[NYTr] Bad Medicine: Prescription Drug-Related Deaths Spike

[All the News That Doesn't Fit]

Newsweek - Sep 11, 2007
http://www.msnbc.msn.com/id/20724894/site/newsweek/?from=rss


Prescription Drug-Related Deaths Spike

A new report reveals an alarming rise in fatal or debilitating
prescription drug-related side effects and raises serious questions
about basic medical safety practices.

By Jenneen Interlandi 
Newsweek

Sept. 11, 2007 - The American medicine cabinet may be a danger zone.
The number of deaths, disabilities and serious adverse medical events
linked to prescription drugs nearly tripled between 1998 and 2005,
according to a study published Monday in the Archives of Internal
Medicine. But while experts agree that the increase is both significant
and troubling, they have yet to determine a cause.

“We’re not disputing the findings,” says Food and Drug Administration
spokeswoman Sandy Walsh. “The numbers are consistent with FDA’s report
tracking, but they don’t tell us why.” That data includes more than
15,000 prescription drug-related deaths in 2005--up from around 5,000
in 1998.

According to Thomas Moore, a researcher at the Institute for Safe
Medication Practices, a nonprofit group in Huntingdon Valley, Pa., and
the study’s lead author, the findings represent widespread failures.
“There’s enough blame to go around,” Moore says. “Nobody wants to think
about drug safety. Drug companies want to focus on the benefits,
doctors don’t want to even consider the possibility that they may be
hurting someone, because it makes them uncomfortable, and patients just
want to get better.”

The number of reported adverse drug events grew four times faster than
the number of prescriptions, according to the study, which analyzed
data from ARES, the FDA’s voluntary reporting system for adverse drug
events, launched in 1998. ARES takes reports from consumers, doctors
and drug companies alike, but the vast majority of reports come from
the drug companies themselves.

While nearly 1,500 drugs were implicated, fewer than 300 of them
accounted for the vast majority of deaths, disabilities and negative
drug reactions. This narrow subset, Moore says, may be the key to
improving drug safety. “All drugs are not equal,” he says. “Pharmacists
need to focus on these high-alert drugs and educate patients, so that
if you’re taking one of these drugs you know more about it.”

Among the 15 worst offenders seven were pain medications, including
morphine, oxycodone, fentanyl and acetaminophen-hydrocodone. Four were
immune-system drugs, such as Infliximab and Interferon beta. And four
were antipsychotics or antidepressants, including Risperidone and
Clozapine.

A handful of new biotech drugs--including the popular anti-tumor drug
“anti-TNF”--contributed heavily to the upward trend. But two-thirds of
the drugs most commonly associated with adverse events have been around
longer than the FDA’s reporting system itself. Insulin, for example,
was linked to 438 serious adverse drug events in 1998, 1,800 in 2005,
and a total of 9,579 adverse events in the seven-year period. Estrogen
fared even worse, accounting for 11,514 adverse events in the same time.

Victims of adverse drug events were evenly divided among men and women
but were disproportionately older, even after adjusting for the fact
that elderly people are more likely to take prescription drugs in the
first place. People over the age of 65 account for 12.6 percent of the
population but 33.6 percent of adverse drug events.

The FDA’s Walsh cautions that adverse event reports, on which the study
is based, do not provide a full picture. “When we get an adverse event
report, there’s always a story behind that report that needs to be
evaluated,” she says. “Sometimes there’s no way to determine how much
the drug itself was actually responsible for the adverse event.” The
FDA has launched a new pilot program to continue evaluating the safety
of new drugs for up to 18 months after they’re approved.

“The tragedy is that we as a society are really quite good at the
business of managing risk,” says Moore. “Look how much we use gasoline,
for example, and how safe we are with that. But when it comes to
medicine we still take for granted that it’s going to help us, not hurt
us.”

© 2007 MSNBC.com