evidence based vets need own union to compete like MD's

Medical guidelines should insists on proof that time-honored medical practices and procedures that cost money and may harm or kill patients are actually effective. This Forum is about how to force organized veterinary medicine to issue Evidence Based Guidelines.

evidence based vets need own union to compete like MD's

Postby malernee » Fri Nov 28, 2003 5:23 pm

http://www.quackwatch.org/04ConsumerEdu ... osteo.html
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Dubious Aspects of Osteopathy

Stephen Barrett, M.D.

Osteopathic physicians (DOs) are the legal equivalents and, in most cases, are the professional equivalents of medical doctors. Although most DOs offer competent care, the percentage involved in dubious practices appears to be higher than that of medical doctors. For this reason, before deciding whether to use the services of a DO it is useful to understand osteopathy's history and the practical significance of its philosophy.

Cultist Roots

Andrew Taylor Still, MD (1828-1917) originally expressed the principles of osteopathy in 1874, when medical science was in its infancy. A medical doctor, Still believed that diseases were caused by mechanical interference with nerve and blood supply and were curable by manipulation of "deranged, displaced bones, nerves, muscles -- removing all obstructions -- thereby setting the machinery of life moving." His autobiography states that he could "shake a child and stop scarlet fever, croup, diphtheria, and cure whooping cough in three days by a wring of its neck." [1]

Still was antagonistic toward the drug practices of his day and regarded surgery as a last resort. Rejected as a cultist by organized medicine, he founded the first osteopathic medical school in Kirksville, Missouri, in 1892.

As medical science developed, osteopathy gradually incorporated all its theories and practices [2]. Today, except for additional emphasis on musculoskeletal diagnosis and treatment, the scope of osteopathy is identical to that of medicine. The percentage of practitioners who use osteopathic manipulative treatment (OMT) and the extent to which they use it have been falling steadily.

Osteopathy TodayThere are 20 accredited colleges of osteopathic medicine and about 44,000 osteopathic practitioners in the United States [3]. Admission to osteopathic school requires three years of preprofessional college work, but almost all of those enrolled have a baccalaureate or higher degree. The doctor of osteopathy (DO) degree requires more than 5,000 hours of training over four academic years. The faculties of osteopathic colleges are about evenly divided between doctors of osteopathy and holders of PhD degrees, with a few medical doctors at some colleges. Graduation is followed by a one-year rotating internship at an approved teaching hospital. Specialization requires two to six additional years of residency training, depending on the specialty. A majority of osteopaths enter family practice.

The American Osteopathic Association (AOA) recognizes more than 60 specialties and subspecialties. AOA membership is required for specialty certification, which forces some practitioners to belong to the AOA even though they do not approve of the organization's policies. Since 1985, osteopathic physicians have been able to obtain residency training at medical hospitals, and the majority have done so. Since 1993, DOs who completed osteopathic residencies have also been eligible to join the American Academy of Family Practice, which had previously been restricted to MDs or DOs with training at accredited medical residencies [3].

Osteopathic physicians are licensed to practice in all states. The admission standards and educational quality are a bit lower at osteopathic schools than they are at medical schools. I say this because the required and average grade-point averages (GPAs) and the Medical College Admission Test (MCAT) scores of students entering osteopathic schools are lower than those of entering medical students [4,5] -- and the average number of full-time faculty members is nearly ten times as high at medical schools (714 vs. 73 in 1994) [5]. In addition, osteopathic schools generate relatively little research, and some have difficulty in attracting enough patients to provide the depth of experience available at medical schools [6]. However, as with medical graduates, the quality of individual graduates depends on how bright they are, how hard they work, and what training they get after graduation. Those who diligently apply themselves can emerge as competent.

In January 1995, a one-page questionnaire was mailed to 2,000 randomly selected osteopathic family physicians who were members of the American College of Osteopathic Physicians. About half returned usable responses. Of these, 6.2% said they treated more than half of their patients with OMT, 39.6% said they used it on 25% or fewer of their patients, and 32.1% said they used OMT on fewer than 5% of their patients. The study also found that the more recent the date of graduation from osteopathic school, the lower the reported use [7].

The percentages of DOs involved in chelation therapy, clinical ecology, orthomolecular therapy, homeopathy, ayurvedic medicine, and several other dubious practices appear to be higher among osteopaths than among medical doctors. I have concluded this by inspecting the membership directories of groups that promote these practices and/or by comparing the relative percentages of MDs and DOs. listed in the Alternative Medicine Yellow Pages [4] and HealthWorld Online's Professional Referral Network. The most widespread dubious treatment among DOs appears to be cranial therapy, an osteopathic offshoot described below.

AOA Hype

Many observers believe that osteopathy and medicine should merge. But osteopathic organizations prefer to retain a separate identity and have exaggerated the minor differences between osteopathy and medicine in their marketing. According to a 1987 AOA brochure, for example: (a) osteopathy is the only branch of mainstream medicine that follows the Hippocratic approach, (b) the body's musculoskeletal system is central to the patient's well-being, and (c) OMT is a proven technique for many hands-on diagnoses and often can provide an alternative to drugs and surgery [9]. A 1991 brochure falsely claimed that OMT encourages the body's natural tendency toward good health and that combining it with all other medical procedures enables DOs to provide "the most comprehensive treatment available." [10] Such statements are consistent with a 1992 AOA resolution that defines osteopathy as:

A system of medical care with a philosophy that combines the needs of the patient with current practice of medicine, surgery, and obstetrics and emphasis on the interrelationships between structure and function and an appreciation of the body's ability to heal itself [11].

