FDA Takes Another Look at Regulating Homeopathic Meds

Homeopathic medicine is an alternative to traditional medical care, and although it involves taking pills, they are not pharmaceuticals and are not, therefore, regulated by the FDA. But last week, that agency held hearings to revisit whether homeopathics should undergo analysis before they are marketed as safe and effective.

As explained on NPR, in 1988, the FDA decided not to require homeopathic remedies to go through the same drug-approval process as standard medical treatments. Many in the scientific community welcome this scrutiny, as homeopathic medicine is not based on studies, and is controversial for its “like cures like” approach.

That involves giving patients a dose of a substance (often a plant extract or a mineral) that normally can cause the symptoms of their illness, but which, according to homeopathic practitioners, also cures it if the substance has been diluted so much that it’s essentially negligible within the medicine.

One practitioner interviewed by NPR said, “We believe that there is a memory left in the solution. You might call it a memory. You might call it energy,” Dr. Anthony Aurigemma explained. He is an M.D. in Maryland who has practiced homeopathic medicine exclusively for decades. He said he became disillusioned by mainstream medicine because of the side effects caused by many drugs. “I don’t reject conventional medicine. I use it when I have to,” he said, then described how homeopathy works.

“Each substance in nature has a certain set of characteristics. And when a patient comes who matches the physical, mental and emotional symptoms that a remedy produces – that medicine may heal the person’s problem,” he explained.

That’s just bunk, critics say, noting that no scientific studies have found evidence that homeopathy works.

“Homeopathy is an excellent example of the purest form of pseudoscience,” Dr. Steven Novella, a neurologist at Yale and executive editor of the website Science-Based Medicine told NPR. “These are principles that are not based upon science.”

Novella and many others say consumers not only waste their money on homeopathic remedies, they can also impair their health. Skeptics are concerned that homeopathic remedies could be dangerous if they’re contaminated, aren’t completely diluted or if they simply don’t work.

“Somebody who’s having an acute asthma attack, for example, who takes a homeopathic asthma remedy,” the NPR report said, could die of an acute asthma if they relied on, as Novella put it, “a completely inert and ineffective treatment.”

Although critics have lobbied the FDA to regulate homeopathy more aggressively for a long time, the feds are seriously considering it only now because of its growing popularity and concern about the quality of remedies.

The FDA recently has issued warnings about individual homeopathic products, including one for tablets marketed as pain relievers for babies who are teething. Several years ago, the FDA recalled a homeopathic cold remedy that might have caused some people to lose their sense of smell.

As you might imagine, practitioners and homeopathic manufacturers are nervous about the FDA’s renewed interest in their wares. “It would be a terrible loss to this country if they were to do something drastic,” Aurigemma said. “There’s no question that it helps patients. I have too many files on too many patients that have shown improvements.

But even he acknowledged that some homeopathic products sold over the counter make misleading claims.

Some patients swear by homeopathic meds, including Wendy Resnick, a longtime patient of Aurigemma who consulted him recently when she couldn’t shake a case of laryngitis and lethargy.

Aurigemma listened to her lungs, checked her throat, then asked detailed questions about her symptoms and other things – was she having unusual cravings for food, for example.

When the examination was complete, Aurigemma didn’t advise a diagnostic screen, or turn to a prescription pad, he consulted a thick book to match Resnick’s symptoms and information with possible diagnoses. Then he decided on the remedy, and gave her some pills.

“So this will be the first dose,” he said. “Then I’ll give you a daily dose, to try to get underneath into your immune system to try to help you strengthen your energy, basically.”

Bunk? Maybe. Probably. But Resnick said previously, Aurigemma’s medicine helped her heal from ankle, knee and back problems.

Maybe that’s the placebo effect, which is the result of a fake treatment with an inactive substance like sugar pill or a saline solution that sometimes improves a patient’s condition simply because he or she believes or expects that it will.

And maybe Resnick’s positive outcomes are due not to homeopathics, but to Aurigemma’s complete attention and communication skills, the time he invests in examining and talking to her. How many medical doctors see their priority as connecting with patient over the priority of seeing as many patients as possible?

Of course homeopathics, like nutritional supplements, should be regulated, and they have escaped such scrutiny for too long because of conflicts of interest and slothful public servants.

But maybe traditional practitioners can learn something from its practitioners that patients already know.

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