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FOR THE RECORD:
CortiSlim —An article in Tuesday's Section A about a Federal Trade Commission lawsuit against the makers and promoters of the diet supplement CortiSlim implied that the companies had claimed the pill prevented cancer. That claim was made about a related product called CortiStress, which has since been pulled from the market.

To some, the pitches have become as obnoxious as Sit 'n Sleep's "You're killing me, Larry" spots. But to people desperate to shed pounds, Cynaumon's mellifluous voice is like a siren song:

"It's not your fault that you're overweight," he intones. "Drop 15 to 50 pounds quickly and keep it off for life."

More than a million people have plunked down $50 for a month's supply of CortiSlim, which is sold over the phone, on the Internet and in drugstores nationwide, making it one of the decade's most successful infomercial ventures.

But if it's true that CortiSlim soothes stress, then the guys who created the beige capsules should be gobbling their product by the fistful.

After hauling in more than $200 million, CortiSlim honchos find themselves besieged by government investigations, lawsuits and revelations of criminal pasts.

The Federal Trade Commission has sued the individuals and companies behind CortiSlim — headed by Window Rock Enterprises Inc. of Brea — for saying their pills help people lose weight or prevent cancer. Such promises "fly in the face of reality," the FTC said.

CortiSlim officials deny the allegations, but until the lawsuit is settled, they've agreed to retool the ads.

As the profits continue to roll in, critics say the case shows how easy it is for dubious merchandise to skirt consumer fraud regulations, particularly after a 1994 law that eased restrictions on over-the-counter health products.

"A lot of companies know the FTC will come after them," said Thomas Haire, editor of Response magazine, which covers the infomercial industry. "They put the dollars for an FTC settlement into their budget."

The saga of CortiSlim involves a Mormon opera singer, two ex-convicts, a toy inventor and a chunk of tree bark.

It all started with an e-mail.

Two summers ago, Cynaumon, a silver-tongued former police officer who recently was fined by the state of California for falsely claiming to be a psychologist, ran across a slim paperback called "The Cortisol Connection."

The book, written by a former nutrition advisor to the Utah Jazz basketball team, outlined the link between stress and obesity. Cynaumon dashed off an e-mail to the author. Is it possible, he asked, to convert the book's message into a pill?

Inside a cluttered, windowless office at the University of Utah, author Shawn Talbott read Cynaumon's note and grabbed a telephone.

"I told him the recipe for such a product could already be found in my book," recalled Talbott, a part-time nutrition professor with a doctorate in nutritional biochemistry from Rutgers University. "But he wanted me to formulate and endorse a specific product."

A deal was soon hammered out. Cynaumon, whose career path includes stints as a Christian talk radio host, toy inventor and pitchman for the Phonics Game, would be the official spokesman for the new product. And his Yorba Linda company, Infinity Advertising Inc., would book the radio commercials.

Talbott, who previously created an arthritis tablet for a division of Nabisco, signed on as scientific expert and pill designer. A Montana company was hired to make the tablets, a blend of herbs, minerals and chemicals.

Ultimately, though, everything fell under the control of Taiwanese-born entrepreneurs Stephen Cheng and his elder brother, Thomas, whose infomercial companies — Window Rock and Pinnacle Marketing Concepts, respectively — had collaborated with Cynaumon on a previous product.

Within weeks, Talbott's concoction was developed, bottled and being hawked on radio and TV. "I used to tell my students, 'If you come to me with a formula for a nutritional supplement, we can get you into business next week.' It's that easy," he said. In hindsight, Talbott wishes he'd moved more slowly: "I probably should've done a little more checking into people's backgrounds."

At first, nothing seemed amiss. In August 2003, Cynaumon test-marketed a batch of CortiSlim ads on Christian radio. TV infomercials followed, airing on the Discovery Channel, TNT and other outlets.

The format was a fake talk show — a common tactic for infomercials — hosted by Cynaumon and opera singer Jonelle Goddard, a former Miss Utah, who was in the 1989 teen film "Hot Times at Montclair High." Their guest was Talbott.

Seated on rented furniture in Stephen Cheng's house, the trio gushed about CortiSlim and fielded phone calls from "viewers" who claimed to be watching the show even though it was prerecorded.

