EmailEmail
PrintPrint
Weighing In: FDA often has been naysayer
Sunday, January 29, 2006

1930s -- A concoction to fight endogenic obesity, called "Marmola," consisted primarily of thyroid, and was sold without a prescription.
1993 -- Jogging in a Jug, a cider vinegar product

Click photo for larger image.

More Coverage:

Shop Smart: A trim life through surgery

FDA panel approves Glaxo weight-loss drug (01/24/06)


ROCKVILLE, Md. -- In the long history of nonprescription diet pills, the Food and Drug Administration often has played the heavy.

Public health concerns have prompted FDA to seize scores of over-the-counter diet products through the years. Not unlike the collective girth of the nation, the task of policing the market seems never-ending, especially considering the forces that have produced so many diet schemes over the years.

"People can make money, so greed is an element," said John Swann, an FDA historian who maintains a collection of seized products dating back to the early 20th century. Manufacturers keep trying because "hope is always there" for dieters, added Mr. Swann, an avid consumer of weight-loss history who plans on writing a book on the subject.

After a committee vote last week, FDA seems poised to take a more positive role toward at least one nonprescription weight-loss product. Committee members endorsed an effort by GlaxoSmithKline to sell an over-the-counter version of Xenical, a prescription weight-loss drug that blocks the absorption of fat.

The vote was big news in Moon, where the company's consumer products division is based. It also represented a breakthrough of sorts in a business littered with evidence of bad intentions.

Standing in the artifact room of FDA's History Office last week, Mr. Swann detailed a history replete with warnings and product seizures -- regulatory actions against everything from a cider vinegar product called Jogging in a Jug to the RelaxAcizor, a fat-jolting device.

Thin wasn't always in.

At the dawn of the 20th century, the concept of a desirable body was shifting away from the more robust vision of the Victorian era. For women, beauty became synonymous with the thin athleticism of flapper girls during the 1920s.

January 1968 -- Life Magazine cover featuring a story on the dangers of diet pills.
Click photo for larger image.

The emergence of diet pills accompanied the shift, and no one was better poised to make a buck selling them than Edward Hayes.

A businessman in Detroit, Mr. Hayes knew a lot about marketing nostrums from his experience selling "manhood restorers," products that purported to help men suffering with everything from insufficient erections to "hastiness" -- premature ejaculations.

A competing product went by the name Make-Man tablets.

At the time, people believed obesity could be caused by either endogenic or exogenic factors -- either internal problems with glands and hormones, or external factors such as eating too much and not exercising, Mr. Swann explained.

Mr. Hayes, the Detroit businessman, marketed Marmola, a concoction to fight endogenic obesity. It consisted primarily of thyroid, and was sold without a prescription at a strength comparable to that used by people with thyroid disorders.

Taking thyroid at such a strength raised safety concerns, Mr. Swann said, but the FDA was powerless to take action because diet pills were considered cosmetic products, not drugs. The 1906 Food and Drug Act, which empowered the FDA and its predecessor agencies, didn't create a way for the government to easily regulate the diet pills as drugs.

Only with the passage of the Food, Drug and Cosmetic Act of 1938 -- sort of a Make-Man tablet for regulators -- did the FDA have the power to banish Marmola from the market.

The 1938 law was passed in response to a variety of horror stories involving loosely regulated products, including diet pills. In the early 1930s, for example, companies began selling weight-loss formulations with the active ingredient dinitrophenol, or DNP. The chemical boosted metabolism, but was linked to a variety of serious ailments.

Despite doctors' efforts to keep the drug in the prescriptions world, there were roughly two dozen products containing DNP in the nonprescription market by late 1934. One carried the name Formula 281, pronounced "Formula Too-Weighty One" in ads. The maker of another product called Redusols spent $4,000 per month on advertising to promote a drug that cost $3 for a 30-day supply -- a typical price for products, Mr. Swann said.

Ultimately, weight-loss products containing DNP were banished by the FDA following the 1938 law.

The most recent chapter in the history of nonprescription diet pills -- Glaxo's effort to sell a lower-dose version of Xenical -- has considerably more science behind it than these early efforts. The profit potential continues to be a factor, however, with company officials saying this week that they expect 5 million to 6 million people per year would purchase the over-the-counter product, if granted final approval by the FDA.

Sold under the name Alli at about $55 for a starter kit, the drug could be one of the company's biggest over-the-counter products in North America with sales revenue that would exceed what the drug company Roche has been seeing in recent years with prescription Xenical. The drug had sales in the United States of $102 million in 2004, according to IMS Health.

The intertwined histories of finance and fat seem, at first sight, an unlikely subject of interest for Mr. Swann. A trim man with glasses, he seemed professorial in a black shirt and herring-bone sport coat as he walked around the FDA History Office's one-room collection of artifacts.

Reaching inside a tall metal cabinet, Mr. Swann pulled out what appeared to be a black attache case, laid it flat on a table with a thud and snapped open two white clasps. He opened the briefcase as if to display tidy stacks of money for an illicit exchange, but the contraband inside is the Figurelite, a device the FDA seized in 1964 due to safety concerns.

An electrical pulse generator, the Figurelite has a cord for plugging the device into an outlet, and a set of pad electrodes for applying electrical impulses to the body. The manufacturer claimed that users could lose as much as one inch of girth in a 30-minute session.

"The idea here was, you would take these pads, attach them to where you wanted to loose weight -- hips, buttocks, arms, chin, whatever -- and apply electrical stimulation," explained Mr. Swann. Next he pulled out a 110-volt RelaxAcizor, a device that worked on the same principle and was the subject of a public health warning in the 1970s.

While he finds the devices interesting, Mr. Swann tries to limit himself to the history of diet pills.

His curiosity in the subject was piqued early in his FDA career when a family from Oregon called to learn about "rainbow pills," a colorful mix of prescription drugs including amphetamines, barbiturates, diuretics, thyroid and digitalis that were dispensed by doctors to dieters during the 1950s and 1960s. Use of the pills ended in controversy, due in part to the finding of an Oregon coroner that several deaths could be linked to the use of the drugs.

But there's also a practical reason Mr. Swann tries not to look beyond pharmaceuticals.

"There's an endless supply of material, I'm sorry to say," he said. "I'm trying to write a book about the history of diet drugs, and there's just too much."

Even an FDA-approved weight-loss product may not stem the tide of quick-fix diet schemes.

First published on January 29, 2006 at 12:00 am
Christopher Snowbeck can be reached at csnowbeck@post-gazette.com or 412 263-2625.