Time to reconsider "alternative" drugs

PeterB wrote:
wrote:
This is the most well balanced discussion I have recently seen. "Food
supplement" is obviously too broad a category which loopholes allows
"alternative" drugs to escape the usual effectivness and safety
considerations that make for the best informed and protected consumer.
We know we need vitamin c and in some specific cases consuming more then
the usual amount needed to prevent deficiency disorders is in order.

The recent thread about a "silver" product being touted for germicidal
use is no "food supplement" in any common sense use of that term. We
don't get an infection for a "silver" deficiency and we don't get cancer
because of a shark product deficiency as we get scurvy for not having
vitamin c.

We also don't get cancer for lack of chemotherapy, heart disease for
lack of statins, or stroke for lack of Plavix.

It is also time the current "supplement" laws require industry reporting
of adverse effects. At present if there are sideeffects they don't
become known until by word of mouth they can no longer be avoided.

If you had reviewed the archives of Poison Control in Wash., DC , as I
have, you would know that adverse events resulting from use of
suppelments is even more minor than allergic response to bee sting.
Far more people, in fact, die from a bee sting each year (about 100)
than do those having an allergic response (or overdose reaction) to
dietary supplements.

BMJ-British Medical Journal

Protect patients from exploitation by alternative medicines
industry

Shark cartilage in the water BMJ Volume 333 p 1129

It is time to protect patients from vile and cynical exploitation by
the alternative medicines industry, argues a cancer expert in this
weeks BMJ.

It is estimated that up to 80% of all patients with cancer take a
complementary treatment or follow a dietary programme to help treat
their cancer, writes Jonathan Waxman, Professor of Oncology at
Imperial College London.

Yet the rationale for the use of many of these approaches is obtuse
one might even be tempted to write misleading, he says.

See this article on Waxman's comments, at
http://www.alliance-natural-health.o...on=news&ID=261.

Indeed the claims made by companies to support the sales of such
products may be overtly and malignly incorrect and, in many cases,
the
products may be doctored by chemicals borrowed from the conventional
pharmaceutical industry. The reason that these products are
accessible
to patients is that they are not subject to the testing of
pharmaceuticals because they are classified as food supplements.

Then such products are not dietary supplements and represent a
violation of law. I would venture that 99% of such products come from
poor countries selling "cures" pitched to individuals who probably have
no covered healthcare whatsoever. No amount of regulation in the world
is going to help that segment of our society. But education might.

So why do patients take alternative medicines" Why is science
disregarded" How can it be that treatments that dont work are
regarded
as life saving"

To begin, medical science uses natural substances in human health more
successfully than any other. Look at a list of medications used in
emergency care, where life-saving drugs are frequently examples of
natural medicine, including insulin, magnesium, thiamine, adenosine,
N-acetylcysteine, and so on. Unlike the vast majority of prescription
medications designed to effect some aspect of perceptual pain,
nutrients (including certain drugs manufactured specifically to mimic
them) are essential in modern healthcare. Chemotherapy drugs, several
of which are modeled on phytochemical substances found in nature, are
effective in some cancers, but in the majority of cancers they are
completely ineffective. Is it therefore quackery to use such medicine
in patients for whom these drugs are certain to fail? Why not?

Waxman believes that it is because the complementary therapists offer
something that doctors cannot offer hope. If you eat this, take that,
avoid this, and really believe this then we can promise you sincerely
that you will be cured.

No one I know is making such promises. You can improve your odds by
taking responsibility for your own health, supporting natural immunity,
and avoiding exposure to chemical toxins, including the unnecessary use
of pharmaceuticals.

And if the patient is not cured, it is the patient who has failed,
not
the alternative therapy. The patient has let down the alternative
practitioner and disappointed his family who have encouraged his
treatment.

Ridiculous. Naturopaths do not blame their patients for not getting
better. They are more likely than conventional doctors, in fact, to
dig deeper for answers.

As well as the complementary medicines they take, many patients will
have changed their diets in order to cure their cancers, says the
author. But although there is a strong dietary basis to the
development of cancer, once cancer has been diagnosed no change in
diet will lead to any improvement in cancer outcomes, he writes.

