'Pill for every ill' creates new risks

[Guest guest]

SSRI-Research@

Sun, 26 Mar 2006 20:07:20 -0500

[sSRI-Research] Minnesota lawmakers seek disclosure of trials

for FDA-approved drugs

 

 

 

'Pill for every ill' creates new risks

Minnesota lawmakers seek disclosure of trials for FDA-approved drugs

 

BY JEREMY OLSON

Pioneer Press

 

http://www.ledger-enquirer.com/mld/twincities/news/local/14182617.htm?source==rs\

s & channel==twincities_local

 

America is manic about medication. Initial hype and hope over the

promise of new prescription drugs can turn to outrage and lawsuits

when risks are revealed.

 

Certain painkillers cause heart problems. An impotency drug is linked

to vision loss. Antidepressants increase the risk of suicide. A

Parkinson's drug seems to encourage compulsive gambling. And a sleep

aid can cause sleep eating.

 

In some cases, these rare risks are known but buried in the packaging.

In others, the risks don't come out until the drugs are broadly used

in the marketplace. Or drug companies withhold evidence of risks.

 

Minnesota lawmakers on Tuesday proposed one solution: a state law that

would require drug-makers to publicly disclose results of clinical

trials conducted before and after drugs are federally approved for

sale. Will more information make a difference in a harried environment

in which patients seek quick-fix pills, doctors are eager to prescribe

and pharmacists don't tell patients the pros and cons?

 

" As a society, we have this mentality of a pill for every ill - that

there is a pill that can put a smile on every face, " said Steve

Schondelmeyer, director of the University of Minnesota's PRIME

Institute, which researches drug-related economic and policy issues.

 

Prescription drug use grew 68 percent from 1994 to 2004, even though

the U.S. population grew only 12 percent in that time. In Minnesota,

the average person has 10 prescriptions filled at retail pharmacies

every year, according to the Kaiser Family Foundation.

 

Hope motivates sick people to believe there is a cure and to overlook

potential side effects, experts say. Drug companies provide ads that

fuel this hope, but they aren't as liberal with drug studies

suggesting problems.

 

Ambien was the latest drug under the microscope. Doctors at the

Hennepin County Medical Center's sleep disorders clinic reported

earlier this month that some patients experienced unhealthy sleep

eating while under the influence of the sleep aid. Ambien has also

been linked to sleep driving.

 

" The general public keeps waiting for a miracle drug - one that does

what it's supposed to do and doesn't have any side effects, " said Dr.

Mark Mahowald, director of the sleep clinic. " There is no such drug. "

 

If the public has unrealistic expectations of medications, Kim Witczak

of Minneapolis believes the drug manufacturers are to blame. Witczak's

husband hanged himself in 2003, three weeks after he started on

Zoloft, an antidepressant, for a sleep disorder.

 

" You see (the drug) advertised on TV, and the doctor gave it to him, "

she said. " I didn't think anything of Zoloft being an antidepressant.

I think the big thing is we trusted the doctor. "

 

Witczak is lobbying state and federal lawmakers to require drug

companies to disclose all clinical test results. She filed suit

against the maker of Zoloft, alleging the company knew of the

potential suicide risk.

 

Even existing drug-risk information is often overlooked, said Don

Uden, associate dean of the University of Minnesota College of

Pharmacy. He specializes in asthma management and estimated that 40

percent of the asthma care in Minnesota contradicts established

guidelines. Doctors are either too busy to digest the guidelines, he

said, or under too much pressure from patients to prescribe medicines,

regardless of whether they are appropriate.

 

" People who go to physicians, or prescribers, are by and large

expecting to get something, " he said. " If they just get information,

they don't believe they've gotten their money's worth. "

 

Survey results highlight the public confusion about prescription

drugs: 80 percent of respondents to a recent Kaiser poll said they

were at least somewhat confident in the safety of their drugs. And yet

only 44 percent expressed favorable views of pharmaceutical companies.

 

Leaders of the pharmaceutical industry struggle to balance the promise

of new medications with the unknown potential for side effects, said

Alan Goldhammer of Pharmaceutical and Research Manufacturers of America.

 

Initial clinical studies - which are needed to gain federal approval -

probably test a drug on 50 to 3,000 patients. If a side effect harms

only one in 10,000 drug users, then it is unlikely to show up in these

trials. And if a single adverse event does occur, the drug company

might dismiss it as an anomaly.

 

As the drug grows more popular in the marketplace, the chance for side

effects grows. Usually there is an initial buzz in the medical

community about side effects, said the U's Schondelmeyer, but it often

takes years before links emerge between a drug and bad outcomes.

 

Judie Evans resents the drug industry for failing to identify and

disclose the Ambien risks. While sleeping, she cooked eggs, swallowed

salad dressing and ate other unhealthy concoctions. The 59-year-old

from Plymouth had put on 30 pounds when her son figured out that she

was sleep eating at night.

 

She is a much tougher consumer now, doing her own research on drug risks.

 

" The doctors are very busy; the pharmacists are very busy, " she said.

" We have to take care of ourselves, and we can't always say yes to

everything. "

 

Jeremy Olson can be reached at jolson or 651-228-5583.

 

Timeline

 

Major events related to prescription drug risks:

 

September 2004: An FDA panel acknowledges heightened risk of suicide

among teens taking antidepressants. Warnings are added to the drug

labeling a month later. Research compels the FDA a year later to warn

of a risk for adults as well.

 

October 2004: Drug maker withdraws Vioxx from market, following

studies establishing cardiac risks. A similar painkiller, Bextra, is

removed from shelves two months later.

 

March 2005: U ophthalmologists report cases of vision loss in men

taking Viagra. The FDA investigates.

 

July 2005: Mayo Clinic psychologist publishes link between a class of

Parkinson's drugs called dopamine agonists and compulsive gambling.

 

September 2005: FDA issues new labeling requirement for Strattera, a

non-stimulant alternative for Attention-deficit hyperactivity

disorder, warning of a heightened risk of teen suicide.

 

March 2006: Hennepin County Medical Center doctors disclose developing

study linking the sleep drug Ambien with cases of sleep eating.

 

© 2006 St. Paul Pioneer Press and wire service sources. All Rights

Reserved.

http://www.twincities.com