Politics and Medicine - AER Dietary Supplement Legislation

Author

AER Dietary Supplement Legislation

Jan Drew

2006-09-24, 9:36 pm

Hijacking health freedoms - ACT NOW!!

http://www.lef.org/featured-article...lert_130906.htm

AER Dietary Supplement Legislation

(http://www.lef.org/featured-article...lert_130906.htm) where you
can learn
more and with one Mouse click you can send a form letter to your senators
and congressman against this bad bill.

Jeff

2006-09-24, 9:36 pm

"Jan Drew" <jdrew1374@sbcglobal.net> wrote in message
news:9BGRg.4825$6S3.1150@newssvr25.news.prodigy.net...
>
> Hijacking health freedoms - ACT NOW!!
>
> http://www.lef.org/featured-article...lert_130906.htm

Thanks. I will let my senators know that I want them to vote for this
legislation.

You have repeatedly talked about how there is not enough oversite for the
drugs. Are you saying that there should be less oversight for adverse
reactions for supplements? If so, this is clearly a double-standard. I mean,
going against this bill is like saying the supplements work, but we should
try to see if they are safe or not. In fact, this is a chance for you to
support that they are safe.

I really like the legislation.

In addition, the legislation requires adverse event reporting for
nonprescription drugs.

I think this is a good idea.

Thanks for pointing this out. I will definitely contact my senators and
representative to support this bill:
http://thomas.loc.gov/cgi-bin/query/z?c109:S.3546:

Jeff

>
> AER Dietary Supplement Legislation
>
> (http://www.lef.org/featured-article...lert_130906.htm) where you
> can learn
> more and with one Mouse click you can send a form letter to your senators
> and congressman against this bad bill.
>

PeterB

2006-09-25, 4:28 pm

Jeff wrote:
> "Jan Drew" <jdrew1374@sbcglobal.net> wrote in message
> news:9BGRg.4825$6S3.1150@newssvr25.news.prodigy.net...
>
> Thanks. I will let my senators know that I want them to vote for this
> legislation.
>
> You have repeatedly talked about how there is not enough oversite for the
> drugs. Are you saying that there should be less oversight for adverse
> reactions for supplements?

We already have decades of Poison Control data demonstrating the
remarkable safety of dietary supplements (the same data that shows
increasing harm caused by pharmaceutical drugs.) We don't need more
ineffective regulatory oversight by FDA at taxpayer expense. DSHEA
requires FDA to prove an unreasonable risk of harm from dietary
supplements, and FDA has only implemented 2 bans over the past 12
years, the most recent being ephedrine (though it is still available in
hundreds of OTC products sold by the drug companies.) In light of HRT
and Vioxx, let's put any additional funds to better use by cleaning up
the agency and improving oversight where it's most needed (ie., the
drug companies.) We can start by making it illegal for the drug makers
to fund any portion of FDA's budget (currently more than 50%), and
other corrupt practices.
[vbcol=seagreen]
> If so, this is clearly a double-standard. I mean,
> going against this bill is like saying the supplements work, but we should
> try to see if they are safe or not. In fact, this is a chance for you to
> support that they are safe.
>
> I really like the legislation.
>
> In addition, the legislation requires adverse event reporting for
> nonprescription drugs.
>
> I think this is a good idea.
>
> Thanks for pointing this out. I will definitely contact my senators and
> representative to support this bill:
> http://thomas.loc.gov/cgi-bin/query/z?c109:S.3546:
>
> Jeff
>

Vernon

2006-09-25, 4:28 pm

PeterB

2006-09-25, 4:28 pm

Vernon wrote:
> "PeterB" <pkm@mytrashmail.com> wrote in message
> news:1159205824.251725.141610@i42g2000cwa.googlegroups.com...
>
>
> But, but, but. If "controlled" substances are dangerous and resulting in
> deaths, even WITH controls, surely those substances that have no control
> MUST be controlled.

Good rendition of a logical fallacy (you might get recruited yet.)

