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From: sbharris@ix.netcom.com (Steven B. Harris )
Subject: Re: Letter From US Attorney To Wright Dropping Charges
Date: 28 Sep 1995
Newsgroups: misc.health.alternative,sci.life-extension
In <DFM7B6.DA3@spdcc.com> dyer@spdcc.com (Steve Dyer) writes:
>In article <44d8kg$n9h@CUBoulder.Colorado.EDU>,
>The Snyder-Dunns <snydere@ucsub.colorado.edu> wrote:
>
>>John's story about the sensor pad is true. The sensor pad is a very
>>simple (But clever) little thing consisting of a couple of sheets of
>>plastic film. It's purpose is to increase the sensitivity of the sense
>>of touch. It is used to improve the ability to detect lumps in the
>>breast. A life or death matter for many women. That is works would seem
>>to be a simple matter of showing it improves "feel".
>
>Er, no. That it works would be a matter of demonstrating that using
>the pad increases the sensitivity of the test (i.e., more lumps
>would be detected using it than without.) I don't know about you, but
>I wouldn't trust this company's promotional blurbs, and only someone
>very credulous takes at face value a claim that a sheet of plastic would
>actually *increase* anyone's sense of touch. Uh-huh.
There might be something to this, if the person is feeling him(her)
OWN skin. In that case, the feedback from the skin being touched may
interfere with concentrating on the sensations in the examining
fingers. So this is not, ipso facto, a crazy idea. I'm rather amazed
that you need a prescription to sell it as a medical device, tho. Come
on!
>Since the FDA is charged with regulating medical devices, and this
>is clearly a "device", it seems appropriate to demand evidence that
>it does what it purports to do.
Sure, but how much evidence is needed? Do you have to run a 10 year
study of 1000 women with risk of breast cancer and show life extension?
Or are a few simple studies with plastic models and blinded examiners
just as good? You know that when large amounts of money have been
involved, the FDA has been quite willing to look at "surrogate" markers
for efficacy (fewer PVCs instead of fewer deaths) for some quite
dangerous drugs. And of course got nailed for doing so. But this
device is not a potentially dangerous drug-- it's just a piece of
plastic for God's sake. At worst, claims for it ought to be
scrutinized by the FTC, like the Thighmasters, as a truth in
advertising issue. It's only the fear of death and disease which has
escalated the FDA, and given them such ridiculous power. The problem
is that all this is irrational-- nearly every damn thing you do all day
effects your chance of death and disease, and in that sense is a
medical decision. What the FDA is essentially saying is that none of
us can be trusted with any of this. You see where this thinking leads.
It makes me nearly as paranoid as John when I get to considering it.
>What if it actually *reduced* the user's sensitivity, and that women who
>might have had a cancer detected early failed to have them discovered as
>a result of using this?
Well, what if it did? How about if we put in the package insert
that a woman should examine herself both ways, just in case?
>Why this isn't crystal clear to you and Hamell and the rest of the
>anti-FDA loons really escapes me.
What's crystal clear is that the idea that some behavior may kill
you is NOT ipso facto good reason to charge the Federal government to
take you in hand like a child and make sure you do it right. People
have died from tooth abscesses-- do you want Washington in your
bathroom making sure you brush correctly? What kind of world do you
really want?
Steve Harris, M.D.
From: sbharris@ix.netcom.com (Steven B. Harris )
Subject: Re: FDA (Supreme Court nixes hemophiliacs class-action lawsuit)
Date: 07 Oct 1995
Newsgroups: misc.health.aids
The Right Lesson To Learn From Thalidomide
(c) 1992 Steven B. Harris, M.D.
The Food and Drug Administration was originally (early in this
century) charged with establishing the purity and safety of foods
and drugs. As such, it was tolerable, and even did a certain
amount of good in acting as policeman against certain types of
actions which we all agree constitute "fraud" (i.e., putting
horsemeat in the hamburger, or putting sugar instead of antibiotic
in the "antibiotic" pills, etc.)
But then, and the late 1950's and early 60's, something
horrible happened, both to the citizen and to the State. In
Europe, a drug called thalidomide was marketed as a tranquilizer.
In America, the FDA official in charge of the American "new drug
application" for thalidomide (submitted Nov., 1960) was a woman
physician (Francis Kelsey, M.D.) whose physician/pharmacist
husband did not like the way routine pharmacologic tests had
been done on thalidomide. Dr. Kelsey was also concerned about
some medical reports in late 1960 that thalidomide might cause
neuropathy (nerve damage) in some of its users. Neither of these
concerns was fatal for the thalidomide application, but together
they were enough to hold up the FDA's approval of thalidomide
for a year, pending more pharmacology tests. Since neither
problem had anything to do with birth defects, it was only
by the sheerest chance that the red-tape in these matters
caused introduction of thalidomide to be delayed in the U.S.
until it began to be suggested in late 1961 that thalidomide
was a dangerous drug for pregnant women. In the end, the
association between thalidomide and birth defects was discovered
in Europe, not America -- and certainly was not discovered by
the FDA. Despite this, on August 7, 1962 a grateful President
John F. Kennedy awarded the Distinguished Federal Civil
Service Award to Dr. Kelsey, who by this time was beginning to
make (in retrospect) statements about how she had been concerned
with the reproductive safety of thalidomide all along.
However much we all like heroic tales and medals, there is
actually very little in the record to bear out the official
heroic version of the thalidomide story. Upon careful examination
it appears that no reproductive tests ANYWHERE were done at all on
thalidomide before 1961, nor indeed did the FDA ask for any. In
fact, it appears that even had any pre-marketing reproductive
tests of thalidomide in rats been done, they would have *still*
shown negative results, for thalidomide (as we learned later)
does not even cause birth defects in rats. We now know that it
would have taken a much more exhaustive set of animal tests to
catch thalidomide than was routinely used anywhere in 1961. An
honest reading of the facts thus forces the conclusion that
(questions of luck aside) Dr. Kelsey's medal was awarded basically
for being a delay-causing bureaucrat and thereby allowing
Europeans to serve as first-class "guinea pigs" for Americans, in
a case where many lab animals would not have done an adequate job.
Yet Dr. Kelsey's medal was soon to become an excuse for much
self-congratulation, regarding FDA policy. Not much thought
was given to what the consequences of a de-facto U.S. marketing
delay policy might be, if applied to all new drugs across-the-board.
Indeed, a simple delay law preventing drugs from being approved
in America until a certain time after they had been introduced in
Europe could be passed, and enforced for much less money
than we pay for an FDA-- but THEN we'd have to face questions
of the actual costs of "deliberate drug introduction delay" head
on, instead of hiding from them, as we do now.
But exactly this was the other fallout from thalidomide
besides Kelsey's medal. In 1962 the thalidomide disaster
gave unexpected new life to several stalled bills on capitol
hill which proposed to give the FDA power over not only safety,
but also the _efficacy_ of new drugs. There was a some irony
in this, since the thalidomide disaster itself was of course an
issue of safety, and had nothing at all to do with efficacy (the
bills were themselves introduced before anyone had heard of
thalidomide). Unfortunately, however, the fine distinction was
lost on congress, which only knew that the FDA seemed to be proving a
good thing and should therefore be made bigger. In 1962 the
so-called "Kefauver Amendments" to the Food, Drug and Cosmetic Act
were passed into law, giving the FDA new broad powers, and thus
the bloated and mutated regulatory agency that we know today was
born. Thalidomide, as it turned out, had proved to be a
monster-producing drug in more ways than one.
Today, thirty years later, the cost of developing and marketing
a new drug in the United States has risen to an average of
about a quarter of a billion dollars PER DRUG. To make a long
story short, a large part of this money is regulatory cost. Not
surprisingly, the huge sums spent in drug development are reflected
in the price which the consumer pays when he/she picks up
any prescription for a newer drug. The reader who wishes to
directly assess the regulatory cost of the FDA is invited to shop
for pharmaceuticals in Mexico, where (except for packaging) the
identical pharmaceutical product made by the identical company
(example: Retin A creme) can sometimes be had for as little
as 1/5th the U.S. price.
The FDA is responsible for high regulatory costs in money; the
regulatory cost in lives is more difficult to assess, but is
probably significant. The high cost of drugs has led not a few
impoverished patients to stop taking what the doctor ordered,
sometimes with expensive or even tragic results. Even worse, the
newest drugs now, as a rule, are available in Europe for years
before being available in the U.S., and in the interim many U.S.
patients almost certainly die for lack of treatment. One
estimate, for instance, puts the number of people who died of
cardiac arrhythmias as the direct result of the historical FDA's
multi-year lag-time in evaluating "beta-blocker drugs," in the
hundreds of thousands-- a number which, if correct, makes up for
thalidomide many times over.
It is important to understand that this situation arises via
one of the significant shortcomings of democracy. In every
political decision, there are effects seen, and effects unseen.
Politically, the FDA comes under severe pressure for passing a
drug which is later shown to be unsafe, but (in an unbalanced way)
comes in for much less political pressure as regards the
equally dangerous failure to swiftly pass a drug which proves
to be efficacious. This lack of balance results from the
fact that patients who die as the result of a drug-reaction
are seen to die because of the drug, but patients who die as
the result of lack of a drug (especially one which the local
docs are not familiar with) are seen to die of the *disease*.
Even if the local doctor understands the FDA's role in
preventing the patient from being properly treated, "Stenosis
of the Government" is not a medical diagnosis, and cannot
be written on a Death Certificate.
It is also important to understand that this situation arises
because of a certain laziness of the citizenry in understanding
that the decision of whether to take a specific drug for a
specific purpose, is only partly a scientific one. The reason
for this is that, even in the rare case where the probabilistic
risks and the benefits of "taking the drug vs. not taking it"
have been fully defined by science, the *balancing* of these
risks and benefits is still an ethical and moral decision, and
one which varies wildly from person to person, due to circumstance
and personal preference. Trying to make such decisions by central
command for people makes as much sense in medicine as it does in
economics, and is as doomed to failure.
To put it succinctly, the decision to try a new and possibly
dangerous treatment may well and properly be influenced by how
much pain the prospective treatment-taker is in, and even upon
how soon he or she can expect to die if nothing is done.
Unfortunately, however, these factors do not directly enter into
decisions made in Washington, basically because Washington is not
in pain, and Washington is not dying. If you are the patient
with a serious problem, therefore, you may expect that having a
decision about your treatment made for you in Washington is less
likely to be satisfactory, if for no other reason simply due to
the fact that they do not know you or your problems in Washington,
and even if they did know you, still could not care about
your problems nearly so much as you and your family do. Empathy
is a function of proximity; all physicians know this. It is an
elementary principle of medicine that nearly any displacement of
medical decision-making away from patient and physician is bound
to result in needless suffering. Thus, the FDA as it functions
today is basically engaged in an evil enterprise which cannot help
but cause suffering. To be sure, the people who run the FDA
may not be evil people (though perhaps some are) but unfortunately,
this does not change the facts about the FDA's generally negative
impact upon the country.
The FDA, it must be remembered, is in the game for the
political power, not for the benefit of the citizenry. This is a
fact which comes across in many issues, large and small:
In large health issues, the FDA is known to bow to political
pressure if it is massive enough (i.e., the AIDS lobby), but
there are very few common fatal diseases in which those struck
by the disease are characteristically young and full of energy (which
can be used for lobbying) for many years before they succumb.
The FDA as an institution is thus free to remain firmly entrenched
to retard development of treatments for hundreds of
equally deadly diseases which have smaller or weaker groups of
victims, by comparison with AIDS. Alzheimer's disease patients,
for instance, do not "ACT UP" and close down the Golden Gate Bridge.
They're too sick. (N.B.: And guess what-- hemophiliacs aren't
going to get far either).
In small health issues the FDA's basic unconcern for health is
neatly illustrated by the fact that the FDA will not permit any
information about the possible dangers or side-effects of
particular herbal preparations to be printed on the bottle label,
even though such warnings might do much good. This is because
the FDA does not want to set the precedent of providing usage
information of any kind on herb bottle labels. The safety of the
consumer is secondary to the politics of the issue.
