Diet Supplements and Safety

[capmack]

While reading this keep in mind that supplement producers are
not required to report adverse effects of their products, as
even aspirin produceres are required. This looks at adverse
effects from another source and likely represents a fraction
of actual adverse events.

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, Senator Orrin G.
Hatch, Republican of Utah, spoke up in their defense.
Herbal remedies have been on the market for centuries, he
said, adding: In fact, most of these have been on the
market for 4,000 years, and the real issue is risk. And
there is not much risk in any of these products.

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. And it stated that dietary supplements are
safe within a broad range of intake, and safety problems
with the supplements are relatively rare.

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.

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.

The number of deaths may be far higher. In April 2004, the
Food and Drug Administration said it had received 260
reports of deaths associated with herbs and other
nonvitamin, nonmineral supplements since 1989. But an
unpublished study prepared in 2000 for the agency by Dr.
Alexander M. Walker, then the chairman of epidemiology at
the Harvard School of Public Health, concluded: A best
estimate is that less than 1 percent of serious adverse
events caused by dietary supplements is reported to the
F.D.A. The true proportion may well be smaller by an order
of magnitude or more.

The supplements linked to the most reactions in 2005,
according to the poison control centers, were ordinary
vitamins, accounting for nearly half of all the reports
received that year, 62,446, including 1 death. Minerals
were linked to about half as many total reports, 32,098,
but that number included 13 deaths. Herbs and other
specialty products accounted for still fewer total reports,
23,769, but 13 deaths. Essential oils were linked to 7,282
reports and no deaths.

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.

But most other types of herbs and specialty supplements
also appear in the annual report. In 2005, the poison
centers received 203 reports of adverse reactions to St.
Johns wort, including 79 hospitalizations and 1 death.
Glucosamine, with or without chondroitin, was linked to
813 adverse reactions, including 108 hospitalizations
and 1 death. Echinacea was linked to 483 adverse
reactions, including 55 hospitalizations, 1 of them
considered life-threatening. Saw palmetto was not listed
on the report.

Injuries to children under 6 account for nearly
three-quarters of all the reports of adverse reactions to
dietary supplements, according to the poison centers. In
2005, the most recent year for which figures are available,
48,604 children suffered reactions to vitamins alone, the
ninth-largest category of substances associated with
reactions in that age group.

Major medical groups and government agencies do not
generally recommend vitamin or mineral supplements for
children who are otherwise healthy. But an analysis of the
National Maternal and Infant Health Survey, published in
the journal Pediatrics in 1997, found that 54 percent of
parents of preschool children gave them a vitamin or
mineral supplement at least three days a week.

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).

While reactions to vitamins, minerals and essential oils
occurred at similarly low levels when people took the
recommended amounts, adverse reactions linked to the
recommended levels of herbs, homeopathic products and other
dietary supplements accounted for 10.3 percent of all
reactions to those products reported to the poison centers
about three times the level seen for most drugs.

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. 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.

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.

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.

[Tc]

Over-processing and over-refining of any food substance can
make it dangerous. Sugar, hfcs, flour, artificial
supplements, etc.

Keep your food real and eat the freshest most nutrient-dense
whole-foods available.

Oh yeah, and as if the pharmaceuticals have a better
track record. Talk about dangerous things to add to ones
diets. Yikes.

