This week, officials of the US Food and Drug Administration (FDA) has taken a 15-hour incursion far outside current scientific . At a hearing of two days, the agency invited public comments on how it should regulate, a traditional healing practice homeopathy has been challenged by many scientific studies. For now, homeopathic remedies, largely sold over the counter, are considered drugs that can be marketed without FDA approval in the United States. But the agency can be prepared to rethink its policy.
"We have had phenomenal growth in the market and also security and emerging quality," Cynthia Schnedar, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research (CDER ) in Silver Spring, Maryland, said science Insider. "in light of this, we thought it was time to take another look."
The 0-year practice of homeopathy, estimated to be a multi-billion the United States-is based on two controversial principles: first, a substance that causes a particular symptom a healthy person can relieve the same symptoms in a sick person if consumed at a very low dose. Second, the dilution several times a substance actually makes a more powerful treatment, although no detectable molecules of the original substance remains.
The 37 speakers at the FDA hearing ran the gamut of true believers to skeptics and supporters of both camps sometimes seem to speak different languages.
"By its own definition, homeopathy can not work," Michael De Dora, director of public policy at the nonprofit Center for Washington, the investigative branch, said the panel in its presentation Monday. Several major metastudies, including a recent analysis by the Medical Research Council of Australia National Health and concluded that homeopathic remedies are no more effective than placebo for the treatment of any condition. "We should not spend much time on it," Dora said, "that the federal government is well aware of the scientific evidence against homeopathy."
But other doctors stakeholders and industry representatives he spent much of their time touting the value of medical treatments. And during the question period of 5 minutes after each presentation, the FDA panelists gently squeezed some of the speakers on their testimony.
"You strike me as someone who uses a lot of tools," Robert Nelson, deputy director of the Office of the FDA Pediatric Therapeutics in Silver Spring, Maryland, said Amy Rothenberg naturopathic physician before ask how she could be sure that his patients benefited from homeopathy alone. Rothenberg said she prescribes exclusively homeopathic treatments to about half of his patients, although some receive other forms of treatment other doctors.
Elaine Lippmann, the regulatory lawyer in CDER's Office of Regulatory Policy, asked the same question to several participants: "What about the scientific method to demonstrate the safety and effectiveness that our approval process that is inconsistent with homeopathy "
" it is like comparing apples and eggs, "said the homeopathic doctor Karl Robinson Houston, Texas. "Homeopathy is a science of observation," he said. Five patients with the same diagnosis official could receive five different treatments according to their mental, emotional and physical complexes. "It's a different paradigm, that's all."
The careful questioning tone reflects the unusual status FDA granted homeopathy. Since 1938, the agency has identified homeopathic products as drugs, partly thanks to US Senator and doctor Copeland Royal homeopath, who co-wrote the Federal Food, Drug and Cosmetic Act. since then, the FDA is based on a document known as the homeopathic pharmacopoeia name of the United States to determine what counts as a homeopathic drug. This list of substances now-1295 long articles is maintained by an independent industry body, the Convention Homeopathic Pharmacopoeia of the United States . the substances may be added to the list after they have had success "prove" to homeopaths trained, which determine how they affect the healthy subjects at various concentrations.
under FDA guidelines issued in 1988, a company can sell homeopathic products on the counter without demonstrating their safety and effectiveness, and unlike dietary supplements, packaging may include claims on the treatment of specific conditions, as long as they are "self-limitation" and not chronic. These conditions include sprains, colds or allergies.
But the FDA not ensure the quality and manufacture of homeopathic products, and recently raised several red flags. In 09 he issued a warning letter to Matrixx Initiatives when have been linked to a loss of smell among users high levels of zinc in several of its remedies against the Zicam cold. In 2010, he warned that homeopathic teething tablets produced by homeopathic Hyland contain potentially dangerous levels of toxic Solanaceae plant. And last month, he advised consumers not to rely on a variety of over-the-counter homeopathic remedies to control asthma attacks. FDA issued 40 warning letters to homeopathic product manufacturers since 09-up of nine letters between 02 and 08.
At the hearing, the agency requested data that would further assess risks and benefits of the products already on the market. Toxicologist Edward Krenzelok the Rocky Mountain Poison and Drug Center in Denver said that nearly 80,000 calls related to homeopathic regional poison control centers from 06 to 2013, 98% of callers reported no effect or side effects of the exposure. Most children-92% of calls -involved under 6.
This relatively clean safety record has been a starting point for many supporters of homeopathy talking. Pediatrician Robert Dumont Raby Institute for Integrative Medicine in Chicago, Illinois, who praised homeopathic remedies as "exceptionally versatile in many medical problems," assured the panel that he did not care about negative interactions with other drugs, because concentrations it generally recommends, "there is nothing in there to interact."
But others have argued that the real risk to public health emerge when consumers uninformed decide to use homeopathic remedies instead of proven medical treatments. Janine Jagger, a professor of medicine at the University of Virginia in Charlottesville and president of Familial Mediterranean Fever Foundation, described over-the-counter homeopathic remedies that list the same active ingredient as a prescription treatment for a rare genetic inflammatory disease. patients who believe that highly diluted substances is comparable to prescription medication may suffer serious harm, she said. "I need to explain more and more and more patients ... and there are cases that I will never have the chance to explain it," she said. "I would have with the FDA."
Just what kind of changes FDA would consider, if necessary, are not yet clear. Schnedar FDA is careful not to suggest that it plans to tighten regulations. "There is no preconceived options on the table," she said.
Several speakers made suggestions. Dora argued that the FDA should submit homeopathic products to the same process prior approval for marketing other drugs, a costly proposition for both regulators and manufacturers. others, including Adriane Fugh-Berman of Georgetown University in Washington, DC, suggested that FDA could at least clear product labels, for example, listing the concentrations of ingredients in milligrams rather than the number of times they were ritually diluted.
Fugh-Berman suspect that, after decades a policy essentially hands-off, the current popularity of homeopathic products can ultimately inspire FDA to draft new regulations. "There were several moments in history where people have simply ignored homeopathy because they thought he was dying, "she said," And it keeps coming.
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