The following discussion on the FDA and empirical analysis grew out of the
following event. I run a mailing list for discussion of
General Semantics,
and sometimes someone posts something a little controversial. A biology
professor posted a pro-FDA article, and I responded by resposting a speech
of mine on
"Why the FDA Should be Privatized". He responded and I
started forwarding posts to the LibProfs Forum ...
=====================================================================
>Date: Fri, 2 Aug 1996 20:59:56 -0700
>From: jmlib (jmlib)
>To: libprofs
>Subject: FDA thread
Recently on my general-semantics list a biology professor posted a
pro-FDA post ... and I couldn't let it slide. So, I posted a speech
I gave about a year ago, and he responded. It looks like he is more
familiar with this kind of material than I am, and I thought a few of
you could easily rebut many/most/all of his points. Here is his post:
---------------------------------
John McPherson wrote:
> There is evidence that the FDA approval lag has
> resulted in _more_ deaths than would have resulted if it were
> replaced with a variety of free-market certification agencies
> and more appropriate anti-fraud policies.
One problem, John, is that we don't know how much your proposal will cost in
dollars or lives. 'New and improved' systems in complex areas like health
care usually cost less, save lives and work better than the present system
... until they are imposed on us guinea pigs! It's easier to see the flaws
in an existing system than in systems that exist only 'on paper.'
> You can see that this is indeed a major problem, but you probably want to
>know just how many people we're talking about here. According to George
>Hitchings, co-winner of the 1988 Nobel prize in medicine, the FDA's 5 year
>delay in approving the anti-bacterial drug Septra cost 80,000 lives. During
>their 10 year delay in allowing propanolol, a beta-blocker for treating
>angina and hypertension and preventing the recurrence of heart attacks, the
>FDA let approximately 100,000 Americans die by withholding that treatment
>>from them.
Were these figures presented in the context of a refereed science journal so
that qualified scientists could review them for reasonableness? What were
the responses to these numbers from statisticians and epidemiologists? A
Nobel Prize in medicine is not the same as a Nobel Prize in health care
economics or epidemiology.
Your examples are a great illustration of selection bias (seeing what we
want to see). You ignore the lives and money saved by the many drugs that
were found useless and/or harmful by the screening process.
> The FDA's extreme politically-biased overcaution would probably
>cause them not to approve penicillin, fluroxene, cortisone, digitalis and
>other life-saving drugs if they were up for approval today, with the
>consequent loss, of course, of thousands upon thousands of lives. A 2-year
>delay in a cancer therapy that reduces mortality by only 10% would cost
>about 66,000 lives - many many more than have died from _all_ cases of drug
>toxicity in this entire century.
If your statistics are true, John, you may be making an argument in favor of
the FDA. Sounds like the agency may have done a pretty good job keeping
deaths from drug toxicity low.
> This political effect is almost enough of an indictment against the FDA
>to shut them down immediately as a danger to society! Still, we hold onto
>the hope that they will prevent tragedies, such as that of Thalidomide. We
>are continually reminded of how the FDA was supposed to somehow be responsible
>for preventing it in America. Well, I have some interesting new for you :-).
>Thalidomide prevents normal limb development in the fetuses of humans,
>monkeys, and one strain of rabbits. So, if animal testing had been performed,
>as it eventually would've in the FDA's sluggish approval process, with
>standard tests with rats and dogs, _the FDA would have approved Thalidomide
>anyway!_ As it turns out, they were saved by default by their bureaucratic
>lag, while the unfortunate, and inevitable, data came in from human fetuses.
Who knows how many cases of 'thalidomide' the FDA has prevented? Have you
reviewed the hundreds of cases where the FDA rejected a drug for failing
safety tests or put special warnings on drugs pertaining to vulnerable
groups of people? We know about thalidomide only because it slipped through
the safety net in Europe. How can you make statements about how many lives
the FDA has cost us if you don't have all these data?
> In truth, there is no such thing as a drug that is safe for everyone.
>Even life-saving penicillin has killed those who were allergic to it. If
>the FDA attempts to license only drugs that are completely 100% safe, then
>they will not approve any new drugs at all, and thousands who otherwise would
>live will die.
This we can agree on. One reason we take the time to do studies is that we
want to find out what the side-effects of a drug will be. If they are too
severe relative to what we are treating (if they do more harm than good),
they will not be approved. Most, if not all, drugs have side effects ... but
they are approved anyway with the appropriate labelling.
> Related to the thalidomide story is an example on the other side of the
>coin. Aspirin deforms the fetuses of almost every animal species _except_
>for humans, so it's almost sure that the FDA wouldn't approve it if it were
>a new treatment today. The irony is that over a dozen clinical studies have
>demonstrated that taking one aspirin every other day reduces the risk of
>heart attack, at least in males, by over 44%. As surprising as that may
>sound to you, these results are widely acknowledged by doctors and scientists, >and you might be wondering why you haven't heard about it. The FDA, in its
>infinite wisdom, has specifically prohibited aspirin companies from
>mentioning this in their advertising and labelling ... because it might
>"encourage people to medicate themselves"! Can't have people taking
>responsibility for their own lives and health, now can we?
Actually, the FDA has approved the use of aspirin as a therapeutic tool for
reducing the probability of a second heart attack. Ads on TV for at least
the past couple years have been informing the public of this use too. I saw
one within the past two weeks. Meanwhile, you can take aspirin for whatever
purpose you want. The FDA will not come get you. Moreover, your doctor is
legally free to prescribe any prescription medicine for you that the doctor
feels would be useful even if the FDA has not approved the drug for that
use. All you got to do is talk her into it. In addition, the FDA allows you
to import for personal use medicines approved in other countries. Last time
I checked (a year and a half ago) your 'life extension foundation' was one
of these importers.
> Clearly, the FDA, a monopoly institution based on the forceful suppression
>of new therapies, has got to go. But how, you may ask, can we have adequate
>mechanisms of consumer protection and minimize the deaths that will occur
>whichever path we take?
If we can move down the abstraction ladder a bit here ... I don't think
Congress authorized the FDA to "forcefully suppress new therapies." Instead,
they instructed the FDA to prevent new therapies from being introduced
wholesale to the public before testing for safety and effectiveness.
Meanwhile, if you can't wait to try a new therapy, the National Institutes
of Health (NIH) and its subsidiary agencies have toll-free numbers you can
call to get information on experimental therapies that are enrolling
applicants ... er, guinea pigs.
> Once we end the aggression of drug licensing laws, patients and their
>doctors could buy whichever drugs they felt might be helpful, regardless of
>the stage of testing. Since they wouldn't be competent to evaluate each
>drug themselves, they would rely on professional and consumer's groups for
>status reports. One such advisory group was the AMA's Seal of Approval
>Program which operated before the FDA ascended the throne. They tested new
>drugs and cosmetics in their own labs, rather than relying on the bureaucratic
>"solution" of merely reviewing reports, as the FDA does.
The FDA is about as close as we get to having a science-based government
agency. The FDA was set up initially to regulate the safety of our food
supply in 1906. It was not until 1938 that Congress extended the FDA
jurisdiction to include regulating new drugs. Before 1938 virtually all
drugs in America were sold 'over-the-counter.' The drug manufacturers didn't
have to prove safety or effectiveness. There were relatively few drugs
available back then -- the first antibiotic, penicillin, wasn't available
until WWII -- and most of these unregulated 'drugs' amounted to 'snake oil.'
Some proved to be deadly. That's why Congress gave the FDA this added mandate.
The FDA is not a testing agency. Most of the drug tests are done by
scientists at the drug companies, in universities, or private testing
facilities. The FDA sets the standards for the tests and hires scientists to
evaluate the data when the tests are completed. Within the past month the
FDA assembled a panel of prominent scientists to evaluate data on the safety
and effectiveness of the 'abortion' pill.
