From: robert@unlv.edu (Robert Cray)
Subject: Re: evidence for homeopathy - who pays?
Organization: University of Nevada, Las Vegas
Date: Tue, 24 Nov 92 02:55:57 GMT

Here is an article from the Las Vegas Review Journal, reproduced without
permission, about homeopathy in Nevada.  Apparently the laws here in Nevada
are less stringent than those of other states.  I found the 4 million
dollar gross income of the one clinic, and the statement that that figure
was low interesting; seems like the homeopaths have plenty of money to
test their stuff.

				--robert

By Steve Papinchak
Las Vegas Review Journal, 11/22/1992

  Nevada homeopaths have built a multimillion dollar industry around
machines they say can diagnose everything from allergies to cancer.
  The machines are called electrodiagnostic devices, and biomedical
engineer Mark Emmerson has taken them apart, searching for their secrets.
  What Emmerson found amid the machines' wires and computer chips is not
good news for Nevada's homeopaths or the tens of thousands of patients
who journey from across the country to Las Vegas and Reno for a special
brand of medicine.
  "There is nothing magic about these machines," Emmerson said.  "I have
a volt-ohm meter that I got (10 years ago) at Radio Shack for $9.98 that
will do the same thing."
  Dr. John Renner, president of the Consumer Health Information Resource
Institute, said the machines have no medical value.  Nevada's tolerance
of the devices makes the state like a cash-starved foreign country that
allows unsafe medical practices to lure desperate patients willing to
cross borders for expensive "miracle" cures, he said.
  "This has got to be one of the worst 10 examples of medical nonsense,
chicanery, quackery and fraud in the U.S.," Renner said.
  Nevada homeopaths say they are the target of a medical establishment that
feels threatened and is unwilling to accept the success of alternative
medicine.
  And Nevada's 18 homeopaths are fighting back, developing new state
regulations, hiring lawyers and taking other actions they say are designed
to protect their right to practice a form of medicine that is uniquely
successful.  Fighting as aggressively as anyone is Dr. Yiwen Tang,
owner of the Century Clinic in Reno, the target of two federal raids in 1990.
  "Although what I do may look very strange, it does have a scientific
foundation, and you guys have to understand this," said Dr. Fuller Royal,
a member of the Nevada Board of Homeopathic Medical Examiners.
  Countless patients, Royal said, journey to his office after finding no
cure at prominent medical centers such as the Mayo Clinic, Scripps Institute
and the UCLA Medical Center.  About 85 percent of his 22,000 patients at
The Nevada Clinic, 3720 Howard Hughes Parkway are from out of state, Royal
said.
  "I have patients from New Zealand, Australia, Israel, France, England
and all 50 states, and they come back to see me," Royal said.  "Why?
Because they get good results."
  Nevada's unique relationship with electrodiagnostic machines dates to the
1983 session of the Legislature, which historically has been open minded
about what some call alternative medicine and others say is quackery.
  Nevada, for examples, in 1977 became the only state to approve the sale
and manufacture of gerovital, allegedly a youth potion, and laetrile, an
apricot pit derivative touted as an anticancer agent.
  Royal played a lead role in another precedent setting lobbying effort,
the passage of a 1983 law that established a seven member homeopathic
board, a move that generally removed homeopaths from the scrutiny of boards
that license medical doctors and osteopaths.
  Homeopathy, which has been around for almost two centuries, is based on
the "law of similars," the theory that says minute doses of herbs, minerals
and other materials can cure certain diseases by stimulating the body's
natural healing process.
  The state's homeopathic law, however, included two words -- noninvasive
electrodiagnosis -- that created an offshoot of classic homeopathy, 
sanctioning a new form of medicine that relies heavily on electrodiagnostic
devices.
  Royal calls this new brand of medicine bioenergetics.
  Bioenergetics, he said holds that channels of energy flow through the
body .  Energy flow disruptions occur before disease develops, allowing the
practitioner to use homeopathic preparations to cure ailments before they
manifest themselves, Royal said.