TC

capmack@shipper.com wrote:
> While reading this keep in mind that supplement producers
> are not required to report adverse effects of their
> products, as even aspirin produceres are required. This
> looks at adverse effects from another source and likely
> represents a fraction of actual adverse events.
>
> 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, Senator Orrin G.
> Hatch, Republican of Utah, spoke up in their defense.
> Herbal remedies have been on the market for centuries, he
> said, adding: In fact, most of these have been on the
> market for 4,000 years, and the real issue is risk. And
> there is not much risk in any of these products.
>
> 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. And it stated that dietary
> supplements are safe within a broad range of intake, and
> safety problems with the supplements are relatively rare.
>
> 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.
>
> 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.
>
> The number of deaths may be far higher. In April 2004,
> the Food and Drug Administration said it had received 260
> reports of deaths associated with herbs and other
> nonvitamin, nonmineral supplements since 1989. But an
> unpublished study prepared in 2000 for the agency by Dr.
> Alexander M. Walker, then the chairman of epidemiology at
> the Harvard School of Public Health, concluded: A best
> estimate is that less than 1 percent of serious adverse
> events caused by dietary supplements is reported to the
> F.D.A. The true proportion may well be smaller by an
> order of magnitude or more.
>
> The supplements linked to the most reactions in 2005,
> according to the poison control centers, were ordinary
> vitamins, accounting for nearly half of all the reports
> received that year, 62,446, including 1 death. Minerals
> were linked to about half as many total reports, 32,098,
> but that number included 13 deaths. Herbs and other
> specialty products accounted for still fewer total
> reports, 23,769, but 13 deaths. Essential oils were
> linked to 7,282 reports and no deaths.
>
> 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.
>
> But most other types of herbs and specialty supplements
> also appear in the annual report. In 2005, the poison
> centers received 203 reports of adverse reactions to St.
> Johns wort, including 79 hospitalizations and 1 death.
> Glucosamine, with or without chondroitin, was linked to
> 813 adverse reactions, including 108 hospitalizations and
> 1 death. Echinacea was linked to 483 adverse reactions,
> including 55 hospitalizations, 1 of them considered
> life-threatening. Saw palmetto was not listed on the
> report.
>
> Injuries to children under 6 account for nearly
> three-quarters of all the reports of adverse reactions to
> dietary supplements, according to the poison centers. In
> 2005, the most recent year for which figures are
> available, 48,604 children suffered reactions to vitamins
> alone, the ninth-largest category of substances
> associated with reactions in that age group.
>
> Major medical groups and government agencies do not
> generally recommend vitamin or mineral supplements for
> children who are otherwise healthy. But an analysis of
> the National Maternal and Infant Health Survey, published
> in the journal Pediatrics in 1997, found that 54 percent
> of parents of preschool children gave them a vitamin or
> mineral supplement at least three days a week.
>
> 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).
>
> While reactions to vitamins, minerals and essential oils
> occurred at similarly low levels when people took the
> recommended amounts, adverse reactions linked to the
> recommended levels of herbs, homeopathic products and
> other dietary supplements accounted for 10.3 percent of
> all reactions to those products reported to the poison
> centers about three times the level seen for most drugs.
>
> 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. 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.
>
> 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.
>
> 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.

[Brentb]

capmack@shipper.com wrote: <snip>
>
> 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.
<snip>

Given the fact that millions are "asymptomatic" with a
borrelia infection there's a very good chance that these
vitamins (namely D and C which are associated with
antimicrobial activity) produce a herx reaction which could
easily be termed an adverse reaction.

Keep in mind these Vitamin D deficiency statistics:

* 32% of doctors and med school students are vitamin D
deficient.
* 40% of the U.S. population is vitamin D deficient.
* 42% of African American women of childbearing age are
deficient in vitamin D.
* 48% of young girls (9-11 years old) are vitamin D deficient.
* Up to 60% of all hospital patients are vitamin D deficient.
* 76% of pregnant mothers are severely vitamin D deficient,
causing widespread vitamin D deficiencies in their unborn
children, which predisposes them to type 1 diabetes,
arthritis, multiple sclerosis and schizophrenia later in
life. 81% of the children born to these mothers were
deficient.
* Up to 80% of nursing home patients are vitamin D deficient.

http://www.newstarget.com/003069.html

With that said good vitamins are the same as food and
allergies do occur. Over 3 million people have an adverse
reaction to peanuts. Do we need FDA oversite for peanuts now?