Jeff

2006-09-25, 9:33 pm

"PeterB" <pkm@mytrashmail.com> wrote in message
news:1159205824.251725.141610@i42g2000cwa.googlegroups.com...
>
> Jeff wrote:
>
> We already have decades of Poison Control data demonstrating the
> remarkable safety of dietary supplements (the same data that shows
> increasing harm caused by pharmaceutical drugs.)

We do? Evidence pelase.

> We don't need more
> ineffective regulatory oversight by FDA at taxpayer expense.

We have basically no regaulatory oversight of the supplement industry.

Tracking adverse events seems to be a good start.

> DSHEA
> requires FDA to prove an unreasonable risk of harm from dietary
> supplements, and FDA has only implemented 2 bans over the past 12
> years, the most recent being ephedrine (though it is still available in
> hundreds of OTC products sold by the drug companies.)

Because there were no data to make decisions on.

> In light of HRT
> and Vioxx, let's put any additional funds to better use by cleaning up
> the agency and improving oversight where it's most needed (ie., the
> drug companies.)

I totally agree that these are good moves. In fact, the National Academy of
Sciences came to the same conclusions.

> We can start by making it illegal for the drug makers
> to fund any portion of FDA's budget (currently more than 50%), and
> other corrupt practices.

I support this as well.

I also support the idea of the FDA tracking adverse events of
nonprescription drugs, as is seen in the bill, as well.

Jeff

Eric Bohlman

2006-09-26, 2:33 am

"PeterB" <pkm@mytrashmail.com> wrote in
news:1159205824.251725.141610@i42g2000cwa.googlegroups.com:

>
> We already have decades of Poison Control data demonstrating the
> remarkable safety of dietary supplements (the same data that shows
> increasing harm caused by pharmaceutical drugs.) We don't need more

Question for you: how would you evaluate the safety of Vioxx based on
nothing more than Poison Control reports? I can answer it: Vioxx would
come across as completely safe (and I certainly agree with you that that
would be an incorrect conclusion). Back in the reality-based community, it
took some fairly sophisticated studies to determine that Vioxx was, in
fact, fairly dangerous. I see no reason to believe that supplements
(remember that 21st-century supplementation involves consumption of natural
substances in much higher doses than people have been consuming over the
last couple centuries) shouldn't be evaluated according to the same
criteria.

Herman Rubin

2006-09-26, 8:32 am

In article <4MGRg.934$Y24.865@newsread4.news.pas.earthlink.net>,
Jeff <jeff@hotmail.com> wrote:

>"Jan Drew" <jdrew1374@sbcglobal.net> wrote in message
>news:9BGRg.4825$6S3.1150@newssvr25.news.prodigy.net...

[vbcol=seagreen]
[vbcol=seagreen]
>Thanks. I will let my senators know that I want them to vote for this
>legislation.

>You have repeatedly talked about how there is not enough oversite for the
>drugs. Are you saying that there should be less oversight for adverse
>reactions for supplements? If so, this is clearly a double-standard. I mean,
>going against this bill is like saying the supplements work, but we should
>try to see if they are safe or not. In fact, this is a chance for you to
>support that they are safe.

There is both not enough and too much oversight for drugs.
Only under unusual circumstances should the FDA have to
"approve" a drug; however, the manufacturer or seller
should have to provide MUCH more information than now, and
the providing of full information should be an absolute
defense against lawsuits.

The same should be the case for supplements. Most of the
supplements have sound scientific evidence that they MAY
be useful. The FDA now restricts the statements that can
be made, often on the grounds that the consumer could not
understand. Anyone who is willing to let the FDA decide
for him should lose the right to vote; one size does NOT
fit all, and neither the FDA nor the physicians knows
enough to make the intelligent decisions.

>I really like the legislation.

>In addition, the legislation requires adverse event reporting for
>nonprescription drugs.

>I think this is a good idea.

This IS a good idea, BUT can be overdone. How many drugs
have as high a frequency of adverse reactions as peanuts?

