The Subversion of Medicine
Through Treatment Guidelines
By Jerry Leonard and Tina J. Garcia
A recent article published in the medical journal Archives of Internal Medicine concluded that recommendations for treatment contained in guidelines published by the Infectious Diseases Society of America (IDSA) were largely based upon opinion. The assumption that the IDSA�s Practice Guidelines for treatment of various infectious diseases represent the best that science has to offer was found to be false by the authors of the article, entitled Analysis of Overall Level of Evidence Behind Infectious Diseases Society of America Practice Guidelines.
The conclusions drawn by the authors of the study are that IDSA Practice Guidelines are only partially based upon scientific evidence. Yet, the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC) and the IDSA promote the Practice Guidelines as "evidence-based."
"Results: In the 41 analyzed guidelines, 4218 individual recommendations were found and tabulated. Fourteen percent of the recommendations were classified as level I, 31% as level II, and 55% as level III evidence. Among class A recommendations (good evidence for support), 23% were level I (1 randomized controlled trial) and 37% were based on expert opinion only (level III)Updated guidelines expanded the absolute number of individual recommendations substantially. However, few were due to a sizable increase in level I evidence; most additional recommendations had level II and III evidence.
Conclusions: More than half of the current recommendations of the IDSA are based on level III evidence only. Until more data from well-designed controlled clinical trials become available, physicians should remain cautious when using current guidelines as the sole source guiding patient care decisions."
http://archinte.ama-assn.org/cgi/content/abstract/171/1/18
Isn't this exactly what Lyme disease patients and their treating physicians have been saying for years about the Infectious Diseases Society of America Practice Guidelines for Lyme disease? Didn't then Connecticut Attorney General Richard Blumenthal state that, as a result of his antitrust investigation of the IDSA and its 2006 Lyme Disease Practice Guideline authors, he found numerous conflicts of interest held by those authors? (Other researchers have shown these guidelines to be largely based on the opinions of a few manufactured "thought-leaders," who largely cited their own flawed studies.)
We simply cannot emphasize and distribute widely enough what Attorney General Blumenthal revealed in his May 1, 2008 press release:
"The IDSA guidelines have sweeping and significant impacts on Lyme disease medical care. They are commonly applied by insurance companies in restricting coverage for long-term antibiotic treatment or other medical care and also strongly influence physician treatment decisions."
"Insurance companies have denied coverage for long-term antibiotic treatment relying on these guidelines as justification. The guidelines are also widely cited for conclusions that chronic Lyme disease is nonexistent."
"This agreement vindicates my investigation -- finding undisclosed financial interests and forcing a reassessment of IDSA guidelines," Blumenthal said. "My office uncovered undisclosed financial interests held by several of the most powerful IDSA panelists. The IDSA's guideline panel improperly ignored or minimized consideration of alternative medical opinion and evidence regarding chronic Lyme disease, potentially raising serious questions about whether the recommendations reflected all relevant science."
Blumenthal added,
"The IDSA's 2006 Lyme disease guideline panel undercut its credibility by allowing individuals with financial interests -- in drug companies, Lyme disease diagnostic tests, patents and consulting arrangements with insurance companies -- to exclude divergent medical evidence and opinion. In today's healthcare system, clinical practice guidelines have tremendous influence on the marketing of medical services and products, insurance reimbursements and treatment decisions. As a result, medical societies that publish such guidelines have a legal and moral duty to use exacting safeguards and scientific standards." (emphasis added)
(http://www.leaparizona.com/ctagpressrelease.htm)
In the case of the IDSA recommendations for treatment of Lyme disease, which is an infectious disease caused by the bacterium Borrelia burgdorferi, the guideline authors disregarded concerns raised by eight infectious disease specialists. The specialists initially corresponded in writing on October 12, 2005 to then IDSA President, Martin J. Blaser, M.D. Subsequent correspondence back and forth also involved IDSA Executive Director Mark Leasure and Chair of the IDSA Standards and Practice Guidelines Committee, Thomas M. File, Jr., M.D., M.S. It is interesting to note that Lyme Practice Guideline Committee Chairman, Gary Wormser, M.D., was copied on IDSA correspondence, so he was well aware of the fact that the Committee he chaired and the opinion he espoused was called into question prior to the 2006 publication of the Lyme Guidelines.
Dr. Joseph G. Jemsek, an infectious disease specialist with extensive experience in HIV and Lyme Borreliosis treatment, wrote the letter to IDSA. Dr. Jemsek and the seven supporting signatories requested the opportunity to provide input into the formulation of the 2006 IDSA Practice Guidelines for Lyme Disease. Dr. Jemsek and his colleagues brought to the attention of the key individuals involved with the formulation and publication of those Guidelines the fact that the Guidelines did not reflect the vast amount of evidence of persistent infection post antibiotic treatment. The ID specialists also pointed out the fact that divergent medical opinion on the subject of Lyme Borreliosis was available and requested that such opinions be seriously considered and made a part of the IDSA Guidelines recommendations. They also suggested that the Lyme Disease Guidelines Committee should have included members who have experience with chronic Lyme infection and its treatment in the clinical setting.
Although Drs. Blaser and File and Mr. Leasure indicated in conversation and return correspondence that scientific evidence and divergent medical opinions were considered, the final publication of the 2006 IDSA Practice Guidelines for Lyme Disease failed to include any recommendations which support the existence of chronic infection or persistence of infection post antibiotic treatment. Informed input that favored the clinical-experience-based view that persistent Lyme infection and extended courses of antibiotic therapy be included within the Guidelines was blatantly ignored.
(http://www.leaparizona.com/jemsekletters.htm)
Even though the IDSA subsequently ridiculed then Attorney General Blumenthal for investigating the organization, the AG's investigation confirmed the validity of Dr. Jemsek and his colleagues' concerns about IDSA bias of opinion, financial conflicts of interest and exclusion of evidence in the formulation of IDSA's Practice Guidelines for treatment of Lyme disease.
