The "Plan of '96"

This is a transcription of the recording of part of the 1996 annual meeting of the Federation of State Medical Boards (FSMB), recorded live, April 10th through 13th, 1996 in Chicago, Ill.

On this page you will find how the FSMB became involved in the conspiracy to stamp out innovation in health care by labeling it all, anything that competes with drugs, drugs, and more drugs, as "quackery."

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This is tape # 5 - Fraudulent Medical Practices

James R Wenn, MD - Moderator  - Thank you very much, Dr. Porter, The panel is coming up and taking their seats. I certainly would like to take this opportunity to express my pleasure at all those individuals who have come to be with us today and have taken time out from their hectic schedules to attend this year's annual meeting. I won't be able, probably, to personally get around and offer my welcome to you as I would like to, but I would like at this point to tell you collectively, 'Welcome to Chicago', and 'Welcome to the Federation's 84th Annual Meeting.' The Federation staff, Board of Directors and leadership is certainly glad that you have chosen to be with us today.

Our first session this morning is entitled: "Fraudulent Medical Practices: Watch and Be Wary." This topic is particularly timely because of the increased attacks on medical practice acts around the country by a number of proponents and practitioners of alternative medicine. And I think we can agree that some of the unconventional medical treatments DO have merit and at times may be truly medically indicated. But the real problem is how do you differentiate between these types of treatments and the treatments that are harmful, dangerous, or simply worthless. That's the question that we ask our presenters to discuss today.

Before introducing our speakers, I'd like to remind everyone, that the sessions throughout the meeting are being tape recorded. I would ask our presenters speak clearly and into the microphone and that during the question and answer period repeat any question from the audience.

Our first speaker this morning, is Dr.William Fleming. Dr. Fleming is a member of the Federation's Board of Directors, and Chair of the Federation's Ad Hoc Committee on Health Care Fraud. Dr. Fleming is also the Chair of the Texas State Board of Medical Examiners and has been a member of that Board since 1990. A Board Certified neurologist, Dr. Fleming received his medical degree from St. Louis University School of Medicine and he is a partner with Memorial Nuerological Associates in Houston, Texas. I ask that you welcome Dr. Bill Fleming.

William H. Fleming, MD  - Dr. F: Thank you. As Dr. Wen mentioned, I am Dr. Bill Fleming, currently the Chair of the Federation's Ad Hoc committee on Health Care Fraud. I must say this has been one of the most entertaining and enjoyable committees with which I've been involved throughout my career. I've had the chance to work with several outstanding and knowledgeable individuals, two of which you'll hear from later on this morning and you'll get a chance to see what I'm talking about.

In April of 1995, Dr. Robert Porter, the President of the Federation, established the Ad Hoc Committee on Health Care Fraud. The members of that committee, include Drs. Joanne Levitt, Paul Steingard, Ralph Stuart, Bryant Golusha and Marilyn Turner. Dr.John Renner, representing the National Anti-Health Care Fraud Committee, Matt Daynard of the FTC, and Dr. Tim Gorski of the Dallas/Fort Worth Council Against Health Care Fraud serve as consultants. Dr. Robert Porter and Dr. Jim West serve as ex officio members. Not included on this slide is Larry Dickson, Executive Director of the Alabama Board who joined the Committee in November.

The charge of the committee was to research, review and evaluate the current status of questionable health care treatment, procedures and/or promotions which may be unsafe and thereby considered a risk to the public's health, safety and welfare; to research, review and evaluate the current status of questionable health care treatments and procedures and/or promotions which may be worthless and thereby likely to deceive or defraud the public; to develop strategies for recommendations to state medical boards for the regulation and discipline of physicians who engage in unsafe and/or deceptive practices. The committee also agreed to expand this charge to include an educational component, to provide objective information to medical boards, legislatures, physicians and the public regarding the efficacy and potential risk of such questionable health care treatments, procedures and/or promotions.

The committee met twice; once in August and once in November of 1995. We developed preliminary recommendations designed to limit the proliferation of quackery and health care fraud. In its review of health care treatments, procedures and/or promotions likely to deceive or defraud the public, the committee concurred that for the purpose of this report, to limit its recommendations to such practices likely to be provided by allopathic and/or osteopathic physicians. I stress that there's much work left to be done by the committee, and that this report should in no way be construed as a final report.

The committee identified the following objectives:

1: Develop strategies to monitor legislative initiative supporting increased access to unconventional and unproven treatments and assist state medical boards in responding to such initiatives on behalf of the public health, safety and welfare.

2: Recommend revisions to a guide of the essentials of the modern medical practices act which would, if adopted, strengthen medical boards' ability to discipline licensees who engage in fraudulent behavior. These recommendations include making the unlicensed practice of medicine a felony, currently this offense is a misdemeanor in most jurisdictions. Develop a final report for distribution to state medical boards to include a glossary of pertinent terms, a listing and brief description of questionable treatments, procedures and promotions which are likely to be offered by physician providers, and recommendations for regulation of health care fraud and quackery.

The third objective is to solicit the support for the Federation's efforts regarding the regulation of health care fraud, and quackery from medical professional organizations, consumer advocacy groups and other appropriate national organizations such as the AARP, Citizens Advocacy Group, the AMA, the AOA, The National Association of Attorney Generals, State Medical Associations. Other organizations include such as those as the Millbank Foundation.

Finally, the committee strongly believes that education is essential in assisting medical board members and staff in successfully prosecuting cases involving fraud and quackery.

The Ad Hoc Committee on Health Care Fraud identified terms pertinent to the committee's task and discussed common definitions for the purpose of clarity in discussing and generating the committee's report. Terms identified for definition are as follows: quackery, health fraud, treatment practices, therapies which are unproven, deceptive or ineffective or inappropriate, The Committee agreed to limit the use of the term alternative therapy in its report at this time as its term is broad and implies therapy which may be equally effective. Again, a glossary of these terms will be included in the committee's final report.