So you want to give the FDA's drug regulating chores to a private group ...
maybe Consumers' Union or the AMA? Unless you plan to lower the standards
for safety, any private agency will still need the experimental data and the
qualified scientists to evaluate the data. These are not the 1930s John.
There are hundreds of drugs in various stages of rigorous testing in the
U.S. each year. Has the AMA indicated they want to take on this chore? I
doubt they would because they know that you would be pissed off at them
within a couple years too. Are you going to protect these private approval
groups from lawsuits if they make a bad decision? As soon as a private group
"approves" a drug that does significant harm they will be deluged with
lawsuits and public outrage. If the 'life extension foundation' recommends
you take hydergine to live forever and you get cancer in 10 years ... you'd
probably be suing them too! As soon as a couple unapproved drugs do major
damage the public pressure on these private agencies will be enormous. Soon
they too will become more cautious ... or Congress will have to re-establish
the FDA! We call it the law of the pendulum.
> It's an unfortunate reality that sometimes people will not want to wait
>for certification, but we have to respect their choice. Afterall, sometimes
>they simply don't have the time to wait.
Some people do not wait today ... they are the 'guinea pigs' for the rest of
us in the studies that are done to test new drugs on humans. Your doctor can
sign you up if you fit the criteria. Or if you are desperate enough, you can
usually find a smooth-talking quack right here in America, as the NYTimes
article revealed, who will treat you with about any hocus pocus you want. Or
you could go to your neighborhood drug house and buy cocaine or heroin.
Just don't dump the bill for your unproven therapies on my insurance company
or me, please! Unfortunately, you probably will, along with the smokers,
bikers who refuse to wear helmets, drunken drivers ....
>The rest of us do, however, and we
>will almost surely support a variety of testing and evaluation groups, which
>provide their members with newsletters and alerts. This is being done today
>on a small scale by "The Medical Letter on Drugs and Therapeutics" and by
>The Life Extension Foundation and other groups.
Some "unexpected tragedies" like cancer or heart disease or alzheimers may
take years to develop. One reason for "delays" in testing is to evaluate the
long-term effects of a medication. "The Life Extension Foundation" is hardly
a scientific group qualified to judge the safety and effectiveness of new
therapies! I cringe at the idea of turning the therapeutic evaluation
process over to pop philosophers like Saul Kent or Durk Pearson or Sandy
Shaw. I encourage you go to a medical library and peruse some of the
research journals to appreciate the difference between rigorous research and
the pabulum that Saul, Durk and Sandy publish. Libertarian 'philosophers'
with an axe to grind because the FDA raided their 'vitamin-drug' warehouse
because they were making outrageous claims for their products hardly qualify
as toxicologists in the drug approval process. On the contrary, the FDA
employs some of the most highly respected toxicologists in the country to
evaluate the data regarding new drugs and therapies. Sometimes the FDA takes
the recommendations of scientific committees formed by the NAS or AMA.
> A major problem with the FDA that I didn't mention is the enormous costs
>they impose on manufacturers. Due to their ridiculously high requirements,
>it now costs more than $231 million and takes about 12 years to bring a new
>drug to market. The costs are, of course, passed on to the consumers. And
>we wonder about the rising cost of health care! What may be worse is that
>this exorbitant imposed cost bars competition from smaller drug companies,
>so we end up with only a few huge firms and a greatly reduced pool of
>possible innovation.
You ignore the money we save by preventing worthless or deadly drugs from
getting to market, or by learning what groups should avoid certain drugs or
drug combinations. Most of the costs of doing drug testing today are the
results of the long-term studies that must be done to test for long-term
damage. You would rather pay that unknown bill 20 years later when you
develop cancer or premature senile dementia?
> After we privatize the FDA, these costs will be reduced tremendously,
>many more researchers will be able to participate, and we'll enjoy a much
>wider range of save and effective therapeutic drugs.
If you or your libertarian friends can demonstrate this in a scientific
journal to the satisfaction of the nation's best health-care scientists,
then sign me up! The polemics that Saul, Durk and Sandy .... send to the
public in their pamphlets hardly qualify as peer-reviewed journal articles!
Why don't you suggest they submit an article to the Journal of Public Health
or the Journal of Epidemiology ... to see how scientists trained in
statistical analysis and the economics of health care respond? Could it be
these "libertarians" don't because they represent more an intensional
'political' movement than one based on rigorous extensional research?
> Another very important measure we need to take concerns what to do about
>fraud, companies claiming to have certification or seals of approval. They
>would be made to compensate in full anyone who is harmed as a result, to make
>them whole again to the greatest possible degree, to right their wrongs.
Our policy today is to pay the price of safety and effectiveness up front as
much as possible, before the damage has been done. Still, many operate
outside the system, like the doctor in the NY Times article, refusing to do
the appropriate studies that could determine the effectiveness of their
treatment. In a society that mostly rejects evolution and accepts astrology,
these fringe medicine men thrive despite the best efforts of the FDA.
EDTA chelation therapy for arteriosclerosis has been evaluated and rejected
by scientist committees of the AMA and the FDA. Nevertheless, some
physicians continue to suck money from their patients using this therapy.
The FDA has been criticized by some consumer reporters as too lax; but this
is largely because the FDA lacks the funds to do proper enforcement.
>This measure effectively takes the profit out of crime and discourages
>negligence.
Not if you include in your definition of 'crime' the foistering of
ineffective therapies and unforeseen consequences onto the public.
> It thus serves to _deter future harm_. In cases where the
>harm cannot be totally undone, as in disability or death, the victims or
>their families might accept a monetary settlement as the best compensation
>available, and of course they could insist that repeat offenders be
>imprisoned to prevent them from harming others ... but this is going beyond
>the scope of this speech.
Sounds like the trial lawyers will be supporting your new health care plan.
> The bottom line is that there is little if any evidence that the FDA
>provides much protection, but there is massive evidence that it is causing
>a great deal of harm.
There are many scientific journals that deal with these issues, John. If
such a sweeping generalization about the FDA were supported by the facts,
then these facts and related conclusions would be widely published in
refereed journals. My purpose here is not to suggest that the present system
is 'the best of all possible worlds,' but to suggest we let the scientific
community lead us in this decision-making process so that we don't end up
creating a bigger mess.
Steven Lewis
http://www.kcmetro.cc.mo.us/pennvalley/biology/lewis/gs.htm
=====================================================================
>Date: Sat, 3 Aug 1996 11:30:18 -0700 (PDT)
>From: Robert Higgs
John,
I know of only one serious attempt to assess the relative orders
of magnitude of lives saved versus lives lost because of FDA drug
regulation (only one area of FDA regulation, of course). That is Dale
Gieringer's Stanford dissertation, which was summarized in part in his
article "The Safety and Efficacy of New Drug Approval," CATO JOURNAL 5
(Spring/Summer):177-201. One could criticize Gieringer's study in
various ways, but I do not see how the major conclusion could be
overturned, as Gieringer finds that the lives lost exceed the lives saved
by approximately an order of magnitude.
Many of the responses to your observations can be refuted fairly
readily just by making international comparisons. For example, the FDA
claims that it has successfully prevented the recurrence of a
"thalidomide-type" tragedy. But elsewhere in the world, absent FDA
jurisdiction, no such tragedy has recurred.
