[Congressional Record Volume 140, Number 134 (Thursday, September 22, 1994)]
[Senate]
[Page S]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]


[Congressional Record: September 22, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]

 
                           DR. XIAO MING TIAN

  Mr. DeCONCINI. Mr. President, the national health care reform debate 
has been instrumental in focusing attention on alternative medicine and 
treatments which are not based on Western medical theory or practice. 
Today, I want specifically to address one approach to pain therapy 
which I and many other Americans have found to be more effective then 
our traditional high-technology and high-cost health care--acupuncture. 
In particular, I want to acknowledge the fine work of Dr. Xiao Ming 
Tian, a leading practitioner in this field.
  Recently, the Washington Post's health section devoted its cover 
story to acupuncture and highlighted Dr. Xiao Ming Tian's successful 
treatment of patients with this therapy. Dr. Ming is a medical doctor 
and acupuncturist who blends Eastern and Western medicine in his 
practice. He holds the unique position of being the sole clinical 
consultant for the National Institutes of Health [NIH] and, on NIH 
request, has used acupuncture to treat some of the most difficult cases 
encountered by NIH doctors.
  While presently Dr. Ming's principal role is to determine whether 
acupuncture can help individual patients at NIH, he is also assisting 
NIH to design controlled studies to verify the positive outcomes of the 
patients he has treated. He will be helping the NIH's Rehabilitation 
Medicine Program conduct the first study of the use of acupuncture to 
control pain and improve mobility in prostate cancer patients this 
fall. This clinical trial represents a significant step in the effort 
to establish the scientific grounds on which the efficacy of 
acupuncture treatment can be evaluated and accepted.
  I can personally attest to the benefits of Dr. Ming's acupuncture 
treatment. Dr. Ming was recommended to me when I was having problems 
with neck pain. His treatments relieved my pain and I do not hesitate 
to join other patients who have experienced significant improvements 
under his care to pay tribute to him. Dr. Ming is an outstanding 
physician who deserves tremendous recognition for working to integrate 
very different approaches to pain treatment.
  Dr. Ming's work with the NIH is instrumental to bringing acupuncture 
into the mainstream of our health care system. I can think of no better 
person than Dr. Ming, whose reputation as a doctor is unsurpassed, to 
do this. I count him among the best doctors whom I have ever used and 
know. The cover story in the Washington Post's health section reports 
nothing but glowing praise for Dr. Ming by his patients. These patients 
credit his treatments with significant pain reduction or other major 
improvements in their conditions.
  Mr. President, I ask unanimous consent that the Washington Post's 
health section cover story on acupuncture, including the insert 
entitled ``How One Young Patient Finds Relief From Joint Pain'' 
regarding Dr. Ming's involvement and work in this important area of 
health care, be reprinted in the Record following my statement.
  There being no objection, the article was ordered to be printed in 
the Record, as follows:

               [From the Washington Post, Aug. 16, 1994]