The committee identified and discussed three categories of harm resulting from questionable health care practices:

1: economic harm which results in monetary loss but represents no health hazard;

2: indirect harm which results in a delay of appropriate treatments, and

3: direct harm which results in adverse patient outcome.

The Committee agreed that the category of economic harm was not within its scope and the committee such focus on patient advocacy as related to safety either directly or indirectly. The committee's report will contain the criteria to be utilized by state medical boards in identifying the most harmful practices and assessing the respective risk to patients. Some of those practices deemed by the committee to be most harmful are identified on this slide:

The Committee considered legislative strategies. The committee recognizes political, and social pressures to provide the public with unconventional and unproven medical treatment as evidenced by various federal and state level proposals. Under the guise of alternative practitioners and alternative medical treatments, proponents are well organized and make exacting regulatory controls on these practices difficult for state medical boards. At least seven states have adopted legislation to permit the use of so-called alternative medical treatment and prohibit state medical boards from disciplinary action based solely on its use.

The State of Oregon adopted such legislation, overriding a gubernatorial veto. A similar measure was recently introduced in the Kentucky State legislature, which would severely limit the medical board's ability to take action against a licensee for any unconventional treatment. This proposed amendment to the Medical Practices Act in Kentucky had several disturbing provisions. Unconventional medicine was defined in such broad terms that any treatment, regardless of scientific basis, would be protected.

Reading as follows: quoted from that piece of legislation - "medical treatments of any and all means which a physician has reasonable expectation of efficacy which has not yet gained general acceptance within the US." The proposal would have required the medical board to utilize experts in any grievance involving non-conventional treatments who dedicate a significant portion of their practice to the use of such treatments.

For example: if the board brought any action against a physician for inappropriate use of chelation therapy, they would be required to consult a chelationist as an expert. This bill also deleted language from the Medical Practices Act prohibiting a licensee from representing that he or she can cure diseases by any treatment which the licensee knows has little or no therapeutic value.

Additionally, the proposal deleted language requiring conduct to conform to the standards of acceptable and prevailing medical practice within a state as well as to the principles of medical ethics of the AMA or the AOA. Through the efforts of the Federation and other interested parties, that piece of legislation was not voted out of committee in Kentucky. I'm sure that this sort of legislative effort will not go away and there will be others to come.

This issue is also gaining interest on a national level. In July of 1995, Senator Tom Daschle introduced the Access to Medical Treatment Act. Although this bill DOES include language which requires adherence to state licensing laws, enactment would limit medical boards ability to regulate and discipline providers of unconventional therapies and treatments. The Ad Hoc Committee on Health Care Fraud believes there may be substantial direct, and indirect harm to patients from enactment of such legislation unless the appropriate safeguards are included.

The Committee further believes that public health, safety and welfare as regard to the delivery of health care by physicians is ultimately the responsibility of state medical boards and that state medical boards should therefore have the legislative authority to regulate these practices being harmful or fraudulent.

The Committee recommends the Federation, through its governmental relations firm, Mark and Associates, work to develop strategies to monitor, oppose or modify federal legislative initiatives in support of increased access to unproven medical treatments. The Committee will also recommend the staff identify states in which legislation such as that mentioned above has been introduced and develop strategies to monitor such initiatives at the state level.

The Committee has developed some preliminary recommendations for its final report:

Number One: The Federation of State Medical Boards should serve as an informational source for the state medical boards in evaluating practices which may be fraudulent, deceptive and/or harmful; the F.S.M.B should encourage state medical boards to report fraudulent, deceptive and/or harmful practices within their jurisdiction to the Federation so that the information may be disseminated among member boards.

The State Medical Practices Act should provide sufficient authority to allow a State Medical Board to monitor physicians who engage in questionable medical practices included, but not limited to, requiring physicians to file treatment plans to the board, report patient treatment outcomes, file periodic reports regarding efficacy of treatment.

The State Medical Practices Act should allow state medical boards to utilize injunctive powers to order physicians to immediately cease practices found to be fraudulent, deceptive or harmful pending final hearing. The Federation of State Medical Boards should assist state medical boards in developing educational information and materials to educate licensees and the public on issues surrounding health care fraud and quackery.

The Federation of State Medical Boards should work with the American Medical Association, the American Osteopathic Association and other physician groups to encourage physicians to report suspected cases of health care fraud and quackery to the appropriate state medical boards.

The Federation of State Medical Boards should communicate with medical professional organizations, consumer advocacy groups and other national groups and agencies soliciting support and diminishing the proliferation of health care fraud and quackery,.

The Federation of State Medical Boards should assist state medical boards in developing processes to effectively monitor health care advertising within their jurisdiction, including soliciting licensees to refer advertisements and promotions to the state medical boards for evaluation and investigation.

The Fed of State Medical Boards should encourage State Medical Boards to interface with the US Postal Service, Federal Trade Commission, State attorneys general, medical societies, and other licensing and regulatory boards on issues surrounding health care fraud, deceptive health care advertising and quackery.

Finally, the Fed of State Medical Boards should include information on the evaluation, case development and prosecution by state medical boards in cases of health care fraud and quackery, in its informational initiatives including the annual meeting board investigative workshop and publications.

As I mentioned at the beginning of this talk, this Committee has a lot of work left to do. We plan to meet again in the late spring or summer of this year. We plan to review and further develop definitions of those practices that are unproven, deceptive and harmful to the public. We plan to develop a glossary of those practices along with a brief description of each one, and we plan to develop final recommendations for inclusion in this committee's final report. It is anticipated that a final report will be presented to the Board of Directors no later than its fall 1996 meeting and it's hoped the final report will be available for dissemination to federation member boards by the end of the calendar year. Thank you for listening. I'll be glad to entertain any questions from the audience. (rousing applause) Questions at the end of the session.