[Dagu]

capmack@shipper.com wrote:
> While reading this keep in mind that supplement producers
> are not required to report adverse effects of their
> products, as even aspirin produceres are required. This
> looks at adverse effects from another source and likely
> represents a fraction of actual adverse events.
>
> 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, Senator Orrin G.
> Hatch, Republican of Utah, spoke up in their defense.
> Herbal remedies have been on the market for centuries, he
> said, adding: In fact, most of these have been on the
> market for 4,000 years, and the real issue is risk. And
> there is not much risk in any of these products.
>
> 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. And it stated that dietary
> supplements are safe within a broad range of intake, and
> safety problems with the supplements are relatively rare.
>
> 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.
>
> 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.
>
> The number of deaths may be far higher. In April 2004,
> the Food and Drug Administration said it had received 260
> reports of deaths associated with herbs and other
> nonvitamin, nonmineral supplements since 1989. But an
> unpublished study prepared in 2000 for the agency by Dr.
> Alexander M. Walker, then the chairman of epidemiology at
> the Harvard School of Public Health, concluded: A best
> estimate is that less than 1 percent of serious adverse
> events caused by dietary supplements is reported to the
> F.D.A. The true proportion may well be smaller by an
> order of magnitude or more.
>
> The supplements linked to the most reactions in 2005,
> according to the poison control centers, were ordinary
> vitamins, accounting for nearly half of all the reports
> received that year, 62,446, including 1 death. Minerals
> were linked to about half as many total reports, 32,098,
> but that number included 13 deaths. Herbs and other
> specialty products accounted for still fewer total
> reports, 23,769, but 13 deaths. Essential oils were
> linked to 7,282 reports and no deaths.
>
> 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.
>
> But most other types of herbs and specialty supplements
> also appear in the annual report. In 2005, the poison
> centers received 203 reports of adverse reactions to St.
> Johns wort, including 79 hospitalizations and 1 death.
> Glucosamine, with or without chondroitin, was linked to
> 813 adverse reactions, including 108 hospitalizations and
> 1 death. Echinacea was linked to 483 adverse reactions,
> including 55 hospitalizations, 1 of them considered
> life-threatening. Saw palmetto was not listed on the
> report.
>
> Injuries to children under 6 account for nearly
> three-quarters of all the reports of adverse reactions to
> dietary supplements, according to the poison centers. In
> 2005, the most recent year for which figures are
> available, 48,604 children suffered reactions to vitamins
> alone, the ninth-largest category of substances
> associated with reactions in that age group.
>
> Major medical groups and government agencies do not
> generally recommend vitamin or mineral supplements for
> children who are otherwise healthy. But an analysis of
> the National Maternal and Infant Health Survey, published
> in the journal Pediatrics in 1997, found that 54 percent
> of parents of preschool children gave them a vitamin or
> mineral supplement at least three days a week.
>
> 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).
>
> While reactions to vitamins, minerals and essential oils
> occurred at similarly low levels when people took the
> recommended amounts, adverse reactions linked to the
> recommended levels of herbs, homeopathic products and
> other dietary supplements accounted for 10.3 percent of
> all reactions to those products reported to the poison
> centers about three times the level seen for most drugs.
>
> 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. 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.
>
> 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.
>
> 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]

capmack@shipper.com wrote:
> While reading this keep in mind that supplement producers
> are not required to report adverse effects of their
> products, as even aspirin produceres are required. This
> looks at adverse effects from another source and likely
> represents a fraction of actual adverse events.

While I haven't had a chance to read Dan Hurley's book, your
comments contain several distortions and omissions. I would
like to address all of these later. Meanwhile, readers should
know that Poison Control reports are seldom based on medical
evaluation, and that most common poison exposures in children
under the age of six result from poisoning by: 1) cosmetics
and personal care products (13.3%), 2) cleaning substances
(10.3%), 3) analgesic (painkilling) drugs (7.4%), and 4)
foreign bodies (7.1%). These figures are directly from the
American Association of Poison Control Centers
[http://www.1-800-222-1222.info/stats/home.asp.] While drugs
make the heavy-hitter list for children (whose "major medical"
impact in year 1998 was 395 times greater than it was for
vitamin products [ref.
http://www.aapcc.org/tessbro/emsc98ph.PDF]), dietary
supplements do not. Obviously, adult poisonings related to
prescription and OTC drugs are many times greater than those
in children, since more adults than children take drugs. More
than 60% of all poisoning fatalities occur in adults between
the ages of 20 to 49, and a substantial percentage of those
are related to prescribed and OTC medications. These data can
be expressed in myriad ways, however placing full emphasis on
absolute numbers for one category of event rather than looking
at the relative differences between two or more categories is
misleading. This is what the drug makers and their PR grunts
in the newsgroups are attempting to cover up.