A full discussion of the FDA's many failings on specific
issues is beyond the bounds of this essay, but there is room for
a last informative illustration. For more than ten years the FDA
has zealously prohibited vitamin companies from making claims
about the ability of the B vitamin folic acid to prevent certain
severe birth defects, even while evidence in favor of this hypothesis
mounted year by year. Finally, this year (1992) the American
Society of Pediatrics, driven by overwhelming scientific
evidence, formally recommended that all women of childbearing age
(whether known to be pregnant or not) routinely take a folic acid
supplement pill. Incredibly, as of this writing, the FDA will
still not permit vitamin manufacturers to inform the public of
this on the bottle label (!) Since there now appears no place
the FDA can hide on this issue, however, it now seems likely
that, rather than admit a health claim for a vitamin pill, the
FDA will instead soon *mandate* adding folate to white flour, as
part of the "enrichment" process. We thus seem likely to go very
soon from a situation where manufacturers are prohibited from
telling of the benefits of the vitamin, to one in which
manufacturers are *obligated* to add it to your food without your
request (perhaps still without being allowed to tell you why).
Going from "prohibited" to "required," without going through the
intermediate state of individual choice, is a nice illustration of
the way our government thinks, to be sure, but in the meanwhile,
until all this is sorted out and everyone is forced into the
"correct" mode, more children will surely be born deformed
because their parents meanwhile lacked information on
supplementation. Once again, however, the mission of the
FDA is POWER, not the prevention of birth defects. Anyone
who still thinks otherwise, did not learn the right
lesson from thalidomide.
--------------
May be reprinted without permission, if reprinted whole.
(c) 1992 Steven B. Harris, M.D.
Compuserve 71450,1773
INTERNET:sbharris@ix.netcom.com
From: sbharris@ix.netcom.com (Steven B. Harris)
Subject: Re: ? Re FDA Hormone Regulation (was:Re: Lost 2 Sizes in 2 weeks!)
Date: 27 May 1996
Newsgroups: misc.health.alternative,alt.com,sci.med,sci.med.pharmacy
In <4ocqv8$cgm@newsgate.duke.edu> SRenick <ser3@acpub.duke.edu> writes:
>The FDA's jurisdiction over various substances is defined by the Federal
>Food Drug and Cosmetics Act, amendments to it, and interpretations of the
>first two (by the agency, by the courts).
>
>The crucial issue is definition...ie which things are "foods", "drugs",
>"cosmetics", "devices" etc.
>
>A drug is any "article intended for use in diagnosis, cure, mitigation,
>treatment, or prevention of disease in man or other animals; and articles
>(other than food) intended to affect the structure or any function of the
>body of man or other animals"
I think the article also has to be intended to be ingested.
Naturally the FDA would like to hold power over everything in your
life. Thus, toothbrushes, thermometers, bathroom scales (if you use
them to tell whether or not you are obese), barbells, and CT scanners
would all be "drugs" under this wacky definition (and I believe all are
"medical devices" even now). So also home pregnancy testing kits,
though most people would not consider pregnancy to be a disease. That
did not keep the FDA from regulating these things-- and they regulate
them today. If the FDA wants it on the shelf, whether the kit tests
for pregancy or for HIV, they'll allow it. If not, not. The law as
written has little to do with it.
>When reading the above one word that should stand out is _intent_. It is
>the intended use of a substance that puts the substance in the "drug"
>category. Whose intent? The intent of the manufacturer/seller/advertiser.
>So while you can purchase something like DMSO from the local hardware
>store (not regulated as a drug because it is labelled and sold as a
>solvent) may be used by the purchaser _as_ a drug (eg used on arthritic
>joints)...but the actions of the purchaser (clearly using it as a drug)
>will not force DMSO into FDA regulation.
>
>If a DMSO included therapeutic claims on the product _then_ you'd have
>yourself a drug according to regulations binding the FDA.
>
>Marlboro cigarrettes (nicotine) aren't "drugs"...Nicoderm patches
>(nicotine) are [one reason the FDA can't regulate tobacco as a drug...not
>as regulations stand today is that cigarrette manufacturers certainly
>aren't going to put _t herapeutic claims_ on their product!].
Actually, the fact that cigarettes are not drugs has nothing to do
with the intent issue. Cigarettes and tobacco products are
specifically exempted from FDA control by act of congress. Otherwise
they would surely be considered drugs.
>This is why "nutritional supplements" (which usually can worm their
way into the "food" definition under the FDCA) and herbal medicines--
both groups fall into "drug" as the BUYER is using them...but the
manufacturer is careful to make vague claims about what the product is
intended for-- make no "hard" therapeutic claims.<
Actually, these things would be drugs too, if not protected (again)
by act of congress (the dietary supplements act). The fact that you
make no claim on a product does not allow you to sell it. Try selling
dessicated thyroid tissue as a "food" and see how far you get. And yet
thyroid does get into pork trimmings (sausage, etc) unless butchers are
careful to trim it off. Makes people sick when it does, too. It's
much more a "food." which people would get in the natural course of
meat preparation, than are a lot of things sold in the health food
store. What sets thyroid appart is that it's DANGEROUS. The courts
interpret the law liberally, and not consistanty, according to
perceived public good.
>The fact that something is naturally occurring, whether in a human
body or in a plant, isn't relevant to the definition of drug or
determining FDA regulation.<
Yep. But again, "intent" does not fully protect the seller, either.
Basically what happens is that the FDA does as it pleases, and the
courts back it if the item has ever caused many people problems, or if
the sellers are too weak to defend themselves in court. The law as
written on the books really has very little to do with what actually
happens in supplement regulation.
Steve Harris, M.D.
From: sbharris@ix.netcom.com(Steven B. Harris)
Subject: Re: GHB
Date: 03 Dec 1996
Newsgroups: misc.fitness.weights,alt.drugs.chemistry,rec.drugs.smart,
misc.health.alternative,alt.support.depression,soc.support.depression
In <32b33760.429897982@news.execpc.com> dpdragon@execpc.com writes:
>From what I've read, the problem is not with the DEA since the
>substance hasn't yet been shceduled. Possession, therefore, is not a
>crime. The FDA may be a problem however if the substance is sold
>over-the-counter with any claims as to efficacy.
>
>I would worry about the home-brewing though since I know know little
>about chemistry. Are there any dangers of ending up with something
>ineffective, harmful, explosive, etc?
>
>Maybe we should find some people in European countries who will mail
>the pharmeceutical grade stuff to us. Again, since it hasn't been
>scheduled by the DEA, there shouldn't be a problem with customs, and
>if it isn't meant for re-sale, there shouldn't be a problem with the
>FDA.
How little you know of the FDA. If the stuff is intended for drug use,
the FDA requires proper labeling ("branding"), and failing to properly
brand ("misbranding") of a drug which is sold, is a felony. So what's
the proper brand for GHB intended for ingestion? FDA hasn't decided.
That leaves you with no correct thing you can do to avoid being charged
with a felony if you sell it. All this is not theoretical-- I know a
man who did some prison time for a GHB sale on just exactly these
grounds.
As for holding up GHB at the border, how little you know Customs.
Customs is a law unto itself. Basically they can do whatever the hell
they want in terms of holding up things at the border. Your court
costs to attempt to get them to do what you want them to do, would be
so prohibitively expensive that you might as well forget it unless you
are Bill Gates and want GHB.
Steve Harris, M.D.
From: sbharris@ix.netcom.com (Steven B. Harris)
Subject: Re: Quacks and Geniuses / Human Experiments
Date: 07 Dec 1996
Newsgroups: sci.med,misc.health.alternative
In <58c980$3ej@h2net.net> dunns@h2net.net (Stephen Dunn) writes:
>In article <58a4sp$b7u@dfw-ixnews3.ix.netcom.com>,
>Steven B. Harris <sbharris@ix.netcom.com> wrote:
>:
>:
>:He did infect himself, he didn't develop ulcer. He got a nasty case of
>:gastritis and was pretty sick.
>:
>:Infecting yourself vs infecting volunteers is a big difference in
>:medicine. The one is hard to stop. The other would be practically
>:impossible with today's human use committees (without the approval of
>:which you cannot get the experiment published).
>:
>: Steve Harris, M.D.
>
>And thank God for that because without these regulations we might be back
>in the medical dark ages of a few years ago when some doctors would
>experiment on their patients - sometimes to their extreme detriment
>without even telling them - for example the famous Tuskagee "Experiment"
>in which Black Men with syphilis were "observed" rather than treated. Or
>the 1950's experiments in which people were injected with radioactive
>plutonium without even being told. One man who claimed that government
>agents had injected him with plutonium was treated as a paranoid schizo
>for years - until it was discovered that he'd been absolutely correct all
>those years! Just because you're not paranoid doesn't mean they aren't
>out to get you. Mengle lives!
I think this is apples and oranges. The experiments described above
weren't done on volunteers.
These days it takes a ridiculous amount of paperwork just to draw
blood on people (far more than it takes to take a whole pint from them
if they want to donate), and this kind of stupidity is inhibiting
research. As for research on people who are ill, thousands would like
the chance you had, but are being denied it. It took until just this
year for the FDA to approve research on people who couldn't give
consent because they were unconscious or clinically dead (as in the
case of resuscitation research in people who had just suffered
unexpected cardiac arrest-- Duh). I can tell you any number of stories
of people cut off from a drug or treatment which was clearly working to
save their lives, just because the FDA protocol didn't cover continuing
it. Compassionate use granting is not automatic, and in fact
applications often fail. Yet whose decission should this really be?
If the patient wants to try it, who is to tell him he shouldn't? The
patient is the one with the pain, and the patient is the one who is
going to die. The FDA cannot factor in those things intelligently,
because government agencies don't feel pain. And apparently don't die,
either.
You see the world through rose-colored glasses. Consider yourself
extremely lucky.
Steve Harris, M.D.
>OTOH, I owe my very life to my participation in a clinical experiment and
>for people facing life threatening diseases, finding the best options in
>clinical trials can be a "way out" of a death sentence in a few cases. I
>had a median life expectancy of less than six months and remain in
>complete clinical remission after more than seven years. But even today,
>although informed consent is required, it is very far from, "everything
>you need to know to make an informed decision" and clinical trials vary
>quite widely in their promise to the patient. So researching the data
>before "signing the papers" is essential!
>
> -Steve Dunn
From: sbharris@ix.netcom.com(Steven B. Harris)
Subject: Re: Dr. Harris' credential (was RE: Ritalin)
Date: Sat, 09 Aug 1997
Newsgroups: sci.med
In <19970808211900.RAA01134@ladder02.news.aol.com> yana97@aol.com
(Yana97) writes:
>Hmmm...makes you really start to wonder if the dumbing down of America
>isn't just maybe a little bit on purpose:):). More regulations, more
>power, more money...it all goes hand in hand when the government considers
>people too dumb to take the responsibility to care for themselves at all.
Well, government as your nanny really started in the era of
Rooseveldt the Second (1933). That year, I think the Feds spent 2% of
the GNP or something, but shortly it started to go up and hasn't
stopped. Perhaps the thing that changed everything was the depression,
perhaps not. My private theory is that this who mess is really the
product of giving women the vote in 1920, something we never should
have done if we didn't want the Feds to treat us like children....
Steve Harris, M.D.
From: sbharris@ix.netcom.com(Steven B. Harris)
Newsgroups: sci.life-extension,sci.med.nutrition,misc.health.alternative,
sci.med,sci.med.pharmacy
Subject: Your Expensive Urine--- Ahem
Date: 24 Feb 1998 10:00:00 GMT
A trial published in the Lancet several years ago called the
Cambridge Heart Antioxidant Supplement (CHAOS) trial showed that
megadose vitamin E was about as effective as aspirin at
preventing a heart attack in subjects at special risk for one.
At that time there was very little comment on the fact that this,
and earlier results on vitamin E and peripheral vascular disease,
as well as one monkey experiment proving pathologically vitamin
E's interference with diet induced atherogenesis, had all gone a
long way toward vindicating the Shute brothers (Canadian
physicians who had claimed that vitamin E was good for heart
disease), and many others whom the FDA had been calling quacks
for years. Wups. Very occasionally the government is wrong.
