FDA Ponders Putting Homeopathy To A Tougher Test

Apr 20, 2015
Originally published on April 22, 2015 2:59 pm

It's another busy morning at Dr. Anthony Aurigemma's homeopathy practice in Bethesda, Md.

Wendy Resnick, 58, is here because she's suffering from a nasty bout of laryngitis. "I don't feel great," she says. "I don't feel myself."

Resnick, who lives in Millersville, Md., has been seeing Aurigemma for years for a variety of health problems, including ankle and knee injuries and back problems. "I don't know what I would do without him," she says. "The traditional treatments just weren't helping me at all."

Aurigemma listens to Resnick's lungs, checks her throat and then asks detailed questions about her symptoms and other things as well, such as whether she's been having any unusual cravings for food.

Aurigemma went to medical school and practiced as a regular doctor before switching to homeopathy more than 30 years ago. He says he got 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," Aurigemma says.

Throughout his career, homeopathy has been regulated differently from mainstream medicine.

In 1988, the Food and Drug Administration decided not to require homeopathic remedies to go through the same drug-approval process as standard medical treatments. Now the FDA is revisiting that decision. It will hold two days of hearings this week to decide whether homeopathic remedies should have to be proven safe and effective.

When Aurigemma is finished examining his patient, instead of pulling out a prescription pad, he uses a thick book to come up with a homeopathic diagnosis. He then searches through heavy wooden drawers filled with rows of small brown glass vials filled with tiny white pellets. They're homeopathic remedies. He pulls out two.

"So this will be the first dose," he says. "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."

Homeopathic medicine has long been controversial. It's based on an idea known as "like cures like," which means if you give somebody a dose of a substance — such as a plant or a mineral — that can cause the symptoms of their illness, it can, in theory, cure that illness if the substance has been diluted so much that it's essentially no longer in the dose.

"We believe that there is a memory left in the solution. You might call it a memory. You might call it energy," Aurigemma says. "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."

Critics say those ideas are nonsense, and that study after study has failed to find any evidence that homeopathy works.

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

Novella thinks consumers are wasting their money on homeopathic remedies. The cost of such treatments vary, with some over-the-counter products costing less than $10.

Some of the costs, such as visits to doctors and the therapies they prescribe, may be covered by insurance. But Novella says with so many people using homeopathic remedies, the costs add up.

There's also some concern that homeopathic remedies could be dangerous if they're contaminated or not completely diluted, or even if they simply don't work.

Somebody who's having an acute asthma attack, for example, who takes a homeopathic asthma remedy, "may very well die of their acute asthma attack because they were relying on a completely inert and ineffective treatment," Novella says.

For years, critics like Novella have been asking the FDA to regulate homeopathy more aggressively. The FDA's decision to revisit the issue now was motivated by several factors, including the growing popularity of homeopathic remedies and the length of time that has passed since the agency last considered the issue.

The FDA is also concerned about the quality of remedies, according to Cynthia Schnedar, director of the FDA's Center for Drug Evaluation and Research Office of Compliance. The agency has issued a series of warnings about individual homeopathic products in recent years, including one that involved tablets being sold to alleviate teething pain in babies.

"So we thought it was time to take another look at our policy," Schnedar says.

The FDA's decision to examine the issue is making homeopathic practitioners like Aurigemma and their patients nervous. "It would be a terrible loss to this country if they were to do something drastic," he says.

He also disputes claims that homeopathy doesn't work and is unsafe.

"There's no question that it helps patients. I have too many files on too many patients that have shown improvements," Aurigemma says, although he acknowledges some homeopathic products sold over the counter make misleading claims.

Companies that make homeopathic remedies defend their products as well.

"Homeopathic medicines have a very long history of safety," says Mark Land, vice president of operations and regulatory affairs for Boiron USA, which makes homeopathic products. "One of the hallmarks of homeopathic medicines is safety," says Land, who is also president of the American Association of Homeopathic Pharmacists.

"The potential risk [of greater FDA regulation] to consumers is if any change in regulation were to limit access to these products," says Land.

That's what worries Resnick. She says homeopathic remedies have helped alleviate a long list of health problems she's experienced over the years. "Why would they want to take that away from us?" she says. "Let us have the freedom to decide what works the best for us."

The FDA says this week's hearing is just a chance to start gathering information to decide what — if anything — the agency should do about homeopathy.

