$ Spent On Vitamin And Mineral Supplements Usa information, tips and advice

How can this happen under the FDA's allegedly strict review process? One answer may be material conflicts of interest within the agency and among its reviewers.

For a drug to be approved it first must pass muster before an FDA advisory committee. These committees are supposed to bring together unbiased experts who review the clinical-trial data on a drug's safety and efficacy. The committee then votes on whether to recommend approval. In practical terms, approval by an advisory committee is tantamount to approval by the agency. Therefore, the committee's role as an "honest broker" is essential to maintaining the integrity of the drug-approval system.

The integrity of the advisory-committee system itself, however, is in question. A review of the official records of the 159 FDA advisory-committee meetings held between Jan. 1, 1998, and June 30, 2000, was conducted by USA Today. The results, published Sept. 25, 2000, revealed a startling fact: In 55 percent of the meetings that took place during this period, at least one-half of the participants had financial conflicts of interest. The types of conflicts included serving as a paid consultant for the company whose drug was under review, owning stock in the company or receiving research subsidies from the company. An astounding 92 percent of the meetings had at least one participant with a financial conflict.

How could this occur? Simple. FDA bureaucrats issued 803 conflict-of-interest waivers during the period reviewed. When asked by congressional investigators why the agency issued so many waivers, the FDA bureaucrats demurred, saying it was the nature of medical research that such conflicts would exist. If they wanted the best people on the committee, they had to issue the waivers.

Yet, there are more than 770,000 licensed physicians in the United States. It defies belief that the FDA could not find 20 (roughly the size of an advisory committee) who did not have financial conflicts of interest related to each drug under review. It also defies belief that such conflicts would not influence reviewers' decisions--both in terms of unwarranted approvals and denied applications from potential competitors.

But there are other financial conflicts of interest plaguing the agency. Since 1992 the FDA has charged a fee to the pharmaceutical companies for new drag-approval applications in order to hire additional FDA staff. On the surface, it seems like a good idea: Drug approvals are faster and the industry foots the bill. Increasingly, however, the user-fee program is becoming the tail that wags the dog.

In its most recent budget request the FDA calls for user fees to increase to $295 million. This equals roughly percent of the agency's total budget. The fees would add 500 industry-funded positions, bringing the total number of FDA employees funded by the pharmaceutical industry to 1,530--roughly one in seven. More important, with the new positions, 55 percent of all drag reviewers would be paid by the pharmaceutical industry. This amounts to putting the fox in charge of the chicken coop!

In fact, the FDA has become so addicted to this money that it now wants to extend the program to encompass regulatory areas beyond prescription drugs. What may be the most pernicious aspect of the alliance between the FDA and the industry it is supposed to regulate is the incentive it creates to stifle the growing competition from alternative and complementary medicine.

Americans are seeking alternatives to traditional medical therapies in record numbers. Polls indicate that anywhere from 50 percent to 70 percent of . consumers have used some form of alternative medicine. Of these, 40 percent say they are regular users. Last year Americans spent more than $30 billion on alternative medicine, a figure that exceeds the total of copays for conventional care. More than one-half of this amount was spent on dietary supplements--vitamins, minerals and herbs.

However, the FDA's heavy-handed regulation of these products has forced Congress to act on two occasions since the mid- 1960s to ensure that the public would have access to them. First, in 1966, the FDA attempted to adopt a rule that would classify vitamin and mineral supplements with potencies greater than 150 percent of the recommended daily allowance (RDA) as drugs. A huge legislative battle ensued generating more than 1 million letters of protest to Congress. After a decade of controversy, Congress passed the Proxmire Amendment that blocked the FDA action.

But the FDA didn't give up the fight. Despite the Proxmire Amendment, it periodically attempted to extend its regulatory grip to encompass dietary supplements. In exasperation, Congress enacted the 1994 Dietary Supplement Health and Education Act (DSHEA), which specifically permitted supplement manufactures to make health claims about their products as long as there was "significant scientific agreement" to back them. It was the specific intent of Congress to keep the FDA from unduly limiting consumer access to vitamins, minerals, herbs and other similar products.

The FDA's response simply was to ignore congressional intent and try to manipulate DSHEA for itself and for the benefit of its pharmaceutical-industry allies. The law instructed the agency to define what "significant scientific agreement" meant. This might seem straightforward enough, but nothing the FDA does is straightforward. It interpreted the phrase to mean that a product must pass the same clinical-trial process as do prescription drugs--at a cost of hundreds of millions of dollars. More important, it excluded from consideration studies by other federal agencies such as NIH or the Centers for Disease Control and Prevention. In other words, it doesn't matter if a product works; all that matters is whether the FDA says it works--and the agency refuses to admit that any dietary supplement works.

The FDA pronouncement so outraged two supplement distributors, Dirk Pearson and Sandy Shaw, that they went to court. In a landmark decision, the . Court of Appeals for the District of Columbia instructed the FDA to allow supplement manufacturers to make true statements about their products.