Hey, it happens.
But we were assured that vitamin E was a fluke. If you took
those devil vitamins from the quacks, so said Dr. Victor Herbert,
you could be sure at least the water soluble vitamins were just
giving you expensive urine. Nothing more.
But then came the annoying evidence regarding homocysteine as
a risk factor for coronary disease, and also the fact that
homocysteine levels are lowered by supplements of folate and B6.
And there were some very odd monkey studies showing regression of
atherosclerosis with B6 supplementation also. Did it happen with
humans?
So far, all we have is epidemiology, but it's epidemiology
that all points in one direction. Just this month come two
studies, one published in Feb 10, 98 _Circulation_, the other in
The Feb 4 _Journal of the Canadian Medical Association._ The
latter study looks at the 80,000 woman enrolled in the Nurse's
Health Study, who have been followed prospectively for more than
15 years. The study found that for every 200 ug of folate
consumed, a woman's heart disease risk fell by 11%, and for every
2 mg increase in B6, it fell by 17%-- in both cases controlling
for all other known risks. The study estimated that the risk for
women getting at least twice the RDA of both vitamins, with or
without supplements, was less than half that of women getting the
RDA (who are rare enough without supplements).
A second, this time multinational, study (the European
Concerted Action Project) reported in Circulation (97: 437-43,
1998) found that men and women not getting the RDA of B6 had
almost twice the stroke and heart disease risk of those getting
RDA levels (this was a case control study, with 750 people with
diseases compared with 800 matched controls). Interestingly the
increased risk was partly independent of homocysteine levels,
suggesting an independent role for B6 in protection from stroke
and heart attack (possibly an antithrombotic one, suggests this
article).
All of this was both good and bad news for the FDA, which for
15 years had fought the idea of supplementing diets with folate
for purposes of prevention of birth defects, right up until the
time it decided to mandate the addition of folate to flour
products, which began on Jan. 1 of this year. Zo now you haff no
choize. You vill eat ziss folate supplement, UNT you vill like
it. But people who sell B6 pills are still vitamin huckster
quacks. Or will be, until B6 also becomes a flour fortification
vitamin in the future. And maybe even after. Vitamins in pills,
bad. Quack, quack. Vitamins removed in processing, and then
re-added to foods by food industry, good. Got it? Never mind
your expensive urine. That only confuses things.
Steve Harris, M.D.
From: sbharris@ix.netcom.com(Steven B. Harris)
Newsgroups: misc.health.alternative,misc.health,alt.health
Subject: Re: Alzheimers News
Date: 7 May 1998 08:35:20 GMT
In <noahdove-ya023480000605981216280001@news.lightspeed.bc.ca>
noahdove@lightspeed.bc.ca (Noah's Dove) writes:
>Alzheimers News Is
>Smoking Gun Pointed at FDA
>by Ken Welch
>May 4, 1998
>
>Researchers met in Holland on last week (4/27) to announce confirmation
>of new discoveries about the causes of Alzheimer's disease, an
>affliction marked by memory loss and mental incapacitation in millions
>of elderly people. The new studies clearly connect the disease to long
>term deficiencies of vitamins B-12 and Folic Acid. As a result,
>Alzheimer's disease has become a smoking gun pointed directly at
>catastrophic prohibition of a nutritional supplement for political or
>financial gain.
Comment:
Oh, stuff a sock in it. The facts are these: The FDA restricted
folate to 400 mcg in multivits, and 800 mcg (ug) in prenatals and
single nutrient products. These levels remain plenty for maximally
lowering homocysteine with folate. So the FDA is off the hook there,
particularly as the low homocysteines in Alzheimer's patients seem to
have more to do with low B12 levels, anyway!
A lot of people couldn't figure out whey the FDA would limit folate
in vitamins. They thought it had something to do with vegetarians
(which it did not). The FDA was worried that too much folate would
mask the characteristic anemia ("pernicious anemia") of B12 deficiency,
and this would cause doctors thereby to miss out on diagnosing low B12.
In the end, the FDAs decision in that case probably helped Alzheimer's
patients, since it got more cases of low B12 diagnosed. (Today, the
whole issue has become irrelevent though cheap lab tests, since today
all competent doctors directly measure B12 levels at least once in
people complaining of cognitive dysfunction-- it's standard treatment,
along with thyroid and many other tests)
The FDA is not a great government agency. It HAS been remiss at
not promoting vitamins (and even persecuting vitamin boosters), and
also in blocking (until 5 months ago) people who wanted to add folate
to bread. This was stupidity. But on the issue of folate in vitamin
pills, the FDA's hands are clean. There's surely plenty enough in
there for people with Alzheimer's disease. Let us be honest in the
matter.
Steve Harris, M.D.
From: sbharris@ix.netcom.com(Steven B. Harris)
Newsgroups: sci.med
Subject: Re: Doctors and the FDA (was Re: Steroids and Asthma)
Date: 23 May 1998 11:23:14 GMT
In <3562612F.1F66@lucent.com> Martin Braff <braff@lucent.com> writes:
>I'm sure the doctors working for the FDA aren't going to
>be perfect, but I would trust them before I would trust
>some random textbook or paper.
Why would you do that? Do you think the FDA has the money to get top
experts? Nah. They hire them in quotas. They underpay and overwork
them. And they require them to be generalists in a place where being a
generalist is not good.
> I'm sure the FDA doctors
>are not allowed to be on a drug companies payroll.
Not until they quit the FDA and go to work for the drug companies.
After which they go back to the FDA. You just can't get paid by both
AT THE SAME TIME. Very important rule. For some reason.
>Government regulatory agencies operate in all industries. Should
>the airlines be allowed to continue flying their 737s without
>making the changes/inspections the FAA is requiring, if they
>can find a research paper saying this is OK? What does the FAA
>know about airplanes anyway?
Are we talking about the agency which still won't let commercial
airliners use shoulder harnesses? Which your car had to have in
(what?) 1975? Doesn't it remind you of school busses, also heavily
regulated?
The FAA has the luxury of overseeing a few dozens of different
aircraft makes. All of which are understood much better than
biochemistry and physiology and medicine, because airplanes are made by
engineers, whereas how the body reacts to drugs is a thing determined
by Mother Nature. And not to be well understood by man. And certainly
not Regulatory Man. If you want a better example, imagine a
government agency of astronomy, telling astronomers what they can and
can't believe, or tell the public, or whatever. How about a government
agency of physics, where a bunch of $50,000 dollar a year green Ph.D.s
have to tell the Einsteins and Feynmans of the world what they can and
cannot tell their students. Medicine is, when you think about it, a
very strange discipline. In the medical schools, doctors and
pharmacists are the experts. In the marketplace, suddenly Washington
is. If you believe that, may somebody sell you some Florida swampland.
>The problem with the PDR/FDA is that somehow we have the following
>completely idiotic arrangement.
>
>Before a drug can be used it has to be shown to be safe and
>effective for some specific indication to the satisfaction
>of the FDA. It doesn't matter what the textbooks or papers
>say about the drug, it can't be used. After it's approved for
>one indication, any doctor can freely prescribe the drug for any
>indication he pleases. This makes no sense at all! Whether
>you like the FDA or not, does anyone really think this arrangement
>makes sense? If the answers are in textbooks of research papers
>and each doctor can evaluate this information, then we don't
>need an FDA or an FAA or an FCC.
>
>Marty Braff
Yes, Marty. You're getting it. We already have a court system
which handles fraud. And the courts are getting more and more savvy
about how to handle matters of science. So let them do their job on
the flagrant cases. Let the government keep its prior-restraining nose
out. Let the government in, and all you get is everybody getting auto
airbags. Whether good for them or not. No choice. That's government.
Steve Harris, M.D.
From: sbharris@ix.netcom.com(Steven B. Harris)
Newsgroups: sci.med,chi.general
Subject: Re: No-consent medical experiments killed in Cook County Hospital:
1998
Date: 23 May 1998 12:03:40 GMT
In <6k11q3$93s@enews2.newsguy.com> Tommy the Terrorist
<mayday@super.zippo.com> writes:
>
>"What we have just taken is a fast ride down the slippery slope, right to
>the absolute depths" - Dr. Jack Kevorkian
>
>
>The following is a compilation of news articles, mostly from Dejanews.
>
>What I know about this is based only on them, but I'll give the Cliff
>Notes version here at the beginning.
>
>(1) In 1996 I was laughing about Cook County Hospital's "research"
>program. Their "cutting edge research" was to take old expired blood
>that some company had extracted the hemoglobin from and cross-linked into
>some kind of fake blood substitute, and give it to patients instead of
>real blood. Suggestions were that it was for "battlefield and third
>world use" - and, of course, for blacks at a public hospital.
>
>(2) This program was expanded using an unprecedented renunciation of the
>Nuremberg Code, to allow use of fake blood WITHOUT THE VICTIM'S CONSENT -
>INSTEAD OF REAL BLOOD - IN THE EMERGENCY ROOM WHERE REAL BLOOD COULD HAVE
>BEEN GIVEN. Literally, medical experimentation solely for finding out
>whether the cheaper and more convenient alternative works, without the
>victim's consent.
You need to remember that the Nuremburg code was about doing things
to people that they would have refused (did actively refuse, but were
forced). It's not the same as experimenting on unconscious people, who
can't make a choice (and who would be expected to choose either
experimental alternative in significant numbers, if they could). Some
people don't want real blood, and certainly would choose the kind
guaranteed to be non-infectious. You just can't tell who they are,
beforehand. And if we knew which was better for you in deep shock, we
wouldn't have to do the experiment in the first place, would we?
There is the tougher ethical problem of testing things to help in
shortages we know are inevitable (as with the blood supply). Do we
wait to test this stuff only in situations in which we don't have
enough real blood? This guarantees delays in development, which
guarantees people will die BECAUSE of those delays. Is that choice
ethical? Actually, many people die now because of blood rationing. We
used to transfuse esophageal variceal bleed patients 50 or 100 units. I
remember those days in the early 80's. Now they get shunted or they
die. That's rationing.
How many people have died since 1983, because we have no good
artificial heart (which really shouldn't cost more than a new car, when
developed and mass produced)? Well? So how come we don't have one?
Because somebody decided we wouldn't use it until it was perfect. Even
on people who would certainly die without it. Was that ethical? No,
but that's what happens when you slow down development. As in all
medicine, you see people who die because of less than perfect
treatments, but you never see people who die because of lack of
treatments that could have been. Because you don't know they could
have been. As I've said many times before, "stenosis of the
government" is not a diagnosis you can put on a death certificate, but
it ought to be.
Steve Harris, M.D.
From: sbharris@ix.netcom.com(Steven B. Harris)
Newsgroups: misc.health.aids
Subject: Re: SPECTRA and the Perth Group
Date: 23 Jul 1998 07:04:07 GMT
In <35B58A94.4299@primenet.com> fred <fredshaw@primenet.com> writes:
>Harris' extra chromosome seems to be coded with the
>gene for an obsessive-compulsive craving for
>public humiliation.
Projecting again,
Fred-of-the-self-sticks-with-AIDS-patient-needles?
>> Harris is a bulldog for BS. Science is, literally,
>> a closed book to him.
Amazing how I got a BS in chemistry and a degree in medicine and
published that research in science journals, huh? I forgot, though,
that you insist on your own private definition of science--- one that
leaves all the governments of the world, and most of the world's
scientists, out. Science is a game I've played, Fred-- with the
grownups. You, by contrast, kibitz with outsiders. If there's a
closed book, it's you staring at it, not me.
>Harris is a quack "science advisor" for a second-level
>company that markets for Hoffman-LaRoche, etc.
I have many hats. I'm soon also to be a faculty medical instructor
at the local medical school, where I now teach and consult. Maybe they
were paid off by Hoffman LaRoche in the grand conspiracy, huh?
> What attracted
>Steve to his career path with Life Extensions Foundation
>seems to have been the 28-count Federal indictment for
>such things as the deliberate mislabeling of illegally
>imported FDA-unapproved drugs for resale or distribution
>in the U.S.
