CAMBRIDGE, Mass. -- The unsettling little secret of Zicam Cold Remedy finally spilled out this week. Though widely sold for years as a drug for colds, it was never tested by federal regulators for safety like other drugs. And that was perfectly legal -- until scores of consumers lost their sense of smell.
One little word on Zicam's label explains all this: "homeopathic."
Zicam and hundreds of other homeopathic remedies -- highly diluted drugs made from natural ingredients -- are legally sold as treatments with explicit claims of medical benefit. Yet they don't require federal checks for safety, effectiveness or even the right ingredients.
Many scientists view homeopathic remedies as modern snake oil -- ineffective but mostly harmless because the drugs in them are present in such tiny amounts.
But an Associated Press analysis of the Food and Drug Administration's side effect reports found that more than 800 homeopathic ingredients were potentially implicated in health problems last year. Complaints ranged from vomiting to attempted suicide.
In the case of Zicam, the FDA says it tied the drug to reports from 130 consumers who said they lost their sense of smell.
The agency on Tuesday told Zicam maker Matrixx Initiatives to stop marketing three products that carry zinc gluconate: Zicam Cold Remedy Nasal Gel, Nasal Swabs and discontinued Swabs in Kids' Size. The agency said the drug must be tested for safety and benefit, like a conventional drug, before it is again marketed. And the FDA warned people not to use the three Zicam products.
"It never occurred to me they could be dangerous and there was no kind of oversight -- like the FDA -- that ensured there was safety," says former Zicam user David Richardson of Greensboro, N.C. He has complained to the FDA about losing his sense of smell and filed his case with a lawyer for a future lawsuit, joining hundreds of others who have claimed in recent years that they lost their sense of smell from Zicam cold products.
Homeopathy's roots
Homeopathy sprang from the inventive -- some would say fanciful -- mind of German physician and chemist Samuel Hahnemann in the late 1700s. Experimenting on himself, he became convinced that if an ingredient causes a symptom in a healthy person, it will treat the disease that causes the same symptom. He also theorized that diluting ingredients to minuscule concentrations paradoxically makes them more powerful.
To this day, homeopaths put forth mystical-sounding explanations involving "vital force" and "healing energy." And with arcane ingredients like "nux vomica" and "arsenicum album," many homeopathic medicines sound like something brewed in a druid's kettle.
Pharmacist Albert Lavender, retired deputy director of the FDA's unit overseeing drug labels, calls it "a big fraud" on the consumer.
"He might not get hurt most of the time, but his pocketbook is getting hurt all of the time," he says. "It doesn't make sense" that the FDA requires homeopathic medicine to bear a label saying what it treats, he says, because, in his view, most of it treats nothing.
Some are sold
Though many homeopathic remedies consist mostly of sugar or alcohol, thousands of patients swear by their effectiveness.
Amanda Rafferty of Haverhill took homeopathic sanguinaria canadensis, made from a toxic herb known as bloodroot, for her monthly migraine headaches. She says her next migraine didn't come back for a full year.
She says she had no idea that such remedies weren't checked by the government but voiced contempt for "the whole system" of government regulation.
Her homeopath, Begabati Lennihan of Cambridge, treats headaches, colds, ear infections, digestive complaints, depression and behavioral problems.
With only about 2,500 full-time U.S. homeopaths, patients routinely diagnose themselves. Dr. Ahmed Currim, one of 13 state-licensed homeopathic doctors in Connecticut, discourages people from buying homeopathic remedies without professional advice, because they "don't know what they're doing."
