Time to reconsider "alternative" drugs

Robert W. McAdams wrote:
> Max C. wrote:
> >
> > Well, I believe *ANY* terminal illness is a special case, not just
> > cancer. Such a diagnosis can change a rational person into a snake oil
> > chaser. I believe it is unethical for a person or company selling a
> > product to knowingly take advantage of such a person with "supplements"
> > that have not been proven to do what they claim. It's all about
> > ethics.
> >
> > Max.
>
> At the same time, you need to consider things from the viewpoint of a
> person who is suffering from a terminal illness for which there is no
> proven treatment. They have two options: Do nothing, or use an
> unproven treatment.
>
> If they do nothing, they will get worse and worse, and will finally die.
> If they use an unproven treatment, they MAY get worse and worse and
> finally die. It's easy to see why "may get worse" is more appealing to
> them than "will get worse". And even if the unproven treatment doesn't
> help them, they will still have the satisfaction of knowing that they
> have advanced medical science by demonstrating that a particular
> treatment doesn't work (at least in their case).
>
> There's also a big difference between a treatment for which there is no
> evidence and a treatment for which there is inconclusive evidence. One
> would hope, of course, that when a treatment is unproven, any company
> offering it would make potential customers aware of that fact, and of
> what evidence, if any, exists to support their belief that it may be
> beneficial. (Is it just some scientist's suspicion that it may have
> benefit, or is there anecdotal evidence, or have one or more studies
> been done showing a benefit?)
>
>
> Bob

I express similar sentiments on my web site at
http://members.bordernet.com.au/~pmo...onal_usage.htm

And you are correct that it is the overpromotional aspect that condemns
the alternative cancer industry as a whole as grossly unethical.

Cancer patients are under immense pressure to give them the benefit of
the doubt. No one esle need do so, in such a desperately important
matter as a cancer cure.

We are entitled to regard them as quacks and crooks when they make the
same unfounded claims year in and year out, for decade after decade
without a trace of serious systematic investigation of the methods, or
even producing any good quality anecdotal material. That is not
difficult or expensive.

Peter Moran

www.cancerwatcher.com

On 30 Nov 2006 14:13:31 GMT, coonskin@amestwp.com wrote:

>"Dietary supplements in the US are generally recognized as Safe (GRAS)
>(including colloidal silver, grandfathered in). They include a lot of
>different agents."
>
>No, only such things as vitamins and minerals etc. are accepted as "safe
>and effective".

Stop right there. MANY botanical agents are GRAS.
http://www.cfsan.fda.gov/~dms/grasguid.html

snip
>
>"There is no FDA mechanism for evaluating effects of DS on mitigating or
>curing diseases. FDA is corrupt and stinks worse than it ever has, a
>puppet to pharma. It took 40 years, for example, for FDA to recognize
>that folic acid supplementation can prevent neural tube defects."
>
>Three points here, there is under food and drug and cosmetics laws a way
>for "alternative drugs" to be accepted as otc, like aspirin. Whatever
>the flaws of fda it does not excuse the many many times worse oversight
>applied to "alternative drugs" under the almost useless laws applying to
>them. The fda does not initiat medical research as in folic acid. Who
>in the end did recognize on a scientific basis its benefit?

In the end took a HELL of a long time--and lots of deformed infants.
OTC status is one way to go. We need more public investment in health
outcomes research is my view.

But come on....if you think the FDA is pristine you're living in a
bubble somewhere. They have become abject stinking whores for a
pharmaceutical industry that has UTTERLY abandoned the last pretense
of giving a flying fuck if their drug helps people or is a significant
advance over other treatments for a condition--it's all about the
money. That distorts science, cripples physician's capacity to treat
and destroys the tattered fabric of healthcare access, given we lack a
single payer healthcare system in the US.

None of that absolves egregious claims being made by dietary
supplements on the other hand--but the difference in terms of
overdosing US citizens, raping bank accounts and increasing morbidity
and mortality unnecessarily and losing the best value of more
conservative use of drugs FAR outstrips the worst the DS industry has
done. The scale is not even close.

What I want to see is SCIENCE restored and a consumer perspective
embraced that looks at health outcomes, regardless of whether an
intervention is considered pharmaceutical, CAM or grandma's best
wisdom.

