1994 Dietary Supplements
Health And Education
Act
Life Flow One
The Solution For Heart Disease
by
Karl Loren
This article appeared in the Wall Street Journal. It provides an interesting background to the 1994 Dietary Supplements and Health Education Act. This act has provided much more freedom than ever in the past for vitamin companies to make truthful claims about their products, but the act has also opened the door for many more fraudulent products and practices. The bottom line is the old motto: "Let the buyer beware." You can get more interesting products on the market today, but you can also get harmed or suckered with great ease. There is no substitute for your own personal investigation and checking out the integrity of your sources of information.
There is also a similar article reprinted from the New York Times. Click here to read that article, on this page. There is a second article from the New York Times. Click Here to read that, about how drug companies can also sell supplements, but at much higher prices than when a "vitamin company" sells the same substance. The deal is that when it is a drug company selling the substance you might get it covered by your health insurance.
Karl
January 27, 1999
Leader
By ROCHELLE SHARPE
Staff Reporter of THE WALL STREET JOURNAL
EDINA, Minn. -- Wayne Josephson dreamed of starting his own business, but he couldn't figure out what to sell. Then he realized the answer was in the tiny white capsules in his kitchen cabinet.
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Shortly after leaving his job at a Minneapolis securities firm last spring, the 49-year-old Mr. Josephson had begun taking androstenedione -- the same substance that made headlines last year when baseball great Mark McGwire said he was using it. Mr. Josephson says it boosted his energy, built up his muscles and even increased his sex drive. "I felt I'd found the fountain of youth," he says. Even better, Mr. Josephson believed he had found the perfect product. He called it "The Stud Pill for Men." |
In October, he began selling the substance, previously marketed almost exclusively to the body-building crowd, as a dietary supplement for older men. He set up a Web site and issued a press release on financial news wires that described the supplement as a "safe," "proven," "FDA legal" substance that increases testosterone levels, "reverses male aging" and "burns fat, builds muscle, and boosts strength, energy and sex drive."
In his first month of electronic commerce, he says, he sold 1,000 bottles, or $30,000 worth of pills. Two months later, he began peddling two more products: "The Passion Pill for Women," a low dose of androstenedione that will "increase sexual desire and energy," he says on his Web site; and "HerbalTrim," a dietary supplement that he says promotes weight loss. None of his products have any side effects, his advertisements say. For the three, he says he now has combined sales of about 1,000 bottles a month -- a figure that his supplier says tallies with the orders he has received -- and projects total sales this year will reach $500,000.
Mr. Josephson's knack for marketing is obvious, but he also has gotten a big boost, however unintentional, from legislation that has in effect sharply reduced the regulatory oversight of dietary supplements.
McGwire and a Good Pitch
As a salesman, Mr. Josephson scores high. He found a product that ties in to two of last year's media comets: Mr. McGwire and Viagra. He plugged into Internet commerce when it was heating up. And he pitched his line to a group he knows well: weary, middle-aged stock-market players.
He also happened to choose a type of product for which, since a 1994 law, there are scant requirements to substantiate claims and scant resources to police misdeeds. So anyone wondering whether the Stud Pill sounds too good to be true can't rely on the government to sort out the facts.
Dietary supplements have never received as much government scrutiny as prescription medicines, which undergo a lengthy review before being cleared for marketing. But under the 1994 Dietary Supplements Health and Education Act, whose purpose was to make dietary supplements more widely and readily available, the oversight grew even more relaxed. Most dietary supplements can be sold without being reviewed in advance for safety or effectiveness by the Food and Drug Administration.
Legal Requirements
Still, there are some rules governing these supplements -- rules that Mr. Josephson says he didn't bother to find out about. He never hired a lawyer to learn about the regulations, he says, because he didn't want to spend a lot of money starting the new business, and because he assumed his androstenedione supplier had taken care of all the legal requirements. But Mr. Josephson's supplier, who declines to be identified by name, says he assumed that his own raw-materials supplier had taken care of regulatory matters.
Despite his "FDA legal" claim, Mr. Josephson acknowledges that he never notified any government regulator about his new business. He adds, however, "I certainly would want to comply with all the rules."