It's most unlikely than any one protocol will change the prognosis for
most cancer patients, and that includes standard treatment. Placing
all hope in chemotherapy, for instance, is no better than placing all
hope in taking an extended vacation. In certain cancers, chemotherapy
is an appropriate option. In ALL cancers, increased vitamin C intake
is not only appropriate, but imperative. Patients should choose those
behaviours that have the most positive impact on natural immunity,
because ultimately, that is how you beat cancer.

Why do patients change their diet" For some it is a way of taking
back
some control of a situation that is entirely out of their control,
says Waxman. For others it is because of the pressure put on them by
families, friends or vested interest groups to go organic.

Its time for legislation to focus on a particularly vulnerable
section
of our society and do something to limit the exploitation of our
patients, he says. Why not subject the alternative medicines industry
to the level of scrutiny that defines pharmaceuticals"

Why not? Because current regulatory scrutiny does not protect the
public from dangerous pharmaceuticals, as you would have us believe.
It does not prevent unscrupulous marketing by the drug makers, nor
prevent conflicts of interest introduced by funding of FDA by the
pharmaceutical companies. Shilling for an additional layer of
bureacracy to address the hype in the dietary supplements industry is
an effort to protect drug maker profits, nothing more.

Reclassify these agents as drugs - for this is after all how they are
marketed - and protect our patients from vile and cynical
exploitation
whose intellectual basis, at best, might be viewed as delusional.

It's delusional not to know that under DSHEA, dietary supplements are
not permitted to be marketed as drugs already. Reclassifying garlic as
a drug will only make everyone a drug addict.

The
current EU initiative to bring forward legislation on this matter is
welcomed.

CODEX is not welcomed by those who appreciate taking responsibility for
their own health if it leads to the unnecessary regulation of
nutritional products, a possibility the Alliance for Natural Health
[http://www.alliance-natural-health.org] is making every effort to
prevent. It has become abundantly clear that citizenship in China
would be more agreeable to you than citizenship anywhere else, so you
may want to start packing.

PeterB

Bob and Peter, great stuff...I agree.

Concerning silver, while the noncorrupt part of our gov't has stated
ASAP has made a patentable silver "antibiotic" for human consumption
certain other gov't agencies are starting their own propaganda machine.

Consider this quote...It appears they now want to consider silver a
pesticide!?!

"This is now being considered a pesticide," Wood said. "So it does have
to be regulated under FIFRA."

http://www.usatoday.com/tech/news/na...epa-nano_x.htm

wrote:
Robert W. McAdams wrote:
wrote:
wrote:

Reclassify these agents as drugs - for this is after all how they are
marketed - and protect our patients from vile and cynical
exploitation


That'd work if the doc know a thing about nutrition or alt. health -
and the more socialized the medicine is, the less you'll be able to
find or choose one that does.

No, it wouldn't.

Let's review the economics of the drug approval process:

1) Someone invents a new drug which they believe will be successful in
treating one or more diseases.

2) The drug is patented, granting the holder of the patent a 20-year
exclusive right to control production of the drug.

3) The patent holder begins the lengthy process of trying to prove the
safety and efficacy of the drug. This process frequently takes years,
and costs a significant amount of money.

4a) If the patent holder is unable to demonstrate the safety and
efficacy of the drug to the satisfaction of the governing agency, the
drug cannot be sold, the patent is essentially worthless, and all of the
costs incurred in steps 1, 2, and 3 will constitute a loss.

4b) If the patent holder is successful in demonstrating the safety and
efficacy of the drug to the satisfaction of the governing agency, the
drug is approved and the holder can begin selling it, marketing it as a
treatment for the disease(s) for which efficacy has been demonstrated.
Doctors, however, are free to prescribe it for any condition whatsoever,
even if its efficacy for that condition has not been demonstrated.
During the remainder of the patent period, the patent holder has a
monopoly on the drug, and can therefore charge a high price, allowing
them to recover the costs incurred in steps 1, 2, and 3, as well as
losses that may have been suffered due to failed attempts to gain
approval for other drugs.


Now, let's examine how the same process would work for supplements:

1) The supplement does not have to be invented, since it is already a
known chemical, but someone has to discover that it may be useful in
treating one or more diseases.