--
This address is for information only. I do not claim that these views
are those of the Statistics Department or of Purdue University.
Herman Rubin, Department of Statistics, Purdue University
hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558

PeterB

2006-09-26, 8:32 am

Jeff wrote:
> "PeterB" <pkm@mytrashmail.com> wrote in message
> news:1159205824.251725.141610@i42g2000cwa.googlegroups.com...
>
> We do? Evidence pelase.

Contact PC in Washington. They will be happy to talk to you. Reported
events associated with painkillers alone outnumber similar reports of
all dietary supplements combined.

>
> We have basically no regaulatory oversight of the supplement industry.

Sure we do, it's called DSHEA, and it's one of the few pieces of
legislation that Americans played a huge role in bringing about. It's
also been far more effective than FDA regulation of drugs, unless you
shrug when thousands of people are knocked off by Merck via Vioxx. You
can't intelligently talk about regulation of vitamin pills if you don't
recognize that regulation of drugs is a failure. How can that system
now magically protect you from vitamin C?

> Tracking adverse events seems to be a good start.

It hasn't worked well with pharmaceuticals, with some estimates saying
just 5% of ADEs are even reported. Rather, we have to look at the
actual science documenting toxicity on the basis of dosing -- it's the
only way to define the relative differences between these substances.

>
> Because there were no data to make decisions on.

Bullshit. There were thousands (not just a few dozen) of deaths
associated with ephedrine in OTC products for many years, yet those
products have remained on store shelves even *after* the ban. What
good is any review process if even death isn't enough to apply a ban
fairly across the board? The elephant in the room is FDA favoritism
toward the drug makers, and data isn't the issue. Elimination of
competing ephedrine-based weight loss products was the issue, and now
Big Pharma doesn't have to worry about supplement makers encroaching on
that part of their market share.

>
> I totally agree that these are good moves. In fact, the National Academy of
> Sciences came to the same conclusions.

That's right. And there is no evidence that we need a new layer of
additional bureacracy applied to vitamin pills.

>
> I support this as well.
>
> I also support the idea of the FDA tracking adverse events of
> nonprescription drugs, as is seen in the bill, as well.

It won't matter if FDA tracks aliens across your bedsheet, and history
proves me right.

PeterB

PeterB

2006-09-26, 4:31 pm

Eric Bohlman wrote:
> "PeterB" <pkm@mytrashmail.com> wrote in
> news:1159205824.251725.141610@i42g2000cwa.googlegroups.com:
>
>
> Question for you: how would you evaluate the safety of Vioxx based on
> nothing more than Poison Control reports? I can answer it: Vioxx would
> come across as completely safe...

Says who? With new information on the danger of Vioxx even after a few
weeks, your argument is tenuous, at best. As for evaluating a drug on
nothing more than Poison Control reports, who said that PC data can be
used to derive a risk-adjusted analysis? My reference to PC data is
simply to show the relative differences in side effects between drugs
and supplements (plus a big disparity in deaths, which is one helluva
side effect.) Obviously, drugs require a far more strenuous set of
protocols before being approved, and PC data just amply demonstrates
that fact.

> (and I certainly agree with you that that
> would be an incorrect conclusion).

No one made that conclusion but you.

> Back in the reality-based community, it
> took some fairly sophisticated studies to determine that Vioxx was, in
> fact, fairly dangerous.

It also took a whistleblower, or had you forgotten?

> I see no reason to believe that supplements
> (remember that 21st-century supplementation involves consumption of natural
> substances in much higher doses than people have been consuming over the
> last couple centuries) shouldn't be evaluated according to the same
> criteria.

The reason they shouldn't be evaluated using the same criteria is
because the body evolved to metabolize nutrients, not drugs. As to
your point about supplements providing higher amounts of nutrients than
people have been consuming for several generations, it's a non
sequitur. Your genes are the product of nutrient synergies at work
*millions* of years ago. Even today, you don't take in the same
quantities of any nutrient, and your ancestors were far more likely to
experience huge variations in nutrient intake, due to the struggle to
even find food. The body has a huge capacity to metabolize wide
variations in nutrient intake, otherwise you wouldn't be here now.