As part of the 2008 legal Agreement signed by Attorney General Blumenthal and the IDSA, an independent Review Panel was selected to review the IDSA Practice Guidelines for Lyme Disease, along with public submissions of medical research. Sixteen scientists and physicians, representing both sides of the debate, were selected to present testimony before the Review Panel at a hearing held in Washington, D.C. on July 30, 2009. Two patient representatives also testified; Tina J. Garcia was one of the advocates selected.
The letters written by Dr. Jemsek and his colleagues were presented to the individual IDSA Review Panel members by Tina Garcia, as part of her testimony before the Panel. PJ Langhoff�s book, The Baker's Dozen and The Lunatic Fringe, which is a huge compilation of patents and other conflicts of interest held by the 2006 IDSA Lyme Guideline authors, was also presented to the Review Panel.
Through their vote to uphold the IDSA Practice Guidelines for Lyme Disease, the Review Panel members ignored the content of the letters and the book, along with the desperate plight of Lyme patients, which was presented in testimony by both patient representatives. The Review Panel upheld each recommendation in the 2006 IDSA Practice Guidelines for Lyme disease, despite being presented with voluminous evidence from a number of Lyme researchers and physicians, which clearly demonstrated persistent infection, the Bb pathogen�s ability to undergo antigenic variation and its use of biofilm for survival.
During a break at the IDSA hearing, Tina Garcia spoke with Dr. David Mushatt of Tulane University, one of the Review Panel members charged with reviewing the Guidelines. Tina asked Dr. Mushatt if he had read PJ Langhoff's book. Dr. Mushatt told her that he had read some of it and in response to her query about what he thought of the content of the book, Dr. Mushatt told her, "It appears to be a good 'ol boys network and that doesn't sit well with me."
Also at the hearing, Tina spoke with another Review Panel member, Dr. Paul Lantos of Duke University, who apologized profusely for the suffering Tina and other Lyme patients have experienced. Yet, despite these spoken sentiments, the IDSA Guidelines were rubberstamped by the Review Panel anyway.
The IDSA Guidelines create a climate of opinion that Lyme disease is hard to catch and easy to cure. Further, the IDSA Lyme Practice Guidelines have been officially adopted by the NIH and CDC and unofficially adopted by insurance companies as the prevailing wisdom.
Although research has been published by the IDSA Guideline authors proving persistence of infection post antibiotic therapy, those same authors deny the existence of persistent Borrelia infection in the Guidelines. Additionally, the Guidelines ensure treatment claim denials by the insurance industry and boost pharmaceutical profits through lifelong drug sales, through the promotion of treatments that address only the symptoms and not the underlying cause of infection and autoimmune/inflammatory response.
The IDSA Lyme Disease Practice Guidelines serve the insurance industry by promoting the least expensive standard of care, which allows the insurance companies to save huge sums of money through claim denials based on the treatment guideline recommendations. It appears that it is relatively easy for industry "thought leaders" to create treatment guidelines for a disease, which allows the infectious agent to go largely undiagnosed, while the symptoms are profitably treated, in perpetuity, all at the same time insurance claims are denied.
The IDSA Lyme Guidelines severely limit the amount of antibiotics a doctor can prescribe to patients, and physicians who dissent are often destroyed through insurance company complaints filed with state medical boards. Such heavy-handed actions render useless the IDSA Disclaimer that the Guidelines should not supplant physician judgment.
Of particular interest, is CDC's apparent involvement with state medical board proceedings against Lyme physicians. In 1993, Dr. David T. Dennis, Director of the CDC Division of Vector-Borne Infectious Diseases (DVBID) in Ft. Collins, Colorado received a fax from Dr. Mary Grace Stobierski of the Disease Surveillance Section at the Michigan Department of Health. The fax, which was reportedly obtained through a Freedom of Information request, indicates that the prosecution of Michigan Lyme doctor, Joseph Natole, had been discussed by the Michigan Health Department and the CDC prior to the proceedings initiated against Dr. Natole. The fax stated the following:
"This press release concerns a physician being investigated for inappropriate treatment of Lyme disease. You may recall that we discussed this matter a few weeks ago."
"Inappropriate treatment of Lyme disease" must mean treating patients with long-term antibiotics, which is contrary to the IDSA Guidelines. Why was the Director of the DVBID at CDC discussing the prosecution of a doctor for the treatment of Lyme disease? Apparently, the CDC oversteps its jurisdiction and responsibility when it comes to bringing Lyme-treating physicians before medical boards for prosecution.
"So now we have a pandemic fueled by political motives coupled with a consummate disregard for public health, and a pandemic which, when the sources, motives, and actions that led to the pandemic come to light, will be incomprehensible in its amorality and foolishness."
--Anonymous, MD
Treatment Guidelines: A Story of Corruption and Collusion
"It is difficult enough for someone suffering debilitating symptoms due to late-stage Lyme disease to get well with the judicious, but adequate, use of long-term antibiotics. Almost no one gets better without these. To deny patients access [to] this care is a travesty. But this happens all the time and patients often travel hundreds to thousands of miles to see one of the small numbers of Lyme experts in this country. How can that be?"
--Jon Sterngold, M.D.
Lyme disease patients are being denied long-term antibiotics, under various pretexts, by a very well-connected minority of academics with ties to the CDC and biowarfare-related research agencies. The IDSA Guidelines were written by this group of academics and are inappropriately used by insurance companies to deny treatment (actually, the IDSA Guidelines are non-treatment under the pretext of treatment). These individuals also serve as "expert" witnesses in medical board prosecutions, testifying against doctors who treat chronic, persistent Lyme disease with long-term antibiotics. The academics use the arbitrary "standard of care" they have dictated and published in the IDSA Guidelines as the basis for their testimony. Amazingly, they get away with this, even though their published treatment standard directly contradicts their previously published research.