George M. Carter

On 30 Nov 2006 06:54:40 -0800, "Max C." <maxc246@gmail.com> wrote:

>
snip
>Well, I believe *ANY* terminal illness is a special case, not just
>cancer. Such a diagnosis can change a rational person into a snake oil
>chaser.

You bet. That's why many people are being duped into shelling out HUGE
amounts for mostly very minimally effective monoclonal antibody
therapies that have at BEST shown only a couple weeks longer life,
usually 2 more weeks of misery and pain.

Then of course the folks who get overdosed on an otherwise great drug
for chemo-associated anemia.

Yep, those snake-oil salesmen in pharma are doing a great job
shoveling billions of dollars of needless drugs down people's throats
while doing their damndest to block access to generic 1st and 2nd line
ARV for people with HIV in developing nations.

All because profit pushes them. Not a genuine and careful
understanding of health outcomes.

Genocidal, isn't it?

George M. Carter

"In the end took a HELL of a long time--and lots of deformed infants."

For which the fda was not at fault, they don't do or solicit research.
It was basic research that did it and the "alternative drug" industry
contributed not a bit.

"OTC status is one way to go. We need more public investment in health
outcomes research is my view."

And mine as well.

"But come on....if you think the FDA is pristine you're living in a
bubble somewhere. They have become abject stinking whores for a
pharmaceutical industry that has UTTERLY abandoned the last pretense
of giving a flying fuck if their drug helps people or is a significant
advance over other treatments for a condition--it's all about the
money. That distorts science, cripples physician's capacity to treat
and destroys the tattered fabric of healthcare access, given we lack a
single payer healthcare system in the US."

Again, I couldn't agree more, except again to mention that with all the
fda flaws it doesn't in even one small bit "prove" or justify
"alternative drugs" nor the almost useless law not being enforced weakly
that oversees them. If the fda didn't exist this is still the reality
and the science it claims still stinks.

"None of that absolves egregious claims being made by dietary
supplements on the other hand--but the difference in terms of
overdosing US citizens, raping bank accounts and increasing morbidity
and mortality unnecessarily and losing the best value of more
conservative use of drugs FAR outstrips the worst the DS industry has
done. The scale is not even close.

No problem, "alternative drugs" are a fraction of all drugs but in
addition to being exactly as the fda approved drugs above, they have in
addition no science in support. Scale is no measure of the morility and
theft of "alternative drugs" as compared to prescription drugs. Scale
in what works is however just the oppisite.

"What I want to see is SCIENCE restored and a consumer perspective
embraced that looks at health outcomes, regardless of whether an
intervention is considered pharmaceutical, CAM or grandma's best
wisdom."

My thoughts exactly, which means that "alternative drugs" and cam will
dissappear for lack of the science to support them.

coonskin@amestwp.com wrote:
> "In the end took a HELL of a long time--and lots of deformed infants."
>
> For which the fda was not at fault, they don't do or solicit research.
> It was basic research that did it and the "alternative drug" industry
> contributed not a bit.

You couldn't be more wrong. Dr. Royal Lee of the Standard Process
company was citing folic acid for pregnant women and infants LONG
before it was realized in the main stream. Like so many other
discoveries he made, the FDA tried to silence him saying "There's no
scientific evidence for your claims on folic acid."

Here's a piece of lit from the Standard Process company on folic acid.
This has been used in their product descriptions for a VERY long time.

"Folic Acid and vitamin B12 are very synergistic B Complex vitamins. As
such, taken together they work to strengthen the health of the blood
cell. Its most important function in the body is its necessity in the
process of the formation of DNA. Like with vitamin B12, it is vital to
the replication of genes. Therefore its deficiency impairs growth and
development. Absent from an animals or child's diet, very little growth
will occur. Like vitamin Bl2, it is needed for the maturation of red
blood cells. Macrocytic anemia can often be treated with Folic Acid
alone."

Of course, my favotir FDA flop on a similar note was when they took Dr.
Lee to court over claims that his Betaine Hydrochloride supplement
would aid digestion. He actually had to prove in court that it did
such... and at that VERY SAME TIME, Marlboro was running TV ads claim
that their product, smoked after a meal, would aid digestion. Didn't
see them in court over that claim, did you?