2) Because the supplement is already a known chemical, it cannot be
patented.

3) The company that wants to sell the supplement as a treatment for the
disease(s) in question begins the lengthy process of trying to prove the
safety and efficacy of the supplement. This process frequently takes
years, and costs a significant amount of money.

4a) If the company is unable to demonstrate the safety and efficacy of
the supplement to the satisfaction of the governing agency, the
supplement cannot be sold and all of the costs incurred in steps 1, 2,
and 3 will constitute a loss.

4b) If the company is successful in demonstrating the safety and
efficacy of the supplement to the satisfaction of the governing agency,
the supplement is approved and the holder can begin selling it,
marketing it as a treatment for the disease(s) for which efficacy has
been demonstrated. Doctors, however, are free to prescribe it for any
condition whatsoever, even if its efficacy for that condition has not
been demonstrated. But since the supplement cannot be patented, other
companies can immediately begin producing their own versions of the
supplement without any need to prove safety or efficacy beyond the fact
that their version of the supplement is identical. Consequently, the
original company will not be able to charge enough for the supplement to
cover the costs incurred during steps 1, 2, and 3, and these costs will
therefore constitute a loss.

The bottom line is that any company attempting to go through the drug
approval process for a supplement would be guaranteed to suffer a loss
whether the approval process were completed successfully or not. So if
Waxman's proposal were adopted, there would be no incentive for any
company to go through the approval process for supplements, and the
effect would therefore simply be to deprive the public of the benefits
of supplements.


Bob

I agree with what you said, except that I think the vast majority of
supplements are as useless as snake oil, so the public would not be
losing anything if they disappeared.

There is no evidence the same is not true of the vast majority of
pharmaceutical drugs. IOM has said that 70,000 mortalities annually
are associated with properly prescribed and dispensed medication. I am
unable to find any public records of data documenting the risk-adjusted
outcomes for the majority of pharmaceutical drugs, nor have industry
apologists operating here in the newsgroups been able to do so. Thus,
no data exists to support the idea that these drugs are saving more
lives than they take. By contrast, a review of Poison Control data in
Washington, DC shows the remarkable safety of dietary supplements,
despite their use by millions of people on a daily basis.

What I see happening, is people wanting to make a buck, go through a
list of common complaints like tiredness, overweight, fear of cancer,
concerns about sexual performance and aging, and then find some cheap
source of some naturally occuring herb or ingredient that might have
some weak link to improving any of these symptoms, then market their
snake oil as a sure-fire cure for it.

Obviously, there are efforts to market products that never measure up.
You must not have been watching commercials for cars, watches, writing
pens, toasters, or pharmaceutical drugs for very long. The closest
relationship of any product class to snake oil is likely to be
prescription drugs, since these are more likely to anesthesize you to
your pain, without addressing the cause. Remember, quick lightning was
rarely just water.

I don't think the world would be
any worse off if all the noni juice, shark fin, and nettle were taken
off the market. dkw

Perhaps, but the only way to rid the world of hype is to adopt a
Chinese model of government, institute regulatory controls that further
burden taxpayers, enrich unworthy bureacrats, and make the state
responsible for what you think while criminalizing your freedom of
choice. Do you *really* want to live in China?

PeterB

wrote:

"Thanks, Bob. I might add that the drug makers like your final
conclusion SOOO much that they are clearly behind the effort to steer
Codex toward that very outcome. Readers who see the fallacy of
regulating dietary supplements as drugs should support the legal
efforts of Alliance for Natural Health
(http://www.alliance-natural-health.org), which is helping create a
balanced scientific approach to these issues."

Looked at the page, saw scant discussion of "science" anything. If I
missed the "scientific balance" then plese provide specific reference.

"Dietary supplement" is by definition not a drug. Many substances now
sold as such are directed toward drug effects in their marketing. The
recent "silver" thread being an example which claimed medical results.
This is not about vitamins and minerals and other plant and animal
substances if indeed they are "dietary" in nature for health benefit.