Stop and consider that for a moment. A federal court had to instruct the FDA to allow people to tell the truth! But limiting free speech concerning supplements isn't the only sign of the FDA's bias against alternatives. Consider that, between 1997 and 2000, the FDA issued 568 "warning letters" to pharmaceutical companies for offenses ranging from false and misleading advertising to substandard manufacturing practices. In virtually every case, no penalty was imposed for the infraction.

In contrast, dietary-supplement manufacturers rarely are warned; they simply are shut down--even where there is a question as to whether an offense actually occurred. For example, a company called Pharmanex developed a dietary supplement, cholestin, that proved to be more effective and safer than the prescription-drag alternatives for lowering cholesterol. In 1998, following complaints by manufacturers of competing--and far more costly--anticholesterol drugs, the FDA went to court to remove the supplement from the market. A district court ruled against the FDA, but was reversed on appeal. The company filed for a stay of the appellate decision and at present the issue still is being litigated.

In May 1998, when the distributor of a natural sweetener called "Stevia" attempted to distribute cookbooks telling consumers how to use his product, the FDA promptly ordered him to destroy them, dispatching agents to his warehouse to supervise their burning.

In 1988, FDA officials solicited the help of King County, Wash., police to mount a SWAT team raid on the offices of the distinguished physician Jonathan Wright. Only later did the police learn that the "dangerous drugs" they were sent to confiscate were injectable vitamins.

Mind you, these extreme actions were taken despite the fact that only 2,500 adverse events are linked to dietary supplements each year--a far cry from the million linked to prescription drugs!

The simple truth is that the FDA is out of control. It is waging war on generally safe, effective dietary supplements while allowing lethal, prescription drags to reach the public. It is fraught with conflicts and has grown too close to the industry it is supposed to regulate. Indeed, instead of protecting the public health, it now endangers it.

BY KATHLEEN DEOUL

Deoul is author of Cancer Cover-up, published by Cassandra Books and a nationally recognized a spokeswoman on alternative and complementary medicine.

NO: FDA cannot allow unsafe ingredients and poor-quality products to reach the marketplace.

A generation ago, only "health nuts" took vitamin and mineral supplements. Herbal medicines virtually were unheard of. Today, one-half of all American adults take supplements, and one in three has tried herbs. Such products, now widely marketed under the banner of "dietary supplements" also include substances ranging from hormones to "glandulars" (processed animal organs sold in pill form). They no longer are just found in small health-food stores, but also are sold widely in major drugstore and supermarket chains.

Consumers hear more and more about promising research showing that some dietary-supplement ingredients may hold the key to preventing cancer and other dreaded diseases. In addition, the aging baby boomers like the idea of so-called "natural" products such as herbal medicines. Furthermore, many Americans are disenchanted with a medical establishment that increasingly funnels patients through doctors' offices as if they were on an assembly line. Consequently, many want to take control of their own health and engage in self-medication.

Certain nutrient supplements indeed are beneficial. Millions of Americans need supplements or foods fortified with calcium to help reduce the risk of osteoporosis. Adequate folic acid intake by women of childbearing age can reduce the risk of neural-tube birth defects in their unborn children. A growing number of studies also suggests that certain non-nutritive supplements can be beneficial. Saw palmetto, for example, can help men with benign enlarged prostates, and Saint-John's-wort can be useful in treating cases of mild depression. The challenge for most consumers is to determine which supplements are beneficial and which are nothing more than 21st-century snake oil--or even dangerous.

The Food and Drug Administration (FDA) has been criticized for failing to protect the public and overregulating the dietary-supplement industry. It is true that the FDA's staff should contain more experts in alternative medicine. In part because of under-funding, the agency has failed to address the public's growing use of nontraditional remedies. The FDA recently told Congress that it needs at least $90 million over a five-year period to ensure that supplements are safe, pure and properly labeled. Last year, however, the FDA only had $6 million available.

The fact is, the dietary-supplement industry itself is to blame for a weak law that leaves consumers in the dark. In 1994, the industry successfully lobbied Congress for legislation that made it more difficult for the FDA to do its job. The industry's lobbying campaign was supported by hundreds of thousands of consumers. Health-food retailers were enlisted to whip consumers into a frenzy by telling them--falsely--that the FDA was about to require physicians' prescriptions for ordinary vitamins. Consumers then were urged to write their members of Congress in support of legislation drafted by industry lobbyists that would curtail the FDA's authority.

Congress responded by passing the 1994 Dietary Supplement Health and Education Act (DSHEA). The 1994 law has led to short-term economic gains for supplement producers, but has caused a myriad of problems for consumers, including unsafe ingredients, low-quality products and a marketplace free-for-all of misleading claims.

First, DSHEA freed manufacturers from the responsibility of demonstrating that supplement ingredients are safe before they are sold. Although the FDA still has the authority to take dangerous products off the shelves, it first must prove that they are unsafe. This often means that the FDA must wait until people have been injured before it has enough evidence to take action.

Dietary supplements now on the market pose a number of different safety concerns. Some are unsafe because manufacturers sell traditional remedies for nontraditional purposes. For example, a herb that may have produced minimal side effects when used in a traditional way may cause severe adverse reactions when used in a different way.