> "OTC status is one way to go. We need more public investment in health
> outcomes research is my view."
>
> And mine as well.
>
> "But come on....if you think the FDA is pristine you're living in a
> bubble somewhere. They have become abject stinking whores for a
> pharmaceutical industry that has UTTERLY abandoned the last pretense
> of giving a flying fuck if their drug helps people or is a significant
> advance over other treatments for a condition--it's all about the
> money. That distorts science, cripples physician's capacity to treat
> and destroys the tattered fabric of healthcare access, given we lack a
> single payer healthcare system in the US."
>
> Again, I couldn't agree more, except again to mention that with all the
> fda flaws it doesn't in even one small bit "prove" or justify
> "alternative drugs" nor the almost useless law not being enforced weakly
> that oversees them. If the fda didn't exist this is still the reality
> and the science it claims still stinks.
>
> "None of that absolves egregious claims being made by dietary
> supplements on the other hand--but the difference in terms of
> overdosing US citizens, raping bank accounts and increasing morbidity
> and mortality unnecessarily and losing the best value of more
> conservative use of drugs FAR outstrips the worst the DS industry has
> done. The scale is not even close.
>
> No problem, "alternative drugs" are a fraction of all drugs but in
> addition to being exactly as the fda approved drugs above, they have in
> addition no science in support. Scale is no measure of the morility and
> theft of "alternative drugs" as compared to prescription drugs. Scale
> in what works is however just the oppisite.

Have you posted the requested list of these alternative drugs yet?
You've been rather vague. I have a hard time believe that there are
zero alternative drugs without ANY scientific support whatsoever.

Max.

> "What I want to see is SCIENCE restored and a consumer perspective
> embraced that looks at health outcomes, regardless of whether an
> intervention is considered pharmaceutical, CAM or grandma's best
> wisdom."
>
> My thoughts exactly, which means that "alternative drugs" and cam will
> dissappear for lack of the science to support them.

Robert W. McAdams wrote:
> chatw@my-deja.com wrote:
>
>> coonskin@amestwp.com 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.

Well, You are not quite correct on this.

If a new and novel use is found for an existing chemical, it is possible
to get a patent for this application, to my understanding.

j.

the efficacy must be demonstrated for patentability.

and if it is to marketed as a drug, with medical claims, then it must be
demonstrated to the FDA as to ability to do so, and the possible risks
thereof.

j.


>
> 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
>

"Have you posted the requested list of these alternative drugs yet?
You've been rather vague. I have a hard time believe that there are
zero alternative drugs without ANY scientific support whatsoever."

Not reading all messages in detail I don't recall a request. Instead of
listing many of them let us consider how the claims of scientific
support is used and misused which most often leaves then in the end
without support for the products.

One of the big problems is definition. With the current law anything
not falling under an existing law comes in the "food supplement" law. In
part this is a way to call it a "food" related product but in every
respect treating and selling it as a "drug" for alleged "health"
benefits. Many of the substances would in any usual manner be
considered "food/nutrition" at all.


So in that far ranging definition such things as vitamins and minerals
and other related things have scientific support, long before the law in
fact. They are true "supplements" and not drugs in the normal sense of
the word unless claims are made about mega doses of them. This leaves
us however with such things as "coral calcium" sold as addressing many
things in addition to the usual benefit of another simple source of
calcium.

One can spot many of them because they are hawked in infomercials. Here
they can claim a kind of "me too" scientific support without having to
show their product has any in fact. For example the human growth
hormone nostrums sold can have it in fact but in such tiny amounts only
to satisfy the claim it is there. Or they can ride on the coattails of
the fact that eaiting protein raises hgh and call their nostrum a
product that rases hgh because it too contains regular protins found in
many foods.

Some don't even bother diong a tap dance of "me too", they just imply
health benefit without having to show it, "shark cartilage" being an
examble. There are many who claim support but when looking at it see it
does not meet even the minimal requirements for being called so. Or the
research is in answer to a question not related to the health benefit
but pasted onto them. I recall one product that only showed it appeared
in the blood at increased levels in tests, which of course did not
support anything else claimed.