The original FDA law of 1908 bars dietary-supplement companies from making false or misleading claims; the 1994 legislation forbids companies to imply that a product treats or prevents a disease. They can't say, for instance, that a substance reduces the risk of prostate cancer, but they can say that a product helps keep the prostate working normally.
They must, however, submit those claims to the FDA, as well as safety data on any ingredients introduced in the U.S. after 1994. If the FDA finds there aren't sufficient safety data, it can tell the company to stop marketing the product. Companies also are required to include on their labels a disclaimer saying that the FDA hasn't evaluated their claims for the product.
Mr. Josephson's products don't include any disclaimers, and he hasn't submitted any information to the FDA or gathered any data for the Federal Trade Commission. Companies must be able to substantiate claims if the FTC comes calling.
The agencies, for their part, haven't contacted him -- but that isn't surprising. With an estimated 20,000 dietary supplements on the market in the U.S. and annual growth of 20%, the $15 billion industry is just too big for government regulators. The FDA has only five employees dedicated to handling dietary supplements. It usually learns of misleading statements from disgruntled customers or competitors.
"We have no systematic process in place" to scrutinize dietary-supplement companies, says Robert Moore, a senior regulatory scientist in the FDA's Office of Special Nutritionals.
Since 1994, the FDA has taken about 100 actions against companies for violating dietary-supplement laws -- in most cases, warning letters. Only a handful of companies have had their products seized by the agency. Neither the FDA nor the FTC would comment on the specifics of Mr. Josephson's business.
Androstenedione, which was discovered by German chemists earlier this century, is chemically synthesized from plants such as wild yams. In the 1970s, German researchers determined its usefulness in enhancing athletic performance. It can be converted naturally in the body into testosterone, the hormone that contributes to energy, muscle strength and sex drive.
The substance was first sold in the U.S. in 1996, two years after the FDA began requiring safety data on new ingredients. But the FDA says it hasn't received any safety information from companies selling androstenedione, of which people in the business say there are about 50.
A Lack of Studies
Scientists are just beginning to do research on the effects of androstenedione. "There are no studies to show it's safe or effective. That's what we're trying to find out," says Conrad Earnest, an exercise physiologist in Newport Beach, Calif., who is currently studying how much androstenedione affects testosterone levels.
Dr. Karlis Ullis, an assistant clinical professor of sports medicine at the University of California's Los Angeles campus, has given androstenedione and a related substance, androstenediol, to male patients trying to combat the effects of aging, but he limits his patients to a 100-milligram dose once or twice a week. If they want to take more, he requires that they undergo medical tests. "I want to know where this goes," he says. Androstenedione could be a risk to the prostate gland, and if converted to estrogen, could make a man obese or have mood problems, he says. Some doctors worry that prolonged use of the compound could result in heart problems.
Mr. Josephson says he believes androstenedione is safe because of his personal experience, and because of his research, conducted by reading up on the substance over the Internet for a week. He recommends that men take one 100-milligram capsule each day.
"I know I'm offering a good product," he says. "I have a clear conscience about it. I've done my research, so I know it won't hurt anybody."
An FDA Warning
For his HerbalTrim, he did less research on safety or efficacy. But it contains one substance for which the FDA has proposed specific restrictions: ephedra, which is also known as Ma Huang. The agency has proposed that products containing ephedra include warnings that the user should limit daily intake of ephedra to 24 milligrams and refrain from taking it for more than seven days. The FDA has received reports of more than 800 adverse reactions to ephedra, including stroke, heart attack and death.
"Interesting," Mr. Josephson replies. He notes that the product has been on the market for six years and says each HerbalTrim pill contains 125 milligrams of Ma Huang, which he says is 8% ephedra -- though he adds that it is difficult to say precisely how many milligrams of ephedra each pill contains. He also says he lost seven pounds while using HerbalTrim for three weeks, and that it didn't cause him any ill effects.
Bryan Bresnahan, an insurance agent in Bellevue, Wash., is so happy with the Stud Pill that he has already ordered a second 90-day supply. He says the pill not only boosted his energy level and sex drive, but also helped him lose weight-dropping to 240 pounds from 260 in three months. As for side effects, Mr. Bresnahan says that during the first two weeks he felt "almost a little jittery," like he was having too much caffeine.