                              Acupuncture

       If all goes according to plan, a team of lawyers will walk 
     up the steps of the U.S. Food and Drug Administration later 
     this week and deliver to federal officials what could be the 
     most peculiar application in the agency's history: A request 
     by the nation's 9,000 acupuncturists to approve acupuncture 
     needles as medical devices.
       The hair-thin stainless steel needles hardly fit the 
     standard image of a medical device. Unlike cardiac 
     pacemakers, X-ray machines and surgical lasers--the kind of 
     device that the FDA is used to assessing--acupuncture needles 
     draw no energy and have no moving parts. Equally unusual, 
     their primary purpose is to stimulate the flow of a life 
     force called Qi (pronounced Chee) through a network of 
     mysterious energy meridians in the body. Since neither Qi nor 
     meridians have been scientifically proven to exist, the FDA 
     may have a hard time judging whether the needles work.
       But the agency has a stake in trying. While 29 states and 
     the District of Columbia have legalized the practice of 
     acupuncture, the needles themselves are still classified by 
     the FDA as ``investigational devices.'' This means they have 
     never been proven safe or effective and their use is supposed 
     to be limited to scientific studies. The FDA is well aware 
     that despite this restriction, acupuncture needles are in 
     widespread use. And the agency would like to avoid another 
     controversy like the one over silicone breast implants, in 
     which it was criticized for allowing their use without having 
     demanded safety data.
       Acupuncturists would also benefit from FDA approval of 
     acupuncture needles. They would be assured of reimbursement 
     by Medicaid and Medicare and by the many private insurers who 
     do not now pay for the treatments. And it would help the 
     fledgling U.S. profession survive the financial shakedown of 
     health care reform; any plan that emerges from Congress is 
     expected to be tough on a medical specialty whose major tools 
     lack FDA approval.
       But perhaps most significant, a nod of approval from the 
     FDA would be a symbolic watershed for consumers. It would 
     mean that an alternative medical system invoking such foreign 
     concepts as ``Qi'' and ``meridians'' can be granted the kind 
     of legitimacy normally reserved for mainstream medicine. It 
     would show there is room in high-tech American health care 
     for low-tech ``nontraditional'' techniques--if a technique 
     that is 10 times older than anything in Western medicine can 
     be properly called nontraditional.
       Until recently, said David Lytle, an FDA research 
     biophysicist, there has been virtually no data by which the 
     FDA might judge the safety and efficacy of acupuncture. ``But 
     that's changing,'' he said. ``And it's changing fast.''


