What Healthcare Reform “Comparative Effectiveness Research” Means to You

By: Jane M. Orient, M.D., 

A key selling point in “healthcare reform” is a new kind of research—a kind that will supposedly make medicine more efficient and less costly, unlike the old kind of research that brought us medical miracles. 

You should care about it, because you will be a subject (or “guinea pig” as some prefer to say), without your consent. And of course you will be paying for it, at a time when so many Americans can’t pay their rent. 

A mere one billion dollars may not sound like much, if you focus on the one rather than the 9 zeroes, but it would buy a $10,000 car (or insurance policy) for 100,000 people. And Comparative Effectiveness Research (CER) won’t buy anything for you; it will just pay bureaucrats and researchers. 

Then there’s the $15 billion (a car for 1.5 million people) to bribe physicians to buy computer systems costing around $50,000 for a start. That’s to keep track of all the information from every doctor visit to feed into the CER and other government and third-party surveillance systems. Unlike your naked image on an airport scanner, which is not supposed to be saved, your medical secrets will stay in the system forever. 

If your doctor likes electronic records, he probably already uses them, and he almost certainly already has a computer. He doesn’t need you the taxpayer to buy him a new one that costs 50 times as much as yours did. The government-approved system may (probably will) slow the doctor down, but there is no evidence that it will make him a better doctor, or improve your treatment. 

A doctor who takes care of you personally, rather than the “System,” can keep track of your medicines confidentially on a paper flow sheet. If he uses paper prescriptions, a pharmacy might have to call him once a month because of an illegible word. Users of e-prescribing often report a huge increase in the error rate. 

No matter. CER is about getting your data. So what will the “researchers” do with all your data? 

One thing they will NOT do with it is discover new treatments. No such claim is even made for CER. 

CER will just compare already existing treatments and determine their “effectiveness,” which has a lot to do with cost-effectiveness. In any event, they define effectiveness; you don’t. If a treatment doesn’t make you well enough to work and pay taxes, even though it enables you to get out of bed without pain, it might be considered ineffective. If a cancer treatment cures a few but on average prolongs life only by a few months, then it probably won’t make the CER cut. 

Remember that childhood leukemia used to be incurable. The early treatments were not very effective, but based on what we learned from trying them, many children are now cured. 

Even the strongest advocates for medical Comparative Effectiveness Research (CER) don’t talk about curing cancer or heart failure, or controlling rheumatoid arthritis, or slowing the progress of Alzheimer’s. They talk about saving money for the System, or increasing the percentage of patients with a blood pressure or cholesterol reading that they consider acceptable. They are not even focused on whether treatment X, Y, or Z is best for you. CER compares the cost-effectiveness of joint replacements for old people with social worker home visits for newborns. Should they spend your money on treatment X for population A, or on treatment Y for population B? 

One expert who rather likes CER cited the Oregon plan as a good example. A purportedly scientific method was used to make a list of some 400 procedures in order of priority, with the idea that managers would draw a line somewhere on the list when Medicaid money ran out. The more “effective” procedures would be paid for; those under the line would not be. Treatment for your kidney stone might not be paid for, while the money was used for contraceptives, smoking cessation counseling, or screening of basically healthy people. 

CER is not about helping you; it is about the System. You contribute data; it classifies you and determines your eligibility for whatever the System decides to offer. It is not exactly a death panel. But the ultimate result is preventable death, pain, or disability for some, while the managers, purveyors of “preferred” preventive drugs, vendors of “health information technology,” and researchers still get paid off the top.


Jane M. Orient, M.D., On Air contributor speaking on Healthcare Reform. Dr. Orient has appeared on NBC, MSNBC, ABC and many major broadcast venues throughout the US, as well and her Op-eds have been printed in hundreds of local and international newspapers, magazines and followed on major blogs. 

Dr. Orient is the Executive Director of the Association of American Physicians and Surgeons. She has been in solo practice of general internal medicine since 1981 and is a clinical lecturer in medicine at the University of Arizona College of Medicine. She received her undergraduate degrees in chemistry and mathematics from the University of Arizona, and her M.D. from Columbia University College of Physicians and Surgeons. She is the author of Sapira’s Art and Science of Bedside Diagnosis; the fourth edition has just been published by Lippincott, Williams & Wilkins. She also authored YOUR Doctor Is Not In: Healthy Skepticism about National Health Care, published by Crown. She is the executive director of the Association of American Physicians and Surgeons, a voice for patients’ and physicians’ independence since 1943. Complete curriculum vitae posted at www.drjaneorient.com.

9 thoughts on “What Healthcare Reform “Comparative Effectiveness Research” Means to You

  1. CER-more left wing magical utopian 1930′s thinking just like ‘medical home’ and so many other euphemisms for centralization and ultimate death of the host!

