Politics and Medicine - FORBES: Five Ways To Fix The FDA

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FORBES: Five Ways To Fix The FDA

Ilena Rose

2005-01-14, 7:14 pm

~~~ Thanks Linda ~~~

http://www.forbes.com/2005/01/12/cx...12fdaintro.html

NEW YORK - The U.S. Food and Drug Administration may have the world's
toughest job.

A quarter of every dollar Americans spend annually--some $1 trillion
in total--is regulated by the FDA. From the start, the safety of
medicines has been the agency's most sacrosanct calling. The FDA was
founded after a 1937 incident in which a poisonous medicine killed 107
people, most of them children.

Since then, the FDA has become synonymous with drug safety. In a
sense, "FDA approved" is the brand that the entire $216 billion U.S.
drug market is founded upon. Dilute the confidence of the public in
the agency, and many billions of dollars in current and potential
sales vanish overnight.

That's exactly what's happening right now in the wake of the biggest
drug withdrawal ever. Last September, Merck (nyse: MRK - news - people
) pulled Vioxx, its $2.5 billion arthritis drug, after it found that
the drug doubled the risk of heart attack and stroke. Very worrisome
but less conclusive evidence has also linked Celebrex and Bextra, both
made by Pfizer (nyse: PFE - news - people ), to some heart risk.
Celebrex and Vioxx have been on the market for five years.

It's possible that tens of thousands of heart attacks would have been
prevented if these drugs had been subjected to more scrutiny. Did the
FDA fall short? And if it's broken, how do we fix it?

Searching for answers, we asked experts in drug safety what they
thought was wrong, and how to fix it. Based on their answers, we've
come up with a five-step plan for making sure medicines are safe.

This can be done without slowing the path of life-saving drugs to
patients, and, although it will cost a great deal of money in the
short term, it could save the U.S. government money in the long run by
making sure that the benefits of the medicines we take outweigh the
risks.

It's vital that change comes quickly, because right now the current
crisis in drug safety could well push the agency in the wrong
direction. Here is our five-step plan. Please click on each fix for a
full explanation of what needs to be done.

FDA Fix 1: Pay Up
How do we expect to police a $216 billion industry on $300 million per
year?

FDA Fix 2: Power Up The FDA
Give the FDA powerful sticks and carrots to compel drug companies to
test their medicines more thoroughly.

FDA Fix 3: Track Side Effects
In order to make sure that medicines are safe, we need to find new
ways to track existing drugs.

FDA Fix 4: Fund Drug Studies
Right now, we depend entirely on companies to test the drugs they sell
us. That's not smart medicine, and it's bad economics too.

Mark Probert

2005-01-14, 7:14 pm

"Ilena Rose" <ilena@san.rr.com> wrote in message
news:gs5gu0h1qfqsneps228pe524fku556i4q3@4ax.com...
> ~~~ Thanks Linda ~~~
>
> http://www.forbes.com/2005/01/12/cx...12fdaintro.html
>
> NEW YORK - The U.S. Food and Drug Administration may have the world's
> toughest job.
>
> A quarter of every dollar Americans spend annually--some $1 trillion
> in total--is regulated by the FDA. From the start, the safety of
> medicines has been the agency's most sacrosanct calling. The FDA was
> founded after a 1937 incident in which a poisonous medicine killed 107
> people, most of them children.
>
> Since then, the FDA has become synonymous with drug safety. In a
> sense, "FDA approved" is the brand that the entire $216 billion U.S.
> drug market is founded upon. Dilute the confidence of the public in
> the agency, and many billions of dollars in current and potential
> sales vanish overnight.
>
> That's exactly what's happening right now in the wake of the biggest
> drug withdrawal ever. Last September, Merck (nyse: MRK - news - people
> ) pulled Vioxx, its $2.5 billion arthritis drug, after it found that
> the drug doubled the risk of heart attack and stroke. Very worrisome
> but less conclusive evidence has also linked Celebrex and Bextra, both
> made by Pfizer (nyse: PFE - news - people ), to some heart risk.
> Celebrex and Vioxx have been on the market for five years.
>
> It's possible that tens of thousands of heart attacks would have been
> prevented if these drugs had been subjected to more scrutiny. Did the
> FDA fall short? And if it's broken, how do we fix it?
>
> Searching for answers, we asked experts in drug safety what they
> thought was wrong, and how to fix it. Based on their answers, we've
> come up with a five-step plan for making sure medicines are safe.
>
> This can be done without slowing the path of life-saving drugs to
> patients, and, although it will cost a great deal of money in the
> short term, it could save the U.S. government money in the long run by
> making sure that the benefits of the medicines we take outweigh the
> risks.
>
> It's vital that change comes quickly, because right now the current
> crisis in drug safety could well push the agency in the wrong
> direction. Here is our five-step plan. Please click on each fix for a
> full explanation of what needs to be done.
>
> FDA Fix 1: Pay Up
> How do we expect to police a $216 billion industry on $300 million per
> year?
>
> FDA Fix 2: Power Up The FDA
> Give the FDA powerful sticks and carrots to compel drug companies to
> test their medicines more thoroughly.
