Comparative Effectiveness: Is it the patient's friend, or a "rationing" wolf in sheep's clothing?

By: Richard G. Fessler, MD, PhD

Comparative effectiveness research is that research which is intended to compare the relative “effectiveness” of different treatments which are intended to treat the same disease or health related problem. Ignoring, for the moment, the fact that no disease proceeds exactly the same way (nor responds to treatment exactly the same way) in every patient, there is inherent logic in performing comparative effective research. In my own practice of spinal surgery, for example, I constantly develop and compare new, less invasive surgical techniques to older, more traditional ones. When the new techniques achieve better results, or equivalent results with fewer complications, shorter hospital stay, or less pain, etc, the older techniques are abandoned in favor of the new ones. That is comparative effectiveness as it should be applied. Another example is the results of the recently published “SPORT” trial. This NIH supported research compared the effectiveness of specific spinal surgery procedures to non-surgical treatment.¹ These three “comparative” studies (for lumbar herniated disc disease, lumbar stenosis, and fusion for spondylolisthesis) showed an overwhelmingly beneficial effect of surgery compared to non-surgical treatment, and convincingly refuted a media “blitz” attempting to discredit the benefits of surgery and deny access to surgery for appropriate patients. Keep in mind, however, that these three studies alone cost over 11 million dollars.

So, if this type of comparative effectiveness research can, in fact, help determine which treatments are more effective, what’s wrong with it? In short, there is absolutely nothing wrong with the research itself, except that, as shown above, it is extremely expensive. Comparative effectiveness research, in fact, has been the model for medical research for decades. The problem comes in the “politicization” of the process. When the direction, interpretation, and application of the research is taken away from the physician/scientist (for whom the benefit of the patient is the primary and only criteria) and transferred to organizations (such as the government) for whom motivations may be different, “comparative” effectiveness research (and decisions) often becomes “cost” effectiveness research (and decisions)! In that transition, the benefit to the individual patient is sacrificed to a calculated cost/benefit ratio for society as a whole and/or the body governing that society. Health care access decisions based on “comparative effectiveness” thus, become a mechanism of rationing health care based on cost. As detailed below, this change impacts not only the individual patient, but the overall “quality” of medical care available as well. Moreover, as specific treatments become institutionalized, research into new treatments slows to a crawl or stops altogether. Thus, the long-term impact of such institutionalized comparative effectiveness on the quality of health care available is compounded over time!

This discussion is particularly important to the American public RIGHT NOW. President Obama has proposed the creation of an “Institute of Comparative Effectiveness” (ICE) as a key component of his health care reform agenda.² This institute would have the authority to determine the clinical and cost effectiveness (and thus, accessibility) of specific medical treatments, procedures, drugs, and devices to the American patient. The recommendations of your physician, and your personal health care decisions, would be irrelevant to the care you were actually able to receive! In that the committee appointed by the president to formulate his health care reform policy contains NO practicing physicians, consider the implications this ICE might have on access to state of the art health care. Frankly, the prospect is chilling! According to Helen Evans:

“Such an approach … would guarantee the incremental advance of government control of private medical decisions. While formally touted as an instrument of efficiency and effectiveness, it would distort scientific research in the service of political or budgetary objectives while denying individual freedom of choice. In that sense, this approach would serve as a propaganda tool designed to legitimize anti-consumerist rationing.”³

The “ICE” is roughly modeled on a similar body in the United Kingdom called NICE (National Institute of Health and Clinical Excellence). A major portion of NICE is the “Centre for Health Technology Evaluation”, an organization which issues formal guidance on the use of new and existing drugs and devices. NICE has been controversial since its inception in 1999, being the object of severe criticism particularly from consumer groups. Why? NICE has consistently denied patient access to state of the art drugs to treat many common diseases such as breast cancer (Herceptin), Alzheimer’s disease (Aricept), and Multiple Sclerosis (beta-Interferon), to name only a few. Moreover, the criteria used by NICE to make these access decisions have largely been kept secret from the public. Interestingly, according to The Daily Mail, the money that NICE spends on communicating its decisions to the public exceeds the money it would have spent if it had allowed access to the same medicines!⁴ NICE is an example of a government run program which has failed. It has failed because in the interest of “cost containment” it has denied appropriate treatment to its citizens. Other models have been similarly unsuccessful in Germany, France, Switzerland, and Denmark.³ Overall, the National Health Service of the UK used approximately 1/10 of the amount of newly marketed drugs compared to France. What does this mean for the health of UK patients? For example, whereas the survival rate for newly diagnosed cancer in Sweden is 60.3 % for men and 61.7 % for women, in Great Briton it ranges from 40.2-48.1 % for men and 48-54.1 % for women. Medical rationing (i.e. utilization based on government initiated and controlled “comparative effectiveness” decisions), means: 1) denial of access to new medicines and treatments, and 2) decreased incentives for research to develop new treatments, and 3) for cancer, at least, a much higher death rate. Multiple countries have already demonstrated these results. There is little question that the trend will be IF repeated this type of cost-effective rationing is instituted in the United States. The end result is that American citizens/patients will see a significant decrease in access to care and to the quality of the care they receive.

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