A 1994 AOA resolution describes osteopathy as "a complete system of health care and as such is much more holistic than medicine in the classic sense." [11].
The American Osteopathic Association's web site glorifies Andrew Still and asserts that osteopathic medicine has a unique philosophy of care because "DOs take a whole-person approach to care and don't just focus on a diseased or injured part." I consider it outrageous to imply that osteopathic physicians are the only ones who regard their patients as individuals or who provide comprehensive care or pay attention to disease prevention. Another AOA web document states:

Osteopathic physicians frequently assess impaired mobility of the musculoskeletal system as that system encompasses the entire body and is intimately related to the organ systems and to the nervous system. Using anatomical relationships between the musculoskeletal and these organ systems, osteopathic physicians diagnose and treat all organ systems [12].

This statement strikes me as the same sort of baloney chiropractors use to suggest that somehow their attention to the spine will have positive effects on all body processes. Spinal manipulation may produce pain relief in properly selected cases of low back pain [13]. However, OMT has no proven effect on people's general health.Chelation Therapy
Chelation therapy is a series of intravenous infusions containing EDTA and various other substances. Proponents claim it is effective against atherosclerosis and many other serious health problems. However, no controlled trial has shown that chelation therapy can help any of them. Chelation therapy with EDTA is one of several legitimate methods for treating cases of lead poisoning, but the protocol differs from that used inappropriately for other conditions. To its credit, the AOA has adopted a negative position statement on chelation therapy:

WHEREAS, chelation therapy utilizing calcium disodium edetateis currently labeled by the Food and Drug Administration and recognized by most physicians as medically acceptable only in the management of acute or chronic heavy metal poisoning; now, therefore, be it
RESOLVED, that pending the results of thorough, properly controlled studies, the American Osteopathic Association does not endorse chelation therapy as useful for other than its currently approved and medically accepted uses. Adopted 1985, revised and reaffirmed, 1990, 1995 [11].

The 1998 member referral list of the American College for Advancement of Medicine (ACAM) , the principal group promoting chelation therapy, identifies about 400 MD members and 121 DO members who list chelation therapy as a specialty. These numbers strongly suggest that the percentage of osteopathic physicians doing chelation therapy is about four or five times as high as the percentage of medical doctors doing it. Curiously, Ronald A. Esper, DO, of Erie, Pennsylvania, who was AOA's president in 1998, is an ACAM member and does chelation therapy.
Cranial Therapy
Practitioners of "cranial osteopathy," "craniosacral therapy," "cranial therapy," and similar methods claim that the skull bones can be manipulated to relieve pain (especially of the jaw joint) and remedy many other ailments. They also claim that a rhythm exists in the flow of the fluid that surrounds the brain and spinal cord and that diseases can be diagnosed by detecting aberrations in this rhythm and corrected by manipulating the skull. Most practitioners are osteopaths, massage therapists, chiropractors, dentists, or physical therapists.
Cranial osteopathy's originator was osteopath William G. Sutherland, who published his first article on this subject in the early 1930s. Today's leading proponent is John Upledger, DO, who operates the Upledger Institute of Palm Beach Gardens, Florida. An institute brochure states:

CranioSacral Therapy is a gentle, noninvasive manipulative technique. Seldom does the therapist apply pressure that exceeds five grams or the equivalent weight of a nickel. Examination is done by testing for movement in various parts of the system. Often, when movement testing is completed, the restriction has been removed and the system is able to self-correct [14].

Another Upledger brochure states:

The rhythm of the craniosacral system can be detected in much the same way as the rhythms of the cardiovascular and respiratory systems. But unlike those body systems, both evaluation and correction of the craniosacral system can be accomplished through palpation.
CranioSacral Therapy is used for a myriad of health problems, including headaches, neck and back pain, TMJ dysfunction, chronic fatigue, motor-coordination difficulties, eye problems, endogenous depression, hyperactivity, attention deficit disorder, central nervous system disorders, and many other conditions [15].

The Upledger Institute also advocates and teaches "visceral manipulation," a bizarre treatment system whose practitioners are claimed to detect "rhythmic motions" of the intestines and other internal organs and to manipulate them to stimulate healing [16].
British osteopath Robert Boyd, who developed a variant he calls Bio Cranial Therapy, claims that it is "extremely helpful" for "chronic fatigue syndrome (CFS); varicosity and varicose ulcers; tinnitus; bladder prolapse; prostate disorders; Meniere's syndrome; cardiovascular disturbances including hypertension, angina; skin disorders (psoriasis, eczema, acne etc); female disorders (dysmenorrhoea, PMS (PMT), menorrhagia etc); arthritis and rheumatic disorders; fibromyalgia and heel spurs; gastric disorders (hiatus hernia, ulceration, colitis); asthma and a range of bronchial disorders including bronchiectasis and emphysema."
The theory underlying craniosacral therapy is erroneous because the cranial bones fuse by the end of adolescence and no research has ever demonstrated that manual manipulation can move the individual bones [17]. Nor do I believe that "the rhythms of the craniosacral system can be felt as clearly as the rhythms of the cardiovascular and respiratory systems," as is claimed by another Upledger Institute brochure [18]. The brain does pulsate, but this is exclusively related to the cardiovascular system [19]. In a recent study, three physical therapists who examined the same 12 patients diagnosed significantly different "craniosacral rates," which is the expected outcome of measuring a nonexistent phenomenon [20].
Osteopathic web sites that espouse cranial therapy can be located by using Google's Advanced Search to lok for "cranial osteopathy" and "Sutherland." The most illuminating source I have found (which no longer appears to be posted) was The Cranial Letter, published quarterly by the Cranial Academy, a component society of the American Academy of Osteopathy. The Summer 1993 issue stated that the Cranial Academy had 989 members. Other issues contained case reports stating that cranial therapy can cause knee pain to disappear within a week (Summer 1992), cure hives (Summer 1993), improve the mental condition of Down syndrome patients (May 1995), and correct crossed eyes (May 1996).
The percentage of osteopaths using cranial therapy is not high, but it apppears to be deeply entrenched within the profession. Many of the osteopathic colleges teach it, and the American Osteopathic Association treats it as legitimate. At least 15 of the 88 items listed in the AOA's 1996 list of "Osteopathic Literature in Print" were written by Sutherland, Upledger, or others who appear to advocate cranial therapy [21]. And in 1998, the AOA's continuing education calendar listed a 40-hour cranial osteopathy course it cosponsored with the American Academy of Osteopathy, which is a practice affiliate of the AOA.
In 2002, two basic science professors at the University of New England College of Osteopathic Medicine concluded:

Our own and previously published findings suggest that the proposed mechanism for cranial osteopathy is invalid and that interexaminer (and, therefore, diagnostic) reliability is approximately zero. Since no properly randomized, blinded, and placebo-controlled outcome studies have been published, we conclude that cranial osteopathy should be removed from curricula of colleges of osteopathic medicine and from osteopathic licensing examinations [17].

The Bottom Line
I believe that the American Osteopathic Association is acting improperly by exaggerating the value of manipulative therapy and by failing to denounce cranial therapy. If you wish to select an osteopathic physician as your primary-care provider, your best bet is to seek one who: (a) has undergone residency training at a medical hospital; (b) does not assert that osteopaths have a unique philosophy or that manipulation offers general health benefits; (c) either does not use manipulation or uses it primarily to treat back pain; and (d) does not practice cranial therapy.AOA Protests
On January 23, 1998, I received a letter from the AOA's law firm objecting to certain passages in a previous version of this article [22]. Since that time, I have clarified some of the points they raised and added additional information and references. I also invited the AOA to submit a letter for posting and further discussion. Through their attorney, they agreed to do so, but none has arrived so far.For Additional Information
Observations about Osteopathy in Early 1960s
Further Comparison Between Medical and Osteopathic Education
The Paradox of Osteopathy (New England Journal of Medicine Editorial)

Reader Comments

An osteopathic student complained about my criticism of the misleading statements the AOA makes about OMT on its web site:
The AOA is not reflective of the majority of osteopathic physicians. To begin with, if one ever hopes to achieve a leadership position in the AOA, one must complete both an osteopathic internship and an osteopathic residency, this effectively eliminates somewhere around 70% of DOs (at least that's the figure tossed around this campus). The remaining 30% of DOs unfortunately includes those who make many questionable claims about OMT. It also includes many excellent physicians. The DOs who continue to make these claims are a very vocal minority; most of us become a little embarrassed when we read this sort of thing.

I replied: I would suggest that you and your future colleagues who think that the AOA is making deceptive claims bring pressure on the AOA because it is the only publicly identified spokesperson you seem to have.

Another osteopathic student commented:
I am greatly impressed by your web site. I found out about it from one of my Biochemistry professors who highly recommended it. (I am a first year student.) I am glad to see that you address some of my (and many of my classmates) concerns about the promotion of osteopathy by the AOA in your article. My class has had the usual slogans and propaganda, like "Osteopaths treat the patient not the disease," etc. (implying that the "allopaths" don't, of course) thrown at us from day one. Two members of my immediate family are M.D.'s, and they both find the not-so-subtle disparaging of allopathic medicine by the AOA and the hard-core osteopathic physicians rather amusing.

A former osteopathic medical school faculty member wrote:
I spent 12 years teaching basic sciences and 7 years as an associate dean at the an osteopathic medical school. However, since the school's faculty came from institutions throughout the United States, I doubt that what I observed differed much from the situation at other osteopathic schools.
Students carried a heavy curriculum in osteopathic manipulative therapy (OMT), beginning in their freshman year. The department of manipulative medicine was completely segregated from the other departments, both in principles and in practice. The osteopathic faculty members in the standard medical departments neither practiced nor taught OMT. Nor did the OMT faculty practice or teach the standard forms of medicine. It was as if OMT was a freestanding form of health care -- one that, unlike other departments, was not necessarily bound by scientific foundations. Being a basic science researcher, I have made attempts to set up an animal model to objectively test the claim that certain harmful forms of sympathetic nerve traffic could be altered by spinal OMT. However, I never received any support from the osteopathic faculty in seeing such a study completed. The general attitude of the osteopathic manipulation physicians was, "since we already know it works, why should we bother with proving it."
Cranial therapy was a large component of the manipulative medicine department, both for patient care as well as for teaching the medical students. Interestingly, while the other faculty accepted most forms of OMT even though they did not use them, they did not endorse the use of cranial therapy. Indeed, I heard many criticisms of the practice by the non-OMT faculty. Their objections were the same as mentioned on Quackwatch -- that the cranial bones fuse early in infancy, after which no motion of these bones takes place. As you indicate, the alleged sensing of such motion forms the heart of cranial therapy.
I have never heard any attempt by an OMT practitioner to offer a tenable defense to such criticism. To me it almost seemed as if the OMT practitioner felt that the practice could not be defended with ordinary logic since its basis lay somewhere in the metaphysical and that only their gifted hands were able to "sense" the cranial motion.
But the seemingly metaphysical did not stop with the practice of cranial therapy. I know of one case in which a student with an undiagnosed illness consulted one of her OMT mentors who concluded that she had "a "hole in [her] aura."