GMCarter wrote:
> On 30 Nov 2006 14:13:31 GMT, coonskin@amestwp.com wrote:
>

> What I want to see is SCIENCE restored and a consumer perspective
> embraced that looks at health outcomes, regardless of whether an
> intervention is considered pharmaceutical, CAM or grandma's best
> wisdom.
>
> George M. Carter

But don't you see that it is the rigid application of the science to do
with whether medications have intrinsic healing properties that causes
the very problems you complain about?

It is the FDA.(and other health bodies') requirement of three
independent, good quality controlled trials before endorsing certain
kinds of health care claim that is *said* to prevent alternative
remedies being given their proper due.

The three trials and various other measures including duty of
disclosure are now required to help prevent sloppy science or bias or
corruption giving false results. It doesn't always work well, but I
defy you to come up with a better system if you want science to be the
yardstick.

I also don't believe that alternative claims about being unable to meet
normal scientific standards is generally true I think some very
clever people have induced that belief so that you will buy alternative
products without really knowing whether they do what they are claimed
to.

My main concern is that the same smoke screen is being quite
inappropriately used to support rampant fraud and quackery within
cancer treatment, where it should be much easier to establish claims of
significant effects on cancer. Even the mainstream relies upon simple
Phase l and Phase ll case series when testing out a new cancer drug.
Any cancer quack should be able to do those if they had the wherewithal
to produce a tenable cancer cure claim in the first place..

I have challenged your views in another thread called "An Important
point". I would be interested in your response.

Peter Moran

www.cancerwatcher.com
..

coonskin@amestwp.com 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.

Like Vioxx or even trans-fats?

--

Pramesh Rutajit - p2976221tongue@newsguy.com - remove tongue to reply.

coonskin@amestwp.com wrote:
> These nutrients are different from the "alternative
> drugs" in question.

What "alternative drugs" are you discussing? Examples required.

--

Pramesh Rutajit - p2976221tongue@newsguy.com - remove tongue to reply.

coonskin@amestwp.com wrote:

> "Have you posted the requested list of these alternative drugs yet?
> You've been rather vague. I have a hard time believe that there are
> zero alternative drugs without ANY scientific support whatsoever."
>
> Not reading all messages in detail I don't recall a request. Instead of
> listing many of them let us consider how the claims of scientific
> support is used and misused which most often leaves then in the end
> without support for the products.

Lets not and stick to the point of getting some real examples.

Apparently, there is no such thing as an "alternative drug". The way you
play this word game, anyone claiming a health benefit, like for example
anyone marketing a "purified water" without chlorine that improves health -
a health claim - would define "purified water" as an "alternative drug"
that you would want to see regulated.

So, name some "alternative drugs" and don't make vague references. Give us
a dozen or two examples.

How about Willow Bark which sometimes includes claims as to having some
effect as a pain killer. Can you work with that example?

--

Pramesh Rutajit - p2976221tongue@newsguy.com - remove tongue to reply.

Concerning having information about "alternative drugs" so one can be an
informed and empowered consumer:

"Like Vioxx or even trans-fats?"

Absolutely, we now hat that information and can act accordingly.
However flawed the process the science upon which we can now act is
there.

I'm all for better oversight of prescription drugs and foods as to
effectivness and safety, something for which the "alternative drugs" is
routinely unknown and unknowable by consumers by law, compounded by poor
enforcement of the weak law.


It bears repeating as often as possible, the quality of the oversight of
prescription drugs is in no way a confirmation of the claims for
"alternative drugs". If oversight of prescription drugs didn't exist
the science in support of "alternative drugs" is just not there in very
large part.

coonskin@amestwp.com wrote:

> "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.

So if any of these ambiguously defined "alternative drugs" have a lower side
effect profile and death rate than aspirin, then they should by all means
be allowed?

--

Pramesh Rutajit - p2976221tongue@newsguy.com - remove tongue to reply.

"So if any of these ambiguously defined "alternative drugs" have a lower
side effect profile and death rate than aspirin, then they should by all
means be allowed?"

Yes, with one more condition that now sets them off, they work as
claimed. We can with confidence based on research say aspirin has
certain predictable outcomes, and for that matter based on same what
level of potential side effects. Some "alternative drugs" are quite
safe, they just can not be supported in any claims about them based on
demonstrated research outcomes for either benefit or side effects.