James R Wenn, MD - Moderator  The next speaker this morning is a very interesting individual which I've come to enjoy being associated with in the work of this committee. Dr. John Renner is the president and medical director of the Consumer Health Information Research Institute in Kansas City, Mo. Dr. R served on the board of the National Council Against Health Fraud. He received his medical degree from George Washington School of Medicine and currently serves as clinical Prof. of family Medicine at the Univ. of MO in Kansas City. I ask you to join me in welcoming Dr. John Renner.

John H. Renner, MDIt's indeed a pleasure to be invited to speak here today. I certainly enjoyed and learned a great deal serving as a consultant to this committee. I thought that was an excellent summary you heard from Dr. Fleming. I'm a family physician that deeply believes in patient participation in their own care.

I've spent 30 years as a health educator in private practice and at the medical school level teaching physicians how to be better communicators. I've spent a lot of time teaching patients how to ask appropriate questions, and I want to tell you I am absolutely frightened at what I see out there in this dialogue I see right now between patients and physicians.

We have major communication and understanding problems going on and you folks are going to have to find a way to deal with this as best you can. I've studied formally the communication processes that go on. We've looked at the media's responsibility. We've looked at what happens within the medical school curriculum. We study and monitor patient support groups. A lot of my time is spent talking to patient support groups, trying to find out where they're coming from. Yesterday at NIH there was a disaster of a meeting with NIH people, CDC people, and patient support groups, raising caine and in essence asking for the resignation of government doctors who are researching an illness, a condition called chronic fatigue syndrome - a nightmare of a challenge.

When I got interested in patient education, I stumbled upon or fell right into looking full square at medical propaganda. Information that was being deliberately given to patients that was incorrect. Sales information that was all varieties. And I tried to figure out how this was going to be torn down - how this barrier to good doctor/patient communication, could be taken away.

One of the things I started to do about 12 years ago as part of my responsibility to better understand the communication process was to really go out and study things and I've been looking around the United States for example of what we are talking about today - medical misinformation, medical and health quackery and fraud. And I want to tell you it's out there. Some of you may shiver a little bit when you heard the word quackery used - consequently I want to put that in a little bit of a perspective. I didn't like using that term when I first heard it.

I have a friend who pronounces it so strangely that it till makes me shiver a little bit - he really gets an inflection into it because of his experiences. But there are five words I'd like to have you think about, because the word 'alternative medicine' as you've heard, is a word we've got to quit using, because it's much too general, and it will be used to confuse and to convince you that you really shouldn't deal with alternative medicine.

I'd like to have you think about five words: folk lore or home remedies, quackery, unproven remedies, treatments, investigational treatments, and unproven. As a family physician I have a lot of respect for ethnic and home remedies. I've written a couple of books about home remedies. I couldn't practice very good family medicine without being aware of my patients needs, but the claims for those home remedies are within common sense boundaries.

Quackery on the other hand makes a mockery of truth - it makes claims that go way beyond any kind of logic or scientific evidence. I'm going to tell you about a few examples of that in a moment. Unproven remedies are something the media is really interested in and any kind you see a TV clip on the rain forest or what's going on in one particular study, you get your appetite kind of whetted for, well jiminy, they really got something this time.

Investigational remedies - are shown every night on television. We have one television production company that supplies film clips to over 150 television stations in this country and every week there's something in it that's on the fringes, most recently, a cure for Alzheimer's Disease coming out of Tucson, Arizona and until I was able to talk to the Alzheimer's Foundation in that area, I wasn't able to put it in perspective.

It didn't sound right, it didn't look right, and indeed after talking to people in that area, they knew that individual - an M.D. Then we have 'proven remedies' - and of course, good science doesn't mean we have proof forever. Good science turns over. We criticize each other like the dickens. We have full departments of medical schools that do nothing but evaluate all of the rest of us and that's what caused and is responsible for our moving forward, our excellence.

But the public doesn't understand that when a medication is put out on the market and then eventually withdrawn that that is because of some new information - that is a sign the system works. Patients interpret that as examples of it should never have been approved in the first place. But I want to go back to Quackery because I have found out that quacks teach MD's DOs, dentists, chiropractors, veterinarians, nurses, how to be quacks - how to tell fibs..

One of the things I've done for the past twelve years is to formally study quackery. Hunting quackery is not like a snipe hunt folks - these rascals are really out there. You can find them in every city, I can guarantee you they're on Chicago radio stations because I have transcripts from them. I can tell you they're not just in Southern California but indeed in the states of New Hampshire and Vermont and all parts of the United States and for that matter, the world.. And we're starting to import quackery in this country.

This past week I was brought a gadget by some investment venture capitol people who have a gadget from China that would diagnose cancer anywhere in the body by using a computer and thermal couples - temperature monitoring devices on six acupuncture points on the back of the thigh, and they were able to tell you whether this was cancer in your nose, or your lungs, or your pancreas, or your liver, or your prostrate or your breast or anywhere.

Unbelievable but evidence tells it was being used in 68 hospitals in China in Hong Kong in Singapore. Well Singapore happens to be a very sophisticated Internet city and the hospitals in Singapore are on the Internet and I was able to e-mail some information and get some information back from a very good and sophisticated oncology physician in Singapore, I talked to the physician who works in the American Embassy in Beijing and got some more insight and was able to warn these people that this is a gadget that's very similar to gadgets that FDA and other state agencies have taken after. That these devised go by the various names of Interro, or Dynatron, some of them may have had some experience with it. I know Washington State has.

Last year I was asked by one of the national media to find an example of a physician who was doing rather unusual things. There was a doctor in Beverly Hills, California that had been talking to the LA Magazine about his patent rights on something called 'thigh cream' - he also had an AIDS treatment machine. Now, I've never seen an AIDS treatment machine so I thought that might be a physician worth visiting, so I went to his office as a patient and the AIDS treatment machine was no longer there, but he had something else that was equally of interest. he asked me how old I was and I told him 62 - he said "Look at you. You've got white hair. I'm sixty two and I've got black hair and I've just fathered a two year old child.

