A Supplemental Pitch

Last week, cardiologists at a prominent Arizona clinic began advising patients to try a new, untested dietary supplement that has never before been used to treat heart disease. It’s not just any supplement, the clinic says; it’s a proprietary formula, designed by doctors.

The idea that top medical specialists are offering guidance in the confusing, controversial world of vitamins, herbs and nutritional products is reassuring to many patients. After all, the guidance is coming from graduates of some of our best medical schools, not holistic gurus or health food store clerks.

But there’s a catch. The Arizona Heart Institute has struck a deal with the supplement’s maker, Vital Living, that gives the clinic a share in profits from sales of the supplement, as well as 1 million shares of stock options in the company.

Although Heart Institute officials say the clinic’s 29 cardiologists will not benefit from product sales, the deal and others like it are raising eyebrows among some others in the profession. At a time when nutritional supplements are one of the most contentious issues in medicine, these critics say, doctors’ arrival in the marketplace threatens to undermine the objectivity of one profession that might help consumers sort through the maze of conflicting claims and incomplete science.

“Having a financial interest in a product, however indirect, sets up an inherent bias,” said Dr. Wallace Sampson, professor emeritus at Stanford University School of Medicine and editor of The Scientific Review of Alternative Medicine. “It’s just human nature; you want the product or approach to work out, and that affects your judgment.”

Long gone are the days when a few maverick doctors, such as Andrew Weil and diet guru Robert Atkins, were among the few voices touting the health benefits of vitamins, minerals and herbs. The Arizona Heart Institute effort illustrates the growing involvement of mainstream medicine in the $18-billion-a-year dietary supplement business.

This change in doctors’ attitudes has not escaped the attention of the supplement companies, which are wooing physicians in hopes that they will then sell or recommend their products to patients. Borrowing tactics from the pharmaceutical business, supplement makers are taking doctors to lunch, sending them free product samples and inviting them to “educational” seminars at resort destinations. Supplement sales by doctors have increased about tenfold since 1997, to nearly $200 million in 2001, according to a recent survey by Nutritionbusiness.com, an Internet-based firm that tracks the supplement industry. While no one keeps specific figures, industry executives estimate that about 20,000 U.S. doctors are pitching supplements, more than double the number that were in the business five years ago.

“This is one of the fastest-growing areas in the entire dietary supplement industry,” said Anthony Almada, founder of Imaginutrition, a Laguna Niguel consulting firm that advises supplement companies on product-testing.

While consumers have been swallowing vitamins and other supplements for decades, many doctors paid scant attention to the phenomenon until 1993, when a Harvard Medical School researcher reported that 34% of American consumers had used some form of unconventional medicine, which included everything from herbal remedies to acupuncture to spiritual healing.

Now doctors, like their patients, read reports almost daily about new research findings on nutrition and health. Dozens of large, federally funded trials have been completed on nutritional and herbal supplements; and some prestigious medical schools, including Harvard and Stanford, have established complementary medicine programs.

Yet, many physicians say the marketing claims of the supplement industry are outrunning the research. Federal regulators have cracked down on some supplement makers for false advertising, and many doctors still consider the field to be more snake oil than sound science.

“People need to understand that some supplements are appropriate for certain people; but many are taken needlessly,” said Judith Stern, a professor of nutrition and internal medicine at UC Davis. “When a doctor begins endorsing or selling supplements it puts his or her signature on the products, and I think it begins to legitimize everything, the entire supplement field.”

It’s one thing for a doctor to send a patient at risk for osteoporosis to a market for calcium pills, or send someone at risk of heart disease for omega-3 fatty acid, or fish oil, supplements. There’s good evidence that those supplements can reduce the risk of disease in many people, researchers say, and they’re widely available at pharmacies and grocery stores.

It’s another thing altogether, Stern said, for a doctor to sell patients a list of vitamins, herbs and other formulations for which the science is murky or nonexistent. In just the past few months, for example, large trials of vitamins C and E (for heart disease, cancer), and ginkgo (memory loss) have come up negative: the supplements did no better than dummy pills in improving people’s health or function. Doctors in the supplement business commonly sell these nutrients, in a variety of different blends and combinations, and each recipe behaves differently in the body.

That’s a critical point. Although some ingredients themselves may be well researched, most specific product formulations are not, experts say. “About 99% of the products out there have no human studies backing them up,” Almada said. “None.”

The American Medical Assn. has raised ethical questions about in-office sales of health related products, for this and other reasons. In the AMA’s opinion, the sales can present a financial conflict of interest which undermines the doctor-patient relationship, said Dr. Leonard Morse, chairman of the AMA’s council on ethics and judicial affairs. “The patient may think, ‘If I don’t buy this, the doctor will be upset with me, and it may interfere with my care,’ ” Morse said.

