December 9, 2007 - Seattle Times
FDA bans import of unproven machine
Unfortunately, Health Canada has known about these devices for years, and has never taken one step to stop their import, or their use. Why is that?
By Christine Willmsen and Michael J. Berens
Seattle Times staff reporters
Trying to shut down a federal fugitive's medical-device empire, the U.S. Food and Drug Administration is blocking the import of the machine he claims can cure diseases such as cancer and AIDS.
The desktop device, called the EPFX, is manufactured in Hungary by William Nelson, who fled the U.S. in 1996 after he was indicted on felony fraud charges related to his invention.
FDA compliance director Timothy Ulatowski, who oversees medical-device regulation, said the action is the first step in a sweeping investigation of Nelson, his distributors and EPFX operators.
"This is pure, blatant fraud. The claims are baloney," Ulatowski said. "These people prey in many cases on consumers who are desperate in seeking cures for very serious diseases."
The FDA said it took action as a result of a recent Seattle Times investigation that uncovered a global network of manufacturers who sell unproven devices and practitioners who exploit unsuspecting patients.
Also in response, a congressional subcommittee is investigating how these manufacturers have taken advantage of federal loopholes to profit from the machines. And last week, the Washington State Chiropractic Association asked a state board that governs chiropractors to ban the EPFX.
The Times series revealed how manufacturers and operators used unproven devices — some illegal, some dangerous — to misdiagnose diseases, divert critically ill people from life-saving care, and drain their bank accounts.
Many operators dupe patients by posing as highly trained health-care professionals through the use of deceptive credentials and degrees from unaccredited institutions.
These victims are casualties in the growing field called "energy medicine" — alternative therapies based on the belief that the body has energy fields that can be manipulated to improve health.
Thousands of these unproven medical devices were found in venues across the country from health-care clinics in Florida to an 866-bed hospital in Missouri.
The FDA and state regulators failed to confiscate or warn the public about a dangerous device, the PAP-IMI, a 260-pound electromagnetic pulsing machine linked to patient injuries and death.
The devices, made in Greece by math professor Panos Pappas, were smuggled into the U.S. as seed germinators. They remain in use today in at least five states, including Washington.
The FDA will take action against the PAP-IMI, Ulatowski said, but he wouldn't give details.
"I don't want to tip my hand to those who might benefit," he said. "They may evade action."
The EPFX is one of the most prevalent energy devices in the U.S., with an estimated 10,000 machines in clinics, offices and homes. More have been sold in the Northwest than in any other region.
Nelson, a native of Ohio, registered his company, Eclosion, with the FDA in 1989 as a maker of biofeedback machines, meaning he could sell his invention but only as a stress-relieving tool.
In 1992, the FDA warned him to stop making fraudulent claims that his device could diagnose and heal. In 1996 he fled the U.S. after he was indicted on nine counts of felony fraud.
Despite his indictment, the FDA never revoked his registration. Nelson re-established himself in Budapest and and began to sell the EPFX once again.
Today, the flamboyant Nelson, 56, rakes in millions of dollars monthly from the sales of devices, accessories and training materials.
Physicians, nurses and chiropractors across the country market and use the device, which now costs $19,900. One of the EPFX's celebrity pitchmen was Jeffrey Spencer, a chiropractor for champion cyclist Lance Armstrong.
Spencer said he used the device to treat some members of the U.S. cycling team during the 2003 and 2007 Tour de France, but never used it on Armstrong. When questioned for the Times series, he said he wouldn't use the machine again.
Ulatowski said Friday the FDA recently revoked Nelson's registration as a manufacturer, which will allow the agency to seize the machines at U.S borders. This first step will not affect those machines already in the country.
The FDA action is expected to cripple his sales network. Five of his six largest distributors are in the U.S. His largest distributor, The Quantum Alliance, is in Calgary, Alberta.
Ulatowski said federal officials are working with foreign regulators to see what actions can be taken.