                          open-minded patients

       Although many scientists are skeptical about the benefits 
     of acupuncture, the specialty has gained an impressive 
     following in this country. An estimated 15 million Americans, 
     or about 6 percent of the population, have tried it with 
     varying degrees of success for chronic pain, fatigue, nausea, 
     arthritis, digestive problems and a range of other ailments. 
     They are participants in a 2,000-year tradition originating 
     in China, where medical doctors still practice the art today 
     in combination with herbal medicine and modern Western 
     techniques. It calls for the insertion of needles ranging in 
     length from a half-inch to three inches into any of the 
     approximately 400 points in the skin that correlate to 
     different organ systems. These points lay along 14 major 
     meridians, or pathways, in the body.
       Acupuncture meridians and points have no known anatomical 
     or physiological equivalents in Western medicine, and there 
     is no scientific evidence for their existence. But that 
     doesn't bother the FDA, an agency that is solely concerned 
     with safety and efficacy and has no interest in debating 
     medical philosophy. So the plan, according to FDA physician 
     Suzanne Parisian, is to judge the needles without regard to 
     the theory and practice of acupuncture.
       That's a feat many acupuncturists deride as impossible, 
     since a needle is only as safe and effective as an 
     acupuncturist makes it. Indeed, some experts have told the 
     FDA that the agency would do better to insist simply that 
     needles will not break during use and that packages are 
     properly labeled with appropriate warnings.
       The task of judging acupuncture needles will also be 
     difficult because of the dearth of well-controlled published 
     research. Unlike medical doctors, acupuncturists are not 
     generally trained to do clinical research; one recent 
     analysis concluded that of the approximately 2,500 
     acupuncture studies published in English since 1960, only 28 
     were designed or written in such a way as to give meaningful 
     information to the medical community.
       But things are getting better, said Monique M. Morris, a 
     University of Southern California biostatistician who 
     recently reviewed the record on acupuncture research for the 
     FDA. In a few areas, she said, there appears to be evidence 
     that acupuncture has a therapeutic effect, although many of 
     the studies are still small.
       Among the most promising uses, according to documents 
     compiled by acupuncturists for the FDA, are:
       Pain control. Acupuncture was first publicized in the 
     American media in 1971, when New York Times foreign 
     correspondent James Reston wrote a first-person account of 
     how acupuncture reduced his post-surgical abdominal pain 
     after an emergency appendectomy in China. (He had had regular 
     anesthesia for the operation.) Since then, research in 
     animals and humans has strengthened the case for 
     acupuncture's potential as a painkiller.
       There have been about a dozen well-controlled studies of 
     acupuncture for pain, said John Reed, a physician at the Pain 
     and Stress Recovery Center in Phoenix, who reviewed the data 
     for the FDA. In studies of lower back pain, neck pain, tennis 
     elbow, migraines, angina attacks, menstrual cramps and dental 
     pain, acupuncture almost always worked better than a placebo 
     treatment, and it often worked better than standard 
     painkilling drugs, he said.
       A recent pilot study also suggests that acupuncture can 
     help people with osteoarthritis of the knee, a painful 
     chronic joint inflammation. Lixing Lao, Brian Berman and 
     their colleagues at the University of Maryland reported in 
     June that twice weekly acupuncture treatments reduced pain 
     and increased walking ability in eight of 12 patients during 
     a two-month treatment period, and that the improvement 
     lingered for a few weeks after treatments stopped.
       How does it work? Bruce Pomeranz, a research physiologist 
     at the University of Toronto who studied acupuncture's 
     effects on nerves, said experiments by him and others have 
     shown that acupuncture stimulates the production of 
     painkilling opiates in the brain, but that other factors 
     probably contribute to acupuncture's value as an analgesic. 
     Both he and Reed said pain control is a well-documented 
     benefit of acupuncture, but they warned that the difficulty 
     of studying and measuring pain objectively may make it hard 
     to convince the FDA that acupuncture has something unique to 
     offer.
       Substance abuse. More than a dozen jurisdictions in the 
     United States have turned to acupuncture to help drug abusers 
     overcome their addictions in a program called Drug Court. The 
     program offers felony drug offenders intensive counseling and 
     acupuncture treatments as an alternative to going to prison. 
     The daily acupuncture sessions, which go on for three to six 
     months, seem to ease withdrawal and reduce the urge to take 
     up drugs again; some continue with the acupuncture even after 
     completing the formal program.
       ``I was astonished at the results,'' said Michael O. Smith, 