  2. I guess we, the patients, could try going to different doctors each time and giving false info. This should put a slight glitch in their system. They probably wouldn’t care to try to correct it anyway. It would be like this years census. I told a census worker that I and several other people had not received a census form or been contacted by a census. He said not to worry that they would get to us. I also informed a city hall office employee that we were not counted. They didn’t know what to do.
    My point being, this is just another example of harmful, wasteful spending of our tax dollars. We have got to do something about our government overstepping its powers.

  3. Comparative effectiveness research is meant to convince Americans that bean counters know more about medical efficiency than doctors and patients. The way I describe it is: If you have a 2009 BMW and a 1972 Vega, and both need a new transmission, which one would your accountant advise you to replace? Now, let your accountant make the decision between saving your mother, or paying for 1,000 immunizations” Enough said.

  4. GIGO dooms it.
    Garbage input by physicians who won’t betray patient privacy
    Dooms this tool of tyranny.

  5. Beautifully written. There is one sizable glitch in the basic premise of CER. They are gathering data using a system of computer care with equipment of unproven benefit tht itself needs to undergo CER. This is sort of a Ponzi scheme of research.

  6. Subject: Informed consent must be obtained for you to do research on Americans! The Belmont Report!

    C. Applications

    Applications of the general principles to the conduct of research leads to consideration of the following requirements: informed consent, risk/benefit assessment, and the selection of subjects of research.

    1. Informed Consent. — Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied.

    While the importance of informed consent is unquestioned, controversy prevails over the nature and possibility of an informed consent. Nonetheless, there is widespread agreement that the consent process can be analyzed as containing three elements: information, comprehension and voluntariness.

    Information. Most codes of research establish specific items for disclosure intended to assure that subjects are given sufficient information. These items generally include: the research procedure, their purposes, risks and anticipated benefits, alternative procedures (where therapy is involved), and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research. Additional items have been proposed, including how subjects are selected, the person responsible for the research, etc.

    However, a simple listing of items does not answer the question of what the standard should be for judging how much and what sort of information should be provided. One standard frequently invoked in medical practice, namely the information commonly provided by practitioners in the field or in the locale, is inadequate since research takes place precisely when a common understanding does not exist. Another standard, currently popular in malpractice law, requires the practitioner to reveal the information that reasonable persons would wish to know in order to make a decision regarding their care. This, too, seems insufficient since the research subject, being in essence a volunteer, may wish to know considerably more about risks gratuitously undertaken than do patients who deliver themselves into the hand of a clinician for needed care. It may be that a standard of “the reasonable volunteer” should be proposed: the extent and nature of information should be such that persons, knowing that the procedure is neither necessary for their care nor perhaps fully understood, can decide whether they wish to participate in the furthering of knowledge. Even when some direct benefit to them is anticipated, the subjects should understand clearly the range of risk and the voluntary nature of participation.

    A special problem of consent arises where informing subjects of some pertinent aspect of the research is likely to impair the validity of the research. In many cases, it is sufficient to indicate to subjects that they are being invited to participate in research of which some features will not be revealed until the research is concluded. In all cases of research involving incomplete disclosure, such research is justified only if it is clear that (1) incomplete disclosure is truly necessary to accomplish the goals of the research, (2) there are no undisclosed risks to subjects that are more than minimal, and (3) there is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them. Information about risks should never be withheld for the purpose of eliciting the cooperation of subjects, and truthful answers should always be given to direct questions about the research. Care should be taken to distinguish cases in which disclosure would destroy or invalidate the research from cases in which disclosure would simply inconvenience the investigator.

    Comprehension. The manner and context in which information is conveyed is as important as the information itself. For example, presenting information in a disorganized and rapid fashion, allowing too little time for consideration or curtailing opportunities for questioning, all may adversely affect a subject’s ability to make an informed choice.

    Because the subject’s ability to understand is a function of intelligence, rationality, maturity and language, it is necessary to adapt the presentation of the information to the subject’s capacities. Investigators are responsible for ascertaining that the subject has comprehended the information. While there is always an obligation to ascertain that the information about risk to subjects is complete and adequately comprehended, when the risks are more serious, that obligation increases. On occasion, it may be suitable to give some oral or written tests of comprehension.

    Special provision may need to be made when comprehension is severely limited — for example, by conditions of immaturity or mental disability. Each class of subjects that one might consider as incompetent (e.g., infants and young children, mentally disable patients, the terminally ill and the comatose) should be considered on its own terms. Even for these persons, however, respect requires giving them the opportunity to choose to the extent they are able, whether or not to participate in research. The objections of these subjects to involvement should be honored, unless the research entails providing them a therapy unavailable elsewhere. Respect for persons also requires seeking the permission of other parties in order to protect the subjects from harm. Such persons are thus respected both by acknowledging their own wishes and by the use of third parties to protect them from harm.

