Just three years since an Ohio salesman started selling penis enlargement pills out of a spare room in his house, his company is raking in more than $200 million a year on unproven palliatives for virtually every malady of the middle-aged middle class.
There's Enzyte, his original product for "natural male enhancement," and Avlimil, its female equivalent. Dromias is for insomnia, Altovis for fatigue. Numovil fights memory loss and Rogisen, deteriorating vision. Rovicid is supposed to lower your cholesterol.
Is there a diet pill? Don't be silly.
In the early days, Steven Warshak pitched his penis pills in cheap advertisements at the back of men's magazines. Now, despite being the defendant in a class-action lawsuit and the target of more than 3,000 complaints to the Better Business Bureau, the company he created has become a thriving phone-order business with an ambitious national advertising and marketing campaign similar to the ones prescription drug manufacturers use to sell their remedies.
"Our ultimate goal is to be the nutraceutical Pfizer, to provide the best dietary supplements and vitamins and minerals and all the naturals that consumers want," Warshak said in a recent interview.
The history of Warshak's company, Cincinnati-based Berkeley Premium Nutraceuticals, demonstrates just how easy it has become to peddle faux pharmaceuticals in today's marketplace. Unlike drugs, which must be proven safe and effective before they can be sold, nutritional supplements are regulated pretty much like any other consumer product. They're legal as long as they don't do any harm, the pills actually contain whatever ingredients are listed on the bottle and the manufacturer doesn't make claims about them that aren't backed up by scientific evidence.
"They can't claim to cure disease, but they can use words that suggest it," said Arthur P. Grollman, a professor of pharmacological sciences at the State University of New York in Stony Brook who has testified to Congress about dietary supplements.
That's why supplement ads often tout products with vague promises to "boost the immune system" or "power up your brain." Its why the TV advertising campaign for Enzyte promises only "natural male enhancement."
Millions of people have seen the television commercials for Berkeley's products. The Enzyte ad features "Smiling Bob," a goofy, grinning everyman who sails through a charmed life with a spring in his step, sinking holes in one on the golf course and returning to "a very happy missis at home" - presumably thanks to what Enzyte has done for his virility.
In the days before Bob, when Warshak was just getting started in the dietary supplement business, his claims for Enzyte were more explicit. He bought ads in the back of GQ and Esquire magazines promising that "over the eight-month program... your erectile chambers, as well as your penis, will enlarge up to 41 percent."
Today most of the company's claims are less specific - but some them still raise legal issues.
Last month, the federal Food and Drug Administration sent Warshak a letter demanding that he stop claiming Rovicid can lower cholesterol and prevent heart disease. The letter also objected to the marketing of Prulato for the prevention of prostate cancer and Rogisen for macular degeneration, an eye disease that leads to blindness.
This March, the law firm Hagens Berman filed a class action suit against Berkeley Premium Nutraceuticals demanding it refund the money of people who bought Enzyte, and pay compensatory and punitive damages.
"Defendant continues to engage in unfair, deceptive and fraudulent promotions and advertising by propagating a claim of 'male enhancement' that is no less misleading than its former, explicit claim of penis enlargement," the lawsuit states. The lawyers who filed it declined to be interviewed.
Consumers have lodged more than 3,000 complaints with the Cincinnati Better Business Bureau about Berkeley Premium Nutraceuticals and related corporate entities. Jocile Ehrlich, the bureau's president, said she has never seen anything like the number of consumer beefs Berkeley has generated.
It seems the company has been offering free trial samples of its products and then enrolling those who call for them in a "Value Added Program" that automatically ships a new supply every month, billing the refill to the customer's credit card.
Berkeley press materials describe the automatic shipments as a service to ensure that customers don't miss a dose. The company's position has been that customers are informed of Berkeley's billing policies either when they talk to a customer service representative by telephone or order products via the Internet. If they choose to ignore that fine print, well, caveat emptor. It's no different from what often happens when you sign up for a "free" magazine subscription trial or order a "free" credit report on the Internet.
"When people are buying it they're so excited... all they care about is how quick are they going to get that product in their house," said Mike Spirakis, a customer service guru who joined Berkeley in May and was appointed president of the company in September. Warshak retains the title of chief executive officer.
With the lawsuit to fight and investigators from the Ohio attorney general's office breathing down their necks, the company announced in August that it was suspending the Value Added Program until Spirakis can set up an improved system.
Warshak generally acknowledges that he has made a few mistakes, attributing them to growing pains rather than lapses of business ethics.
"We want to be very consumer-focused and do the right things," he said.
According to the August announcement, Berkeley has reached a deal to sell its products through GNC stores. With more than 5,000 outlets worldwide, GNC prides itself on having "set the standard in the health and nutrition industry."