To me, the most interesting observation one can make--it's
expressed in the title of Gieringer's CATO article--is that neither the
FDA itself nor any of its friends in the medical establishment have, to
my knowledge, ever made any serious study to show that FDA's benefits
(even if defined narrowly as lives saved) exceed its costs (even if
defined narrowly as lives lost). Is it asking too much to require that
this leviathan rest on some scientific basis? If the matter is so
obvious, why has no one ever demonstrated the agency's net benefits? All
the FDA officials ever do is (1) to ASSERT that the agency does far more
good than bad and, when challenged about egregious actions, (2) to
retreat to the idiotic justification for their harmful actions that they
are just ENFORCING THE LAW. Whenever anyone criticizes FDA, the reply is
always: Where's your scientific study (fall-down-and-worship peer
reviewed and all that)? We have even more grounds for turning the
question around. In Gieringer's phrase, where is the scientific, peer
reviewed study showing that FDA's regulation does more good than bad?
It's true that the journals are full of articles that have some bearing
on this issue, but none--again so far as I know--dealing with it in the
comprehensive, multifaceted way that the question requires. Evidently,
we poor little nonscientists (who lacks the billions of taxpayer dollars
available to the pro-FDA researchers) are supposed to just assume that
everything is hunky-dorry because, after all, the scientific community is
not up in arms about FDA.
The whole business is a travesty.
Bob Higgs
=====================================================================
>Date: Sun, 4 Aug 1996 08:02:11 -0500 (CDT)
>From: Tibor R Machan
Dear John:
As far as I follow this dispute, both sides have various facts
and figures that bolster their position provided we do not pay any
attention at all to the issue of "whose life is it anyway." Both parties
can give reasons for why either private firms or government agencies
ought to address the safety issue. And no one can determine ahead of
time, beyond a reasonable doubt, which approach will offer the best
balance between safety and life enhancement. Free will can screw up and
paternalistic bureaucrats can succeed.
My confidence that free people on average do better at finding
this balance between life enhancement and safety does not suffice to
settle for me which public policy approach is best, the voluntary testing
of the free market versus the coercive testing of FDA type bureaucracies.
This is because that is at best a good generalization, with pretty good
general historical evidence in its support. Yet exceptions to the
general truth are not uncommon -- in other words, some coercive policies
do accomplish better results sometimes than policies that arise from
voluntary cooperation. In short, it is not an a priori truth that
freedom works, nor, however, is it proven without fail a posteriori. And
if one places one's confidence on the a posteriori case, one will always
find folks who are panicky enough about some issue that they don't care
that in general coercive measures work out less well than voluntary ones
- the need for immediate action or some such thing -- or as Mill called
it, "necessity" - will over ride the call for prudence.
What clinches the argument about whether to prefer voluntariness
over coercive measures - regarding whether safety or life enhancement
ought to be pursued - is the very general idea that human beings are, by
their very nature, free moral agents who ought to exercise their decision
making capacity as fully as possible.
This is not a plain empirical matter - it involves, after all, an
"ought." Yet if human life is normatively laden and has an indispensable
moral dimension, it is intellectually misguided to keep insisting on the
"empirical" method alone. That may fit some people's scientistic frame
of mind and give others the illusion that they are the good guys since
they are not dabling in the never-land of ethics and normative
politics. But it also ignores a very large chunk of reality and misses
out on some vital information. (Notice, as well, that the very idea that
the empirical or consequentialist approach is superior to others
presupposes a non-consequentialist, non-empirical notion - one that did
logical positivism so much intellectual, philosophical harm: there are
better and worse things in human living that cannot be empirically
established without vicious circularity!)
Since "ought" implies "can," the political freedom at stake in the
pro versus anti-FDA dispute is a precondition for a society that is fit
for human living where every adult is in the position to be a moral agents
and avoid being a ward of the state. So the FDA is a bad institution for
human community living, even if on and off its coercive measures save
lives without reducing life enhancement provisions. The coercive way is
morally wrong: it undercuts the voluntary aspects of human behavior,
thereby contributing to the abolition of morally significant choice in
people's lives.
John, in the past year our list has hashed out the
"consequentialist" versus "teleologist" versus "deontologist" debate, with
a good deal of side issues explored. Of course, no consensus was reached
- we are, after all, a bunch of individualists, too, which tends to
incline us toward an attitude of sticking to our idiosyncratic guns,
seeing even the most objectively evident, well argued positions in the
light of experiences and studies we take ourselves to have mastered quite
well. In short, lots of folks are proud and stubborn, present company not
excluded, and this will tend to lead us to prefer only our own take on an
issue, period. (No doubt many of us tend to cloak all this in various
intellectually respectable terms.)
The FDA issue is actually a particular instance of that general
debate. In fact, it is a very good one, seeing how both of the
disputants had a good deal of data to go on.
Best,
Tibor
=====================================================================
>Date: Mon, 5 Aug 96 10:08:30 PDT
>From: hanson@dosh.hum.caltech.edu (Robin Hanson)
Robert Higgs writes:
>I know of only one serious attempt to assess the relative orders
>of magnitude of lives saved versus lives lost because of FDA drug
>regulation (only one area of FDA regulation, of course). That is Dale
>Gieringer's Stanford dissertation, which was summarized in part in his
>article "The Safety and Efficacy of New Drug Approval," CATO JOURNAL 5
>(Spring/Summer):177-201.
I also found this older paper, estimating other costs and benefits:
Sam Peltzman (1973) "An Evaluation of Consumer Protection Legislation:
The 1962 Drug Amendments", Journal of Political Economy, 81:5, pp.1049-91.
Robin Hanson hanson@hss.caltech.edu http://hss.caltech.edu/~hanson/
=====================================================================
>Date: Mon, 5 Aug 96 10:22:21 PDT
>From: hanson@dosh.hum.caltech.edu (Robin Hanson)
Tibor writes:
>if one places one's confidence on the a posteriori case, one will always
>find folks who are panicky enough about some issue that they don't care
>that in general coercive measures work out less well than voluntary ones
>- the need for immediate action or some such thing -- or as Mill called
>it, "necessity" - will over ride the call for prudence.
I am working on a paper which offers a game-theoretic formalization of
this intuition. This will most likely be my job talk in the economics
market this . An tentative title and abstract is included below - the
paper is waiting on my proving my main theorem.
>What clinches the argument about whether to prefer voluntariness
>over coercive measures - regarding whether safety or life enhancement
>ought to be pursued - is the very general idea that human beings are, by
>their very nature, free moral agents who ought to exercise their decision
>making capacity as fully as possible.
The problem with this argument of course is that most folks aren't
committed to the premise of your implication.
Robin Hanson hanson@hss.caltech.edu http://hss.caltech.edu/~hanson/
--------------------------------------------------------------------
A Model of Paternalism - Why Good Regulators Ban (vs. Lablel) Products
If consumers were rational, if a product were "private"
(competitively marketed with no use-externalities or signaling
functions), and if regulators simply had better information, then
instead of banning this product, consumers should prefer regulators to
impart the equivalent information by requiring a simple clear "would
have banned" label (perhaps a standard red X).
Regulators do, however, ban many products. Economists mostly
explained this behavior as due to non-private products or captured
regulators. But most product bans, including professional licensing,
building codes, and food, drug, and financial security approval, are
politically justified as preventing consumers from hurting themselves.
We should predict, however, that largely uncaptured regulators would
ban many private products to prevent rational consumers from hurting
themselves. This is because regulator labeling is a cheap talk
signaling game, and so even a small degree of expected regulator bias
can dramatically reduce the information content of regulator labels.
Thus, if a product is bad enough, an unbiased regulator would rather
ban a product than live with the consequences of consumers who
discount their label advice.
Even so, it turns out that consumers are ex-ante better off when
regulators are prohibited from banning private products. Thus private
product bans can be seen as a commitment failure. Without a
commitment not to ban, even an ideal regulator will want to ban in
equilibrium. But consumers who know that regulators are
constitutionally prohibited from banning will interpret regulator
labels differently, to their ex ante benefit.
