Steve <fjqi@hdsx.inv> wrote in news:0cq5t09gj6h6ie5b3tgo5it6m229kbrs77@
4ax.com:

I think you're putting words into Mr. Rubin's mouth. He never used the word
"poison".

And what of drugs that attempt to interfere with the body's abnormal
functioning? Are they "poison" too?

L.

Quite so. And even in the case of so called abnormalities...what we are
sure we know today may not be the case tomorrow.

HRT was promoted on the basis that menopause is an illness. Must treat.
Must introduce a substance (poison) that the body never could make even
prior to menopause: estrogen from pregnant mares.

Cholesterol is promoted as being dangerous in all but the lowest
numbers. Yet our bodies produce it. Are we sure a continually changing
danger level (determined by scientists in conflict of interest) is a
pathology? Maybe we should exercise, reduce stress, stop smoking and
drinking to excess, and follow prudent diet; consistently, throughout
our lives, and not just temporarily for three months before we agree to
take a poison designed and proven to lower cholesterol (but little
else).

Zee

"A new analysis of four-year-old data shows a 'significant' increase in
heart attack and stroke in patients taking Vioxx after as little as six
weeks."

http://www.forbes.com/technology/2004/12/30/cx_mh_1230vioxx.html

Vioxx: More Debate, More Data
Matthew Herper, 12.30.04

As doctors struggle to come to grips with what the withdrawal of Vioxx
means for drug safety, the letters pages of the normally sedate New
England Journal of Medicine have turned into a battleground.

Today's issue contains a letter from Merck, defending itself against
charges from Dr. Eric Topol, the Cleveland Clinic's top cardiologist,
who has said repeatedly that the company should have known far earlier
that Vioxx increased the risk of heart attack.

It also contains Topol's response, in which he publishes a new analysis
of four-year-old data that he says shows a "significant" increase in
heart attack and stroke in patients taking Vioxx after as little as six
weeks. The data was previously available only in briefing documents
prepared by staff at the Food and Drug Administration.

The fight is more than just academic. The dueling letters are one of
the few times that Merck's scientists have publicly defended their
approach to the drug since the company pulled it off the market. And
Topol's analysis seems to show that even if Merck wasn't aware of the
possible risks to the heart posed by Vioxx, perhaps it should have
been.

In their letter, Peter Kim, Merck's research chief, and Alise Reicin,
who headed up much of the development of Vioxx, defend their company's
handling of the matter. "Merck has been proactive and conscientious in
evaluating the cardiovascular profile of rofecoxib (Vioxx)," they
write. "Dr. Topol's remarks to the contrary in his Perspective article
(Oct. 21 issue) are false."

Before 2000, they say, there was little clinical evidence of a heart
risk for Vioxx. Based on a theoretical risk alone, the executives
argue, Merck took care to watch for heart attacks and strokes in its
big clinical trial. The data from both less-reliable observational
studies and clinical trials was conflicting, and Merck began three big
cancer prevention studies that could also assess any risk Vioxx caused
to the heart. One of these studies was the one that resulted in Vioxx
being pulled from the market.

"The record, in short, is one of careful analysis at every stage, a
continued commitment to research and prompt and decisive action in
response to clinical-study results," the scientists say.

Merck's defense all along has been that Vioxx looked bad because
naproxen, another pain killer that it was compared to, actually
protected the heart. Naproxen is an older drug sold by Bayer as Aleve.

But in his response, Topol looks at data from a previous study that
compared 390 patients taking Vioxx to 588 patients taking a placebo.
The study, called 090, showed that five, or 1.3%, of patients taking
Vioxx had heart attacks or strokes, compared to one, or 0.2%, in the
placebo group. Although those numbers are small, they were
statistically significant, according to Topol. The data he based his
analysis on has previously been buried in FDA briefing documents.
Merck's Peter Kim has said in interviews that '090' was too small to be
considered a strong result.

For those that have been following the underlying scientific fight over
the testing of Vioxx, the letters are an interesting new twist. But
unfortunately for Merck, at this point the important forum for these
questions is not in The New England Journal of Medicine, but in the
courts, where the first Vioxx liability case could go to trial in 2005.
================================================================

Usually, the latter can be found in the PDR material, and
occasionally comparison with placebo.  If the drug is not
enough better than placebo, the FDA is unlikely to approve
it as it stands.  The information about the tests and their
results should be readily available, and the advertising
should say where it is.  The manufacturers will supply this
if required.