Mr. Josephson's current business is a long way from his previous career. A graduate of the Wharton School at the University of Pennsylvania, he worked on Wall Street for nearly 20 years. He spent time analyzing bonds at Moody's Investors Service Inc., worked as an investment banker at Merrill Lynch & Co., and later joined Fitch Investors Service Inc., a credit-rating agency. There he devised a way to separate credit-card operations from other aspects of department stores' businesses -- an innovation that became the subject of an article in The Wall Street Journal in 1993. (Fitch to Separate Credit-Card Operations From Others in Rating Retailers' Debt, Oct. 4, 1993)
He left New York for Minneapolis in 1996 in search of a slower-paced life with his family. Within two years, his securities company, Dain Bosworth, merged with another firm and offered him a buyout. He accepted, thinking he could finally create the business he had always wanted.
For months, he couldn't figure out what to do. Then, he began to read about Mr. McGwire's experience with androstenedione. In an Associated Press report last August, Mr. McGwire was quoted as saying, "Everything I've done is natural."
His Own Guinea Pig
Searching for information about the substance on the Internet, Mr. Josephson discovered that some health professionals recommended androstenedione to combat the testosterone drop in older men that is linked with loss of energy and sex drive. Mr. Josephson, who felt tired and was frustrated that he was having trouble staying in shape, decided to try it himself.
The day after he took his first pill, he says, he "jumped" out of bed, and felt years younger. Within days, he noticed that he wanted to exercise more and was less sore after his workouts. It occurred to him that he had found the focus for his new business. He became convinced that older men would clamor for the supplement if they understood its effects, and welcome the convenience of online ordering for a product that isn't readily available in many health-food stores.
So, he began his venture into electronic commerce, calling his company AndroFit LLC. In his dimly lighted basement, with its concrete floors and cinder-block walls, he set up his computer on an old wooden table next to the furnace and not far from his NordicTrack machine. He found a supplier for androstenedione, had a Web page designed, and started putting out press releases on news wires. Wealthy, aging male stock traders who stare at these news wires all day would be intrigued by his Stud Pill ads, he thought, and readily pay $29 to buy 100 pills.
Within 10 minutes of putting out his first press release last October, Mr. Josephson got his first order. He sold 30 bottles the first day, 40 bottles the second and 50 bottles the third. He handles the packing and mailing, sometimes helped by his wife and children. Though sales have cooled a bit, he is still doing better than he expected.
But some of his claims, such as the pill's being "FDA legal" and "safe," remain questionable. Anne Maher, the FTC's assistant director for advertising practices, says the agency has successfully brought cases against companies that claimed their supplements were safe and implied their product was approved by a government agency. She says any of Mr. Josephson's advertising claims should be substantiated with scientific evidence.
The FDA says it has received no reports of adverse reactions to androstenedione, but it remains interested in the substance. Agency officials have been meeting with officials at the Drug Enforcement Administration to see whether it should be classified as a controlled substance and be prescribed only by doctors.
Mr. Josephson says it is unfortunate that androstenedione is "shrouded in negative controversy." But he is delighted with the way his business is going and with the increased vigor he has felt since he started taking the supplement in August. "I'm going to take it for the rest of my life," he says.
Copyright © 1999 Dow Jones & Company, Inc. All Rights Reserved.
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February 9, 1999
Americans Gamble on Herbs as Medicine
Related ArticlesBy JANE E. BRODY
erbal medicine, the mainstay of therapeutics for centuries before modern purified drugs relegated it to the status of near-quackery, has in the last five years emerged from the fringes of health care with an astonishing flourish and now shows clear signs of joining the medical mainstream.
Despite many cautionary tales about adulterated and even dangerous products, herbs formulated as capsules, tinctures, extracts and teas -- and increasingly as additions to common foods like potato chips and fruit drinks -- are now routinely used by a third of American adults seeking to enhance their health or alleviate their illnesses. Each day the herbal realm wins new converts, particularly among those who have become disillusioned with the cost and consequences of traditional drugs, distrustful of conventional physicians and convinced that "natural" equals "good."