Connecticut Lyme pediatrician, Dr. Charles Ray Jones, was disciplined for years by the Connecticut Medical Examining Board for minor technical violations in the way he diagnosed and treated three children suspected of having tick-borne disease. None of Dr. Jones� treatments have resulted in patient harm; in fact, he has treated thousands of children with Lyme disease from around the world and restored their health. His medical decisions were motivated by his desire to begin, as soon as possible, the treatment of those three very sick children. Dr. Jones (now in his eighties) has had $20,000 in fines levied upon him. The Connecticut Medical Examining Board certainly is not ignorant of the cost of attorneys' fees incurred by Dr. Jones in defending the minor charges.
Yet, the same Medical Board punished other Connecticut physicians for very serious charges, such as substance abuse, sexual misconduct, mental illness and Medical negligence, and these physicians received a fine no larger than $5,000. The inequity of fines imposed by the Connecticut Examining Board is obviously biased against Lyme-treating physicians.
The message being hammered into the minds of doctors who treat Lyme disease with long-term antibiotics is this - if you treat Lyme disease longer than the IDSA recommends, you risk being brought before your state medical board for possible fines and suspension or loss of license. Many physicians have too much invested in their practices to take such a risk, so instead, they refuse to treat Lyme patients and pawn the patients off on other physicians. With Connecticut Lyme cases on the rise, children suffer without treatment for a chronic infection that has the potential to debilitate them for life.
"There is a core group of university-based Lyme disease researchers and physicians whose opinions carry a great deal of weight. They work with government agencies to bias the agenda of consensus meetings and have worked to exclude from those meetings and scientific seminars those with alternate opinions. Because of this bias by this inner circle, Lyme disease unfortunately is both underdiagnosed and undertreated in this country to the great detriment of many of our citizens."
--Dr. Joseph Burrascano, Congressional Testimony, 1993
"Physicians who have cared for persons with chronic Lyme disease have faced harassment at a minimum and for some, their careers have been ruined. Researchers who have seriously dedicated themselves to the scientific study of chronic Lyme disease in humans and/or animals have often found themselves attacked or marginalized. To persist in their researches would have resulted in virtual career suicide and some have been forced, by exigencies of survival, to leave the field."
--Kenneth B. Liegner, M.D.
How is this being accomplished? Control over treatment is dominated by giant corporations with a vested interest in not treating the underlying disease - pharmaceutical and insurance companies. These corporations are, in fact, practicing medicine without a license through third-party "information laundering." They utilize private medical societies, such as the IDSA, and fund "thought leaders" to create business-friendly fraudulent science as a basis for treatment denial. The disease and its treatment are defined in a commercialized, symptom-treatment version that perpetuates the symptom cycle, rather than a patient-centered version that would treat the underlying cause of disease.
Treatment guidelines published by so-called independent medical societies are the perfect vehicle for third-party organizations to emphasize symptom-treatment for a disease, while ignoring the underlying infection that caused it. Without adequate treatment, those suffering with Lyme disease may have their symptoms treated in perpetuity by doctors who blindly and foolishly follow the IDSA guidelines.
"The denial of chronic Lyme disease by IDSA is an important factor in pharmaceutical marketing. According to the IDSA Lyme guideline authors, regardless of how long one has had the infection, how entrenched it is in immune protected sites, or how disabling it is, a short course of antibiotics will eradicate the disease from the body. This has never been proven. Numerous scientific studies have shown IDSA's claims to be false�according to IDSA, after a few weeks of antibiotic treatment a person is "cured" of Lyme disease. Then, suddenly, ongoing symptoms are due to some other unidentified problem which can be managed with ongoing drug treatment. IDSA Lyme guideline authors have known financial ties with pharmaceutical companies, making perfect financial sense for this false claim of cure.
It is only the undeserved clout of the CDC and IDSA and the gullibility of the media that give this incredible information any credibility. The market for symptomatic treatment of Lyme disease through pharmaceuticals is undoubtedly immense. The pharmaceutical market for arthritis alone generated $15.9 billion in revenues in 2008. Worldwide sales of Parkinson's disease therapies will increase modestly from $2.5 billion in 2008 to $2.8 billion in 2018 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. According to PharmaLive, pharmaceutical industry experts expect the fibromyalgia drug market to quadruple to $2 billion by 2016. Leonard Sigal, a rheumatologist and contributor to the IDSA Lyme guidelines, is heavily involved with promoting fibromyalgia as an alternative diagnosis. Sigal, a former academician, now works for a pharmaceutical company. He has also testified in legal cases, on behalf of insurers, against Lyme disease doctors and victims."
--Miguel Perez-Lizano, Pharmaceutical Windfalls, June 2010.
It is important to understand that a Lyme Borreliosis infection, depending upon genetic factors and where in the body the infection takes hold, can manifest as Multiple sclerosis, rheumatoid arthritis, fibromyalgia, chronic fatigue, lupus, Crohn's disease, autism, ALS, Parkinson's, Alzheimer's and other autoimmune or neurodegenerative diseases. It also manifests as a number of psychiatric disorders and research has shown that Lyme infection can cause certain lymphoma cancers.
"In recent years, drug companies have perfected a new and highly effective method to expand their markets. Instead of promoting drugs to treat diseases, they have begun to promote diseases to fit their drugs."
