Forensic Psychiatry & Medicine - GNC Goes Through Anabolic Angst Before Approving Sale of "Steriod"

GNC Goes Through Anabolic Angst Before Approving Sale of "Steriod"

by Dan Morse The Wall Street Journal, August 16, 1999:A1

"We Have Andro," blares a sign on the door of a GNC store on New York's West 72nd Street. The simple message: Come in and buy the hormone-boosting pills made famous by home-run king Mark McGwire.

But behind the sign is a tale of anabolic angst inside General Nutrition Cos., the nation's largest dietary-supplement retail chain, over whether to sell andro, a legal substance of great consumer appeal but unknown safety and dubious effectiveness.

Last year, with the stuff available at all sorts of rival vendors, GNC franchisees were clamoring to be able to sell it. But the company said no. Then, in April, it said yes.

What changed? Officials of GNC say they discovered new information that allayed their concerns about a substance reputed to raise testosterone levels. Specifically, company officials said in an April 30 memo to their 4,200 stores, their scientific advisers had been swayed by five new sources of information.

No Data

But here are the five GNC was talking about: an article written by a sometime spokesman for an andro supplier; favorable comments by a professor who was doing andro research at Eastern Michigan University, research financed by the same andro supplier; and three papers that didn't address the substance's long-term safety. One of the researchers, Conrad Earnest, says that there is "certainly no data that (a) andro is safe and (b) it has any effect."

The company acknowledges that not all the sources in its memo provided new support to its decision to sell. Still, it points to three factors that did: the Eastern Michigan research, the lack of any reports to the U.S. Food and Drug Administration of andro-related health problems, and its own decision to use warning labels.

This may seem a bit short of high science. But it is more than most of GNC's competitors did, and it says a lot about how hard it is to square solid research with retail pressures in the $14 billion-a-year U.S. dietary-supplements industry. The FDA, in contrast to the rigorous research it requires of prescription medicines, barely regulates dietary supplements at all, thanks partly to a 1994 law that limited its powers. And many sellers of the products, unlike GNC, don't even have an outside scientific advisory board. Fad products come and go, with scant study of whether they are safe, how pure they are, whether they work, or, if they do, what the dosage should be.

Lost Sales

"Initially, GNC did the right thing by taking a stand," says Scott Trappe, an exercise physiologist at Ball State University in Muncie, Ind., and member of GNC's scientific advisory board. "Now I think GNC is just meeting the demands of the public."

Certainly the initial decision not to sell andro was a costly one. Franchisees and the outlets owned by GNC itself (which has just been acquired by Numico NV, a Dutch maker of nutrition products) lost millions of dollars in sales to drugstores, other supplement retailers, online vendors, Wal-Mart and even supermarkets. Nevertheless, says GNC President and Chief Executive William Watts: "Being on the high road made sense ... . It isn't worth any amount of short-term sales to do something that might put the entire brand in jeopardy." Of the company's reversal, he says: "I felt very good about the way our company handled this whole issue."

Andro is short for androstenedione, a substance that occurs naturally in the body, where it is converted into testosterone. Decades ago, the East Germans provided andro to their athletes, along with anabolic steroids. The two are so similarly structured that many scientists simply call it an anabolic steroid, although to be classed as one it would have to be shown to spur muscle growth -- a test it hasn't met so far. Andro's use was eventually banned by the National Football League, the National Collegiate Athletic Association and the International Olympic Committee, but not by Major League Baseball.

Unproven Claims

And it remains a legal over-the-counter substance. By the late 1990s, even before the McGwire disclosure, andro was growing popular in the U.S., viewed as a safer way to build muscles than prescription steroids. But by then, GNC had learned some hard lessons about selling products with unproven claims.

Back in 1969, the Federal Trade Commission accused GNC of making false ad claims relating to tonics and vitamins, a spat that was settled with a consent decree. In the 1984, a federal grand jury in Buffalo, N.Y., charged GNC and three of its executives with trade fraud and violating food and drug laws, based on claims for benefits of a supplement called oil of evening primrose. The company and two executives eventually pleaded guilty to misdemeanor charges, with charges against the third person dropped.

GNC later tangled with regulators over Healthy Greens, made from dehydrated vegetables, which GNC had called "just possibly your best hedge against cancer." And in 1994, GNC signed a consent decree barring it from making claims of lessened hair loss relating to another product.

In early 1998, with andro's popularity in weight rooms rising, GNC sought the opinion of its outside scientific panel about whether to sell the product. But with no data on andro's long-term safety and little on its effectiveness, GNC chose not to carry it. Headquarters even sent threatening letters to a handful of franchisees who tried to peddle it on their own.

Then came Aug. 22, 1998. An Associated Press reporter who had spotted a bottle of andro in Mr. McGwire's locker wrote about it, creating something of a sensation. The slugger defended andro as legal and said that "everything I've done is natural."

Andro manufacturers' sales surged. Few independent retailers or online merchants paused before offering it for sale, despite widely known health concerns about prescription anabolic steroids. Within weeks of the McGwire story, Wal-Mart Stores Inc. had stocked its shelves with andro, sometimes inside its new One Source store-within-a-store sections, designed, in part, to compete with GNC.

