According to a story by Reuters dated Jan 6, 2000, the FDA stated that it wanted to increase its watchdog role in keeping herbs, vitamins and other nutritional supplements safe for the public by becoming more involved in the monitoring of supplements and by establishing new manufacturing guidelines. To do the job, the agency needed more funding from Congress so it could expand tracking of serious adverse effects and promote research of supplements and their effects as part of a 10-year plan for implementing the 1994 law regulating supplements. However, a Feb 14, 2000 story in the San Francisco Chronicle said that the FDA had announced that it would no longer even attempt to track the adverse effects of dietary supplements. Shortly after, NCRHI learned that the Chronicle story was in error, and that the FDA plans to continue tracking adverse reactions to dietary supplements through its Special Nutritionals Adverse Event Monitoring System which is part of the MEDWatch medication monitoring program. Since its inception in 1993, the program logged 2,612 adverse reactions including 184 deaths--38 from ephedra products. Such reports are only the tip of the iceberg. Since the dietary supplement industry is generally hostile to oversight in the first place, it is not surprising that the most dubious of its constituents are uncooperative in the tracking of adverse effects. One company admitted to receiving over 3,500 consumer complaints about its ephedra-based diet regimen, none of which were passed on to the FDA. It would take serious undercover detective work to discover the inhouse problems of scofflaw companies. The Chronicle story was meant to notify the public that the FDA lacks the resources it needs to adequately police the supplement industry. The agency apparently does not want than to creat a false feeling of security among consumers that the FDA is doing its consumer protection job.
It is clearly up to the media to expose the outrageous situation congress created with the 1994 dietary supplements law by covering the tragedies that befall consumers as they self-experiment with dietary supplements. Health professionals must do their part by uncovering adverse events and reporting them in the medical literature as case reports, letters to editors, and studies of emergency room visits, etc.
Should a 2-week-old infant with a fever be referred to emergency
care? That was one of the questions two researchers from Children's
Hospital, Harvard Medical School, in Boston asked 23 homeopaths
and 15 naturopaths in a survey. The results, published in the
Archives of Pediatrics and Adolescent Medicine, were reported
by Reuters Health (Jan 18) and suggest that these alternative
practitioners may miss serious illness in children, such as fever
in a young infant. Sixty percent of the naturopaths and 50% of
the non-MD homeopaths would not send a baby with a fever to an
MD or emergency room. The practitioners also saw patients an average
of three times before deciding therapy was not working. And less
than a third of the homeopaths and naturopaths recommended immunizations
for children. Around one-third of the patients of the practitioners
in the study were children. Pediatricians worry that complementary
and alternative medical practitioners may use treatments that
are toxic for children, that they are against immunizations, and
that they may not recognize serious illness in children.
[Reuters Health, Jan. 18, 2000]
An editorial in the Jan 13, 2000 issue of the New England
Journal of Medicine discusses the response to mass psychogenic
illness. The same issue contains a report of mass psychogenic
illness at a high school in McMinnville, Tennessee. The editorial's
author, Simon Wessely, MD, of Guy's, King's, and St. Thomas' School
of Medicine in London, states that "invisible viruses, chemicals,
and toxins," have replaced the spirits and demons of days
past that once triggered such outbreaks of hysteria. What's crucial
today is the response to these outbreaks once they have been identified
as psychogenic. It's important to remember that the symptoms are
very real physical symptoms, causing real pain and suffering,
and to say such illnesses are "all in the mind" belittle
what people are experiencing.
[New Engl J Med, Jan 13, 2000]
A PRNewswire story Jan 12, which lists the Maharishi Ayurvedic Foundation as its source, reported on a speech given by Maharishi Mahesh Yogi via satellite worldwide to celebrate the 40 years since Transcendental Meditation (TM) "actively became a global movement." The release states that the "scientific validation of Maharishi Mahesh Yogi's work has reached unprecedented heights." National Institutes of Health grants examining Maharishi Vedic Medicine now total $18 million, according to the press release, and more than 500 reports of TM have been published, some in leading peer-reviewed journals.
The news release cites the following:
The latest: Maharishi Vedic Vibrational Technology (MVVT), "a non-invasive, non-medical approach, utilizes subtle vibrational sounds to stimulate the body's self-repair mechanism and restore balance to the specific areas of need." It claims "impressive results" in treating asthma, arthritis, migraine, digestive conditions, skin diseases, diabetes, depression and anxiety, eye problems, allergies, cancer and many other conditions. Finally, adoption of TM in Mozambique's institutions has improved the quality of life in that country, and buildings and communities around the world are using Maharishi's approach to architecture and town planning. [PRNewswire, Jan 12, 2000]
Editorial Comment: Wow! Does this guy want to take over the world? Has anyone bothered to check out whether all these research studies in peer-reviewed journals really support TM? Have any been replicated?