A few years ago, I posted the following after interviewing the
Washington DC Poison Control Center for a better understanding
of how such reports are filed and what they mean. I believe
reposting those comments in response to the other poster's
"analysis" may be helpful.

TESS (Toxic Exposure Surveillance System) refers to the
database of poisoning reports collected by Poison Control
centers. I contacted Poison Control and interviewed a
specialist to be sure I understood the process. Here is what I
learned. When a person contacts Poison Control, the caller is
surveyed with a few simple questions and a report documenting
the call is created. Naturally, anything ingested within 24
hours prior to the adverse medical event is recorded. If more
than one item is indicated, for instance aspirin and ginseng,
both are catalogued. At this point, things get tricky. Only
one of these products will be identified as representing a
"probable" cause of illness in the report. What is the
criteria for "probable" cause? In most cases, since a caller
does not seek medical care, a medical examination never
occurs. That means in the great majority of cases, about 70%,
individuals are never subject to any type of toxicology at
all. In the absence of such forensics, "probable cause" is
just the call taker's best guess. It is here, in my view, that
Poison Control introduces an unfortunate bias into the
reporting process. When an OTC or prescription drug is taken
in addition to an herbal by a poison victim, though it cannot
be known whether the adverse event results from a chemical
reaction between them, if that is suspected, the tally stroke
is applied to the herbal if the drug is doctor prescribed.
Please read this again. It means that a prescription drug
under such conditions is *assumed* to be unrelated to the
reported medical event, even if the drug has been associated
with such medical events in the medical literature. I find
that quite remarkable. And because of such bias, the following
statistics are all the more alarming. According to Poison
Control, only 2.4% of all human poisoning in the US is
associated with the entire spectrum of dietary supplements. By
contrast, 11.4% of all poisonings are associated with just
**ONE** class of pharmaceutical drug -- the analgesics, or
painkillers, such as aspirin and tylenol. A similar breakout
for the majority of prescription drugs, including depressants,
anti-depressants, antibiotics, beta blockers, blood thinners,
statins, cytotoxics, anorectics, and other drug classes, are
available for viewing in the TESS reporting system online,
which you can see for yourself. A crucial point here is that
any disparity between the two produce classes (pharmaceutical
drugs and dietary supplements) in terms of product safety, are
probably even wider than the data already shows.

What are specific categories of medical impact related to
either drug or dietary supplement poisoning? The largest
subgroup are those individuals experiencing a complication
despite having taken the proper dosage. This group includes
those who experience a potentially serious allergic reaction
that may be fatal or cause organ damage. Another subgroup are
children who become victims by accidental exposure, whereas
children represent at least 50% of all reported poisonings.
Very few accidental poisonings in children are related to a
dietary supplement, and fewer still (in that category) are
fatal. The last group is a set of mortalities resulting from
suicide. Autopsy will usually settle the question in such
cases, whereas it should come as no suprise that prescription
and OTC drugs are frequently the method of choice. By
contrast, the great majority of dietary supplements are so
safe that taking an entire bottle still wouldn't be enough to
kill you. The data shows clearly that pharmaceutical drugs
are several orders of magnitude more dangerous than dietary
supplements, and that regulatory oversight by FDA is largely
ineffective, due to inadequate testing and regulation of
these products. Any call for greater regulation of dietary
supplements by FDA, when the same mechanisms for oversight of
drugs so clearly fails to protect public health, is a product
of industry media efforts asimed at protecting existing
market share.

In summary, the fact that many millions of dietary supplements
are consumed each and every day with only a handful of
mortalities *potentially associated with them* is quite
astonishing. Unless you ignore the medical literature, death
by bee sting (estimated to be about 100 deaths per year -- a
little piece of data quite difficult to nail down, by the way)
is a more serious threat to public health than products
purchased at a health food store. If the drug industry had a
record like this, FDA would have closed its doors long ago,
saving the taxpayer many billions of dollars, not to mention
saving millions of lives.