    The third parties chosen should be those who are most likely to understand the incompetent subject’s situation and to act in that person’s best interest. The person authorized to act on behalf of the subject should be given an opportunity to observe the research as it proceeds in order to be able to withdraw the subject from the research, if such action appears in the subject’s best interest.

    Voluntariness. An agreement to participate in research constitutes a valid consent only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence. Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence, by contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable.

    Unjustifiable pressures usually occur when persons in positions of authority or commanding influence — especially where possible sanctions are involved — urge a course of action for a subject. A continuum of such influencing factors exists, however, and it is impossible to state precisely where justifiable persuasion ends and undue influence begins. But undue influence would include actions such as manipulating a person’s choice through the controlling influence of a close relative and threatening to withdraw health services to which an individual would otherwise be entitle.

    2. Assessment of Risks and Benefits. — The assessment of risks and benefits requires a careful arrayal of relevant data, including, in some cases, alternative ways of obtaining the benefits sought in the research. Thus, the assessment presents both an opportunity and a responsibility to gather systematic and comprehensive information about proposed research. For the investigator, it is a means to examine whether the proposed research is properly designed. For a review committee, it is a method for determining whether the risks that will be presented to subjects are justified. For prospective subjects, the assessment will assist the determination whether or not to participate.

    The Nature and Scope of Risks and Benefits. The requirement that research be justified on the basis of a favorable risk/benefit assessment bears a close relation to the principle of beneficence, just as the moral requirement that informed consent be obtained is derived primarily from the principle of respect for persons. The term “risk” refers to a possibility that harm may occur. However, when expressions such as “small risk” or “high risk” are used, they usually refer (often ambiguously) both to the chance (probability) of experiencing a harm and the severity (magnitude) of the envisioned harm.

    The term “benefit” is used in the research context to refer to something of positive value related to health or welfare. Unlike, “risk,” “benefit” is not a term that expresses probabilities. Risk is properly contrasted to probability of benefits, and benefits are properly contrasted with harms rather than risks of harm. Accordingly, so-called risk/benefit assessments are concerned with the probabilities and magnitudes of possible harm and anticipated benefits. Many kinds of possible harms and benefits need to be taken into account. There are, for example, risks of psychological harm, physical harm, legal harm, social harm and economic harm and the corresponding benefits. While the most likely types of harms to research subjects are those of psychological or physical pain or injury, other possible kinds should not be overlooked.

    Risks and benefits of research may affect the individual subjects, the families of the individual subjects, and society at large (or special groups of subjects in society). Previous codes and Federal regulations have required that risks to subjects be outweighed by the sum of both the anticipated benefit to the subject, if any, and the anticipated benefit to society in the form of knowledge to be gained from the research. In balancing these different elements, the risks and benefits affecting the immediate research subject will normally carry special weight. On the other hand, interests other than those of the subject may on some occasions be sufficient by themselves to justify the risks involved in the research, so long as the subjects’ rights have been protected. Beneficence thus requires that we protect against risk of harm to subjects and also that we be concerned about the loss of the substantial benefits that might be gained from research.

    The Systematic Assessment of Risks and Benefits. It is commonly said that benefits and risks must be “balanced” and shown to be “in a favorable ratio.” The metaphorical character of these terms draws attention to the difficulty of making precise judgments. Only on rare occasions will quantitative techniques be available for the scrutiny of research protocols. However, the idea of systematic, nonarbitrary analysis of risks and benefits should be emulated insofar as possible. This ideal requires those making decisions about the justifiability of research to be thorough in the accumulation and assessment of information about all aspects of the research, and to consider alternatives systematically. This procedure renders the assessment of research more rigorous and precise, while making communication between review board members and investigators less subject to misinterpretation, misinformation and conflicting judgments. Thus, there should first be a determination of the validity of the presuppositions of the research; then the nature, probability and magnitude of risk should be distinguished with as much clarity as possible. The method of ascertaining risks should be explicit, especially where there is no alternative to the use of such vague categories as small or slight risk. It should also be determined whether an investigator’s estimates of the probability of harm or benefits are reasonable, as judged by known facts or other available studies.