Yet, because herbal products are classified as dietary supplements, not drugs, and face none of the premarket hurdles drugs must clear, consumers have no assurance of safety or effectiveness. Indeed, scores of products sold in the United States are listed by European and American authorities as ineffective, unsafe or both, and manufacturing standards to assure high quality have been proposed but are not yet in force.
Thus, countless consumers are wasting their money on useless products or jeopardizing their health on hazardous ones. Among the serious side effects that have been linked to herbal remedies are high blood pressure, life-threatening allergic reactions, heart rhythm abnormalities, mania, kidney failure and liver damage. A few widely available products, including sassafras and comfrey, contain known carcinogens.
At the same time, according to a report last year in the journal Psychosomatics, unsuspecting consumers "have used herbal remedies with good results only to discover that the benefit was actually derived from the presence of undisclosed medicines," including steroids, anti-inflammatory agents, sedatives and hormones.
"The lack of quality standards is the No. 1 problem in the whole industry," said Dr. Varro Tyler, emeritus professor of pharmacognosy (the study of active ingredients in plants) at Purdue University. Tyler, who has no financial connection to herbal products and is arguably the nation's leading independent expert on herbal medicine, said: "I feel sorry for the typical consumer. How is he or she to know what is best, what products are reliable and safe? Even when a label says the product has been standardized, the consumer has no way to know if it actually meets that standard." And even if an herbal product has been reliably made in some standard dose, it does not mean that scientific studies have shown it to be effective.
The industry itself is promoting a "good manufacturing practices" doctrine. Annette Dickinson, director of scientific and regulatory affairs for the Council for Responsible Nutrition, a trade organization for producers of dietary supplements, said a consortium of associations submitted a document of manufacturing standards to the Food and Drug Administration two years ago. Although such a standard would say nothing about an herb's safety or effectiveness, it would result in reliable methods that the industry would have to use to assure the identity and quality of its products. The agency has issued a notice of proposed rules but no final ruling as yet.
Nonetheless, botanicals -- as herbal products are more accurately known -- are enjoying an annual retail market approaching $4 billion, up from $839 million in 1991 and growing about 18 percent a year. Hundreds of products formulated with virtually no government oversight are crowding shelves of health food stores, food markets and pharmacies nationwide. Supplements are also widely sold by marketers like Amway, through catalogs and on the Internet.
Now, even major pharmaceutical companies like Warner Lambert, American Home Products, Bayer and SmithKline Beecham are introducing herbal products, adding respectability to this marginalized market.
Some herbs -- like echinacea, goldenseal, American ginseng and wild yam -- have become so popular that their continued supply from natural sources is in danger. As the plants become scarcer and more expensive, products containing them are increasingly likely to be adulterated and may even contain none of the herb listed on the label. Peggy Brevoort, president of East Earth Herb Inc., a company in Eugene, Ore., that produces botanicals, said the demand for St. John's wort, used for mild depression, and kava, a calmative said to reduce anxiety, now exceeds their supply, introducing the "danger of adulteration" by "unscrupulous dealers."
At the same time, two major new publications -- a 1,244-page Physicians' Desk Reference for Herbal Medicines, produced by the same company that publishes the Physicians' Desk Reference, and an English-language edition of Germany's therapeutic guide to herbal medicines, The Complete German Commission E Monographs -- have been issued to help educate physicians, pharmacists and interested consumers about the known uses, proper dosages and safety concerns of more than 600 botanicals now sold in this country. The evaluations in both books are based on studies, most done in Germany and reviewed by teams of experts.
Last month, the National Institutes of Health began listing on the Internet international bibliographic information on dietary supplements, including herbal products. The address is www.nal.usda.gov/fnic/IBIDS/.
In addition, a few medical and pharmacology schools have recently introduced courses in phytomedicine, the study of botanicals. And next month the American Pharmaceutical Association will conduct a two-day program on herbal medicine as part of its annual meeting. Still, most doctors remain wary of botanicals, especially when patients choose self-medication with plant extracts over established medical remedies.
The very act of Congress that has fostered this growth -- the 1994 Dietary Supplement Health and Education Act -- has also permitted chaos to reign in the botanical marketplace, with no mechanism to assure that products are safe or effective. Pushed heavily by Republican Sen. Orrin Hatch of Utah, the home base of many supplement makers, and passed over the objections of the FDA, the law created a new product class, the dietary supplement, that was not subject to regulations applied to drugs. Now any substance that can be found in foods, regardless of amount or action and including substances that act as hormones or toxins, can be produced and sold without any premarket testing or agency approval.