  "If you can get the electrical energy to cycle in a normal fashion --
I don't care what the disease -- the patient will get well," he said.
  By including electrodiagnosis in the definition of homeopathic medicine,
lawmakers sanctioned the use of devices that Emmerson and other medical
fraud watchdogs say are not approved by the federal Food and Drug
Administration.
  Medical devices -- everything from bed pans to pacemakers -- must gain
FDA approval, a process designed to assure the safety and efficacy of medical
equipment.
  Prior to getting the FDA's full approval, medical device manufacturers
can undergo "investigational testing," which requires a scientific review
panel, detailed studies of how the device works on patients and regular
reports to the FDA.
  Emmerson, who monitors compliance with federal and California state medical
device regulations, said no electrodiagnostic machine has been approved by
the FDA.  nor are any devices undergoing legitimate investigational testing
he said.  The FDA would not confirm that, however, saying such information
involves trade secrets.
  Electrodiagnostic devices are marketed under brand names that include
EAV Dermatron, ViTel, Prophyle, Interro, Biopath, Listen and Computron.
  In September, Emmerson displayed several of those devices during an
appearance in San Mateo, California, before the Northern California Fraud
Investigators Association.  The devices shown at the gathering had been
seized by his department.
  The more than 100 police and insurance investigators at the meeting
listened attentively as Emmerson reviewed dozens of phony medical devices
everything from hair growth machines to anti-AIDS gadgets -- before turning
to the electrodiagnostic machines.
  Electrodiagnostic machines are openly featured at Nevada seminars and
then brought back to California, he said.
  "Nevada is a lot looser than the state of California, in many ways,"
he said, getting laughs from the investigators.
  After his presentation, Emmerson, and expert on medical device
engineering, opened up several of the electrodiagnostic devices.
  They're all, he said, basically the same:  devices that discharge a weak
electric charge through a pointer that is pressed on acupuncture points
in the hands or feet.
  It's a simple mechanism; so simple that the same task can be performed by
any common volt-ohm meter, he said.
  But the software programs that are attached to the basic device -- and the
chips and circuitry that supports them -- are impressive and sophisticated,
even though they serve no known medical purpose, Emmerson said.
  It is the software program, he said, that tells the homeopath and patient
that the body's circuitry  is awry and diagnoses diseases that could
include viruses, lung disease, kidney disease, high cholesterol, cancer
or childhood exposure to radiation or radon.
  Royal said that almost all his patients undergo an electrodiagnostic
examination.  But, he added, the electrodiagnostic revie is accompanied
by a physical exam, blood tests and all the other tests that other doctors
give.
  Homeopaths sometimes liken themselves to pianists.  Just as the pianist,
not the piano, makes the music, it is the homeopath, not the machine, that
makes the diagnoses, they say.
  But Dr. Samuel Wise, medical director of the rehabilitation unit at
Humana Hospital Sunrise, sees it another way:  "It's not the box that does
the magic trick, it's the magician that perpetrates the fraud," he said.
  Those who use electrodiagnostic devices are practicing "technofraud,"
said Wise, a physiatrist, a doctor of physical medicine and rehabilitation.
  Few people are sophisticated in high-tech equipment, and they are
easily impressed by modern day faith healers who use electrodiagnostic
devices and other gadgets sporting "bells and whistles," he said.
  Wise said he's studied the electrodiagnosis and has used electrodiagnostic
devices on patients with nerve and other neurological damage.  But this type
of technology is limited, and it certainly can't be used to diagnose ailments,
he said.
  Renner, a Kansas City, MO, family practice physician and national medical
fraud watchdog, said electrodiagnostic machines, aside from being alluring,
can be dangerous.  Diabetics and others with serious medical problems have
been steered away from life sustaining treatment in favor of unproven
machines and cures, he said.
  "People are dying because of that kind of medical process," he said.
