Who's Watching the FDA? Follow the Drug Money
by Mike Fillon

Anyone who follows today's health news knows that numerous studies have validated many of the health claims for vitamins, minerals and herbs the FDA had earlier rejected (some say suppressed). For example, the FDA for years refused to acknowledge research data concerning vitamin E and heart health.

First and foremost, the FDA is a public health agency, charged with protecting American consumers by enforcing the Federal Food, Drug, and Cosmetic Act (FD&C Act) and several related public health laws. The FDA originated in the late 1930s after the Massengil company marketed an antibiotic product called Elixir Sulfanilamide without prior toxicity testing of its solvent. The solvent-diethylene glycol (which is used today as automotive antifreeze) caused the death of 107 people, mostly children. This tragedy prompted the passage of the FD&C Act in 1938 and eventually led to the establishment of the FDA.

If a company is found violating any of the laws that the FDA enforces, the agency can "persuade" the firm to voluntarily correct the problem or to recall a faulty product from the market. A recall is generally the fastest and most effective way to protect the public from an unsafe product. When a company can't (or won't) voluntarily correct a public health problem with one of its products, the FDA can initiate legal sanctions. The agency can go to court to force a company to stop selling a product and to have items already produced seized and destroyed. When warranted, criminal penalties, including prison sentences, are sought against manufacturers and distributors.

For decades, the FDA tried to regulate the sale and use of vitamins, herbs and other dietary supplements. The FDA ruled that any products that are intended to affect the structure or function of the body are considered drugs. Throughout the 1950s and 1960s, the FDA brought hundreds of court actions against nutrition manufacturers for making health-related claims for their products. Under threat of law, food manufacturers were even prevented from labeling the fat, cholesterol, or other nutritional content of their food. Such labeling was later allowed with the Nutrition Labeling and Education Act of 1990 which made nutrition labeling mandatory.

The FDA actively prosecuted vitamin retailers that sold vitamins and other supplements in conjunction with books or pamphlets that extolled their use as a “drug” in curing or preventing disease. In 1975, the FDA expanded its control over supplements by declaring that vitamins sold in dosages as little as twice the federal recommended daily allowance (RDA), were automatically considered drugs. As a result, high-potency vitamins were effectively made illegal by this ruling because they could not be sold without FDA approval and the FDA would not approve supplements that it considered to be "unnecessary." Vitamin manufacturers and consumers fought back, and Congress passed the Proxmire Vitamin Mineral Amendment of 1976, which stated that the FDA could not classify a mineral or vitamin as a drug "solely because it exceeds the level of potency the FDA determines is nutritionally rational or useful."

Under the protection of the Proxmire Amendment, the dietary and nutritional supplement industry expanded. Undaunted, the FDA stepped up enforcement again in the early 1990s after thirty-eight deaths were attributed to L-tryptophan, an amino acid widely used for treating depression and building muscle mass. The Centers for Disease Control later exonerated L-tryptophan in the deaths, which were caused by a contaminant and not L-tryptophan. However, the FDA still has not lifted its ban on over-the-counter sales of L-tryptophan.

In 1985, the FDA lost a bitter battle with the Federal Trade Commission (FTC) and the National Institutes of Health (NIH). Under recommendation from the National Cancer Institute, a division of the NIH, the FTC permitted Kellogg's to claim that a high-fiber diet reduced the probability of certain types of cancer. The FDA wanted to sue Kellogg, but the FTC argued that the ads presented "important public health recommendations in an accurate, useful, and substantiated way." Under pressure, the FDA backed down, and food products could then advertise a "substantiated" health claim without going through the FDA drug approval process. Later, in 1993, the FDA announced that it planned to regulate all amino acids, herbs, and other supplements including fibers and fish oils as “drugs.” The FDA immediately found itself under a furious attack from millions of consumers and the supplement industry in general.

In response to the rising controversy between the FDA and its regulation of the supplement industry, the Dietary Supplement Health and Education Act (DSHEA) was passed in 1994. As a result, this law created a new regulatory framework for the safety and labeling of dietary supplements. Congress stated that there may be a positive relationship between sound dietary practice and good health, and that, although further scientific research is needed, there may be a connection between dietary supplement use, reduced health-care expenses and disease prevention.

