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Legislation is working its way through Congress that could put your access to supplements under siege. The supplement industry has been under attack for years and this time the battle is getting serious.

Can you imagine a Federal Agent cuffing you for using a controlled substance? This could be the unintended consequence of legislation that uses the stimulant ephedra and hormone precursors as a Trojan horse for changing the way all supplements are regulated, principally by treating them as drugs rather than foods.

The threat to the supplement industry has arrived in the form of S. 722, a bill introduced to the Senate of the United States at the end of March by Illinois Sen. Richard Durbin. (Should it be passed into law, the bill would become the Dietary Supplement Safety Act of 2003.)

The $22-billion-a-year U.S. dietary supplement industry will be required to report consumer side effects from its products under a bill that Congress passed and President Bush is expected to sign. Could the supplement industry as we know it wither away?

That supplements are foods, not drugs, seems self-evident, but from a regulatory standpoint it wasn’t codified until 1994, when Congress modified the Federal Food, Drug, and Cosmetic Act of 1938 by passing the Dietary Supplement Health and Education Act. It did so in response to a series of proposals made by the Food and Drug Administration that supplement companies felt would have limited the availability of their products to consumers.

“DSHEA has been very successful because it allowed consumers to have more access to products,” says David Seckman, executive director and chief executive officer of the National Nutritional Foods Association, based in Newport Beach, Calif., the largest natural-products trade association. (For the record, NNFA opposes S. 722.) “Second, it provided the framework and statutory authority for the FDA to go ahead and protect consumers from products determined to be unsafe.”

Currently nutritional supplement companies are not required to inform the FDA of side effects, although many do so voluntarily.

Sen. Richard Durbin initially sought more extensive regulation, including safety testing of supplements, when two athletes died after taking the now-banned supplement ephedra. After strong opposition from the supplement makers, Durbin and his cosponsors agreed to limit the measure to the reporting requirements.

The bill wasn’t seriously challenged until the stimulant ephedra became a media buzzword. In fact, Durbin alluded to it, along with hormone-precursor supplements, in the press release announcing S. 722:

“Millions of Americans take dietary supplements every day without any ill effects; in fact some dietary supplements provide consumers with significant health benefits. However … [a] small number of products–primarily stimulants and steroids masquerading as herbal compounds–have proven lethal to consumers.”

Ephedra is clearly problematic, if only because its pharmacological effects are greater, and its contraindications more numerous, than those of most supplements. Increasing the velocity of the discussion was the untimely death, from heatstroke, of Baltimore Orioles pitcher Steve Bechler in spring training, during which time he had been taking a dietary supplement which contained ephedra.

The complicated, potentially interdependent medical factors that likely set off a chain reaction inside Bechler’s body illustrate how the stigma attached to ephedra has caused even the most rational people to disregard science and reach premature conclusions.

To understand why the negative impact of S. 722 could be seismic, consider the unique nature of the pharmaceuticals industry, whose regulatory standards supplement makers would have to meet should this bill pass. On average, researching and developing a drug and then bringing it to market costs half a billion dollars or more. The implications on the supplement industry to meet these same standards would be great to say the least.

© 2006 Garden of Healing. All rights reserved.

QUESTION:

I understand that bioidentical hormones are identical to the hormones the body produces. But aren’t they constructed synthetically? That is, they are not taken from the human body (or is there a ranch somewhere in Montana where they are extracted from humans?).

“Bioidentical” and the word “natural” (as per Suzanne Somers) makes it sound like it’s “safe” estrogen. But if it’s estrogen, it comes with all the possible dangers of excessive estrogen. It seems to be all marketing and driven by the power of the words “bioidentical” and “natural.” No one is saying what they really are and the consumer is misled. Maybe you can do that. Thanks.

ANSWER:

You have good and ample company in your shaky view of bioidentical hormones (and I like your humor about it).

Here’s a stab at clarifying the picture using estrogen as an example.

It may help to use the term “laboratory-manufactured” instead of “synthetic.”

The prescription product Premarin consists of conjugated estrogens extracted from equine sources (pregnant mares). This estrogen is not laboratory-manufactured. It’s “natural” but different from the natural estrogen produced in the human body.

The prescription products Cenestin and Enjuvia are conjugated estrogens that are laboratory-manufactured from plants. This estrogen is derived from natural sources, but is different from the natural estrogen produced in the human body.

Enter “bioidentical” estrogens, which also are laboratory-manufactured from plants (yams and soy), a natural source. In this case, though, the derived estrogen products are identical in chemical structure to the estrogen produced in the body.

For this reason, the body can’t tell any difference between its own estrogen and manufactured bioidentical estrogen.

Your observation is correct: Bioidentical estrogen products would be expected to carry the same risks (and benefits) as the body’s own estrogen. Bioidentical estrogens include estradiol, estrone, and estriol. Bioidentical progesterone is micronized in the laboratory to increase its absorption.

As I noted in a prior column, bioidentical hormones are available in numerous FDA-approved prescription products. An increasingly popular practice is to have bioidentical hormones custom-mixed at a compounding pharmacy. This allows individualized combinations, doses, and preparations.

The interest in bioidentical hormones has surged since 2002. That’s when the Women¹s Health Initiative (WHI) trial was shut down early when Prempro was found to slightly boost the risk of breast cancer, stroke, and blood clots in postmenopausal women.

Prempro is a combination of estrogens and progestin (conjugated equine estrogens and medroxyprogesterone acetate). These hormones are not bioidentical.

There are reasons to hope that bioidentical hormones might pose less risk, but there’s little evidence to support this view currently. Research is needed to compare the various hormone products, doses and forms of administration.

When hormone replacement therapy is prescribed, bioidentical or not, the lowest effective dose should be used and treatment can be stopped once menopausal symptoms subside.

Lastly, it’s important to realize that the body stops making its own estrogen for a reason. To everything there is a season. Menopause is not a disorder, but a natural phase of life.

Richard Harkness is a consultant pharmacist, natural medicines specialist, and author of eight published books.

Richard Harkness, Pharm, CDM, Natural Medicines Specialist

He can be reached at: rharkn@aol.com

© 2006 Garden of Healing. All rights reserved.