SILVER SPRING, Md. -- A panel of FDA officials heard a wide variety of opinions during a 2-day hearing on how strictly homeopathic medicines should be regulated.
"I am most concerned about the stocking of homeopathic remedies labeled for specific conditions alongside regular over-the-counter (OTC) drugs," , associate professor of pharmacology and physiology at George Washington University in Washington, said Monday. "Most consumers have no idea what homeopathy is and may assume ... these are dietary supplements or even conventional drugs."
Popularity on the Rise
Homeopathic drugs have become more popular in recent years, as the FDA noted in a notice announcing the meeting. In 1988, the homeopathic drug market was considered a "multimillion dollar industry," but in 2007, the CDC's National Health Interview Survey "estimated that adults spent about $2.9 billion on the purchase of homeopathic medicine." The agency said it called the hearing to seek "broad public input on the current enforcement policies related to drug products labeled as homeopathic in an effort to better promote and protect the public health."
In its (CPG) describing conditions under which homeopathic drugs may be marketed, the FDA defines homeopathy as "the practice of treating the syndromes and conditions which constitute disease with remedies that have produced similar syndromes and conditions in healthy subjects."
The guide defines a homeopathic drug as "Any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopia of the United States (HPUS), an addendum to it, or its supplements," and adds that "Drug products containing homeopathic ingredients in combination with non-homeopathic active ingredients are not homeopathic drug products."
Fugh-Berman, who has written several books on complementary medicine and formerly worked at what is now the National Center for Complementary and Integrative Health at the NIH, is no fan of homeopathy. She cited a by Australia's National Health and Medical Research Council, which looked at 57 systematic reviews involving 176 studies of homeopathy.
The paper concluded that "there was no reliable evidence from research in humans that homeopathy was effective for treating the range of health conditions considered: no good-quality, well-designed studies with enough participants for a meaningful result reported either that homeopathy caused greater health improvements than placebo, or caused health improvements equal to those of another treatment."
But others speaking at the hearing begged to differ with Fugh-Berman's opinion. "I have found homeopathic medicines to be a very valuable addition to my practice," , a pediatric pulmonologist at Northwestern University's Feinberg School of Medicine in Chicago, said at Tuesday's session.
In addition to using homeopathic medications alongside standard asthma treatments such as inhalers and steroids, Chung said she also uses them "in conditions where we have no effective drugs, or to treat side effects of drugs ... I've used them in chronic cough, for dyspnea due to vocal chord dysfunction syndrome ... and also for prevention of recurrent croup, which allows us to decrease emergency department visits."
Many homeopathy proponents who spoke pointed out the lack of side effects engendered by homeopathic remedies. , a consulting clinical toxicologist at the Rocky Mountain Poison Control Center, in Denver, said that a study by the center found that from 2006-2013, there were 12 million single-product exposures reported to poison control centers, and 80,456 of those involved homeopathic products.
The vast majority of the homeopathic exposures -- 92% -- involved children under 6, and fewer than 500 of those exposures involved follow-up care at a healthcare facility, Krenzelok said. The study was funded by the Consumer Healthcare Products Association, a trade group for the makers of OTC healthcare products.
But having no adverse effects doesn't mean something is harmless, said , president of the Familial Mediterranean Fever (FMF) Foundation. Jagger, who is also a professor of medicine at the University of Virginia in Charlottesville, noted that even though there is an effective treatment -- colchicine -- for FMF, many patients see a homeopathic remedy called colchicum autumnale and decide to try that instead, thinking that it's an OTC form of colchicine.
"In the case of FMF, substituting nothing for prescription colchicine is very serious when the patient is deprived of [effective therapy]," she said. "I ask that the FDA provide very explicit labels to avoid this kind of mistake by consumers."
Changes Called For
Fugh-Berman also suggested that homeopathic drugs should be separated from non-homeopathic remedies. In addition, "homeopathic remedies should have to disclose ingredients ... using standard dosage terms, including how much of the active ingredient they contain," she said. Fugh-Berman urged that these medications be submitted under a New Drug Application and reviewed by the FDA, but until that happens, "I strongly recommend a disclaimer be added to homeopathic drug label saying it's a homeopathic remedy and has not been reviewed by the FDA."
On the other hand, , of the Arizona Homeopathic and Integrative Medical Association, said during Monday's session that in his group's opinion, "there is no need to change the CPG guidelines; the public is adequately protected by FDA regulatory authority ... good manufacturing practices, the Federal Trade Commission, and the legal system."
Shelton, of Phoenix, added that the current CPG "provides substantial guidance for the marketing of homeopathic products."
One thing that many speakers did agree on -- including both supporters and critics of homeopathy -- was the need to crack down on manufacturers who labeled their products as "homeopathic" even though they also contained other ingredients.
"We've found a number of products that use several ingredients where the homeopathic drug is only one part and the rest of the active ingredients are not homeopathic," , of Enfield, Conn., board member of the American Association of Naturopathic Physicians (AANP), said Monday. "The AANP agrees with FDA that these should not be marketed as homeopathic products, and this comes back to ... accuracy that needs to go into any labeling that's done."
Evidence of Efficacy?
The FDA officials on the panel questioned several homeopathy proponents about the evidence available to show that homeopathy is effective. After , interim president of the North American Society of Homeopaths, said that there was a "long-established record of safety and efficacy in homeopathy," panelist , regulatory counsel at FDA's Center for Drug Evaluation and Research, asked Kell where the evidence for efficacy could be found.
"This is more a compilation of anecdotal evidence; when I studied social work, that was an accepted form of evidence," replied Kell, of Nashville, Tenn. "Homeopathy has hundreds of millions of [anecdotal stories] and we feel they are a legitimate source of data."
Homeopathic medications are typically tested for efficacy using "provings," a process in which the homeopathic remedy is given to an otherwise healthy person to see if it produces symptoms of the disease that the medication is being used for. Lippmann asked , of the Texas Society of Homeopathy, what it is about the FDA's approval process -- which involves reviewing data from randomized, controlled trials -- that is inconsistent with the practice of homeopathy.
"It's a totally different paradigm," said Robinson, of Houston. "Conventional drugs are first tested on animals and then later on sick people. Ours are only tested on healthy human beings."
He added that homeopathic treatments are very individualized. "Let's say you have five people with infectious Hepatitis A. A homeopath might well ... give five different homeopathic medications, all of which could work and restore the patient to health within a short time."
One point of agreement for many speakers was that the proper use of OTC homeopathic remedies is only for acute, self-limiting diseases such as colds. , president and CEO of Southwest College of Naturopathic Medicine and Health Sciences, in Tempe, Ariz., noted that some OTC homeopathic medications have been wrongly marketed for chronic conditions such as asthma, "ignoring the OTC limitation to self-limiting disease conditions amenable to self-treatment."