A June 21 editorial in the Washington Times made the point that it was the accuracy of claim placed on the side of the Cheerios box promoting the cereal’s cholesterol-lowering properties that did it in, not false statements or misrepresentation. Apparently, the term “coronary heart disease” was way too specific for tender eyes at the FDA, as opposed to plain vanilla “heart disease,” and thus General Mills, Inc. was slapped with a mandate to obtain an approved drug application in order to market Cheerios legally. FDA press officer, Susan Cruzan, made the FDA into a laughingstock when she explained how the preciseness of the cereal-maker’s language outweighed truthfulness.
The FDA, formed in 1906, is today an agency comprised of nine offices and bureaus under the umbrella of the U.S. Department of Health and Human Services. Post 9/11, this huge behemoth works in tandem with the likes of the Drug Enforcement Agency and the Department of Homeland Security to safeguard the people’s foods, dietary supplements, drugs, vaccines, biological medical products, blood supplies, medical devices, veterinary merchandise, and even cosmetics. The original justification for the agency was to protect public health and inspect for dangerous diseases and faulty drugs before products got to grocery and pharmacy shelves.
But like so many bureaus and offices since the 1960s, the FDA has become “too big for its britches,” throwing its weight around helter-skelter while neglecting the job for which it was created. Drug after drug has come to market, only to be recalled very publicly after many people have been sickened and even died.
Psychiatric drugs comprise a case in point, since these are among the newest products aggressively being marketed, especially to youngsters who either are misbehaving or experiencing learning difficulties. For reasons that escape many pediatric neurologists, such as Dr. Fred Baughman of California, the FDA questions neither the whole concept of “emotional diseases” nor the drugs purported to cure them. Indeed, most such drugs haven’t been around long enough to support a track record. The only thing known for sure is that these legal, mind-altering substances are so riddled with side-effects that a virtual cocktail is frequently dispensed to counteract the unwanted outcomes.
One would think alarm bells would have gone up long ago in offices at the FDA when children on psychotropic drugs started committing spectacular atrocities. Instead, the FDA is busy slapping black-box warnings on one psychotropic drug after another, after the fact, and cautioning manufacturers of all pharmaceuticals to provide TV viewers and magazine readers with page-long lists of “possible side effects” in their promotions. Unfortunately, most patients lack the training necessary to assess whether this confusing list applies to them.
Meanwhile, tainted foods (spinach leaves, peanuts, etc.) are being distributed through our groceries and restaurants at an alarming rate. The peanut scare that resulted in salmonella being transmitted through peanut butter is just one in a long list of recent incidents pointing to a lack of inspection services that the public has grown to expect for its FDA tax dollars.
The FDA has bigger fish to fry than Cheerios. For example, over-the-counter medications like Excedrin Migraine contain the exact same ingredients as Extra Strength Excedrin, yet the former claims to stop migraines — a patently ridiculous assertion to any sufferer who reads the ingredients. Like the cop who prefers to troll for easy marks along a tame stretch of roadway-turned-speed trap, the FDA pursues the simple cereal-maker over a more complicated pharmaceutical industry.
Over-the-counter medications are not the only items with misleading packaging. Pharmaceutical moguls have figured out that they can rope in additional population sectors by simply changing the name and packaging of existing products. Take Eli Lilly’s so-called “antidepressant,” Prozac. It got a new color (pink) and a new name (Sarafem) for treatment of premenstrual dysphoric disorder (PMDD) in women.
What is PMDD? The list of symptoms includes depression, anxiety, irritability, anger, lethargy, changes in appetite, and bloating. Had advertisers left it at “bloating” — a confirmable, objective ailment, if not quite a disease — they might have gotten by with the ruse, even if the drug didn’t work. But in the rush to legitimize more mental “illnesses” and administer mind-altering drugs to as many people as possible, Lilly opted for Sarafem, which reads like a dead-ringer for Prozac, given the identical empirical formula (reprinted in a 2006 book by investigative journalist Kelly O’Meara, Psyched Out). But it was the directions that gave the game away. Women were supposed to take Sarafem only during the two weeks before their menses — “a new concept, a mental illness: [one that] comes and goes every two weeks,” interjects author O’Meara — whereas Prozac patients have to take their drug every day and avoid discontinuing it too suddenly! So, if the ingredients in Sarafem are identical to the ingredients in Prozac, the warning given in the directions makes no sense. To underscore the farce, O’Meara reprinted a sentence from Lilly’s letter to healthcare professionals: “Prozac [is] no longer authorized for treatment of … PMDD.”
Meanwhile, the only persons not being harassed over their medications are junkies and drug-runners. The laughable Health Insurance Portability and Accountability Act (HIPAA) injects the usual slew of useless paperwork into an already compromised individual privacy gambit and a failed War on Drugs. Numerous folks have reported picking up their prescriptions and signing for them, only to get home and receive notification an hour later on their computers (usually landing in their spam filters and junk mail) offering the same medication cheaper from questionable, online sources. Some of these medicines are atypical, lending credibility to the idea that pharmacy computers are being hacked by opportunists. Worse, however, is that this means so-called privacy laws like HIPAA, enacted by government, are unworkable or maybe even bogus.
The fact is, most people, including Baby Boomers, have never used “recreational” drugs, abused prescription drugs, or driven a car “under the influence.” Yet, these law-abiding citizens are targeted, while traffickers of illicit drugs are out on probation in a New York minute. When law-abiding citizens have a painful medical condition, they often run a gamut of insulting drug-screening tests (aimed actually at illegal drugs) on a regular basis merely to obtain their prescriptions, while officials look the other way when a member of the political elite has a record of selling or partaking of illicit drugs in their younger days. Worse, good citizens who play by the rules are not protected after helping law enforcement stop traffickers and identify gang members (see: No Angel, the biographical bestseller by Jay Dobyns, the undercover cop at Arizona’s office of the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives whose family and home was targeted by Hell’s Angels thugs).
Moreover, the FDA’s Cheerios charade is symptomatic of much more than bureaucratic overkill. It is about a government that is out of control — a government that protects itself, not American citizens.
Beverly K. Eakman is a former teacher and retired federal employee who served as speechwriter for the heads of three government agencies. Today, she is a Washington, D.C.-based freelance writer, the author of five books, and a frequent keynote speaker on the lecture circuit. Her just-released book is Walking Targets: How Our Psychologized Classrooms Are Producing a Nation of Sitting Ducks (Midnight Whistler Publishers).
Photo: AP Images