And he said, you know how I did it. I changed my DNA. Now I'm a little worried folks. I'm not just in the office of someone that's got an AIDS treatment machine and thigh cream, I'm in the office of someone with some really weird ideas, and he said he was going to show me how to do it. So he takes me into another room , a very well furnished office, immaculately clean, and he hooks me to a machine with a computer and after a half hour, gives me a computer printout that says I have 35 different illnesses, including bovine immune deficiency syndrome.

I had to go back to my books to find out what that was all about. He gave me a homeopathic remedy and then had his technician mix up a mixture of ketamine and some herbs and tell me that was going to help my condition which was a back problem which I really have on occasion. I want to tell you that kind of physician really scares the socks off me - board certified, in a couple of specialties.

I talked to the boards as to whether they could impose or have ethical standards. It's very difficult to do once someone gets board certified. I think we've got some real challenges, because this individual is using his board certification as a marketing device. I've taught family physicians when I was at the University of Wisconsin. I'm very proud of all our commitment to excellence, but it can be used for nonsense.

I have given you a printout from the Internet of a very strange newsletter publication. I think you can get a feel for that. Many of you may be familiar with this very angry newsletter that circulated all over the country. I'm sure many of you had this brought to your attention. There's three new journals out on alternative medicine and most frightening, there's now a new book that is recommended as a textbook to be used at medical schools to teach about alternative medicine.

And at some of the alternative medicine conferences I've gone to, there's a mixture of 'oh, let's do research on it', and at the same time, 'let's promote it'. And I can tell you after talking to numerous medical students and residents we're going to have a real problem keeping their eyes on the good science and the evidence and the documented material rather than the propaganda the public relation and the sales pitches that are apparent in some of these activities.

Could we turn on the slides? One of the things I do is go to quack conventions. (big laugh) Sometimes I've gone as John Renner, and once in a while I get in and out without problems, but I want to show you some really famous quacks who have been responsible for teaching patients, for teaching professionals how to be rascals. Here's the granddaddy of all the quacks in the country, Kurt W. Donsbach. A chiropractor, we think we have chelationists around the country that pulled a phony kind of board certification up as a credential.

Now, one of the things I'd like to do is show you a few slides of some of the things that can make you a little bit aware. I've prepared a bibliography for you, I've also given you an outline of only one classification of alternative medicine. I have seven or eight sources of information that classify alternative medicine and we can get up to 350 different subtopics under that.

Don't let the legitimate words on this page confuse you about alternative medicine - if they put down dermatology they're putting down a type of dermatology that would use bizarre remedies. Very seldom would they be listed in a directory of alternative medicine unless they were doing something really far out. You have to get very very specific.

Donsbach had a naturopathic degree for a while until the Arizona Naturopathic Board found out his diploma was created on a copying machine that didn't exist for seven years after the date. So they lifted his naturopathic degree. He has run an institution known as Donsbach University and given out phoney degrees of all kinds - Ph.D. degrees.

The medical Director of HerbaLife was a graduate of Donsbach Univ. and when CNN reporter asked him whether he had to write a thesis for his Ph.D. degree, this Dr. Marconi said 'Yes'. What was the title of your Ph.D. degree. Marconi said 'I can't remember'.

They asked him what year he graduated and he couldn't remember that either. Donsbach has within the last month pleaded guilty to income tax evasion and smuggling drugs. He was taking chemotherapeutic agents and telling people they were herbs. He was giving labanosol in people in his little hospital in Tijuana. And you're probably going to hear a lot about Tijuana over the next few years. Here's an example of his school.

Here's a doctor in Oklahoma City that I've been interested in for years. He's a chelationist, but he's best known for adding hydrogen peroxide to his chelation and he calls it chetox - so he injects hydrogen peroxide intravenously into the people. He has also testified in a federal trial in Biloxi, Miss this past year, stating he had been nominated for the Nobel Prize. I got a copy of that letter, I called the person who wrote it and indeed an 83-year old journalist wrote a letter to the Nobel Foundation, stating I hereby nominate Dr. Charles Farr for the Nobel Prize.

But that doesn't make him a legitimate Nobel Prize nominee. I now have five quacks that have done that. One lady from Europe says he's been nominated seven times. They don't even know or have the ability to find out what a legitimate nominee is. We have a veterinarian running around the country right now being introduced at large public meetings as a Nobel prize nominee, and he sells a tape and he has material called "Dead Doctors Don't Lie'. Some of you may have heard about this tape. It's a very angry tape. It also says in there that the average doctor only lives to be 58 years of age.

There's information available showing the average male physician lives a couple of years longer than the average male - 77 years - and women live over 81. But he says, "Dead Doctors Don't Lie" and he uses this 'dead at 58' to convince you doctors don't know how to take care of themselves, which may not be a bad thing to think about. But not from those statistics.

Anyhow, this is a man - I asked if I could take his picture at an alternative medicine meeting in Washington, and he said, sure go ahead. I wanted to show it to some friends of mine. The only way you can really find out what they're saying to patients is to be one yourself for a while. So sometimes I go to quack meetings in disguise. Here they're drawing my blood, putting it under a microscope, flipping it up with a TV camera a dark field lens, this gadget - this is legitimate equipment to use, but when they use it for inappropriate purposes, you've got problems. But they'll flip it up on a screen and say, 'There goes a diabetic cell.'