--Marcia Angell, Former Editor of the New England Journal of Medicine
A select group of academic physicians, who serve as pharmaceutical consultants and CDC spokespersons, are involved in eliminating other doctors for treating a pandemic the academicians claim doesn�t exist. Disinformation is being spread under the guise of education. The IDSA, with funding from CDC, offers continuing education for Lyme disease on its website; and this continuing medical education for clinical physicians reflects the false information in the IDSA Lyme Disease Practice Guidelines. They claim that the case studies contained in the educational course "are designed to educate clinicians regarding the proper diagnosis and treatment of Lyme disease and also provide an opportunity to better understand the IDSA guideline." The IDSA claims that the "cases included in this course were written by expert faculty members, some of whom authored the guideline." At the completion of the course, IDSA claims that participants will be able to evaluate and diagnose Lyme disease, utilize effective therapy to treat Lyme disease and review and interpret the IDSA Guidelines
The IDSA workgroup and independent reviewers who created the course with CDC funding included the following IDSA kingpins:
Eugene Shapiro, M.D., Professor of Pediatrics, Epidemiology & Public Health, and Investigative Medicine, Yale University; Metropolitan Life Insurance Company: Reviewing claims of disability related to Lyme disease; Served as an expert witness in medical-malpractice cases related to Lyme disease, (including the Connecticut Medical Board prosecution of Lyme pediatrician Dr. Charles Ray Jones); SUNY Downstate: Honoraria.
Allen Steere, M.D., Professor of Medicine, Harvard Medical School; NIH, the Dana Foundation, G Harold and Leila Y. Mathers Foundation, CDC: Research Grants/Contracts.
Allen Steere was the Chief Clinical Trial Investigator for the Lymerix vaccine that caused Lyme disease in a subgroup of recipients. It was known prior to FDA approval of the Lymerix vaccine that it would have this effect on recipients with a certain gene.
Dr. Steere also used European, high-passage, lipid-free strains of Bb when conducting the research utilized by CDC and other agencies in establishing what is known as the Dearborn serological testing standard (ELISA as a screening test with Western blot for confirmation and only certain bands designated in the criteria by CDC's Lyme Medical Cartel). This testing standard was accepted in 1994 and is still utilized today, despite the fact that the Western blots at the time were unreadable and Dr. Gary Wormser found that only 14% of patients tested positive with this standard. The carefully-designed, current Dearborn testing standard allows the remaining 86% of patients to fall through the cracks of the inaccurate and deceiving testing scam.
Gary Wormser, M.D., Chief of Infectious Diseases and Vice Chair Department of Medicine, New York Medical College; Department of Justice; Expert testimony in a medical malpractice case related to Lyme disease; Retained in other medical-malpractice cases involving Lyme disease; NIH, Bio-Rad, and Diasorin: Research Grants; Merck, Astra Zeneca, and Pfizer.
Paul Auwaerter, M.D., Clinical Director, Division of Infectious Diseases, Johns Hopkins University School of Medicine; Expert testimony in medical malpractice cases related to Lyme disease.
"Some of the doctors receiving the most money sit on committees that prepare guidelines instructing doctors nationwide about when to use medicines."
--Gardiner Harris and Janet Roberts, Doctors' Ties to Drug Makers Are Put on Close View, New York Times, March 21, 2007.
The CDC "Expert" Myth
Lyme disease is hard to catch, easy to cure, tests are accurate, it is a
non-chronic infection and short-term antibiotics are adequate.
The Lyme Patient and Treating Physician Reality
Lyme disease is easy to catch, difficult to cure, is relapsing-remitting and debilitating, can exist as a chronic infection, tests are inaccurate, disseminated medical information is politically dumbed-down, the disease is sophisticated and requires long-term antibiotic regimens.
One pretext that the NIH, CDC and IDSA Guideline authors use is that antibiotics can have dangerous side-effects. However, Lyme physician Dr. Joseph Burrascano stated,
"You"re not going to withhold treatment for a potential side effect, which may never occur, and ignore a known infection that desperately needs to be treated."
Another pretext is that long-term antibiotics create drug-resistant strains of diseases. However, it is also the undertreatment of infection that perpetuates drug-resistant strains of Lyme disease.
"Patients infected with many other kinds of common bacteria - such as those that cause tuberculosis, bronchitis, or UTIs - can experience relapses after an initial course of antibiotic treatment fails or proves inadequate. Doctors routinely retreat patients who relapse in order to achieve a cure and prevent chronic symptoms. Why should patients with Lyme disease be treated differently?"
--Daniel J. Cameron, M.D., Proof That Chronic Lyme Disease Exists, (http://www.ilads.org/news/lyme_news/73.html)
Tuskegee Then and Tuskegee Now
The following is a direct quote from the CDC website at http://www.cdc.gov/tuskegee/timeline.htm:
"In 1932, the Public Health Service, working with the Tuskegee Institute, began a study to record the natural history of syphilis in hopes of justifying treatment programs for blacks. It was called the "Tuskegee Study of Untreated Syphilis in the Negro Male."
The study initially involved 600 black men - 399 with syphilis, 201 who did not have the disease. The study was conducted without the benefit of patients' informed consent. Researchers told the men they were being treated for "bad blood," a local term used to describe several ailments, including syphilis, anemia, and fatigue. In truth, they did not receive the proper treatment needed to cure their illness. In exchange for taking part in the study, the men received free medical exams, free meals, and burial insurance. Although originally projected to last 6 months, the study actually went on for 40 years.
What Went Wrong?
In July 1972, an Associated Press story about the Tuskegee Study caused a public outcry that led the Assistant Secretary for Health and Scientific Affairs to appoint an Ad Hoc Advisory Panel to review the study. The panel had nine members from the fields of medicine, law, religion, labor, education, health administration, and public affairs.
The panel found that the men had agreed freely to be examined and treated. However, there was no evidence that researchers had informed them of the study or its real purpose. In fact, the men had been misled and had not been given all the facts required to provide informed consent.
The men were never given adequate treatment for their disease. Even when penicillin became the drug of choice for syphilis in 1947, researchers did not offer it to the subjects. The advisory panel found nothing to show that subjects were ever given the choice of quitting the study, even when this new, highly effective treatment became widely used.
