fda

[Guest guest]

Grayce,

I found this after my last e-mail:

Regards,

Tom

Consumers Health Freedom Coalition 720 Fort Washington Avenue New York, NY 10040

October 29, 2003 Sen. Hillary Clinton US Senate Washington, DC

20510

Dear Senator Clinton:

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

Safety Act S.722. A review 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 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 much greater for 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 RAND 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. Even these low numbers could be attributed to random errors in

reporting from the millions of supplement users.

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 established and reported in major medical journals. Nevertheless

the product was removed and brought back as a much more expensive prescription

drug.

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.

9 enclosures (The attachments were copies of pages printed out from the Poison

Control Reports)

Sincerely,

Arnold Gore

Remember Ann is NOT A Doctor and has NO medical training.