Actually, I knew all the people at LEF long before that. I was
confident the indictment wouldn't stick, and (as a matter of fact) it
didn't.
As I said, I had no idea you were just a lover of the FDA, Fred.
And that they stood for you as measures of truth, light, and the True
American Way.
In truth, I think getting indicted by the FDA can be an honor. If
it weren't for the associated expense, it's one I'd enjoy myself. If I
thought any differently about the gross incompetence of the FDA, I
certainly wouldn't have agreed to be a LEF advisor.
The LEF was begging pregant women to take folic acid in 1984. The
FDA didn't start doing that until 1998. I figure the FDA is about 4
to 14 years behind the times, and I'd rather be on the cutting edge
than the dull one. The LEF and I have a long history of urging use of
medications before the FDA finally got around to approving them: For
example, also just this year the FDA approved ribavirin for hepatitis
C, and oral progesterone for hormone replacement. This stuff is old
hat at the LEF, and in my own practice, too. How many people have
sufferered in the meantime, as a result of being blind followers of the
dumb and foot dragging bureaucracy in Washington? Eh, Fred?
How long before the geniuses at the FDA figure out that
antioxidants are good for heart disease and AIDS? Tell us your guess.
Steve Harris, M.D.
From: dyer@ursolaris.spdcc.com (Steve Dyer)
Newsgroups: sci.med.pharmacy
Subject: Re: Info from the FDA online, interesting
Date: 23 Jul 1998 22:55:42 GMT
In article <35b7a2b3.219166@news.supernews.com>,
Justin <jdaras[nospam]@cyberzone.net> wrote:
>Stumbled upon would an appropriate adjective. It seems the FDA has a
>tremendous amount of information online. For your marcabe viewing
>pleasure, check out http://www.fda.gov/cder/warn/warn1998.htm It
>lists, and gives full text of, all warning letters sent by the FDA to
>drug companies concerning their advertising.
I'm not sure why you posted this a second time, a few days after no one
responded, but I checked the page out back then, and I was surprised
at my uncharacteristic reaction, which verged on the Republican.
These are letters sent by the FDA to drug manufacturers, pointing out
problems and errors in their advertisements and demanding corrections.
Most of the letters I read struck me as meddlesome bureaucratic nitpicking
performed at a level only an all-powerful governmental agency can.
Imagine if the editors of Consumer Reports had the force of law and
an enforcement agency behind them, rather than just the persuasive
power of their magazine, and you get a sense of the letters' self-righteous,
petit-bureaucratic tone. (This is not a criticism of CR, BTW. I just
appreciate them as advocates, and not as policymakers.)
On the other hand, the whole thrust of marketing and advertising is
to bend and twist the facts about any given product so that it appears
to address the target customer's needs, and the distortions which
might be expected for consumer items aren't supposed to appear in
the promotion of drugs and devices to medical professionals. You can
only imagine the ads which would appear in the absense of the FDA
acting as a watchdog. So, it's not that I necessarily think the FDA
is wrong, but many of their complaints reproduced in the web pages
struck me as small-minded quibbles and hardly matters important to
the public health. Not very marcabe [sic] at all.
Frankly, I'd love to see the FDA monitor the software industry.
Could you imagine a "Dear Programmer" letter sent out to Microsoft's
customers in response to a letter taking issue with claims about
a piece of software? The possibilities for parody are endless!
--
Steve Dyer
dyer@ursa-major.spdcc.com
From: sbharris@ix.netcom.com(Steven B. Harris)
Newsgroups: misc.health.alternative
Subject: Re: MSM is a load of b.s. and other news
Date: 3 Sep 1998 20:18:29 GMT
In <DQzH1.313$uz5.394995@news.mci2000.com> "AF"
<nospam@no-more-idiots.com> writes:
Tom Matthews:
>>And, in general, it is
>>well established that many supplements can be very valuable for
>>diseaseprevention and therapy.
>
>
>It is not well established. If it was, you would be able to
>demonstrate a substantial scientific literature, and these products
>would be FDA approved and sold under the same regulatory constraints
>as OTC medicines like Advil.
ROFL. First of all, what makes you think the FDA reads the
scientific literature unless somebody makes them? They read new drug
applications. If nobody submits one, they generally sit with one thumb
in their mouths and the other in their rears. Sometimes, they trade
thumbs.
I refer you to the FDA's foot-dragging on folate supplementation to
prevent neural tube defects, which lasted for FIFTEEN years beyond the
time when it was obvious to anybody familiar with the literature that
the problem would NOT be solved unless all women of childbearing age
took supplements, OR folate was added to the food supply. All that
happened THIS year. Fifteen years of babies who won't ever walk, or
who got born with their brains hanging out, are the result. I had been
pointing out the stupidity of the FDA's stand long before it decided to
add folate to the flour early this year. Some of my old essays are
available on the net.
Ribavirin is another case in point. Studies were more than adequate
to show 2 years ago that it doubles or triples chances of a cure in
somebody taking the really vicious course of interferon necessary to
treat hepatitis C. But the FDA, as part of a vendetta against ICN
phamaceuticals, did not approve it until June of this year (and then
only for those who failed interferon mono-treatment, another piece of
silliness when the interferon is expensive, toxic, and likely to fail.
And since the literature shows you lose absolutely nothing by not
treating with the full 2-drug regimen first. I had written all this up
and posted it in the sci.med and alt.support.hepatitis forums two years
ago. So am I a genius, or are the FDA idiots? You pick. The life
extension foundation has been pushing ribavirin for heptitis C for many
years longer than I have. They must all be Einsteins.
>I have been researching this subject for four years, extensively. I am
>deeply familiar with the scientific literature on so-called herbal and
>nutritional supplements as medicines. It is a sparse literature
>consisting of a large measure of speculative theory and in vitro studies,
>a smaller measure of clinical and epidemiological evidence, and a tiny
>number of well-designed controlled clinical trials.
Well, how many well-designed controlled clinical trials which are
positive, does it take? How familiar are you with the selenium
literature? Can you tell me (for example) why people aren't getting
selenium pills from their doctors as often as they get (say) lovastatin
pills? Are the reasons scientific or political? Now this is a serious
question, and you're going to demonstrate your "deep knowledge" by
answering it. And since I also have some claim to have knowledge of
the literature, if you screw up, I'm going to point out where. How
does that sound?
Steve Harris, M.D.
From: sbharris@ix.netcom.com(Steven B. Harris)
Newsgroups: sci.med
Subject: Re: Antimatter and PET scans
Date: 27 Nov 1998 07:11:14 GMT
In <etdyaoxg3fm.fsf@m2-225-11.mit.edu> Alex <alex@somewhere.round.here>
writes:
>> Yes, we are now running a bunch of stored inventive vigor from the
>> 50's and 60's, which is being strangled now with federal and state
>> regulations.
>
>Hi, Dr Harris.
>
>What exactly do you mean by stored inventive vigour?
I mean that the new breakthrough devices we run on now were nearly
all developed in the 50s and 60s, except in pure electronics (where the
old pace of innovation still continues, thank God). In medicine and
aviation/space, and indeed anything to do with biology of humans or
complex organisms, invention ran at an UNBELIEVABLE pace in the 50's and
60's. Since then, safety considerations have largely killed most of it
(genetic engineering is an exception, but that uses mostly bacteria).
The rest is a snail's pace now, mostly limited to incremental
improvements in previous leaps. It's disgusting. People are dying.
They are dying NOW for lack of research. And research is getting
exponentially harder to do.
From: sbharris@ix.netcom.com(Steven B. Harris)
Newsgroups: misc.health.alternative,sci.med
Subject: Re: FDA too much power
Date: 11 Feb 1999 01:21:39 GMT
In <36c19f3d.1027246@news.mindspring.com> bachcole@mindspring.com
(bachcole) writes:
>dep218@aol.com (Dep218) wrote:
>
>>i agree.....they have too much control and it not for the good of the
>>people.......basically it comes down to politics and
>>money.......unfortunately!
>
>The FDA means literally "The Food and Drug Administration". They are
>there to protect the food and drug industries.
>
>Roger
I think if you gave the drug industry the choice between today's
FDA and the FDA that existed before 1964, they'd certainly choose the
former. Nobody wants companies that sell products that aren't what it
says on the label. That's to nobody's advantage, although you
certainly don't need the FDA for it (you could give that job to the
USDA, or for that matter, the FTC). The FDA that has been screwing
things up this last 35 years is the one that demands costly clinical
trials before a drug can be approved-- trials which nothing but a
well-capitalized company with a new proprietary patented drug can
afford. That means that most innovation from the use of herbs,
nutrition, natural substance, and older drugs simply does not happen.
Which, of course, is a source of real problems in medical progress.
Since the FDA took over the control of medical devices not long ago,
I've personally seen progress in that market nearly grind to a halt.
The only new stuff coming out is slight modifications of older devices,
which can be approved with a much cheaper 510K scheme. So you see a
ventilator with a few more bells and whistles at your tradeshow, but
you don't see any breakthroughs any more.
Let me give you an example. When the doctor wants to know what the
oxygen level or CO2 level in your blood is, he or she generally has to
have a sample drawn from a line in your artery, and sent down to a lab
somewhere, where they stick it into a machine. If you are in real
trouble (say, your heart has just stopped and they are trying to
resuscitate you), the turnaround time on that is (needless to say) too
long to help much. Devices are available in which a catheter can be
inserted into an artery and read your blood gases continuously for many
days, at the bedside. They just barely made it though before the FDA
clampdown.
But now, consider-- the settings on your ventilator are made by
looking at your blood gases. This can be a minute by minute decision
for a difficult case. The feed back loop is still somebody drawing a
sample and sending it away, and them adjusting a (now fully
computerized) ventilator. Why not simply have a smart ventilator which
can "see" your blood gases, and adjusts itself (within parameters and
danger limits) to keep them where the doctor would like them to be?
It's mainly a matter of hooking one device up to the other, and writing
some difficult medical software (which the FDA now has control over,
also). So, although we have the capability of doing all of this (and
did 5 years ago) it's not happening. Your government has pretty well
held it up in red tape.
There are hundreds of examples of this out there. The same monitor
can literally see the oxygen content of brain tissue in head injury
case, if the sensor is inserted through the "bolt" which doctors
already use to monitor brain pressure in head injury cases. That's the
number you want. The FDA has yet to approve this use, although in
Europe they've been using the standard arterial sensors for years for
this (works great). Certain types of resuscitation chest compressors
can be mechanical, replacing the human being doing chest massage (which
isn't very effective when humans do it, mainly due to lack of
feedback). These are approved, but are dumb. What kind of feedback do
you need in the field, or an ICU, if you're doing chest compression?
You'd like to know the CO2 production of the patient, which can be read
with an existing device. You'd like to know the arterial pressure
pulse waveform. You'd like to know the blood gases. There are even
non-invasive ways to estimate cardiac output. But the machine which
does the compressions is not aware of any of them, since the FDA is
holding up the hookups, and the software. So none of it is very
effective. If the FDA was in charge, the "fly by wire" system that
runs the space shuttle and the 777 (to which you trust your life every
time you fly) would still be investigational. And far more people are
dying in ICUs as a result of lack of these innovations than ever died
in aircraft mechanical failures. We see them as dying of diseases.
And they are. The main one is Sclerosis of the Government.
Steve Harris, M.D.
From: "Steven Belknap, M.D." <sbelknap@uic.edu>
Newsgroups: misc.health.alternative,sci.med
Subject: Re: FDA too much power
Date: Thu, 11 Feb 1999 23:41:44 -0600
> I think if you gave the drug industry the choice between today's
> FDA and the FDA that existed before 1964, they'd certainly choose the
> former. Nobody wants companies that sell products that aren't what it
> says on the label. That's to nobody's advantage, although you
> certainly don't need the FDA for it (you could give that job to the
> USDA, or for that matter, the FTC). The FDA that has been screwing
> things up this last 35 years is the one that demands costly clinical
> trials before a drug can be approved-- trials which nothing but a
> weel-capitalized company with a new proprietary patented drug can
> afford. That means that most innovation from the use of herbs,
> nutrition, natural substance, and older drugs simply does not happen.
