Time to reconsider "alternative" drugs

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.

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.


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.

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.

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"

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.

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.

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.

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"

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

wrote:
This is the most well balanced discussion I have recently seen. "Food
supplement" is obviously too broad a category which loopholes allows

Some reasonable, affordable form of standardization, purity and
authentication would be the solution. That and prominent, approved
warning / counter-indication labels.


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

You could make a case for monecular medicine or micro-nutrition. Any
sufficiently small or processed substances like these found in the
normal diet could possibly help immunity or alter gene expression.


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.

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

Robert W. McAdams wrote:

an excellent case in logic

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.

Also see the article addressing Waxman's comments, at
http://www.alliance-natural-health.o...on=news&ID=261

PeterB

This is the most well balanced discussion I have recently seen. "Food
supplement" is obviously too broad a category which loopholes allows

"Some reasonable, affordable form of standardization, purity and
authentication would be the solution. That and prominent, approved
warning / counter-indication labels."

As far as this goes I agree. We need to know if it works, as in
research results, and we need to know if it is safe.

This seems to me like at a minimal level the kinds of information we
have for aspirin. A rating system could be used for the first, highest
score for vitamin c and a zero rating for "coral calcium" for doing
nothing as supported by research. Requiring companies to show any
history of safety concerns and reporting of all adverse events would be
useful at a minimal level.

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

"You could make a case for monecular medicine or micro-nutrition. Any
sufficiently small or processed substances like these found in the
normal diet could possibly help immunity or alter gene expression."

You could but they did not. They proposed a mix of 5 to 40 parts in a
million of silver in water antigermicidal properties. As for any other
claim research as for aspirin would be asked.

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."

I don't see this as relevant, if it works it would be in the stores like
aspirin regardless the system for medical funding. Recall, nutrition is
not the question about these "alternative drugs", they do not
"supplement" but are marketed to have some disease/disorder altering
effect in a drug like manner.

"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.

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

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.

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. 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

Regarding "alternative drugs":

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

This is not the point, "nutritional supplements" such as vit c and
"alternative drugs" are two different things. The recent "silver"
product is touted as such an "alternative drug" not related to nutrition
in any way.

All the drugs you mention are designed to evoke some biological pathway
or process or another to promote the bodies own self controls to work or
to prevent damage. They are not something added because something is
lacking such as the snake oil "coral calcium" and its claims, for
example.

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."

In part we don't know about adverse effects because marketers of
"alternative drugs" are not required to report them. Does the poisin
database include the "alternative drugs" from india which are toxic?
Like many examples this was found quite by accident and was in part due
to the contents of "alternative drugs" not having any meaningful
enforcement to disclose what's in them.

In my mind it is an extreme adverse effect when people are taken in by
marketing alone and desperation to use "alternative drugs" where no
scientific research can support its medical claims in the least. When a
cancer patient uses coffie enemas and a handful of dubious nostrums dies
that is the ultimate adverse effect. Are they in the database?

I know what's in aspirin, I can trust the labels completely, I know its
safety record and possible side effects and can consult public databases
as to research related to it. Why don't we know about 99 percent of
"alternative drugs" at this level? How can we be informed consumers and
empowered to make health decisions when we don't have that information
at the level of aspirin?

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