WASHINGTON – After her son Devin was born last October, Grainne Ostrowski was determined to do whatever she could to protect him from the flu. When he was a few weeks old, Ostrowski, 32, let him suck on the same pellets she had taken during her pregnancy: an over-the-counter drug called Influenzinum, made from extremely diluted flu vaccine long marketed as an alternative to the conventional flu shot.
The executive leadership coach at the National Geospatial-Intelligence Agency says she and her son are taking the same pills now while they wait for the manufacturer, Washington Homeopathic Products, to ship this year’s seasonal-flu remedy, which may be combined with diluted H1N1 vaccine.
“He hasn’t been sick,” said Ostrowski, of Arlington, Va. “Homeopathy has no side effects. ... We don’t hear about people dying from homeopathy.”
Mounting concern about H1N1 and shortages of the vaccine are refocusing attention on homeopathic remedies, which are increasingly being used as an alternative to prevent or treat various forms of flu: swine, bird and seasonal. U.S. health officials say children younger than under 4 are among the groups most at risk from swine flu and have designated them a priority group for vaccination.
Meanwhile, the Food and Drug Administration has mounted an aggressive campaign against products making unproven or unapproved claims to fight swine flu.
While the gold standard for drugs and vaccines is proof of effectiveness in the form of trials, there is no rigorous evidence that homeopathy works. That hasn’t stopped a growing number of Americans from using it to battle a panoply of ailments, including arthritis, herpes and flu. A federally financed survey in 2007 found that in the previous year nearly 5 million Americans used homeopathic remedies, made from substances including duck liver, arsenic and poison ivy.
“I think consumers should be aware that many homeopathic products are manufactured and distributed without FDA approval,” said Elizabeth Miller, the Internet and health fraud team leader in the FDA’s Center for Drug Evaluation.
Homeopathic drugs “are not necessarily safe,” said David Schardt of the non-profit Washington-based Center for Science in the Public Interest. Homeopathic drugmakers “don’t have to play by the same rules – and I think consumers probably don’t realize that.”
Most homeopathic drugs don’t require a prescription because they are used for self-limiting conditions that resolve without treatment. Many are sold over the Internet, in health-food stores and in pharmacies, where they may be placed next to conventional over-the-counter drugs.
That is the case with Zicam, a homeopathic remedy, which is supposed to fight colds.
In June, the FDA warned consumers not to use three forms of Zicam because they had been linked to permanent loss of smell believed to be caused by zinc, the product’s active ingredient. In 2006, manufacturer Matrixx Initiatives agreed to pay $12 million to settle 340 lawsuits brought by consumers who claimed that Zicam Cold Remedy, a nasal gel and the company’s flagship product, had damaged or destroyed their sense of smell. Matrixx denied that Zicam was responsible and said that the damage was caused by a virus.
Washington Homeopathic Products, founded in 1873, has grown dramatically since 1991 when it was bought by farmer Joseph Lillard and his wife, Linda Sprankle-Lillard, who moved the storefront business from Bethesda, Md., to Berkeley Springs, W.Va. Eighteen years ago the firm had five employees, 3,000 customers and annual revenues of $150,000. Today it employs 40 people, serves more than 70,000 customers including 423 pharmacies and 1,000 health-food stores, and claims annual revenues of about $3 million.
Lillard said that Influenzinum, which he expects to make and ship soon in its 2009-10 formulation, is one of his more popular products. He says he can’t point to scientific studies showing that it works, although he says he uses the product and hasn’t gotten the flu. “People tell me it works,” he said. “I’m not sure what ‘science’ means.”
The FDA is mounting an aggressive swine flu fraud campaign, and it is limiting the claim’s that Lillard’s company can make about Influenzinum. The product, which is made by several companies, has been manufactured for decades. Until recently, the firm’s Web site said Influenzinum “is used to treat flu symptoms and possibly prevent flu.”
After FDA officials were asked about those claims, Lillard received a warning letter from the agency, which officials declined to discuss.
The Oct. 6 letter says that the Web site’s claims about Influenzinum 08-09, the product made last year, are “false and misleading” and ordered them “and all other promotional materials” immediately removed from the site.
Lillard said that he is complying with the FDA’s order and that this year’s Influenzinum will say it is “for flu.”
Ostrowski said the warning letter doesn’t alter her views of the product. “There are a lot of things out there that haven’t been scientifically proven that we take,” she said.
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