> Which, of course, is a source of real problems in medical progress.
>
> Since the FDA took over the control of medical devices not long ago,
> I've personally seen progress in that market nearly grind to a halt.
> The only new stuff coming out is slight modifications of older devices,
> which can be approved with a much cheaper 510K scheme. So you see a
> ventilator with a few more bells and whistles at your tradeshow, but
> you don't see any breakthroughs any more.
<snip>
> If the FDA was in charge, the "fly by wire" system that
> runs the space shuttle and the 777 (to which you trust your life every
> time you fly) would still be investigational. And far more people are
> dying in ICUs as a result of lack of these innovations than ever died
> in aircraft mechanical failures. We see them as dying of diseases.
> And they are. The main one is Sclerosis of the Government.
>
> Steve Harris, M.D.
Dr. Harris raises some valid points. There is sclerosis of the
government. But the FDA is not the cause of the problem, in my view.
Rather, the problem is that the government spends nearly all of its
research funds on basic research. Relatively little is spent on
clinical research. This despite the fact that Medicare and Medicaid
waste enormous sums of money on worthless medical care.
There is a shortage of persons capable of conducting clinical
pharmacology research because the NIH has drastically cut back on
funding of training programs. There is a serious shortage of trained
investigators who could competently conduct clinical trials of new
drugs, and the situation is worsening as the ones we do have near
retirement age.
Meanwhile, millions are wasted on "alternative" research, which has
revealed little if anything.
Part of the solution is to increase funding for clinical research and
for training clinical researchers. Another part of the solution would
be to begin restricting payment for medical care to situations where
evidence supports the care being given.
Finally, lets remember that the FDA is required to follow laws passed
by Congress. Some of those laws make about as much sense as the laws
which govern the IRS. Its not really fair to blame the IRS and the FDA
for bad laws passed by Congress.
-Steven
From: sbharris@ix.netcom.com(Steven B. Harris)
Newsgroups: misc.health.alternative,sci.med
Subject: Re: FDA too much power
Date: 12 Feb 1999 07:36:01 GMT
In <sbelknap-110219992341447700@mac0.uicomp.uic.edu> "Steven Belknap,
M.D." <sbelknap@uic.edu> writes:
>Finally, lets remember that the FDA is required to follow laws passed
>by Congress. Some of those laws make about as much sense as the laws
>which govern the IRS. Its not really fair to blame the IRS and the FDA
>for bad laws passed by Congress.
Alas, Congress passes only enabling legislation. Institutions like
the FDA and the IRS write most of their own regulations, which become,
in effect, laws. If they want to speed approval process up for some
class of drugs, they don't have to ask congress-- they just do it. And
take the credit for it. Well, the opposite applies also. Sauce for
the goose is sauce for the gander.
From: sbharris@ix.netcom.com(Steven B. Harris)
Newsgroups: misc.health.alternative,sci.med
Subject: Re: FDA has too much power
Date: 12 Feb 1999 11:31:30 GMT
In <36C2534C.E8F444CE@iname.com> Ken <ir4al@iname.com> writes:
>(old stuff snipped)
>
>>
>>I also should have said ...The FDA was too busy protecting *certain
>>people* from the pressures of the free market, and holding up progress!
>>
>>The fact of the matter, and what I think you are trying to avoid is, as
>>of June 5, 1997, almost exactly a year before I broke my arm,
>>Switzerland, Spain, Portugal, Scandinavia, Finland, the UK, Ireland
>>(Ireland for God's sake!) and Southern Germany were all legally able to
>>use the Norian SRS.(Although a distribution agreement was not reached
>>untill Dec 22, 1997 Still a year before US FDA approval.) (source:
>>norian.com)
>>
>>The FDA didn't approve it untill December 23, 1998!
>
>And you want to make something sinister out of that. You want to say that
>the FDA was deliberately dragging its heels. You want to say that the FDA
>was "protecting" someone.
>
>To the best of my ability I view it neutrally, although I did suffer
>because of this *deliberate* delay. Which would cause me to have some
>personal bias. Personally, I don't view it as sinister, just immoral and
>unethical. Either way, they most certainly were providing a buffer for
>the people that will be forced to adapt because of this new technology.
>They most certainly were protecting someone. And they most certainly were
>_holding_up_progress_.
>
>Who were they protecting? The cast manufacturers? If it's all that big a
>deal, the stuff would never have been approved.
>
>Since I'm not a spy in the FDA I don't have a detailed log of every
>person or company that will undergo dramatic change because of SRS. You
>think that it is impossible that there are orthapedic surgeons who lobby
>the FDA, or have good old boys in high offices?
>
>This new technology is a major break though in the field of orthapedics.
>It is a time when the old are being weeded out and replaced by the new.
>It surprises you that the FDA is protecting them?
Comment:
Actually, it would surprise me. The FDA does untold damage to
orthopedic surgeons and indeed all doctors with its stupid regulations.
In general, medical progress does not take money out of doctors'
pockets no matter how fast it goes-- I hope you understand that. There
are ALWAYS enough sick people and ill people to go around, and the
fraction of dollars that society has advocated for health care in one
way or another always get spent. It just gets spent on different stuff
(polio vaccine vs iron lungs). And different diseases (HIV vs TB and
infant diarrhea). And, ultimately, older people. But the doctors
still get their share.
No, the FDA does not do it to protect domestic doctors. Or domestic
medical device and drug manufacturers (that's a REAL horselaugh). Or
domestic medical industry investors. Come ON. These people really DO
suffer because they have a smaller market (there are lots of US medical
device firms that only EXPORT).
The FDA does it to protect ITSELF. The FDA is held responsible for
bad drugs and bad devices, but not for failure of availability of
treatments for bad diseases. THAT would take enormous voter
sophistication. When you hold up approval for a couple of years, you
get to use people in other countries as guinea pigs. There are really
very few political penalties to holding up a good treatment for a
couple of years, because people rarely know what they're missing. The
world is not quite that connected, yet. They think they're suffering
from a disease, not from lack of a cure that is used in Europe (your
story, for instance, will be quite a surprise to 99.9% of people even
on this newsgroups who read it; now consider Joe Sixpack who is the
average voter...). But there is a terrible political penalty for
approval of something too early, which turns out to have really nasty
side effects, which get advertized in the morning headlines. 10 people
DIE OF DIET PILL! So the FDA has every political reason to hold stuff
up here for a while, and hardly any to be pathbreakers.
It's the old argument of Bastiat, who wondered why the economy does
not improve if you break a window in a bakery. Does it not employ the
contracter and the glazier and the sand and soda and coal and tin
miners, and so on? An ever expanding array of jobs created? Sure. But
the problem is that the baker has to buy a new window with money that
otherwise would have gone for a new suit, which would have employed the
tailor and the clothmaker and the cotton grower and and the fertilizer
producer, and so on. For every job created there's an invisible one
destroyed-- also in an every expanding array. The effect on the
economy is the same, except that the baker doesn't have his new suit.
Quality of life goes down.
There are things seen, and there are things unseen, as Hazlett says
(again and again) in his wonderful book _Economics in One Lesson_.
It's easy to see what is, and hard to see what would have been if the
decision had been the other way. It's easy to see the fancy federal
highway to nowhere built with government money, and hard to see all the
other consumer goods, from braces to dance lesons to toilet paper,
which didn't get bought with the same money, which would have
contributed to the economy just as much and employed the same number of
people, all while giving people a lot better quality of life, because
they all got more exactly just what they wanted. That's the great
problem and conundrum of politics and democracy.
In medicine, there are things seen, and things unseen. You see the
side effects of drugs approved too early. You don't see the side
effects of drugs approved too late. It's very, VERY hard to see the
lack of a thing you've never heard of.
Steve Harris, M.D.
From: sbharris@ix.netcom.com (Steven B. Harris)
Newsgroups: sci.med.aids,sci.med.diseases.hepatitis,sci.med,
sci.med.diseases.cancer
Subject: Re: Patents & Pricing: New Legislation
Date: 6 Mar 1999 10:22:34 -0600
In <54396@sci.med.aids> nagle@netcom.com (John Nagle) writes:
> Just some exposure of some drug industry practices might help:
>
> Congress has given the drug industry some breaks on extensions of
> patent terms. That needs to be publicized more. Congress can
> take that back.
But shouldn't. I'll address that in another message.
> - The business of patenting one isomer of a stereoisomer is
> a bit much; that's clearly an "obvious combination". Allegra,
> for example, is one isomer of Seldane, but that gets that family
> of drugs another two decades of patent protection.
Allegra is a metabolite of Seldane. This fact was not so obvious
that you got it right. Nor was it completely obvious that the way to
get around the cardiac toxicity of Seldane when given with other drugs
was to market the metabolite instead. Nor are we talking about a whole
class of drugs. The patent here is for one molecule-- fexofenidine.
There are other non sedating antihistminines to chose from, some also
without the cardiac toxicity problems (eg, Clariten). Competition
continues.
> - Some drugs are sold to HMOs at a TENTH the price they sell to
> pharmacies, because the HMOs can bargain to put a drug in their
> recommended list if they get a good price.
So? It's called a volume discount. Not unknown in the retail
business. Ten to one is rather rare (though not unknown) in other
volume businesses from wholesaler to jobber to distributor (for milk,
no-- for diamond jewelry, yes). But that much is rare in the drug
industry also. If you think Exxon sells gasoline to service station
chains for close to the same price you pay per gallon in your tank,
think again. Or that you pay close to the same price for concrete
poured in your own driveway, as that which is quoted to the contracting
company for the skyscraper downtown, or the dam up the river. You can
call it unfair if you like. But you wouldn't if you were a contractor.
And by the way, what DO you do?
> Markups on generic drugs have increased significantly in the
>last year.
Yes, and for this you can thank your dear FDA, which has steadily
been raising the bar to how many tests you have to do on a generic to
market it, and how long it will take you. That cost gets passed to
you, the consumer. If it didn't, some other company would make the
same stuff and sell to you for less. In a free market, you pay the
minimum it takes to get the stuff to you (patents aside). And as for
patents-- well-- anybody's free to discover a molecule. Even you. If
you think it costs too much to get new molecules into people, or even
old ones in fixed combinations, perhaps you're unaquanted with the
expenses that researchers incur.
> None of this, though, is really relevant to AIDS, where the
>expensive drugs really are new and required extensive new, specialized
>research.
>
> John Nagle
Average cost to develop the average drug is 250 million. Not
counting AIDS drugs. You want cheaper drugs? Do something about the
regulations that drive these prices up. But do not complain about drug
safety then. You can have your new drugs reasonably fast, reasonably
cheap, reasonably safe. Pick any two. You cannot have all three,
because the universe does not work that way. If you don't like THAT,
you can go out and shake your fist at the sky. But neither the
pharmaceutical companies or even the FDA are responsible for biology.
Steve Harris, M.D.
From: sbharris@ix.netcom.com (Steven B. Harris)
Newsgroups: sci.med.aids,sci.med.diseases.hepatitis,sci.med,
sci.med.diseases.cancer
Subject: Re: Patents & Pricing: New Legislation
Date: 6 Mar 1999 14:44:13 -0600
In <54367@sci.med.aids> gmc0@ix.netcom.com (GMCarter) writes:
>I need help with an idea.
>
>Today on NPR, they discussed how healthcare organizations are all
>buying each other up, premiums are increasing and people are losing
>their healthcare, causing premiums to increase further to make up the
>shortfall in income from people bailing out.
>
>One reason for increased costs is the outrageous cost of drugs and
>tests (which NPR didn't discuss). Schering's Rebetron curiously
>springs to mind as an egregious example of price gouging--Serono's
>human growth hormone, foscarnet, fluconazole, etc., ad nauseam ad
>infinitum.
>
>Nothing new here. What I am suggesting is a broad, national campaign,
>involving health activists from all walks and even possibly the
>insurance industry and whomever else might be interested in signing
>on. The campaign centers around legislation that we need to write that
>essentially states:
>
> PATENT LAW IS NOT A JUSTIFICATION FOR PRICE GOUGING.
