Diet Supplements and Safety

"PeterB" wrote in message
oups.com...

GMCarter wrote:
On 18 Jan 2007 16:59:56 GMT, wrote:

While reading this keep in mind that DAN HURLEY...has about the same
credibility as other luminaries of the media like Celia Farber and
morons infesting the quackwatch world.

I pulled up Hurley's book cover online yesterday and it reads exactly
like the script our pharmboys use here in the newsgroups. Amazon's
website also peddles a fluff piece in its "editorial review." It
refers to Hurley's criticism of the supplement industry for
"strong-arming the 1994 Dietary Supplement Health and Education Act
through Congress-a law that rendered the FDA virtually powerless to
regulate these remedies-and observes the FDA's "coziness" with the
industry it regulates. From snake oil and shark cartilage to ephedra,
Hurley consistently animates patches of dry legal and medical material
with harrowing case studies." What's bizarre here is the phrase "FDA's
coziness with the industry it regulates." Since FDA only actively
regulates the drug industry (if you want to call that regulation), this
reference would logically refer to FDAs cozy ties to its primary
funding source, the drug makers, who cover most of FDA's operating
budget. I don't know whether this was a zombie-like confession or if
someone aware of the truth managed to slip it in. The statement that
the supplements industry "strong-armed" the Congress to pass DSHEA,
however, is just ridiculous. More Americans sent letters and made
calls to Congress on this one issue than they did during the Vietnam
war, and it was the most widely supported legislation at a grass roots
level than any other law in history. As far as any review of
"harrowing case studies" involving dietary supplements, that would be
like spotting meteors in the night sky before going to bed. For every
such case you might find linked to a dietary supplement, you would find
literally thousands linked to a pharmaceutical drug. So yes, I smell a
rat.


No matter which side one is on, there should be ZERO REGULATION.

If the government pays for testing and having multiple results published,
fine.

NO PRESCRIPTIONS
That doesn't mean that all of the drugs available now would not be
available, just an open market.

The only thing we get out of an FDA allowed "prescription" drug is the FACT
that the "GOVERNMENT" has decided that the particular substance is DANGEROUS
enough to be REGULATED.

Mark Probert wrote:
PeterB wrote:

The statement that
the supplements industry "strong-armed" the Congress to pass DSHEA,
however, is just ridiculous.

Wrong. First, there is Orrin Hatch of Utah, home of some of the largest
supplement manufacturers.

Yeah, so? Is it wrong for a Senator to represent the interests of
constituents living and working in his state? The problem is not fair
representation, but undue influence by the drug makers using the
largest lobbying machine in history, defeating efforts that would have
saved consumers millions, if not billions, as well as avoiding
liability for dangerous drug side effects. And unlike you, I'll prove
what I say. Read the articles at
www.publicintegrity.org/rx/report.aspx?aid=794 and also at
www.case.edu/news/2004/3-04/lobbyists.htm.

Second, I read the FDA and FTC websites and have read many letters that
have very similar, if not the same, verbiage opposing FDA/FTC actions
regarding supplement makers. They are complaining that the requirement
that medical claims be backed up is an unfair limitation on the free
speech of the supplement sales people.

Any company has the right to express its views, and efforts to suppress
health claims related to nutrient function does violate constitutional
freedoms because there is scientific study to support those claims.
The passage of DSHEA was a result of massive consumer outcry that
unncessary regulation of dietary supplements by a complicit FDA would
not be tolerated. If that effort had failed, life-saving nutrients
like vitamin C and vitamin E would only be available in effective doses
through AMA's prescription pipeline. Industry should never have a
monopoly on naturally-occuring nutrients and if your sponsors want to
participate in the future of medicine, they need to start getting into
the business of health and stop trying to commoditize disease.

After reading these letters, it is clear to me that there is an
organized effort. Strong armed tactics.

Equating "organized effort" to "strong armed tactics" is like equating
your brain to a Brain Trust (ie., meaningless.)

vernon wrote:
"PeterB" wrote in message
oups.com...

GMCarter wrote:
On 18 Jan 2007 16:59:56 GMT, wrote:

While reading this keep in mind that DAN HURLEY...has about the same
credibility as other luminaries of the media like Celia Farber and
morons infesting the quackwatch world.