Five brands of shark oil capsules available over-the-counter
internationally have been found to contain high levels of polychlorinated
biphenyls (PCBs), according to a report Jan. 20 in Reuters Health.
The Hong Kong Consumer Council named the brands as Squalene from
Canada, Purity Natural Squalene Shark Liver Oil from Australia,
Squalene 500 from the United States, Natural Boddi Super Squalene
from the United States, and SQ from Canada. SQ had the highest
levels--312 picograms per maximum daily dosage, which is 1.3 times
the tolerable daily limit of 240 picograms established by the
World Health Organization (WHO). Natural Boddi Super Squalene
contained the lowest amount at 152 picograms and was under WHO's
[Reuters Health, Jan. 20, 2000]
The Toronto Star newspaper ran a special report, "An
Investigation into Alternative Medicine," Jan 15-23, 2000.
Herbal "cures" were examined by Star reporter Leslie
Papp in the first installment of the series, perhaps prompted
by the imminent opening of Canada's new Office of Natural Health
Products. As part of the report, three herbal products were tested
by The Star. None of the three brands of garlic supplements met
their claims of how much allicin compounds they contained. Yet
allicin is the ingredient used to measure the potency of the product.
Ditto for ginseng and feverfew: Five of the six ginseng products
tested did not contain the levels of ginsenoside they claimed,
and two of six feverfew products failed to live up to their claims
of parthenolide. The article points out that up to 10 million
Canadians use herbal products, spending up to half a billion dollars
in 1999 on natural health products, a 10 percent increase over
1998. Another frightening fact: Herbs are being added to food
products, such as Echinacea to instant chicken soup, ginkgo biloba
to soft drinks, and saw palmetto to granola bars. Yet the safety
of these natural products is unproven. A Vancouver Island woman
is quoted who used Sleeping Buddha from China for her insomnia
and ended up suffering withdrawal symptoms. Turns out the pills,
which have been taken off the market, contained two prescription
sedatives. In another case, dandelion root pills were tainted
with buckthorn ball, causing vomiting and diarrhea. And warnings
have been issued by Health Canada for more than a dozen Chinese
herbal medicines because they contained unacceptable levels of
toxins or heavy metals. The reporter also cites a 1998 article
from the Archives of Internal Medicine which found some
of the dangerous side effects or interactions of certain herbs
with other medicines. And in Canada, it's the producer of the
herbal remedy who can decide whether it's sold as a food item,
a drug or a half-way category -- and what type of standards will
have to be adhered to.
[Toronto Star, Jan 15, 2000]
An article on the WebMD website gives valuable information on how to evaluate research claims of alternative and complementary medicine. As the article points out, if alternative and complementary medicine are to become part of a new "integrative" medicine that uses all approaches, then alternative and complementary medicine treatments must be tested through contemporary scientific research. The article goes on to explain all levels of evidence, from testimonials (the lifeblood of alternative medicine) to double-blind, placebo-controlled human studies. In addition, the unique challenges of examining complementary therapies is discussed (just how do you eliminate or control for the placebo effect from a study of chiropractic or acupuncture). The article contains useful guidelines that perhaps should be required reading for anyone who wants to understand information about medicine. But the article concludes with a more mystical feel. The author editorializes on the need to examine the role of the placebo effect and how it could be used in medicine. The "mysterious nature of the healing process" is mentioned along with the desire for medicine to become once again "a healing art." [www.WebMD]
Editorial Comment: Perhaps one of the attractions of alternative medicine is the amount of time and caring provided by alternative practitioners, especially when compared to many physicians. The rise of managed care and concern over the bottom line may be partly to blame for today's doctor doing less hand-holding and apparent caring than the Marcus Welby of the past. But will selling nutritional supplements and hiring an on-site massage therapist make up for the fact that the doctor still only spends 23 seconds listening to the average patient's complaint? Does the cure for the medical profession lie in alternative treatments or in learning to listen to their patients and to spend more time with their concerns? No matter what, compassion is hollow without medical competency.
Washington State's Supreme Court agreed in a unanimous decision
to uphold a 1996 law that requires health insurance companies
to reimburse for such alternative medical services as chiropractors,
naturopathic doctors and nutritionists, according to HealthSCOUT.
The state's Insurance Commissioner Deborah Senn, a fan of alternative
medicine, stated, "This law is one of the most popular health-care
laws that the [Washington] legislature ever passed." On the
other hand, a spokesperson for the Health Insurance Association
of America in Washington, DC, points out his concern that such
coverage will drive up the cost of health insurance and that a
more pressing need is that of providing coverage to the uninsured.