=====================================================================
>Date: 5 Aug 1996 15:16:21 -0500
>From: "Robert Sade"
Actually, Sam Peltzman wrote a book on the subject, which contains an
exhaustive economic analysis of the costs and benefits of FDA regulation. It
is a classic: Benefits and Costs of New Drug Regulation, 1972, U. Chicago
Press.
Robert M. Sade
Department of Surgery
Medical University of South Carolina
=====================================================================
>Date: Mon, 5 Aug 1996 13:43:58 -0700 (PDT)
>From: Robert Higgs
Robert,
A good general rule is: never trust any empirical analysis by Sam
Peltzman. In his analysis of drug regulation, Peltzman probably
arrived at more or less the correct conclusion, though by sheer accident.
Even if Peltzman's work were credited, defenders of the FDA would
reply that it is now completely outdated. FDA's own way of admitting
problems is to say: Yes, but we've just fixed that (or are doing so even
as we speak), so there's nothing to worry about any more.
Bob Higgs
=====================================================================
>Date: Mon, 5 Aug 1996 15:47:20 -0700
>From: jmlib (jmlib)
Thank you for your responses. I haven't yet had a chance to read them
all in detail, but I plan to do so and compose a post to answer Mr. Lewis.
In the interim, he posted my speech to a health fraud listserve, which
he is a member of, and Lewis posted the best response (pro-FDA) from that
list ... which I include below:
------------------------------------------------------------
McPherson wrote:
> Primary sources: (See below for specific references cited by these
> works)
>
> 1. _Healing Our World_, by Dr. Mary J. Ruwart (chapter 6).
>
> 2. Libertarian Party's Health Care Proposal "Project Healthy Choice",
> plank 4: "Replace the FDA".
>
> 3. _Freedom of Informed Choice: FDA versus nutrient supplements_, by
> Durk
> Pearson and Sandy Shaw (chapter 3 and app. 6)
>
> 4. _The Machinery of Freedom_, by David Friedman (chapter 21)
>
Scott Ballantyne's response:
Well, that's quite a list of references --- I'm
speechless. Libertarian Party, Pearson and Shaw, `Machinery of
Freedom'. No possible bias there, heh heh heh...
> Yet, this is exactly the effect of what the FDA is now doing. It is
>ripping life-saving medicines out of the hands of thousands of
>Americans and _letting them die_!
Well, that's quite a nice bit of rhetoric, very stirring. It doesn't
really wash though, and Burzynski is a prime example. If the FDA is
'ripping' drugs out of peoples hands, why has Burzynski been in
operation for close to 20 years now? I have some of the
correspondence between Burzynski and the FDA and it's perfectly clear
that the FDA was trying *very* hard to find out if Burzynski had
anything to offer, not just closing him down for political gain. There
are many examples of this, which if anything show that the FDA is
*too* lax in their enforcement policies.
> According to George
> Hitchings, co-winner of the 1988 Nobel prize in medicine, the FDA's 5
> year
> delay in approving the anti-bacterial drug Septra cost 80,000 lives.
I don't believe it. First of all, Septra is just a combination of two
already well known, well used and approved drugs, Trimethoprim and
sulfamethoxazole in a ratio of 20:1. Even if the combination was not
approved for marketing, any MD could prescribe it and have a pharmacy
make it up. It's used for a lot of not very serious infections
(uncomplicated urinary tract infections, bacterial respiratory tract
infections, shigellosis). In any case, the one serious disease it is
used for is P.carinii, a severe and life threatening infection in
patients with AIDS. But claiming that 16,000 people die a year from
P.carinii because there was no Septra is bogus, (a) because other
equally effective treatments exist (pentamidine), (b) because Septra
could always be given just as it often is now, as two doses orally of
already approved drugs, (c) You don't tell us how many of these 80,000
would have died anyway, from other causes (they had AIDS, remember?).
> During their 10 year delay in allowing propanolol, a beta-blocker
> for treating angina and hypertension and preventing the recurrence
> of heart attacks, the FDA let approximately 100,000 Americans die by
> withholding that treatment from them.
100,000? Where on earth do you get these figures???? Propanolol (more
commonly known as Inderal) is most commonly used to treat hypertension
and angina. Effective treatments existed prior to propanolol and are
still used today, and angina is not life threatening. The only people
who would die without propanolol are those who do not respond to any
other drugs or to those who have life threatening arrhythmias, when it
has to be given intravenously. Many of these die anyway, because
intravenous propanolol is not found on any street corner, no doubt
because the FDA is holding up the approval of your basic $0.75
intravenous Inderal vending machine: deposit coins, insert arm,
wait, remove.
> The FDA's extreme politically-biased overcaution would probably
> cause them not to approve penicillin, fluroxene, cortisone, digitalis
> and
> other life-saving drugs if they were up for approval today, with the
> consequent loss, of course, of thousands upon thousands of lives.
This is quite unlikely, and incidentally you haven't substantiated
that the basis of FDA operations is political, not scientific.
> A 2-year delay in a cancer therapy that reduces mortality by only
> 10% would cost about 66,000 lives - many many more than have died
> from _all_ cases of drug toxicity in this entire century.
Please - this is *too* convoluted. First of all, the FDA's existence
has *reduced* the effects of drug toxicity, remember, so the
comparison is bogus to start with. Secondly, not all drug toxicity is
immediate --- there was a drug marketed in the 50's (it took the FDA
something like 10 years to get it off the market) whose main
ingredient was radium. People guzzled it - how many cases of cancer do
you think showed up down the road from this treatment? Finally, let's
not forget that the FDA is also responsible for food safety...
[deletia]
> In truth, there is no such thing as a drug that is safe for everyone.
> Even life-saving penicillin has killed those who were allergic to it.
> If
> the FDA attempts to license only drugs that are completely 100% safe,
> then
> they will not approve any new drugs at all, and thousands who otherwise
> would
> live will die.
>
Well, it seems that once someone has read Dirk and Sandy brain damage
is irreversible as this resurrection of the '100% safety' strawman
shows. The FDA does not require that drugs be 'completely 100% safe'
(to use your own mild redundancy), so your 'thousands who otherwise
would live will die' refrain doesn't apply here either.
> Related to the thalidomide story is an example on the other side of
> the
> coin. Aspirin deforms the fetuses of almost every animal species
> _except_
> for humans, so it's almost sure that the FDA wouldn't approve it if it
> were
> a new treatment today.
Don't be a goof. There are drugs in use now that deform fetuses - they
are marketed with warnings not to be used when pregnancy is a
possibility. Incidentally, high dose vitamin A is known to have
harmful effects on fetuses. I don't see warnings about pregnancy on
the Life Extension Foundation products. Did I miss them? Is LEF trying
to mislead us? Nah, couldn't be --- they're a for profit organization
and therefore immune to corruption....
> The irony is that over a dozen clinical studies
> have
> demonstrated that taking one aspirin every other day reduces the risk of
> heart attack, at least in males, by over 44%. As surprising as that may
> sound to you, these results are widely acknowledged by doctors and
> scientists,
> and you might be wondering why you haven't heard about it.
Everybody's heard about it - you'd have to be living in a cave not to
know about this.
> The FDA, in
> its
> infinite wisdom, has specifically prohibited aspirin companies from
> mentioning this in their advertising and labelling ... because it might
> "encourage people to medicate themselves"! Can't have people taking
> responsibility for their own lives and health, now can we?
>
Because they are afraid of irresponsible behavior by the drug
companies. Aspirin reduces heart attacks related to atherosclerosis.
(You don't mention this -- why not? There are other causes for heart
disease, donchano?). It ALSO increases the incidence of hemorrhagic
strokes, something shown by the physicians health study. If you don't
have atherosclerosis, you *shouldn't* be taking every other day
aspirin tablets. Frankly, I'd rather have a heart attack than a
hemorrhagic stroke...