David E. Jones, Ph.D.

An osteopathic physician in postgraduate training at a university medical center wrote:
I have found my osteopathic school training to be quite equal to that given to my great allopathic colleagues. One of the things I did find disconcerting in my training is what you have pointed out on your site. Osteopathic physicians in training are bombarded with the views that A.T. Still was some kind of god. Most of the people in my class pretty much saw through this and concentrated on the positive aspects of our medical training. I continue to be dismayed at the attitude of the AOA in maintaining a "separate but equal" status for D.O.s. This smacks of an "us versus them" mentality which most mature people have little time for. I and a number of other D.O. colleagues believe that it is time to merge the professions into one cohesive medical discipline. This would allow us to concentrate on caring for our patients with proven modalities as well as produce a stronger lobby for the real danger in medicine: quackery.

An osteopathic physician from Texas wrote:

Another osteopathic physician responded to the above letter:
I am a double boarded D.O. who completed an M.D. residency. I have never practiced manipulation and agree with much on your web site regarding osteopathy. I am profoundly embarrassed by the abobe letter from an "Osteopathic Physician in Texas." I would hope that the author is not really a physician, but I fear that he is because of some of his statements. The letter is very inflammatory and does little to expose the frauds of "cranial therapy" and other outlandish practices. If possible, could you consider removing the letter? I feel discussion is needed and the letter will simply drive people away from meaningful discussion.

I replied: Thanks for your note. It's always nice to hear from a rational D.O. The writer identified himself and was listed in the AOA directory. I posted it because most responses I get from D.O.s and students are negative and about 20% are just as nasty.

Another osteopathic physician responded:
I read with interest your article on the dubious aspects of osteopathy. I was disturbed by your note, appended to a letter which, in its turn, responded to the inflammatory and profane comments by a Texas osteopathic physician. Although it disturbs me to hear that such a high percentage of responses by osteopaths are negative -- even profane -- I am not entirely surprised.
In what seemed to be an effort to build and maintain a separate identity, there was a considerable degree of indoctrination and propagandizing aimed at the students while I was in osteopathic medical training. It is not surprising, therefore, that you should receive such responses from what I would hope to be a vocal minority of the strongest adherents to the "osteopathic faith." For the record, I am in agreement with much of what you have written.
I am pleased that the education I received has enabled me to practice evidence-based Family Medicine alongside my medical peers for the last decade. Graduates of my school perform admirably in postgraduate training alongside graduates of M.D. schools.
Unfortunately, those osteopaths who practice and preach the cranial message and other dubious methodologies still influence students of medicine today, and there are always those who will embrace such things and prey on those searching for the elusive magic bullet.
I appreciate your website and the information you provide. I would have no objection to a merging of professions as mentioned in the article by yourself and others. I feel, biased as I may be, that I received an excellent medical education through my osteopathic medical training, and I hope that time will show that osteopaths as a group will become more respectable with the attrition of some of the older, more "dubious" influences on the profession. I hope, as the numbers of osteopathic practitioners increase, the percentage of those engaged in cranial and chelation nonsense will fall to more nearly match those of the medical profession as a whole (although one would wish it to fall to zero).
I note with professional gratitude that you do not paint all osteopathic practitioners with the quackery brush. I hope this feedback will improve the balance, reducing the percentage of negativity you receive from the osteopathic community. Please keep up the good work. Your site is a very useful tool for my own and my patients' education.
Kindest regards.
Note: Please do not post my name or location. I have the privilege of training osteopathic medical students, and I enjoy imparting reason and discernment in the matter of evidence-based medical practice. Being seen as a "heretic" would impair my ability to continue to serve in this manner.

Still AT. Autobiography -- with a history of the discovery and development of the science of osteopathy. Reprinted, New York, 1972, Arno Press and the New York Times.
Gevitz N. The D.O.'s: Osteopathic Medicine in America. Baltimore, 1982, The Johns Hopkins University Press.
Gugliemo WJ. Are D.O.s losing their unique identity? Medical Economics 75(8):201-213, 1998. (Clarification regarding AAFP membership published in Medical Economics 75(14):21, 1998.)
Doxey TT, Phillips RB. Comparison of entrance requirements for health care professions. Journal of Manipulative and Physiological Therapeutics 20:86­91, 1997.
Ross-Lee B, Wood DL. Osteopathic medical education. In Sirica CM, editor. Osteopathic Medicine, Past, Present and Future. New York, Josiah Macy Jr. Foundation, 1996, page 95.
Jones DE. Allopathic (M.D.) versus osteopathic (D.O.) medical Schools: Views of a basic scientist with experience in both. Cardiovascular Concepts Web site, accessed 5/21/99.
Johnson SM et al. Variables influencing the use of osteopathic manipulative treatment in family practice. Journal of the American Osteopathic Association 97:80-87, 1997.
Alternative Medicine Yellow Pages. Puyallup, Washington. Futurer Medicine Publishing, Inc., 1994.
Osteopathic medicine: A distinctive branch of mainstream medical care. Undated brochure, distributed in 1987. Chicago: American Osteopathic Association
What is a D.O.? (Brochure) Chicago: American Osteopathic Association, 1991,
AOA Position Papers, Aug 1996. In AOA Yearbook and Directory. Chicago: American Osteopathic Association, Jan 1997, pages 565-588.
Position Paper on Osteopathic Manipulative Treatment (OMT) & Evaluation and Management services. Part II: The Standard of Care for Osteopathic Manipulation and the E&M Service. AOA web site, September 1998.
Gunnar BJ and others. A comparison of of osteopathic spinal manipulation with standard care for patients with low back pain. New England Journal of Medicine 341:1426-1431, 1999.
Discover CranioSacral Therapy. Undated flyer distributed in 1997 by the Upledger Institute.
Upledger CranioSacral Therapy I. Brochure for course, November 1997.
Visceral manipulation. Upledger Institute Web site, accessed Aug 15, 2001.
Hartman SE, Norton JM. Interexaminer reliability and cranial osteopathy. Scientific Review of Alternative Medicine 6(1):23-34, 2002.
Workshop catalog, Upledger Institute, 1995.
Ferre JC and others. Cranial osteopathy, delusion or reality? Actualites Odonto-Stomatologiques 44:481-494, 1990.
Wirth-Pattullo V, Hayes KW. Interrater reliability of craniosacral rate measurements and their relationship with subjects' and examiners' heart and respiratory rate measurements. Physical Therapy 74:908-16, 1994.
Osteopathic literature in print, October 1996. In AOA Yearbook and Directory. Chicago: American Osteopathic Association, Jan 1997, pages 756-757.
Prober, JL. Letter to Dr. Stephen Barrett, January 23, 1998.