Prescription drugs need to undergo various steps before they are approved for use. The industry boldly claims the cost of developing a new prescription drug is probably over $800 million. Public Citizen, a consumer watchdog group, seriously doubts this estimate. Suspecting the pharmaceutical industry is either not being truthful or they have really lousy accountants, they believe the true figure is more than likely at least 75 percent lower because much of the research is conducted under government grants. One thing is for sure, drug companies aren't too fond of untested dietary supplements that compete against their drugs.

According to a USA Today October 2000 article, the well-known pharmaceutical company Johnson & Johnson sent a team of executives to a Holiday Inn in Silver Spring, Maryland to persuade the FDA's panel of independent experts that their expensive antibiotic, Levaquin, should be the first drug approved to treat penicillin-resistant pneumonia. For Johnson & Johnson executives, the FDA's Anti-Infective Drug Advisory Committee included some people it knew quite well. At least two of the experts were paid consultants for J & J that had worked on the very same medicine they were being asked to evaluate for approval. The case of Levaquin shows how deeply rooted money and influence from the pharmaceutical industry can penetrate the drug approval process. The fact is, FDA advisory committees consist almost entirely of pharmaceutical industry consultants and researchers.

Because of the increased expense due to reforms and other costs, the FDA, Congress and the pharmaceutical industry negotiated the Prescription Drug User Fee Act of 1992. These user fees "forced" (or allowed, depending on your take) drug companies to pay a portion of the FDA' s cost to review marketing applications for drugs. Since user fees were first authorized ten years ago, the FDA has taken in $162 million dollars from the pharmaceutical industry. User fees also have provided Congress with a good reason to continue to underfund the FDA. As a result, there is not enough money for inspectors to regularly visit drug manufacturing plants in the U.S. and abroad to make sure good manufacturing standards are maintained, nor are there enough to regularly inspect the safety of the thousands of food products that come under FDA authority.

Overmedication and adverse reactions, including unnecessary deaths due to prescription drugs are also a big problem that seems to be “overlooked” by the FDA. In 1994, pharmaceutical drugs accounted for 106,000 deaths, according to the Journal of the American Medical Association. More people are killed by adverse reactions to prescription drugs than by pulmonary disease or accidents. It's now estimated an average of 137,000 people die each year just as a result of taking prescription medication where no mistakes or abuse is involved. Studies estimate that two million Americans are hospitalized annually from drug side-effects.

Part of the FDA's job is to track side-effects of the medication after it's approved for sale so that health officials can take action if unexpected problems arise, and to develop strategies for preventing drug related injuries. But the FDA learned of just 9,961 medication-related deaths and 33,541 hospitalizations in 1997, said a 1998 report from the Health and Human Services inspector general. Why? The problem lies in the voluntary nature of the injury reporting system, the report said. In simple terms, the FDA can require drug manufacturers to report only the injuries they learn about that involve their drugs. The FDA does not have the authority to require doctors and hospitals to report injuries, either to the government or to the drug companies themselves.

Advertising and marketing prescription drugs escalated more than 12 percent per year in five of the eight years between 1993 and 2000. Spending on retail prescription drugs increased 18.8 percent from 1999 to 2000 and it’s anticipated that the increase will continue to be between 15 and 20 percent annually for the foreseeable future. Major drugs in these classes are extensively advertised both to prescribing physicians and directly to consumers. Interestingly, the ten drugs with the heaviest direct-to-consumer advertising accounted for 34 percent of the total increase in spending. Those drugs will probably sound familiar. They include: Vioxx and Celebrex (COX-II inhibitors), Claritin and Allegra (for allergies), Paxil (for depression), Prilosec and Prevacid (for GERD), Zocor and Pravachol (for hyperlipidemia) and Viagra (for erectile dysfunction).

The FDA also has control over approving new foods and ingredients. Let's examine the case of the fat substitute olestra. When first announced, many people were excited about olestra because of the possibility it could assist people in eating diets lower in saturated and overall fat, thereby preventing obesity and heart disease. But there were some problems. Simply put, olestra causes gastrointestinal disturbances (which are sometimes severe), including diarrhea, fecal urgency and loose bowel movements.

Data is lacking on the health effects of olestra on potentially vulnerable segments of the population like those already with compromised lower digestive disease (Crohn’s disease, IBS, colitis, etc.) Key tests were unacceptably brief.

Excerpted and edited with permission from the new book, “Ephedra Fact & Fiction: How Politics, the Press and Special Interests are Targeting Your Rights to Vitamins, Minerals and Herbs” (Woodland Publishing; 2003; $14.95; www.woodlandpublishing.com). Fillon is also the author of “Real RDAs for Real People.”