The Study Ends and Reparation Begins
The advisory panel concluded that the Tuskegee Study was "ethically unjustified"--the knowledge gained was sparse when compared with the risks the study posed for its subjects. In October 1972, the panel advised stopping the study at once. A month later, the Assistant Secretary for Health and Scientific Affairs announced the end of the Tuskegee Study.
In the summer of 1973, a class-action lawsuit was filed on behalf of the study participants and their families. In 1974, a $10 million out-of-court settlement was reached. As part of the settlement, the U.S. government promised to give lifetime medical benefits and burial services to all living participants. The Tuskegee Health Benefit Program (THBP) was established to provide these services. In 1975, wives, widows and offspring were added to the program. In 1995, the program was expanded to include health as well as medical benefits. The Centers for Disease Control and Prevention was given responsibility for the program, where it remains today in the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. The last study participant died in January 2004. The last widow receiving THBP benefits died in January 2009. There are 16 offspring currently receiving medical and health benefits.
Timeline
1895 Booker T. Washington at the Atlanta Cotton Exposition, outlines his dream for black economic development and gains support of northern philanthropists, including Julius Rosenwald (President of Sears, Roebuck and Company).
1900 Tuskegee educational experiment gains widespread support. Rosenwald Fund provides monies to develop schools, factories, businesses, and agriculture.
1915 Booker T. Washington dies; Robert Motin continues work.
1926 Health is seen as inhibiting development and major health initiative is started. Syphilis is seen as major health problem. Prevalence of 35 percent observed in reproductive age population.
1929 Aggressive treatment approach initiated with mercury and bismuth. Cure rate is less than 30 percent; treatment requires months and side effects are toxic, sometimes fatal.
1929 "Wall Street Crash"--economic depression begins.
1931 Rosenwald Fund cuts support to development projects. Clark and Vondelehr decide to follow men left untreated due to lack of funds in order to show need for treatment program.
1932 Follow-up effort organized into study of 399 men with syphilis and 201 without. The men would be given periodic physical assessments and told they were being treated. Motin agrees to support study if "Tuskegee Institute gets its full share of the credit" and black professionals are involved (Dr. Dibble and Nurse Rivers are assigned to study).
1934 First papers suggest health effects of untreated syphilis.
1936 Major paper published. Study criticized because it is not known if men are being treated. Local physicians asked to assist with study and not to treat men. Decision was made to follow the men until death.
1940 Efforts made to hinder men from getting treatment ordered under the military draft effort.
1945 Penicillin accepted as treatment of choice for syphilis.
1947 USPHS establishes "Rapid Treatment Centers" to treat syphilis; men in study are not treated, but syphilis declines.
1962 Beginning in 1947, 127 black medical students are rotated through unit doing the study.
1968 Concern raised about ethics of study by Peter Buxtun and others.
1969 CDC reaffirms need for study and gains local medical societies' support (AMA and NMA chapters officially support continuation of study).
1972 First news articles condemn studies.
1972 Study ends.
1973 Congress holds hearings and a class-action lawsuit is filed on behalf of the study participants.
1974 A $10 million out-of-court settlement is reached and the U.S. government promised to give lifetime medical benefits and burial services to all living participants. The Tuskegee Health Benefit Program (THBP) was established to provide these services.
1975 Wives, widows and offspring were added to the program.
1995 The program was expanded to include health as well as medical benefits.
1997 On May 16th President Clinton apologizes on behalf of the Nation.
2001 President's Council on Bioethics was established.
2004 CDC funds 10 million dollar cooperative agreement to continue work at Tuskegee University National Center for Bioethics in Research and Health Care.
2004 The last U.S. Public Health Service Syphilis Study at Tuskegee participant dies on January 16.
2006 Tuskegee University holds formal opening of Bioethics Center.
2009 The last widow receiving
THBP benefits dies on January 27.�
Similarities Between Tuskegee I (Syphilis) and Tuskegee II (Lyme disease)
A study of the natural history of a disease is epidemiology. Such a study cannot be accomplished if patients receive treatment and become well. If Lyme disease patients receive treatment, the final outcome of the effects of the chronic disease cannot be studied. Through establishment of the present fraudulent disease parameters (treatment guidelines), free reign has been granted for the U.S. Public Health Service/CDC Epidemic Intelligence Service (EIS) to monitor long-term effects - the natural history -- of untreated Lyme disease.
This is a sophisticated method of continuing and expanding the Tuskegee
Experiment (Part II), using the medical system as a whole. The disease
parameters designed by the NIH, CDC and IDSA, through the IDSA Practice
Guidelines for Lyme Disease, allow this vast epidemiological study to be
carried forth without accountability for safety in bioethical human
experimentation. USPHS/CDC EIS member, Dr. Allen
Steere, withheld antibiotic treatment for years from
children while he conducted a study of the "natural history" of Lyme
arthritis. (http://xa.yimg.com/kq/groups/15466188/1455360058/name/1.pdf
) Yet, he still gets millions in government grants, capitalizing on studying
a complex disease he trivializes when it comes to treatment.
Summary of Lyme Pandemic
Lyme Borreliosis is a pandemic of misinformation, misdiagnosis and misery for Lyme patients and their treating physicians. Yet, the same CDC "experts," who have been wrong from the beginning, are still running the show and calling the shots. These CDC spokespersons have created a nightmare of disease and suffering for patients. If you count the numbers of people who have been diagnosed with Multiple sclerosis, rheumatoid arthritis, fibromyalgia, chronic fatigue, lupus, Crohn's disease, autism, ALS, Parkinson's and Alzheimer's, realizing that the majority of people suffering with diagnosed chronic Lyme infection were first misdiagnosed with these other diseases, there is high probability that many suffering with these other diseases may actually be infected with Borrelia bacteria as the cause of these disease manifestations.