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This page was revised on August 18, 2003.

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government "interference" with unscientific practi

Postby guest » Wed Mar 17, 2004 9:22 pm

Testimony against the
Access to Medical Treatment Act (H.R. 746)
Thomas J. Moore
On February 4 and 12, 1998, the House of Representatives Government Reform and Oversight Committee held hearings on the Access to Medical Treatment Act, a bill intended to prevent government "interference" with unscientific practitioners. Mr. Moore was the only witness who testified against the bill. This was his prepared statement.


Should consumers, especially those with a serious or life threatening illness, have the right to any drug or alternative medicine even though it has not been proven safe and effective and approved by the Food and Drug Administration?

Let me tell a story of what could happen if that were the case. In this age of media hype, it is plausible that literally millions of Americans could be persuaded to take a pill every day that they hoped would prevent cancer -- especially if it included some natural ingredient or a vitamin.

Suppose that long after millions of people were popping this cancer prevention pill, proper, expensive randomized clinical trials were finally conducted to see if the hoped for benefits in fact existed.

Now suppose that those clinical trials-the only real scientific evidence we have whether drugs work or not -- showed that these anti-cancer pills either didn't work at all -- or actually caused lung cancer. Millions of Americans would be spending their hard earned money on a remedy that at best was ineffective-and at worst could give them cancer.

Am I telling you a fanciful, alarmist story? This is a true story. It already happened -- and the treatment involved was beta-carotene supplements. Like so many new drug treatments, it sounded promising but proved to be worthless or harmful when tested [1,2].

Humans have dreamed of powerful medicines since the dawn of history. But for most of the last seven thousand years consumers were mostly victims of hazardous, poisonous, or merely unpleasant drugs. The era of modern beneficial drugs began only a few decades ago when society began to insist that drugs be tested for safety and efficacy in well controlled clinical investigations. Real progress began only when we used randomized clinical trials to separate beneficial drugs from those that were worthless or harmful.

This morning you have heard some dramatic stories from individuals who believe they were greatly helped -- perhaps saved -- by a treatment that is not available in the United States. The question therefore is should Americans have access to a medical treatment if there are individuals who can personally testify that it is valuable?

The most simple test case would be a remedy for obesity. Here seems to be a treatment every consumer can judge. Either you lose weight or you don't. Suppose for our test case that the FDA had approved the drugs-so they had been subject to at least modest levels of safety testing. Should not then the consumer-and not government regulators or health authorities-be the judge this treatment?

You all ought to know the answer to this question. This episode also happened, and the result may turn out to be one of the greatest drug disasters that our nation has experienced. Last September the diet drugs Pondimin and Redux were hastily withdrawn after the FDA received evidence that an astonishing 31% of the people tested showed some evidence of damage to their heart valves [3,4]. At the time, more than 5 million Americans were taking these drugs.

Did the consumers notice? Could they judge for themselves? They could not. Until it became very severe, the heart damage had no symptoms. Did their doctors notice? They did not. Pondimin was on the market for more than 20 years before two alert medical workers in North Dakota noticed something suspicious. What is the first lesson of the diet drug debacle?

Not only does it take systematic testing to discover whether drugs work, it also takes systematic scientific study to discover serious adverse effects that are potentially harming millions of people. If we don't have the proper safety system in place, people will be harmed for years or decades. In their potential to harm millions of people there are few rivals for drug treatments -- whether they are mainstream prescription drugs or alternative remedies. This is exactly why society has erected the safeguards now being examined in this hearing.

Another aspect of the issue today is more difficult. Should people with advanced cancer, or Parkinsons Disease or full-blown AIDS have the right to any treatment they choose? Some of these people might not live long enough for the kind of drug testing I believe so important to protecting the public. Should they not be entitled to take any risks they choose?

On the surface, the case for individual liberty seems compelling. However, another example will illustrate the dark problems underlying this seemingly straightforward idea.

Suppose you are dying of cancer, and I offer you this ghoulish shell game. In one of my hands, I have hidden a treatment that might save your life. In the other hand, is a quack medicine that will make you so sick you can hardly get out of bed, and will hasten your death. I can give you a free choice. But which hand holds the lifesaving drug? The left hand? Or the right hand?

This is not a meaningful choice. Without extensive drug testing we just can't tell which hand holds a dangerous poison, and which conceals the life saving drug. Without proper testing even a potentially life saving treatment may be harmful if given in the wrong dose, or to the wrong patients. I want people to have choices too. But they should be real choices, involving scientific data about how much harm and good various treatment alternatives can be expected to achieve.

