In an attempt to halt the sale of homeopathic remedies that may be ineffective or even “potentially harmful,” the U.S. Food and Drug Administration announced on Monday that it would move toward tougher scrutiny of some products.
“Until relatively recently, homeopathy was a small market for specialized products,” the FDA’s announcement noted. “Over the last decade, the homeopathic drug market has grown exponentially, resulting in a nearly $3 billion industry that exposes more patients to potential risks associated with the proliferation of unproven, untested products and unsubstantiated health claims.”
The American Association of Homeopathic Pharmacists (AAHP) responded with a statement, noting that it “shares the FDA’s commitment to protecting public health and applauds the Agency’s plan to take quick action against illegal or unsafe homeopathic medicines. In fact, the Association encouraged FDA to do just that in its comments at the regulatory body’s April 2015 workshop on the topic.”
The AAHP’s volunteer spokesperson, Alissa Gould (also a paid spokesperson for Boiron, the France-based manufacturer of many of the most popular homeopathic over-the-counter products), stressed that the FDA’s announcement is not as dire as many in the alternative-health world seem to fear. “We’re not surprised by it, and we’re pleased that they took some of our recommendations,” she tells Yahoo Lifestyle.
Still, some homeopathic professionals and adherents see the move as just the latest in a systematic attempt to discredit the field.
“The FDA’s concerns in this case are completely misplaced,” Larry Malerba, D.O. (doctor of osteopathy) and author of the book Dynamic Medicine: The World According to Homeopathy, tells Yahoo Lifestyle. “You can have unscrupulous homeopathic product makers on the fringe who are not following the rules. They do exist,” and should be rooted out, he says, but “if [the FDA] were truly concerned about safety, it’s conventional pharmaceuticals that don’t hold a candle” and are what should be more deeply scrutinized for safety.
Some proponents of homeopathy took to social media to express feeling unnerved by the announcement.
Homeopathy is an ancient approach to healing, codified 200 years ago by a German physician. It’s based on the principal that “like cures like,” meaning that highly diluted doses of the symptoms themselves (made from animal, vegetable, or mineral matter) are used as remedies to get to the root of an illness, helping the body repair itself. The approach is viewed as a respected alternative medicine in countries around the world, including Switzerland (where a large study deemed it both effective and cost-effective), Brazil, India, and the U.K. (where members of the royal family are reportedly fans), all of which include it in their national health systems.
The system’s popularity in the U.S. has grown recently — with usage up 15 percent in five years, according to a 2016 health survey out of Harvard — and celebs including Cindy Crawford, Paul McCartney, David Beckham, and Usain Bolt have sung the praises of homeopathy. Meanwhile, products traditionally relegated to health-food stores, such as Oscillococcinum, Coldcalm, and Arnicare —over-the-counter, homeopathic remedies that target flus, colds, and body pains, respectively — now sit on the shelves of stores like Walgreens, right beside mainstream options such as NyQuil and Icy Hot. And they are among the many products carrying the official label of the Homeopathic Pharmacopeia of the U.S. (HPUS), which “tells you it’s been made according to standards,” says Malerba.
The proliferation of products has come about, in part, because of the FDA itself, which has had relaxed policies over the years. While homeopathic remedies are technically required to meet the same approval rules as other drugs in the U.S. market, a 1988 FDA policy called for “enforcement discretion” to allow distribution of homeopathic remedies with regulation but without FDA approval.
Now, as per the latest announcement, that could change, with enforcement and regulatory actions becoming a priority — at least when it comes to products deemed as having “the greatest potential to cause risk to patients.”
“Under this approach, many homeopathic products will likely fall outside the risk-based categories described in the new draft guidance and will remain available to consumers,” the announcement notes. Instead, the FDA plans to focus on the following types of homeopathic products: those with reported safety concerns; products with “ingredients associated with potentially significant safety concerns”; those administered in ways other than orally or topically, meant to treat serious and/or life-threatening conditions; items meant for “vulnerable populations”; and those that “do not meet standards of quality, strength or purity as required under the law.”
FDA Commissioner Scott Gottlieb notes in the announcement, “In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse — that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren’t adequately tested or disclosed to patients.”
Specifically, the agency points to past incidents in which homeopathic teething tablets were found to contain the toxic nightshade belladonna, and in which pellets (the common form of homeopathic medications, which are placed under the tongue) labeled “nux vomica” were a derivative of strychnine.
But, says Gould, “I hope [the FDA] understands what a high dilution this is when you’re talking about ingredients that can sound a little scary.”
Stories covering the FDA’s announcement this week stated that homeopathy was “worthless,” and noted that critics claim there is “no scientific evidence to support homeopathy,” all referring to a widely publicized 2015 study by the Australian government. But that study has been pointedly discredited by critics, including the scientists at the London-based nonprofit Homeopathy Research Institute, which claims the following problems, among others: that an original report with more favorable homeopathic findings was buried; that the report drew evidence from only 176 studies, rather than the oft-cited total of 1,800; and that the leader of the report’s committee was the undisclosed head of a homeopathic-skeptics organization.
The controversy over the Australian study wound up becoming featured in a new documentary about homeopathy, Just One Drop, by New York City filmmaker Laurel Chiten.
“I knew there was evidence that homeopathy works, so I was like, what is this about? And I was compelled enough to get on a plane to Australia,” Chiten tells Yahoo Lifestyle about her reaction to news coverage of the report, which broke while she was in the midst of making the film. “Homeopathy is so implausible to some, so they think people who practice it are charlatans,” she says. “But it’s had great success. We just don’t yet fully understand it.”
Malerba, who has been practicing for 30 years, stresses that part of the disconnect is that while allopathic, or traditional Western medicine, treats the diagnosis — pneumonia, depression, the flu, etc. — homeopathy treats the person, with a trained physician like himself figuring out the specific cocktail of pellets to target those very individual symptoms.
“We are programmed to think in terms of diagnostic labels and paint-by-numbers medicine, but my pneumonia is not the same as your pneumonia,” says the doctor, adding that regulatory agencies like the FDA “know damn well that’s how it works. But you’ve got to conform to conventional drug research standards. So the game is rigged.”
Bottom line, he says, “It should be about freedom of choice.”
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