  Royal, who also was trained as a medical doctor, said it is unfortunate
that those who don't understand bioenergetics criticize it.  Few of his
critics have accepted his open invitation to visit his clinic, view his
work and talk to patients, Royal said. 
  Medical schools focus on the mechanical physics, things that can be seen,
touched or measured, while generally ignoring bioenergetics, the energy fields
in health, but most doctors refuse to review them and draw an open minded
conclusion, Royal said.
  "It's not taught in medical school, therefore it is quackery," he said.
  Proof of the success of his form of medicine can be found, Royal said,
both in medical studies and in the thousands of satisfied patients who
go to Nevada homeopaths.  Only 38 patient complaints have been filed
against homeopaths since the board was founded in 1983, he said.
  But a big complaint was voiced when the FDA raided the Century Clinic
on September 6, 1990, and again on October 24, 1990, hauling off 20 EAV
Dermatron electrodiagnostic machines, patient files, business records and
enough items to fill a 14-page inventory.  The FDA says the seizure was part
of an investigation.
  Since the raids, Tang has hired a series of attorneys who have filed
motions and made federal court appearances in an effort to get back the
confiscated machines and records.  The clinic's appeal is before the 9th
U.S. Circuit Court in San Francisco.
  In earlier rulings, District Court Judge Howard McKibben and federal
Magistrate Phyllis Halsey Atkins supported the seizures.  Atkins said
there is probable cause to find that the machines are a health hazard, and
that they were used with the intent to defraud or mislead the public,
a felony.  McKibben endorsed Atkins' order.
  Bob Martin, director of the Century Clinic, notes that the FDA so far
only has been able to get search warrants that is says are needed to
gather evidence for its investigation.  No criminal or civil charges
have been filed despite federal lawyers' efforts to seek formal charges
from a federal grand jury that ended its term without taking action,
he said.
  "They've been before the grand jury five times, and each time they (jury
members) threw them (federal lawyers) out, and everyone knows you can get
an indictment for a ham sandwich," Martin said.
  Philip Frappaolo, deputy directory of the FDA Office of Compliance and
Surveillance, said it's against agency policy to discuss current cases.
  Frappaolo said he wasn't familiar with recent developments in the
Century Clinic case, but he disputed critics' charges that the FDA has
backed off the case and has given a lower priority to forcing compliance
with medical device regulations.
  But one thing is certain:  The FDA's action against the Reno clinic is
being taken very seriously by Nevada's homeopathic board, which is made up
of four homeopaths and three citizen members who support homeopathic
medicine.  All are appointed by the governor.
  In reaction to the FDA's action in Reno, the board is developing a
regulation that would specify the approved uses of the devices and set
other standards.
  The homeopathic board is taking action that, among other things, will
expand the "states' rights" defense that the Century Clinic's lawyers have
included in their legal briefs.
  Federal law takes precedence over state law, but the board's adoption of
detailed state regulations governing the use of electrodiagnostic 
machines would throw up new legal roadblocks, should the FDA take
additional action against the devices.
  Meanwhile, the state's homeopaths have scrapped their Dermatron machines,
the type seized in the Reno raids.  Those devices have been replaced by
different brands of electrodiagnostic devices, or by machines made by the
Nevada homeopaths, actions that present the FDA with new legal issues.
  The Century Clinic is attempting to work out a settlement with the FDA,
said Martin, the clinic's manager.  If those efforts are unsuccessful,
however, the clinic will launch a vigorous legal attack against the FDA,
alleging abuse of its powers, he said.
  Tang last year told a television reporter that his clinic grosses $4
million a year and nets a $1.5 million profit annually.  Martin, though,
recently said "Dr. Tang gave a low figure" to the reporter.  Tang was
out of the country and could not be reached for comment.
  The Century Clinic has spent more than $1 million on legal fees and,
if necessary, it can afford to spend more, Martin said.
  The legal fight is costly, "but the fact is that no one is going
hungry around here," Martin said.
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