The question each product must answer is does it work and is it safe.
We can answer that with a good degree of certainity about aspirin.

"Apparently, there is no such thing as an "alternative drug". The way
you play this word game, anyone claiming a health benefit, like for
example anyone marketing a "purified water" without chlorine that
improves health - a health claim - would define "purified water" as an
"alternative drug" that you would want to see regulated."

I make the the distinction because of the way the law and the marketing
about these substances is done. Amulti-vitamin is a "nutritional
supplement", it is not an "alternative drug", that is the difference.

Advocates of any nostrum for any purpose that does not fall within
existing regulatory law throws it into a "nutritional supplement".
"Coral calcium" is an example. Obviously it is a "nutritional
supplement" because it is made of calcium in compound, but claims of
multiple other "medical" benefits as an "alternative drug" as I'm using
it were marketed without any support whatsoever. Even with the now weak
law it had to withdraw from the market for unsupported medical claims.

"So, name some "alternative drugs" and don't make vague references.
Give us a dozen or two examples."

Read the contents of your spam filter or attend to radio/tv infomercials
or read the newsgroups. "

How about Willow Bark which sometimes includes claims as to having some
effect as a pain killer. Can you work with that example?"

Absolutely, it along with other botanical sources contains a substance
that is the active ingredient in aspirin and thus is known to have
potential benefits.

Here is the rub however. Under current law it can be sold because of
lax
enforcement of a weak law even if it contains even a tiny amount of the
bark amongst otherwise filler material. It can be adulterated with
substances of unknown origin, activity and toxicity. It can vary
greatly
in level of the active substance from batch to batch. It can be the
bark
of a "willow" species which has no activity. There is no method to
insure
a standardized dose. If there are adverse events and side effects they
don't have to be reported to any central source for reference. If
adverse
events happen they will become known only by word of mouth and accident.

Now allow me to ask you a wquestion. What about Ayurvedic herbal
medicine, sold as examples of "alternative drugs". Using the above
brief outline of the weaknesses of the current law and on each of the
points made, how can we eevaluate them?

coonskin@amestwp.com wrote:
> "So if any of these ambiguously defined "alternative drugs" have a lower
> side effect profile and death rate than aspirin, then they should by all
> means be allowed?"
>
> Yes, with one more condition that now sets them off, they work as
> claimed. We can with confidence based on research say aspirin has
> certain predictable outcomes, and for that matter based on same what
> level of potential side effects. Some "alternative drugs" are quite
> safe, they just can not be supported in any claims about them based on
> demonstrated research outcomes for either benefit or side effects.
>
> The question each product must answer is does it work and is it safe.
> We can answer that with a good degree of certainity about aspirin.

That raises another interesting question: What if the manufacturer of
the alternative drug makes no claims about it, but simply manufacturers
it for anyone who, based on their own reading of the scientific
literature, decides they want to use it?


Bob

Robert W. McAdams wrote:
> chatw@my-deja.com wrote:
>> coonskin@amestwp.com 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.

Third method:

An approved medication is patented for a use not previously considered,
or medically justified. However, the target audience are a group of
parents who would do anything, including mortgaging the farm, to cure
their kids.

A doctor, in cahoots with the BigPharma company, patents the USE of this
drug for this treatment which has never been proven to be effective.

Virtually no start up costs and he gets royalties on the use, assuming
another physician is as dishonest as he is.

GMCarter wrote:
> On Wed, 29 Nov 2006 21:27:16 GMT, Peter Bowditch
> <myfirstname@ratbags.com> wrote:
>
> snip
>> 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.
>
> Oh, horseshit.

Who is selling that as a dietary supplement?

Does it treat horseshit deficiency syndrome?

dkw12002@yahoo.com wrote:
> Robert W. McAdams wrote:
>> chatw@my-deja.com wrote:
>>> coonskin@amestwp.com 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
>
A point I have made. The snake-oil supplement industry goes:

1. A possible medical effect is discovered regarding some plant.

2. The plant is harvested, extracted, and sold as a cure. Skip the
safety and efficacy testing.

One day there will be a serious problem due to this.

> The question each product must answer is does it work and is it safe.
> We can answer that with a good degree of certainity about aspirin.

