Are the homeopathic drugs that you pick up to treat allergies and colds bogus?
That question was hotly debated during a Food and Drug Administration public hearing Monday on whether to step up regulation of homeopathic products, which don't face the same scrutiny as regular drugs. Homeopathic drugs have been in existence for more than 200 years and have become a multibillion-dollar industry.
They are developed based on the 200-year-old theory that disease symptoms can be cured by small doses of substances that would make healthy people sick, according to the FDA.
A key part of the hearing was whether the products are effective.
"The evidence for homeopathy's effectiveness is between scant and nil," said Adriane Fugh-Berman, a pharmacology professor at Georgetown University Medical Center at the meeting.
Fugh-Berman cited a recent effort by Australian researchers to pore through more than 170 studies on homeopathic medicines. The researchers concluded there is no reliable evidence homeopathy is effective.
A supporter of homeopathy shot back that the Australia study was "poorly done" and doesn't take into account specific treatments or conditions and do analyses of those treatments.
While there have been some studies that showed homeopathy to be effective, those results should be discarded due to the placebo effect, said Michael De Dora, director of public policy for the advocacy group Center for Inquiry. The studies also can't explain how the treatment worked, added De Dora.
Under the placebo effect, a patient takes a fake treatment like a sugar pill and believes he or she is getting better.
Physician Bruce Shelton said he has used homeopathy throughout his practice for the past 25 years. He said it is critical to his practice and has never had any safety or quality issues.
Another supporter added that over decades of use, no problems of variability with the quality of homeopathic products have been found, and no toxicity has been reported, said Amy Rothenberg, a board member of the American Association on Naturopathic Physicians, a group of physicians who practice homeopathy.
However, the agency does have some safety concerns with the products. A 2012 report of data from U.S. poison centers found 10,311 reported poison exposure cases related to homeopathic agents that year, and a large majority were linked to children, the FDA said in the federal register notice announcing the meeting.
The FDA hasn't looked at regulation of homeopathic drugs since 1988, and the agency hasn't reviewed the class of products for safety and efficacy, according to the notice.
A homeopathic product must meet strength, quality and purity standards outlined in a large book called a pharmacopeia published by experts. The book explains how a specific homeopathic product should be made. The manufacturer of a product must generally meet the book's standards for strength, quality and purity.
The FDA has recognized the pharmacopeia for homeopathic products and approves over-the-counter drugs the same way.
De Dora said that homeopathic drugs should meet the same requirements as regular drugs, including clinical trials, to ensure they are safe and effective.
Homeopathic drug makers pushed back against further agency oversight.
"There is this misperception that homeopathic products escape the scrutiny of the FDA," M'lou Arnett, CEO of Matrixx Initiatives Inc., told the Washington Examiner last week. Matrixx makes the homeopathic cold and allergy treatment Zicam.
Arnett emphasized that manufacturers must register with the agency and meet manufacturing quality standards. Such products also have to meet labeling requirements but don't have to test their active ingredients.
The regulatory framework "as it currently stands is adequate and appropriate to ensure that consumers have continued access to the products they enjoy for their self-care needs," said Arnett, who also testified at the hearing, which continues on Tuesday.