"Stress causes you to overproduce a fat-retaining hormone called cortisol," Cynaumon said in one ad. CortiSlim "controls cortisol, so you release those excess pounds."

CortiSlim's phone lines were bombarded.

Hits are rare in the infomercial universe. Of the 10 new infomercials that surface each week, nine vanish almost instantly, said John Kogler of Jordan Whitney Inc., a firm that tracks the industry.

Window Rock rolled out a sequel called CortiStress. The claims for the second pill were even more sensational. In an infomercial linking cortisol to cancer, heart attacks, strokes, diabetes and Alzheimer's, Cynaumon asked Talbott how long people should take CortiStress to keep their bodies "nontoxic."

Talbott replied: "You take CortiStress for as long as you want to have good health."

(The FTC says no research exists to back up the claims for CortiStress. Window Rock has pulled the pill from the market.)

The theory behind the pills is rooted in science. When a person experiences physical or psychological stress, the adrenal glands secrete a hormone called cortisol, which sends a jolt of energy to the brain and muscles.

Excessive cortisol "can have a range of damaging effects throughout the body," including weight gain, said Robert Sapolsky, a neurology and biology professor at Stanford University whose book "Why Zebras Don't Get Ulcers" was praised by Talbott as "perhaps the best" work on stress physiology.

The question is whether the ingredients in CortiSlim — such as green tea extract, magnolia bark, calcium and bitter orange peel — can regulate cortisol or burn fat.

Sapolsky is skeptical: "In my more than 25 years of research in this area, I've never seen a single study published in a peer-reviewed journal about any of these compounds, or seen any evidence that they've struck any serious scientist in the business as worth more than two seconds of thought before being dismissed as nonsense."

The people involved with CortiSlim have been scrutinized as well. Cynaumon, 49, is the most visible.

In 1987, while working as a decorated vice and narcotics detective in the Buena Park Police Department, he was fired for falsifying information in an arrest report, according to court documents. Cynaumon sued to be reinstated but dropped the case after the city sealed his personnel file and listed resignation as the reason for his departure.

Cynaumon said that if he hadn't altered details in the arrest report, a confidential informant might have been killed.

After leaving the police force, Cynaumon obtained a doctorate in psychology from Sierra University, a correspondence school that was later shut down by the state of California. He parlayed the degree into a talk show gig on local Christian radio station KBRT-AM (740).

Since then, he has devised a slew of products, including a Dr. Laura Schlessinger game sold by Hasbro, a "Left Behind" game based on the popular Armageddon novels and a proposed dream-interpretation phone line patterned after the Psychic Friends Network.

Not everything on his resume appears to check out. In media interviews dating to 1992, Cynaumon has identified himself as a psychologist or therapist, although he was licensed as a psychological assistant. In October, two state boards fined him $1,000 for misrepresenting his credentials.

"I was wrong and I flat out made a mistake about the terminology," Cynaumon said in a telephone interview (he answered other questions by e-mail). Of course, paying fines isn't as serious as serving time in federal prison.

In 1996, Window Rock President Stephen Cheng and his brother, Thomas, were arrested by undercover U.S. Customs Service agents for importing 100,000 bootleg CDs of concerts by the Beatles, the Grateful Dead, Dave Matthews Band, Bob Dylan and others.

"They were the largest distributors of bootlegs in the U.S.," says attorney Brian Phillips, who prosecuted the case in Orlando, Fla. "They were savvy, focused entrepreneurs."

After their arrests, the brothers cooperated with U.S. Customs to set up a sting at Disney World that nabbed 11 more bootleggers. Thomas was eventually sentenced to 21 months in prison for conspiring to sell unauthorized concert recordings; Stephen got 15 months.

"They made a mistake, they paid their time … and I believe they are now trying to run a legitimate, legal business," said Beth Ley, a Minnesota nutrition author who met the Chengs three years ago and has worked with Window Rock.

Stephen Cheng realizes some people will see the criminal record and assume the worst about his motives for CortiSlim. His response: "They don't know the whole story."

In an interview at the Wild Artichoke restaurant in Yorba Linda, the soft-spoken 31-year-old reflected on his arrest, his childhood and how the death of his mother indirectly led to CortiSlim.

After graduating from Brea Olinda High School at age 15 (he skipped fifth and sixth grades), Cheng was attending UCLA when his brother asked for help with his "music business."

