Pharmacists struggle with their own reluctance, lack of information
Herbals, botanicals, alternatives, homeopathics, phytomedicinals, supplements, naturals. No matter what you call them, the ever-growing boom in consumer use of plant and vitamin-based remedies is working its way into mainstream pharmacy. Consumers are already spending more than $3 billion annually for herbal remedies, vitamins, and supplements. These supplements have become ubiquitous in retail pharmacies for a very good reason: Pharmacists can make $3 to $6 per bottle sold vs. the $1 or $1.50 per prescription they are paid by managed care companies.
With their growing popularity, all pharmacists are struggling with what to tell their customers about these supplements. For hospital pharmacists, this knowledge gap is more acute because their patients have immediate potential for drug reactions or interactions. "The real thing pharmacists are grappling with is the lack of information," says Nancy Jordan, PharmD, BCPS, director of drug information at Holyoke (MA) Hospital, and consulting editor for Drug Utilization Review.
What kind of information? It runs the gamut - from dosing and interactions to an overall sense of what constitutes sound medical and scientific advice. Unfortunately, there are few comprehensive American clinical trials to provide these data.
"The pharmacy department and the P&T committee's job is to review FDA-approved drugs. Now here's a whole other group not going through that process and not even classified as drugs," Jordan explains. (Under Congress' 1994 Dietary Supplement Health and Education Act, herbals fall into the same categories as food.) "A lot of us don't want to get involved with them and don't want to force the pharmacy to dispense a nonapproved drug to an inpatient. We haven't had any physicians writing orders, but the day will come when somebody writes an order, so the pharmacy better have a plan," she says.
Several factors are bringing that day closer. The FDA has finalized a proposal for stricter labeling requirements, which will weed out some dubious herbal manufacturers and increase consumer confidence. Large manufacturers in the alternative medicine industry are also beginning to take measures to police themselves, which will also boost consumer acceptance. While large hospitals are assembling committees to consider the addition of certain botanicals into the formulary, large managed care companies, such as Oxford Health Plan, already are providing alternative therapies, such as chiropractic, and weighing the merits of the coverage and reimbursement on some botanicals.
Pharmaceutical companies are also getting into the act. Warner Lambert has introduced cold remedies with a popular herbal and mineral supplement: Halls Zinc Defense and Herbal Comfort Echinacea throat lozenges. Bristol Myers Squib has contracted with the Italian herbal manufacturer Indena (1997 total sales, $170 million) to supply the drug maker with botanical raw materials, and Bayer is producing its own St. John's wort line - a purported antidepressant - in Germany.
"I think it's really the final evolution of these products, from their beginning at health food stores to chain drug stores and supermarkets, and ultimately now onto the pharmaceutical companies taking a look at a segment of the industry that continues to grow, which more or less validates what we're doing," says Greg Ris, USA vice president of Indena's American operations in Seattle since 1989.
"Right now Ginkgo biloba and St. John's wort are prescribed more in Europe than Prozac, and Saw palmetto more than Proscar," says Michael Murray, ND, a professor of botanical medicine, consultant, and author of A Textbook of Natural Medicine. (For more on ginkgo biloba and saw palmetto, see Drug Criteria & Outcomes, p. 63.)
The key word from Murray is "prescribed." Herbals in Europe have been used longer and are considered more of a viable medical option. Consequently, regulation is tighter there, and much of the clinical testing being reviewed in the U.S. comes from European trials. Botanical companies based overseas now marketing products in America tout European oversight as a basis for acceptance here.
Alternative meds heading for pharmacists
But for all of the above factors, it's the growing consumer demand - fueled in part by the commercial media and word of mouth - that will, most likely and most quickly, land botanical issues in the laps of pharmacists. To prepare for this, pharmacist organizations have begun to include alternative medicine sessions in their programs. The American Pharmaceutical Association included a two-day alternative medicine symposium in its 1998 annual meeting in Miami in March. Also, the American Society of Hospital Pharmacists included similar programs at its midyear conference this past December.
Alternative medicine has also entered the mainstream medical press. American Health Consultants, publishers of DUR, now produces a monthly newsletter on alternative medicine (see story, p. 62). The Journal of the American Medical Association carries a monthly alternative medicine column, as well. The National Institutes of Health has opened an Office of Alternative Medicine. The Austin, TX-based American Botanical Council and the Boulder, CO-based Herb Research Foundation are also providing scientific data, clearinghouse information, and continuing education.
Jordan feels hospital pharmacists can develop their own alternative medicine knowledge by broadening standard medication histories when patients come in. "With all of these herbals we better start asking about them, not just what drugs a patient is on but what remedies they're using," she says. Her point is well taken. A recent study found that while 33% of responding patients said they'd used an herbal remedy in the past year, 72% of them did not tell their doctors.