     director of the substance abuse division at Lincoln Hospital 
     in the Bronx, where recovering addicts can be seen resting 
     quietly with acupuncture needles in their ears. About 50 
     percent of the addicts opting for Drug Court in the Bronx 
     stay in the program for a full three months of daily 
     sessions--a graduation rate ``tremendously better than any 
     residential treatment program could imagine attaining,'' 
     Smith said, and at a cost of less than $1,000 a person.
       Hugh Rodham, an attorney and brother of First Lady Hillary 
     Rodham Clinton, helped get Drug Court off the ground in Miami 
     in 1989. He said 78 percent of the program's graduates there 
     have gone two years without getting rearrested, compared to 
     between 15 and 20 percent in standard drug diversion 
     programs. ``Acupuncture proved itself,'' Rodham said. ``We've 
     had more than 15,000 people come through our clinic who have 
     been cured of an addiction that nobody thought could be 
     cured.''
       No one knows precisely how acupuncture may be helping these 
     drug users kick their habit. Experts said it's impossible to 
     know, for example, how much of the program's success is due 
     to the acupuncture and how much from the general increase in 
     attention that Drug Court participants get. But according to 
     researchers involved in the program, addicts themselves say 
     the acupuncture is crucial. The addicts say the needles in 
     the ear trigger a deep relaxation, which in turn seems to 
     lower their craving for drugs. Some researchers suggest that 
     increased production of the body's own opiates may contribute 
     to the lack of craving by providing a ``home-grown'' 
     substitute for an illicit drug.
       Nausea and vomiting. More than half of all patients who 
     receive anesthesia before undergoing surgery experience 
     nausea or vomiting after awakening from the ordeal--usually a 
     reaction to the opium-related ``pre-anesthesia'' drugs given 
     an hour or two before surgery.
       But there is ``very compelling evidence'' that a few 
     minutes of acupuncture in the hour or two before surgery can 
     significantly reduce the incidence of nausea and vomiting in 
     the recovery room, said National Institutes of Health 
     researcher Andrew Parfitt. Most of those studies have 
     involved a single needle stuck into the so-called Neiguan 
     point, also called P6, located about a finger's width above 
     the crease on the inside of the wrist.
       Acupuncture has also proved effective against nausea in 
     patients taking the cancer drug cisplatin, Parfitt said. And 
     unlike most anti-nausea medicines, he added, acupuncture for 
     nausea seems to cause no side effects.
       Asthma and other respiratory ailments. Many acupuncturists 
     and patients swear by acupuncture's benefits for asthma and 
     other breathing problems. But very few controlled studies 
     have been done in this area, said Kim A. Jobst, an Oxford 
     University clinical researcher who in 1986 performed perhaps 
     the best study of asthma and acupuncture in the West. Of the 
     handful of good studies, he said, some have found no benefit 
     while others, including his own, showed improvement as 
     measured by ``quality of life'' scores, breathlessness 
     measures and reduced dependence on medicine. Of the 16 best 
     studies, Jobst said, 10 showed benefits of acupuncture, three 
     showed no benefit, and in three the people who got 
     acupuncture did worse than the controls. Although more and 
     better studies are clearly needed, he said, ``I still think 
     this is terribly exciting''--especially since long-term use 
     of some asthma drugs has recently been shown to exacerbate 
     many people's condition.
       Stroke and paralysis. In China, doctors typically use 
     acupuncture on heart attack victims in the belief that it can 
     reopen blocked blood vessels leading to the heart. In the 
     United States, some studies suggest that acupuncture's 
     capacity to enhance blood flow may be real, and may benefit 
     some victims of ischemic stroke, who become partially 
     paralyzed because of a blocked blood vessel in the part of 
     the brain that controls movement.
       Studies by Margaret Naeser at Boston University School of 
     Medicine indicate that acupuncture treatments given two to 
     three times a week for two to three months will increase 
     mobility in about 60 percent of patients who have had a 
     stroke. Acupuncture appears especially helpful when less than 
     half of a patient's motor neuron pathway in the brain has 
     been damaged by the stroke, Naeser said. A CAT scan given at 
     least three months after the stroke can show how much damage 
     has been done to that area and help predict which patients 
     may benefit from acupuncture.
       Naeser, an associate research professor of neurology, said 
     she thinks acupuncture increases blood flow to the brain and 
     may enhance the brain's natural ability to reorganize its own 
     neurons in ways that compensate for the loss of other neurons 
     in a stroke. She said researchers in Sweden and Taiwan have 
     also found that acupuncture can increase arm and leg 
     mobility, hand strength, balance and gait in many stroke 
     patients.