Marketed as neither a food nor a drug, herbal products are not obliged to meet any established standards of effectiveness or safety for medicinal products, which require extensive laboratory and clinical trials before approval. As with other substances classified as dietary supplements, the FDA can restrict the sale of an herbal product only if it receives well-documented reports of health problems associated with it. The agency took four years, and more than 100 reports of life-threatening symptoms and 38 deaths, to act against ephedra, often sold as the Chinese herb ma huang, a stimulant that can prove disastrous to people with heart problems.
With FDA authority limited by the 1994 law, the Federal Trade Commission, which monitors advertising, has taken a more active role in monitoring supplement makers.
The FTC last year took legal action against seven manufacturers that had broken rules requiring advertising be truthful and verifiable. The companies were selling remedies or purported cure-alls for ailments like impotence, cancer and obesity.
The commission also sent e-mail warnings to 1,200 Internet sites that it said had made "incredible claims" for drugs, devices and supplements, including herbal remedies that would supposedly ward off AIDS. Also, the commission late last year issued its first set of advertising guidelines aimed specifically at the supplement industry.
Still, the current regulations have created a quagmire of consumer confusion and set up potential health crises that even industry officials say could ultimately hurt producers as well as users of herbal products. Under the 1994 law, consumers have no assurance that an herbal product contains what the label says it does or that it is free from harmful contaminants. Independent analyses of some products, particularly those containing costly or scarce herbs, revealed that some have little or none of the purported active ingredient listed on the label.
Adding to the confusion is that botanical makers are allowed to describe products only in terms of their effects on the structure or function of the body, not their potential health benefits. Thus, a product label might say "promotes cardiac function" but it cannot say "lowers cholesterol."
Likewise, although the law does allow health warnings on the label, most manufacturers have yet to include them.
Consumers are warned, however, that federal drug safety officials are not watching the store. All botanicals must display a disclaimer on the label following the description of the product's structural or functional role: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease." To which Tyler commented, "If that is true, why on earth would anyone use it?"
The seeds of the modern herbal market were sown in the '60s when "green, organic and natural became buzzwords," Tyler said. But they did not mature until the '90s with the growing consumer interest in "self-care and controlling one's destiny," he said. Many turned to herbs as a gentler way to treat health problems and a potential tool for preserving mental and physical health.
The interest has spawned scores of Internet sites and hundreds of books on various herbs. But much of the literature is replete with poorly documented health claims and, with few exceptions (among them, Tyler's books), advocacy prevails over objectivity.
Because plants contain a mixture of relatively diluted chemicals, they naturally tend to have milder actions, both in their therapeutic benefits and side effects, than the concentrated, single chemicals in most drugs. Thus, botanicals generally take longer to act than regular pharmaceuticals and few have the potency of a prescription, the one possible exception being saw palmetto, which a well-designed study indicated may be as helpful for an enlarged prostate as the more expensive and riskier drug, Proscar.
The combination of chemicals in botanicals is potentially both a plus and a minus. When two or more chemicals enhance one another's activity, the therapeutic benefit could theoretically exceed that of an isolated substance formulated as a drug. Mark Blumenthal, who heads the American Botanical Council, noted that the herb St. John's wort, widely used in Germany and increasingly in the United States to counter mild depression, is standardized for a substance called hypericin. But, he explained, "hypericin is not directly linked to its antidepressant activity." Rather, other substances in the herb seem to have diverse actions on brain chemicals, all of which work together to counter depression.
Equally possible, though, when using an herb with two or more active chemicals, is that one will cancel the benefits of another or introduce a hazard. Without careful chemical tests and large, well-controlled clinical trials such actions are often hard to detect.
Consumer confidence in herbal medicine is bolstered by the common but erroneous assumption that "natural" equals "safe" and the public's failure to realize that many plants contain chemicals that are potent drugs or outright poisons. Natural laxatives like the herb Cascara sagrada are just as habit-forming and harmful to the colon as laxatives sold as drugs.