There's one doctor in California telling people there's an AIDS virus he can see with that. Well that's a light microscope. He'd had to have unbelievable magnification. But they show these slides. Now this is penetrating all segments of our society. At an athletic trainer's meeting, in Indianapolis at this past year, they had this gadget and they were drawing blood on coaches, and on trainers. the physicians that were there were just kind of curious about this machine. They didn't know what it was. But, there's just - here's one that resulted in the largest fraud in the history of the country.

This is the so-called 'rolling labs'. They were in California but they also spread out to other states. The FBI closed one down in St. Louis , MO just a few hours after they opened. What they were doing was telemarketing people, telling them to come in for all kinds of tests that they would just bill the insurance companies for. And I think this amounted to eventually over a billion dollars.

I can only today in this small time give you a small sample of the kinds of activity - but I want to tell you, quackery activity teaches doctors how to throw down their scientific background. How to become professional marketers. It's unreal what's going on. The media feeds this. All I have to do is mention the Sixty Minutes program on shark cartilage. Shark Cartilage is one of the biggest selling items in the country - not just to terminal cancer patients. We have people with AIDS taking it. We have people who don't want to get cancer taking it. It's not just for those few patients who are desperately ill. People start to use it for all kinds of reasons.

We've got a major problem. I wish we had more ideas of the solutions, but I think we're just going to have to keep our eyes open; learn a lot more about quackery. If in any way I can help any of you get specific information about any of these activities, you've got my name and phone number and e-mail address on that.

This has been a tremendous learning experience for me. every day I hear something that is new. I really welcome and am delighted to be participating in your procedures. I brought some books with me. Some examples. I thank you for this opportunity to speak with you.

Dr. P. John asked me to inform you he did bring some copies of his book. That each state can pick up a copy and put it in the library at your medical board. I think you'll find it a very helpful reference in dealing with Some of these issues. I think it's fair to say, from John's presentation, that as economic pressures increase, many physicians may move to embracing some of these schemes in order to maintain their income and of course, that's what the medical boards are going to have to be alert to and understand some of these fraudulent practices.

Side Two:

James R Wenn, MD - Moderator  - Our next speaker, Mr. Robert Bell, is a member of the Health Quality Enforcement Section of the California Attorney General's office in Los Angeles. As such, Mr. Bell represents the medical board of California in disciplinary actions against physician licensees. He is a career prosecutor with degrees from Stanford and Loyola University of Los Angeles. He focuses on technically complex and high profile quality of care cases. Please join me in welcoming Mr. Robert Bell.

Robert M. Bell, JD I'm sorry your three ring notebooks do not contain my information - you will find them on the right hand side of the exit door - as you leave the room, so if there are any particularly detailed items, such as telephone numbers and addresses and so forth you will find them on that handout.

I'm flattered to be included in such a prestigious organization's program. I am an obscure lawyer from California. I think I came to the attention of a couple of your board members as a result of litigation conducted a couple of years ago for the State Medical Board of CA. involving a chelation physician which was of rather large magnitude. We had a successful outcome in that case, I've been asked today to talk from the perspective of a prosecutor about what it takes to investigate and successfully prove a case.

First of all, a couple of conceptual matters. Quackery is really unproven medical cures or however you may wish to refer to it is really a rather large bore problem for the United States, and in the early 1980's, the House committee on a aging, chaired by Claude Pepper, issued a report in which they estimated the net loss to consumers in the United States at that time was in the order of ten billion dollars. More contemporary estimates have placed that figure at between fifteen and twenty billion dollars.

Now excluding vitamin preparations, over the counter matters, and simply focusing on physician-prescribed remedies that have a significant consequence for patient harm, probably an estimate on the order of 5 billion dollars would be appropriate although nobody knows for sure. This is a problem of major proportions.

My impression is that most people exposed to it for the first time consider bad doctors, or quack doctors or whatever you may wish to call them, as sort of back room operators, scattered very thinly here or there, located on both sides of the United States and not very much in the center doing a very small scale business and not taking home very much at the end of the day. The reality however is considerably different. It's an entire sub-culture of medicine that flourishes quite well. There are literally thousands of persons involved in it, many of them licensed physicians, some of them holding significant degrees and board certifications, who meet across the United States quite frequently in very elegant surroundings such as you're sitting in right now. They take their business deadly serious; they're politically organized in a manner that would give modern organized medicine quite a jolt if they were to see it and they're effective in the legislature of the United States and in the fifty states.

As Bill Fleming pointed out, they currently have bills pending, to liberalize - in effect defang - state medical boards in about twelve to fifteen states, and they've already had striking success in a number of states already, including the State of New York.

These cases, to prosecute and I'm referring to physician misconduct cases involving unproven therapies of a dangerous nature are time consuming, expensive and extremely contentious. In my particular instance, after filing a fairly run of the mill accusation, as we call them in California, I was confronted by a lawyer who had moved from South Carolina to Southern California rented a house in San Clemente for a year at the expense of the physician who was in turn being backed by his professional organization. He brought with him a paralegal and an investigator and installed themselves strictly to do this case.

What then happened was, a torrent of paper consisting of 108 pounds of proposed trial documentation, and a listing of 61 proposed expert witnesses from 20 states and four foreign countries. It took the better part of two years on an almost exclusive basis to bring this matter to a successful conclusion. These are certainly challenges of an unusual nature.

I'm going to assume that you as a medical board person learns that one of your licensees is using a unproven and potentially dangerous therapy - we call it the xyz cancer cure, let us say -and how are you going to address this? I'd like to discuss several steps along the way - the investigative stage and how you might research this; the filing of charges, pre-trial, the trial and ultimately the political arena that cannot be dismissed in connection with this.

First of all, learning about a non-standard medical cure or an asserted medical cure - the xyz cancer cure, or chelation therapy or iridology or whatever - is about as hard as getting Madonna's home phone number. You don't look it up in a standard reference. And you, as a board investigator, board prosecutor, manager, quickly need to find a reliable expert. The average clinician will not suffice as an expert.