"I'd like to invite Mr. Nelson back into the country. I'm sure we'd have a good welcome for him here," Ulatowski said.
Neither Nelson nor Quantum officials responded to requests for comment.
For years, the FDA did not warn the public about the dangers of the PAP-IMI nor address Nelson's outrageous claims and the rapid spread of the EPFX.
Ulatowski said the FDA thought it had tackled those problems when it helped to bring the fraud charges against Nelson and shut down a Los Angeles PAP-IMI clinic.
"These products in general are like weeds," Ulatowski said. "You stamp them out and you take action and they well may pop up again. Here we are again. We have to address it, and the agency will."
The Times found that unscrupulous device makers and operators took advantage of federal regulations that let them operate on an honor system in clinical studies.
The FDA routinely cedes its oversight of such studies to committees of medical professionals called institutional review boards, or IRBs. Review boards are required to oversee the design and safety of clinical studies.
Scores of private companies sell IRB services, which offer the promise of quick study approval and oversight for as little as a few thousand dollars.
The medical devices involved in clinical studies will be included in the investigation being conducted by a U.S. House Energy and Commerce subcommittee, which oversees the FDA.
Rep. Jay Inslee, D-Bainbridge Island, requested the expanded investigation. He wants to eliminate "IRB shopping," in which a device maker can hire a private overseer for a study. The FDA does not track most of the studies.
Rep. Bart Stupak, subcommittee chairman, and Rep. John Dingell, chairman of the full committee and a subcommittee member, said in a statement that FDA regulations may not adequately protect the public. Both are Michigan Democrats.
"We share your concern that Americans are being duped by dangerous, unproven devices that illegally claim to diagnose, treat and even cure their illnesses," they wrote to Inslee.
Christine Willmsen: 206-464-3261 or firstname.lastname@example.org
Michael J. Berens: 206-464-2288 or email@example.com
More related stories from Seattle Times
By Michael J. Berens and Christine Willmsen
Our position was clear - It's BUNK and always has been!
Fall 2005 - Some licensed medical doctors are obviously deluded enough to believe that QXCI machines can help their patients. It doesn't take much of an imagination to jump to the alternative medical camp to see what they think. Are they true-believers, or are they just plain and simply out for a buck.
Jumbled together with a myriad of burned-out social workers, housewives, garage mechanics, vitamin pedlars, and their ilk some of these people are actually licensed health professionals. They can in some cases actually bill their publicly funded insurance programs for this quackery. In some jurisdictions, when they are not covered by your tax dollars, they bill private insurance companies to complete the fraud.
In some electronic design circles it has now become a game to design machines that are classified as biofeedback devices in order to escape government regulations. I've been hooked up to one of these wacky machines and listened to their pitch about how I could make tens of thousands of dollars if I had one of them in my practice. These sophisticated (sometimes valued at tens of thousands of dollars), devices, sometimes almost Startrekkian, enables the quacks to pinpoint and test for various non-existant illnesses or allergies.
It's frightening enough when a medical doctor uses one of these, but even more frightening when they teach others to do the same thing to make a buck.
Of course the main idea is to pump you up with a skillfully contrived sales-pitch. They convince you with totally false information that this device will be able to get to the root of your problems, even of course if they are only buried deep inside your worried brain. Then, based on this useless information you now have to make a decision that might effect you for the rest of your life. In some cases, this advice could be deadly.
The majority of the more sophisticated machines are still being made by foreign electronics manufacturers, and marketed through catalogs and sales reps who serve the medical, chiropractic, homeopathic, and naturopathic professionals.
But what is really frightening, some of these companies sell to anyone with the money. At the world-famous Perimeter Institute in Waterloo, Ontario one of the companies that happened to be located right across the street placed their glossy brochures inside their building without permission. He is a member of our Chamber of Commerce. He operates out of an apartment building.