Indeed, one quarter of prescription drugs and hundreds of over-the-counter products were originally isolated from plants. Ephedra, for example, contains a natural stimulant that is approved for use as a decongestant and bronchial dilator in some pharmaceutical products. However, when used in uncontrolled dosages or by people with certain underlying health problems, it can cause a dangerous rise in blood pressure and, in its herbal form, has been responsible for serious adverse reactions and dozens of deaths, mainly among people who inappropriately used it as a stimulant or diet aid.
Complicating the safety issue is the fact, shown in several recent surveys, that most patients fail to tell their physicians they use herbal supplements and thus sometimes risk dangerous drug interactions or endure costly tests or treatments when an herb causes an unrecognized side effect. Experts say many patients withhold information about herbal drug use because they fear being ridiculed by their doctors.
Although all German physicians must take courses on herbal remedies, only a handful of American medical and pharmacology schools offer courses in this field.
A year ago, the President's Commission on Dietary Supplement Labels recommended that the FDA appoint a committee to evaluate the safety and effectiveness of herbal products. "This could be the most important step in the United States toward legitimizing herbal medicine," Tyler said.
However, the agency responded that it lacked the budget to support such an effort. American physicians have completed and published only a few well-designed studies of some popular botanicals. Among them were studies showing that saw palmetto can shrink an enlarged prostate and ginkgo biloba can improve memory in patients with early Alzheimer's disease.
The Office of Dietary Supplements at the National Institutes of Health is helping to finance a three-year multicenter study of St. John's wort as a treatment for clinical depression and a study of plant-based estrogens as a preventive for postmenopausal health problems.
However, thousands of studies of botanicals have been completed abroad -- mainly in Germany -- that strongly suggest a health-promoting role for more than 200 plant products. Germany's Commission E evaluated 380 botanicals, approving 254 as safe and reasonably effective and disapproving 126 as ineffective, unsafe or both.
The Germans use a different criterion to assess an herb's benefits -- a doctrine of "reasonable certainty" that the herb has the desired effect and is safe, Blumenthal said. Whereas standard testing of a drug for approval by the FDA can cost as much as $500 million per product -- a prohibitive amount for companies to spend on botanicals that cannot be patented -- tests to establish "reasonable certainty" would cost only $1 million to $2 million, Tyler estimated.
In June 1996, Dr. Robert Temple, director of medical policy for the FDA's Center for Drug Evaluation, suggested that, rather than subjecting botanicals to the extensive tests required for drugs, the agency might consider applying less stringent criteria to assess an herb's effects, at least when a product is to be used only for a short time. He said, "A long history of safe use might provide sufficient safety information for products that are intended for short-term use."
More than four dozen botanicals or botanical formulations have been submitted to the agency as investigational new drugs. If any meet the agency's criteria for safety and effectiveness and are eventually approved as drugs, they would be allowed to carry direct health claims -- instead of just structure and function statements -- on labels and in advertising.
Meanwhile, Dr. Joerg Gruenwald, medical director of a German phytomedicine company and primary editor of the new Physicians' Desk Reference for Herbal Medicines, said professionals can rely on that volume for current, documented information about botanicals. The volume, to be issued annually, updates the Commission E reports and adds several hundred other products sold in the United States, listing effects, side effects and conditions in which their use is inadvisable.
Copyright 1999 The New York Times
Company
"I was flabbergasted," said Kovarik, a lawyer in South Palm Beach,
Fla., with a life-threatening genetic disorder known as Wilson's disease. To
fight its symptoms, Kovarik needs an effective treatment to keep copper from
accumulating in his body and destroying his vital organs.
He had been taking a drug that could have caused irreversible and sometimes
lethal side effects. So, Kovarik said, he negotiated the maze of his health
maintenance organization to find a doctor who would prescribe a newer and safer
drug, Galzin.
But when his insurance company, Humana Inc., refused to pay for Galzin,
Kovarik angrily called the company from the pharmacy counter.
"I was telling them that I have this life-threatening disease,"
Kovarik said, "and that this drug is life sustaining. I told them that the
drug I was using was having deleterious side effects. I told them that Galzin is
FDA approved." Later, he wrote letter after letter, to no avail.