Any substance otherwise marketed as having drug like effects is the
issue for me. Aspirin has always seemed a useful benchmark for these
discussions, as an over the counter drug it is regulated but unlike
prescription drugs. We need the kinds of information based in science
as is aspirin so we may be informed consumers and not merely the pawns
of clever marketing.


It's a great pity that now there is no patent on aspirin, nobody will
bother to sell it.

Wait a minute ...

The "it can't be patented" excuse for not testing snake oil is so weak
that I can't understand how alternauts don't get embarrassed using it.

(I'm off now to take my out-of-patent metformin that I can't get
because there is no profit in things which can't be patented.)

--
Peter Bowditch aa #2243
The Millenium Project http://www.ratbags.com/rsoles
Australian Council Against Health Fraud http://www.acahf.org.au
Australian Skeptics http://www.skeptics.com.au
To email me use my first name only at ratbags.com

What needs to be held foremost in the mind is the desperation of
pharmaceutical
companies to save themselves from decline or possible extinction.

They will bribe politicians, they will design fraudulent "studies" and
they will use
lying propaganda to get their way. In particular, drug advertisements
on televsion
are immoral. You need the "little purple pill"! Do they even tell you
what the pill
is intended to do? As Chris Rock notes, the only difference between
them and
the neighborhood pusher is size.

DHEA? Fish Oil? Quick!, let's design a study that "shows" them to be
worthless!
Meanwhile, let's overlook studies that question the effectiveness of
Copaxone,
anti-depressants and countless other drugs. Let's not tell people that
many
cancer treatments are CARCINOGENIC! And let's raise doubts about
Canadian
pharmaceuticals! (in one Congressional hearing, the FDA raised the
issue of counterfeit
drugs without being able to offer a single example - what utter
frauds!)

Their massive power to corrupt is why supplements must avoid ALL
REGULATION.
They- and their political lackeys - must NOT be trusted in any way.
I rejoice in seeing a divided Congress, since the best we can hope for
is them to
do nothing and leave us alone.

"There is no evidence the same is not true of the vast majority of
pharmaceutical drugs. IOM has said that 70,000 mortalities annually are
associated with properly prescribed and dispensed medication. I am
unable to find any public records of data documenting the risk-adjusted
outcomes for the majority of pharmaceutical drugs, nor have industry
apologists operating here in the newsgroups been able to do so. Thus,
no data exists to support the idea that these drugs are saving more
lives than they take. By contrast, a review of Poison Control data in
Washington, DC shows the remarkable safety of dietary supplements,
despite their use by millions of people on a daily basis."


There are two parts to the question, does it work and is it safe.
Prescription drugs must show both, "alternative drugs" don't even at the
level of over the counter aspirin. Misuse/prescribing of drugs can be
harmful, use of "alternative drugs" have an unknown record because
adverse events are not recorded. But most of all they fail the first
question, do they work? The answer is close to "pig in a poke".

"Obviously, there are efforts to market products that never measure up.
You must not have been watching commercials for cars, watches, writing
pens, toasters, or pharmaceutical drugs for very long. The closest
relationship of any product class to snake oil is likely to be
prescription drugs, since these are more likely to anesthesize you to
your pain, without addressing the cause. Remember, quick lightning was
rarely just water."

Silly of course, prescription drugs go through many many more degrees of
scrutiny then any other of the other products. If adverse events start
to happen they are reported and if increased attention taken and action
starts.

"Perhaps, but the only way to rid the world of hype is to adopt a
Chinese model of government, institute regulatory controls that further
burden taxpayers, enrich unworthy bureacrats, and make the state
responsible for what you think while criminalizing your freedom of
choice. Do you *really* want to live in China?"

Smile, after the hand waving the facts emerge, china has one of the most
lax legal structures when it comes to "alternative drugs". Only
recently did the government say that closer attentiion would be paid to
fly by night snake oil marketing and products. They can now come to
america, see them on an infomercial near you soon.

The oppisite side of that coin is exactly what? Marketing alone rules
the "alternative drug" industry, if the chumps will buy it we will sell
it. We used to have exactly that system during which priod the term
"snake oil" was coined. Then too was the fda born because of the damage
to people it caused, been there, done that, have the tombstones to prove
it.