[HealthSCOUT, Jan 14, 2000]
Chaparral, an herb from the creosote bush, a desert shrub,
was used by Native Americans in the Southwest and Mexico a hundred
years ago for everything from venereal disease to snakebite, according
to HealthSCOUT. But today it's regarded as dangerous because
of liver toxicity, say herbalists. It made Consumer Reports'
potentially harmful list and was removed in 1968 from the FDA's
"generally regarded as safe" list. An article in the
Archives of Internal Medicine reported adverse reactions
in 18 people between 1992 and 1994. Although it was used by Native
Americans, they usually drank it as a weak tea, which contains
fewer chemicals. The modern usage of putting the herb in capsule
form or in an alcohol-based tincture intensifies its effects.
Dr. Mary Hardy, medical director of the Integrative Medicine Medical
Group at Cedars-Sinai Medical Center in Los Angeles, is quoted
saying, "The difference between poison and treatment is often
just [a matter of] dose." Erica Kipp, manager of the Plant
Research Laboratory for the New York Botanical Garden, summarizes
the attitude that can make self-treatment with herbal medicines
so dangerous: "I think people have the misconception that
anything from a plant is natural and good and benign--and this
is not necessarily the case."
[HealthSCOUT, Dec 27, 1999]
The National Cancer Institute, along with the National Center
for Complementary and Alternative Medicine, all part of NIH, have
awarded a five-year $1.4 million grant to study a controversial
treatment for pancreatic cancer using coffee enemas. Nicholas
J. Gonzalez is a Manhattan doctor who treats his cancer patients
with coffee enemas, a restricted diet, and up to 160 vitamin and
enzyme capsules a day. The Washington Post reported he
had been disciplined by a state medical board and had no traditional
training in cancer treatment. The study at Columbia University's
cancer center will enroll up to 90 pancreatic cancer patients.
[HealthSCOUT, Jan 18, 2000]
Editorial comment: The committee that approved this grant did not bother to determine whether there was biopsy evidence of a correct diagnosis to back up Dr. Gonzalez's claims for his treatments. It is easier to treat pancreatic cancer if none exist in the first place. John Hopkins researchers have found in another study that some pancreatic tumors diagnosed as malignant were actually benign.
Michael Montagne, PhD, Rombult professor of pharmacy at Massachusetts College of Pharmacy and Health Sciences in Boston, describes the myths and realities of alternative therapies. He stresses that alternative treatments, whether homeopathic or herbal, often have a pharmacological activity. He says that scientific information does exist on many herbs, but it's been published in other languages, in inaccessible journals, or long ago, and this information needs to be made available. And, of course, just because these products are natural doesn't always mean they're safe. Dr. Montagne also argues against the idea that so many people have turned to alternative therapies out of dissatisfaction with conventional medicine. He concludes with a discussion of what the role of the pharmacist should be in this explosion of alternative therapies, arguing for open-mindedness and keeping the patient's welfare as the top priority. Original article is Myths and Realities of Alternative Therapies published in US Pharmacist, Dec, 1999.
Editor's note: Keeping an open mind does not mean losing you ability to reason. Homeopathy does not make any sense to most scientists. Dilution is dilution is dilution. How can a substance have any pharmacological activity if it is so diluted that the solution has no molecules left of the original substance. I know, magic.
In the last of a series on alternative medicine entitled, "Blind Trust," the Toronto Star's staff reporter Leslie Papp takes a close look at alternative therapies in Canada. As in the United States, the public has overwhelmingly accepted alternative medicine, while physicians' reactions vary--some oppose it while others figure, "If you can't fight them, join them" and start selling nutritional supplements in their offices and hiring alternative practitioners, such as massage therapists and acupuncturists, to join their practices. The public's desire for caring as much as for healing has led to the condition of modern medicine today. An estimated three out of four Canadians have tried some kind of alternative medicine treatment, and they spent an estimated $3 billion on alternative medicines alone last year. [Toronto Star Jan 23, 2000]
The Los Angeles Times took a long, hard look at the growing problem of mixing herbs and other dietary supplements with prescription medications. An article by health writer Jane E. Allen starts with a report of a retired engineer who was on a prescription blood thinner discovered that the ginkgo biloba and garlic pills he was taking also inhibit blood clotting. More and more people are self-medicating with herbs and nutritional supplements. Some $13.9 billion a year in dietary supplements were sold in 1998, according to Nutrition Business Journal in San Diego. A survey for Prevention magazine found 49% of adults had used herbs in the last year and 24% used them regularly. In November, 1998 JAMA reported that 42% of Americans used alternative medicine and 40% didn't tell their physicians.