PeterB

Herman Rubin

2006-09-26, 4:31 pm

In article <Xns984A5D10602ebohlmanomsdevcom@130.133.1.4>,
Eric Bohlman <ebohlman@omsdev.com> wrote:
>"PeterB" <pkm@mytrashmail.com> wrote in
>news:1159205824.251725.141610@i42g2000cwa.googlegroups.com:

[vbcol=seagreen]
>Question for you: how would you evaluate the safety of Vioxx based on
>nothing more than Poison Control reports? I can answer it: Vioxx would
>come across as completely safe (and I certainly agree with you that that
>would be an incorrect conclusion). Back in the reality-based community, it
>took some fairly sophisticated studies to determine that Vioxx was, in
>fact, fairly dangerous. I see no reason to believe that supplements
>(remember that 21st-century supplementation involves consumption of natural
>substances in much higher doses than people have been consuming over the
>last couple centuries) shouldn't be evaluated according to the same
>criteria.

The studies that Vioxx use was somewhat dangerous, and
I would not call it fairly dangerous, were not at all
sophisticated. Every drug has risks and benefits, and
it should be the consumer, not the FDA, to balance them.
The alternatives to Vioxx also have their risks, including
one which would be unlikely to show up in a test at this
time, higher susceptibility to bacterial or viral infection.

As for much higher doses, before 1500 Europeans had not
eaten corn, green or chili peppers, lima beans, tomatoes,
potatoes, and many others. The recommendation by those
who have studied antioxidants for various foods and
extracts for those substantially exceed what people were
able to get before the 20th century.

The recommendations for calcium and vitamin D keep going
up, and the same for many other food chemicals. I am now
taking moderate megadoses of B vitamins on the recommendation
of physicians. The cost of getting a drug approved by the
FDA runs to hundreds of millions of dollars; could we get
fish oil or green tea extract approved at those prices?
Could we get the amount of vitamin D now recommendend in
Finland for young children past the FDA? Yes, there are
dangers, and older children suffered from big overdoses.
--
This address is for information only. I do not claim that these views
are those of the Statistics Department or of Purdue University.
Herman Rubin, Department of Statistics, Purdue University
hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558

PeterB

2006-09-26, 4:31 pm

Herman Rubin wrote:
> In article <Xns984A5D10602ebohlmanomsdevcom@130.133.1.4>,
> Eric Bohlman <ebohlman@omsdev.com> wrote:
>
>
>
>
> The studies that Vioxx use was somewhat dangerous, and
> I would not call it fairly dangerous, were not at all
> sophisticated. Every drug has risks and benefits, and
> it should be the consumer, not the FDA, to balance them.
> The alternatives to Vioxx also have their risks, including
> one which would be unlikely to show up in a test at this
> time, higher susceptibility to bacterial or viral infection.
>
> As for much higher doses, before 1500 Europeans had not
> eaten corn, green or chili peppers, lima beans, tomatoes,
> potatoes, and many others. The recommendation by those
> who have studied antioxidants for various foods and
> extracts for those substantially exceed what people were
> able to get before the 20th century.
>
> The recommendations for calcium and vitamin D keep going
> up, and the same for many other food chemicals. I am now
> taking moderate megadoses of B vitamins on the recommendation
> of physicians. The cost of getting a drug approved by the
> FDA runs to hundreds of millions of dollars; could we get
> fish oil or green tea extract approved at those prices?

That's exactly why you find yourself here arguing the point, Herman.
It's the reason the drug makers were caught trying to fix prices on
vitamins in 1999; it's why they are pushing for regulatory controls
that will unduly burden the supplement makers and drive them out of
business. Support the Alliance for Natural Health in their legal work
to guide Codex using independent science and you won't have to worry
about losing access to nutritional products.

