Over-the-counter sales have been banned in Canada, England, and France
Unless a dark horse
appears soon, melatonin will likely be the self-help drug of the decade. Sometimes touted as an anti-aging, sex-enhancing, and anti-cancer agent, it's best known as a sleeping pill and a way to fight jet lag.
Such "miracle" drugs pop up every few years, and our media-driven society quickly popularizes them. But melatonin has a huge following for a number of reasons -- most importantly, its easy availability and cheapness. Sold in drug and health food stores without prescription, melatonin typically costs about $5 a month.
Yeah, but does it work? Generally without side effects except in megadoses (and then, the only side effect is drowsiness -- not exactly a drawback to a sleeping pill), it has an immediately noticeable sleep-enhancing quality for many people. Melatonin, unlike many previously-claimed miracles, seems to deliver. Well, at least on most of the claims. Sorry -- the cancer and sex angles seem likely to be hype.
Dr. Peter Madill, who specializes in neurology and substance abuse, has found melatonin useful for some of his patients with sleep problems. It "definitely but not universally" has worked to produce natural sleep patterns, he says.
"We should be watching the safety data, but I don't think any of the animal studies have shown any real danger," Madill says. What does concern him is the"more is better syndrome," where people assume that if a little bit helps, a larger dose will do more. While waiting for further research on the claims that melatonin may help reduce heart disease and fight AIDS through immune system stimulation, he notes that "the research on animals suggests an anti-aging effect."
Madill would like to see other melatonin research, and proposes that industries that force people to do rotating shift work or to routinely cross time zones should help fund the research. Airlines would be a natural sponsor; he points out that some studies on flight attendants have shown that they age more quickly than people in most other occupations.
But he also wonders who will do further research, since no one could currently profit by doing such studies. You can buy melatonin in health food and drug stores, even in supermarkets -- at least for now. Over-the-counter sales have been banned in Canada, England, and France. Many fear that the FDA will issue a similar ruling in this country.
The company would have a monopoly on "nature's sleeping pill"
If the FDA
makes melatonin a prescription drug, only a company called Interneuron Pharmaceuticals could sell it as a sleep aid. Interneuron is one of three companies that holds patents on melatonin. Because melatonin occurs naturally in food, no one can patent it and gain sole rights to sell it the way a company can patent a synthetic drug it develops. (The other companies are Lilly and Alza, which control melatonin patents that allow them to sell it as an aid in preventing jet lag.)
So an FDA ruling that melatonin could be sold only by prescription would probably make Interneuron and these other companies happy. Providing that Interneuron produces studies proving that Melzone, their brand of melatonin, is indeed safe and effective, the company would have a monopoly on "nature's sleeping pill."
And if melatonin does becomes a prescription-only drug, it will likely also please Dr. Richard Wurtman, who has repeatedly warned that the drug is unsafe. A media favorite, Wurtman is regularly quoted by reporters and often appears on television when a story involves drugs and the human brain, usually credited as professor of neuroscience at the Massachusetts Institute of Technology.
Just last September on the NBC Nightly News, Wurtman said melatonin has "dangerous side effects. I'm really scared that someone's going to take chronic doses of melatonin in high doses for a long time, and have all kinds of disturbances in their biologic rhythms, maybe drive into a telephone pole." In 1994, he warned that wrong doses of melatonin could cause mood-altering side-effects.
Unless OTC sales are banned, Interneuron will have to convince the public that their product is superior
Is there any
connection between Dr. Wurtman and Interneuron? Yes, there is. Late last year, USA Today revealed that he owns about $19 million worth of stock in the company.
And that's just the beginning. SEC documents show that Dr. Wurtman sits on the Interneuron's Board of Directors, and that the company pays Wurtman and his wife more than $225,000 per year to serve as consultants, as well as other generous perks.
When contacted by the Albion Monitor, Wurtman shrugged off possible conflicts of interest between his stake in the company and statements about melatonin dangers. "Three companies hold melatonin patents, " he points out.
Interneuron's rights involve the sale of the drug in low doses to promote regular sleep patterns. Melzone is a .03 milligram tablet. Dr. Wurtman says that the standard 2.5 to 3 mg dose available in health food stores "raises the body's melatonin levels to 100 times the normal range."
Unless the FDA bans over-the -counter sales, Interneuron will have to convince the public that their product is superior because, as Wurtman says, it has the "correct dose and purity."
But since millions of people already use and seem satisfied with the relatively inexpensive melatonin supplements currently sold with no reports of any purity problems, it might be a hard sell. Couple this with Interneuron's $15 million loss in the six month period ending March 31, 1996 (and a $10 million loss in the corresponding period last year) and it's easy to imagine the pressure on the company to turn a profit for its shareholders.
But recently, Montgomery Securities recommended that its clients buy Interneuron stock, citing likely high profits 2 or 3 years down the road. These expected profits may take some of that pressure off Interneuron's need to have the FDA declare melatonin a prescription drug.
Success of diet pill may determine future of melatonin
melatonin's future may be determined by the success -- or failure -- of a new diet pill. Montgomery's recommendation came in anticipation of the FDA's approval of the sale of Redux, Interneuron's name for dexfenfluramine, an anti-obesity drug already on sale in Europe. The saga of Redux is worth telling, if there remains any doubt that companies like Interneuron wield clout with the FDA.
Just a few months ago, serious doubts about the drug's safety made FDA approval uncertain. Its advisory committee gave preliminary approval on a close 6 to 5 vote in November, a vote not binding on the FDA committee that issues final approval.
The dissenting members were concerned because about one in 40,000 users contracts a serious lung condition, called primary pulmonary hypertension, that does not always go away when one stops using the drug. The drug works by raising serotonin levels in the brain and is the same neurotransmitter that Prozac and other anti-depressants called "serotonin reuptake inhibitors" work on, but unlike these drugs, dexfenfluramine has been found to alter the serotonin neurons in the brain.
One study on squirrel monkeys showed significant reductions in serotonin levels that continued 17 months after they were given high doses of dexfenfluramine for only four days.
Despite these concerns, the FDA approved the use of Redux to treat obesity. Interneuron expects to have it on the market by next month, and Wurtman predicts "$600 million in annual sales."
What will happen to melatonin is anybody's guess
With the billions
of dollars Americans spend on diet drugs of dubious value, Redux could be a windfall for the company. Does that mean melatonin is safe from regulation? Not at all. Even without lobbying from Interneuron or the other patent holders, the FDA could still restrict it. The Administration works in mysterious ways, and no one can predict what it will do. But it's also been historically reluctant to regulate substances that naturally occur in foods. Bananas and rice both contain melatonin, albeit in tiny amounts.
Yet the regulatory agency also has seized on flimsy pretexts to ban drugs. The amino acid l-tryptophan was banned after a Japanese company manufactured one faulty batch that killed 40 people about a decade ago. The substance has been in use in Europe since then with no further incidents but remains forbidden in this country.
What will happen to melatonin is anybody's guess. The real debate centers upon money and politics than the efficacy of the drug, and those variables are almost impossible to predict. It's worrisome, but at least you don't have to lose sleep over it -- after all, melatonin is still available in your health food store.
At least for now.
Albion Monitor May 27, 1996 (http://www.monitor.net/monitor)
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