"That raises another interesting question: What if the manufacturer of
the alternative drug makes no claims about it, but simply manufacturers
it for anyone who, based on their own reading of the scientific
literature, decides they want to use it?"

This can happen now. There are some products I use which are marketed
for use in food production which are also known by research to have
other properties related to health benefits. I get them from the
wholesaler/manufacturer not for their food properties but for health
reasons. These are true "nutrition supplements" but when used in a
particular way have valid medical effects and are also a "alternative
drug" in that sense.


The question you ask is however more of how does a consumer get to know
of the research and where to find it. All consumer products come under
some category of regulation, especially if they are to be consumed
orally. They must still comply with guidelines about the quality of the
contents, its purity, what othr material might be in it, and so forth.

The important point you make is that it has a scientific track record of
working. More often then not if humans are used in the research safety
is also carefully controlled and recorded.

Most companies hawking a product do not if fact make it, most only
rebottle and / or combine substances. They are likely the source of
claims. It is they who bear the obligation to meet all laws. Which are
in fact weak and poorly enforced.

"> Oh, horseshit.

Who is selling that as a dietary supplement?

Does it treat horseshit deficiency syndrome?"

I don't know about horse shit, but cow shit is used for alledged medical
claims, as an "alternative drug" said to treat various complaints.

coonskin@amestwp.com wrote:

>"> Oh, horseshit.
>
>Who is selling that as a dietary supplement?
>
>Does it treat horseshit deficiency syndrome?"
>
>I don't know about horse shit, but cow shit is used for alledged medical
>claims, as an "alternative drug" said to treat various complaints.

It's a major cause of neonatal tetanus in some parts of the world,
where it is put on the umbilical stump. Of course, it must work and be
safe, because it is so natural.
--
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

GMCarter wrote:
> On 30 Nov 2006 14:13:31 GMT, coonskin@amestwp.com wrote:
>
> >"Dietary supplements in the US are generally recognized as Safe (GRAS)
> >(including colloidal silver, grandfathered in). They include a lot of
> >different agents."
> >
> >No, only such things as vitamins and minerals etc. are accepted as "safe
> >and effective".
>
> Stop right there. MANY botanical agents are GRAS.
> http://www.cfsan.fda.gov/~dms/grasguid.html
>
> snip
> >
> >"There is no FDA mechanism for evaluating effects of DS on mitigating or
> >curing diseases. FDA is corrupt and stinks worse than it ever has, a
> >puppet to pharma. It took 40 years, for example, for FDA to recognize
> >that folic acid supplementation can prevent neural tube defects."
> >
> >Three points here, there is under food and drug and cosmetics laws a way
> >for "alternative drugs" to be accepted as otc, like aspirin. Whatever
> >the flaws of fda it does not excuse the many many times worse oversight
> >applied to "alternative drugs" under the almost useless laws applying to
> >them. The fda does not initiat medical research as in folic acid. Who
> >in the end did recognize on a scientific basis its benefit?
>
> In the end took a HELL of a long time--and lots of deformed infants.
> OTC status is one way to go. We need more public investment in health
> outcomes research is my view.
>
> But come on....if you think the FDA is pristine you're living in a
> bubble somewhere. They have become abject stinking whores for a
> pharmaceutical industry that has UTTERLY abandoned the last pretense
> of giving a flying fuck if their drug helps people or is a significant
> advance over other treatments for a condition--it's all about the
> money. That distorts science, cripples physician's capacity to treat
> and destroys the tattered fabric of healthcare access, given we lack a
> single payer healthcare system in the US.
>
> None of that absolves egregious claims being made by dietary
> supplements on the other hand--but the difference in terms of
> overdosing US citizens, raping bank accounts and increasing morbidity
> and mortality unnecessarily and losing the best value of more
> conservative use of drugs FAR outstrips the worst the DS industry has
> done. The scale is not even close.
>
> What I want to see is SCIENCE restored and a consumer perspective
> embraced that looks at health outcomes, regardless of whether an
> intervention is considered pharmaceutical, CAM or grandma's best
> wisdom.
>
> George M. Carter

that was a holy shit post...nice.

