Getting to the Point : Acupuncturists have asked the government to rule that the ancient Chinese therapy is safe and effective. FDA approval could bring insurance coverage--at least for some conditions.
In a fascinating twist of government bureaucracy, the Food and Drug Administration has been asked to approve of a medical device that has been in widespread use in the United States for about 150 years.
The FDA is expected to rule by early summer on a petition filed in November by the nation’s 9,000 acupuncturists, beseeching government regulators to decree that the tiny needles used in the ancient Chinese therapy are safe and effective.
Rarely has the FDA been asked to rule in regard to an “alternative” medical practice. Moreover, the “citizens’ petition”--a way to obtain approval of a device already in widespread use--seeks approval of the Eastern medicine for which there is no scientific explanation in Western medicine.
The government acknowledged its dilemma during a hearing last April, says Richard Hammerschlag, a biochemist in neuroscience at the City of Hope’s Beckman Research Institute who participated at the hearing and is a proponent of acupuncture. During the hearing, acupuncturists submitted their best scientific data to FDA officials in order to avoid the need for additional clinical trials.
“The FDA basically said: ‘You’re asking us to approve one of the simplest devices we’ve been asked to approve, but you’re asking us to approve it in context of a medicine of which we know nothing about,’ ” says Hammerschlag, who has studied acupuncture and its link to Western medicine.
Nevertheless, many health experts predict that the time is right for acupuncture to make its official foray into mainstream medical practice. A nod from the FDA would almost certainly help establish the practice as safe and effective--and suitable for insurance coverage--for at least a few medical conditions.
“With approval from the FDA, more consumers will use acupuncture, more research will be done on it, and it will propel this medicine forward,” says Dr. Daoshing Ni, president of Yo San University of Traditional Chinese Medicine in Santa Monica.
“It would be especially important for California because . . . half the licensed acupuncturists in the country are here, and one-third of the acupuncture colleges are here,” says Hammerschlag, who teaches a course on the biomedical understanding of acupuncture at Yo Sun University.
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Acupuncture represents the ancient Eastern belief that physical health is governed by qi (pronounced chee), an energy that flows through the body, and that any interruption or imbalance in this flow creates illness. To restore the balance, acupuncturists use needles to stimulate energy pathways. Each acupuncture point correlates to a particular organ or system in the body.
“It doesn’t view the body as individual organs; it views the body as systems through which energy flows,” says Hammerschlag, who became intrigued with the practice when he tried it for sciatica and found success. Traditional treatments had failed.
Western science provides no explanation for how acupuncture works, although many experiments suggest that the needles stimulate production of the body’s natural painkillers.
FDA officials say they are thankful that the petition does not ask them to rule on how acupuncture works. Instead, the petition merely requests that the tiny acupuncture needles be relieved of their “investigational” status.
For decades, the boxes of needles have carried a mandatory label saying that they should be used only as part of a government-approved clinical trial. In a concession to the popularity and relative safety of acupuncture, however, the FDA has long chosen to ignore that rule, allowing acupuncturists to practice freely.
So why bother to seek FDA approval now? The main reason, proponents say, is that enough high-quality scientific studies have been done on acupuncture to convince regulators of its effectiveness. But the petition organizers cite several other motivations:
* Approval would increase the chances for insurance reimbursement of certain types of acupuncture.
* It would nudge the states that don’t allow acupuncture to legalize it.
* It would convince skeptics that the therapy has legitimate benefits and is not just quackery.
While no one will venture a guess on how the FDA might rule, government officials appeared to be receptive to the scientific studies presented at last year’s hearing, Hammerschlag says. “What people in general felt at the acupuncture hearing is, no one had been at a meeting where so much good, clear evidence had been presented.”
Nevertheless, there is still widespread doubt among Western doctors about acupuncture’s efficacy, says Dr. John Renner of the Consumer Health Information Research Institute, based in Independence, Mo.
“Approving a device doesn’t mean the person behind the device has authenticity or training,” he says. “It doesn’t mean it will be used ethically and appropriately. I want to keep an open mind about acupuncture, but I think it is still in the category of experimental. We need to see more evidence. We are just at the infancy of understanding this.”
Renner says there should be specifications regarding what training and qualifications should be required of acupuncturists, what the risks of the procedure are and under what conditions it should be used.