"I didn't know it was illegal," Stephen said of bootlegging.

Reminded that his brother had been arrested in California in 1991 on suspicion of bootlegging recordings of U2 and Depeche Mode concerts, Cheng says, "Now that you mention it, I think he was. I don't remember the details; I was at UCLA then."

Thomas Cheng didn't return messages requesting comment for this story. The Recording Industry Assn. of America says its records indicate the 1991 case was dropped.

"People make mistakes," Stephen Cheng added. "Truly, that chapter of my life was one I learned from. I developed a lot of character and it made me grow up."

After prison, the brothers invested in the stock market, Stephen Chang said. Then, in 2000, their mother was diagnosed with lung cancer. "I kind of lost my motivation to do anything," he said. "I just took care of her."

As the disease progressed, Cheng decided to enroll in cooking school. His mother gave her blessing. "She wanted me to have a happy life."

Two weeks after she died in February 2002, Cheng said, his older brother again asked for help with a business venture. Thomas wanted to market coral calcium, which was being touted as a purported cure for cancer and heart disease.

Ley, the nutrition author, said Thomas Cheng was motivated by frustration with conventional medicine's inability to help his mother. "He heard about coral calcium and wanted to know why the public didn't know about it."

Stephen Cheng felt torn. The coral calcium proposal "was not my natural choice," he said. "But I told my brother if we could help one person, it would be worth it. That's what our mom would have wanted us to do. That's the story people don't know and don't want to believe."

Coral calcium's heyday was short-lived. The biggest promoter was infomercial mogul Kevin Trudeau, whose claims for the substance ran afoul of government regulators. In June 2003, federal marshals raided Trudeau's operation, and the Food and Drug Administration sent cease-and-desist letters to 18 other coral calcium marketers. The Chengs weren't among those targeted.

Scrambling for a new signature product, the brothers teamed with Cynaumon to introduce Career Genius, a kit to help people get a raise within 90 days. It included a "raise quotient" test and lessons on how to become "indispensable" to your boss.

The infomercial, hosted by movie critic Michael Medved, flopped. But as Career Genius stumbled, CortiSlim was in the pipeline. Introduced in August 2003, the diet capsule was an instant hit.

Eight months after CortiSlim's debut, the FDA began nosing around Window Rock's concrete-and-glass headquarters in a Brea office park, demanding proof for the company's weight-loss claims. Around the same time, an Irvine company sued Window Rock for patent infringement.

The case, which was settled out of court in May, revolved around tree bark. Bob Garrison of Next Pharmaceuticals Inc. says his company owns exclusive rights to use magnolia bark for cortisol-related weight loss. Neither side would discuss terms of the settlement.

Last July, a New York law firm filed a class-action suit against Window Rock on behalf of 16 CortiSlim users who alleged that the pills either didn't work or caused them to gain weight. Window Rock denies the charges.

Not everyone is critical of the product. Radio personalities Phil Hendrie and Danny Bonaduce gave glowing testimonials for CortiSlim during paid ads on their shows. And clerks at GNC health food stores, which sell CortiSlim, say they have customers who swear by the stuff.

Such testimonials didn't satisfy the FTC. In September, the agency sued Window Rock, Stephen Cheng, Talbott, Cynaumon and Infinity for false advertising. Thomas Cheng and his Pinnacle Marketing Concepts were added to the lawsuit in April. Pinnacle has reached a tentative settlement with the FTC, but the lawsuit is moving forward against the other defendants, said FTC attorney Heather Hippsley.

Like most infomercial companies, Window Rock is tight-lipped about money. But Talbott said documents submitted to the FTC showed CortiSlim pulled in $200 million before the end of 2004.

How much of that is profit? Infomercial veteran Trudeau says net income usually runs 10% to 30% of total sales. If so, Window Rock could've pocketed $20 million to $60 million.

It's unclear how the money was divvied up. Talbott, who said he never had a lawyer read his contract, surrendered all rights to his formula in exchange for a "very small royalty" on net profits. "It's not a windfall," he said. "I'm not buying yachts."

Cynaumon apparently fared better. In addition to a royalty, he received commissions for buying radio ads. TNS Media Intelligence, a market research firm, showed CortiSlim's radio budget averaged $1.1 million a month in 2004. If Cynaumon got the standard 15% commission, he would have been earning $165,000 per month.