Can the QXCI brigade justify their claims. In my opinion - they can't. So why haven't regulators stepped in? My feeling is that the government is sick and tired of investigating them. The charges rarely shut the manufacturers down. They just change their brochures, or modify their presentations to please them. But that does nothing to stop their use as a medical device that is promoted with the express purpose of scamming people, including those who buy them.
Once the machines are in the hands of the quacks and licensed doctors, the government throws their hands up in most cases. It's then up to courts or the consumer fraud departments to step in. And that, my friends has almost never happened.
So, as the\ QXCI lobby gets ready to take aim at me, it may be wise to discuss the situation with your insurance carrier. If you find that your health insurance carrier pays for QXCI, then ask them why? Tell them that it is health fraud, and file complaints when you see advertisments for any of these devices. Good luck and beware.
Terry Polevoy, MD
Where is the evidence?
OPEN LETTER TO THOSE WHO PROMOTE QXCI
My Dear Dr. Quack:
So, you are one of the licensed health professionals who use the QXCI system in your practice. You may also teach other people how to use the device to diagnose and treat their customers even though they are not licensed?
Are you also one of those doctors who is using QXCI as a business opportunity because your own practice is going down the drain? You must have been really impressed with their colourful brochures and became a true-believer in Quantum Technology.
Perhaps you listened to a QXCI spiel on the internet that convinced you that the QXCI was able to create a link to your unconscious that hides behind your left ear. Or, perhaps you are tired of your old QXCI and want to step up to the latest technology, the amazing SCIO device. After all it's another quantum leap of faith and it will make you a lot more money.
Perhaps you were treated yourself by one of the largest quack operations down in Sarasota, Florida while you were on vacation. Or, maybe you got suckered into the Distance Healing scam performed by that same clinic. You didn't even have to leave your Ontario office. Wow, isn't that amazing!
After paying for your unit you had to endure a grueling 8-9 hour training period before you could use the device on your patients. Of course, you knew that health insurance did not pay for QXCI "therapy" for a very good reason. It doesn't work. But, that won't stop you from using it. Why, what do you care, your patients pay you with cash, check or charge card. They do this because you are a good salesperson. You have convinced them that you can help solve their condition (real or imagined). You do this even though there is not one scintilla of evidence that what you do is either accurate or effective.
Where in the world are your ethical values? If you are licensed or registered as a chiropractor or medical doctor do you know that you are in all probability violating your professional code of conduct, Board or College policies, or even legislated regulations?
The problem is basically this. Have you ever considered for one moment that when you collect hundreds of dollars from a perfectly healthy client to help pay for your $13,500 U.S. quack QXCI biofeedback device that you are in all probability making fraudulent representation to the client? As a person who takes an oath to do no harm, do you really care that you have scared them to death, or caused them economic hardship because you promote QXCI?
Take the case of a young mother who was told that she had a brain tumour and she had to leave the Province and pay money out of her own pocket for a CT scan?
Are you that delusional that you can't face the truth? It's one thing to use an unapproved device to convince hypochondriacs that they have a real problem, like too much candida, or an imbalance of their bowel flora. Those are just the average tactics used by unlicensed charlatans. But, let's face facts. The QXCI device and all of its software are in all probability nothing more than a scam, and that you are part of the expensive fraud that ruins people's lives. When you have those bloody professional initials after your name, it's even worse.
Please respect your profession and give it up. Don't use this device to scam people, and don't tell them that it's just investigational. It's a bunch of crap, and you know it. If you don't know it, then you are basically delusional, and should be seen by someone who can help you.
Terry Polevoy, MD
Dr. Deborah Drake - Ontario physician in trouble again
- QXCI promoters include Deborah Drake, MD as it appeared in an archive of the QXCISCIO.COM web site on Jan. 7, 2006. Deborah was the subject of a complaint to the College of Physicians and Surgeons of Ontario (CPSO)in August 2004 because of the claims made on her web site and her advertising that was in violation of CPSO policies.