> Clearly, the FDA, a monopoly institution based on the forceful
> suppression
> of new therapies, has got to go.
Of course, the USA is the leader in drug development and the
introduction of new therapies, unlike other countries which lack our
efficacy standards. Gosh, let me think: If you can't make money unless
you market effective drugs, would this encourage or inhibit the
production of effective drugs? Wow, that's a really, *really* hard
question, donchathink? Gosh, I guess maybe the FDA has had something
to do with this achievement, wow --- imagine that.
>
> Once we end the aggression of drug licensing laws, patients and their
> doctors could buy whichever drugs they felt might be helpful, regardless
> of
> the stage of testing. Since they wouldn't be competent to evaluate each
> drug themselves, they would rely on professional and consumer's groups
> for
> status reports.
HAH HAH HAH. Oh, sorry - you're serious. Well, I'm sure Life Extension
Foundation would love to be making money off of all these Seals of
Approval, but no thanks. Anybody else remember the private,
independent certification company CARF that certified Narconon (a
bogus drug treatment program which fronts for the Scientologists) as
safe and effective? It was a key step in getting it installed in
Oklahoma. I called them up and tried to apply pressure to get the
certification revoked, but no luck. When that failed, I had no place
else to turn. With a private company, you have no recourse. At least
with a government institution you have some means to bring pressure if
they make a mistake like this.
No question that the FDA needs improvement, what doesn't? I think
they've done pretty well at speeding up the approval process. Look how
fast the recent protease inhibitors came to market. On the other hand,
speed isn't everything. I'm still rankled by the FDA approval of the
completely ineffective Betaseron. Rankle, rankle, rankle..... They
should have taken more time...
Scott Ballantyne
---------------------------------------------------------------
McPherson again ...
I haven't yet read this post in detail yet, either, but I'm
getting the impression that the FDA-supporters/pro-statists
may have more "facts and figures" and people devoted to
particular issues and special interests than do we. So, they
have us in terms of sheer volume (of paper and voice) and
sheer numbers (of apologists for the State and of people who
seem to buy into collectivist morality, perhaps by default) ...
but then, there's a certain appeal in rooting for the underdog,
fighting an uphill battle and winning it, seeing David triumph
over Goliath, etc. I agree with Tibor that we also need to
challenge their moral premises, even though it looks like
Mr. Lewis and Mr. Ballantyne may not themselves be swayed ...
perhaps others in the audience won't be quite so dogmatically
coercively-collectivistic.
--
John McPherson (jmlib@genius.ucsd.edu)
* Host, Professors of Liberty Email Network
=====================================================================
>Date: Tue, 6 Aug 1996 13:15:24 -0400
>From: jnarveso@watarts.UWaterloo.ca (Jan Narveson)
>Subject: FDA, etc.
A comment on this, from Tibor, with appended quick response from Robin Hanson:
[Tibor:]
> What clinches the argument about whether to prefer voluntariness
>over coercive measures - regarding whether safety or life enhancement
>ought to be pursued - is the very general idea that human beings are, by
>their very nature, free moral agents who ought to exercise their decision
>making capacity as fully as possible.
The problem with this argument of course is that most folks aren't
committed to the premise of your implication.
Robin Hanson hanson@hss.caltech.edu
Robin is right about this, and the folks he has in mind are also
right.There are an infinity (for all practical purposes) of matters with
regard to which any of us *could* exercise our decision-making capacity,
but we don't. In fact, lots of us spend a fair amount of money and some
effort *avoiding* decisions. You might invest an an automatica system that
turns your yard and porch lights off and on by themselves when the sun goes
down; this saves a whole lot of decion-making, enabling one instead to veg
out in one's bath or whatever. These are free moral agents doing this,
understand. Clearly Tibor has way overstated the case. IF we can trust an
FDA to make a lot of good and very important decisions about drugs, then so
far as they go, bully for them! The question is whether they do, and
whether agencies with no governmental powers might not do better. Certainly
in many cases there's very good evidence that the answer is in the
affirmative.
The sheer fact that an agency has monopoly-type powers of enforcement is
worrisome, for it opens doors to irresponsible decision-making: the
incentives operating on the providors are detached considerably from the
interests of the people they're supposed to be serving. That's important,
but it is not a priori certain that they will in fact act irresponsibly
just because that is so - merely, I shold think, very likely.
In the case of the FDA, what we would expect is ultra-caution in approving
drugs, with its flip side, the use of irrelevantly tight criteria for
disapproving them. Are we getting those? One needs to know, but it isn't
certain that we are, is it?
__________________________________________________________________________
Jan Narveson (Professor)
Department of Philosophy, University of Waterloo;
Waterloo, Ontario, Canada, N2L 3G1
(519) 888-4567-1-2780# (from touch-tone); or 885-1211, ext. 2780 (via
switchboard); FAX (519) 746-3097 Home: (519) 886-1673 (answering machine)
e-mail: jnarveso@watarts.UWaterloo.ca
=====================================================================
>Date: Tue, 6 Aug 1996 12:48:45 -0500 (CDT)
>From: Tibor R Machan
It is I who purchase the automatic system for my house whereas I do not
hire the FDA. That's the very, very big difference. Of course, some of
my decisions will be long range commitments to a course over which I will
no longer have to make micro-decisions - as when I say "I do" at my
wedding or sign the employment agreement with my firm or university. But
those long range arrangements stem from my decisions, combined with other
free moral agents with whom I have voluntarily joined in some endeavor.
The FDA has been imposed on us but some supposed majority, some group of
people who kid themselves by thinking they are authorized to commit the
rest of us to their scheme of safety, whether it works sometimes, all the
time or never. (I could freely hire a disfunctional dentist who rarely
fixes my teeth and keep him working for me, as it were, despite this, so
long as it is my choice - and many do just that by continuing with bad
restaurants, lousy lawn mowing services, and pointless marriages!)
Best,
Tibor
=====================================================================
>Date: Tue, 6 Aug 1996 11:24:09 -0700 (PDT)
>From: Fred Foldvary
Recent research concludes that aspirin may help prevent and
treat heart attacks. The FDA recently approved labels indicating
this, but only for doctors. Aspirin sold to the public will
not be allowed to have this information. This restriction on
the labels might lead to many deaths which could be avoided.
The labels would also caution those using aspirin for this
purpose to use a low dosage; some who have heard of these
findings may not consult a doctor and use a too-high dose.
Fred Foldvary
=====================================================================
>Date: Tue, 6 Aug 1996 15:25:51 -0400
>From: jnarveso@watarts.UWaterloo.ca (Jan Narveson)
Tibor Machan objects, to my earlier posting,
>It is I who purchase the automatic system for my house whereas I do not
>hire the FDA. That's the very, very big difference.
Now, we are, of course, entirely agreed on that. But it's one thing to say
that that the individual in question must always be the one whose decision,
at some level, is what determines what he does -- and quite another to say,
as your original quote seemed to, that the agent positively ought to
maximize use of his decision-making powers.
It's the difference between saying that *only* person A's decision should
fundamentally determine what A does, and saying that if A has his choice
between having B decide what A shall do and having A decide it, then A
*must* choose the second. Clearly that's not so, and would, for almost
everyone, be an irrational thing to do. That was Robin's point, and is
surely right.
=====================================================================
>Date: Tue, 6 Aug 1996 15:05:02 -0500 (CDT)
>From: Tibor R Machan
On Tue, 6 Aug 1996, Jan Narveson wrote:
> [It is] quite another to say,
> as your original quote seemed to, that the agent positively ought to
> maximize use of his decision-making powers.
If you understood me to have said such a thing, I grossly mispoke
myself. Sorry. It is the point on which we agree that counts. Of
course, there the fact that when one delegates decision-making, one still
often assumes full responsibility for the ensuing results. If I hire an
inept doctor, I blame myself, in part, for the malpractice that results.