We have only one proven solution. We need public policies to promote more drug testing, not still more new loopholes that could endanger the heath and safety of millions of people.

Some may ask, "But aren't people going denied a life-saving treatment for the several years it takes for human testing and drug evaluation?" My answer is that we don't know that it is a life-saving drug until it is tested. Even if proven life-saving, we can't truly hope to save lives until we have done enough testing to know how to use it properly. The history of modern drug treatment includes many cases of valuable drugs that proved ineffective or harmful because they were used in the wrong patients, or at the wrong time in the progression of a disease [5,6]. Until it is tested, and we know how to use it, a drug cannot properly considered a life-saving treatment.

Alternative medicines pose special problems that deserve the attention of this committee. They are falling between the cracks of the system we have devised to search for new medicines. Large drug companies are expected to invest millions of dollars in the elaborate drug testing we wisely require. In return they are granted patents that are so lucrative that a single blockbuster drug can sustain an entire multinational pharmaceutical giant. This system has provided many beneficial medicines, but at a price. Only large firms can afford the extensive testing required by law. Large organizations tend to follow conventional thinking; daring innovators often work alone or in small firms. It is certainly possible there are neglected therapies that involve common molecules or natural ingredients that cannot be readily patented. Also there may be promising scientific avenues of advance that were ignored or abandoned by mainstream medical research and its partners in the pharmaceutical industry. The tiny office in the National Institutes of Health devoted to alternative therapies doesn't have even a fraction of the resources needed to investigate the most promising leads.

What is needed is money and a structure to target research and assign priorities. The funds could be come from general tax receipts -- as do the funds for the National Institutes of Health. Or the research could be financed by a small tax paid by industry. I believe that consumers would be willing to pay an extra amount to insure they got a product that might benefit their health rather than harming it. The policy problem is to figure out how to get the necessary scientific testing done. The solution is not to expose more Americans to untested and possibly ineffective or harmful compounds.

Finally, I would like to address the issue of the FDA and experimental cancer treatments. My main concern is that there is already too much experimental treatment of cancer patients rather than not enough.

A survey by the General Accounting Office showed that 23% of all cancer patients receive an experimental treatment; another GAO study estimated that about 56 percent of cancer patients receive a drug for off-label use -- which can be considered quasi-experimental use of an approved drug [7,8]. Despite the billions we spend on research and treatment, the mortality rate from cancer is higher today than it was in 1970, despite dramatic declines in most other major causes of death [9]. The use of so much experimental treatment may be one important reason we have had such disappointing results. Does the U.S. Congress want to expose more patients to experimental cancer agents without the safeguards required for formal National Cancer Institute protocols or human drug testing studies under FDA supervision?

Finally, some people seem to believe that heartless FDA bureaucrats are somehow keeping valuable drugs away from people in life or death situations. I have published articles and books filled with criticism of the FDA, detailing many failings and numerous ways it could do a better job. But I also am here to testify that after 20 years in Washington I have not found a group of more capable public servants more sincerely dedicated to protecting the American public. By the large, they work at a thankless task under very difficult circumstances, and I for one, have great respect for their efforts.

In conclusion, I believe the central issue before the committee today is not access to treatment, but assuring that the proper and necessary drug testing is conducted to insure that both mainstream medical therapies and alternative medicines help rather than harm people. That is easier said than done. But with sound public policies, we can move towards this goal. However, if Congress abandons the essential safeguards of drug testing, there is no limit to the harm that may occur.

1. Omenn GS and others. Effects of a combination of beta carotene and vitamin A on lung cancer and cardiovascular disease. New England Journal of Medicine 334:1150-1155, 1996.
2. Hennekens CH and others. Lack of effect of long-term supplementation with beta carotene on the incidence of malignant neoplasms and cardiovascular disease. New England Journal of Medicine 334:1145-1149, 1996.
3. HHS News. FDA Announces withdrawal of Fenfluramine and Dexfenfluramine. U.S. Department of Health and Human Services, Food and Drug Administration, Office of Public Affairs, September 15, 1997.
4. Department of Health and Human Services, Food and Drug Administration, Division of Pharmacovigilance and Epidemiology. FDA analysis of cardiac valvular dysfunction with use of appetite suppressants. briefing paper. Undated.
5. Concorde Coordinating Committee. Concorde: MRC/ANRS randomized double-blind controlled trial of immediate and deferred zidovudine in symptom-free HIV infection. Lancet 343:871-881, 1994.
6. Echt, DS and others. Mortality and morbidity in patients receiving Encainide, Flecainide or placebo. New England Journal of Medicine 324:781-788, 1991.
7. United States General Accounting Office. Off-Label Drugs: Initial Results of a National Survey. Washington, D.C.: U.S. General Accounting Office. GAO/PEMD-91-12BR, February, 1991.
8. United States General Accounting Office. Off-Label Drugs: Reimbursement Policies Constrain Physicians in their Choice of Cancer Therapies. Washington. D.C.: U.S. General Accounting Office GAO/PEMD-91-14, September. 1991.
9. Moore, TJ. Look at the mortality rates: The 'War on Cancer' has been a bust. The Washington Post; July 23. 1997, editorial page.
10. Moore TJ. Deadly Medicine: Why Tens of Thousands of Heart Patients Died in America's Worst Drug Disaster. New York: Simon & Schuster, 1995.
11. Moore, TJ. Prescription for Disaster. The Hidden Dangers in Your Medicine Chest. New York: Simon & Schuster, 1998.
About the Author
Mr. Moore, a senior fellow at the George Washington University's Center for Health Policy Research, specializes in issues involving prescription drug safety. His writings have appeared in many magazines and newspapers. His most recent book is Prescription for Disaster: the Hidden Dangers in Your Medicine Cabinet, an examination of the risks of prescription drugs and the performance of the safety system intended to control those risks. His previous book, Deadly Medicine: Why Tens of Thousands of Heart Patients Died in America's Worst Drug Disaster, was a case study exploring why a family of drugs for irregular heartbeats was so widely used without researchers and regulators realizing the drugs frequently caused cardiac arrest. He has testified before Congress and lectured at universities and other research institutions about drug safety and other issues involving the medical care system. Before turning to full-time research and writing on health policy issues in 1988, he was a national correspondent in Washington for the Knight-Ridder newspaper chain. He also has worked on the staff of the U.S. Senate.