The CPSO ordered restrictions of her practice in decision of the Executive Committee on June 7, 2008 and the Discipline Committee rendered a severe penalty and restrictions on her practice again on August 12, 2009. Dr. Drake must conduct her practice according to conventional medicine. When you click the link above you will notice that the earlier decision is not available at the present time. In essence this is what that earlier decision said:
"If Dr. Drake suggests that the patient may benefit from the EPFX
for stress reduction, Dr. Drake will explain to the patient that,
while the EPFX is licensed by Health Canada for stress reduction
and for the treatment of stress, is not licensed in Canada for
the purpose of making a diagnosis. She will also explain to the
patient that, at the present time, the scientific literature with
respect to the reliability of the EPFX is still at the early
"As of June 17, 2008, Dr. Drake shall only be permitted to
practice if a supervisory/monitoring arrangement is in place, in
the form attached as Appendix 1, by which a physician acceptable
to the College shall review all of Dr. Drake's charts weekly.
That monitor shall report regularly to the College and shall
report immediately if Dr. Drake is not complying with the terms
of this Order. The undertaking at Appendix "1" shall be
provided, in executed form, to the College by June 17, 2008."
The stipulation at her latest disciplinary hearing in August 2009 was that she must stop using the QXCI device for diagnostic purposes. However, it seems that as of March 7, 2010 Dr. Drake has not done that. A link to her web site called Harmonize Your Health demonstrates the total inability of the CPSO to do its job.
How much money did the CPSO spend on the hearings, and how much have they spent to "supervise" her practice since this all began?
"HYH.com provides educational and clinical expertise in the use of a safe, non invasive energy technology called Quantum Biofeedback, which is used to map and balance the immune system with precision vibrational or sound wave therapy, in order to identify and influence stress, pain and relaxation related issues in people, pets or places. Our medical director is a conventional medical doctor traditionally trained in emergency, family, psychotherapy, sports, Integrated complementary and alternative medicine, has become an international Examiner and Instructor in Quantum Biofeedback."
She appears to still be marketing and/or teaching the use of these quack devices.
WHAT CAN WE PROVIDE FOR YOU?
1. Marketing Bio-Energetic Sensor Technology Installation for Practitioner Support,
2. Consulting guidance to expose individuals, clinics and groups access to new, enhanced non invasive evaluation tools
3. Problem Solving Foresight to lend experience to lead innovative project deployment from inception to transformation and implementation.
4. Certifications to be Able to train and direct practitioners in clinical skills
5. Legal Mentorship in issues Technician or Health Care Practitioner Authority and experience to direct technician to practice in a legal and compliant manner
6. Leadership with Medical Compliance Officer for templated protocols that work
7. Clinical Research Templates with access to guidance by an experienced Bioenergetic Medical Research Director to ensure proper protocol, etiquette, consent, language and skill transition from evaluation to medical interpretation skills.
8. Deployment experience in start up and rapid training for Turn Key operations
9. Clinical Deployment Methods with template strategies for rapid return on investment.
10. Cyber Mentorship with Membership to BEST TRIAGE problem solving group.
11. TAO Technology assisted Observations are made using the BEST sensitive and specific, peer reviewed technology available currently.
12. EBM - Evidence Based Medicine platform insists that for internal quality control and external peer review, all facets of our business are provided at the level of professionalism that they could withstand peer review, skeptical scrutiny and public safety concerns.
13. Pain, Stress, Relaxation and Peak Performance Advisors for setup, insight and activity protocols as ready made research templates to pilot various clinical projects.
At the time of the original complaint the QXCI device was NOT licensed for any use at all in Canada.
In October 2005 the Complaints Committee finally rendered their decision and here is a summary of what they concluded:
- The use of the QXCI in her practice is being managed in a manner that is inconsistent with the College's policy on Complementary Medicine.
- The advertising of the QXCI does not comply with the College's Advertising Policy in two respects. She can not make superlative claims, and she can not make reference to a specific drug, appliance or equipment.