It is an ambitious marketing effort assisted by drug and insurance company consultants who, as so-called independent scientists, publish cherry-picked research in journals such as the New England Journal of Medicine. This group of consultants is known as the Steere-Camp (after Dr. Allen Steere) aka the Lyme Medical Cartel. The goal of these crypto-lobbyists is to generate an artificial demand for pharmaceutical products (which they and their employers may hold patents on). This is accomplished through creating a man-made, expanding pandemic based on misinformation about the contagious nature of a disabling and deadly disease, which is listed as a Level II biowarfare agent.
IDSA Guideline author, Mark Klempner, M.D., also authored what is known as the Klempner Study funded by NIH, which is used to rationalize the non-treatment of Lyme patients. Klempner was an editor for the New England Journal of Medicine, the journal that published his "Tuskegee Study," which discredits the long-term treatment of Lyme disease with antibiotics. It is noteworthy that his research was halted before long-term treatment could even be administered. Yet, NIH, CDC and IDSA use Klempner's study as the gold standard of "evidence-based medicine," which Lyme victims bear the brunt of. Remarkably, after Mark Klempner completed the "definitive treatment study" that ended all further NIH/CDC-funded Lyme treatment studies, he was positioned as Director of a biowarfare lab in Boston, Massachussetts.
Klempner had previously published researched demonstrating the fact that Borrelia burgdorferi persists in fibroblasts after antibiotic treatment. The NIH-funded Klempner study not only contradicts Klempner's own research, but also contradicts treatment recommendations of other persistent bacteria as well. U.S. Department of Health and Human Services/CDC publication Questions and Answers about TB states the following:
"If you have TB disease, you will need to take several different drugs. This is because there are many bacteria to be killed. Taking several drugs will do a better job of killing all of the bacteria and preventing them from becoming resistant to the drugs."
NIH, CDC and IDSA Guidelines recommend against using combination therapy for Lyme disease and "sell" this negligent recommendation on the opposite basis that long-term antibiotic therapy (only in the case of Lyme disease) causes antibiotic resistance. Again from the same publication:
"TB bacteria die very slowly. It takes at least 6 months for the medicine to kill all the TB bacteria. You will probably start feeling well after only a few weeks of treatment. But beware! The TB bacteria are still alive in your body. You must continue to take your medicine until all the TB bacteria are dead, even though you may feel better and have no more symptoms of TB disease.
If you don't continue taking your medicine after you feel better or you aren't taking your medicine regularly, this can be very dangerous. The TB bacteria will grow again and you will remain sick for a longer time. The bacteria may also become resistant to the drugs you are taking. You may need new, different drugs to kill the TB bacteria if the old drugs no longer work. These new drugs must be taken for a longer time and usually have more serious side effects. When TB patients do not take their medicine as prescribed, the TB bacteria may become resistant to a certain drug. This means that the drug can no longer kill the bacteria."
Compare the recommendations made by these "highly-esteemed" government agencies:
Professor Garth Nicolson, Ph.D., a microbiologist, stated in an In Short Order radio interview that he found the antibiotic resistance argument to be "particularly lame." He also admitted that by administering only short-term antibiotics as treatment for Lyme disease, the government is, in fact, creating antibiotic-resistant germs under the pretext of not creating them.
The Lyme Cartel experts perpetuate the pandemic while appearing to treat it with deliberately-designed, ineffective treatment guidelines. Thus far, these charlatans have been successful in creating a fraudulent science-base (the Klempner study), as an intellectual justification for perpetuating the ineffective IDSA Practice Guidelines. This aids in limiting the number of doctors capable of administering effective treatments to halt the pandemic and also serves to emphasize the profitable treatment of symptoms, in lieu of curing the disease at its source.
Previous articles published in medical journals by these lobbyists proved the persistence of the organism despite antibiotic treatment. Recent contradictory articles published by these drug and insurance company consultants deny the persistent, pervasive and pleomorphic nature of the extraordinarily complex Borrelia organism. The articles also deny the plurality of devastating manifestations, which often result due to the deliberately-designed, ineffective treatment regimens recommended by NIH, CDC and IDSA. They previously referred to the disease in their research as "chronic Lyme disease." Now, they have the audacity to claim that chronic Lyme infection does not exist, and they refer to persistent symptoms as PLS (Post Lyme Syndrome) or MUS (Medically Unexplained Symptoms).
It is the Cartel's numerous connections to symptoms-proliferation interests, rather than an interest in eliminating the infectious etiology of the disease, that defines its ideology. This is why the Steere-Camp is so at odds with the component of the scientific community concerned with symptom-elimination. The symptom-elimination professionals are a threat to the profits of the symptom-proliferation industries that fund and publish the so-called research of the Steere-Camp Lyme Medical Cartel.
Following are additional conflicts of interest of members of the Lyme Medical Cartel who authored the New England Journal of Medicine article entitled A Critical Appraisal of "Chronic" Lyme Disease.
Dr. Henry Feder reports receiving lecture fees from Merck and serving as an expert witness in medical-malpractice cases related to Lyme disease.
Dr. Barbara Johnson of the CDC reports holding patents on diagnostic antigens for Lyme disease.
Dr. Susan O�Connell reports serving as an expert witness related to Lyme disease issues in civil and criminal cases in England.
Dr. Eugene Shapiro reports serving as an expert witness in medical-malpractice cases related to Lyme disease, reviewing claims of disability related to Lyme disease for Metropolitan Life Insurance Company, and receiving speaker's fees from Merck and Sanofi-Aventis.
Dr. Allen Steere reports receiving a research grant from Viramed and fees from Novartis.
Dr. Gary Wormser reports receiving research grants related to Lyme disease from Immunetics, Bio-Rad, and biopeptides and education grants from Merck and AstraZeneca to New York Medical College for visiting lecturers for infectious-disease grand rounds, being part owner of Diaspex (a company that is now inactive with no products or services), owning equity in Abbott, serving as an expert witness in a medical-malpractice case, and being retained in other medical-malpractice cases involving Lyme disease. He may become a consultant to Biopeptides. No other potential conflict of interest relevant to this article was reported.