Cynaumon declined to reveal his income, but says he didn't buy all of CortiSlim's radio ads.

By all accounts, most of the profits are going to the Cheng brothers — Stephen, who controls Window Rock, and Thomas, whose Pinnacle Marketing runs the phone bank and TV infomercial purchases.

Yet Stephen seems miserable. The last three years have been nothing but work, he said: "I haven't had time to grieve my mother's death." Eyes welling, he confided that he never cried after she passed away. He said that he had forsaken longtime hobbies such as rock climbing, and that his dream of being a chef was on hold.

"I don't care about money," he added. "I learned that from the first time [with bootlegging]. As fast as you make money, you lose it, and it means nothing in the end."

So why stay? Cheng said he felt obligated to his employees and business partners.

Cheng declined to discuss his brother, saying Thomas was intensely private. A search of public records and interviews with past and present associates turns up some details: Thomas, 34, is married to a friend's former housekeeper, has two children, lives in a gated community in Fullerton and owns a 33-foot boat docked in Newport Beach.

The FTC lawsuit has caused fallout for the CortiSlim crew. In December, Talbott was forced to resign his university post. "We felt it reflected poorly on the University of Utah," said Wayne Askew, his boss at the school. "He's not a charlatan … but the step he missed was doing a clinical trial to show whether [CortiSlim] worked."

More recently, L.A.'s Fox News reported on the Cheng brothers' criminal past, showing undercover video footage.

Remarkably, CortiSlim sales seem unaffected by the controversy. How can a company sell a diet pill when the FDA and the FTC forbid any claims that the product works?

Easily, said Trudeau.

The original CortiSlim ads "drilled the impression into people's heads that if you take this pill, you'll lose weight," he said. If an advertising message is repeated long enough and loud enough, the impression sticks, even if the ad's content later changes.

For example, Trudeau said: "Finish this sentence: 'Please don't squeeze the — ' " Although the slogan hasn't aired in years, he said, many people have no trouble recalling the missing word — "Charmin."

Hippsley, the FTC attorney, said the new CortiSlim commercials met government regulations. Nevertheless, although the ads make no specific claims, critics say they still imply CortiSlim reduces weight. One new spot brags that CortiSlim was named "product of the year" by Ms. Fitness magazine. Another urges listeners to "step off the scale and into the CortiSlim lifestyle," a program of exercise, diet and CortiSlim pills.

Nutritionist David Schardt of the watchdog Center for Science in the Public Interest said the wording implied CortiSlim was as essential to weight loss as exercise and diet.

Eleven years ago, none of this would have been happening. Before Congress and President Clinton approved the 1994 Dietary Supplement and Health Education Act under intense lobbying pressure, manufacturers of over-the-counter pills and potions couldn't make health claims without FDA approval. Now, the burden of proof has shifted. A product is considered safe and effective unless the government proves otherwise.

The law gave consumers access to herbs and other supplements believed to have health benefits. But it also allowed companies to "say just about anything they want," Schardt said. "Consumers have no way to tell what's true and what isn't."

As the FTC tightens its noose around CortiSlim, ad time has been scaled back and the key players are turning against one another. Window Rock's latest court papers blame Cynaumon for any advertising content that violated FTC rules. Cynaumon, in turn, insisted the Chengs controlled and scripted all CortiSlim ads. And Talbott has hired lawyers to negotiate a separate settlement with the FTC.

Meanwhile, Cynaumon is working on an independent venture, an infomercial he hopes to launch this summer. He describes the project as an EBay for inventors, in which companies can bid on ideas for new products.

So, what advice would he give to a client who approaches him with a new diet pill?

Cynaumon laughed. "I'd ask if they have masochistic tendencies."

Associated Press
Barr Gets FDA OK for Antidiuretic Drug
07.05.2005, 10:48 AM

Barr Pharmaceuticals Inc. said Tuesday that its Barr Laboratories Inc. unit received final approval from the Food and Drug Administration to market generic versions of DDAVP, an antidiuretic marketed by Aventis, now part of Sanofi-Aventis SA.

The agency approved Barr's application to market 0.1 milligram and 0.2 milligram tablets of DDAVP, or desmopressin acetate. Barr said it is launching the product immediately.