If the FDA forces me to abstain from using some drug and as a result I
keep being sick or get worse, or, indeed, if I am better off, I get none
of the credit in my own eyes and shouldn't in the eyes of others. Some,
of course, are proud to have supported the FDA, thinking this makes them
champions of safety. Well, not only are they complicit in at least a
modicum of tyranny or paternalism, they may well contribute to massive
complacency about drugs safety in the society at large.
Best,
Tibor
==============================================================================
>From: MaryRuwart@aol.com
>Date: Thu, 8 Aug 1996 10:04:44 -0400
If your general rule is not to trust Sam Pelzman's empirical analysis, you
should include your justification. Otherwise, how do we know we can trust
your generalization?
==============================================================================
>Date: Thu, 8 Aug 1996 10:15:54 -0500 (CDT)
>From: Tibor R Machan
Dear Mary:
I applaud your post - Bob Higgs' slam agains Sam Peltzman, whom I
have known for decades, came out of the blue and I was too shocked to
respond. I first thought it might have been some kind of inside joke.
But your post woke me to the possibility that this was a pretty serious
thing to say about someone, even in the informal setting of this list.
Tibor
==============================================================================
>From: MaryRuwart@aol.com
>Date: Fri, 9 Aug 1996 09:29:02 -0400
John, in a recent post you expressed concern that the pro-FDA supporters have
more "facts and figures" than "we" do. Not so. If you read Scott
Ballantyne's responses, you'll see that he provides no facts and figures to
support his hypothesis; he simply dismisses the ones you've provided.
For example, you give a list of sources. He dismisses them with "Well,
that's quite a list of references--I'm speechless. Libertarian Party, Pearson
and Shaw, 'Machinery of Freedom' No possible bias there, heh heh heh..."
To your quote that FDA is ripping life-saving medicines out of the hands of
thousands, Ballantyne says "Well, that's quite a nice bit of rhetoric" and
goes on to wonder why Burzynski is still in business after 20 years (how does
this refute you?). He fails to mention that the FDA has, during those 20
years, run Burzynski out of the country, shut down his labs in the Carribean,
and only looked at what he had to offer because a member of Congress became
interested for personal reasons. He offers no studies or statistics, only
antecdotes with pertinent information omitted. He fails to cite the numerous
cases where the FDA has successfully shut down others or address your
statement at all.
To Nobel Prize winner George Hitchings' estimate that the FDA's 5 year delay
in approving the anti-bacterial drug Septra cost 80,000 lives, Ballantyne
dismisses the expert's evaluation with a simple "I don't believe it." In
this case, he does at least provide a rationale for his position, that "even
if this combination was not approved for marketing, any MD could prescribe it
and have a pharmacy make it up." I assume from this statement that
Ballantyne is not a practicing physican. In real life, most MDs would be
unaware of the benefits of such a combination, since they largely rely on
drug companies to educate them. Such education is against the law until drug
approval. Furthermore, MDs shy away from asking pharmacists to prepare
something special, especially if it involves prescribing anything that is not
FDA-approved because of the current litiginous atmosphere.
To the estimation of propranolol deaths, Ballantyne exclaims "Where do you
get these figures?" and goes on to give his opinion, not data or studies, as
to why this couldn't be right. The study in question was performed by Arthur
D. Little, Inc. and is titled "Beta-blocker reduction of mortality and
reinfarction rate in survivors of myocardial infarction." The estimation of
10,000 U.S. deaths per year is based only on reinfarction rates (second heart
attack) and such is a very conservative estimate. It does not include deaths
prevented in people with angina and hypertension, who might have taken a
beta-blocker as a preventative. Propranolol was introduced into Europe 3
years before the FDA allowed it in the U.S. However, 10 years went by before
the FDA approved it for hypertension and anginia, by far its most widespread
use.
Reading Ballantyne's descriptions of "effective treatment existing prior to
propranolol" suggests to me that Ballantyne was not practicing cardiology
when the beta-blockers came to market. The other "effective treatments" had
considerable side effects and were prescribed conservatively as a
consequence.
Need I go on? I suspect that Ballantyne has already made up his mind about
the issue. Instead of seriously considering data of experts and
well-documented studies (Pelzman, Gieringer, etc.), he simply substitutes his
own opinion. Without knowing his qualifications, I don't know how much
credence to give his statements, although I can tell you that they don't
match my experience at all. After 25 years in drug-related research, my
personal dealings with the FDA, and review of the historical literature, I am
convinced that the FDA does much more harm than good. Read on, and you'll
see that at least three former FDA commissioners agree with my evaluation.
Surely, they should know!
Frankly, I find it difficult to fault most of the folks at the FDA. If they
approve a drug, any drug, they get criticism from someone. Ballantyne
himself says "I'm still rankled by the FDA approval of the completely
ineffective Betaseron. Rankle, rankle, rankle...They should have taken more
time..." If a side effect shows up (and which drug doesn't have one?), FDA
takes the heat. The FDA is under intense pressure NOT to approve drugs with
even the smallest wart. In the words of former FDA commissioner Alexander
Schmidt, "...rarely, if ever, has Congress held a hearing to look into the
failure of FDA to approve a new entity; but it has held hundreds of hearings
alleging that the FDA has done something wrong by approving a drug...Failure
to approve an important new drug can be as detrimental to the public health
as the approval of a potentially bad drug."
Deaths due to delay in approval is probably minor compared to drugs that
don't make it to market at all. During my years at Upjohn, the FDA called to
encourage me to push for the development of prostaglandins for liver disease.
No effective therapy was available and the work I had done with a university
collaborator suggested that prostaglandins might help. However, the efficacy
studies for this chronic disease were so costly that we didn't proceed.
Current law forbids a company to sell a product and say "It's safe under
these conditions, and it works in animals, but we don't know if it works in
people. Please make your own choice."
Many drugs, and many valuable indications for marketed drugs, are never
brought to light because of this. I'm not sure how to calculate the impact,
but if my experience base is any indication, many more people suffer and die
from drugs and indications that never make it to market than they do from
delays in approval. Prof. William Wardell at the University of Rochester, NY
agrees: "If even one new drug of the stature of penicillin or digitalis has
been unjustifiably banished to a company's back shelf because of excessively
stringent regulatory requirements, that event will have harmed more people
than all the toxicity that has occurred in the history of modern drug
development."
What does former FDA commissoner Donald Kennedy say about this type of thing?
"...the pattern of intervention into science from a combination of local,
state, and federal sources has moved from reasonable control to something
close to chronic strangulation."
Because the FDA is so stringent, new drugs are twice as likely to be tested
and marketed overseas, even though the parent drug company is most likely to
be in the U.S.! When AIDS patients went overseas to get drugs they thought
might be beneficial, the U.S. Customs agents confiscated them as unapproved
medications.
Seeing this situation, former FDA commissioner Frank Young took a bold step.
"We're not prepared to march into people's homes like the Gestapo and take
drugs away from desparately ill people," he proclaimed. In 1988, he decided
to let U.S. citizens import drugs from other countries, even if they weren't
approved here, for their own personal use. Kessler, the current FDA
commissioner, appears to be doing all in his power to take that back.
Three former FDA commissioners (don't you want to applaud their courage?)
recognize the problem that Ballantyne simply sweeps under the carpet. In a
nutshell, it is this:
Taking time to test and approve life-saving drugs means that many people will
die needlessly during the wait. Marketing drugs with no testing at all means
that some people will come to harm. There is a life-and-death endpoint at
either extreme and everywhere in between.