Robert W. McAdams wrote:
wrote:
wrote:

Reclassify these agents as drugs - for this is after all how they are
marketed - and protect our patients from vile and cynical
exploitation


That'd work if the doc know a thing about nutrition or alt. health -
and the more socialized the medicine is, the less you'll be able to
find or choose one that does.

No, it wouldn't.

Let's review the economics of the drug approval process:

1) Someone invents a new drug which they believe will be successful in
treating one or more diseases.

2) The drug is patented, granting the holder of the patent a 20-year
exclusive right to control production of the drug.

3) The patent holder begins the lengthy process of trying to prove the
safety and efficacy of the drug. This process frequently takes years,
and costs a significant amount of money.

4a) If the patent holder is unable to demonstrate the safety and
efficacy of the drug to the satisfaction of the governing agency, the
drug cannot be sold, the patent is essentially worthless, and all of the
costs incurred in steps 1, 2, and 3 will constitute a loss.

4b) If the patent holder is successful in demonstrating the safety and
efficacy of the drug to the satisfaction of the governing agency, the
drug is approved and the holder can begin selling it, marketing it as a
treatment for the disease(s) for which efficacy has been demonstrated.
Doctors, however, are free to prescribe it for any condition whatsoever,
even if its efficacy for that condition has not been demonstrated.
During the remainder of the patent period, the patent holder has a
monopoly on the drug, and can therefore charge a high price, allowing
them to recover the costs incurred in steps 1, 2, and 3, as well as
losses that may have been suffered due to failed attempts to gain
approval for other drugs.


Now, let's examine how the same process would work for supplements:

1) The supplement does not have to be invented, since it is already a
known chemical, but someone has to discover that it may be useful in
treating one or more diseases.

2) Because the supplement is already a known chemical, it cannot be
patented.

3) The company that wants to sell the supplement as a treatment for the
disease(s) in question begins the lengthy process of trying to prove the
safety and efficacy of the supplement. This process frequently takes
years, and costs a significant amount of money.

4a) If the company is unable to demonstrate the safety and efficacy of
the supplement to the satisfaction of the governing agency, the
supplement cannot be sold and all of the costs incurred in steps 1, 2,
and 3 will constitute a loss.

4b) If the company is successful in demonstrating the safety and
efficacy of the supplement to the satisfaction of the governing agency,
the supplement is approved and the holder can begin selling it,
marketing it as a treatment for the disease(s) for which efficacy has
been demonstrated. Doctors, however, are free to prescribe it for any
condition whatsoever, even if its efficacy for that condition has not
been demonstrated. But since the supplement cannot be patented, other
companies can immediately begin producing their own versions of the
supplement without any need to prove safety or efficacy beyond the fact
that their version of the supplement is identical. Consequently, the
original company will not be able to charge enough for the supplement to
cover the costs incurred during steps 1, 2, and 3, and these costs will
therefore constitute a loss.

The bottom line is that any company attempting to go through the drug
approval process for a supplement would be guaranteed to suffer a loss
whether the approval process were completed successfully or not. So if
Waxman's proposal were adopted, there would be no incentive for any
company to go through the approval process for supplements, and the
effect would therefore simply be to deprive the public of the benefits
of supplements.


Bob

That was almost like reading poetry, Bob. Excellent job lining that
out. You're very articulate.

Max.

pmoran wrote:
Robert W. McAdams wrote:
wrote:
wrote:

Reclassify these agents as drugs - for this is after all how they are
marketed - and protect our patients from vile and cynical
exploitation


That'd work if the doc know a thing about nutrition or alt. health -
and the more socialized the medicine is, the less you'll be able to
find or choose one that does.

No, it wouldn't.

Let's review the economics of the drug approval process:

1) Someone invents a new drug which they believe will be successful in
treating one or more diseases.

2) The drug is patented, granting the holder of the patent a 20-year
exclusive right to control production of the drug.

3) The patent holder begins the lengthy process of trying to prove the
safety and efficacy of the drug. This process frequently takes years,
and costs a significant amount of money.

4a) If the patent holder is unable to demonstrate the safety and
efficacy of the drug to the satisfaction of the governing agency, the
drug cannot be sold, the patent is essentially worthless, and all of the
costs incurred in steps 1, 2, and 3 will constitute a loss.