If one "Follows the Money Trail," it is clear that medical corruption and collusion is why Lyme disease patients are suffering and pleading for help.
Jerry Leonard and Tina Garcia urge recognition of this deplorable situation by prominent, responsible journalists and government investigators who have the courage and the means to bring this dark chapter of medical history into the light of day. They also ask what mechanisms were put in place during the governmental investigation of the Tuskegee Phase I program to report the ongoing and expanding "Phase II" part of the program.
Post Script:
A
Doctor Gets Lyme Disease and Stumbles Upon
The CDC's Tuskegee Experiment, Part II
The fact that Epidemic Intelligence Service member, Dr. Allen
Steere, values the study of the �natural
history� of Lyme disease more than treatment for patients is evident in the
following account from a physician who contracted Lyme infection on Shelter
Island in the 1970's.
"Here is my story with Dr. Steere. It was the mid-1970's and Lyme Disease was not a household word. ... I rented a summer cottage on Shelter Island, on the Eastern End of Long Island. An idyllic place. It was strange to note that several of the locals had facial palsy - nice people all, but it was a great summer. There was a pond, many deer...
One day, I happened to notice that I had a bright red mark on my forearm. A VERY bright red mark. It was a little hot, otherwise unremarkable, but odd because of its brightness. I ignored it. The next day it was still there. A day later, it was bigger. Over subsequent days, the "mark" became a coin shaped lesion, then bigger but oblong, and bigger and bigger and bigger. At some point I went to a local gp in New York who - like me - had no idea what was wrong. "Let's watch it," he said. The rash kept growing. It became larger than a silver dollar. And hot. Along with this, I was now really ill. I had fatigue, restlessness, malaise, and flu-like symptoms. Something was clearly wrong but I had no idea what!
That weekend, I was back on Shelter Island, on my wonderful porch, reading the local freebie paper. A tiny article caught my attention about a "new disease" discovered on Shelter Island. It was tick borne. THEN I REMEMBERED. The time, before the rash, back in New York City after a weekend on Shelter Island, when I awoke in the middle of the night with a stinging pain in my arm, and went into the bathroom, not clear what was wrong. There was nothing, no something small. A magnifying lens did the trick - a small tick!! Ugghh!! I removed it with Vaseline and tweezers, went back to bed, and promptly forgot the whole incident. But the red spot came precisely where the tick had bitten me.
So I went back to Cornell (my old medical school) and visited my old (real old - Professor Emeritus) parasitology teacher - the distinguished Dr. Ben Keen. Is this a Lyme tick bite? I will never forget his wizened smile as he raised his arm in triumph and pride!! "Congratulations, young man," he said - "You have made the correct diagnosis." What to do? Without hesitation, he told me that THE place to go to was Yale, where there was a doctor Steere who was THE expert in this emerging illness. He would help me as much as anyone could. This was the place to go.
But first I went to the library and read everything I could about Lyme. I did not like what I read. The facial palsy association, for example, was already there, but little about treatment or prognosis. No one knew!! However, it was known the causative organism was a spirochete - fine, I thought, syphilis. This upset me because I knew how hard syphilis was to treat - you thought you eliminated it and you didn't - it could come back, much worse, years later. And worse, come back not as the rash, or initial lesion, but come back anywhere - as brain disease, joint disease, and more and more and more. "Well," I thought, "like syphilis", so there ARE medications that treat syphilis - these must be the same medications to take -"but I bet you gotta blast it, like syphilis," "and your first shot is your best shot, like syphilis - you gotta blast it to smithereens so it doesn't come back and 'blast' you."
Off I went to Dr. Steere. He agreed to see me quickly, he was professional, busy, not particularly friendly. But he exuded all of the airs that one might expect from an international authority from Yale. The diagnosis was easily made. But he told me there was no treatment. It looked like syphilis but the antibiotics that I wanted to take were ineffective. They would not work. He would not give them to me, despite my requests. They were completely useless - he had studied this, had all the data, all the reports, and nothing good ever came from antibiotics in the case of Lyme. Even though there was this "family resemblance" to syphilis - even though a spirochete was causing the problem, this particular spirochete did not respond to medication. The only thing to do was join his clinic as a patient and have him follow me. They were studying Lyme, they would eventually have a treatment. There were some tantalizing leads concerning immunity and some possible things to do in that way. He could treat me with what they developed as they developed it. I was to see him from time to time and in time....For the present, nothing. Dr. Steere was adamant that this was the ONLY way to go. No treatment for now. I was stunned. But I trusted Dr. Steere, and Yale, and the powerful expertise regarding Lyme that he had assembled.
I had been EAGER to treat this "bug" with a "bug" medicine. But I was a doctor and I had learned to be a "good patient." You do what your doctor tells you. And he was the best in the world!! So quite miserably, but confident that I was doing all that I could, I got on the train and went home.
And I got sicker and sicker and sicker. Days passed, and more and more. The rash got larger and larger and larger. Finally it circled completely around my arm like a band-bracelet with one end overlapping the other. And I was incapacitated. Calls to Steere were unhelpful - just wait it out, he said, we are studying this.
So, finally, I did what I had never thought that I would do - I got some antibiotics and treated myself. I really blasted myself. I felt very bad about doing this (and very fortunate that as a doctor, I could actually get antibiotics.). VERY, VERY quickly - very soon after I took these pills - the rash started to break up!! It got blotchy and weaker. It stopped growing. The next day blotchier still. Like a miracle!! And I started to feel better, for the first time since this started. Much better.
