‘Natural’ Defense Trapped Metabolife

Dangerous consumer products fall into three general categories. There are the things everyone knows are dangerous but get openly marketed anyway, like cigarettes and power mowers. There are the relatively benign products subject to isolated cases of contamination, whether by nefarious design or otherwise, such as bottles of Tylenol or batches of processed meat.

Then there are products like Metabolife 356, which claim to be safe but about which doubts are growing.

David Brown would no doubt dispute any categorization of Metabolife 356 as dangerous goods. Brown is the president and chief executive of Metabolife International Inc., the herbal products company that collects an enormous share of its revenue and profit from this suspect dietary supplement.

Metabolife 356 is chiefly made of ephedra, a relative of the stimulant ephedrine, and caffeine. During a perfectly cordial hour or so we spent together at Metabolife headquarters in San Diego last week, Brown compared the growing public campaign to ban ephedra to a “witch hunt.”

I had traveled to Metabolife to see how a company handles life in a crossfire largely of its own making. Metabolife 356, which is supposed to promote weight loss by speeding up the body’s metabolism and reducing fatigue, is the company’s bestselling product -- or at least it was until recently.

Now, the public spotlight has fallen on reports of ephedra’s possible links to heart problems and stroke, a situation that has Metabolife complaining about its opponents’ reliance on anecdotal evidence and what it calls “junk science.” That, and a “high-profile event such as the death of an athlete,” as Brown put it.

He was referring to the death in February of Baltimore Orioles pitcher Steve Bechler, who keeled over from heatstroke while working out with a huge dosage of ephedra in his body. From Brown’s standpoint, Bechler’s death was the crowning moment of a long nightmare. (Bechler’s ephedra-caffeine supplement was made by a Metabolife competitor, but its active formula was similar to Metabolife 356.) Sales of Metabolife 356 have fallen off the table, dropping by 30% over the last year, according to statistics compiled nationally from retail bar-code scans. Federal regulators have announced that they’re considering a ban on the compound.

“We’ve taken a big hit,” Brown acknowledges. The company laid off a quarter of its workforce in October, after some big retailers cut back orders for Metabolife 356. Hoping to recover ground, Metabolife has started marketing an “ephedra-free” weight-loss and energy supplement.

The company steadfastly disputes that any hard scientific evidence exists showing a cause-and-effect relationship between ephedra and heart and vascular problems. It maintains that Metabolife 356 is safe and effective “when taken as directed” -- an all-purpose dodge to protect makers of over-the-counter drugs.

But the core of Metabolife’s defense is that people who claim ephedra produces serious adverse side effects are practicing superstition.

“Reason, logic and science have long since left the discussion,” Brown lamented to me.

He did not say who first purged these three desirable attributes from the discussion. The answer is: the herbal supplement industry, which in 1994 persuaded Congress to exempt their products from the pharmaceutical jurisdiction of the Food and Drug Administration. The rationale was that these were “natural” and therefore as benign as jujubes, in contrast to the synthetic concoctions purveyed by Big Pharma.

From the start, critics assailed this as a fanciful distinction. “It does not make sense to say that just because something is natural, it’s safe,” says Sidney Wolfe, director of the health research group of Public Citizen, the Washington-based public interest group. “There are all kinds of poisons that are natural but that are not safe, and this is one of them.”

The FDA exemption -- consistently supported by Metabolife -- has led to the usual absurdities that arise when Congress tries to do favors for special-interest groups. Although the FDA banned prescription and over-the-counter ephedrine-caffeine products in 1983, for example, “herbal” ephedra-caffeine fatigue-beating pills are widely available today at health food shops, convenience stores and truck stops.

Paradoxically, however, the FDA exemption places herbal promoters in a tough corner when their products come under fire. Because the law does not require them to substantiate the safety and effectiveness of their goods and forbids the federal agency from meddling in advance, they seldom have a body of reliable clinical studies at hand to muster in their own defense.

For his part, Brown maintains that “reams of data and clinical support for ephedra and ephedra-caffeine” do in fact exist. In all, Metabolife lobbyists contend, 30 or so clinical studies prove ephedra’s safety and efficacy for weight loss.

But that opinion is far from universally shared in the medical establishment, which considers at least some of these studies to be of shoddy methodology or otherwise inadequate.

The longest study for ephedra’s weight-loss efficacy lasted six months, according to Paul Shekelle, principal author of a recent Rand Corp. survey of the literature. That’s not long enough to prove that the compound’s effects are sustainable over time; to be approved by the FDA, prescription weight-loss products have to undergo clinical trials lasting at least a year.

Even without FDA intervention, ephedra seems to have caused Metabolife a fair amount of grief over the years. Last November, an Alabama jury awarded $4.6 million to four plaintiffs who blamed Metabolife 356 for their heart attacks or strokes. (The verdict is under appeal.)

The company’s handling of consumer complaints led it into another quagmire. In 1998, Metabolife’s co-founder and then-president, Michael Ellis, blithely told the FDA that the company had “never received one notice from a consumer” alleging any serious health problem from Metabolife 356.

But it soon emerged that the company had been receiving complaints via its customer-service phone line for years. Under pressure, Metabolife sheepishly turned over 15,000 complaints, many of which company operators had scribbled haphazardly onto calendars, sticky-pads and scraps of blank paper.

Once deciphered, they were found to include reports of three deaths, 20 heart attacks, 24 strokes, 40 seizures, 465 episodes of chest pain and 966 reports of heart arrhythmia -- enough to lead federal authorities to initiate a criminal investigation into whether Ellis had lied to the government.

The company says it is not a target of the ongoing probe and, in any event, the complaints were so “anecdotal” that they didn’t count as formal reports or as “any evidence of anything.”

Beyond that, Metabolife’s defense of its position often seems to come from the pot-calling-the-kettle-black school of public relations.

Brown hinted darkly that ephedra’s critics are funded by trial lawyers slavering for more big scores. “I’m not a conspiracy theorist,” he says, “but there are politicians who receive tremendous amounts of money from the plaintiffs bar, who also happen to be among our most vociferous critics.”

Yet Metabolife itself is hardly shy about trying to buy influence. According to figures compiled from campaign reports by Dwight L. Morris & Associates, the company has contributed nearly $2 million to federal political coffers since 1997, including $34,250 ponied up to Sen. Orrin Hatch, the Utah Republican who was the co-author and principal sponsor of the FDA exemption.

Despite such efforts, we may today be witnessing the twilight of ephedra.

Brown, for one, sounds like a man who senses the end is nigh.

“It’s simply a pity that negative news and negative media based upon erroneous and misleading information can cause damage to a company and an industry that’s undeserved,” he says, imagining his critics in full gloat. “It’s not like we’re dealing cocaine.”

Golden State appears every Monday and Thursday. Michael Hiltzik can be reached at golden.state@latimes.com.