>
>In the legislation, we might define a formula for arriving at a
>reasonable profit derived from generally accepted standards for other
>industries. What figures sound right? 20% mark-up? 150%? A range?
>There must be a maximum.
Comment:
Actually, I think it's rather an evil idea you want help
with. We've discussed this before. This society, as a whole, has
rather a lot of disdain for intellectual property, unless it can be
copyrighted (which can last 100 years from date of creation, or even
more if the author manages to live more than 50 years after creation)
or if the idea is trademarked (which lasts forever, so long as in
use).
It seems, however, that many of the ideas that move the world
and better the lot of mankind, unfairly win nothing for their
originators. History is full of inventors getting screwed. Eckart
and Mockley went broke trying to sell Univacs, while IBM laughed at
them for being fools. Then realized they weren't when they saw what
the machines could do and were doing, and promptly took the ideas and
made all the money.
"So what?" you say. So what is this: when creators are not
paid to create, in fact are even punished for it by being laughed
at and reviled, they eventually quit creating and do something
else. Tesla, who invented so much which made Westinghouse what
it was, wound up a bitter old man, burning the papers which had
his last ideas. And why not? Newton didn't get too much money
for the invention of the law of gravity or the calculus, and
seems to have spent a lot of his genius fighting silly priority
issues because recognition was all there was to be paid in. The
government and university gave him jobs, but they were nothing
compared with what he deserved. Einstein, too, got the Nobel
prize and a nice position at the IAS, but what he contributed was
worth far more. Too often, inventors of the best ideas never see
them put into profit. Watson and Crick made nothing from genetic
engineering, though they made it all possible. And even where
money is made, it is often made too late. Orville Wright made a
million dollars from the invention of the airplane, but Wilbur,
though he lived many years, still died before this happened, and
missed out on any of that. That happens too often.
This state of affairs is what I've called information
socialism. It has the same bad effects on the creation of new
information as agricultural socialism has on the growing of more
food. But we persist in thinking it's a good thing. We continue
to see proposals like yours, which amount to the same thing (perhaps
information fascism would be a better term for what you propose-- but
it's a difference in degree only).
I don't know why people think this way when it comes
to industry. You may write the great American novel, and
want to sell it for $100 a copy. If you did, nobody would
accuse you of "gouging" -- they simply wouldn't buy it
(unless it enriched their lives by at least $100). Or you
could make the Great American Movie and charge $25 to see it.
If the market would bear it. We all realize, though, that the
idea is silly for a movie, because the market would NOT bear it.
But people WILL buy a piece of software for thousands of
dollars if they need it for their business. People pay what
things are worth: indeed, that's how you find out how much
they ARE worth. The only thing that copyright laws or
trademark laws do is prevent people from stealing your
intellectual work, by copying it. The problem with
drugs is that when your intellectual work is in the form
of new molecule design rather than a building design or a new
tune or song, suddenly society gets the idea that you don't
own it for as long. That's fine-- except that the flow of
new drugs is stymied by just that amount, because many
people who could be creating new drugs, and new medical
treatments, are no fools, and so do something else.
And so they fade into obscurity or other successes, and
what they could have done does not get done. Instead,
because of laws protecting intellectual property we value,
we get Hollywood-- and our heros are actors. Or sports
stars whose multi-million dollar salaries are paid
from broadcast rights. But scientists who make the whole
things work? They're too poor to be heros. They don't
make much of the money they provide the path to creating,
and never have.
And, of course, a certain amount of resentment is created by
this. Intellectuals who have their ideas stolen by people who
make a lot of money by applying them, tend to become
paranoid and angry with capitalism and capitalists. The best
they can do to make a living is teach, and of course what they
teach is hate. And as I've noted before, that is why univers-
ities fill up with leftist professors who loathe industrialists.
What do you expect?
This kind of thing is bad for the professors, even if they are
not haters, because they are forced to leave academia, or else do
dangerous things for compensation that should have been automatic.
By example, I just read the biography of one of the world's great
physicists, Erwin Schroedinger, an Austrian who had left a top
professorship at Berlin (no less than the Max Planck Chair) in
protest when the Nazis took over in 1933, BUT nevertheless a few
years later unwisely left relatively safe Oxford for Austria,
then under threat of the Nazis, because he needed a university
appointment with a good pension plan ("My wife can't live on the
Shroedinger Equation"). With the result that the Nazis, now
rather angry with him, eventually did get him, and he was lucky
not to be sent to the camps (he got out of Europe with a 1 lb
Sterling note and the clothes on his back-- and then only by a
piece of incredible luck and a lot of charity). So it goes.
Others weren't so lucky.
And this kind of thing is very bad for the rest of society.
I've remarked in another message that Schroedinger was the only
major non-Jewish German professor who voluntarily left Germany,
due to the policies of the Nazis (even though he was a rather a-
political man). The rest of the German professors did nothing.
They, and the Nazis, had watched Jewish entrepreneurs make money
from any idea which came along, and from any social problem (eg
WW I), for decades. In a poor, inflation torn country, they
resented it. But, as usual, they were resenting the wrong thing:
the problem was not a particular group of people (like the Jews),
but rather the basic problem of unfairness resulted from an evil
IDEA. It was, in fact, with the old idea of information
socialism, combined with capital ownership. The Jews, from long
necessity, had learned to thrive on this combination. And to
counter it, in Germany this time they proposed merely a different
kind of socialism (National Socialism), while hating all other
kinds. But still German National Socialism was a system which
promised that those who made money from ideas not their own would
have the money confiscated, and with state control of industry,
all would again be fair. Very satisfying to those who didn't own
the industry. And to those who did own it, it seemed fine also--
- until they realized way too late just what it was they had
supported.
As for the Nazis, they never realized that ideas themselves
have value, and you cannot steal them from people you've exiled.
So they didn't get the atom bomb, and we did (mainly from brainy
people who had left Europe). Wups. The Soviets were better at
stealing ideas, and did quickly steal this one. And they sort of
learned to pay people in privileges for ideas when it came to
atom bombs and missles, but they never figured it out for things
like agriculture and manifacturing. Eventually, their bomb
system worked great, but nothing else did, and they went under.
China finally liberalized agriculture, and kept from going
under, but still does not understand about information (they are
the world's chief copyright thieves). So it goes. Somehow,
where ever you go, this lesson is the hardest one that people
have to figure out. Do it, and your society thrives. Fail, and
you suffer to the extent that you don't get it.
Socialism is ever the politics of envy, no matter who proposes
it. In every capitalist society those undercompensated leftist
academics with their envy of rich idiots, do a real brainwashing
on a society of capitalists which sends its progeny to those
universities to be taught values. Among them (supposedly)
fairness, and thou shalt not steal. Except it's not happening.
Instead, they're being taught that those who figure out a way to
charge the market the full value of a new idea (which happens
mainly for industrialists), are "gougers" and "monopolists." And
so it goes. It's the same old story, just in a different guise.
The professor expels a student looking at another student's exam
in a test, and would be shocked of somebody photocopied his
textbook-- but be wants full freedom of information when it
comes to industrial knowledge, so that somebody doesn't profit
"unfairly." Very curious. Very curious indeed.
Let me say this one more time, George, and I'm sorry if I
sound like Ayn Rand here (she was right about this one thing).
But the root of all evil is not the love of money. Money gotten
in fair trade means you did somebody a favor, since they needed
what you had worse than the money. The root of all evil is
THEFT. For there is no value but life, and we all trade pieces
of our lives for something, every day. This is moral, and in
fact in a good trade, both parties gain in life (as when I trade
some of my vitamins for some of your minerals, etc). When you
*steal* however, you steal a piece of someone's life. And that
is why it is wrong. Stealing a man's money is stealing a little
bit of his life (the part of it he spent to get the money). So
is stealing his ideas (for they take time and effort to produce
as surely as a field of corn). When you take an idea and make
money from it without returning some to the inventor, it's a
little bit of murder.
So when you steal, you'd better make sure that your own life
is at stake, and there are no other alternatives. And when you
steal from inventors, it' just the same. People who live in
houses with TVs and cars and doodads and gewgaws and computers,
and want lower drug prices, are not in that position. If you
argue for stealing only life-saving drug designs, and those only
for people so poor they have nothing to trade, you'll get much
more sympathy from me. But most drug companies have programs to
get free drugs to such people NOW. The cost of those indigent
patient programs is shifted to those who buy the drugs at full
price. Or to the taxpayer. Somebody is stolen from, always,
when you have a situation in which there is no trade. Please
remember that. You're just arguing for stealing instead from the
people who create the wealth, rather that from somebody else who
needs what they have made, and has a little more money. If you
steal to save a life in an emergency it may not be horribly
immoral--- but if you steal from the person creating the wealth,
it certainly can be dumb. Because if they're smart enough to
create the wealth, they're smart enough to eventually get the
hell away from your hooks. Thou shalt not bind up the mouths of
the kine who tread the grain, George.
Steve Harris, M.D.
From: sbharris@ix.netcom.com(Steven B. Harris)
Newsgroups: misc.kids.health,sci.med,misc.health.alternative
Subject: Re: Do medical doctors think for themselves?
Date: 13 Feb 2000 20:04:08 GMT
In <eUAp4.464$KD.32585@news1.epix.net> "Jeffrey Peter, M.D."
<kidsdoc2000@hotmail.com> writes:
>Provide evidence for your statement. Actually, many of the people working
>for the FDA are professionals who want to ensure a safe supply of drugs.
What they want personally, and what the system they work within
provides for their being able to do, in practice, may not be the same
thing. The paperwork for a investigational new drug application fills
a moving van. Buried in that is the meat of the data, but the drug
company has many ways of not drawing attention to it. You may have 300
adverse drug reaction reports, most of which involve minor stuff, and a
few which are major things, but happen to people who already have 3 bad
diseases. You have to sort them out, which takes a high level of
expertise. No, you don't have Dr. Ben Casey on your staff, and if you
did, he's surely go crazy. Or else, within 2 years of not being in
practice, would be a dinosaur, out of touch with contemporary medicine.
And then there's the drug company "pull." Did the FDA "know" about the
hepatic problems with zileuton/Zyflo from animals studies, before
approving it for people. Well, yes... It was buried in the moving
van. Did somebody see it? Good question. Did they approve it
without warnings to look for hepatotoxicity? Yes. Did it kill some
people? Yes.
Newsgroups: sci.med.pharmacy
Subject: Re: Glucophage
From: dyer@spdcc.com (Steve Dyer)
Date: Sat, 03 Feb 2001 08:53:22 GMT
In article <3a7ba177$0$16373$7f31c96c@news01.syd.optusnet.com.au>,
PharmStud <anon@anon.com> wrote:
>:) ...
>Diabex and Diaformin available in good ole Aussie! :)
>is Glucophage the only form of Metformin available there!?
Yes, which is really preposterous, since metformin has been in use
in every country except the US since the late 1950's. Frankly, I
don't understand what authority the FDA has to grant exclusive
US marketing rights to a manufacturer of a drug that has long since
gone off patent, and which is not a so-called "orphan drug",
since this is an exercise of power that is completely out of
the bounds of the FDA's original mandate from Congress to
guarantee drugs' safety and efficacy.
--
Steve Dyer
dyer@ursa-major.spdcc.com
From: Steve Harris <sbharris@ix.netcom.com>
Newsgroups: sci.med.cardiology,sci.med,sci.med.pharmacy
Subject: Re: spin-doctored: how pharma reps control what drug you get
Date: 7 Jun 2005 14:01:29 -0700
Message-ID: <1118177100.263118.69020@g44g2000cwa.googlegroups.com>
>>I feel we have found much common ground, but are no closer to any
agreement on reforms to the FDA, government's specific role in the drug
safety, manufacture or testing. Any suggestions? <<
COMMENT:
Yes. Limit FDA's role to the one it had before 1963, which was
primarily to keep tabs on the safety and purity of foods and drugs. For
drugs, this meant primarily looking at toxicity and side-effect data.