My first experience which made me gear up and get better the second time around was having my clock cleaned at a hearing in which I was basically given the assistance of two very well-intended suburban physicians who when examining the therapy under consideration, essentially said, they'd never learned about this in medical school, none of their colleagues practiced it and therefore, it was bad. That it was non-standard, unconventional and probably wasn't doing the patient any good.

The ensuing cross examination left blood all over the floor; the doctors were forced to admit they had never read any literature from the proponents, they really didn't know much about the therapy, how it worked, what its components were, what its mechanism of actions assertedly was, concluding with questions essentially to both of them that went: "then doctor what you're telling us today is that you're prejudiced not medically learned in this matter, to which they were both forced to confess to the affirmative.

You need someone who knows this as well as the proponents and if you're going to explore the underworld, you don't want an angel as your guide (lots of laughter). You need someone who has been there before. You must become the master of your topic. You have to know what happened. What was done to the patient. You have to become an information vacuum cleaner about this. I suggest that IF it is known at the early investigative stage that you're dealing with a quack, you get a prosecutor involved to assist in the investigation and guide it.

Items that should be obtained are any items used to produce patient consent to the treatment such as brochures, videos, books and of course, any informed consent document. It's frequently unknown until the end of the process what was used to sell this patient on doing it and there are a lot of organized materials, usually which are not part of the doctor's record. They may well be on his counter space; they may be in his waiting room but not typically part of his medical record.

If drugs are being used, you need to obtain a sample of the drug for analysis or identification, plus the manufacturer's package insert. If it is the novel compounding of several drugs, you need the description what drugs are mixed together and in what proportion, the names of the manufacturers and the package inserts for each of those. If it is a device, I suggest you consider a seizure operation, or at the very least photographing it and obtaining the manufacturer's specifications, operating manual, name of the maker and importer and so forth and so on. Some years ago, we had a case involving an electro-acupuncture and treatment device called an EAV electro-acupuncture according to Voll, a German physician, a device being used in Southern California, which was essentially being assembled, brought into Canada, disassembled, brought into the United States as so-called electronic parts, reassembled in the north of our country, then used on patients.

The investigator unfortunately simply said this device is being used. took one Polaroid picture and presented the case for prosecution. It's a little difficult to prove a case when all you have is a Polaroid and no details regarding the device itself. You need to obtain proponent literature, describing the therapy and providing its medical / scientific justification.

I'm sorry to go in this vein, but it's very difficult when you're running a board enforcement operation or acting as a prosecutor when all you know is you've got the XYZ cancer cure - nobody, but nobody at the medical center knows anything about it, and the only thing that may be submitted will be a simple newspaper article.

However, you will find a great deal of information if you go digging. One of the most useful features that we found is the computer research devices such as Lexis, or its companion service, Nexis or Westlaw. You can search for the name of the therapy. You can search for the persons involved in the therapy or the organizations to which it belongs. This produces literally hundred of articles about chelation therapy which started us on our way.

The National Council Against Health Fraud located in Southern California serves as a clearing house for information on promoters of quackery and can help locate expert witnesses and documents. On the handout back there, I have their telephone and fax number.

You should determine if the AMA or one of the specialty boards have taken a position on the therapy in question or have issued a position paper. If they have, you should obtain it. Frequently they do. An excellent and inexpensive source on quack therapy which I recommend to all of you is the AMA's readers guide to alternative health methods, which is a paper back which costs about ten dollars which discusses just about everything alphabetically that you would want to know, containing both references to the scientific literature both for and against these therapies.

Copies can be obtained by dialing an 800 number which is on the handout to AMA's order department.

If the dubious practice involves a drug, you should contact the drug's manufacturer and ask them do they approve of this use of the drug. Frequently we will find drugs , for example, EDTA which is an amino acid component of chelation therapy, being touted as an otherwise FDA-approved drug so 'why are being concerned about this, Mr. Prosecutor? Well, the reason is that neither of the two manufacturers existing in the United States approve of it for cardiovascular care and it is being compounded into a device which is chemically novel and for which the manufacturing companies have never done any research.

Electronic bulletin boards are extremely useful, indeed they are the means by which non-traditional practitioners are communicating with each other so you can sort of listen to what the other side is having to say. I search by my name now and find a number of hits. CompuServe has a natural medicine forum - you type "Go Holistic";

America Online has a Better Health and Medical forum; there are a number of bulletin board systems, perhaps the most prominent of which is the ARC BBS run by Arline Brecher. The World Wide Web and Internet newsgroups, if you just use a web crawler, Yahoo or something like that, you'll find a number of references to your XYZ cancer therapy or whatever you have.

I wish I could say the FDA is a great source to go to. In my personal experience I have found them extremely tight lipped about things. I have a very strong feeling that the persons I've spoken to have a personal view on things, but going public with government prosecutor on them is just not their style. Unless for example, they've issued a publication. For example, chelation therapy was identified in a public outreach document in 1987 as one of America's ten leading health frauds.

Mentioned with it were baldness cures, impotence remedies and so forth. So occasionally, they will go on record publicly with respect to certain drugs or therapies. The US Public health service has DATA documents or technical assessment documents. The Health Care Finance Administration which of course researches therapies to recommend them as paid-for therapies to Medicare can be helpful. The insurance Companies and their bureaus.

Certainly networking with other state licensing boards is helpful. If there are executive officers from the various states, you may recall a letter from me saying do you have any experience with chelation therapy. I thank you now for all who answered. And certainly court records both through Nexis and Westlaw. It's quite astonishing what you can find - in my particular case, really striking information about prior testimony given by experts on the other side of my case, including two of them who were quoted in the appellate decision as saying chelation therapy was not generally accepted anywhere in the United States for cardiovascular purposes. And they were prepared to take the stand and testify to the exact polar opposite in my trial. When confronted by their testimony as recorded by an appellate court, they were of course forced to retreat.