The problem is that Galzin is zinc acetate, and zinc acetate is sold both as
a prescription drug and over the counter as a food supplement. The supplement
and the drug are supposed to be the same, but the supplement is not licensed by
the Food and Drug Administration, so its manufacture is not regulated and there
is no guarantee that the dose on the package is correct.
Humana questioned why it should pay for a prescription drug when the
supplement was available. A month's supply of Galzin costs $95, Kovarik said. If
he bought the supplement, it would cost $10 to $15, he said.
"We do not cover nutritional supplements," said Valerie Kennedy, a
Humana spokeswoman.
But cost is not the crucial issue, said officials at Teva Pharmaceuticals
U.S.A. of Sellersville, Pa., which makes Galzin. "The real issue here is
the safety of the patient," said Dr. Carole Ben-Maimon, a senior vice
president. "The patients taking a prescription product know what they are
getting and how it was made."
A product can be a drug if a company tests it for safety and efficacy,
receives approval from the FDA and makes the product according to federal
standards. But many of the same products can be sold as supplements if they do
not make drug claims.
"The boundary between food and drugs is by no means clear and
sharp," said Dr. John Hathcock, the director of nutritional and regulatory
science for the Council for Responsible Nutrition, which represents the
supplement industry. "It is perfectly legal and, I believe, also legitimate
for some products to be on the market both as supplements and drugs."
Patients who need products to treat diseases can take the drugs if their
doctors prescribe them, Hathcock said, others can buy the supplements.
But patients, their advocates and companies that try to sell drugs like zinc
acetate say it is not that simple. Because a substance sold as a supplement is
not regulated by the FDA, there is no guarantee that it will contain the product
on its label or that the dosage stated on the label is accurate.
Although only a few products are sold as both drugs and supplements, some are
vital to patients, especially those with rare disorders who must take them
regularly and in fixed amounts.
"It's a big problem," said Abbey Meyers, the executive director of
the National Organization for Rare Disorders, an advocacy group based in
Fairfield, Conn. "If your life depends on one of these products, you can't
take a chance on buying an over-the-counter supplement that may contain no
ingredient or half the ingredient or two or three times more of the
ingredient."
Ms. Meyers said her group financed a study in which Duke University
scientists analyzed over-the-counter L-carnitine supplements from a variety of
companies. They found that doses varied markedly, even in pills coming from the
same bottle, with some pills containing no carnitine, others containing more
than the label specified and most providing less than 60 percent of the dose
promised on the label.
And yet, said Lynn McHenry Morgan of Concord, Calif., when she changed
insurance companies last February, her new insurer, Blue Shield, told her it
would not pay for prescription L-carnitine for her two children, who need the
drug to treat a rare and debilitating disorder involving the mitochondria, which
provide energy to cells.
Ms. Morgan said she lobbied Blue Shield for three months before the company
agreed to pay.
Dr. Nancy Stalker, the director of pharmacy services at Blue Shield of
California, said the company wanted patients to get the care they needed, but
had a policy restricting payments for drugs that also were nutritional
supplements.
Doctors who treat patients in similar circumstances say they often end up
imploring insurance companies to pay for the prescription drugs. Dr. Susan
Winters, a geneticist who treats children with rare metabolic disorders, said
she aggressively fought for insurance coverage for drugs like L-carnitine, but
said she did not always win.
Ms. Meyers said that drug companies realized that testing a drug and getting
the FDA's approval to market it might not be worthwhile if the drug could also
be sold as a supplement. With zinc acetate, she said, her group actively sought
a company to sell the product as a drug. "Nobody would do it," Ms.
Meyers said. "Who wants to put the money into making a pharmaceutical grade
zinc when you can buy zinc over the counter?" Finally, she said, Teva
agreed to do it.
But the situation can be different when a drug is not urgently needed for
patients with an otherwise lethal disease. Dr. Richard J. Wurtman, a co-founder
of Interneuron, a small drug company, in Lexington, Mass., was convinced that
melatonin worked as a sleeping pill if the dose was correct. He wanted to test
and market it as a drug. But when he urged this course on his company, he said,
he was met with " absolutely zero interest."
"The problem is convincing a company in this country to invest the tens
of millions of dollars to get the drug on the market and then have it come out
and compete with a supplement," Wurtman said. "As long as something is
available as a dietary supplement, no company will invest in it."