“There are risks to acupuncture,” he says. “There are more than 90 reported cases of complications in the scientific literature from 1972 to (the present). Unless there is some real proven efficacy, you just don’t do it. And the training of acupuncturists varies from state to state.”
The acupuncturists’ petition seeks approval for five distinct applications: the treatment of chronic pain, vomiting (usually following chemotherapy), alcohol and drug addiction, respiratory disorders (primarily asthma) and rehabilitation for paralysis in stroke victims.
“The FDA can pick one or all five,” Hammerschlag says. “The label would still be changed, but it would say these devices are safe and effective for chronic pain or asthma or whatever. In any case it will move considerably the whole playing field.”
It’s not likely all five uses will receive the FDA’s stamp of approval, says Monique Morris, a biostatistician at USC’s Norris Cancer Center, who was asked by the FDA to review the data. But she agrees that government regulators appear open to endorsing acupuncture for some uses.
“The evidence in some areas is not as strong as in other areas,” Morris says. “There is some very poor research out there. The more recent the study, generally the better.”
Some studies were well-done, but the authors failed in their attempts to convert their findings to terms familiar to and accepted by Western practitioners, Morris says. “Sometimes they did (the study) in the proper fashion but didn’t state it in the proper fashion.”
One type of study the FDA will consider compares patients undergoing acupuncture for a particular problem to patients with the same problem who have needles inserted at random body points. But a second, more accurate type of study compares patients who receive acupuncture for a particular condition to patients who receive the standard Western medical treatment, Hammerschlag says. In these studies, the patients and their doctors obviously know which treatment they are getting, but the person who evaluates the patient’s health at the end of the treatment does not know how the person was treated.
For example, Hammerschlag says: “There have been two very recent impressive studies where basically all the patients in those studies got the usual kind of stroke rehabilitation and half also got acupuncture. The patients who also got acupuncture recovered quicker and better than the other patients.”
Abundant evidence also exists for the effectiveness of acupuncture for chronic pain. But for the treatment of addictions, the scientific evidence is not as strong as anecdotal reports that acupuncture works, he says.
“As far as controlled clinical trials, that evidence is just beginning to come in. That is a weak area and the biggest discrepancy between case reports and (data),” he says.
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FDA approval would certainly solidify the growing acceptance of acupuncture in the United States, says Ni, whose clinic at Yo San University serves about 400 patients a week. “The public is more readily accepting of the treatments. They see the usefulness of it.”
Some surveys show that as many as 6% of Americans have tried acupuncture.
Douglas Tipping, a Los Angeles bank vice president, was raised by his parents to consider both traditional and alternative medicines. But he didn’t try acupuncture until a few years ago when he experienced intense pain after having his wisdom teeth removed.
“Painkiller (medications) are fine, and I took them, but I could feel this muscle tension,” Tipping says. “I thought that acupuncture could accelerate my body’s own healing process. I think acupuncture goes to the causes of pain better than Western medicine.”
His muscle tension and pain diminished after only one or two treatments, he says. He continues to receive acupuncture regularly for stress reduction.
Dr. Al Plechner, 57, decided to try acupuncture for his high blood pressure. The veterinarian, who lives in Calabasas, wanted to wean himself from high blood pressure drugs that made him feel poorly.
“I was looking for an alternative, and acupuncture was recommended,” he says. “I was fascinated by it. It has worked beautifully.”
He no longer needs medications for his blood pressure and now is researching the various uses of acupuncture for his own patients--the animals he treats at his pet hospital in West Los Angeles.
Charles K. Haun, a USC biologist who has studied the scientific basis for acupuncture, says the practice is “safe and effective if used properly.” (Most practitioners use only disposable needles.)
“The needles, due to their diameter, which is more often less than that of the typical hypodermic needle, can go right through blood vessels and not necessarily cause any leakage from the blood vessel,” he says.
Moreover, acupuncture’s low costs--about $60 per treatment--make the time right for the FDA action, Hammerschlag says.
“We need cost-effective medicine now, and Chinese medicine is certainly cost-effective,” he says. “I think the time is right to integrate the two medicines. For example, for post-operative pain, rather than give morphine, it’s much better to be treated with acupuncture to stimulate the body’s own pain-relieving system.”