                          awaiting the verdict

       Notwithstanding these and other seemingly impressive 
     results, the FDA's decision on needle approval will not be 
     easy. The biggest problem, Parisian and other officials said, 
     is that acupuncture experiments have varied widely in quality 
     and design, making it difficult to combine the evidence from 
     several studies into a single convincing case.
       Researchers still don't agree, for example, on the best way 
     to include `'controls''--the comparison group of people who 
     do not get acupuncture. Controls are a standard element in 
     modern medical studies, but it's not clear what would 
     constitute an appropriate control group for an acupuncture 
     study.
       Some experts say control patients should get ``sham'' 
     acupuncture treatments, in which they are poked with needles 
     in random locations. That might allow researchers to tell 
     whether acupuncture's effects depend on a real system of 
     points and meridians or are just a result of getting pricked 
     anywhere. But others disagree, saying sham treatments are not 
     true controls because they may inadvertently stimulate points 
     that also have therapeutic potential. Moreover, the mere 
     trauma of getting pricked may stimulate the brain to make 
     painkilling endorphins that could fool people into thinking 
     their condition had improved.
       Indeed, some scientists believe that acupuncture is not a 
     medical science at all but a sophisticated means of fooling 
     the body into feeling well. They see acupuncture as a 
     combination of pain control caused by endorphins and 
     psychosomatic recovery caused by the power of suggestion. If 
     ``real'' acupuncture works better than ``sham'' acupuncture, 
     they say, perhaps that's because ``real'' acupuncture points 
     have more nerve endings than sham points, thus triggering 
     more pain, more endorphins and more relief.
       ``Where hypnosis works, acupuncture will work,'' said 
     Victor Herbert, a professor of medicine at the Mount Sinai 
     and Bronx Veterans Affairs Medical Centers in New York. ``Ten 
     percent of Americans are profoundly suggestible and another 
     80 percent are somewhat suggestible and these are the people 
     who will respond to acupuncture.''
       Herbert, who went to China in 1979 with a team of U.S. 
     doctors to investigate the value of acupuncture as surgical 
     anesthesia, said he was disappointed by what he saw. He said 
     even Chinese doctors screened their patients for 
     suggestibility and only relied on acupuncture in patients who 
     were easily hypnotized. All told, he said, ``I'd prefer to 
     use hypnosis. Nobody has ever gotten hepatitis from 
     hypnosis.''
       Now the FDA must weigh such skepticism against 
     acupuncturists' claims as it reviews the petition for needle 
     approval. It will have to do so quickly. Unlike the case for 
     drug approvals, which often languish with the FDA for years, 
     the agency is required by law to rule on medical device 
     applications within six months. That means the verdict on 
     acupuncture needles should be in by February.
       Even if the FDA approves the needles for only one purpose--
     for the treatment of substance abuse, for example--it will be 
     a major victory for acupuncturists and their patients. That's 
     because any device approved for even a single indication can 
     be legally used for other purposes, just as medical doctors 
     today can prescribe drugs for conditions other than those 
     they were originally approved for.
       Whatever the FDA's decision, acupuncture seems destined to 
     grow in this country. The number of acupuncturists graduating 
     from the nation's 47 acupuncture schools is expected to 
     increase by almost 60 percent in the next two years, from 
     about 850 in 1994 to an estimated 1,350 in 1996, said Barbara 
     Mitchell, chairwoman of the National Commission for the 
     Certification of Acupuncturists.
       Harvey Kaltsas, president of the American Association of 
     Acupuncture and Oriental Medicine, predicts that acupuncture 
     will be-come a popular substitute for many medicines in the 
     next decade.
       ``We have treatments for major diseases like hypertension, 
     and we'll be competing against pharmaceutical companies,'' 
     Kaltsas said. ``We're not even a blip on their screen,'' he 
     said, ``but they're in for a surprise. They can't even 
     imagine we are as effective as we are.''
                                  ____