And so Interneuron joined the supplement makers. It is marketing melatonin as
a supplement that can induce sleep, through a subsidiary called InterNutria.
February 9, 1999
Drug or Food? Patients Stumble Into Gray Area
Related Articles
By GINA KOLATA
ohn
Kovarik got a rude shock one day last year when he went to his pharmacy to fill
a prescription: His insurance company refused to pay for it.
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SUBSCRIBE: The Wednesday Letter is a free electronic monthly newsletter written and published by Karl Loren. You can view more than 50 back issues of this publication by clicking here. The Wednesday Letter subscription list is maintained on a secure server, no name is ever given or sold to anyone, and it is never used except for this Newsletter. It is automatically published on the Tuesday night just before the first Wednesday of every month. You can subscribe to this free monthly electronic letter by entering your eMail address and name below. You will then automatically receive a request for confirmation, sent to whatever address you have entered. If you do NOT receive this confirmation request, then you will not be subscribed. There may have been an error with your address and you should resubmit. The letter is never sent twice to the same address -- so you do not have to worry about a duplicate subscription. When you receive this confirmation request you must reply to it, or your subscription will not become active. No one can subscribe your name, and address, without you being notified, and if you get an unwanted notice of subscription you only need to DO NOTHING and the subscription will NOT be active.
REMOVAL: You can remove yourself from the subscription list in several different ways. Click here to read about this entire newsletter system. Every edition of The Wednesday Letter is delivered to your address with YOUR name and address in view on the letter, with a link that allows you to remove THAT name from the subscription list. If you try to send this removal message from an address different from the one you used to send in your original confirmation, then you will get a warning notice first, sent to the subscription address, asking you to confirm that you want to be removed from the list -- by replying to THAT request for confirmation, you will then be automatically removed. Thus, no one else can unsubscribe you, from some other computer, without your knowledge. But, if you send in the unsubscribe notice from the same machine used to receive the Letter, then the removal from the subscription list is automatic.
Personal Message: When you send a personal message to Karl Loren, you will receive a personal reply as per his instructions. Karl pledges that every personal message will get a personal answer. When you provide your mail address, we will send you free information including our free catalog and a cassette tape lecture by Karl Loren about heart disease, no charge, by mail, even if outside the US. You can select particular information you would like to receive, along with the free cassette tape and catalog.
Click here to add the Wednesday Letter as a Channel on your desktop. If your browser is so-equipped, you will be guided through a series of simple questions (about subscription information). Depending on your choices you can show the Vibrant Life Wednesday Letter as one of your "active channels" which will automatically download the new Wednesday Letter every month. In this way you can have the Wednesday Letter delivered to your desktop during the night (or your schedule) for immediate viewing in your browser. You can turn on or off this channel, at will, and delete the channel from your desktop at any time. With this feature operating you can click on the Wednesday Letter channel at any time to read the most recent copy of this electronic letter.
You can reach Vibrant Life in many ways, including by mail to Vibrant Life, 2808 N. Naomi St., Burbank, CA 91504. Within the US and Canada, use the toll free number: (800) 523-4521, the local number: (818) 558-1799, the FAX: (818) 558-7299, eMail to kimberly@oralchelation.com or any one of the hundreds of message forms throughout the 50 web sites. Vibrant Life normally ships the same day we get an order. There are message forms on each of the 100,000+ pages on this and other sites where you can communicate with Vibrant Life. Check out our companion site, at: http://www.oralchelation.net where Karl's 2000 page book is published. Karl Loren is the author and webmaster for this BOOK, as well as for another web site about ORAL CHELATION. His personal philosophical articles are at PHILOSOPHY.
Copyright © April 25, 2008 2:40 AM by Karl Loren on behalf of Vibrant Life, ALL RIGHTS RESERVED. Permission is granted for non-commercial downloading, copying, distribution or redistribution on two conditions: One, that some form of copyright notice is included in every copy distributed or copied, showing the copyright belonging to Vibrant Life, Burbank, CA, at www.oralchelation.com . The second condition is that the material is not to be used for any purpose contrary to the purposes and objectives of this site. This permission does not extend to materials on this site which are copyrighted by others.
