FDA Alert: Watch for Suicide of Kids on AD's 10/27/03

In news message: ,
Mark D Morin typed:
On Thu, 30 Oct 2003 23:48:10 GMT, "Lucky" wrote:

First, Quiote quoted text from the manufacturers insert for wellbutrin,
which is not one of the 8 anti-depressants included in the FDA's alert.

That's not all he said.

Secondly, the text he quoted was 10 mos old, not 10 years old.

If you read again, you will find that is in error.


Thirdly, the text he quoted is irrelevant to this discussion because it
merely asserts that suicide ideations are inherent to depression, and
such ideations are not the ones the FDA is alerting the public about.

The FDA alert is about suicidal ideations TRIGGERED or activated by 8
anti-depressant medications.

You should read the alert again.

Now, quit muddying the waters.

The FDA widely publicised its alert that suicide ideations are caused by
8 antidepressant drugs,

and again.

This is rather amusing, watching somebody rave on second-hand about me even
when ignored. Is it possible for her to miss my (and your) points any futher
than she already has?

I'm betting "yes". I'm a sucker for the sure thing.

What's so sad is if she had attempted to rein in her vitriolic emotionalism
in the first place and simply stuck to her points, I would have been willing
to continue to converse with her - but she's just not amenable to reason
without imagining an ulterior motive that somehow conspires against her and
so rushes to insinuating attack in her haste to defend herself.

Pity, because it does appear that she's capable of coherent response, even
if it's somewhat clueless.

I'll be very surprised if I'm not now included as part of "your" camp (as
she's defined it) simply because I'm willing to talk to you without
condemning you constantly. Sheesh.

--
Jon Quixote
What is axiomatic frequently isn't.

Press Release Source: Knight Ridder


Knight Ridder Exclusive: Off-Label Drug Prescriptions Skyrocket in
U.S.
Sunday November 2, 12:01 am ET
Thousands Became Ill Last Year After Taking Nation's Most Popular
Drugs Off-Label

http://biz.yahoo.com/prnews/031102/sfsu001_1.html


WASHINGTON, Nov. 2 /PRNewswire-FirstCall/ -- A three-part
investigative series by Knight Ridder Newspapers has found that
patients nationwide are being injured and killed as doctors routinely
prescribe drugs in ways the Food and Drug Administration has never
approved as safe and effective. The study, based on a sample of
top-selling drugs, found that the number of off-label prescriptions
has nearly doubled in five years. The Knight Ridder analysis released
today is perhaps the most comprehensive ever done of off-label
prescribing.
The series by investigative reporters Alison Young and Chris Adams is
based on interviews with patients, doctors, researchers and drug
companies, and the review of thousands of records from lawsuits,
government hearings and regulatory actions, medical records and
scientific studies. The complete results will run over the next three
days in Knight Ridder newspapers across the country.

Off-label prescribing is legal, widely accepted and defended by
doctors and the American Medical Association. Victims of off-label
prescribing interviewed by Knight Ridder have suffered heart attacks
and strokes, had permanent nerve damage or lost their eyesight. Based
on the FDA's own data, the report estimates that at least 8,000 people
became seriously ill last year after taking some of the nation's most
popular drugs for off-label purposes.

Among the report's findings on prevalence of off-label prescribing:
21 percent of the prescriptions examined were for off-label uses
115 million off-label prescriptions for the drugs analyzed by Knight
Ridder were written in the U.S. last year, nearly double the number of

five years ago

As many as 90 percent of the prescriptions for some drugs were
off-label uses.
Three-quarters of anti-seizure medications are prescribed off-label,
as are nearly two-thirds of antipsychotics and about one-quarter of
antidepressants
Some Drugs Sold Mostly for Unapproved Purposes

The report tracks some of the most widely prescribed drugs in the U.S.
It found that doctors are giving their patients epilepsy drugs for
depression, hot flashes and to help them lose weight. They use
antidepressants to treat premature ejaculation and pain, and powerful
antipsychotics for insomnia and attention deficit disorder. High
blood-pressure pills are prescribed for headaches and anxiety;
antibiotics are used to treat viruses.

Eight out of 10 prescriptions for the epilepsy drug Topamax aren't for
epilepsy. Thalidomide, the morning-sickness drug that caused horrible
birth defects and ushered in today's FDA drug-safety rules, even is on
the market, and 99 percent of its prescriptions are off-label.

Methodology

To calculate how often drugs are prescribed off-label, Knight Ridder
analyzed the three top-selling drugs in 15 classes of medications,
comparing what doctors said they prescribed them for with the FDA's
approval for each. The analysis looked at 900 million prescriptions
written in 1998 and 2003 for more than 1,000 different ailments. Its
estimate of the prevalence of off-label prescribing excluded cancer
treatments or pediatric off-label uses, because they already are known
to have a large percentage of off-label use.

To estimate how often patients are harmed by this practice, Knight
Ridder reviewed the FDA's database of adverse drug reactions. The FDA
estimates that only 1 to 10 percent of reactions are reported. Knight
Ridder identified more than 800 reports filed during 2002 of serious
reactions involving off-label prescriptions for its sample of 45
drugs. Experts say that means anywhere from 8,000 to 80,000 people
probably were affected.


--
‘All policymakers must be vigilant to the possibility of research data being manipulated
by corporate bodies

and of scientific colleagues being seduced by the material charms of
industry.

Trust is no defence against an aggressively deceptive corporate sector.’

Editorial (2000). Resisting smoke and spin. Lancet 355, 1197.