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by Grace E. Jackson, M.D. April 12, 2009 Dear Federal Coordinating Council: This statement is written with respect to the allocation of money (1.1 billion dollars) from the 2009 Recovery Act fund for the purpose of achieving Comparative Effectiveness Research. Recommendation #1 Prioritize the End of Corporate Fraud Research into the comparative effectiveness of medical treatments is a laudable goal, but only if it does not repeat the same errors of the past. When, in the early 1990s, medical journals, medical schools, residency and postgraduate training curricula, and health care facilities came under the influence of Evidenced Based Medicine (or EBM), the favored treatments in American medicine came to reflect the following values and priorities: 1) symptom suppression (rather than elimination of root cause of illness) 2) short-term studies (e.g., Randomized, Placebo Controlled Trials) 3) fraudulent research designs (e.g., placebo washout/lead-in) 4) concealment of data unfavorable to the interests of the drug industry 5) academic censorship (e.g., non-disclosure and confidentiality agreements) 6) distortions in the medical literature (ghostwriting, file drawer effect) 7) treatment by consensus (rather than treatment based upon science) Each of these developments contributed to the hegemony of sham standards of care. Effectiveness Research will be meaningless if it repeats these errors of the past. Recommendation #2 Focus Upon Basic Science and Biology The current system for approving new medications and medical devices emphasizes proof of efficacy in principle, rather than proof of effectiveness in fact. This system has given rise to the introduction and widespread use of one, after another, copycat therapies based upon dubious definitions of benefit (e.g., checklists of subjective symptoms in psychiatry; measurements of "risk factors" and surrogate endpoints as substitutes for real progress in ameliorating the symptoms of chronic disease). Most critically, the past 20 years of American medicine have diverted attention away from the study of basic physiology and the mechanisms of disease. Unless and until the treatment paradigm in American medicine returns to an emphasis upon root causes of illness and disease, and upon the eradication or amelioration of those causes, the system of healthcare will continue to reflect interventions which are largely futile for patients. What might be done: 1) identify environmental sources of illness and map the epidemiology of risk factors and diseases related to same [e.g., the U.S.A. needs a national equivalent of Green Cross International] 2) re-evaluate national healthcare policy with respect to HPDP [Health Promotion / Disease Prevention] -- verify or refute high cholesterol as the necessary and sufficient cause of heart disease -- verify or refute the existence of cumulative safety thresholds for diagnostic radiology -- verify or refute the long-term harmfulness of the current immunization schedule (particularly, with respect to autoimmune dysfunction, diabetes, asthma, obesity, and neurobehavioral syndromes) -- verify or refute the long-term harmfulness of fetal ultrasound -- verify or refute the long-term hazards of fluoridation -- verify or refute the validity of Gallo's work, positing HIV as the cause of AIDS [see Nortin Hadler's books: The Last Well Person and Worried Sick] Recommendation #3 Prevent and Mitigate Iatrogenic Harm The allopathic model of medicine is failing America because authorities will not acknowledge the unnecessary harmfulness of synthetic chemicals. All of the existing training programs, textbooks, Board Certifications, and treatment algorithms emphasize the use of pharmaceuticals that are based upon short-term drug trials, and short-term studies in lab animals. Yet, human subjects (at least, in the U.S.A.) are increasingly encouraged to consume multiple medications for life. This philosophy of lifetime, prescription drug dependence ignores the scientific realities of what happens to patients under the influence of chronic medication. Unless and until health care providers, policy makers, and regulators recognize the problems of allostatic load (the body's adaptations to therapy which ultimately result in diminishing benefits or worsening disease) and prioritize the avoidance, amelioration, and/or reversal of target organ toxicity, no amount of "effectiveness research" will be meaningful. What might be done: 1) effectiveness research must involve considerations of treatment UTILITY ( Benefits and Hazards) 2) effectiveness research must include considerations of Target Organ Toxicity [e.g., how various treatments harm the diseased organ] and allostatic load [e.g., how various treatments induce changes in gene expression which may result in delayed but potentially long-lasting effects] 3) effectiveness research must include considerations of treatment effects upon the environment (e.g., xenobiotic diffusion via sewage; air pollution from hospital incinerators) and environmental effects upon treatment (proximity of treatment facilities and patients to radon, radioactive waste, Superfund or other toxic waste sites, petrochemicals, etc) Recommendation #4 Recruit the Best Treatments from Around the World The federal government gives lip service to the importance of research in the areas of complementary and alternative systems of health care. However, the U.S.A. has become a pharmaceutical oligarchy which permits no challenge or rival to allopathic medicine. No amount of effectiveness research will be meaningful unless and until the yoke of pharmaceutical authoritarianism is broken. Ideally, effectiveness research will incorporate the "best treatments" (herbs, diet and lifestyle modification, environmental modification) from around the world. Recommendation #5 Protect the Privacy of Patients and Physicians Given the pervasiveness of corporate fraud and the denigration of integrity within the American health care system -- particularly, as these have progressed in the era of Evidence Based Medicine -- patients and physicians require protection from harmful practices. Treatment facilities, insurance companies, and State Medical Boards mandate compliance with a corporately shaped, corporately biased Group Think. Clinicians have lost the right to practice medicine by using their best clinical judgment, informed by an understanding of basic science, direct observation, and the consideration of the unique circumstances of each and every patient. It is extremely unlikely that America's pharmaceutical oligarchy will ever be displaced or transformed into the kind of system which serves mankind, rather than profit and power. This being so, the results of effectiveness research must not be allowed to infringe or violate the privacy of patients, nor the rights of clinicians who desire the freedom to honor the ethical principles of patient autonomy, physician beneficence, and physician non-maleficence. What might be done: 1) patients and providers must be allowed to opt out of electronic medical records system, health care registries, and other databases where biological and social information can -- and most likely will -- be used to ration health care, restrict employment or travel, or reduce entitlements 2) patients must be protected from medical tyranny (i.e., medical blackmail --- the allocation of therapies or benefits based upon compliance with dubious and potentially harmful treatments) 3) health care providers must be protected from medical tyranny (i.e., medical blackmail in the form of Pay-for-Performance programs, "Consensus" Statements, Sham Peer Review/Disruptive Physician proceedings, etc). Summary Effectiveness research is a laudable goal, but only if it is conducted in a way which avoids the tragic errors of the past (i.e., the corporate medical fraud which has gained traction under the influence of EBM, the Daubert decision of 1993, the Prescription Drug User Fee Act, the Bayh-Dole Act, Direct-to-Consumer Advertising, etc), and only if it anticipates new challenges of the future. Particularly in the context of emerging technologies (brain mapping, gene mapping, high-speed information exchange), there will be ever more opportunities for the leaders of allopathic medicine -- and for the leaders in government -- to enslave, rather than to serve, the providers and consumers of health care. Ultimately, effective health care must also be ethical health care. This will require a return of integrity in the conduct of American medical research. It will also require a health care system which prioritizes the delivery of services that are consistent with fundamental human rights, and with the human species' duty to protect (rather than to plunder) the planet's biosphere. Thank you for the opportunity to contribute these ideas and opinions. Respectfully, Grace E. Jackson, MD Wilmington NC 28405 |