I pulled up Hurley's book cover online yesterday and it reads exactly
like the script our pharmboys use here in the newsgroups. Amazon's
website also peddles a fluff piece in its "editorial review." It
refers to Hurley's criticism of the supplement industry for
"strong-arming the 1994 Dietary Supplement Health and Education Act
through Congress-a law that rendered the FDA virtually powerless to
regulate these remedies-and observes the FDA's "coziness" with the
industry it regulates. From snake oil and shark cartilage to ephedra,
Hurley consistently animates patches of dry legal and medical material
with harrowing case studies." What's bizarre here is the phrase "FDA's
coziness with the industry it regulates." Since FDA only actively
regulates the drug industry (if you want to call that regulation), this
reference would logically refer to FDAs cozy ties to its primary
funding source, the drug makers, who cover most of FDA's operating
budget. I don't know whether this was a zombie-like confession or if
someone aware of the truth managed to slip it in. The statement that
the supplements industry "strong-armed" the Congress to pass DSHEA,
however, is just ridiculous. More Americans sent letters and made
calls to Congress on this one issue than they did during the Vietnam
war, and it was the most widely supported legislation at a grass roots
level than any other law in history. As far as any review of
"harrowing case studies" involving dietary supplements, that would be
like spotting meteors in the night sky before going to bed. For every
such case you might find linked to a dietary supplement, you would find
literally thousands linked to a pharmaceutical drug. So yes, I smell a
rat.


No matter which side one is on, there should be ZERO REGULATION.

If the government pays for testing and having multiple results published,
fine.

NO PRESCRIPTIONS
That doesn't mean that all of the drugs available now would not be
available, just an open market.

The only thing we get out of an FDA allowed "prescription" drug is the FACT
that the "GOVERNMENT" has decided that the particular substance is DANGEROUS
enough to be REGULATED.

You are, however, ahead of your time. I agree with every point you
make, but the practical reality is that eliminating the largely
ineffective regulatory process would put an end to monopoly profits,
and there is no mechanism in place for that to happen. If we could (as
we should) make lobbying illegal, that might do it. I think the best
we might hope for, though, is a drug approval process based on more
robust toxicologies (12mos), risk-adjusted outcomes using larger sets
of clinical data before the drug makers mass market (already under
"review"), elimination of off-label uses without additional clinical
study, and hopefully elimination of drug-maker funded study to support
approval of their own drugs.

wrote:
....
Diet Supplements and Safety: Some Disquieting Data

By DAN HURLEY

In October 1993, during a Senate hearing on a bill to regulate herbs,
vitamins and other dietary supplements on the presumption that they
were safe...

That benign view was written into the bill when it was passed by both
houses the following year. While the law, the Dietary Supplement
Health and Education Act of 1994, forbade manufacturers to claim that
their products treat, cure or prevent any disease, it allowed them to
make vaguer claims based on a standard that did not require them to
do
any testing.


Sounds perfectly reasonable. They cannot make definite claims.


....

But hiding in plain sight, then as now, a national database was
steadily accumulating strong evidence that some supplements carry
risks of injury and death, and that children may be particularly
vulnerable.


Practically any drug or anything that you put into your body has some
risk of adverse effects. The same can be said for OTC and prescription
meds. That is not news. And spare us another it's to "protect our
children" argument.


Since 1983, the American Association of Poison Control Centers has
kept statistics on reports of poisonings for every type of substance,
including dietary supplements. That first year, there were 14,006
reports related to the use of vitamins, minerals, essential oils
which
are not classified as a dietary supplement but are widely sold in
supplement stores for a variety of uses and homeopathic remedies.
Herbs were not categorized that year, because they were rarely used
then.

By 2005, the number had grown ninefold: 125,595 incidents were
reported related to vitamins, minerals, essential oils, herbs and
other supplements. In all, over the 23-year span, the association a
national organization of state and local poison centers has received
more than 1.6 million reports of adverse reactions to such products,
including 251,799 that were serious enough to require
hospitalization.
From 1983 to 2004 there were 230 reported deaths from supplements,
with the yearly numbers rising from 4 in 1994, the year the
supplement
bill passed, to a record 27 in 2005.
....

No one doubts that some herbs and supplements may result in adverse
effects, sometimes serious ones, in some persons. In depends on many
factors, including dose, other medications, individual differences, etc.
It would certainly be desirable to keep track of possible adverse
effects and interactions. Actually, some people in the field have been
doing that for some time. It doesn't take laws to get things done.


