[at-l] FantasyLand <OFF TOPIC> {Was: Did Any of You See This?---}

[jbryankramer at msn.com (J Bryan Kramer)]

You know you are a real horse's ass, are you capable of polite discourse?

The drug was Tambocor or flecainide. The surrogate that the drug was tested
for was ekg changes. And apparently several thousands of people died.

"The medical community was looking for an oral lidocaine. ... In the 1980s,
the experience in the coronary care unit showed that lidocaine given by vein
could get rid of irregular heartbeats and prevent your heart from
fibrillating -- that's where your heart just stopped pumping. That
experience led physicians to say, "We need a pill to be able to treat
patients which come to see us who may or may not have had a heart attack.
But they've got an irregular heart rhythm, they can feel the palpitations,
they can feel their heart skip. We want to get rid of that, because we think
it puts them at risk for sudden death."

A lot of the companies were developing these drugs. Patients were prescribed
medicines to make their heart rhythm regular, hoping it would prevent death.

But when the cardiac arrhythmia suppression trial [CAST] was done, we found
that even though the cardiogram was looking better and the irregular
heartbeats were gone, there were actually twice as many deaths in the people
taking encainide or flecainide, another medication known as Tambocor, than
the people taking placebo. So Tambocor stayed on the market with major
restrictions, encainide was removed, and it stopped the development of a
whole class of drugs, because we recognized a toxicity that would never have
been found if the NIH hadn't done a prospective, randomized, controlled
trial. . "

http://www.pbs.org/wgbh/pages/frontline/shows/prescription/interviews/woosle
y.html

your preferred socialial peoples broadcasting system website too, the book
was:

DEADLY MEDICINE by Moore

"Moore makes clear that proof of the effectiveness (much less the safety) of
Tambocor has never been adequately established. Approval was based on a
theory that by suppressing premature ventricular complexes (PVCs) doctors
would save their patients from sudden death. There was no evidence for such
a theory. This was the pet idea of some of the marquee
professors--convenient, since drugs existed to stop PVCs. But the theory
turned out to be wrong, tragically wrong. And hundreds of thousands of
people may have lost their lives because of this drug company inspired
theory. It makes one wonder where exactly is the "science" in "scientific
medicine"?

What finally exposed Tambocor was an NIH clinical trial called the Cardiac
Arrhthymia Suppression Trial (CAST). This showed that Tambocor and Enkaid
caused dramatically more deaths than did the placebo. The story of how this
test unfolded is extremely detailed and at times may be difficult to follow.
But it is worth whatever effort you put into understanding it. Moore's book
explains, better than any other writings I know, how drug companies
manipulate the whole testing process. One small bright spot is that NIH
officials come off better in this account than you might expect, especially
when viewed in comparison with FDA."

http://www.ralphmoss.com/cach381.html


Sorry I wasn't able to satisfy you instantly with the book title and drug
name, I read hundreds of books a year and they tend to blur together. A
problem I know you don't have since its so hard to insert a book up your
anal cavity where your head is.

Bryan




 Lex et Libertas -- Semper Vigilo, Paratus, et Fidelis!

> -----Original Message-----
> From: W F Thorneloe [mailto:thornel@attglobal.net]
> Sent: Saturday, July 17, 2004 14:59
> To: J Bryan Kramer; at-l
> Subject: RE: [at-l] FantasyLand <OFF TOPIC> {Was: Did Any of You See
> This?---}
>
>
> Oh, some book you saw a few years ago - but can't recall the name or the
> examples. _They_ must have made it up.
>
> Yeh, right.
>
> Bryan, try reading on this topic at www.FDA.GOV You might take a
> shortcut to
> http://www.fda.gov/fdac/special/newdrug/ndd_toc.html which
> reviews the process
> from animal trials, human trials and larger population efficacy
> studies. It
> even reviews MedWatch, a program to detect problems post-approval
> when a large
> enough population takes a drug to demonstrate rare but
> significant problems.
> Sometimes, drugs are even withdrawn from the US market.
>
> Yes, researchers like to propose a pathophysiological reasons/theories to
> invest millions in researching a chemical. We have many great stories of
> serendipitus discoveries, but those are becoming increasingly
> rare. I really
> would like to see if you can find a single drug approved by the FDA solely
> because a pharmaceutical company claimed that it would have an
> effect on an
> enzyme/marker/anything, and never looked at any supporting
> evidence for safety
> and efficacy.
>
> OrangeBug
>
> --- J Bryan Kramer <jbryankramer@msn.com> wrote:
> > I picked up a book at the library a couple of years ago which describes
> > what's now happening. Apparently the FDA allows drug companies
> to show that
> > some biochemical marker is reduced by the drug treatment. For
> instance if
> > enzyme x27 is *thought* to be a marker for heart failure; then
> a drug that
> > reduces enzyme x27 would be allowed to be marketed for
> treatment of heart
> > failure. The drug never has to be shown that it effectively
> reduces disease
> > mortality, just the marker reduction. There is some name for
> this theory but
> > it escapes me at the moment.
> >
> > The example the author used was some major drug released for
> heart failure
> > under this theory that proceeded to kill a lot of patients. I
> don't recall
> > the name of the drug but it was ten years or so ago.
> >
> > There was also a lot of covering up going on by the drug company in that
> > particular case. I can try to dig up the name of the book if anyone is
> > really interested.
> >
>