As to comparing different drug options, finding this
information is quite difficult now, and the physicians
normally do not have any comparison; they may know the
options.  With advertising, the public is likely to know
the options.  When it comes to comparing the options,
individual variations come in quite strongly; for a
doctor to ignore these is bad medicine.

This will not change if advertising is prohibited.  

I doubt if the usage of Vioxx and Celebrex would be any
less if there had been no advertising.  These are Cox-2
inhibitors, and for those with stomach or other sensitivity
to the usual NSAIDS, they were the drugs of choice before
there was advertising.  Advertising may have increased the
number taking them, but those who changed to them would
not have been considered doing anything worse than possibly
spending more than necessary.

The advertising is required to provide a fair amount of
information about side effects; the physicians do so
much less often.  In fact, most physicians do not know
as much as is included in the advertising.

It is not so much research, as development.  From the time
research, theirs or others, has produced a promising chemical,
until it is approved for the company to make available, is
likely to cost a half billion or more.  Also, the ones which
do not end up being marketed, but which are tested, are likely
to run to 100 million on the average.  And if the FDA does not
think they have done enough testing, back it goes.

The cost of testing is not the drug, per se.  It is the medical
care of those being tested, whether given the drug or a placebo
or an alternative.  There is the question of dosage, and it may
be necessary to test different dosages on thousands of people.
The "worst case" scenario is not often, but all of this enters.
It is for this reason that patents on drugs last at least until
10 years after the drug is approved for marketing; it may take
more than 10 years from the discovery of the chemical and its
possible usefulness for the approval to occur.

Do you ever want to get a useful drug?  If a drug is
suspected of increasing the cancer rate ten years down
the line, it would be at least 10 years of substantial
use before the drug can be used for any but experimental
patients.

The Rezulin problems were about one in 50,000, even
without liver testing.  For HRT, many studies of
several years produced no indication of an increase
in cardiovascular problems, until there was a long
study with carefully randomized patients.  This is
very difficult to do, as for any long study, many will
drop out.

At this time, it seems the AMA at least wants to restrict
information.  In fact, our miseducational system has done
its best to see that laypeople have difficulty in finding
and getting the information, as does the medical establishment
until recently.  Instead of advertising, we will have people
looking in the literature and finding a posting of some kind,
and there are many of those now, and disseminating it.  These
disseminations are not as subject to regulations as advertising.
I have followed up on several of those, and find them to be
lacking, including some on which medical decisions have been
based by those whose knowledge of statistics is pure religion.

If you do not allow this, you will not be able to get any
drugs.  Have you seen the suit about children's Aleve?
Considering that millions take it, do you not think that
someone will react badly?

We certainly can see that the medical information is
translated.  For those with cognitive "challenges", we
have problems in any case.  If a manufacturer states
that one in 10,000 may get such a side effect from the
drug, should there be any liability if that side effect
occurs to that one?  Take a look at any drug in the PDR,
and see the information on side effects and indications
of serious adverse reactions.  Much of that is required
to be in the advertising.

As I stated, the drug advertising I have seen in magazines
and on television is quite fair.  For prescription drugs,
one would have to see a doctor in any case.

It is often the case that a patient has more available
evidence than most physicians.  There was even one case
when I asked a faculty member at a medical school about
certain properties of a drug.  He considered the question
reasonable, but did not find the information in the
medical sources in his office.  It took some "googling"
by me to find it.

No, it would not.  If someone sues a manufacturer for
events warned by the manufacturer, the one suing
would have to pay all costs, including the costs of
the manufacturer defending it.  The same would be the
case for suits against doctors for not achieving the
best possible results.

The present litigous system is due to expecting that
all drugs are "safe and effective", and that if there
are bad results in an operation, the doctor must have
done something drastically wrong.  We need to educate
people to the fact that everything has risks and
benefits, and as long as they, including the best
estimate of the odds, are clearly stated, that there
is no liability for poor results.

Not only would we have to educate the public, but the
physicians.  They do not know how to think that way.
We also are likely to need to provide computer programs
for the evaluation; I am quite adept at both theory and
computation, and I am likely to need that.