PeterB

[Gmcarter]

On 18 Jan 2007 16:59:56 GMT, capmack@shipper.com 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.

[spamfree]

On 18 Jan 2007 13:08:09 -0800, "PeterB"
<pkm@mytrashmail.com> wrote:

>Unless you ignore the medical literature, death by bee sting
>(estimated to be about 100 deaths per year -- a little piece
>of data quite difficult to nail down, by the way) is a more
>serious threat to public health than products purchased at a
>health food store. If the drug industry had a record like
>this, FDA would have closed its doors long ago, saving the
>taxpayer many billions of dollars, not to mention saving
>millions of lives.

But what about a cost benefit analysis. The health food store
does virtually no good to anyone who eats a healthy diet and
has reasonable activity. So even one belly ache is too much to
pay, IMHO. Whereas the huge benefit from the modern
pharmacopoea saving countless thousands of lives is well worth
the occasional adverse reaction or even death.

jack

[Peterb]

GMCarter wrote:
> On 18 Jan 2007 16:59:56 GMT, capmack@shipper.com 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.

[Peterb]

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.)

[Peterb]

vernon wrote:
> "PeterB" <pkm@mytrashmail.com> wrote in message news:116921-
> 9275.642255.228030@v45g2000cwv.googlegroups.com...
> >
> > GMCarter wrote:
> >> On 18 Jan 2007 16:59:56 GMT, capmack@shipper.com 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.

[Dr. Zarkov]

capmack@shipper.com 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.

[Mark Probe]

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.

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.

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

[Vernon]

"PeterB" <pkm@mytrashmail.com> wrote in message
news:1169219275.642255.228030@v45g2000cwv.googlegroups.com...
>
> GMCarter wrote:
>> On 18 Jan 2007 16:59:56 GMT, capmack@shipper.com 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.

[capmack]

Flip the coin and substitute "alterblogger" pr terms in the
rightplaces for the below, it works the same. All of this done
without benefit of reading the book and the evidence presented
of course.

>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.

[Gmcarter]

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

[Mark Probe]

Robert wrote:
> "PeterB" <pkm@mytrashmail.com> wrote in message news:116921-
> 9275.642255.228030@v45g2000cwv.googlegroups.com...
>> GMCarter wrote:
>>> On 18 Jan 2007 16:59:56 GMT, capmack@shipper.com 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."

[Mark Probe]

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?

[Mark Probe]

PeterB wrote:
> 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

Like I have said in the past, organized lobbying is something
that needs to be regulated and curtailed. Your article is
somewhat funny, as it makes much ado about a paltry $44M which
is less than $1M per state....

and also at
> www.case.edu/news/2004/3-04/lobbyists.htm.

Like I have said in the past, organized lobbying is something
that needs to be regulated and curtailed.

However, as you customarily do, you are engaging in the
fallacy of special pleading. I want uniform rules for all.
Period. You do not.

Oh, and Hatch OWNED an interest in a supplement company, and
you do know what his son does for a living, don't you?

Talk about undue influence.

>> 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.

Agreed. So do individuals. However, I pointed this out when
you made the claim: The statement that the supplements
industry "strong-armed" the Congress to pass DSHEA,however, is
just ridiculous.

No, it is not ridiculous, and your snipping of that takes my
comments out of context. This editing on your part changes the
meaning of what I wrote and makes it appear that I propose
silencing the companies and individuals. IOW, Petey, you are
intellectually dishonest, which is well documented.

> 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.

No, it would not, Mr. Red Herring.

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.

Screw you with the sponsors bullshit.

>> 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.)

Like I said, you are intellectually bankrupt, and you never
miss an opportunity to prove it.

Note that I made NO personal attack on you until you
initiated it.

[Gmcarter]

On Sat, 20 Jan 2007 08:59:18 -0500, "Dr. Zarkov"
<Ming@Mongo.com> wrote:

>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?