4b) If the patent holder is successful in demonstrating the safety and
efficacy of the drug to the satisfaction of the governing agency, the
drug is approved and the holder can begin selling it, marketing it as a
treatment for the disease(s) for which efficacy has been demonstrated.
Doctors, however, are free to prescribe it for any condition whatsoever,
even if its efficacy for that condition has not been demonstrated.
During the remainder of the patent period, the patent holder has a
monopoly on the drug, and can therefore charge a high price, allowing
them to recover the costs incurred in steps 1, 2, and 3, as well as
losses that may have been suffered due to failed attempts to gain
approval for other drugs.


Now, let's examine how the same process would work for supplements:

1) The supplement does not have to be invented, since it is already a
known chemical, but someone has to discover that it may be useful in
treating one or more diseases.

2) Because the supplement is already a known chemical, it cannot be
patented.

3) The company that wants to sell the supplement as a treatment for the
disease(s) in question begins the lengthy process of trying to prove the
safety and efficacy of the supplement. This process frequently takes
years, and costs a significant amount of money.

4a) If the company is unable to demonstrate the safety and efficacy of
the supplement to the satisfaction of the governing agency, the
supplement cannot be sold and all of the costs incurred in steps 1, 2,
and 3 will constitute a loss.

4b) If the company is successful in demonstrating the safety and
efficacy of the supplement to the satisfaction of the governing agency,
the supplement is approved and the holder can begin selling it,
marketing it as a treatment for the disease(s) for which efficacy has
been demonstrated. Doctors, however, are free to prescribe it for any
condition whatsoever, even if its efficacy for that condition has not
been demonstrated. But since the supplement cannot be patented, other
companies can immediately begin producing their own versions of the
supplement without any need to prove safety or efficacy beyond the fact
that their version of the supplement is identical. Consequently, the
original company will not be able to charge enough for the supplement to
cover the costs incurred during steps 1, 2, and 3, and these costs will
therefore constitute a loss.

The bottom line is that any company attempting to go through the drug
approval process for a supplement would be guaranteed to suffer a loss
whether the approval process were completed successfully or not. So if
Waxman's proposal were adopted, there would be no incentive for any
company to go through the approval process for supplements, and the
effect would therefore simply be to deprive the public of the benefits
of supplements.


Bob

What you say is largely true. This argument does not, however,
absolve those promoting alternative cancer treatments from producing
ANY substantive evidence that their methods do what they claim, or
excuse them for using extremely deceptive methods of promoting them.

Why not require anyone promoting alternative cancer methods as a
possible cure of cancer to produce two or three well-documented recent
examples of their ability to make serious cancers go away? I have
explained how that might work here .

http://members.bordernet.com.au/~pmo...it_works_2.htm

PM

Just to exchange tit for tat, why is it that even WHEN a seller of a
specific supplement makes a medical claim that HAS been scientifically
evaluated, the FDA knocks on their door anyway telling them they can't
use that data to promote their product because it makes the product a
drug?

Example:
http://www.fda.gov/foi/warning_letters/g5549d.htm

Apparently statements such as this were a violation of the law:
"Researchers at Michigan State University were among the first to
identify the presence of three powerful anthocyanins in tart cherries
with the potential to inhibit the growth of colon cancer tumors ."

"Tart cherries contain anthocyanins and bioflavonoids which . . .
prevent inflammation in the body. Further investigations revealed that
daily consumption of tart cherries has the potential to reduce the pain
associated with inflammation, arthritis, and gout."

"The antioxidant activities of the anthocyanins may account for the
beneficial effects derived from the consumption of fruits and
vegetables high in anthocyanins, such as cherries, against
cardiovascular and other diseases."

And heaven forbid a site should contain testamonials!

How about this example?
http://www.fda.gov/foi/warning_letters/g6034d.htm

Why should there be any question to the validity of statements such as:
"Coconut oil is . . . uniquely rich in lauric acid, which is converted
to the same disease-fighting substance--monolaurin--that nursing babies
derive from lauric acid in mother's milk. Research has demonstrated
coconut oil's anti-microbial, anti-viral and anti-parasitical
properties . . .."

