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Viagra Boom Spurs Wave of Quack Products

By: Source: AARP Bulletin Today Date Posted: 2003-06-20 12:30:49

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An ages-old deceptive practice—the bilking of men who are impotent or concerned about their sexual prowess—is roaring back to life, riding the wave of popularity of the legitimate and sensationally successful drug Viagra.

The development has prompted the Federal Trade Commission (FTC), the consumer watchdog agency, to issue a "red alert," advising men to be on their guard.

Potential victims include many of the 30 million men over 40 who suffer some form of impotence and choose, usually out of embarrassment, to buy questionable products by direct mail or through the Internet instead of seeking treatment by a physician.

In the biggest case of its kind so far, involving some 150,000 customers, the FTC has charged one company with selling a potion with a Viagra-sounding name but no proven value from "institutes" and "clinics" that were in fact only mail drops. The agency says the company bilked its victims out of as much as $19 million.

"Fraud is trendy and…impotence is now 'in,' " says Sondra L. Mills, a senior attorney in the FTC's Bureau of Consumer Protection. "It's attracting well-financed con artists."

Although she says the FTC has no way of knowing how many fraudulent operators there are, Mills says her investigations lead her to believe that there are "buckets" of impotence profiteers at work.

And more than money is at risk.

Medical experts warn that impotence—known technically as "erectile dysfunction"—can be a symptom of serious and even life-threatening illnesses and that failure to get a proper diagnosis can have dangerous consequences.

They also warn that men who consume the bogus products may run the risk of harmful drug interactions.

"There are all sorts of negative ramifications of not treating impotence," says John J. Mulcahy, M.D., professor of urology at Indiana University Medical Center in Indianapolis.

PROVEN TREATMENTS AVAILABLE

The irony, physicians say, is that the vast majority of men can now be treated successfully with a variety of approved products and devices in addition to Viagra. That drug, which was cleared for prescription use last March, is the first of a new, ground-breaking class of pharmaceuticals. Taken an hour before intercourse, it acts by improving the penile blood flow needed for an erection.

In its major impotence case, the FTC charges that David A. Brady of Doraville, Ga., operating as the American Urological Corp. and under other names, made false representations in promoting his product line. His products included the sound-alike "Väegra," the "Celldenaphil-pc System" (which is similar to sildenafil citrate, the generic name of Viagra), "Urophil," "Testosterone-21" and "Prosta-Gen," according to the FTC.

In addition to the American Urological Corp., the FTC says Brady sold his products through such scientific-sounding entities as the Institute of Sexual Research Inc., the American Urological Clinic and the New England Institute for Impotence and Prostate Care—all of which the FTC alleges exist in name only, as mailing addresses.

Last August, the agency succeeded in getting a court order temporarily halting the marketing of Brady's products and freezing his assets. That was followed by a stipulated preliminary injunction. FTC is currently seeking a permanent injunction that would prohibit future misrepresentations and allow past customers to gain redress.

Brady's lawyer, Jerome Froelich of Atlanta, says his client "admits to making some mistakes in terms of advertising, but the products themselves are not harmful and may be helpful."

"Taking advantage of consumers seeking treatment for a very personal, potentially serious medical condition is just plain wrong," says Jodie Bernstein, director of the FTC Bureau of Consumer Protection, "[and] the commission is committed to stopping it."

CONSUMER ALERT ISSUED

The agency issued its consumer alert at a conference on impotence sponsored by the National Institutes of Health, the American Foundation for Urologic Disease, Inc. (AFUD) and other professional groups.

The FTC advisory says consumers should consider the following when evaluating impotence treatment claims:

• If the product is advertised as effective for treating impotence but requires no prescription, " forget it. It won't cure the condition. "
• If the product is said to be a " breakthrough, " or " scientifically proven " or is promoted by a " medical organization, " check with your doctor. Chances are it's not legitimate.
• If the product is described as " herbal " or " all-natural, " dismiss it. " To date, " the FTC says, " no 'herbal' or 'all-natural' substance has been shown to be an effective treatment for impotence. "

Non-prescription impotence products of unproven value are widely available and usually expensive, a recent check by the Bulletin shows.

This sampling of products, costing from $15 to $150 and sold by companies other than Brady's, included "an exciting new supplement for men" to "heighten sexual energy, function and desire without expensive drugs or embarrassing doctors' visits"; a rubber "comfortable support sleeve for those times when a man cannot sustain a natural erection"; various mechanical devices; and capsules containing ginseng, yohimbe and bee pollen, among other ingredients.

The indiscriminate use of various alternative therapies—herbal products, especially—has raised red flags with many in the medical community. "Make no mistake—some alternative therapies and herbal remedies are quackery," says Yank Coble, M.D., an endocrinologist in Jacksonville, Fla., who is a member of the American Medical Association's board of trustees. "They're unproven and ineffective. At best—they're a waste of time and money. At worst—dangerous and even deadly."

The FTC's Mills adds: "The appeal of alternative medicine will remain in the future as a major problem [because] many people think nonprescription products work and are safer than prescription drugs."

Ginseng, a root often used in impotence products because it is considered an aphrodisiac in the Orient, may slow the time it takes blood to clot and should not be used by men taking blood thinners, according to Lucinda G. Miller, a doctor of pharmacy who published her findings in the Archives of Internal Medicine. In addition, she says, ginseng should not be used by men with diabetes or those taking the heart drug digoxin.

Yohimbe, which is derived from the bark of a West African tree, is also commonly used in nonprescription impotence products. Doctors say this drug should not be taken by men with a history of kidney problems or ulcers or those taking antidepressants.

Irwin Goldstein, M.D., professor of urology at Boston University School of Medicine, is among the many physicians who believe that embarrassment is the chief reason many impotent men resort to unproven nostrums instead of seeing a doctor.

He stresses that a man with impotence should have a thorough medical exam, during which hidden problems—such as diabetes or heart disease—sometimes are diagnosed and then can be treated. Impotence can be a sign of such life-threatening diseases as prostate cancer, which can be treated successfully if it's caught early.

"We must guard against 'impotence mills,' " Goldstein concludes.

A lack of understanding is another factor that keeps men from seeking proper care.

A recent Louis Harris poll showed that 41 percent of the adults surveyed couldn't name any medical conditions that cause impotence. One in five said psychological problems cause impotence, and 11 percent attributed it to stress.

The facts: Today, most experts believe that while temporary impotence can be brought on by fatigue, illness, stress or "performance anxiety" (as occurs sometimes with a new partner), chronic impotence is attributable to specific physical causes.

Further, they say that although the incidence of impotence increases in older age groups, that is often attributable to disease or drugs taken to treat the disease and that sexual activity need not stop at any age.

Medical science is also providing more and more treatments for impotence when it does occur. This is significant because while Viagra has been proven effective in some 70 percent of cases, in other cases it either doesn't work or its use is proscribed. [See Viagra: Wonderful But… for details.]

Proven treatments for impotence include penile injection therapy, penile prostheses, vacuum constriction devices and psychotherapy or behavioral therapy. The last is for men in whom no organic cause of impotence can be found or who don't want drugs or surgery; it is often combined with other treatments.

One recently developed treatment is the so-called medicated urethral system for erection. It helps induce an erection when a man inserts a drug pellet into the end of the urethra, the tube carrying urine out of the body.

According to the Sexual Function Health Council of AFUD, "The good news for men and their partners is that erectile dysfunction can usually be treated safely and effectively. In light of recent medical advances, men no longer need to suffer from erectile dysfunction in silence, nor must their impotency be a dividing force in their relationships."