"Peter Bowditch" <myfirstname@ratbags.com> wrote in message
news:5u12n2t73mj4kf039lp76jg4b54r3ph4ci@4ax.com...
> coonskin@amestwp.com wrote:
>
>>"> Oh, horseshit.
>>
>>Who is selling that as a dietary supplement?
>>
>>Does it treat horseshit deficiency syndrome?"
>>
>>I don't know about horse shit, but cow shit is used for alledged medical
>>claims, as an "alternative drug" said to treat various complaints.
>
> It's a major cause of neonatal tetanus in some parts of the world,
> where it is put on the umbilical stump. Of course, it must work and be
> safe, because it is so natural.

Isn't it called:

HRT - "Horseshit Remedy Treatment." or am I getting the wrong waste mixed
up?

Cheers, Rod

> 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

In article <1164835097.409977.270450@14g2000cws.googlegroups. com>,
PeterB <pkm@mytrashmail.com> wrote:
>
>dkw12002@yahoo.com wrote:
>>
>> 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.

"I can't find this info, and nobody is willing to spoon-feed it to me,
therefore it does not exist."

One hardly knows where to begin. Or when to stop laughing.

-- David Wright :: alphabeta at prodigy.net
These are my opinions only, but they're almost always correct.
"If George Bush were my dad, I'd be drunk in public so often that
James Baker would have me killed." -- Bill Maher on the Bush twins

coonskin@amestwp.com wrote:
> "Apparently, there is no such thing as an "alternative drug". The way
> you play this word game, anyone claiming a health benefit, like for
> example anyone marketing a "purified water" without chlorine that
> improves health - a health claim - would define "purified water" as an
> "alternative drug" that you would want to see regulated."
>
> I make the the distinction because of the way the law and the marketing
> about these substances is done. Amulti-vitamin is a "nutritional
> supplement", it is not an "alternative drug", that is the difference.
>
> Advocates of any nostrum for any purpose that does not fall within
> existing regulatory law throws it into a "nutritional supplement".
> "Coral calcium" is an example. Obviously it is a "nutritional
> supplement" because it is made of calcium in compound, but claims of
> multiple other "medical" benefits as an "alternative drug" as I'm using
> it were marketed without any support whatsoever. Even with the now weak
> law it had to withdraw from the market for unsupported medical claims.
>
> "So, name some "alternative drugs" and don't make vague references.
> Give us a dozen or two examples."
>
> Read the contents of your spam filter or attend to radio/tv infomercials
> or read the newsgroups. "
>
> How about Willow Bark which sometimes includes claims as to having some
> effect as a pain killer. Can you work with that example?"
>
> Absolutely, it along with other botanical sources contains a substance
> that is the active ingredient in aspirin and thus is known to have
> potential benefits.
>
> Here is the rub however. Under current law it can be sold because of
> lax
> enforcement of a weak law even if it contains even a tiny amount of the
> bark amongst otherwise filler material. It can be adulterated with
> substances of unknown origin, activity and toxicity. It can vary
> greatly
> in level of the active substance from batch to batch. It can be the
> bark
> of a "willow" species which has no activity. There is no method to
> insure
> a standardized dose. If there are adverse events and side effects they
> don't have to be reported to any central source for reference. If
> adverse
> events happen they will become known only by word of mouth and accident.
>
> Now allow me to ask you a wquestion. What about Ayurvedic herbal
> medicine, sold as examples of "alternative drugs". Using the above
> brief outline of the weaknesses of the current law and on each of the
> points made, how can we eevaluate them?

It would appear that you are trying to tie the food supplement industry
and the "alternative drug" industry together. Yet at the same time,
you're attempting to make a distinction between them when it suits
your purpose. Above you say:

> I make the the distinction because of the way the law and the marketing
> about these substances is done. Amulti-vitamin is a "nutritional
> supplement", it is not an "alternative drug", that is the difference.

But before that post, you clearly lumped the alternative drug makers
together with the makers of folic acid supplements. In a reply to the
mention of folic acid, you said:

> For which the fda was not at fault, they don't do or solicit research.
> It was basic research that did it and the "alternative drug" industry
> contributed not a bit.

So which is it? Are food supplement makers and alternative drug makers
the same in your opinion or not?

You're not only being purposefully ambiguous about this, it would
appear you're deliberately shifting your position based on the reply at
the time.

Clearly state your position so we can move forward with this debate.

Max.