John Tozzi at Bloomberg is also on the homeopathy story.
On a recent afternoon in midtown Manhattan, I popped into a chain drug store and picked up some $12 sleep tablets whose label promises both “courage and peace of mind” and “focus when ungrounded.” I also got a $17 tube of cream offering “rapid, soothing relief of pain” from conditions as varied as arthritis, carpal tunnel syndrome, and bug bites. Both products sat on shelves alongside familiar drugs such as Tylenol and Claritin, which regulators have carefully scrutinized for safety and effectiveness. The half- dozen products I bought—labelled as “homeopathic”—aren’t vetted for either.
Tablets that give you courage and peace of mind – that’s funny. I suppose it wouldn’t have sounded spiritual enough to say “calms you the fuck down” – not that it does that either.
About 3.3 million Americans spent $2.9 billion on homeopathic treatments in 2007, according to the latest estimates from the Centers for Disease Control (CDC), though private industry research suggests a smaller market. The industry has “mushroomed” since the early 1980s, when homeopathic sales were just $1.5 million a year, says Bill Nychis, who worked at the FDA for 39 years in compliance and enforcement. At the time, the agency was midway through a decades-long process reviewing older over-the-counter drugs for safety and efficacy. The FDA had the authority to regulate homeopathic remedies, but because sales were so small, the agency opted to outsource much of that job to the industry itself. “Risk is always depending upon the number of products on the market and the sales volume of the products,” says Nychis, who now advises importers at FDAImports.com.
In 1988, the FDA issued a policy guide “where we basically allow these drugs to come to the market without premarket approval,” says Cynthia Schnedar, director of compliance for the agency’s Center for Drug Evaluation and Research. Federal regulators allow the sale of any substance listed in the Homeopathic Pharmacopeia, a document published since the 1800s and maintained by a nonprofit industry association. The remedies need to meet certain FDA manufacturing guidelines and can be marketed over the counter only for “self-limiting” conditions, meaning illnesses like colds that go away on their own.
Oh? Is that right? Then why are homeopathic asthma “treatments” sitting on the shelf at the chain drugstore less than a mile from where I am at this moment? Sitting on the shelf with the real asthma medications?
Critics of homeopathy say FDA action is overdue. Stephen Barrett, a retired North Carolina psychiatrist who operates the fraud-busting site Quackwatch, petitioned the agency in 1994 to require that homeopathic remedies meet the same standards for safety and effectiveness as other drugs. The agency has cracked down on claims that homeopathic products can treat cancer or substitute for flu vaccines, but Barrett says it hasn’t done enough to warn consumers about common over-the-counter remedies. “You can’t separate safety from effectiveness,” he says. “If it’s not effective, it’s not safe.”
And there are homeopathic asthma “treatments” out there. I can’t emphasize this enough. It’s not just for headaches and other things that can be hard to treat and aren’t fatal. Asthma.
Manufacturers of homeopathic products argue that the consumer should be the judge. “Millions of Americans use homeopathic medicines and want access to them,” says John P. Borneman, chief executive of Hyland’s Homeopathic and president of the industry association that publishes the Homeopathic Pharmacopeia. “These medicines are very effective, people like using them, [and] it’s part of consumer choice in the United States.”
No. Medicine is a technical subject. People can’t evaluate medicines on their own, and manufacturers can’t (and shouldn’t and mustn’t) be trusted to give all the necessary information on the package. Manufacturers of homeopathic products are doing it to make money, and they’re not going to say on the label “THIS IS FAKE MEDICINE.” It has to be an outside body that does that, one with no financial stake in the outcome – a disinterested party.
In the U.S., homeopathic remedies have become more common at national pharmacy chains, says Yale historian Naomi Rogers, who has studied the history of medicine and homeopathy. “Homeopathic drugs didn’t disappear, but they moved from prescription drugs to all over-the-counter drugs,” she says. “They start to be seen as—or even packaged as—the equivalent of special vitamins, special kinds of extra things you can take to stay healthy, or to get healthy, or to treat something that you have that you don’t want to go to a doctor for.”
Or just as one of the several asthma treatments on the shelf, and one that is cheaper than the others.
At this week’s hearing, the FDA will consider whether its current approach is “appropriate to protect and promote public health in light of the tremendous growth of the homeopathic market.” Barrett says the answer is no, and he suggested a way 20 years ago to deal with it: “Hold homeopathic drugs to the same standards as other drugs.” Which would probably make them harder to find at your local pharmacy.
I sure as hell hope so. It horrified me to find homeopathic asthma “treatments” right there on the shelf.