level of activism within the Medical Profession

Postby guest » Thu Apr 29, 2004 9:00 am

Empowered by insurers and states, nonphysicians push
practice limits
Organized medicine educates legislators about the patient
safety issues in scope-of-practice debates.
By Myrle Croasdale, AMNews staff. Feb. 9, 2004.

Growing pressure from allied health professionals and
alternative medicine practitioners to expand their scopes
of practice has inspired a new level of activism within the
medical profession.

As 2004 unfolds, a raft of proposed laws seeking to expand
or create new scopes of practice are hitting physicians.
The new laws come essentially from two groups -- the allied
health professions or nonphysicians such as optometrists,
psychologists, and those working in the field of
complementary and alternative medicine, such as

The Federation of State Medical Boards' special panel on
scope of practice and a working group formed under the
auspices of the AMA are in the midst of creating resources
for state medical groups and legislators that will address
patient safety and other issues that routinely arise with
each piece of scope-of-practice legislation.

Non-MD, non-DO practitioners, who have argued successfully
that expanding their scope expands access to care, are
emboldened by past victories. These include a congressional
mandate that chiropractors become part of the Veterans
Health Administration, prescribing rights for psychologists
in New Mexico and independent status for certified
registered nurse anesthetists in 12 states.

The road to change in CRNA status in those states was paved
by a federal rule letting states opt out of Medicare

And alternative medicine practitioners have been energized
by consumer demand. Studies show that an estimated 43% of
Americans have used some form of complementary or
alternative medicine and spend up to $40 billion on it a

Americans spend $40 billion a year on alternative medicine.

Health insurers also are more willing to cover such care. A
2002 industry survey conducted by the American Assn. of
Health Plans-Health Insurance Assn. of America reveals that
58% of plans pay for herbal medicines and 34% cover

Russ Newman, PhD, executive director for professional
practice for the American Psychological Assn., said the
public in general is unwilling to be limited in what kind
of health care they can receive.

"After 10 years of market-driven managed care that really
restricted access, there has been a public backlash in
response to that," Dr. Newman said. That backlash also has
helped fuel the drive to broaden public access to mental
health care, he said.

In 2002, New Mexico became the first state to award
psychologists prescribing authority.

"It came out of the blue," Dr. Newman said. "New Mexico
didn't have to work as long as you usually do to get this
through, because the access issue rang true there.
Seventy-two percent of the population had access to only 18

Psychologists are gearing up to pursue the passage of
similar bills in other states and say the access argument
will be key in Tennessee. Psychologists say Tennesseans
face an average wait time to see a psychiatrist of six
weeks -- eight weeks in rural areas and four weeks in urban

But Peter Frizzell, MD, president of the Tennessee
Psychiatric Assn., called the access-to-care debate a red
herring. "I don't believe that psychologists are any more
dispersed in rural areas than psychiatrists, so I don't
believe that's a legitimate question on their part," he
said. "Our primary care physicians are much better
qualified to provide some level of pharmacological therapy
than psychologists, who would go through a questionable
training experience that couldn't duplicate medical school
and residency."

Educating legislators
As medical societies and state medical boards gear up to
address such legislation, organized medicine hopes to equip
them with some new resources.

"It's a hot issue that the boards have brought to the
federation," said cardiologist Grant La Farge, MD, a member
of FSMB's special committee on scope of practice. "There
isn't a single [medical] board in the U.S. that hasn't had
some form of legislation pending, some repeatedly, which
makes the medical profession howl. Certain kinds of
increased scopes of practice can be accepted, but rules for
patient safety need to be protected."

43% of Americans have used some form of complementary and
alternative medicine.
The FSMB has found that state legislators are hungry for
advice on how to approach such legislation. "They hear
strong voices on both sides of the issue, and they don't
know how to sort this out," Dr. La Farge said. The special
committee's white paper on scope-of-practice legislation is
unlikely to be finalized before 2005, but Dr. La Farge said
it aims to give legislators guidelines to make informed
decisions on scope-of-practice issues.

One key recommendation will be that states require an ad
hoc committee for each scope-of-practice issue. Instead of
putting the process entirely in the hands of politicians,
who typically have no medical background, these panels
would bring professionals from both sides together to
examine the scientific basis for a service and weigh the
need for it against its hazards. They also would help
determine what level of training is required.

AMA Executive Vice President Michael Maves, MD, agreed that
the need to protect the public is increasingly necessary.
"There's building momentum on the scope-of-practice side.
There is a lot of pressure from the allied health

The AMA working group is tackling scope-of-practice
pressures from a different perspective. Composed of six
state medical societies, which have been actively involved
in scope-of-practice issues, and six specialty
organizations, which frequently face scope demands, the
group aims to improve communication among physician groups
and make it easier for them to share expertise.