Hasn't the history of failed "free market" bullshit not taught
you anything? No new antibiotics for many common and dangerous
infections, particularly TB, out-of-control pricing for drugs,
devices and diagnostics, narrowing pipelines, failed new drugs
with higher costs and toxicities, physicians prescribing based
on salesmen's bullshit, twisting of scientific data to market
drugs, misleading journal articles, influence peddling, etc.?

[Gmcarter]

On Sat, 20 Jan 2007 16:45:31 GMT, Mark Probert
<markprobert@lumbercartel.com> wrote:

>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.

Who is "we"? The FDA didn't approve this indication until just
the past couple of years.

>> 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.

Evidence abounds but I doubt it will ever be
satisfactory to you.

>> 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?

It already DOES a lot of it--then hands over the discovery to
industry where they subsequently rape the public.

They should do MUCH more and the NIH budget greatly expanded.
Science and health outcomes should be the first order of
business, not profit.

Reining in costs up and downstream in the discovery process
would further facilitate this. As it is, the hideous tangle of
patents for everything from PCR to drugs has stymied research
and added undue burden to costs while further limiting sharing
of data and information among disparate scientists to enhance
discovery.

The private business model has failed absolutely.

George M. Carter

[Mark Probe]

GMCarter wrote:
> On Sat, 20 Jan 2007 16:45:31 GMT, Mark Probert
> <markprobert@lumbercartel.com> wrote:
>
>> 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.
>
> Who is "we"? The FDA didn't approve this indication until
> just the past couple of years.

My wife and I. I bought them, she took them, thus the we. The
doctor recommended a vitamin which was high in folate for just
the reason you cited. Like you said, the FDA did not get on
board for several years afterwards.

>>> 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.
>
> Evidence abounds but I doubt it will ever be
> satisfactory to you.

When I see it, I will believe it. So far, the evidence is all
conjecture, coincidence, etc.

>>> 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?
>
> It already DOES a lot of it--then hands over the discovery
> to industry where they subsequently rape the public.
>
> They should do MUCH more and the NIH budget greatly
> expanded. Science and health outcomes should be the first
> order of business, not profit.

Agreed.

> Reining in costs up and downstream in the discovery process
> would further facilitate this. As it is, the hideous tangle
> of patents for everything from PCR to drugs has stymied
> research and added undue burden to costs while further
> limiting sharing of data and information among disparate
> scientists to enhance discovery.
>
> The private business model has failed absolutely.
>
> George M. Carter

[Brentb]

Dr. Zarkov wrote:
> GMCarter wrote:
> > "Dr. Zarkov" <Ming@Mongo.com> wrote:
> >>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 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?
> >
> >
> > Hasn't the history of failed "free market" bullshit not
> > taught you anything? No new antibiotics for many common
> > and dangerous infections, particularly TB, out-of-control
> > pricing for drugs, devices and diagnostics, narrowing
> > pipelines, failed new drugs with higher costs and
> > toxicities, physicians prescribing based on salesmen's
> > bullshit, twisting of scientific data to market drugs,
> > misleading journal articles, influence peddling, etc.?
>
>
> The superiority of free markets over government is so
> obvious that government apologists have to resort to that
> sort of unsubstantiated and outright false bullshit.
>
> Where is the evidence for "physicians prescribing based on
> salesmen's bullshit"? Maybe you'd be na=EFve enough to
> prescribe a drug based on a sales pitch, but physicians are
> far too sophisticated to do so. And most physicians have
> been exposed to sales hype so often and for so long that
> they are not about to let it affect their judgment.
>
> Considering what a disaster government has been in others
> areas (eg, the "War on Drugs"), what possible reason is
> there to believe that more government intervention would do
> any good in this area?
>

Really bad example. The war on drugs is not about a caring
gov't trying to protect it's citizens. It's about the fact
that pot is a really good drug for many symptoms such as pain,
nausea,glaucoma,etc and infringed on the profits of BigPharma.
That is why it's illegal. I'm for gov. funding if and only if
they can get out of BigCorps influence.