Therefore, the real question becomes, "Who should decide when enough
information is available for an individual to take a drug?" Obviously, the
person who must bear the consequences of the choice should have the final
say. This is the only principled and practical stand. Since the FDA and its
supporters have no way to take the consequences of their assessments, they
should--at most--advise.
I suspect that is why Kessler, with all his pro-FDA rhetoric, has been
reluctant to shut down the underground pharmacies that supply AIDS patients
with bootlegged copies of drugs in clinical trials. To people with a limited
life-span, waiting isn't an option. These underground pharmacies are so
pervasive, that the drug companies sometime have trouble recruiting patients
for their studies that haven't yet been exposed to the supposedly new drug.
If Kessler believed his own rhetoric, he'd be shutting these places down,
not raiding vitamin docs. Maybe he just doesn't want anymore blood on his
hands!
Please feel free to query me if you need more information.
==============================================================================
>Date: Fri, 9 Aug 1996 17:53:58 +0100
>To: sdlp, libclubs-d
>From: szterpak@mailhost1.csusm.edu (Mary Szterpakiewicz)
>Subject: Another reason to abolish the FDA
Another good reason to abolish the FDA, according to a recent medical
industry newsletter:
"It is well known that the FDA is keeping close tabs on the Internet for
device regulation violations. The agency has already issued several
warning letters for violations of labeling regulations gleaned from medical
device manufacturer's web sites. If the FDA doesn't like what it sees, it
can tell a manufacturer to remove certain information from their site."
--Mary
==============================================================================
>Date: Mon, 12 Aug 1996 10:06:54 -0700 (PDT)
>From: Robert Higgs
Mary,
The two best reasons for relying on anyone's judgment about the quality
of someone else's empirical work are (1) you know the judge to be a
person of good character (as opposed to most economists, who merely play
a kind of intellectual game, with no regard for truth, honesty, or any
other aspect of integrity) and (2) you know that the judge knows whereof
he or she speaks, as shown by the judge's own demonstrated proficiency in
empirical analysis. For those who know nothing about me or my own record
as an empirical analyst, these criteria won't help. That leaves me with
only the possibility of stating in some intelligible way why Peltzman's
empirical analysis is unreliable. Unfortunately, doing so would take the
equivalent of at least a professional journal article and, perhaps, an
entire book, to document exactly what Peltzman has done wrong. An
internet list is hardly the place to carry out such an undertaking, nor
would I use my time to do so. About all I can do is to say that Peltzman
has repeatedly commited econometric mistakes such as using implausible
surrogate variables, adopting misspecified models, using improperly
defined or grossly inaccurately measured variables, arbitrarily deleting
or omitting data from time series, and various other sins against good
empirical procedure. Noting the repeated commission of these sins, the
observer has little choice but to conclude that the man is either
incompetent, or a charlatan, or just doesn't give a damn. I have no way
to know which is the case.
I hope that this all-too-brief reply gives you at least the flavor of
my justifications for mistrusting Peltzman's empirical analysis. I've
spent 30 years doing and teaching empirical analysis in the social
sciences, and I believe--perhaps vainly--that my own work speaks well of
my abilities in this area. In my judgment, Peltzman's empirical work
also tells a pretty plain tale.
Bob
On Thu, 8 Aug 1996 MaryRuwart@aol.com wrote:
> If your general rule is not to trust Sam Pelzman's empirical analysis, you
> should include your justification. Otherwise, how do we know we can trust
> your generalization?
==============================================================================
>Date: Mon, 12 Aug 1996 13:25:32 -0700
>From: jmlib (jmlib)
I forwarded Dr. Mary Ruwart's excellent post re: the FDA to my general-
semantics email list, and biology prof. Steven Lewis sent this in response:
-------------------------------------------------------------------------
After reading Dr. Mary Ruwart's statements on drug regulations in the United
States I do not see any reason to withdraw my earlier evaluation of John's
speech. I reiterate that if Dr. Ruwart and her colleagues can convince the
majority of the scientific community who specialize in drug regulations and
health care economics that we should privatize the FDA -- then sign me up
too. Convincing T.C. Mits, however, is not enough for me, nor should it be
for any serious student of General Semantics. Do we want a nation of
'private philosophies' or one guided by consensus science?
[McPherson: if any of you didn't see Mr. Lewis' evaluation of my
speech, I can forward it to you (and my speech as well). I don't
know who "T.C. Mits" is. I don't know how to simply sum up
General Semantics, but a rough idea might be "applied scientific
epistemology". Unfortunately, the founder, Alfred Korzybski, was
thoroughly steeped in collectivism and wrote his book, _Science
and Sanity_, in 1933 and it is riddled through with that political
bias. There seems to be a strong sentiment in the g.s. community
that the bulk of humanity is still in its "childhood", don't know
how to evaluate properly, and so should be led by those who know
better than them ... someone at least trained in science, and
preferably general-semantics. I find that g.s. does have value
in updating how we communicate, think, learn, use language, etc.,
but the collectivist moral baggage stinks.]
Dr. Ruwart says the FDA is too political, too easily influenced by public
pressure. Nevertheless, privatizing the FDA's responsibilities will not
necessarily make effective therapies more readily available, for the
underlying problem, insofar as there is one, is our litigious society and
pseudo-scientific standards of evaluation common among the public. The
private companies that manufacture cigarettes and silicone breast implants
have found that when their customers have a bad experience they hire a
lawyer and sue. It does not matter if the cigarette package contains a
warning about the harmful effects of the product, or if the scientific
consensus is that silicone breast implants do not cause autoimmune disease.
The 'victims' sue and, if they have good lawyers, they win big settlements
and force, in many cases, useful products off the market. Any 'private'
groups that would replace the FDA would be faced with these same concerns
and public pressures and trial lawyers. We have relatively few contraceptive
choices in this country compared to some other countries not because the FDA
won't approve them but because drug companies don't feel they can make a
profit here when they factor in the inevitable costs of litigation over real
or imagined harm.
>In real life, most MDs would be
>unaware of the benefits of such a combination, since they largely rely on
>drug companies to educate them. Such education is against the law until drug
>approval. Furthermore, MDs shy away from asking pharmacists to prepare
>something special, especially if it involves prescribing anything that is not
>FDA-approved because of the current litiginous atmosphere.
A decade ago I edited the proceedings of medical conferences sponsored by a
local drug company. Researchers and physicians were invited to these
conferences and told about alternative and experimental uses for their
drugs. For those physicians who could not attend, the drug company would
send them summaries or transcripts of the proceedings so they could know of
and prescribe these 'unapproved' uses for their drugs. All this was done
quite legally.
>After 25 years in drug-related research, my
>personal dealings with the FDA, and review of the historical literature, I am
>convinced that the FDA does much more harm than good.
Now all you have to do is convince the majority of your scientist peers who
are appropriately trained in health care economics and toxicology.
>Therefore, the real question becomes, "Who should decide when enough
>information is available for an individual to take a drug?" Obviously, the
>person who must bear the consequences of the choice should have the final
>say. This is the only principled and practical stand.
Ultimately the patient decides today. FDA approval makes a drug readily
available and helps weed out extremely dangerous and ineffective drugs, and
helps us discover the many side effects and interactions that a drug can
have. FDA approval does not mean a patient has to take a drug if prescribed
or that a drug will cure the patient. A patient may instead import drugs
approved elsewhere for their personal use. Or a patient may join an
experimental program to test a new therapy. Or a patient can try the wide
variety of "alternative" therapies that are abundant in our society. Please
don't ask the rest of us to pay for these 'fishing' expeditions, however.
>I suspect that is why Kessler, with all his pro-FDA rhetoric, has been
>reluctant to shut down the underground pharmacies that supply AIDS patients
>with bootlegged copies of drugs in clinical trials. To people with a limited
>life-span, waiting isn't an option. These underground pharmacies are so
>pervasive, that the drug companies sometime have trouble recruiting patients
>for their studies that haven't yet been exposed to the supposedly new drug.
