Time to reconsider "alternative" drugs

" Oh, horse****.

Who is selling that as a dietary supplement?

Does it treat horse**** deficiency syndrome?"

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

wrote:

" Oh, horse****.

Who is selling that as a dietary supplement?

Does it treat horse**** deficiency syndrome?"

I don't know about horse ****, but cow **** 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, 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 **** 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 **** post...nice.

"Peter Bowditch" wrote in message
...
wrote:

" Oh, horse****.

Who is selling that as a dietary supplement?

Does it treat horse**** deficiency syndrome?"

I don't know about horse ****, but cow **** 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 - "Horse**** 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 . com,
PeterB wrote:

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

"Robert W. McAdams" wrote in message
...
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.

The company can sell the supplement without any testing for safty or
effectiveness. See DSHSEA. Look at the hundreds of supplements not approved
by the FDA.

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.

What a joke.

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

Do your research.

Robert

Robert wrote:

The company can sell the supplement without any testing for safty or
effectiveness. See DSHSEA. Look at the hundreds of supplements not approved
by the FDA.

Had you bothered to read the first sentence of the post to which you
were responding, you would have known that the post was a discussion of
what would happen if the law were changed to treat supplements as drugs.


Bob

"Max C." wrote in message
oups.com...

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

Even though the supplement part was mostly fiction.

Robert

"GMCarter" wrote in message
...

snip--someone with the rather despicable handle of "coonskin" 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.
On 29 Nov 2006 13:18:17 -0800, "PeterB" wrote:

There is no evidence the same is not true of the vast majority of
pharmaceutical drugs.

I think that both statements are merely absurd and polemical.

Dietary supplements in the US are generally recognized as Safe (GRAS)
(including colloidal silver, grandfathered in). They include a lot of
different agents.

Safe but not effective.

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.

Some DS and some drugs are quite clearly beneficial. Many are abused,
but the abuse by pharma is both more costly and FAR more likely to be
more dangerous.

Read Overdosed America. Great book.

George M. Carter

On Mon, 4 Dec 2006 21:10:49 -0800, "Robert"
wrote:


"GMCarter" wrote in message
.. .

snip--someone with the rather despicable handle of "coonskin" 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.
On 29 Nov 2006 13:18:17 -0800, "PeterB" wrote:

There is no evidence the same is not true of the vast majority of
pharmaceutical drugs.

I think that both statements are merely absurd and polemical.

Dietary supplements in the US are generally recognized as Safe (GRAS)
(including colloidal silver, grandfathered in). They include a lot of
different agents.

Safe but not effective.

So you think that folic acid is ineffective for preventing neural tube
defects? Or that calcium and vitamin D3 are not important for bone
health and preventing osteopenia?

My point is that your statement is inaccurate. Dietary supplements can
have efficacy.

The PROBLEM is that we don't curerntly have -- well the next
paragraph:

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.

Some DS and some drugs are quite clearly beneficial. Many are abused,
but the abuse by pharma is both more costly and FAR more likely to be
more dangerous.

Read Overdosed America. Great book.

Robert, I've read some of your knee-jerk replies. They're not very
helpful to the discussion and indicate a bigoted mindset. Am I wrong?

George M. Carter