As to crafting legal charges after you accumulate your information, most states, except those who have been legislatively neutered have provisions against gross negligence, incompetence, repeated negligent acts, clearly excessive describing of drugs or therapies, and of course, false advertising, which is frequently overlooked. At the pre-hearing stage. your prosecutors should make focused pre-trial discovery demands, aimed at obtaining details about the therapy, not provided during the investigation, and the names and qualifications of expert witnesses for future research.

The people who will be thrown up against you are really quite dumbfoundingly diverse and frequently have checkered backgrounds. You should request a pre-hearing conference or evidentiary hearing before the trial ever begins to ferret out and suppress 'junk science'. Does everyone know what 'junk science'is? It is sort of like science but without any calories. It sounds like science but it isn't. While real science would rely on replicatable, clinical trials, junk science relies on patient testimonials and anecdotal observations by clinicians, while real science relies upon peer-reviewed journals which go through a process of refereeing and which are - published and which are part of the Index medicus.

Junk science relies on privately published tracts which come out of someone's workroom or garage in rural Virginia, But it all sounds quite persuasive.

Now in California we have to try our cases before Administrative Law judges - they're lawyers with five years of experience and we try to put them on a special panel to hear medical board cases, but to be fair, these gentlemen and ladies last experience with science on a personal level was probably dissecting a frog in the tenth grade. They are not physicians. They're not expected to be. If someone quite plausible in a nice looking suit and a tie on comes up and says I'm board certified in this and that, they might not noticed it's not one of the boards mentioned by the American Boards of Medical Specialties- it might be a self-created vanity board. "And I'm here to tell you that using strychnine in the treatment of AIDS is a great advance and might save thousands of lives." And there's a tendency not to disbelieve your fellow man, especially if he or she is plausible in physical appearance.

These people obviously have to be brought down to reality. There's a very interesting book I recommend to all of you even if you're not directly involved. It's Galileo's Revenge - Junk Science in the Courtroom by Peter Hubert. Mr. Huber is a former clerk for Associate Justice Sandra Connor of the Supreme Court, and it's a very fascinating look at the extent to which corrupted science is being used, not only in medical board matters, but more commonly in tort cases involving everything from auto crashes to birth control defect cases and so forth.

Now where junk science comes into this discussion is as follows. American law generally speaking requires that if any disputed scientific testimony is to be used at trial it has to meet a standard of general acceptance. That is, it isn't enough to say 'This is my opinion." One's professional opinion as a physician or scientist is only good if it is shared generously by the profession. There are a number of court cases that have so found. You'll find it in my handout. The result of this is, that since non-traditional therapy is by definition not generally accepted, much of their literature and their oral testimony can be excluded. If I'm, going to come up as a doctor and tell you that strychnine cures AIDS, I as a prosecutor am going to object to that testimony and say it does not represent generally accepted science.

The judge should, as the gatekeeper of evidence before it goes to trial, exclude it if it is irrelevant, which it most frequently is. At trial, you must plan not only to prove your case, but to disprove the proponent of the dubious medical care or treatment. You have to carefully research witnesses to be used against you by the defense and your witnesses should be prepared not only to establish your case but also provide forceful rebuttal.

I want to tell you the way organized quack medicine defends itself is not to lay down and ask to have its tummy scratched. They get real forceful about this. You will find yourself in a mini-Scopes trial - if you will recall Inherit the Wind in which Darrow and the others discuss the whole idea of creationism. You can find yourself bewilderingly on a Tuesday morning in a courtroom, discussing what is science? Why do we believe things? what is peer-review literature? What's replication? and all the rest of this.

Because they want to put these things on trial. They want to tell a judge that a medical journal published in a garage is as good as the new England Journal; they want to put somebody out who may be the only one in the world who believes something or only one of a hundred and present it as mainline medicine.

Finally, there's a political aspect to this which Dr. Fleming has touched upon. Clearly these cases are being argued not only in a trial type setting but also in the legislature. Those of you in the five or seven states that have recently enacted medical freedom laws, I'd be very grateful, since we just had one introduced in our senate last month, if you could contact me at some point. In fact the legislators asked to know what your experience is in those states. They're re Alaska, Oklahoma, Oregon, North Carolina, Washington and South Dakota.

Finally, if you are to engage in a prosecution regarding quack medicine, you need to keep your back covered. You need to inform the legislative leaders, the attorney general needs to be informed and your board needs to be informed of the enforcement action you're undertaking and the reasons for it. You don't want the first notification of this to be when a politically motivated consumers group comes forth and says you're off on a witch hunt. You want those people to know there's good cause for your proceeding.

Thank you. I'm sorry there 's not more time to go on, but I hope I've given you a flavor of how difficult it is to prosecute these cases, and why significant resources have to be given to them if you wish to succeed, which I hope you do. (rousing applause).

James R Wenn, MD - Moderator  - Now I would like to introduce you Matt Daynard, Senior Attorney at the Federal Trade Commission's Bureau of Consumer Protection. Matt has been with working on cases concerning fraud and deception and the delivery of health care services.

Matt Daynard, JD From Washington it's been a little cold. I appreciate this opportunity to share with you FTC activities. What we've learned so far - fraud is out there - of the one trillion dollars - as much as one billion lack the information I can tell you, they're absolutely right. Because much of it is local in nature, and because of diminishing resources, it's essential the states and the FTC and other public agencies work together to identify and eliminate these problems. You've got some things in your program book I'd like to go through to give you an idea of Under Section Five - illegal, unfair my charge is a bit broader than the Ad Hoc committee. The focus has been on alternative medicine.

The FTC's focus is broader at that. We look also at the stems from mainstream physicians, procedures being used for purposes not approved by the FDA. Procedures being exaggerated in terms of efficacy, in terms of safety, in terms of risk. We're only recently getting involved in the alternative medical field.

