This week, officials from the food and drug administration (FDA) took a 15-hour trial outside the scientific mainstream. During the two-day hearing, the agency invited the public to provide input on how to regulate homeopathic remedies – traditional rehabilitation methods are being questioned by numerous scientific studies. Currently, homeopathic medicines, which are mainly sold at the counter, are classified as unfda approved drugs listed in the United States. But the agency may be ready to reconsider its policy.
“We have the huge growth in the market, and also appeared some new problems of safety and quality,” Silver Spring, Maryland drug evaluation and research (CDER) compliance office director Cynthia Schnedar told Science Insider. “In view of this, we think it is time to see again.”
This 200 – year – old homeopathy – valued in the United States is a multibillion-dollar industry – is based on the principle of two controversial: first of all, cause specific symptoms in healthy people material can relieve the symptoms of a sick person if same at very low doses. Second, even if there is no detectable raw material molecule residue, repeated dilutions can actually make the treatment more effective.
The 37 speakers at the FDA’s hearing, from true believers to radical sceptics, have different manifestations – the two camps sometimes speak different languages.
“Homeopath is not feasible according to your own definition,” Michael derdola, director of public policy at the nonprofit research center in Washington, dc, told the panel in a statement on Monday. Including Australian national health and medical research council, a recent analysis of several big reaction has come to the conclusion that homeopathic treatments are not more effective than placebo in the treatment of any diseases. “We don’t have to spend a lot of time on this,” dedora said, “because the federal government is very clear about the scientific evidence against homeopathy.”
But other speakers – doctors and industry representatives – did spend a lot of time celebrating the medical value of treatment. During the five minutes after each conversation, the FDA team members carefully provided evidence to some of the speakers.
“You make me a man USES a lot of tools,” silver spring, Maryland, vice director of office of treating children Robert nelson told naturopathic physician Amy broom, then ask her how to make sure her patients benefit from the homeopathic alone. Ms. Rotenberg responded that about half of her patients started using homeopathy, although some received other forms of treatment from other doctors.
Elaine Lippmann, a legal adviser at the CDER’s office of regulatory policy, asked several of the same questions: “what is the scientific approach to safety and efficacy that is not consistent with homeopathic remedies?”
“It’s like comparing apples and eggs,” explains Carl Robinson, a homeopathic doctor in Houston, Texas. “Homeopathy is an observational science,” he says. Five patients with the same official diagnosis can receive five different treatments according to their complex mental, emotional and physical qualities. “It’s a different paradigm, that’s it.”
The cautious tone of the interrogation reflects the unusual position of the FDA for homeopathy. Since 1938, the agency has defined homeopathic products for drug, partly due to the United States senator and conveniently physicians Royal Copeland, he co-authored the federal food, drug, and cosmetic act. Since then, the FDA has relied on American homeopathic pharmacopoeia to determine what homeopathic medicine is. The list of substances – now 1,295 items – is maintained by an independent industrial organization, the United States convention on homeopathy. The material can be added to the list after the successful “proof” of homeopathic treatments, and the latter determines how they affect healthy subjects at different concentrations.
According to the FDA guidelines issued in 1988, the company can be on the counter sales of homeopathic products, but not to prove its safety or efficacy, and – unlike dietary supplements – their packaging can include treatment of specific diseases statement, as long as they are “self-limiting” is not a chronic. This can include sprains, colds or allergies.
But the FDA does monitor the quality and production of homeopathies, and recently raised some red flags. In 2009, when high levels of zinc in its Zicam cold medicine were associated with a loss of olfactory sense, it sent a warning letter to Matrixx Initiatives. In 2010, it warned that Hyland’s Homeopathic production of Homeopathic Homeopathic remedies for the potentially hazardous levels of poisonous nightshade plants. Last month, it advised consumers not to rely on various over-the-counter homeopathic asthma drugs to control their attacks. Since 2009, the FDA has issued 40 warning letters to homeopathic products manufacturers, increasing from 2002 to 2008.
At the hearing, the agency requested data to further assess the risks and benefits of listed products. Denver’s rocky mountain drugs and drug center toxicologist Edward Krenzelok said that during the period of 2006 to 2013, nearly 80000 times and regional poison control center call homeopathy, affects 98% of caller reported no or mild. Most of the calls – 92% – involve children under the age of six.
This relatively clean safety record is the talk point of several homeopathic proponents. Raby of Chicago, Illinois institute of general medical pediatrician Robert Dumont praised homeopathy “are very versatile in many medical problems,” assured the panel, and he was not worried about the adverse effects of other drugs, because he often suggested that under the concentration, “where there is no any interaction.”
But others believe that real public health risks arise when uninformed consumers decide to use homeopathic products instead of proven drugs. Charlottesville, professor of medicine at the university of Virginia and familial Mediterranean fever foundation chairman Janine Jagger describes the over-the-counter homeopathy, will be the same active ingredient as a rare hereditary inflammatory disease of prescription drugs. She says patients who think the highly diluted substance is comparable to prescription drugs can suffer serious injuries. “I have to explain this to patients over and over… And there are cases where I will never have a chance to explain that, “she said. “I hope to get help from the FDA.”
What changes the FDA will consider, if any, is unclear. The FDA’s Schnedar is careful not to suggest that it plans to tighten its rules. “There is no preconceived choice on the table,” she said.
Several speakers proposed De Dora argue that the FDA should make homeopathic products and enjoy the same pre-market approval process as much as other drugs – for regulators and manufacturers is a costly proposition. Others, including Georgetown university in Washington, dc, Adriane Fugh – Berman, suggested that the FDA to clarify the product label at least – for example, the concentration of the ingredients listed, in mg, rather than diluted with instrument.
Fugh-berman suspects that the prevalence of homeopathies may eventually inspire the FDA to draft new regulations, after decades of largely unhanded policy. “There are a few people in history who ignore homeopathy because they think it will die,” she said. “it keeps coming back.