Rense: Death Sentence for Dietary Supplements

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Misty L. Trepke

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Death Sentence for Dietary Supplements

31 July 2003

by Wyn Snow, Managing Editor

http://www.supplementquality.com/editorials/Senate722.html

 

Senate bill 722 is like using a nuclear bomb to catch Sadaam

Hussein: It might work, but the cost is too high because many

innocents would be killed as well.

 

The consequences of this proposed legislation (S.722) are

unacceptably severe. It would introduce massive inefficiencies in

both government and industry, and would not be an effective use of

taxpayer money. It is also likely to remove important supplements

that consumers rely on from the marketplace, not just the riskiest

ones, and drive up the cost of those that remain.

 

Just one serious event triggers investigation of safety

 

The report of a single " serious adverse dietary supplement

experience " would enable the FDA to require the manufacturer to

submit safety data on that product. Senate 722 then gives the FDA

the authority to decide whether that safety data is adequate. If

not, the supplement would be removed from the marketplace.

 

Getting safety data sounds like a good thing. Who wouldn't want a

dietary supplement to be safe? Especially when reports of athletes'

deaths associated with ephedra hit the headlines every year. But

this bill ignores the fact that all supplements are already required

to be safe—by existing laws and FDA regulation—and that most

supplements have a better safety record than FDA-approved drugs,

both prescription and over-the-counter.

 

The underlying purpose of S.722 is to move the burden of proof from

the FDA (to show a supplement is not safe and must be removed from

the marketplace) to the manufacturer (to show a supplement is safe

and can continue to be available to consumers). However, its

methodology hands the FDA a blank check for removing any supplement

it chooses from the marketplace. Given the FDA's continuing hostile

stance on supplements (as shown in its 400-page preface to newly

proposed good-manufacturing-practice regulations), it is safe to

predict that safety criteria would be set excessively high, and

ephedra would be only the first of many supplements to be banned.

 

No scientific proof of causality needed

 

Senate 722 defines an " adverse dietary supplement experience " as a

negative health experience that is associated with, but not

necessarily caused by, a dietary supplement. A " serious " adverse

dietary supplement experience is one resulting in severe

consequences—such as death, hospitalization, and anything involving

pregnancy, including premature labor and low birth weight (which

affect 11% and 8% of the USA's 4 million annual births,

respectively).

 

Thus, any hospitalization or low-birth-weight baby becomes a serious

adverse experience if the patient was taking a supplement—regardless

of whether that supplement had anything to do with the reason for

hospitalization or the baby's condition. Perhaps an elderly woman

falls and fractures a hip. Perhaps a youngster develops bone cancer.

Perhaps an alcoholic's liver succumbs to cirrhosis. Perhaps the

mother smokes.

 

Bill would create massive piles of paperwork

 

Roughly fifty percent of Americans take dietary supplements of one

kind or another. Half of those needing hospitalization are likely to

take supplements—creating at least 17 million such " serious adverse

experiences " per year.

 

Senate 722 would require each of these serious experiences to be

reported to the FDA and would require both the manufacturer and FDA

to investigate the event. This in itself would create a mountain of

paperwork making Mt. Rushmore look like a molehill, but S.722

doesn't stop there. The bill would also require manufacturers to

report all the non-serious adverse experiences as well—and this

mound of paperwork could easily outweigh Mt. Everest.

 

All this for a simple fishing expedition—as Perry Mason might have

described it. The FDA cannot possibly want all this paper clogging

the in-boxes and file cabinets of its personnel. What it really

wants is a " smoking gun " —which S.722 provides by defining a single

serious adverse experience as the threshold for requiring safety

data. Senate 722 also makes it easy to get a single serious adverse

experience for any dietary supplement on the market today.

 

The real issue is ephedra

 

The real issue behind Senate 722 is made clear by the testimony

surrounding it: The FDA wants to remove ephedra from the

marketplace, and so far has been unable to do so. Scientific

studies, all relatively small, have not found significant

differences in rates of adverse events between groups of people who

take ephedra and those who don't.

 

Experts agree that supplement safety ranges from the exceptional

(such as vitamin C) to the questionable (such as ephedra, anabolic

steroid precursors and others). But is creating a new mound of

paperwork the best way of addressing the challenges posed by ephedra?

 

We say no. There are better uses of the $10 million that S.722 would

appropriate.

 

Scientific research preferable to mounds of paperwork

 

Ten million dollars could fund a lot of scientific research into

ephedra safety—which would apply the money directly to the problem.

Large-scale research projects could establish whether ephedra is

safe when used as directed by healthy people, or causes serious

health problems for some otherwise apparently healthy people. Given

the quantities of people who are clamoring to continue using

ephedra, it would be easy to find many volunteer study subjects! A

similar process could be applied to other supplements that are

determined to be " high risk " through some scientifically-based

process.

 

Let's focus on the real problem

 

In conclusion, the current system works well for 98 percent of the

supplements in the marketplace. Senate bill 722 would create a

mountain of paperwork, place excessive burdens on supplement

manufacturers, and allow the FDA to use unduly high and arbitrary

criteria for deciding that a supplement was unsafe and cannot be

made available to consumers.

 

A better use of limited funds and resources is enforcing existing

laws and regulations (taking action against shoddy manufacturers and

sleazy marketeers)—and finding scientific answers to questions

raised when a specific supplement is associated with an unusually

high incidence of serious adverse events.

 

Call, write or fax your Senators today to oppose Senate bill 722.

 

[Editor's note: We will soon compile a summary and commentary on all

the features of Senate bill 722.]

 

Sources

 

Agency for Health Care Policy and Research. " Table 1. Statistics for

1996 HCUP Nationwide Inpatient Sample, by multi-level CCS diagnosis

(principal diagnosis only), Hospital Inpatient Statistics, 1996. "

Healthcare Cost and Utilization Project (HCUP).

www.ahcpr.gov/data/hcup/his96/table1a.htm.

 

Senator Durbin. " Senate 722: Dietary Supplement Safety Act of 2003 " .

108th CONGRESS, 1st Session.

 

TeacherVision.com, Ask the Editor. " What percentage of live births

yearly in the United States are premature? " Website

TeacherVision.com. www.teachervision.com/askeds/8-2-00askeds.html.

 

Washington State Department of Health. " Compared to U.S., Washington

has fewer low-birth weight babies, higher death rates due to suicide

and Alzheimer's. " 15 November 1999.

www.doh.wa.gov/publicat/99_news/99-97.htm.