Among herbs and other specialty products, melatonin and homeopathic
products prepared from minuscule amounts of substances as diverse as
salt and snake venom had the most reports of reactions in 2005. The
poison centers received 2,001 reports of reactions to melatonin,
marketed as a sleep aid, including 535 hospitalizations and 4 deaths.
Homeopathic products, often marketed as being safe because the doses
are very low, were linked to 7,049 reactions, including 564
hospitalizations and 2 deaths.


This makes me very suspicous. Homepathic products causing serious
reactions and deaths? And melatonin is very safe. Just how were these
supposed events evaluated? It sounds as if a lot of them were of the
"post hoc ergo propter hoc" variety.

....
Advocates of the products correctly point out that the poison centers
figures do not prove a causal link between a product and a reaction
and that, in any case, far more people are injured and killed by
drugs. Painkillers alone were associated with 283,253 adverse
reactions in 2005, according to the poison centers, more than twice
as
many as with supplements. But only 3.5 percent of those reactions
occurred when people took the prescribed amount of painkiller; most
were from overdoses, either accidental or intentional. The same was
true of asthma drugs (3.6 percent of reactions were associated with
the prescribed dose) and cough and cold drugs (3.1 percent).


With that I can agree. Hopefully they and everyone else involved
realizes how this affects the argument.
....
Drugs marketed in the United States go through a rigorous F.D.A.
approval process to prove that they are effective for a particular
indication, with the potential risks balanced against the benefits.
While the approval process has come under attack in recent years as
unduly favorable to drug companies, it remains among the toughest in
the world.

There is no comparable requirement for supplements.


Because herbs and supplements cannot generally be patented, no one is
going to spend the hundreds of billions to go through the testing and
approval process.


Even so, hundreds
of millions of tax dollars have been spent since the early 1990s on
hundreds of studies to test the possible benefits of supplements. The
National Center for Complementary and Alternative Medicine,
established by Congress in 1991 to investigate and validate
unconventional medical practices, has a 2007 budget of more than $120
million.

Since April 2002, five large randomized trials financed by the center
have found no significant benefit for St. Johns wort against major
depression, echinacea against the common cold, saw palmetto for
enlarged prostate, the combination of glucosamine and chondroitin for
arthritis, or black cohosh and other herbs for the hot flashes
associated with menopause.


That is being extremely selective about the studies. For example, a
number of good studies have reported benefits for St. John's wort and
glucosamine/chondroitin, eg,

Philipp M, Kohnen R, Hiller KO. Hypericum extract versus imipramine or
placebo in patients with moderate depression: randomised multicentre
study of treatment for eight weeks. BMJ 1999 Dec 11;319(7224):1534-9.

Deal CL, Moskowitz RW. Nutraceuticals as therapeutic agents in
osteoarthritis. The role of glucosamine, chondroitin sulfate, and
collagen hydrolysate. Rheum Dis Clin North Am. 25(2):379-95, 1999.


A new source of data on adverse reactions to dietary supplements will
soon become available: in December, Congress passed a measure
requiring the manufacturers of dietary supplements and
over-the-counter drugs to inform the F.D.A. whenever consumers call
them with reports of serious adverse events. The bill was signed by
President Bush the day after Christmas. It is a welcome
acknowledgment
that natural does not always mean safe.


No one ever said that it does. And what the article does not mention is
that the FDA has repeatedly tried to BAN many supplements and herbs, and
in fact has succeeded in banning a few (eg, tryptophan). What the FDA
and many nanny state proponents can't get through their heads is the
difference between laws against fraudulent promotion of a supplement and
laws banning the supplement itself; between approval something as "safe
and effective" is not the only criterion that an individual might use in
deciding whether to take it; that individuals have the ultimate right to
decide what they can and cannot put into their own bodies.


Dan Hurley is the author of the new book Natural Causes: Death, Lies
and Politics in Americas Vitamin and Herbal Supplement Industry
(Broadway Books), from which this essay is adapted.

"PeterB" wrote in message
oups.com...

GMCarter wrote:
On 18 Jan 2007 16:59:56 GMT, wrote:

While reading this keep in mind that DAN HURLEY...has about the same
credibility as other luminaries of the media like Celia Farber and
morons infesting the quackwatch world.