Barr filed an application with the FDA for the drug in July 2002, and was sued that December for patent infringement by Aventis and Ferring BV, which makes the drug for Aventis. In February, the District Court of Southern New York found that the patents were unenforceable and not infringed.

The company said that DDAVP tablets had annual sales of about $191 million, based for the twelve months ending in April.

The drug is used to manage central diabetes insipidus, a pituitary gland disorder characterized by intense thirst, and temporary excessive urination and thirst following head trauma. DDAVP is also indicated for the management of bed-wetting.

Barr shares rose 67 cents to $50.59 in morning trading on the New York Stock Exchange.

Posted on Tue, Jul. 05, 2005


Researchers find no link between testosterone, women's libidos

BY MARIE MCCULLOUGH
Knight Ridder Newspapers

PHILADELPHIA - (KRT) - A new study has found that the quality of women's lives in the bedroom has nothing to do with the amount of testosterone in their blood.

This might seem to be bad news for the score of drug companies developing testosterone products in hopes of tapping the estimated $1 billion market for a female counterpart to Viagra.

"Our study is going to frustrate a lot of doctors," said the lead author, Susan Davis, an endocrinologist at Monash Medical School in Australia. Treating female sexual complaints "is not just about giving testosterone. It's far, far more complicated."

But the Australian researchers who conducted the study are not counting testosterone out. While levels in the blood may be meaningful, levels in the brain, bone, and fat - where the hormone can't be measured - may affect the female libido.

"Our results," they conclude, "are not in conflict with testosterone being used ... to treat hypoactive sexual desire disorder" - the new term for women bothered by low libido.

The results do not support testosterone being used, either, Davis said in a telephone interview from Victoria, Australia.

The study, appearing in Wednesday's issue of the Journal of the American Medical Association, is also sure to fuel controversy over the safety and science behind female testosterone supplements - before a single one is approved.

In December, advisers to the federal Food and Drug Administration unanimously voted that Procter & Gamble had not proved the safety of its experimental testosterone patch, Intrinsa. A majority also judged Intrinsa's effectiveness to be unproven in studies, since a placebo also perked up menopausal women's sex lives.

Procter & Gamble is still seeking to market the patch in the United States, Europe and Canada, company officials said Monday.

As for the Australian findings, P&G physician Kathryn Wekselman said hormone levels do not always correlate with symptoms.

"If you look at estrogen levels, you cannot predict which menopausal women will have hot flashes," she said. "So if that (disconnect) was the same with testosterone, it would not be unprecedented."

But while estrogen clearly works for hot flashes, testosterone is unpredictable for women bothered by lagging libidos. In Intrinsa studies in postmenopausal women, for example, patch users had on average one more "satisfying sexual" episode per month, over six months, than women on a placebo; in a second study, the patch made even less difference.

Still, doctors have for decades prescribed testosterone creams and pills to improve female sex drive, particularly in women who have undergone sudden menopause due to a hysterectomy. The FDA permits such "off-label" treatment.

The Australian study involved 1,021 women aged 18 to 75 who completed a questionnaire on sexual well-being developed by Procter & Gamble. (Although P&G did not fund the study, Davis has worked on the Intrinsa research.)

The researchers measured their blood levels of testosterone as well as DHEA sulphate, a hormone produced by the adrenal glands that is converted to estrogen and testosterone.

While the testosterone level was irrelevant to the women's reported arousal, desire, orgasm, and self-image, low levels of DHEA sulphate did correlate with sexual problems in women under 45 and, to a lesser degree, in women over 45.

Nonetheless, the researchers could not say DHEA therapy is a good idea, any more than they could say testosterone therapy is a bad idea.

New York psychiatrist Lenore Tiefer, a critic of the push for testosterone treatment, found that conclusion illogical.

"The one thing that does emerge is that DHEA may be useful," said Tiefer, a sex therapist. "But DHEA is an over-the-counter dietary supplement, so there's no money in it" compared to prescription products.

Tiefer speculated that since testosterone is relatively difficult and expensive to measure in the blood, drug companies may welcome the new evidence that measuring it is pointless.

"The companies are going to spin this to say, `Now we have proof that you don't need to measure testosterone,'" Tiefer said. "The companies want women to go directly from having subjective (sexual) distress to getting the product - no diagnosis, no workup."

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© 2005, The Philadelphia Inquirer.