A ‘Natural Product’ Plots Its Course for Mainstream Acceptance
The new product was launched earlier this year in a fashion typical of top-notch pharmaceuticals: Fourteen years of studies, $25 million spent on research and development, 30 clinical trials ongoing worldwide and a $5-million marketing campaign featuring nationally known doctors as spokespeople.
Only this is not a typical medication.
Promensil, which was introduced in the United States in April, is a so-called “natural product” for the relief of menopausal symptoms. Classified as a dietary supplement, it is sold without a prescription at about $26 for a one-month supply.
And it’s a sign that alternative health products are, slowly but surely, beginning to look a lot like mainstream treatments.
“There is clinical research behind this product,” says Elinore White, a New York City publicist working for Novogen, the Australian maker of Promensil. “They want to be seen as a serious, science-based company with science-based products.”
Made of red clover that contains estrogen, Promensil has the purported benefits of alternative products (no prescription, natural, mild) while addressing conventional medicine’s acknowledged failure to help more women with the discomforting symptoms of menopause.
The most common remedy for menopausal symptoms such as hot flashes and insomnia is hormone replacement therapy. But surveys show that many women are loath to take hormones because of side effects or fears about safety.
“Many menopausal women and the physicians who are treating them are looking for safer alternatives,” notes a recent report on herbs for menopause in the Journal of Women’s Health.
Soliciting Support
Surveys show menopausal women have a keen interest in natural products, such as licorice, black cohash, dong quai and ginseng. But the real test for Promensil, says Novogen Chairman Graham Kelly, was gaining credibility with health professionals.
The company asked leading gynecologists in the United States to test Promensil before introducing it here.
“The downside of being a natural product is that we get lumped into the category where there are a lot of less-than-ethical companies operating,” said Kelly. “If we are going to have the long-term support of doctors, we have to present ourselves in the right light. But there is no reason why natural products can’t have important health benefits and gain the support of doctors.”
One of the physicians solicited to test Promensil is Dr. Lila Nachtigall of New York University, an authority on menopause. Until this product came along, she said she routinely steered patients away from alternative health products.
“My answer to patients usually was that there [are] no scientific studies, no quality control and no FDA approval, so side effects don’t have to be reported. This is the first time I do feel comfortable with an alternative product. It does look really good,” she said.
Clinical studies done in Australia attest to Promensil’s effect, Kelly said. American studies are still being conducted. But, unlike hormone treatments, Promensil did not need--and does not have--Food and Drug Administration approval of its safety and effectiveness.
Clearly, even the most credible-seeming alternative treatments require a leap of faith.
Says Nachtigall: “I hope I don’t discover I’m wrong about this.”