I pulled up Hurley's book cover online yesterday and it reads exactly
like the script our pharmboys use here in the newsgroups. Amazon's
website also peddles a fluff piece in its "editorial review." It
refers to Hurley's criticism of the supplement industry for
"strong-arming the 1994 Dietary Supplement Health and Education Act
through Congress-a law that rendered the FDA virtually powerless to
regulate these remedies-and observes the FDA's "coziness" with the
industry it regulates. From snake oil and shark cartilage to ephedra,
Hurley consistently animates patches of dry legal and medical material
with harrowing case studies." What's bizarre here is the phrase "FDA's
coziness with the industry it regulates." Since FDA only actively
regulates the drug industry (if you want to call that regulation), this
reference would logically refer to FDAs cozy ties to its primary
funding source, the drug makers, who cover most of FDA's operating
budget. I don't know whether this was a zombie-like confession or if
someone aware of the truth managed to slip it in. The statement that
the supplements industry "strong-armed" the Congress to pass DSHEA,
however, is just ridiculous. More Americans sent letters and made
calls to Congress on this one issue than they did during the Vietnam
war, and it was the most widely supported legislation at a grass roots
level than any other law in history. As far as any review of
"harrowing case studies" involving dietary supplements, that would be
like spotting meteors in the night sky before going to bed. For every
such case you might find linked to a dietary supplement, you would find
literally thousands linked to a pharmaceutical drug. So yes, I smell a
rat.

Please give the source for this statement.

"vernon" stillhere@anhere wrote in message
m...

"PeterB" wrote in message
oups.com...

GMCarter wrote:
On 18 Jan 2007 16:59:56 GMT, wrote:

While reading this keep in mind that DAN HURLEY...has about the same
credibility as other luminaries of the media like Celia Farber and
morons infesting the quackwatch world.

I pulled up Hurley's book cover online yesterday and it reads exactly
like the script our pharmboys use here in the newsgroups. Amazon's
website also peddles a fluff piece in its "editorial review." It
refers to Hurley's criticism of the supplement industry for
"strong-arming the 1994 Dietary Supplement Health and Education Act
through Congress-a law that rendered the FDA virtually powerless to
regulate these remedies-and observes the FDA's "coziness" with the
industry it regulates. From snake oil and shark cartilage to ephedra,
Hurley consistently animates patches of dry legal and medical material
with harrowing case studies." What's bizarre here is the phrase "FDA's
coziness with the industry it regulates." Since FDA only actively
regulates the drug industry (if you want to call that regulation), this
reference would logically refer to FDAs cozy ties to its primary
funding source, the drug makers, who cover most of FDA's operating
budget. I don't know whether this was a zombie-like confession or if
someone aware of the truth managed to slip it in. The statement that
the supplements industry "strong-armed" the Congress to pass DSHEA,
however, is just ridiculous. More Americans sent letters and made
calls to Congress on this one issue than they did during the Vietnam
war, and it was the most widely supported legislation at a grass roots
level than any other law in history. As far as any review of
"harrowing case studies" involving dietary supplements, that would be
like spotting meteors in the night sky before going to bed. For every
such case you might find linked to a dietary supplement, you would find
literally thousands linked to a pharmaceutical drug. So yes, I smell a
rat.


No matter which side one is on, there should be ZERO REGULATION.

If the government pays for testing and having multiple results published,
fine.

NO PRESCRIPTIONS
That doesn't mean that all of the drugs available now would not be
available, just an open market.

The only thing we get out of an FDA allowed "prescription" drug is the
FACT
that the "GOVERNMENT" has decided that the particular substance is
DANGEROUS
enough to be REGULATED.

I cannot believe that anyone in the year 2007 would want to let anyone make
sell medicine without any controls.

Robert

On Fri, 19 Jan 2007 11:02:29 -0700, "vernon" stillhere@anhere wrote:

snip
No matter which side one is on, there should be ZERO REGULATION.

Spoken like a true blue Libertarian nut job.

There NEEDS to be regulation. What's missing from DSHEA in my view is
product identity, potency and purity oversight. There needs to be
legislation with teeth and funding for reviewing products

There needs to be a mechanism for approving claims of medical value to
supplements tha works better than it taking 40 years to recognize that
folic acid supplementation prevents neural tube defects, for example.

There is a CLEAR industry bias in favor of NOT permitting claims that
might affect pharma profits.

I believe we also must dismantle or sideline the idiotic privatized
R&D and drug development industries. They are NOT more efficient; in
fact, they are FAR less so and result in profit/bottom line and the
perversions of capitalism that are currently in play, murdering
millions globally on an annual basis.

George M. Carter

GMCarter wrote:
On Fri, 19 Jan 2007 11:02:29 -0700, "vernon" stillhere@anhere wrote:

snip

No matter which side one is on, there should be ZERO REGULATION.


