Fwd: FW: POLITICAL ACTION ALERT: Copy of Letter to Sen.Schumer on Supplement Safety Act

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Fri, 28 Nov 2003 16:48:04 -0900

Sandy Mintz

FW: POLITICAL ACTION ALERT: Copy of Letter to Sen.Schumer on

Supplement Safety Act

" Sandy Mintz (Sandy Mintz) "

 

From Arnold Gore:

 

Below is a letter outlining and summarizing the presentation we made. I

handed to Mr.Towbman at the meeting, in case he wants to refresh his memory.

Which at this point I doubt, unless there is a FLOOD of calls to

Sen.Schumers office.

 

Consumers Health Freedom Coalition

 

720 Fort Washington Avenue New York, NY 10040

212-795-6460

 

November 23, 2003

Senator Charles Schumer

757 Third Avenue

New York, NY 10017

Attn: Michael Towbman

 

Dear Senator Schumer:

 

I would like to urge you to reconsider your co-sponsorship of the Supplement

Safety Act S.722. A review of the actual data on the incidence of adverse

reactions to dietary supplements shows the problem to be extremely small.

This bill tries to deal with a problem that is in reality so small as to be

a statistically random error.

The American Association of Poison Control Centers' (AAPCC) annual reports

document the incidence of reported adverse events associated with Dietary

Supplements as well as other exposures causing injuries and death. The

latest annual report for the year 2002 listed the following statistics

associated with deaths from ALL vitamins 2, from electrolytes & minerals 5,

amino acids 0, herbs and botanicals 3 (of which 2 were from formulas

containing ephedra in combination with other herbs and 1 having ephedra as a

single ingredient) and 1 unknown supplement or homeopathic. This was a total

of only 11 for all supplements. Major adverse events were all vitamins 64,

electrolytes and minerals 69 and all herbs, botanicals and other dietary

supplements 195 for a total of 328. This was reported in the American

Journal of Emergency Medicine Vol.21, no.5, pp 406-407 & 409-410-September

2003-see enclosures. The figures for prior years are similarly low. The 2002

report even showed a decrease in deaths of 42% from a total of 19 deaths and

294 major adverse reactions reported in the American Journal of Emergency

Medicine Vol.20, no.5,pp.439-440 and 442-443,September 2002. see enclosures.

The report is available on the website of the AAPCC www.aapcc.org

 

While no death is unimportant, these figures demonstrate that the problem of

safety is very small compared to FDA approved prescription drugs which the

Journal of the American Medical Association, vol. 279,no.5:1200-1205,April

15,1998 estimated to result in 106,000 deaths and 2.2 million adverse

reactions resulting in hospitalization. These were not the result of

overdoses or errors, but from prescriptions correctly prescribed and

dispensed and taken as directed. Since this study only included in-hospital

cases it is an underestimate of the extent of the real problem with FDA

approved prescription drugs. If the Congress and the FDA are concerned with

safety, prescription drugs offer a major opportunity for improvements.

Placing restrictions on the safer dietary supplements, sometimes used as

alternatives to prescription drugs can only exacerbate the extent of the

real problem.

 

The strength of the connection to even those very few instances of adverse

reactions is not very well established. The FDA press release of February

28,2003 " HHS Acts to Reduce Potential Risks of Dietary Supplements

containing Ephedra " stated that the RAND report called such cases

" sentinel events, " because they may indicate a problem exists, but do not

prove that ephedra caused the adverse event. Their report recognized that

such case studies are a weak form of scientific evidence.

 

Ironically, one of the compelling reasons why consumers and patients prefer

to use supplements is the relative safety and lack of serious side effects

and complications attributed to prescription drugs. Presently supplements

are much cheaper than prescription drugs, if this bill is enacted many

supplements may be removed from the market since it provides that " . if

1(one) or more serious adverse events indicate that a dietary supplement

..appears to present a significant or unreasonable risk of illness. " it can

be removed.Sec,416 (d)(1). This is a very draconian power to give to an

agency that has shown suspicion and hostility to the use of dietary

supplements. Even if the supplements stay on the market or are returned to

the market, the price will be considerably greater as happened with

L-Tryptophane. This inexpensive sleep aid and anti-depressant was removed in

1989 when a contaminated batch of a new genetically engineered formula was

imported and caused several deaths. This cause was scientifically

established and reported in major medical journals. Nevertheless the product

was removed and brought back as a much more expensive prescription drug.

This is the same FDA that used supposed safety concerns to oppose

re-importation of cheaper drugs to limit competition. You saw through it

that time.

 

Under current law the FDA has authority to remove genuinely dangerous

supplements. I hope you seriously reconsider the wisdom of this proposed

legislation and support the DSHEA Full Implementation and Enforcement Act

S.1538 sponsored by Senator Tom Harkin which addresses the safety issue.

This less arbitrary standard gives FDA authority to remove a supplement if

it " presents a significant or unreasonable risk of injury " . In view of the

very good safety record, this is a reasonable criterion to meet if millions

of consumers are to be denied access to a supplement..

 

Consumers are afraid these increased costs will be used to increase prices

and decrease competition by pricing smaller manufacturers out of the more

competitive dietary supplement market. I hope you will recall that when

DSHEA was passed in 1994, there were more letters to congress on this single

issue than any issue since the Saturday Night Massacre of Watergate in 1973.

When signing the bill President Clinton praised the Congress for assuring

the rights of health conscious consumers to have access to supplements and

to be given truthful information about the product. This law should not be

overridden just because the FDA and the drug companies seek to limit

competition from cheaper supplements in the face of Court cases upholding

the law.

Sincerely,

 

_____________

Arnold Gore

9 enclosures

 

Sandy Mintz

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" Eternal vigilance is the price of liberty. " - Wendell Phillips (1811-1884),

paraphrasing John Philpot Curran (1808)