>
> FDA Fix 3: Track Side Effects
> In order to make sure that medicines are safe, we need to find new
> ways to track existing drugs.
>
> FDA Fix 4: Fund Drug Studies
> Right now, we depend entirely on companies to test the drugs they sell
> us. That's not smart medicine, and it's bad economics too.

You missed the last one:

FDA Fix No. 5: Forget Labels
Adding warnings to drugs has a limited effect. Does the FDA need its own ad
agency?

This article is right on the money, and expresses my concerns.

Herman Rubin

2005-01-20, 7:07 am

In article <aUUFd.1903$Vb3.1873@fe08.lga>,
Mark Probert <Mark Probert@lumbercartel.com> wrote:

>"Ilena Rose" <ilena@san.rr.com> wrote in message
>news:gs5gu0h1qfqsneps228pe524fku556i4q3@4ax.com...
[vbcol=seagreen]
[vbcol=seagreen]
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Those who have this STUPID attitude are the real menace.

Every substance has risks and benefits. Instead of the FDA
deciding on what is "effective" and what is "safe", both of
which involve subjective judgments, the job of the FDA is to
see that honesty prevails, that the public is given the known
information, including the bad information, and that the
individual has the right to make the decision.
[vbcol=seagreen]

From what to what? Over the period of the study, how high
did it make the risk? Is this a continuing increase in risk,
or are a small proportion of people at a considerably higher
risk? And what are the benefits? ALL of the arthritis drugs
have side effects, and what works for one does not necessarily
work for another.
[vbcol=seagreen]

The other direction has its flaws. How many people would have
been saved from accidental death if Thalidomide had been left
on the market with appropriate warnings? I have seen an estimate
of 6000 per year around the time it was banned.

The FDA has been accused of causing many deaths by taking so
long to approve beta blockers. My diabetes treatment might
well be quite different if metformin had been approved a few
years earlier; it had been used for a long time in Europe.
[vbcol=seagreen]
[vbcol=seagreen]

It is not just life-saving drugs. If you take that
attitude, would Vioxx or Celebrex or Naproxen be even
considered? The relief of pain is a legitimate reason
for approving a drug, and all pain relievers have risks.
One suggested remedy, to add an acid inhibitor to an
acid-producing pain relieve, increases the chance of
infectious disease. NOTHING is safe.
[vbcol=seagreen]
[vbcol=seagreen]

How well are foods protected? Much less than drugs.
[vbcol=seagreen]

NO! Make them, as some are now doing, provide the full
information. The actual testing, for a drug like Vioxx
runs to about a half billion, and this is under somewhat
unusual (and costly) conditions. What is needed is to
have followups, and this must be done by the physicians
in the field; all side effects of all drugs are supposed
to be reported. This would still not find an increased
risk of cardiovascular problems, which might or might not
be due to the drug; one cannot conduct the proper type of
test to make it clear in humans. Look at the problem with
the use of HRT; here even the early large tests indicated
decreased risk of side effects, and only a long prospective
test showed the contrary. We cannot wait ten years for
side effects to show up.
[vbcol=seagreen]

Agreed. But this involves the physicians, not the manufacturers.
[vbcol=seagreen]

And how many studies of this kind are you going to fund?
The companies that test the drugs put in half a gigabuck
for drugs approved, and 100 megabucks on those which do
not make it, and this takes many years. Do you think that
it will cost less if done by the government? The FDA now
decides when enough testing is done.
[vbcol=seagreen]
>You missed the last one:

>FDA Fix No. 5: Forget Labels
>Adding warnings to drugs has a limited effect. Does the FDA need its own ad
>agency?

I disagree; it is not an "add agency", but the user of the
drug should be entitled to all the available information.

Drugs do not work the same for all people, and the information
needs to be given in such a way that the person can make a
better decision on what to take, based on his evaluation of
his condition (with information from the medical profession)
and his evaluation of the various consequences. This is
something the government should not even be allowed to do.

That more people do not understand the present information,
or could not use more, is the fault of the government and the
miseducational establishment. Legislators and bureaucrats
need to be personally responsible for go/nogo decisions, and
have no immunity from lawsuits for this. Manufactureres should
be immune if they provide all the information they have, and it
is honestly obtained. The FDA should generally be limited to
seeing that this is done, and possibly adding to the caveats,
but not make decisions.

>This article is right on the money, and expresses my concerns.

No, it is not "on the money"; the government cannot be trusted
to act in the interest of the citizens, and protecting the
stupid by keeping the intelligent from using their brains to
make decisions, which is being done too often, is the mistake.

--
This address is for information only. I do not claim that these views
are those of the Statistics Department or of Purdue University.
Herman Rubin, Department of Statistics, Purdue University
hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558