Spoken like a true blue Libertarian nut job.

There NEEDS to be regulation. What's missing from DSHEA in my view is
product identity, potency and purity oversight. There needs to be
legislation with teeth and funding for reviewing products

There needs to be a mechanism for approving claims of medical value to
supplements tha works better than it taking 40 years to recognize that
folic acid supplementation prevents neural tube defects, for example.

There is a CLEAR industry bias in favor of NOT permitting claims that
might affect pharma profits.

I believe we also must dismantle or sideline the idiotic privatized
R&D and drug development industries. They are NOT more efficient; in
fact, they are FAR less so and result in profit/bottom line and the
perversions of capitalism that are currently in play, murdering
millions globally on an annual basis.


Spoken like a typical thoughtless statist.

There needs to be ACCOUNTABILITY--that does not necessarily mean
government regulation of everything. To "dismantle or sideline the
idiotic privatized R&D and drug development industries" would be about
the most idiotic thing that could be done. Hasn't the history of
government failures and inefficiencies taught you anything? If
anything, government should be gotten out of the process. The
pharmaceutical industry and nearly every other industry exerts undue
power mainly through government.

"The government solution to a problem is usually as bad as the problem."
"Many people want the government to protect the consumer. A much more
urgent problem is to protect the consumer from the government."
--Milton Friedman (Nobel Prize in economics, 1976)

GMCarter wrote:
On Fri, 19 Jan 2007 11:02:29 -0700, "vernon" stillhere@anhere wrote:

snip
No matter which side one is on, there should be ZERO REGULATION.

Spoken like a true blue Libertarian nut job.

There NEEDS to be regulation. What's missing from DSHEA in my view is
product identity, potency and purity oversight. There needs to be
legislation with teeth and funding for reviewing products

Agreed.

There needs to be a mechanism for approving claims of medical value to
supplements tha works better than it taking 40 years to recognize that
folic acid supplementation prevents neural tube defects, for example.

Absolutely correct. We did that in the 1980's when it was recommended by
our ob/gyn who had 40 years in practice.

There is a CLEAR industry bias in favor of NOT permitting claims that
might affect pharma profits.

Not so. I have yet to see real proof of that.

I believe we also must dismantle or sideline the idiotic privatized
R&D and drug development industries. They are NOT more efficient; in
fact, they are FAR less so and result in profit/bottom line and the
perversions of capitalism that are currently in play, murdering
millions globally on an annual basis.

So, you are in favor of the government doing the R&D?

Robert wrote:
"PeterB" wrote in message
oups.com...
GMCarter wrote:
On 18 Jan 2007 16:59:56 GMT, wrote:

While reading this keep in mind that DAN HURLEY...has about the same
credibility as other luminaries of the media like Celia Farber and
morons infesting the quackwatch world.
I pulled up Hurley's book cover online yesterday and it reads exactly
like the script our pharmboys use here in the newsgroups. Amazon's
website also peddles a fluff piece in its "editorial review." It
refers to Hurley's criticism of the supplement industry for
"strong-arming the 1994 Dietary Supplement Health and Education Act
through Congress-a law that rendered the FDA virtually powerless to
regulate these remedies-and observes the FDA's "coziness" with the
industry it regulates. From snake oil and shark cartilage to ephedra,
Hurley consistently animates patches of dry legal and medical material
with harrowing case studies." What's bizarre here is the phrase "FDA's
coziness with the industry it regulates." Since FDA only actively
regulates the drug industry (if you want to call that regulation), this
reference would logically refer to FDAs cozy ties to its primary
funding source, the drug makers, who cover most of FDA's operating
budget. I don't know whether this was a zombie-like confession or if
someone aware of the truth managed to slip it in. The statement that
the supplements industry "strong-armed" the Congress to pass DSHEA,
however, is just ridiculous. More Americans sent letters and made
calls to Congress on this one issue than they did during the Vietnam
war, and it was the most widely supported legislation at a grass roots
level than any other law in history. As far as any review of
"harrowing case studies" involving dietary supplements, that would be
like spotting meteors in the night sky before going to bed. For every
such case you might find linked to a dietary supplement, you would find
literally thousands linked to a pharmaceutical drug. So yes, I smell a
rat.

Please give the source for this statement.


Petey's imagination comes to mind. His ability to dismiss anything
antithetical to his firmly held beliefs.

Petey is the prototypical user of the fallacy of "special pleadings."