That's just a fact. It's not even a questionable fact.

How about:
"Research shows that vitamin K regulates calcium and keeps it in the
bones and out of arteries-stopping heart attacks and osteoporosis at
the same time."

Dr. Mercola has links to all of the research when he makes claims such
as the one above.

While I agree that we need ways to prevent someone from putting their
yard clippings in a little baggie and selling them as a cancer cure, I
have to think that the harmfulness of that scenario is far less than
the harm caused by the supression of known, peer reviewed, scientific
facts that could potentially be used to increase the health and well
being of readers everywhere.

Max.

The bottom line is that any company attempting to go through the drug
approval process for a supplement would be guaranteed to suffer a loss
whether the approval process were completed successfully or not. So
if
Waxman's proposal were adopted, there would be no incentive for any
company to go through the approval process for supplements, and the
effect would therefore simply be to deprive the public of the benefits
of supplements.

We are talking about "alternative drugs" not "food supplements", the
difference is very important. Vitamins and minerals and other herbs and
animal substances are not at issue.

So the alternative is exactly what? Using aspirin as the benchmark, we
know it works, it is safe in large part with known side effects and the
contents are accurate.

In india and china there is much research effort involving traditional
"alternative drugs" that meets scientific rigor. It's time te
"alternative durg" industry foots the bill to show what works and what
doesn't and take it out of the marketing departments where it resides
now only.

If they want to sell these as over the counter drugs they need to meet
that standard at least and adverse event reporting during the testing
phase. When this is done they can meet the "generally considered as
safe" standard.

If I want to sell a new cough medicine formulation then I show the
contents have some effect and are safe as above, I don't have to do
prescription drug confirmation for it.

Max C. wrote:
pmoran wrote:
Robert W. McAdams wrote:
wrote:
wrote:

Reclassify these agents as drugs - for this is after all how they are
marketed - and protect our patients from vile and cynical
exploitation


That'd work if the doc know a thing about nutrition or alt. health -
and the more socialized the medicine is, the less you'll be able to
find or choose one that does.

No, it wouldn't.

Let's review the economics of the drug approval process:

1) Someone invents a new drug which they believe will be successful in
treating one or more diseases.

2) The drug is patented, granting the holder of the patent a 20-year
exclusive right to control production of the drug.

3) The patent holder begins the lengthy process of trying to prove the
safety and efficacy of the drug. This process frequently takes years,
and costs a significant amount of money.

4a) If the patent holder is unable to demonstrate the safety and
efficacy of the drug to the satisfaction of the governing agency, the
drug cannot be sold, the patent is essentially worthless, and all of the
costs incurred in steps 1, 2, and 3 will constitute a loss.

4b) If the patent holder is successful in demonstrating the safety and
efficacy of the drug to the satisfaction of the governing agency, the
drug is approved and the holder can begin selling it, marketing it as a
treatment for the disease(s) for which efficacy has been demonstrated.
Doctors, however, are free to prescribe it for any condition whatsoever,
even if its efficacy for that condition has not been demonstrated.
During the remainder of the patent period, the patent holder has a
monopoly on the drug, and can therefore charge a high price, allowing
them to recover the costs incurred in steps 1, 2, and 3, as well as
losses that may have been suffered due to failed attempts to gain
approval for other drugs.


Now, let's examine how the same process would work for supplements:

1) The supplement does not have to be invented, since it is already a
known chemical, but someone has to discover that it may be useful in
treating one or more diseases.

2) Because the supplement is already a known chemical, it cannot be
patented.

3) The company that wants to sell the supplement as a treatment for the
disease(s) in question begins the lengthy process of trying to prove the
safety and efficacy of the supplement. This process frequently takes
years, and costs a significant amount of money.

4a) If the company is unable to demonstrate the safety and efficacy of
the supplement to the satisfaction of the governing agency, the
supplement cannot be sold and all of the costs incurred in steps 1, 2,
and 3 will constitute a loss.