If a company wanted to market a very toxic and nasty drug (for example
a chemotherapeutic agent) only then would they need to present efficacy
data, in order to argue that benefits outweighed risks. Otherwise,
companies should be able to market a reasonably non-toxic drug and let
the market and scientific community decide questions of whether it
works on disease, or not. FDA would be free to require makers to put a
label on the bottle in the meantime, stating that the FDA had made no
efficacy determinations for the drug. In such cases, doctors would be
free not to prescribe it, and patients not to use it. Much as happens
with products that aren't approved by non-government testing labs
today, such as URL.
SBH
From: Steve Harris <sbharris@ix.netcom.com>
Newsgroups: misc.health.alternative,sci.life-extension,alt.health,sci.med,
misc.headlines
Subject: Re: THE REAL DRUG WAR IS VIOXX
Date: 12 Jun 2005 16:28:45 -0700
Message-ID: <1118618925.116565.196090@g14g2000cwa.googlegroups.com>
>New statistics reveal a mounting death toll from the blockbuster
>pharmaceutical drug Vioxx. The highly touted pain killer is estimated
>to have caused roughly 140,000 heart attacks, 44% of which led to
>death. The total number of U.S. deaths from this pharmaceutical drug
>that the FDA had claimed was "safe", is over 60,000, which is about the
>same as the combined number of deaths of all U.S. soldiers killed in
>the Vietnam war, Desert Storm, and the current Iraq quagmire.
>http://www.organicconsumers.or=ADg/Politics/medicine052605.cfm
COMMENT:
But what DON'T you see on the other side of the equation? How many
people died in the same time before the age of 70, of potentially
treatable problems which lacked a treatment, because the FDA had
blocked development of a cure, due to political pressure to only pass
"safe" drugs. Begin alive is not safe.
I think the FDA is responsible for killing more people from drug delay
that from drug fast-tracing. The FDA's delay on US introduction of beta
blockers alone is estimated to have cost tens of thousand lives.
You can see an estimate of net cost vs net benefit of the FDA at:
http://www.fdareview.org/harm.shtml
Estimate is the FDA saves 5,000 to 10,000 lives per decade by drug
scutiny, relative to other countries which don't have a careful a
system. But FDA delays DUE TO THIS PROCESS COST 20,000 to 120,000 lives
per decade. That's the part you DON'T see. Vioxx merely helps redress
this balance, but it's still not going to make up for the problem.
SBH
From: Steve Harris <sbharris@ix.netcom.com>
Newsgroups: sci.med,talk.politics.medicine
Subject: Re: diseases of rich deprive poor of drugs
Date: 13 Sep 2005 18:56:50 -0700
Message-ID: <1126663010.282321.300880@o13g2000cwo.googlegroups.com>
O'Hush wrote:
> I really meant that it seems to me you spend a lot of time and effort trying
> to punch holes in everyone else's arguments, but you rarely offer
> substantive solutions of your own.
>
> ~~Patti
That's because most of my solutions to government problems are so
simple they are usually missed: Just have the government stop doing
that! Have it get out of that whole business! Not invading Iraq is
really simple. Now that we're there, getting out is necessary. We can
do it in 3 months, or we can do it in 5 years. The end result will be
the same (civil war) and the end result of that civil war will be the
same (I don't know what, but I do know we can't change it). So it's
like Vietnam. It's no kindness to hang a man slowly. If you're going to
do it, just DO it. Do it NOW. There, you can frame THAT.
As for the FDA, my grand "solution" is to scale back the organization
to what it did in 1960. Which was look after the purity and labeling
and (gross safety) of foods and drugs, and didn't make complex
tradeoffs between safety and (permitted) efficacy claims. How effective
a drug is, and for what population, is a question to be determined by
scientists and the scientific community, and by doctors and their
individual patients with individual problems and risks and values.
Mankind has nothing better to offer than that system. It's not perfect,
but no appeal to authority will do anything more than *&%% that up.
Therefore, let the FDA GET OUT OF THAT BUSINESS. If you're not a
scientist, don't play scientist. It's like having the federal
government decide on whether or not the Earth is or isn't warming, or
whether evolution of apes into humans did or didn't happen. It's not
something government should be concerned with. They have other things
they're supposed to be doing, like (right now) flood damage cleanup.
Whining: I think you could fairly call it whining if I was always going
on about my personal problems with the FDA. I don't. I'm just letting
you know the FDA is trying to kill YOU. And your family. That's a
mighty strange sort of whining. I would have thought "warning" would be
a better word. And I would have thought you'd think more of me for it,
since I don't (lord knows) get anything for doing this dirty job. But
have it your way.
SBH
From: Steve Harris <sbharris@ix.netcom.com>
Newsgroups: sci.med,talk.politics.medicine
Subject: Re: diseases of rich deprive poor of drugs
Date: 14 Sep 2005 01:29:31 -0700
Message-ID: <1126686571.371174.252100@f14g2000cwb.googlegroups.com>
O'Hush wrote:
> > Therefore, let the FDA GET OUT OF THAT BUSINESS. If you're not a
> > scientist, don't play scientist.
>
> So instead of arguing with relatively powerless people on usenet about it,
> why not channel some of your energy into potentially making that happen? I
> bet you could dig up some other Libertarian, FDA-hating doctor/scientist
> colleagues and start an FDA-hating club. (Still smiling sweetly.) You
> could collectively write papers estimating the various negative impacts of
> the FDA on our healthcare system and submit them to peer-reviewed journals.
> Or you could all just hang out and drink beer.
COMMENT:
Way ahead of you. I give comfort to, aid and (some would say) abet the
Life Extension Foundation (www.lef.org). Who, with the assistance of
some top notch constitutional lawyers and some great campaigns, have
given the FDA more grief in the last 18 years than any other three
organizations put together.
But it's not enough, and it's not easy. Big Pharma is in an uneasy
alliance with the FDA, as a co-dependent. And not because the drug
companies are in some all-out battle to crush the world's health by
making it take pills, or keeping it from eating vitamins, or some other
silly nonsense like you hear in misc.health.alternative. But more
because of a sort of Stockholm syndrome. Big pharma doesn't fight the
FDA for the same reasons that Soviets said nice things about Stalin
when Stalin was alive, even though they didn't like Stalin. Get the
drift?
Anyway, the sector of the US economy regulated by the FDA, and
therefore more or less controlled by the FDA, represents a large
fraction of the medical industry, and therefore an *unbelievable*
amount of $ and political power. I was going to say that only the US
military-industrial complex outdoes it, but I cam not sure even of
that. The last time the military had a million units of frozen blood
stored away for the next war, and it didn't fit FDA specs, they had to
throw it out. These are guys with nukes and tanks, remember, but it did
them no good. I can't play in that game, and never will. So I do what I
can, but it's not going to be much.
> Holy shit! Please explain to me how the FDA is *trying* to kill me and my
> family.
COMMENT:
By holding back progress on all the kinds of medical research that
could stave off your diseases, slow your aging process, and extend your
life. Starting with stem cell research and going on from there. In just
my own field of resuscitation, there must be 2 dozen drugs that work to
protect the brains of animals that have been deprived of oxygen. Some
we've known about for 20 years. Do you know how many of them have made
it past clinical trials, and onto market? None. And not because
there's anything wrong with them. It's because the process of getting
them to market is basically politically impossible, and the FDA is at
fault for that. So if you ever have a cardiac arrest or your kid
drowns, and their heart is restarted but there's not much upstairs,
you'll know why. And that story can be repeated in every field of
medical research there is. Endlessly. Courtesty of this one government
agency which does not (as I say) feel your pain. And never will.
> I really didn't mean to upset or offend you.
>
> ~~Patti
That's okay, you haven't. Have a good one.
SBH
From: Steve Harris <sbharris@ix.netcom.com>
Newsgroups: sci.med,talk.politics.medicine
Subject: Re: diseases of rich deprive poor of drugs
Date: 14 Sep 2005 13:56:35 -0700
Message-ID: <1126731395.013122.73150@g49g2000cwa.googlegroups.com>
O'Hush wrote:
> I do. I don't read MHA, and I am familiar with pharm industry connections
> with the FDA.
> And does that include you? Could pissing off people at the FDA be a bad
> career move for you?
No, it's too big an agency to have any memory. It's not like they have
an enemies list like Nixon.
>
> I don't want to get you fired up again, but this is starting to sound a
> little like "learned helplessness." That and you seem to think you're one
> of the rare people on the planet with any sense at all (I mean that in a
> nice way), which I imagine makes it difficult for you to negotiate with
> others or carry on a discussion that leads to understanding rather than
> detente.
True. I have other people do it for me. People who can kiss up and take
FDA officials out to lunch in DC (yes, this is routinely done) without
throwing up in the salad.
And if it makes you feel any better, I may actually one day make quite
a lot of money from drug preparations that I invented but somebody else
(better at ass-kissing) got through the regulatory system.
> Sometimes if you're open-minded you may find there are smart folks
> in the world who disagree with you sometimes, and they may occasionally have
> a useful perspective.
Sure, everybody has a useful perspective. I've talked to these people.
They think they're saving the world from bad drugs. And that would be
true if they were all immortal and ageless, and bad drugs and car
accidents were all that killed people.
> How about this: Maybe you and your colleagues could take your case to the
> public by writing articles for widely-read periodicals.
Been done to death. Number of lives lost due to FDA has been calculated
by economists and pharm wonks, etc.
http://www.isil.org/resources/lit/death-regulation.html
Drowned out, however, by the number of exposees on drug companies, for
which the authors only can think of one solution: More FDA--- bigger,
longer, and uncut. Deaths we know are due to bad drugs slipping through
are never complared to probable deaths from drug that were held up. And
that's the ONLY way to do this problem.
> Okay, but they're not *trying* to kill anybody. They believe they're
> protecting me and my family, and to some extent they probably are. I hear
> you saying that the FDA is obstructing medical research that could save live
> s, and you're in a better position to know about that than I am, but that's
> not the same thing as *trying* to kill people.
>
> ~~Patti
No, that's what I mean about the doctrine of double efffect. If you
bomb Baghdad with purpose of destroying military command and control,
and you're not specifically TRYING to kill anybody, and certainly not
civilians, then it's okay if you do! It was a side effect. You're not a
bad person. You just caused bad things to happen in your pursuit of
truth, justice, and the American Way. So it's all right.
And you know, up to a point, I agree with that. But there comes a point
after which people should have learned from the unintended consequences
of their actions. And with government regulation of the drug industry,
we're well past it. What we did in 1962 by greatly expanding FDA's
powers, didn't work. In fact, it made the problem far worse. Innovation
dropped, drug prices soared. The solution is not to do more of what we
did. That's madness.
SBH
From: Steve Harris <sbharris@ix.netcom.com>
Newsgroups: sci.med,talk.politics.medicine
Subject: Re: diseases of rich deprive poor of drugs
Date: 14 Sep 2005 00:40:40 -0700
Message-ID: <1126683640.892044.212940@g14g2000cwa.googlegroups.com>
SJ Doc wrote:
> As for the FDA, I would suggest that "evil" is less appropriate
> a descriptor (for the guys at CDER, at least) than are terms
> like "craven," "lazy," "incompetent," and "stupid." If there's a
> better physical instantiation of the Iron Law of Bureaucracy,
> I've yet to have anyone convince me of it.
Comment:
I believe I was taking a page from Pearson and Shaw and using the
functional definition of evil, which is that evil is, as evil does.
Which holes that an organization might not be composed of evil people
or even have evil intent, and yet it may reasonably be defined as an
evil organization, based on its fruits.
Now, I know this is a controversial idea. Because basically in society
we use the concept of "authority" to separate functional issues of
evil, even for similar kinds of intent. For example, if I want to blow
up a pharmaceutical plant or a city block to make a point, and happen
to kill a night watchman or some baby, it would be assumed that I could
reasonably have foreseen the consequences of my action, and I would be
charged with terrorism and murder. But give me the authority to drop
those bombs in a war, or as a state action, and now the killings become
collateral casualties, and I'm not evil at all. And the killings aren't
murders. They are like civilians who get run over in police chases. If
the bank robbers run over them, they are murders. If the police run
over them, they are still murders, but ascribed to the bank robbers.
And if there are no bank robbers and the police made a mistake
responding to a wrong call, they still aren't murders, but mere
accidents. And yet, the same damage has been done in all cases.