- The Committee has concerns about the fact that Dr. Drake is using (and promoting the use of by others) a medical device which has not yet been licensed for sale in Canada.
- The Committee requested the appearance of Dr. Drake before the Committee to be cautioned and to provide direction to her about the steps the Committee believes she must take in order to avoid future difficulties.
Dr. Deborah Drake's CPSO registration in Ontario indicatest that she is certified in Emergency Medicine. She actually has her own web site where she lists almost all of her vital statistics including her OHIP billing number, which is supposed to be kept confidential. She also lists references, and hospital staff contacts.:
Health Cirquet Integrated Medicine Centre
Family Medicine Centre CirQUESTudio
6633 Highway #7 East
Markham ON L3P 7P2
Tel: (905) 294-3322, Fax. (905) 294-5011 Tel: (905) 294-3403
Dr. Drake explains some of the various procedures and tools that she uses, including the QXCI.
Make sure you check out the BioShield and the amazing PenEnergizer. I have personally never seen such rubbish on any medical doctor's web site in Canada.
Drake's web site also contains links to Royal Body Care Products. Does the good doctor sell them to her patients, too?
Perhaps she hasn't time to look at the evidence and negative opinions of colloidal minerals and those who sell them, like the quack non-doctor Patrick Flanagan.
Does she ask her patients to sign up under her as a distributor?.
- Dr. Drake's 2003 presentation on leaky gut is another example of total and complete lack of knowledge of medical subjects. Yet it is still available in .pdf format.
Does Dr. Drake violate CPSO policies on advertising?
Is her use of the QXCI device a violation of the recently updated CPSO Policy #1-00 on Complementary Medicine?
In treating patients, physicians should:
- Have demonstrated education, knowledge, skills and currency in their area of practice.
- Act honestly and always in their patients' best interests.
- Provide sufficient information to allow patients to make informed choices, and to refer to, or consult with, others when the practitioner requires assistance or when the standard of practice requires it. It should not be misconduct to refer a patient, honestly and without conflict of interest, to unconventional or complementary practitioners when appropriate and when there is no reason to believe such a referral would expose the patient to harm.
- Not misrepresent information or opinion; patients must be given the general degree of certainty or uncertainty of efficacy of a given therapy, notwithstanding the practitioner's individual beliefs.
When she acts as a spokesperson for Royal Body Care she endorses a specific product. Is she in violation of the Advertising Regulations of the CPSO?
Ontario Regulation 114/94 made under the Medicine Act, 1991
(2) Information communicated under subsection (1) must not,
(a) be false, misleading or deceptive by the inclusion or omission of any information;
(b) contain a testimonial or any comparative or superlative statements; or
(c) contain any reference to a specific drug, appliance or equipment.
(4) No member shall,
(a) cause or permit his or her name to appear in any communication offering a product or service to the public; or
(b) otherwise cause or permit himself or herself to be associated with the advertising or promotion of any product or service,Ê
other than the member's medical services in accordance with subsections (1), (2) and (3).
Does Dr. Drake really believe that systemic candidiasis is responsible for fibromyalgia and other diseases? She claims to be doing research, but her web page has not been updated since 1998.
- Carri Drzyzga, DC - Prana Chiropractic Group - Ottawa"Dr. Carri's holistic approach for evaluation and treatment incorporates many modalities such as locating structural misalignments in the spine; determining biochemical imbalances such as heavy metal toxicity, parasitic infections, nutrient deficiencies or excesses; as well as finding suppressed emotions that may be sabotaging your health.
Motivated by her desire to always ensure that her patients are receiving the best care possible, Dr. Carri regularly attends seminars, workshops and training in the most up-to-date and effective treatments available. In addition, Dr. Carri trains other practitioners on the QXCI - a highly sophisticated biofeedback system."