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RENEE MONTAGNE, HOST:

Today in Your Health, we'll explain why watching TV may be good for you. First, though, we'll take a look at homeopathy. That form of medicine has become popular and controversial as an alternative to modern medicine. This morning, the Food and Drug Administration opens a two-day hearing to scrutinize homeopathy. NPR health correspondent Rob Stein has more.

ROB STEIN, BYLINE: It's another busy morning at Dr. Anthony Aurigemma's office in Bethesda, Md.

WENDY RESNICK: How are you?

ANTHONY AURIGEMMA: How are you doing? It's good to see you again.

STEIN: Wendy Resnick's 58. She's been seeing Dr. Aurigemma for years for all sorts of things. Today, she's back because she just can't seem to shake a nasty bout of laryngitis.

RESNICK: I don't feel great. I really don't. I don't feel myself. I look at myself - my eyes - I don't have a lot - the degree of energy that I normally have.

AURIGEMMA: Well, let me look at your throat. Just put out your tongue. Say ah.

RESNICK: Ah.

AURIGEMMA: OK.

STEIN: Aurigemma went to medical school and practiced as a regular doctor, but switched to homeopathy more than 30 years ago.

AURIGEMMA: So open your mouth and take a deep breath.

STEIN: He listens to Resnick's lungs, but also asks her lots of questions that go beyond her symptoms - how she's sleeping, whether she's having any weird cravings.

RESNICK: I'm craving saltier - like cheese - mustard; like, kind of spicy.

STEIN: Eventually, instead of pulling out a prescription pad, he looks through a thick book, using her answers to come up with a homeopathic diagnosis. He then searches through heavy wooden drawers filled with rows of small, brown glass vials - vials filled with what look like tiny white pellets. He pulls out two.

AURIGEMMA: That's the first dose. That's a higher dose. And then I'll give you a daily dose. Really, it's to try to get underneath into your immune system to try to help you strengthen your energy, basically, 'cause, you know, the healing comes from within, not from the medicine.

RESNICK: Yes.

STEIN: This kind of medicine is hugely controversial. Here's why - it's based on something called like cures like, which basically means if you give somebody something, like a plant or a mineral that can cause the symptoms of an illness, it will cure that illness if it's been diluted so much it's essentially no longer there.

AURIGEMMA: We believe there is a memory left in the solution. You might call it a memory. You might call it an energy. You might call it a sub ectopic charge. In any case, each substance in nature has a certain set of characteristics - physically and mentally. When a patient comes who matches the physical, mental and emotional symptoms that a remedy produces, that medicine may heal the person's problem whatever it happens to be.

STEIN: But critics say those ideas are nonsense. Study after study has failed to find any evidence it works.

STEVEN NOVELLA: Homeopathy is an excellent example of the purest form of pseudoscience.

STEIN: Steven Novella is a neurologist at Yale.

NOVELLA: These are principles that are not based upon science, run contrary to physics, chemistry, physiology, biology, medicine, and homeopathic remedies can't work. And when we look at them, they don't work.

STEIN: And there's some concern they could be dangerous if they're contaminated or not completely diluted or even if they simply don't work.

NOVELLA: Somebody who is having, for example, an acute asthma attack who takes a homeopathic asthma remedy may very well die of their acute asthma attack because they were relying upon a completely inert and ineffective treatment.

STEIN: So for years, critics like Novella have been asking the FDA to crack down on homeopathy. The FDA doesn't require homeopathic remedies go through the same drug approval process as regular medical treatments and prove they are safe and effective. But today, for the first time in 25 years, the FDA is starting to revisit that policy. The agency's Cynthia Schnedar says that's for two big reasons - first, homeopathy's popularity has exploded in recent years.

CYNTHIA SCHNEDAR: In addition, we've seen some emerging safety and quality concerns, and so we thought it was time to take another look at our policy.

STEIN: But this is making a lot of people nervous, like some of the companies that sell homeopathic remedies, and practitioners like Dr. Aurigemma who use them.

AURIGEMMA: It would be a terrible loss to this country if they were to do something drastic. There's no question that it helps patients. I have too many files on too many patients that have shown improvements. All I could say is that it's a form of medicine that should be allowed to be continued and studied and fostered.

STEIN: His patient Wendy Resnick agrees.

RESNICK: Why would they want to take that away from us, from those of us that, you know, have found it to be so helpful? That, you know, let us have choice. Let us have the freedom to decide what works the best for us.

STEIN: The FDA says this week's hearing is just a chance to start gathering information and decide what, if anything, the agency should do about homeopathy. Rob Stein, NPR News. Transcript provided by NPR, Copyright NPR.