All of this derives from the Roman Catholic idea of double intent. They
invented it when Catholicism became the state religion, and Catholics
started having to kill innocent people in the prosecution of wars and
generally the running of states. So the jesuits found a way out. It
allows priest-chaplains to this day, to minister to warriors. It's kept
many an RC soldier and bombadier out of eternal damnation, or so I'm
told.
It is civil authority which turns robbery into taxation, premeditated
murder into collateral damage from freedom fighting, kidnapping into
detention for military purposes (in a never-ending war), counterfeiting
into normal currency creation, and so on. If I as private citizen were
to (by force) to prevent the access of a citizen to a drug which might
save his or her life, on the basis that I thought I knew what was best
for that citizen, and decided I knew he or she should not be allowed to
take the risk----- and the person then died, that would probably be
charged against me as a felony, and a capital one at that. But let an
institution with "authority" do it, and it's business as usual.
But that's the funny thing about authority--- it exists only in the
mind of the beholder. For the Iraqi citizenry, the superior weapons in
the hands of the American occupiers gives them the POWER, but it will
never give them the authority, no matter how much they outgun the
opposition. That idea alone is one of tremendous power. For you must
beat an enemy in his own mind before you truly break him. Otherwise,
you may kill him, but his brothers will merely take up where he left
off, and that process will continue so long as anyone is left alive.
If you cannot convince a person to accept your authority, you cannot
even *punish* him! All you can do is merely hurt him. Otherwise he acts
like a POW, and you teach him nothing at all.
And by the way, if you asked any American commander under what moral
authority he continued to occupy Iraq right now, he would have a
difficult time giving you an answer, I suspect. It is no longer a
matter of self-defense--- all admit that. And nobody really wants to
resort to the last and final argument that might makes right, and that
finally all authority grows from the barrel of a weapon. For anyone can
find oneself on the wrong end of that argument on some dark night, in
some dark place. Even an American.
And what God of justice do you call on, then?
So (sorry for the long windedness, but you did imply a rather
philosophical problem), where am I left, with the FDA? Answer: I see
it as having power, but no moral authority. The right of persons to
control their own bodies in defense of their own health, and act to
perform some action to save their own lives when their lives are in
danger from illness, trumps any claim of the government otherwise. It
must! For what else is it that we believe the purpose of government to
be, after it has ensured for the common defense? It is to defend the
citizen in his choice of how best to try to survive.
Thus, the FDA is merely a gang of people using force of arms not in
self-defense, or national defense, or even in defense of people who've
requested defending in all cases. But rather, FDA uses force to make
health choices for people who are ill, and in many cases, these choices
are against their wishes (or what their wishes would be if they were
informed of what they might have for their money, on the open world
market).
Any rational society should view this behavior as intrinsically
criminal; as a basic violation of human rights. And should view the
persons engaged in it, however well-intended, as being in some sense
responsible for the evil that comes of their actions. Behold, the whole
stink from the Tuskegee scandle rose from the idea that people were
being "experimented on" without their knowledge, by *withholding* from
them treatment that they might have desired, and been able to pay for,
and would certainly have availed themselves of in many cases, had they
known about it. The whole *point* was that this kind of withholding of
possible treatments-- and even the knowledge of their existence--- is
not the kind of thing you want to decide *democratically.* It's a
personal and human right whether or not you want, or do not want, to
undergo medical treatment of some kind, if you can afford it. But with
the FDA, half of that's out the window. THEY decide what to withhold,
and for how long. They decide FOR you.
Tuskeegee, say I.
SBH
From: Steve Harris <sbharris@ix.netcom.com>
Newsgroups: sci.med,talk.politics.medicine
Subject: Re: diseases of rich deprive poor of drugs
Date: 14 Sep 2005 14:11:28 -0700
Message-ID: <1126732288.628624.35170@z14g2000cwz.googlegroups.com>
Steven Bornfeld wrote:
> > Tuskeegee, say I.
> >
> > SBH
>
> I assume this is a bit of hyperbole. Otherwise, I'll assume you'll
> voluteer your ethnic group for the next Tuskeegee-type experiment.
COMMENT:
I don't have to. It's already been done FOR me. And your ethnic group,
too, BTW. If there's ever a drug treatment for Tay-Sachs, Gaucher's
or Niemann-Pick, you can be sure the FDA will make them test it on what
they regard as an appropriate rodent model first. An inbred strain
decended from Fievel Mousekewitz, no doubt. Meanwhile (you should live
so long) you will get bupkis.
SBH
From: Steve Harris <sbharris@ix.netcom.com>
Newsgroups: sci.med,talk.politics.medicine
Subject: Re: diseases of rich deprive poor of drugs
Date: 14 Sep 2005 15:05:30 -0700
Message-ID: <1126735530.956972.7490@g14g2000cwa.googlegroups.com>
Mark & Steven Bornfeld wrote:
> Steve Harris wrote:
>
> > Steven Bornfeld wrote:
> >
> >>>Tuskeegee, say I.
> >>>
> >>>SBH
> >>
> >> I assume this is a bit of hyperbole. Otherwise, I'll assume you'll
> >>voluteer your ethnic group for the next Tuskeegee-type experiment.
> >
> >
> >
> > COMMENT:
> >
> > I don't have to. It's already been done FOR me. And your ethnic group,
> > too, BTW. If there's ever a drug treatment for Tay-Sachs, Gaucher's
> > or Niemann-Pick, you can be sure the FDA will make them test it on what
> > they regard as an appropriate rodent model first. An inbred strain
> > decended from Fievel Mousekewitz, no doubt. Meanwhile (you should live
> > so long) you will get bupkis.
> >
> > SBH
> >
>
> Maybe I'm thick, but I'm not aware there have been any treatments for
> these.
COMMENT:
There aren't! Nor are there likely to be any time soon, for reasons
explained!
> And the subjects at Tuskeegee weren't selected because they
> wanted to study an ethnically-charged disease.
No, they were mostly selected out of convenience. They had a lot of
people who'd had syphilis, recovered, and had never been treated for
possible latent teriary disease (which there was no clinical evidence
of anybody having, BTW). Should people in that circumstance even BE
treated? Well, it makes sense, but so did hormone replacement <g>. In
any event, it would have been better to have done the experiment on
people aware of the issues, and who'd had it explained to them.
> Certainly PART of the stink was that people were being experimented on
> without their knowledge and consent.
Absolutely.
> But the real stink was that it was
> easy to treat black people as lab rats, which means the whole issue of
> human rights becomes moot.
>
> Steve
At Tuskegee, many of the local referring and treating doctors and
certainly the main study coordinator nurse were black, also. It's been
a while since I read the Jones book, but I remember some of the detail.
It would have been easy to treat any group of poor uneducated Southern
sharcroppers as lab rats! But had this been a bunch of old *white*
crackers with tobacca juice dribbling down their chins, it would have
sunk with barely a ripple.
As I recall (correct me if wrong) the study started in the early 30's a
dozen years before penicillin. Available arsenical treatments were
nasty, and some of them were employed. By the time penicillin was
available, the question was whether or not by that time it would do any
good for latent disease. This study still didn't provide the answer,
which could have been found by randomized treatment. But that was not
done, and penicillin was withheld from everybody. So not only was it
unethical science, but badly done science as well--- so reminiscent of
the Nazis. We didn't even learn the answer, damnit!
In any case, the point is that here was a treatment that might have
helped, that these people were not allowed to have. That they were
black makes it a racist story. But it's really a human rights story,
and it's not one that has ended with Tuskegee. You still can't get
certain treatments for certain diseases in the US, because the FDA is
waiting to see what happens to people getting them in other countries.
That's bad. It shouldn't matter what your ethnicity is, when the
government won't allow you a drug that may help a problem you have,
because that would mess up their scientific study. It's ethically bad,
even if you're Caucasian :).
SBH
From: Steve Harris <sbharris@ix.netcom.com>
Newsgroups: sci.med.cardiology
Subject: Re: Merck & FDA fought over Vioxx label warning for 2 years -
while people died
Date: 30 Sep 2005 14:52:08 -0700
Message-ID: <1128117128.534410.193610@g49g2000cwa.googlegroups.com>
Sharon Hope wrote:
> Congress CAUSED this situation. Congress "added" funding for the FDA from
> "user fees" - a bonus cut of the profits from approved drugs.
Actually, no. It's paid up front with the application in one lump sum,
and for small companies or companies with no drugs already on the
market, it represents a giant barrier to market entry. I personally
know of a new drug formulation of a certain generic that will be sold
for vet uses first in Mexico, and you won't see it in the US for years,
maybe a decade. And this is partly due to the ANDA user-fee problem.
And yet it's clearly superior in many ways to the problem-causing gunk
on the market now, which you will in the meantime be stuck with. You'll
have to take my word for that. Too bad for you.
> This was
> portrayed as an addition to regular funding to reimburse some of the costs
> of testing in the approval process.
>
> Then, Congress slowly whittled away at the 'regular' FDA funding, making the
> FDA dependent upon User Fees. That means that any time the FDA enlarges a
> market, its budget is directly and immediately benefitted. Conversely,
> anytime the FDA takes any action that might slow or stop sales, the FDA's
> budget is cut directly in proportion to the Pharmco's loss of sales.
>
> Congress needs to correct the situation that Congress created - and it will
> take more than a law or two.
COMMENT
In the meanwhile, we may observe that it's a lovely example of the law
of unintended consequences. When it went into effect, no consumer group
objected, because it looked like just one more way to screw pharma, and
who cares about pharma? But guess what? That's where new medicines
come from. There is no Santa Claus.
Still, you've all been very naughty little boys and girls, and you
deserve what you get from drug regulation, because (in a way) it's what
you wished for.
SBH
From: Steve Harris <sbharris@ix.netcom.com>
Newsgroups: sci.med.nutrition
Subject: Re: FDA getting desperate
Date: 25 Aug 2005 12:43:51 -0700
Message-ID: <1124999031.837003.49960@g14g2000cwa.googlegroups.com>
TC wrote:
> Officials first had to decide which part of the agency had oversight --
> its biological or device division, said Mark Melkerson, acting director
> of the FDA's division of general, restorative and neurological devices.
>
>
> "The primary mode of action for maggots is chewing," Melkerson
> explained. "For leeches, it's the eating of blood. Those are mechanical
> processes." Thus, the agency decided that maggots and leeches were
> devices, he said.
COMMENT:
Sheesh, the FDA's reputation for incompetence remains intact, since
they didn't even get the mechanical MECHANISM right for maggots.
Maggots don't chew. They spit out digestive enzymes like spiders, than
suck up the liquid remaining. Live tissue is simply resistant to this
kind of digestion because the blood inactivates these enzymes or
carries them away. <Sigh>. Will the FDA EVER know WTF they're
doing???
SBH
From: Steve Harris <sbharris@ix.netcom.com>
Newsgroups: sci.med.nutrition
Subject: Re: FDA getting desperate
Date: 25 Aug 2005 17:30:54 -0700
Message-ID: <1125016254.212727.254460@g47g2000cwa.googlegroups.com>
Cubit wrote:
> So, presumably, the drug companies could develop a mix of enzymes to be
> applied to wounds instead of the maggots....
Absolutely.
In 1990 you could buy GHB in any good health food store for about a
dollar a gram. Then it got branded a date rape drug, then outlawed and
classed with LSD and Heroin, then finally FDA-approved as a narcolepsy
drug. Now you can buy it in solution as "Xyrem" in the same drug class
as codeine, for 10 times the price that it once sold for. Progress!
THC is now sold in capsules for cancer patients. But it's expansive.
One day they'll genetically engineer the genes to make it in some
plant. Maybe even into a weed. Who knows what Monsanto may come up with
next? And self-igniting microturbo inhalant delivery systems for THC
are in the works, too.
Once we get all these tissue eating enzymes all cloned and made by
bacteria, we're going to need a delivery system for them, as well.
Maybe the pharm companies can build small robot delibery vehicles that
will actually crawl into a wound and squirt them where they're needed.
In the future, anything's possible.
SBH
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