- Quantum Life web site
- CIHS - Centre of International Holistic Studies - Colin Paddon is a quack who practices with a fake PhD and trains people to use the QXCI in his Quantum Biochemical Rebalance Training Program. I wonder if he gets a piece of the sales, too? His office are in the Stoney Creek, Ontario area, just down the road from Hamilton, and Niagara Falls. He claims affiliations with all sorts of bogus schools around the world. If you want to learn all about the legal implications of using this device on people, just take their Level #1 course. Take a look at his Level #2 course for further information. They offer certification for an extra $500 for the Canadian Examining Board of Healthcare Practitioners which has zero status anywhere in the world. He has two additional teachers who help him educate the public, and they are distributors for the QXCI, too. Just in case you missed out, or couldn't afford the QXCI course, don't dispair. Paddon also runs courses in acupuncture and reflexology. A few years ago Paddon appeared on CHML radio and claimed to be a nutritionist or sorts. He also sported that fake PhD. Paddon teaches the QXCI and other devices and techniques off-shore in the Bahamas with Bill Nelson, the inventor of QXCI who lives in Hungary.
- QXCI Biofeedback Course - This five-day course is given by the staff of the Centre of International Holistics Studies in Campbellville, Ontario. These folks were at the Total Health Expo in Toronto on March 20-21, 2004. The device and software was demonstrated for two days. It sells for about $13,500 U.S. and that does not include the laptop computer.
- Energy Medicine Ministries - Ozark, MO treats patients and markets not only QXCI systems, but also the latest SCIO units as well. The owners are Ginger Bowler, Th.D, Ph.D and LaRae Palo, M.O.M. who formally owned and operated Southern Herb Co., Inc.
"Energy Medicine Ministries works with numerous Energetic / Vibrational Technologies: QXCI, VIBE Machine, subtle energies, prayer, foods, supplements, education (specializing in Hanna Kroeger's work)."
- Har Hari Khalsa, D.C. and his wife in Los Angeles have built their practice around the QXCI and they sell them, too. Here are their claims:
"What does the QXCI actually do? The QXCI scans the patient's body like a virus-scan on a computer, looking for everything from viruses, deficiencies, weaknesses, allergies, abnormalities and food sensitivities. It reports on the biological reactivity and resonance in your body and indicates needs, dysfunctions and vulnerabilities. The information provided is fundamentally different from X-rays, blood tests, etc.., as it tells us about the energetic state of your body and the direction in which the body is focusing its energy."
- MSB-Holistics comes to University of Waterloo -
QXCI promoter Randy McCreary came up from Buffalo to deliver an informal talk at the University of Waterloo's Conrad Grebel College on March 20, 2004.
- QXCISIO - The Xxeroid Xpress This is an Adobe .pdf file and contains defamatory comments by Tim Bolen who we all know and love as the former p.r. fellow for Hulda Clark during her more glorious days after she beat the rap for practicing medicine without a license in Indiana. For a more complete picture who these people are, and why Bolen would probably fit right in with the wing-nuts who promote pseudo-science:
- Hulda Clark
- Tim Bolen
- Transformational Learning Center - Ohio"The QXCIª system is based on principles very different from those used in conventional medicine. The system stimulates the body to promote self-Ê healing. Our goal is to remove barriers limiting the bodyÕs ability to heal itself, rather than short-term suppression of symptoms."
Why you can even get your innate body balanced, too, and do it without a chiropractor sitting on your neck.
- Lawsuit against QXCI - This lawsuit describes what happened to a man who was victimized through the use of a Quantum Xrroid device. After Nelson failed to defend, a default judgment was issued, which Nelson was able to get dismissed on a technicality. Rex's attorney hopes to renew the suit against the distributor who sold the QXCI.
- Some Notes on the Quantum Xrroid (QXCI) and William C. Nelson - Stephen Barrett, MD - Quackwatch.com
Dr. Barrett carefully documents the credential, or lack thereof, for William C. Nelson, and reviews the evidence for the QXCI device over the years. It is a real eye-opener, and I believe it to be the TRUTH.
- Critique of QXCI and "Dr." Nelson - Peter Bowditch - The Millenium Project master