           How One Young Patient Finds Relief From Joint Pain

       Sixteen-year-old Margaret Clark lies face down on a bed in 
     the nation's preeminent research hospital--the clinical 
     center of the National Institutes of Health--where many of 
     medicine's newest experimental therapies are first tried. But 
     there is nothing new about the treatment she is about to get: 
     seven stainless-steel needles, thinner than sewing pins, 
     stuck into her legs, lower back and shoulder, in much the 
     same way as has been done in China for the past 2,000 years.
       Clark has fibromyalgia, a poorly understood disease that 
     causes a spectrum of problems from muscle spasms to crippling 
     joint inflammation. After years of getting bounced from one 
     doctor to another, none of whom could treat her successfully, 
     she was referred to Xiao Ming Tian, a medical doctor and 
     acupuncturist who has practiced a blend of Eastern and 
     Western medicine since arriving in the United States from 
     China in 1982.
       The Washington area is rich with acupuncturists--in part 
     because it is home to two acupuncture colleges: the 
     Traditional Acupuncture Institute in Columbia and the 
     Acupuncture School of Maryland in Bethesda. But Ming has the 
     distinction of being the only acupuncturist on call for the 
     federal government; he is an NIH ``clinical consultant,'' 
     asked to use his needles on some of the tougher cases at the 
     federal research facility. Cases like Margaret Clark's.
       ``A lot of doctors we went to said, `There's nothing we can 
     do,''' said Clark's mother, who brings the 10th grader in for 
     treatments once a week from their home in Clarksburg, Md. ``I 
     don't know how many thousands of dollars we spent getting 
     blood tests just to find out she had a hormone imbalance. Dr. 
     Ming knew from looking at her fingernails she had hormonal 
     problems.''
       Ming leans over his young patient and feels her bare back 
     with his finger while swabbing his target areas with an 
     alcohol pad. Then, with a speed that belies the accuracy of 
     his aim, he stabs a thin disposable, four-inch needle sharply 
     into the skin below the girl's left shoulder blade, pushes it 
     in about a half an inch and deftly twists it clockwise and 
     counterclockwise for a few seconds.
       Clark barely flinches.
       In quick succession, Ming fixes two needles into her lower 
     back, two others into the backs of her calves and two into 
     her ankles, again twisting them. ``Feel that?'' he asks. He 
     knows he's in the right place if, when he twists each needle, 
     his patient gets a deep sense of numbness or heaviness in the 
     area.
       ``Yes,'' she says, ``but it doesn't really hurt.'' Like 
     most acupuncture patients, she describes the treatment as a 
     series of stings and tingling sensations with an occasional 
     electrical buzz, just short of real pain.
       Clark said her joint pain has gotten better in the month 
     since she has started getting acupuncture, as has the chronic 
     pain in her lower back. Moreover, she said, ``I used to get a 
     lot of headaches, and they've gotten less.''
       Ming said there is not much that can be concluded from the 
     assorted NIH patients he treats, since each is a single case 
     and there are no untreated controls to compare them to. His 
     role at NIH is to see what he can do for individual patients 
     and then to help design controlled studies that may verify 
     the initial results he has begun to see. The first such trial 
     of acupuncture on the NIH campus is set to begin this fall, 
     when Ming and NIH chief of rehabilitation medicine Lynn 
     Gerber will conduct a study to see if acupuncture can reduce 
     pain and increase mobility in patients with prostate cancer.
       One thing that's obvious without a scientific study: Ming 
     has the affection of his patients. Three other patients at 
     NIH treated the same day by the soft-spoken doctor gushed 
     with praise for the acupuncturist and his art.
       ``He just knows what to do,'' said Tony Bonanno, a 48-year-
     old Beltsville guitarist and music teacher who has been 
     coming to Ming for the past 18 months for treatment of nerve 
     and muscle degeneration caused by chemotherapy for Hodgkin's 
     disease. Bonanno credits Ming with a major turnaround in his 
     condition that has allowed him to regain his strength and 
     fine motor coordination and continue playing the guitar.
       Indeed, acupuncturists in general seem to have a knack for 
     gaining the trust and affection of their patients--so much so 
     that some skeptics have questioned how much of acupuncture's 
     success comes from a placebo effect. After all, who wouldn't 
     feel better after a visit to a healer who is generous with 
     kind words, offers a gentle touch and is much less rushed 
     than the typical MD? But acupuncturists counter that these 
     critics are making an artificial distinction when they try to 
     separate medical technique from the manner or mood in which 
     it is performed. There are many facets to healing, they say. 
     And what's wrong with a little placebo effect if it actually 
     helps where other techniques fail?
       ``I don't think about separating out, `Here's how I am with 
     my patient and here is what I actually do to them,''' said 
     Hannah V. Bradford, an acupuncturist in private practice in 
     Bethesda and co-president of the Society for Acupuncture 
     Research, which seeks to put acupuncture on a firmer 
     scientific footing.
       ``It's all part of the same thing,'' she said. ``Being is 
     doing in acupuncture.''

                          ____________________