"Our sense is there is a lot that goes on in states that
the specialty societies aren't aware of, and [we want] to
try to provide the states with the expertise that the
specialties have abundantly to share strategies on what
works," Dr. Maves said. "My sense was there has not been a
lot of dialogue between national specialty societies and
state societies, but scope of practice is high on all their

The working group is also speaking with allied health
professional organizations. "We need contributions from
physicians and from the allied health side to approach this
in a rational fashion," Dr. Maves said.

What's covered
A survey by the American Assn. of Health Plans-Health
Insurance Assn. of America found that in 2002, 94% of
insurers covered chiropractic care. Other coverage

Massage/relaxation therapy 70%
Acupuncture 67%
Acupressure 58%
Herbal medicines 58%
Biofeedback 49%
Homeopathy 34%
Hypnosis 11%


Back to top.

Widening their scopes
Several health professions are expected to pursue
legislation on scope-of-practice issues this year.

Advanced-practice nurses
Continuing efforts to gain independent practice rights in
Asking Congress for direct access to Medicare patients.
Seeking authority to diagnose disorders of hearing and
balance systems in children and adults, as well as to
provide comprehensive treatment of these disorders in
Michigan and New Jersey.
Asking to remove physicians from the board of examiners for
audiologists, hearing aid dispensers and speech language
pathologists in Maryland.
Pursuing the designation as primary care physicians in
Seeking to expand the scope to the head, neck and beyond
for dentists with oral surgery privileges in Indiana and
Seeking independence from physician supervision for
nurse-midwives in Massachusetts.
Seeking licensure and independent practice authority for
lay midwives in Missouri.
Pursing authority to perform laser surgery in Missouri.
Seeking unlimited prescribing authority and the ability to
treat glaucoma in Vermont.
Asking for authority to modify prescriptions in Wisconsin.
Physical therapists
Seeking authority to prescribe medication, debride wounds
and perform electrotherapeutics in Massachusetts.
Physician assistants
Seeking permission for physicians to delegate prescriptive
authority to PAs in Ohio and Louisiana.
Seeking permission for physicians to delegate prescriptive
authority for controlled substances to PAs in New Jersey.
Pursuing prescribing privileges in Georgia, Hawaii,
Illinois, Louisiana, Maine, New Hampshire, Oklahoma and
Sources: AMA Advocacy Resource Center, National Conference
of State Legislatures, American Academy of
Otolaryngology-Head and Neck Surgery, American Academy of
Physician Assistants, American Psychological Assn. (Note:
Because not all state Legislatures have convened their new
sessions, this list may not be complete.)

EBM or Faith Based Medicine

Postby guest » Tue Dec 28, 2004 10:00 am

Evidence-Based Medicine or Faith-Based Medicine?
Posted 12/10/2004

George D. Lundberg, MD

I was recently contacted by an American doctor who asked for some good references on evidence-based medicine (EBM) to help him prepare for a debate with another physician who was opposed to EBM. After recovering from the shock that some 2004 doctor would take the opposing position, I offered him what I thought were good sources, and decided to try to make a succinct case for EBM.

Some years ago, the US Preventive Services Task Force[1,2] determined the hierarchy of quality of evidence to support interventions, such as:

At least 1 properly randomized, controlled trial;
Well-designed, controlled trials without randomization;
Well-designed, cohort or case-control analytic studies;
Multiple time series with or without the intervention;
Dramatic results in uncontrolled experiments; and
Opinions of experts or committees, clinical experiences, and descriptive studies.
Thus, the randomized, controlled clinical trial with blinding and sufficient numbers to have statistical power became the gold standard. Recognizing that not all interventions have been properly studied but that physicians must make clinical decisions anyway, David Sackett[3] is credited with having defined EBM as the "integration of best research evidence with clinical expertise and patient values."

I consider the near opposite of pure EBM to be pure FBM -- faith-based medicine. St. Paul defined faith as "the substance of things hoped for, the evidence of things unseen.[4]" This was OK for medicine in the first century AD, but in 2004, when there is evidence, I choose it as the basis for my care. That's my opinion. I'm Dr. George Lundberg, Editor of MedGenMed.

Readers are encouraged to respond for the editor's eye only or for consideration for publication via email: glundberg@webmd.net.

Lawrence RS, Mickalide AD. Preventive services in clinical practice: designing the periodic health examination. JAMA. 1987;257:2205-2207.
Fontanarosa PB, Lundberg GD. Alternative medicine meets science. JAMA. 1998;280:1618-1619.
Sackett DL, Straus SE, Richardson WS, Rosenberg W, Haynes RB. Evidence-Based Medicine. How to Practice and Teach EBM. New York: Churchill Livingstone; 2000.
Holy Bible, New Testament. St. Paul; Hebrews 11:1.

George D. Lundberg, MD, Editor-in-Chief, Medscape General Medicine

Misleading claims by the American Osteopathic Association

Postby guest » Wed Mar 02, 2005 5:48 pm

American Osteopathic Association accused of false advertising.

Dr. Stephen Barrett believes that the American Osteopathic Association (OA) has a misleading message posted to its Web site. The 1-minute spot was created as part of a nationwide advertising effort in which about 75 AOA members recorded interviews for distribution to their local and regional media. During the interview, the osteopathic physician suggests that doctors of osteopathy: (a) have more training than medical doctors, (b) make more "complete" diagnoses, (c) "really get to the root" of their patients' problems, and (d) use osteopathic manipulation to "try to help the body heal itself." [Barrett S. Misleading claims by the American Osteopathic Association. Quackwatch, March 2, 2005] http://www.quackwatch.org/12Web/aoa.html

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