The Chinese herb ma huang (also known as ephedra) traditionally was used in China to treat short-term respiratory congestion. In the United States it is sold as a stimulant and used for extended periods by consumers trying to lose weight. The FDA estimates that ephedra use in the United States has led to more than a dozen deaths and hundreds of serious injuries, including heart attack and stroke. In 1997, the agency proposed restrictions on ephedra but withdrew the proposals in 2000 after industry groups and a congressional audit said they were not supported by sufficient scientific evidence.

Still, a subsequent analysis in the New England Journal of Medicine found that at least 54 deaths and about 1,000 adverse reactions have been linked to the supplement since the mid-1990s. The National Institutes of Health now is suggesting that the safety of the substance be reviewed by the National Toxicology Program, an intergovernmental-agency group that typically examines dangers from toxic chemicals.

Other dietary supplements may pose hazards by interacting with prescription medicines. For example, the FDA issued a Public Health Advisory in February 2000 warning that Saint-John's-wort may reduce the effectiveness of a variety of common prescription drugs used for birth control, heart disease and depression. In Great Britain and Sweden, there have been at least two recent reports that women using Saint-John's-wort to treat mild depression became pregnant despite the use of contraceptive pills.

Consumers also are at risk because of weaknesses in the FDA's adverse-event reporting system. Under DSHEA, the FDA has no authority to require that firms report consumer complaints about adverse reactions. Instead, the agency must rely on companies voluntarily to report problems. The extent of underreporting is illustrated by the fact that in just one private lawsuit involving a weight-loss product containing ephedra, lawyers uncovered 3,500 complaints that never had been forwarded to the FDA.

Second, the law fails to require the supplement industry to adhere to strict quality standards. Such rules, which have been in place for over-the-counter and prescription drags for decades, would help ensure that products are, among other things, free of contaminants. Poor quality has been a nagging concern for the industry. For example, an independent study by revealed that eight of 21 brands of ginseng had unacceptable levels of pesticide residues. Two brands contained residues at more than 20 times the amount considered safe. Furthermore, two tested brands contained high levels of lead.

While Congress authorized the FDA to issue new quality standards for supplements, it did not provide the agency with any additional funds for that formidable task. Although the FDA finally drafted proposed regulations before the end of the Clinton administration, the Bush administration inexplicably has failed to approve them for public comment, thus delaying indefinitely the time when consumers can be assured of dietary-supplement quality.

Third, the 1994 law allows manufacturers to make health-related labeling claims without first proving to the FDA that the claims are valid. An avalanche of misleading claims has resulted. One can find products in health-food stores for almost every ailment under the sun, ranging from improving sex drive to burning fat. But even some nationally advertised brand-name products sold in large supermarket chain stores have crossed the line.

For example, several leading manufacturers have claimed that garlic supplements can help lower cholesterol and reduce the risk of heart disease. The . Agency for Healthcare Research and Quality convened an expert scientific advisory panel that concluded that it is "unclear" whether garlic-supplement pills can produce lasting changes in cholesterol levels. The panel's analysis of the scientific evidence found that garlic lowers cholesterol levels slightly after three months of use, but that effect did not persist to six months or longer. Three months is too short a period to have any significant impact on the risk of suffering a heart attack. (Preliminary evidence still holds out hope that garlic pills may help prevent blood clots, another risk factor in heart disease.) But without the authority to demand that such claims be authorized prior to marketing, the FDA is unable to protect the public; the agency lacks the resources to engage in lengthy "after-the-fact" litigation against the hundreds, perhaps thousands, of products that make misleading claims.

Unsafe ingredients, poor quality and misleading claims now may be adversely affecting sales; recent figures suggest that supplement sales are declining. The industry is running a public-relations campaign in an attempt to woo consumers back to supplements. But by continuing to demand weak regulation, the dietary-supplement industry essentially is shooting itself in the foot. And as more and more adverse reactions to supplements are reported in the media, and misleading health-related claims proliferate, consumers likely will turn away from supplements in greater and greater numbers. That would be unfortunate, as many supplements provide real health benefits.

It is, therefore, incumbent upon both industry and consumers to support a systematic, comprehensive review of dietary-supplement safety and efficacy. The review should be paid for by the industry and supervised by a public-health agency. Panels of scientific experts not associated with industry should choose priorities for review, based on risks to health, sales volume and other relevant factors. The panels should issue scientific monographs setting forth conditions for safe use, manufacturing standards, effectiveness and labeling requirements.

The National Academy of Sciences is finishing the first phase of a government-funded project to develop six prototype monographs on the safety (but not the effectiveness) of leading dietary supplement ingredients. That is a good start. But Congress should require companies that profit from supplement sales to pay for a comprehensive review of all products now on the market. Ultimately, Congress must modify the law so that the public is protected from ingredients found to be hazardous or useless.

BY BRUCE SILVERGLADE

Silverglade is director of legal affairs at the nonprofit Center for Science in the Public Interest, a health-advocacy group focusing on nutrition and food safety, based in Washington.

ILENE RINGEL HELLER, SENIOR STAFF ATTORNEY AT THE CENTER FOR SCIENCE IN THE PUBLIC INTEREST, CONTRIBUTED TO THIS ARTICLE.