Because herbal and dietary supplements were designated - and therefore regulated - as food products by Congress, the FDA, the Federal Trade Commission, and the U.S. Department of Agricul-ture have a hand in oversight. But until now, those agencies were only acting on a case-by-case basis. The FDA's new labeling proposal is aimed at requiring standard contents, common and Latin names, and controls on health claims. The action is borne out of June 1997 recommendations by the presidential Commission on Dietary Supplement Labels. The commission also recommended tracking adverse effects and the establishment of a Botanical Ingredient Review Board.
With this FDA action, it becomes less likely that the United Nations and World Health Organization's CODEX Committee on Nutrition and Foods for Special Dietary Uses - which sets "cradle to grave" regulations on vitamins, minerals, and botanicals in 156 countries - will be expanded to include the United States. A comprehensive set of guidelines dating back 30 years, the WHO regs would designate botanicals as drug products rather than food products, allowing for increased FDA oversight.
Will label proposal go far enough?
The current FDA labeling proposal is the most sweeping American action since 1994 and should displace the mostly reactionary government rulings to date. Those include a November 1996 order by the FTC that three makers of chromium-based supplements halt weight loss labeling claims. That was followed more recently by action against products labeled as herbal phen-fen.
In June of last year, the FDA went beyond labeling claims to propose limitations on consumer use of ephedra, or ma huang, after the Chinese herb became widely used as an overall energy stimulant and asthma, weight loss, and cold and flu remedy. Its synthetic counterpart ephedrine is widely used in products like Bronch-aid, for example. The FDA based the action on reports of adverse reactions and the range of extracts available on the market and has proposed only allowing doses of 8 mg a serving, four times a day for only seven days.
That proposal earned the ire of manufacturers, eight of which banned together to form the Dietary Supplement, Safety and Science Coalition in Washington, DC, to lobby against the proposal becoming a final ruling. "That type of dosage would hamper the effectiveness of the product," says coalition member Kristin Battista. "The government realizes this is a fast growing industry, and there needs to be some regulation. But we prefer it to be reasonable and, as they say, based on science. We're happy when the government comes out against herbal phen-fen, but sometimes good companies get lumped in. We also want good regulation but give us a seat at the table," she says.
The FDA took comments on the ephedra proposal through the end of December and is expected to publish a final ruling by this summer. But more recently, the FDA went the other way and praised the science behind the soluble fiber psyllium, made from psyllium seed husks, and will allow labels to state that the botanical can lower total and LDL cholesterol.
Still, Battista's response echoes much of the rhetoric of botanical manufacturers, who see regulation coming and with it the need to police their own industry in order to stave off federal intervention. Many herbalists simply don't think the government - or mainstream doctors or pharmacists - understand or want to understand botanicals.
They know the traditional medical community fears the herbal industry as a financial threat, and they want to avoid confrontation.
"Proposed regulations from the FDA are usually a mixture of good things and problems, born out of misunderstandings based on the nature of herbal products," says Rob McCaleb, president of the nonprofit Herb Research Foundation.
"For example, one of the things we expect the FDA to reverse is an earlier proposal that requires labels to list the extract solvent used in the products. But that extract is removed in drying, so we question the consumer interest. But more than that, listing the solvents could promote the use of lesser extracts if those ingredients were out there from each company," he says, alluding to the proprietary information or trade secrets such labeling requirements reveal.
And that brings up the not so subtle effort within the industry to weed out its dubious elements. "There is the issue of quality," says Ris. "And one of the concerns is borrowed science. Ginkgo, for instance, has different varieties, and many producers claim similar content levels. But if the extracting is from different solvents, you cannot claim the herb will have the same effect as tested products.
"I think testing and trials will improve. There are a number of products with sound clinical data supporting their efficacy, and some fall short in that area. Greater testing will benefit the supplier and the manufacturer. But too often a broad stroke is used to criticize our data, and that's a fallacy."
Indena supplies brands with the herbal raw materials for nine of the most common and highest selling herbals, including St. John's wort, ginkgo biloba, billberry, grape seed, echinacea, and saw palmetto.
The company's literature lists standard extract percentages of the active ingredients in each herb. For example, Ginkgo biloba is listed as a standard extract of 24% ginkgoflavoneglycosides, 6% terpenes, and 5% ginkoic acid, which parallels what some of the FDA labeling will require.
McCaleb at the Herb Research Foundation agrees that standard labeling will help pave the way for increased U.S. trials and greater legitimacy for the industry. "I think there is going to be a race to do these trials. They are expensive, but the FDA has waived pre-clinical work on dietary supplements, and that's a tremendous savings. Those having the money could do a fairly simple trial and have the only American trial, but the value of that would be tremendous. It will also bring up the level of research and scrutiny to help eliminate the opportunists."
In the meantime, progressive elements in the industry are behind standardized labeling contents for the reasons mentioned earlier, as well as others. "Standardization is essentially a sophisticated form of consumer price comparison and allows researchers to assure dose consistency. Our foundation is behind that in terms of consumer knowledge," says McCaleb.
"I think that's the way to go for obvious reasons," agrees Murray. "And I think pharmacists respond more favorably to the whole concept of standardization."