    Finally, assessment of the justifiability of research should reflect at least the following considerations: (i) Brutal or inhumane treatment of human subjects is never morally justified. (ii) Risks should be reduced to those necessary to achieve the research objective. It should be determined whether it is in fact necessary to use human subjects at all. Risk can perhaps never be entirely eliminated, but it can often be reduced by careful attention to alternative procedures. (iii) When research involves significant risk of serious impairment, review committees should be extraordinarily insistent on the justification of the risk (looking usually to the likelihood of benefit to the subject — or, in some rare cases, to the manifest voluntariness of the participation). (iv) When vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated. A number of variables go into such judgments, including the nature and degree of risk, the condition of the particular population involved, and the nature and level of the anticipated benefits. (v) Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process.

    3. Selection of Subjects. — Just as the principle of respect for persons finds expression in the requirements for consent, and the principle of beneficence in risk/benefit assessment, the principle of justice gives rise to moral requirements that there be fair procedures and outcomes in the selection of research subjects.

    Justice is relevant to the selection of subjects of research at two levels: the social and the individual. Individual justice in the selection of subjects would require that researchers exhibit fairness: thus, they should not offer potentially beneficial research only to some patients who are in their favor or select only “undesirable” persons for risky research. Social justice requires that distinction be drawn between classes of subjects that ought, and ought not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on already burdened persons. Thus, it can be considered a matter of social justice that there is an order of preference in the selection of classes of subjects (e.g., adults before children) and that some classes of potential subjects (e.g., the institutionalized mentally infirm or prisoners) may be involved as research subjects, if at all, only on certain conditions.

    Injustice may appear in the selection of subjects, even if individual subjects are selected fairly by investigators and treated fairly in the course of research. Thus injustice arises from social, racial, sexual and cultural biases institutionalized in society. Thus, even if individual researchers are treating their research subjects fairly, and even if IRBs are taking care to assure that subjects are selected fairly within a particular institution, unjust social patterns may nevertheless appear in the overall distribution of the burdens and benefits of research. Although individual institutions or investigators may not be able to resolve a problem that is pervasive in their social setting, they can consider distributive justice in selecting research subjects.

    Some populations, especially institutionalized ones, are already burdened in many ways by their infirmities and environments. When research is proposed that involves risks and does not include a therapeutic component, other less burdened classes of persons should be called upon first to accept these risks of research, except where the research is directly related to the specific conditions of the class involved. Also, even though public funds for research may often flow in the same directions as public funds for health care, it seems unfair that populations dependent on public health care constitute a pool of preferred research subjects if more advantaged populations are likely to be the recipients of the benefits.

    One special instance of injustice results from the involvement of vulnerable subjects. Certain groups, such as racial minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as research subjects, owing to their ready availability in settings where research is conducted. Given their dependent status and their frequently compromised capacity for free consent, they should be protected against the danger of being involved in research solely for administrative convenience, or because they are easy to manipulate as a result of their illness or socioeconomic condition.

    ——————————————————————————–

    (1) Since 1945, various codes for the proper and responsible conduct of human experimentation in medical research have been adopted by different organizations. The best known of these codes are the Nuremberg Code of 1947, the Helsinki Declaration of 1964 (revised in 1975), and the 1971 Guidelines (codified into Federal Regulations in 1974) issued by the U.S. Department of Health, Education, and Welfare Codes for the conduct of social and behavioral research have also been adopted, the best known being that of the American Psychological Association, published in 1973.

    (2) Although practice usually involves interventions designed solely to enhance the well-being of a particular individual, interventions are sometimes applied to one individual for the enhancement of the well-being of another (e.g., blood donation, skin grafts, organ transplants) or an intervention may have the dual purpose of enhancing the well-being of a particular individual, and, at the same time, providing some benefit to others (e.g., vaccination, which protects both the person who is vaccinated and society generally). The fact that some forms of practice have elements other than immediate benefit to the individual receiving an intervention, however, should not confuse the general distinction between research and practice. Even when a procedure applied in practice may benefit some other person, it remains an intervention designed to enhance the well-being of a particular individual or groups of individuals; thus, it is practice and need not be reviewed as research.

    (3) Because the problems related to social experimentation may differ substantially from those of biomedical and behavioral research, the Commission specifically declines to make any policy determination regarding such research at this time. Rather, the Commission believes that the problem ought to be addressed by one of its successor bodies.

    ——————————————————————————–

  7. As long as doctors accept Medicare, the government will be involved in healthcare decisions.
    PROVE YOUR INDEPENDENCE. STOP ACCEPTING MEDICARE. CHARGE SENIORS A FEW DOLLARS FOR MEDICAL TREATMENT OR SURGERY, OR TREAT THEM FOR FREE.
    The AAPS can take the lead by becoming a Medicare/Medicaid free organization. Otherwise, “if you call the tune, you will one day pay the piper…..”

  8. “Comparative effectiveness” is just another pseudo-scientific tool for rationing. The tragedy is that physicians are often naïve enough to support it. Thank you Jane for opening their eyes.

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