> If Kessler believed his own rhetoric, he'd be shutting these places down,
>not raiding vitamin docs. Maybe he just doesn't want anymore blood on his
>hands!
Desperate people will try anything, and are easy fodder for 'underground
pharmacies' and other con games. I'm not aware of any of these 'pharmacies'
dispensing a cure for AIDS, or of any other country having a cure for AIDS.
In that sense the money that AIDS victims have spent on their unapproved
therapies has been wasted ... and, as Ruwart indicates, may have impaired
our finding a genuine cure for AIDS.
Steven Lewis
http://www.kcmetro.cc.mo.us/pennvalley/biology/lewis/gs.htm
========================================================================
>From: MaryRuwart@aol.com
>Date: Mon, 26 Aug 1996 13:21:48 -0400
Thank you for forwarding Steven Lewis' comments. I'd like to make some
responses, which I assume you can forward to him.
Mr. Lewis correctly points out that the rash of lawsuits is not likely to
diminish just because drug evaluation is privitized. However, it seems
likely that drug companies would require a person who requests a drug that is
not fully tested to waive legal recourse in case of a problem. Whether our
legal system would actually permit that is another question.
Lewis statement that "We have relatively few choices in this country
compared to some other countries not because the FDA won't approve them but
because drug companies don't feel they can make a profit here.." This
certainly does not match my experience. I worked for a company that was
denied FDA approval for a contraceptive that had been in the market over a
decade overseas. One of the reasons we were given was that US women had too
many choices already!
For almost every new drug we developed, we went overseas first, both for the
testing and marketing, because of the faster time line available outside the
U.S. This is common practice in the industry.
Drug companies almost always make the best profit in the U.S. Perhaps Steve
can enlighten me as to where his statement to the contrary comes from.
Steve states that "Ultimately the patient decides today," to my statement
that the final decision should rest with the person who takes the
consequences of that decision. How I wish it were true! UNTIL the FDA
approves a drug it is very difficult for a patient in the US to get it.
Going overseas is one choice if the drug is available elsewhere, but this is
a strategy that works only for the informed or the well-to-do. My sister,
for example, went to Mexico for a cancer treatment because it was not
available here.
Patients cannot just "join an experimental program to test a new therapy" as
Steve suggests. First of all, these are double-blind studies, so that
neither the patient nor doctor knows what therapy the patient is getting.
The patient cannot CHOOSE to take the new drug; they may in fact end up with
placebo and miss their window of opportunity for healing. Also, patients are
carefully selected to match a standard to make the analysis more
straightforward; a patient that doesn't meet the selection criteria is out of
luck. Furthermore, the number of patients in these studies is limited. All
in all, attempting to get in an experimental protocol is difficult and may
not result in treatment with new drug.
Steve asks "Please don't ask the rest of us to pay for these 'fishing'
expeditions, however." I couldn't agree more--the finanical responsibility
should be on the shoulders of those who chose and take the consequences.
Steve also indicated he wasn't aware of any underground pharmacies. There
have been several articles on these the past few years in mainstream
publications. If anyone needs this information, have them contact me and
I'll try to dig it out of my files.
One proposal to deal with those on both sides of the FDA question was
proposed by Pearson & Shaw. They suggest that people who wish to take drugs
not yet approved by the FDA be allowed to "opt out." In essence, they would
make a legally-binding declaration that they wished to take such medication
and would accept all the risk. FDA would then not prosecute such individuals
or those who supplied them with drugs. Such a solution seems to address many
of Steve's concerns and would greatly enhance a person's ability to choose
for themselves.
Lewis describes a pharmaceutical-sponsored conference of a decade past that
included discussions of unapproved uses. This was the fall back position of
companies after the FDA forbade companies to let their detail men describe
such uses on their visits to physicians. By using a conference format, the
companies could avoid the accussation that they were advertising unapproved
uses.
Hopefully, my next response will not take so long to get back to you--I
attended the ISIL conference in Vancouver last week and didn't have my laptop
along.
========================================================================
>Date: Tue, 27 Aug 1996 15:28:23 -0700
>From: jmlib (jmlib)
Hello Mary,
Thanks for your comments to Prof. Lewis; I've forwarded them to the
general-semantics list. I also couldn't help but throw in some comments
of my own ... the whole FDA thread has veered far from discussions
pertaining to general-semantics (a sort of "applied neuro-epistemology"),
so I added this:
-----------------------------------------------------------------------
It occurs to me that this topic has veered off topic from g.s.-related
discussion, and that perhaps if we want to bring it back on topic, some
additional observations may be made. The word is not the thing ... the
PR, promo, "image", official statements, stated intent, etc. of the FDA
is not the real extensional results of the FDA ... and the same can be
said about many govt programs. Look for a third option ... the choice
is not necessarily binary, between A (govt agency "protecting" the public)
and not-A (no govt agency "therefore" no protection) ... we may have a
third option B: a variety of competing and specialized market agencies
succeeding in protecting the public as well as the govt agency, at
reduced cost, while allowing freedom to experiment with alternative
"non-approved" therapies. A proper map should include something about
the mapmaker ... the FDA's version of the story about the FDA may well
differ from versions outside the FDA. The FDA(1996) is not the FDA(1986)
... we can expect changes in FDA behavior as administrations, people,
laws, etc. change. The map doesn't cover all of the territory ... the
map of "an efficient caring FDA meeting the needs of the people" may not
include the storeowner who was put in jail by the FDA for not changing
the labels on her dogfood fast enough, the health food stores raided by
armed govt agents confiscating inventory of safe (but "unapproved") items,
the 1000's of patients who died because of treatments withheld by the
FDA, the treatments that haven't been developed because it would cost too
much to even try to pass all the tests and jump through all the hoops, etc.
FDA1 is not FDA2 ... well, there _is_ no "FDA2" ... that's part of the problem!
Anyway, these kind of considerations can bring this thread back to g.s.
relevance, if we're all going to pursue it.
---------------------------------------------------------------------------
I expect that Mr. Lewis will respond to your comments, and when
he does, I'll forward them. At some point, I expect we'll have
to challenge him on his faith that the masses are too stupid to
govern themselves, that they need to be directed by a central
scientifically-trained oligarchy. Perhaps it can be helped along
by pointing out that in a free society people will still seek out
expert opinion ... there will be a market for scientifically-trained
experts. He did point out that the FDA is the most "scientific"
of the govt agencies, hence it may be especially worth proving
our case here. I believe Mr. Lewis represents what might be
called "Scientific Statism" ... but maybe I'm being too harsh.
--
John McPherson (jmlib@genius.ucsd.edu)
* Host, General Semantics mailing list
http://genius.ucsd.edu/~john/p/gs_dir/
==============================================================================
>Date: Fri, 30 Aug 1996 20:15:07 -0700
>From: jmlib (jmlib)
>To: libprofs
>Subject: FDA followup
So far, Prof. Lewis hasn't responded to Mary Ruwart's most recent comments
(which I forwarded), but I did find this buried in his most recent post:
"The problem is that this list is not populated by the folks who could give
you the appropriate feedback regarding whether you are 'right'. [...]
Per our earlier discussion
of privatizing the FDA ... the folks you need to convince are the folks who
understand the facts, including the experimental techniques .... Convincing
us does not prove much of anything." [...]
So, it may be that Mr. Lewis has bowed out of the debate with the
excuse that none of the list participants are qualified to make
an informed decision, and/or that they are irrelevant anyway in
the larger scheme of things ... which would seem to be consistent
with his apparent "elitist scientific statism", but again, maybe
I judge him too harshly. If he posts a more formal response, I'll
forward it here.