Wednesday, April 15, 2009


David Vladeck to FTC

When Dan Troy left his role as FDA Chief Counsel in 2004, he had only a few comments to the press. One was his reflection, "We won," referring the the 2004 Bush reelection and perhaps more.

Troy continued to impact matters FDA and the superstructure of rule-making--the 2006 preamble, the CBE changes, etc.--all of which were to be part of the yellow brick road to preemption.

Of course, as it turned out, the road was a house of cards. It was whisked away as "meritless" in the Levine majority and essentially ignored in the dissent. It turned out that nothing was won after all, at least not on that front.

So, with relevant perspective, we can celebrate a bit here after learning of the appointment of David Vladeck to FTC. (Hat tip to Pharmalot in exile and various links along the line). Most here will know Vladeck through his writings against preemption that, it turns out, were cited at significant points in the majority opinion in Levine.

So there are still battles to fight: Device preemption as represented by the Riegel decision; Michigan's odious shield law which is on another legal planet even relative to the dissent in Levine. But there should always be a moment when we can kick back, check in on a link,

open a brewsky, and say--with relevant satisfaction--"We won."

And they didn't.


  1. Open Letter for Readers of Pharmalittle
    [sent to Department of HHS - FCC on 4/13/2009]

    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 Evidence 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 lifelong, 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
    [i.e., how various treatments harm the diseased organ] and allostatic load
    [i.e., 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 authoritianism 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

    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).


    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.


    Grace E. Jackson, MD
    1201 Clipper Lane
    Wilmington NC 28405

  2. GEJ--Terrific post, which belongs as much under the comparative efficacy thread as this one. Thank you.

  3. Grace Jackson's letter is brilliant.

    We've made a permanent link to Dr. Jackson's letter at our own web site:

    We hope other web sites will do the same!

  4. Dear Dr. Jackson,

    I am very happy you found Pharmalittle. Thank you for your post. I agree with every word. It seems that the rules are working against us, not for us. I have been working with several groups to bring awareness of the dangers of our healthcare and the erosion of our civil rights under such odious policies as FDA Preemption and Michigan’s Drug Immunity Law.

    As a Michigan resident, I found out the hard way that we have no legal recourse when harmed by a FDA approved drug. Most people in our state do not know that the drug industry was granted full immunity from product liability 14 years ago. Our media seems to be suffering from lock jaw.

    Please keep up the good fight and help spread the word about Michigan. Thank you.


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