GNC officials contacted by The Associated Press said they did not have information about the deal, and the August press release announcing the deal has been removed from Berkeley's Internet site.
But according to Spirakis, Enzyte and Avlimil are already being sold at GNC and Berkeley's other 10 products will soon be on the retailer's shelves.
Advertisements for most of Berkeley's newer products don't have the comic value of the 'Bob' spots. Instead, they look and feel a lot like ads for prescription drugs. A casual viewer might not even distinguish an ad for Merck's prescription cholesterol-lowering drug Zocor from one for Berkeley's Rovicid.
That's just because people don't understand what nutraceuticals are, Warshak protests.
"They're not a replacement for pharmaceuticals," he said.
The way he sees it, life has three stages: youth, middle age and old age. When you're young, everything works fine. You don't have to do anything to keep yourself healthy. In middle age, things begin to slow down. And finally, in stage three, real disease sets in. That's when it's time to see a doctor about prescription medications.
Berkeley Premium Nutraceuticals are for the middle stage, before things really go downhill, Warshak explains.
"Stage two is an area where you may not need a prescription for your issue just yet," he said. "But a dietary supplement can help a lot."
While prescription drugs have been proven effective in scientific studies, there is little evidence that dietary supplements like the ones Berkeley sells really do much.
Enzyte, for example, contains the vitamins niacin, copper and zinc; the amino acid L-arginine; and a pharmacopeia of herbs in a 1,000-milligram pill. In clinical trials, some of these substances have helped relieve some men of erectile dysfunction. But those results came at much higher doses than those in Enzyte.
Avlimil, the female sexual enhancement pill and "hormone balancer," contains 11 herbal extracts that have been used by folk healers to boost sex drive, regularize menstruation and relieve hot flashes associated with menopause. But there is not much data supporting their effectiveness. There have been no tests of Avlimil itself, although Berkeley has contracted two Los Angeles physicians to set up a trial.
Suvaril, the weight loss pill, is basically a multivitamin, though not a very potent one.
"None of that's going to do anything," concluded Steven Heymsfield, medical director of the weight control unit at St. Luke's-Roosevelt Hospital in New York City, after hearing a list of Suvaril's ingredients.
Altovis, which is supposed to fight fatigue, is more or less No-Doz with a few herbs thrown in.
Some customers shrug off the lack of scientific support. Leo R. Barrile of New York City swears that Rogisen, which contains generous quantities of zinc, selenium, copper and vitamins A, C and E, has dramatically improved his night vision.
He paid $200 for a six-months' worth of Rogisen and Altovis, the Berkeley pep pill. That's about four times what he would have paid for a comparable supply of multivitamins and caffeine pills, although those supplements wouldn't have exactly the same doses or all of the herbs and extracts in Berkeley products.
"After about a month I saw a decided difference," said Barrile, who is 72 and has diabetes.
It may be that Barrile's vision improved after he started taking Rogisen. But if it did, the improvement was likely due to the placebo effect.
Time and time again, doctors have found that a surprising proportion of medical complaints - especially vague ones such as fatigue, joint pain, stress and the like - can be cured with a sugar pill. A person's mind, thinking help is on the way, enlists the body's own defenses against the malady.
Recent studies have shown that this effect is not just psychological; placebos can produce real physical effects.
In one study, neuroscientists showed that activity in the brain's pain-responsive regions decreased after patients were given a fake pain reliever. Another showed that a placebo caused the brains of patients with Parkinson's disease to release more dopamine, a neurotransmitter that is deficient in people with that illness.
Perhaps Enzyte, Avlimil and the rest of the Berkeley apothecary are working in a similar way.
University of California, San Francisco researchers recently tested the effectiveness of red clover extract - an ingredient of Avlimil - in reducing hot flashes. A supplement company called Novogen funded the research, hoping that its product would prove effective.
UCSF researcher Jeffrey Tice and his colleagues gave one form of the supplement to 84 women, and a slightly different formulation to another 84. A third group of 84 got a placebo.
The researchers found that both forms of red clover extract did indeed decrease hot flashes. But so did the placebo - and it worked equally well.
Because the placebo did just as well as the two forms of red clover, Tice and his colleagues wrote in the Journal of the American Medical Association, "neither supplement had a clinically important effect on hot flashes or other symptoms of menopause."
Representatives of Novogen interpreted the results a different way, calling it "undeniable" that their product reduced hot flashes - which is true thanks to the placebo effect.
As for Berkeley's products, Warshak considers it misguided to talk about effectiveness.
"It's not about whether something works or doesn't work," he said. "It's more about whether it can help or not."
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