Cardiologists at the Arizona Heart Institute will not sell products out of their offices, the clinic said. They will recommend the product to patients, who can call an 800 number and order it straight from Vital Living, for $49 a month. Only the clinic’s founder and owner, Dr. Edward Diethrich, stands to benefit directly.

Diethrich said the supplement contains ingredients that have been shown to be safe and effective in improving cardiovascular health: omega-3 fatty acids, niacin, and folic acid among them. In a study published this April, for instance, Italian research reported that omega-3 fatty acid supplements significantly reduced the risk of sudden death in people who’d previously suffered a heart attack. “Our patients look to us for advice on supplement usage,” said Diethrich, “and we want to provide them with credible information and options that complement their heart care.”

Doctors who do sell supplements from their office make the same point: Their patients want credible guidance. This is especially true today, when about 80 million Americans are regular or occasional supplement users, said Kent Holtorf, a family physician in Torrance who dispenses a range of dietary supplements to his patients. Providing products from the office enables a doctor to control what patients take, and to make sure the regimen doesn’t interfere with any medications they might be on, these doctors say.

“If I tell a patient to go buy products at the store, I have no idea what they’re getting, how good the product is, or whether they’ll get it at all,” Holtorf said. “If I provide the products, I know my patients are getting the very best there is, and they’re much more likely to use them properly.”

Dr. Ron Rothenberg, who runs a preventive medicine clinic in San Diego, acknowledges that the science is mixed for many nutritional and herbal products. Rothenberg views them as a kind of health insurance. “These are things that cause little or no side effects, when used as advised, and we have good reasons to believe they protect against disease,” he said. Many family doctors, internists and other general practitioners feel the same way, and these are the kind of physicians most likely to get financially involved in selling supplements, said Jeffrey Bland, president of Metagenics, a San Clemente-based firm that is one of the largest supplement suppliers. Although younger MDs who have been more exposed to the study of complementary medicine occasionally sell supplements to patients, most customers are experienced doctors looking to change their approach to patient care, he said.

“These are doctors in their 50s, in their prime, who’ve paid off their school loans, and decide that the things they learned in medical school aren’t working that well,” Bland said. “This business offers them a different way to interact with their patients, and often re-energizes them.”

It’s also a way to re-energize a physician’s profits. Some doctors who sell supplements, Bland says, have become discouraged by the influence of managed care and government health programs that have steadily eroded the fees they receive for treating patients. If patients are going to use supplements anyway, some doctors figure, why not get advice from an MD instead of a clerk at the local health food store--and make a little extra money as well.

There’s little doubt that patients, armed with newspaper articles and information pulled off the Internet, are peppering doctors with questions about supplements. Maureen Cologne, 54, a high school counselor from Rancho Palos Verdes, found Holtorf’s office after many years of searching for an effective treatment for chronic joint pain and fatigue. “I went from doctor to doctor, and they would just do a few blood tests, prescribe a pill, and that was it; it was getting me nowhere,” she said. She now takes about 12 supplement pills a day, including omega-3 fatty acids and feels much better. “I used to crash about 2 p.m. every day,” she said. “Now I don’t.”

Doctors like Holtorf see such improvement as evidence that supplements are the wave of the future, not a passing phenomenon. “Five years from now,” he said, “the AMA will be recommending the same stuff we’re using right now.”

Millions of consumers don’t want to wait. Bree Walker, a former Los Angeles television news anchor who now runs a production company, has been taking a variety of products under the guidance of Rothenberg to build bone strength and maintain overall health. “I may be spending my money to produce expensive urine, but I’m willing to take that chance,” she said. “The Baby Boomers I hang with are all concerned with staying young and healthy, and this may very well help. We are the first generation of guinea pigs, really.”

That’s why doctors’ objectivity and independence are so important, said Stern, the UC Davis researcher. The more physicians get financially entangled with supplement companies, the more likely consumers are to act on faith rather than evidence, she said. Some will make the right choices, like those who began consuming more omega-3 fatty acid supplements years ago. Others could do themselves harm. “Right now it’s still a big uncontrolled experiment,” Stern said.

The Arizona Heart Institute plans to proceed with its experiment slowly. Though it originally announced plans to recommend its supplement to about 175,000 patients, the clinic has decided to start with a group of about 60, and see how they respond. “We’re very confident it’s going to help patients,” said Ken Lind, president of Vital Living, the supplement’s maker. “This product was designed by physicians.”