> Could we get the amount of vitamin D now recommendend in
> Finland for young children past the FDA? Yes, there are
> dangers, and older children suffered from big overdoses.

Toxicity from vitamin supplements is virtually unknown. Even Merck
admits that.

> This address is for information only. I do not claim that these views
> are those of the Statistics Department or of Purdue University.
> Herman Rubin, Department of Statistics, Purdue University
> hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558

David Wright

2006-09-27, 2:34 am

In article <1159278962.159623.234030@i3g2000cwc.googlegroups.com>,
PeterB <pkm@mytrashmail.com> wrote:
>
>Eric Bohlman wrote:
>
>
>The reason they shouldn't be evaluated using the same criteria is
>because the body evolved to metabolize nutrients, not drugs. As to
>your point about supplements providing higher amounts of nutrients than
>people have been consuming for several generations, it's a non
>sequitur.

On the contrary, it's highly relevant. If you disagree, do us all a
favor and start consuming about 6 g of B-6 per day for the next few
months. After that, we should be free of your drivel for quite some
time, because you'll be too incapacitated and in too much pain to
operate a computer.

-- David Wright :: alphabeta at prodigy.net
These are my opinions only, but they're almost always correct.
"George Bush is a gruesome boob." -- Bill Maher

D. C. Sessions

2006-09-27, 2:34 am

In message <efbdd2$3q9a@odds.stat.purdue.edu>, Herman Rubin wrote:

> As for much higher doses, before 1500 Europeans had not
> eaten corn, green or chili peppers, lima beans, tomatoes,
> potatoes, and many others.

The most recent word I see suggests that we, as a species, have
only gotten started on adapting to dietary cereals, and we've
been cultivating *them* for several thousand years.

I know I'm risking the Attack of the Celiac Sprue Brigade.
Well, I'll take the chance.

--
begin signature.exe
A:_Because_it_messes_up_the_order_in_which_people_normally_read_text.
Q:_Why_is_top-posting_such_a_bad_thing?
A:_Top-posting.
Q:_What_is_the_most_annoying_thing_on_usenet?

Jan Drew

2006-09-27, 2:34 am

"David Wright" <wright@l1000.prodigy.net> wrote in message
news:wvlSg.4948$TV3.1742@newssvr21.news.prodigy.com...
> In article <1159278962.159623.234030@i3g2000cwc.googlegroups.com>,
> PeterB <pkm@mytrashmail.com> wrote:

PeterB" <pkm@mytrashmail.com> wrote in message
news:1159278962.159623.234030@i3g2000cwc.googlegroups.com
>
> On the contrary, it's highly relevant. If you disagree, do us all a
> favor and start consuming about 6 g of B-6 per day for the next few
> months. After that, we should be free of your drivel for quite some
> time, because you'll be too incapacitated and in too much pain to
> operate a computer.
>
> -- David Wright :: alphabeta at prodigy.net
> These are my opinions only, but they're almost always correct.
> "George Bush is a gruesome boob." -- Bill Maher

Mark Probert

2006-09-27, 4:30 pm

PeterB wrote:
> Jeff wrote:
>
> We already have decades of Poison Control data demonstrating the
> remarkable safety of dietary supplements (the same data that shows
> increasing harm caused by pharmaceutical drugs.)

Petey, you seem to be the resident expert on Poison Control date, etc.
Are you aware of any collection system where the myriad of poison
control centers are able to pool their data?

We don't need more
> ineffective regulatory oversight by FDA at taxpayer expense. DSHEA
> requires FDA to prove an unreasonable risk of harm from dietary
> supplements, and FDA has only implemented 2 bans over the past 12
> years, the most recent being ephedrine (though it is still available in
> hundreds of OTC products sold by the drug companies.) In light of HRT
> and Vioxx, let's put any additional funds to better use by cleaning up
> the agency and improving oversight where it's most needed (ie., the
> drug companies.) We can start by making it illegal for the drug makers
> to fund any portion of FDA's budget (currently more than 50%), and
> other corrupt practices.
>
>