Wal-Mart, unlike GNC, doesn't have an outside scientific advisory panel. A spokesman for the mass merchant says its buyers watch for data about problems and rely on advice from their andro supplier. "We're not aware of any scientific data that there are problems with the product," says the spokesman, Mike Maher.

Giant Foods supermarkets were carrying andro even before the McGwire story broke, although today, the chain says that because of recent concerns, it has put the product "under review for deletion from our shelves." Giant is owned by Royal Ahold NV of the Netherlands.

Coming Under Pressure

By the end of 1998, 80,000 shoppers had bought $25 million worth of andro, the Nutrition Business Journal in San Diego estimates. But GNC's top executives were feeling pressure from more than just competitors. Their marketing department, too, wanted to sell andro. And in the field, some franchisees fumed as they were forced to turn away customers, as many as 35 a week.

All the while, manufacturers pressed GNC to get in on the action. They directed their pitches to Donald Smith, GNC's head of retail sales, who told them GNC wouldn't sell andro without scientific support. "It was frustrating," he says. "There were people on the inside wondering and questioning why we weren't doing it."

Collecting material, Mr. Smith saw an analysis written by a spokesman for an andro producer, later published in a magazine called Exercise For Men Only (in an issue that also had a story about tailoring workouts to your zodiac sign). An executive of the producer, Bodyonics Ltd., told Mr. Smith about research it was financing at Eastern Michigan University in Ypsilanti and put him in touch with the researcher there. The researcher, Tim Ziegenfuss, had found that a product he was testing raised testosterone and appeared safe. (Bodyonics is a unit of Phoenix Labs in Hicksville, N.Y., which also owns supplement retailer Great Earth.)

GNC's marketing department took its case to Mr. Watts, GNC's president, who said to bounce it off the outside scientists. "I respect their position," he says. "I respected it enough a year ago to lose a lot of business." GNC sent packets of andro articles to two of its scientific advisers. The two said the data didn't show andro was safe.

But they were willing to speak with other scientists about it, so GNC put the two on a conference call with Dr. Ziegenfuss. He told them he was testing a Bodyonics product called Androstat Poppers, which are taken under the tongue and contain a chemical cousin of andro called androstenediol. He said the Poppers gave testosterone levels a modest boost, in the same range as what a young man might get while rooting for his favorite football team. (As his research progressed, he later put the boost much higher, as much as 98%.)

GNC also spoke with Carlon Colker, a doctor in Greenwich, Conn., who gave andro to men middle-aged men with low libido or low testosterone; they took only one or two doses a week, an hour before sex, and could see for themselves whether it made a difference. At that dosage, Dr. Colker told GNC, any risks were low. The gist of his advice to GNC: "Let's target the old guys," Dr. Colker recalls.

Strong Stuff

Eventually, the outside advisers told GNC that if it sold andro, it should use warning labels. An in-house scientist informed colleagues in a memo that the two had "agreed that it would be acceptable for GNC to sell" andro if warnings were used. The advisers say they left the sales decision to GNC. "There was not a point where we signed off," says one of the two, Washington, D.C., physician Walter Glinsman.

In any case, within days, GNC informed its stores they could sell andro. But it required warning labels saying that males under 18 and women shouldn't take it, that men who did try it should consult a doctor first, and that andro should be "cycled": used for three to four weeks followed by one to three weeks off.

The memo cited five sources of data backing the decision to lift the ban. But four of these sources were part of a packet that had been sent to the two advisers, a packet the advisers said didn't show enough data that andro was safe. Mr. Smith says he cited them because they were part of what generated discussion within GNC, and "so that if a customer comes into a store and asks, 'Why are you now selling it?' Basically we can say, 'Well we now have more information.'"

The sources show just how little was known about andro. For instance, the paper by Dr. Earnest, an exercise physiologist in Aptos, Calif., found only a slight boost in testosterone from andro. "Does it have any effect? You can't say from my study," he says. Another paper GNC looked at was by Dr. Colker, who says of daily use of the supplements: "I don't think anyone can answer the question of whether they are safe in the long term, and effective. It can't be said."

More recent events suggest that GNC can't catch a break when it comes to andro. In June, the Journal of the American Medical Association published the most thorough study of andro so far. Researchers at Iowa State University in Ames studied 30 young men, in good health but not accustomed to weight training. Some did weight training in addition to taking andro during the eight-week study.

There was no sign that andro increased their strength, their muscle mass or their testosterone levels. It did appear to raise estrogen levels (the body's handling of these substances is complex, the researchers noted). And it evidently lowered HDL, the so-called good cholesterol, one reason the researchers said andro might have adverse health consequences.

GNC says the study isn't relevant to its offerings because some of the doses were too high. And Dr. Ziegenfuss says the subjects' sudden burst of weight training could have skewed the results. GNC intends to keep on selling the supplement.

But franchisees are still smarting from its earlier andro ban, which they say the company kept in place far too long. "They lost tons of sales and potential future customers," says Dan Brandt, a franchisee in Washington state. "It's kind of past the time it was hot.... They missed the boat."