Mainstream medicine remains an area of very significant health care deception. We certain know - it also may forego treatments that are worthwhile. The cases I'm involved with since 1990 - one is cosmetic surgery. We've brought cases against liposuction providers, chemical face peels, the misrepresentations - about safety, times for recovery period, risks, pain, successful outcomes and we did the kind of preparation for this that Kim Bell was stalking about. We used the National Council Against Health Fraud, experts from academia, and we got the relief you see on the right there.

Mostly we require the providers have a reasonable basis for the substantiation for their claims. And the substantiation may be clinical trials. Junk science does not cut the mustard. We can generally get around that. Kim is absolutely right. These folks are organized. Hire a former FTC Commissioner. They can be just as forceful. Relief involves disclosure of risks, some basis in the relevant profession conducted. In the area of varicose veins, we brought cases against - side effects, permanence of the procedure. In the infertility clinic area, we brought cases, for basically misrepresenting their success rate. They failed to disclose. The remedies bans on the success - requiring substantiation for success rate claims.

One of the most important things that I hope to get across today is that it's necessary for us to work together. One of the areas that's come to smoking cessation - one of the most heavily advertised services in the country.

A couple of years ago we decided to get involved with the states in this areas. - the first case against the four largest the group hypnosis seminars where they'll advertise for a couple of weeks before they come to the city, where the Surgeon General has claimed - lose weight without dieting or really trying and they'll gather a group this large in a hotel and practice their shtick.

The evidence showed - claims were outrageous. We challenged four of the largest groups - signed on the dotted lines and said they will go and sin no more. But then, we don't have the resources to follow up with the criss cross over all the regions, so we sent a letter to the National Association of Attorney generals giving them the facts of the case, we sent that to all of the states with the encouragement they bring cases like that around the country.

I got about seven, eight states, to respond. They said Great- we've got a guy down here - I need the name of an expert, need your affidavit, what else can you do for me? And that worked very well. Now in effect, what we're doing. We're involved with several states - involves optometrists, not physicians, but we're working together, and we're working with about fifteen states. We hope to file simultaneously in court pretty soon. Don't tell anyone. The effort involves physicians - some optometrists in Connecticut are - for the purposes of scraping the cornea off and helping myopia and optometrists say they can do that as well as anyone.

What we're concerned with is the exaggerated - results are permanent, or stable or predictable. The science in that area is increasing and they're toning down on some - some help for low and moderate myops - but not the high myops - you still might need them for night vision or

But we're involved in all those areas - and with the states as well. In the area of budget constraints these days, we've got a problem - you have to get more bang for the buck. To Partner - once we get past the hospitalized and large multi-state chains, most of these problems occur locally, maybe personal commitment she wanted to relate to you today - I made a presentation to you in 1990 how we look at advertising how we look at claims. Well, we're kind of past that now. We all know there are problems out there. We've been working with you. My colleagues at home work with several of your state board members in the chelation area, it's something we're looking at.

And thank you Ken very much. For telling us how to prosecute that case because we know ACAM is a very politically well organized group. But we don't have some of the other problems. We don't have problems saying anecdotal evidence doesn't cut the mustard because we know it doesn't. The Commission requires competent scientific evidence in the area of health and safety and we have access to experts and access to some funds. Next year, our budget is actually going to remain flat - which is a great thing in Washington these days. You can glean from the information having the program book. We also engage in consumer education. We had a conference with NAG in Dallas - our commitment, to get involved with the media more. We're trying to get on TV a lot, not just because she's good looking. We're getting involved with more and more agencies all the time.

James R Wenn, MD - Moderator   -  At this time, ask the panelist for any questions you might have. Jim Borg, delegate from Colorado, recently dealt with this issue in Colorado. These individuals call themselves complementary physicians - complementary meaning they were not doing their care for free, but a complement to regular medicine, and that's another term people might want to be aware of. We were able, at least so far, I think to defeat that legislation and that's because we allied ourselves with the medical society who worked with us in helping to defeat it. And also because we were able to present pretty good data to show we were not persecuting these people. But we were prosecuting but not to any greater extent than we prosecute other people in other areas, and that was quite helpful. The question I have for this panel or for other members of the audience, the states in which this legislation has passed, how are they dealing with this, or how do they propose to deal with it?

Renner: I testified before the North Carolina hearings. They had a horrible bill that was introduced there, but it ended up not being quite as bad as it started out to be. I'm not sure that any state has any long term experience. Alaska was the first - and they in essence turned around and put an alternative practitioner on the state licensing board which caused tremendous furor. When the new governor came in that was rearranged. But the doctor up there began running ads. Come to Alaska - home of anything goes in some of the alternative publications. North Carolina had to appoint one individual to their board. Some of the issues there were homeopathy, naturopathy, and chelation. Even though this is a very small group of people, they create a ripple effect and they know how to go out and get other organizations to help them. One bit of advice: Don't take this on just with your medical society. Get other groups to help you. There are lots of pro-science - groups that are going to be willing to help you. You're going to have to turn to groups like AARP and others who know this will end up in rip-off of their constituents. I'm thrilled to hear you beat it in Colorado, and frankly if you can beat it in Colorado with everything going on there, you can stop it anywhere. I think each state is a little different. They've hired a professional lobbyist and we've gotten their transcripts. She gave a talk. Her name is Monica Miller and she's been going around. She was in Kentucky. It's been held up in committee in Wisconsin. Each state is a little different. It depends how much warning you have.. I talked to someone in the American Cancer Society in California who was not even aware of who we're going to have to call. Other wise they're going to pick you off one at a time. The one other comment I'd like to make is that we've also taken them on head on. Some of these people also practice regular conventional or osteopathic medicine. When we've been able to aggressively pursue them that kind of reduces their numbers a little bit.

This concludes our session this morning on health care fraud. And I thank the presenters.