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Doctors Develop, Sell 'Active Heart' Vitamin

Posted on: Wednesday, 17 August 2005, 00:00 CDT

Aug. 17--In an unusual and controversial move, two local doctors are selling a heart-health vitamin they developed with a former health food store owner and trainer from New Jersey.

Dr. Harvey Castro of Hellertown, Pa., an emergency medicine specialist in training, and Dr. Luis "Lucho" Tejada of Center Valley, Pa., an interventional cardiologist, are selling the supplement "Active Heart" on the Internet and at several local health food stores.

Although some chiropractors sell vitamins and dermatologists sell creams and face washes, few other area doctors have sold products they created to their patients. Also, the practice can present a conflict of interest if the doctors do not reveal their financial interest to their patients -- something these doctors said they are making clear.

Castro said he wanted the pill for himself and others at risk of cardiovascular disease.

"My Dad passed when I was in medical school. He died at age 45," the 31-year-old emergency medicine resident said. "I was worried I would hit that path at that age."

Although other heart-health vitamins exist, Castro and Tejada said their formula, price and bilingual labels set their product apart. Critics said there's no proof that the Active Heart formula will work any better than the ingredients taken separately, or that the cocktail in the pill is appropriate for all who take it.

"This is a shotgun, irrational formula," said Dr. Stephen Barrett, a retired psychiatrist and national authority on medical quackery who lives in Allentown. "It contains ingredients that won't help and some that have the potential for adverse effects."

Barrett, who takes high doses of niacin and folic acid and modest amounts of B6 and B12 for cardiovascular health after having undergone heart bypass surgery in 1989, said the problems the new pill is intended to correct "should be dealt with individually under medical supervision."

It states on the company Web site that he "earned a Ph.D. from the American Holistic College of Nutrition," a college not accredited by the Commission on Accreditation for Dietetics Education, the American Dietetic Association's accrediting agency.

Passante said CADE is just one accrediting agency nationwide and his credits from the college have been accepted by other institutions.

"I've been in this industry for 30-plus years," Passante said, adding that he has advised people with the AIDS virus and cancer.

In turn, Passante questioned Barrett's opinions on supplements, noting his quackwatch Web site also takes issue with Dr. Andrew Weil, a nationally respected Harvard-educated physician, columnist and authority on alternative medicine.

Castro said he did not know that his partner's college was not accredited by CADE but said he still has confidence in Passante's knowledge. The two met about 15 years ago when Castro was in high school in New York City and worked with Passante at a health food store.

Their company, Vital Complex LLC, was founded in 2004 and uses Passante's home address in Dumont, N.J., which is also the shipping site. The Active Heart Web site www.vitalcomplex.com explains the rationale for the white capsule's ingredients.

Vitamin E, for example, was added at a low dose, the developers explain, because "in excess of normal daily intake may slightly increase the risk" of heart attacks. The cutoff appeared to be 400 international units per day, they said, while Active Heart provides 240 iu a day.

Tejada said the goal was to create one pill to be taken once a day, but with all of the ingredients the pill would have been too big to swallow. So, doctors broke the doses into three and advise patients to take one at each meal or all three at one sitting.

The supplement is not recommended for children or pregnant women without a physician's consent. A disclaimer, required by the U.S. Food and Drug Administration, states the product has not been evaluated by the agency and is not intended to diagnose, treat, cure, or prevent any disease.

Tejada said he recommends Active Heart to all his patients with coronary artery disease but not all with heart problems. "This is mostly for patients with blockages or risk factors: smokers, those with high-cholesterol or a family history," he said. "It is important to tell patients it is not instead of medicines they might need, such as cholesterol medicine."

Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania in Philadelphia, said it also is important -- to avoid a conflict of interest -- for the doctors to tell patients they stand to make money on the sale of vitamins they developed and that other alternatives exist that might be just as good.

Tejada said he does not sell the vitamins in his private practice or at St. Luke's Hospital in Fountain Hill, Pa., where he and Castro both work. Both doctors refer patients to the product Web site and health food stores.

Internet and health food store sites reveal a variety of supplements for heart health, including fish oil, Omega 3 fatty acids, folic acid, CoQ10 and formulas for blood pressure and vascular health, which range in price for a one-month supply from about $8 to $60.

Lehigh Valley heart and lung surgeon Dr. Raymond Singer said there are fewer vitamins in Active Heart than in Centrum vitamins, and the doses are smaller than those commonly found in health food stores.

"The bottom line: A healthy diet consistent with the American Heart Association's recommendations will supply all of the vitamins and nutrients needed for a healthy heart," Singer said.

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Source: The Morning Call, Allentown, Pennsylvania

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