Lack of Research. There simply isn't enough research yet to know just what all the interactions are. But there is evidence for a number of warning areas: St. John's wort should not be mixed with antidepressants because it intensifies their effects; St. John's wort should not be mixed with the heart medicine, digoxin, because it reduces the effectiveness of digoxin; ginkgo biloba and aspirin should not be combined with prescription blood thinners because of potential excessive bleeding; and, licorice root should not be mixed with the heart drug, Lanoxin, because such could deplete the body's store of potassium.
Information Sources. Some websites have information
about these interactions. A spokesperson for Nature Made
supplements, a product of Pharmavite Corp, puts information on
interactions on its website. The company also offers a toll-free
phone line for questions and sends materials to pharmacists. Some
individual pharmacists have become knowledgeable about nutritional
supplements. Also, the NIH has funded botanical research centers
at the University of Illinois and UCLA so information on supplements
can be made available to physicians across the country. Much more
research needs to be done so that information on drug-herb interactions
can be available to the public.
[Los Angeles Times, Jan 10, 2000]
Deepak Chopra, best-selling author and guru of his idea of
mind-body healing, may have a new mission in life. "Maybe
it is my karma to dismantle the corruption in the San Diego judicial
system," he is quoted as saying in an article by Anne Krueger.
Chopra's comment came after jurors voted 12 to 0 that Joyce Weaver,
a former employee, did not attempt to blackmail Chopra for $50,000
in exchange for not releasing tapes she allegedly made of a former
prostitute's phone call claiming she had had sex with Chopra.
Weaver also had claimed sexual harassment against Chopra, but
those charges were dropped because of the statute of limitations.
Other claims of retaliation and wrongful termination are pending.
The Union reports that Chopra says he's already spent more than
$1 million in lawsuits. The judge in the first case removed himself
from presiding over additional cases because of comments he made
the previous week about one of Chopra's attorneys. The two sides
can't even agree on just what the judge said or what he may have
[San Diego Union, Jan 11, 2000]
Vanadium is thought to mimic the actions of insulin and to improve insulin sensitivity, but more studies are needed before it can be recommended for these purposes. Concerns about long-term toxicity and adverse GI effects caused The Pharmacist's Letter (Feb, 2000) to discourage its use at this time.
A 39-year-old nurse in Colorado ended up with liver damage
after visiting a massage therapist for deep tissue manipulation,
according to HealthSCOUT. The therapist worked on the woman's
abdominal muscles. The woman developed nausea and abdominal pain
and, after 72 hours, went to the hospital. She had to have a two-pint
blood transfusion because of internal bleeding from a bruise the
size of a small pineapple in her liver. She lost 23 pounds over
six months due to the nausea. Her physician wrote about the case
in a letter to the New England Journal of Medicine. Although
he's not opposed to massage, he warns that it can result in serious
complications such as embolisms and aneurysms. To reduce your
risks, choose a massage therapist who is licensed (if your state
is one of the 30 that does so) and belongs to a national organization.
Tell the therapist about any health problems you may have and
don't ever allow any bruises to be massaged. Let the therapist
know if you experience pain.
[HealthSCOUT, Dec 22, 1999]
The Medical Expenditure Panel Survey (MEPS) is the first national probability survey to gather data about use of visits for unconventional therapies in the context of health insurance, health status, and the use of different types of medical services. The sample size in this study is 4 times larger than any previous survey of unconventional therapies in the United States, and the sampling technique make it highly representative of the general U.S. adult population. 16,068 adults 18 yrs and older were included in the analysis. The survey examined only unconventional therapies delivered through a practitioner.
Findings. During 1996, an estimated 6.5% of the US population had visits for both unconventional therapies and conventional medical care; 1.8% used only unconventional services; 59.5% used only conventional care; and 32.2% used neither. Those who used both types of care had significantly more outpatient visits (7.9 vs 5.4; P<.001), and used more of all types of preventive services except mammography, compared with those who used only conventional care. The list of unconventional therapies asked about included: acupuncture; nutritional advice or lifestyle diet; massage therapy; herbal remedies purchased; biofeedback training; training or practice of meditation, imagery, or relaxation techinques; homeopathic treatment; spiritual healing or prayer; hypnosis; traditional medicine such as Chinese, Ayurvedic, American Indian, etc; and, other complementary or alternative treatments. Use of unconventional therapies was substantially lower than reported in previous national surveys.
[Druss BG, Rosenheck RA. "Association between use of unconventional therapies and conventional medical services," JAMA, 1999;282:651-6]