps 20
percent of people, is the drug effective? What about 50 percent?
Eighty percent? What is the number?”

What about 0.75 percent? That is the increased likelihood of
heart attack or stroke resulting from taking Vioxx, a recent study
found.

For arthritis patients who endure crippling pain and have had
problems with intestinal bleeding, that is probably a safe enough
price to pay for the benefit of relief. And when you realize that
figure comes from a study of patients on high doses of Vioxx for
long periods of time, the risk seems even more negligible.

So why did Merck remove Vioxx from the market ““ and
“voluntarily” at that? When researching this topic on
Google, I came across just about as many offers telling me
“Vioxx lawyers can get you money. Find out if you
qualify!” as I found legitimate news sources.

I somehow doubt these will be the last such offers I receive.
I’ve already created a new spam filter for my inbox in
preparation.

Though I certainly cannot blame Merck for being fearful of a
potential multibillion-dollar class-action lawsuit, the effects of
the drug withdrawal weren’t uniformly beneficial.

Perhaps some people’s lives were “saved” by
not being able to take the drug anymore, but what about the people
who were in pain and left without access to the drug?

Risk assessment is an essential part of beginning any
prescription regimen. If consumers rely on the FDA for know-all
advice and expect perfect drugs from manufacturers, they will find
themselves not only demanding the impossible, but also supporting a
never-ending cycle of litigation when they don’t get it.

Hurst is a first-year chemical engineering student. E-mail
him at khurst@media.ucla.edu. Send general comments to
viewpoint@media.ucla.edu.

Leave a comment

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