4b) If the company is successful in demonstrating the safety and
efficacy of the supplement to the satisfaction of the governing agency,
the supplement is approved and the holder can begin selling it,
marketing it as a treatment for the disease(s) for which efficacy has
been demonstrated. Doctors, however, are free to prescribe it for any
condition whatsoever, even if its efficacy for that condition has not
been demonstrated. But since the supplement cannot be patented, other
companies can immediately begin producing their own versions of the
supplement without any need to prove safety or efficacy beyond the fact
that their version of the supplement is identical. Consequently, the
original company will not be able to charge enough for the supplement to
cover the costs incurred during steps 1, 2, and 3, and these costs will
therefore constitute a loss.

The bottom line is that any company attempting to go through the drug
approval process for a supplement would be guaranteed to suffer a loss
whether the approval process were completed successfully or not. So if
Waxman's proposal were adopted, there would be no incentive for any
company to go through the approval process for supplements, and the
effect would therefore simply be to deprive the public of the benefits
of supplements.


Bob

What you say is largely true. This argument does not, however,
absolve those promoting alternative cancer treatments from producing
ANY substantive evidence that their methods do what they claim, or
excuse them for using extremely deceptive methods of promoting them.

Why not require anyone promoting alternative cancer methods as a
possible cure of cancer to produce two or three well-documented recent
examples of their ability to make serious cancers go away? I have
explained how that might work here .

http://members.bordernet.com.au/~pmo...it_works_2.htm

PM

Just to exchange tit for tat, why is it that even WHEN a seller of a
specific supplement makes a medical claim that HAS been scientifically
evaluated, the FDA knocks on their door anyway telling them they can't
use that data to promote their product because it makes the product a
drug?

Example:
http://www.fda.gov/foi/warning_letters/g5549d.htm

Apparently statements such as this were a violation of the law:
"Researchers at Michigan State University were among the first to
identify the presence of three powerful anthocyanins in tart cherries
with the potential to inhibit the growth of colon cancer tumors ."

"Tart cherries contain anthocyanins and bioflavonoids which . . .
prevent inflammation in the body. Further investigations revealed that
daily consumption of tart cherries has the potential to reduce the pain
associated with inflammation, arthritis, and gout."

"The antioxidant activities of the anthocyanins may account for the
beneficial effects derived from the consumption of fruits and
vegetables high in anthocyanins, such as cherries, against
cardiovascular and other diseases."

And heaven forbid a site should contain testamonials!

How about this example?
http://www.fda.gov/foi/warning_letters/g6034d.htm

Why should there be any question to the validity of statements such as:
"Coconut oil is . . . uniquely rich in lauric acid, which is converted
to the same disease-fighting substance--monolaurin--that nursing babies
derive from lauric acid in mother's milk. Research has demonstrated
coconut oil's anti-microbial, anti-viral and anti-parasitical
properties . . .."

That's just a fact. It's not even a questionable fact.

How about:
"Research shows that vitamin K regulates calcium and keeps it in the
bones and out of arteries-stopping heart attacks and osteoporosis at
the same time."

Dr. Mercola has links to all of the research when he makes claims such
as the one above.

While I agree that we need ways to prevent someone from putting their
yard clippings in a little baggie and selling them as a cancer cure, I
have to think that the harmfulness of that scenario is far less than
the harm caused by the supression of known, peer reviewed, scientific
facts that could potentially be used to increase the health and well
being of readers everywhere.

Max.

You may be right, although shonky concerns often allow the testimonials
to make the more outrageous claims for their products, and that may be
what prompted action in the first case.. And I assume the research
on lauric acid refers to in vitro studies that can be reproduced by
almost any chemical in sufficient concentrations -- ones commonly not
obtainable in the human body. I haven't looked at the research on
vitamin K.

I am glad you agree that cancer is something of a special case.

Peter

"PeterB" wrote in

Perhaps, but the only way to rid the world of hype is to adopt a
Chinese model of government, institute regulatory controls that further
burden taxpayers, enrich unworthy bureacrats, and make the state
responsible for what you think while criminalizing your freedom of
choice. Do you *really* want to live in China?

Holy Christ! Here's an idiot that hasn't even a Time Magazine knowledge of
China circa now. "Supplements" have a hard time from "unworthy bureaucrats"
there?

moo