Gleefully, I called Dr. Steere. Antibiotics helped after all!! I wanted to rush over to his clinic, show him the improvement in progress, have him follow this, have him test me, and have him offer this to others. I will never forget our phone conversation. First of all, he was obviously irritated that I had done this. His voice was strained and very, very cold. I had messed things up by doing this! He told me that the strong temporal association between my taking antibiotics and my dramatic improvement could have been a coincidence!! (There is no doubt that there was a VERY tight temporal relationship and remarkable rapidity of relief following medication -- After weeks - more than a month - of unrelenting misery.) He had heard of other such stories and such "cures", but he would not accept them - the placebo response, suggestibility, it was going away anyway, etc., etc. So I asked him why he had not told me earlier on that he "had heard of such cures". I had plainly, and repeatedly asked him about antibiotics and the very antibiotic class that I had taken - the one for spirochetes. And he had simply told me - with clear finality - that they just did not work. I asked him for medication and he told me it NEVER worked. He didn't tell me about these other cases. And now he was quite clear - what happened to me - and what happened to others like me - had nothing to do with medical science. Only data from clinical trials with placebo controls prove anything, and he was saving me for such a trial. In fact, what I did merely undermined his science!! My personal experience had no scientific value or clinical value. In fact, it was a bad thing. I should stop doing what I was doing immediately.
I was stunned. There was something very wrong with what this man was doing. He wouldn't even see me. He wouldn't even look at my arm or my blood as a natural work-in-progress. Further calls to him and his group clarified what he was doing and where he was coming from. He was a "scientist". He wanted me and the other "clinical material" to be pure for his "clinical experiments." The hell with patients as people - clinical reality and people's lives in the here and now. He was studying immunity in Lyme - (or some such thing) - the crusade was the thing - the science, and not his present patient's daily needs. I accused him of this and he (I suppose naturally) got colder and more distant. There was nothing left to say. So I "fired" him. He had felt that he was doing the clinical science. He wouldn't even see me as a "work-in-progress." Clearly there was room here - with disclosure about limitations - for an "open labeled clinical trial" (give some other people like me the same antibiotic that I and others had taken, and study what was happening). But he was saving us for bigger, more impressive studies. He didn't tell me what he knew, even in response to my direct questioning, and he was doing the same to his other patients (his other "clinical material"). Our being sacrificed for others would be worth it - in his mind - our own needs and beliefs be damned. Talk about arrogance and playing God!!
"Alan", I had said (of course I am paraphrasing - over 20 years have passed - but like the Kennedy assassination, these horrible moments are burned into your brain with remarkable accuracy seemingly forever). "This antibiotic saved me from great misery and from God knows what horror in the future." The response to the medication was totally dramatic - the temporal sequence of what happened before my trial and afterwards - cure locked in step with treatment. I CERTAINLY WAS A BELIEVER IN WHAT HAPPENED TO ME. I, WHO LIVED THIS, WAS CONVINCED!! So why not at least present some patients with my syndrome with an open labeled trial of medication..........But I was clearly wasting my time.
And within a few days, it was all gone. The rash and all the symptoms. And I felt fine for the first time since this all started. I FELT FINE!! Were there sequelae? Clinically, I don't think so. But with an insidious spirochete you never know. Is this aging or Lyme. This I live with but this is life. Years after the incident with Steere, the medication that I had taken was the standard treatment. At doses even higher than the ones I gave myself, so I got a titer, had high levels, and took a (then) standard treatment. And so it goes.
I think I became a better doctor. I think that I listen to patients more than I might have. I understand why the classic healers of Greek mythology - Aesclepius and Chiron - were ill themselves. Also, I have published an uncontrolled clinical trial myself, and I strongly endorse them. I have written about the value of the "single case study." So much in medical science has come from single case studies but there is a bias against this and in favor of large, double-blind placebo controlled studies. Of course they have their place, but they have drastic limits also (there are numerous papers in the scientific literature that describe the limits of these types of studies - but many, many academic leaders have blinders here and treat the "double-blind placebo controlled study - rather mindlessly - like a sort of 'Holy Grail.') I try to fight this mindlessness - that is part of why I founded AAPP. However, fighting the establishment on these issues is kind of like fighting the wind....
After all these years - and the fact that I avoided major tragedy by taking action myself - I still despise Alan Steere...He lied to me - he held back information - that antibiotics had helped others - information that HE didn't think was important enough but to me, the patient, what could be more important!! The b______ was playing GOD with my life, and he was treating me like a child - I did not have the judgment to make up my own mind - he would do it for me. Also, he was deceiving himself - he thought that he was doing it correctly. He was saving me - in an untreated state - for his studies. The studies took priority over the "material" (human beings) who were being studied. I suppose that he felt that this was justified because knowledge gained could help much larger numbers of human beings. But if he felt this was justified - and I am merely surmising - who knows how he felt, or if he even can feel at all - he was wrong, tragically wrong, and he was deluding himself. His own career had too much to gain - and his patients too much to lose - for him to think that he could be objective in such a belief. I did call him once ( when I was taking my second course of medications - the very ones he had denigrated and now they were the standard treatment - but he had nothing to say - other than something such as "we didn't have the data then". The man clearly has no people skills....The problem is the ethics and the view of science and the way researchers are rewarded....I hope and pray that other patients have a better experience with Dr. Steere and his 'colleagues' than I did."
http://www.actionlyme.org/AAPP_STEERE.htm
Jerry Leonard is a Lyme disease patient and author. He has written three books on unethical medical experiments conducted by the government -- including experiments involving injecting tumor cells and monkey cancer virus in humans so that model forms of cancer could be induced and maintained in human subjects for pharmaceuticals research. Jerry's books are available at Amazon.com. Contact Jerry at jerryleonard999@yahoo.com.
Tina J. Garcia is a Lyme disease patient and advocate who founded Lyme Education Awareness Program at www.leaparizona.com. Tina is a freelance writer, author and Patient Life Coach at www.kaleidoscopehealth.net. Contact Tina at tinajgarcia@yahoo.com.