Science Fairs Come to Medicine April 14, 2009
Posted by kirby8047 in CE-Comparative Effectiveness Research.add a comment
COMPARATIVE EFFECTIVENESS RESEARCH
Science Fairs Come To Medicine
March 2009
Comparative Effectiveness Research (CER) is a straightforward issue. We learned all about CER in middle school science projects when at least 10% of the class chose to do experiments on which paper towel was more absorbent Bounty or Brand X?. These simple head to head studies would often find that “Bounty” or some other brand was the better soaker upper. So if your buying decision was based on the question, “which paper towel is more effective at absorbing liquids” you had your answer and could act accordingly. Pure straightforward answers are assumed to happen as a result of Comparative Effectiveness Research (CER). Compare two treatments side by side and see which one does the job for the least amount of money.
But wait-there’s more! Which paper towel is best for the environment? Which has the prettiest designs so it looks nice on the kitchen dispenser? Which is best when used as a dust cloth? Other issues make the simple study on absorption now seem isolated and somewhat limited. This is what will happen to the CER as proposed in the ARRA legislation. One study simply leads to more questions and will not yield the cost savings holy grail we all would like to have. CER will end up being another Federal boondoggle.
CER as currently portrayed by many as a way to increase our knowledge base about what works and what doesn’t.(1) In theory the results of CER studies should tell us which medicine is the best for high blood pressure. Or which medication is the best for depression, and which one lowers cholesterol in the least expensive way? Proponents indicate that the new government entity that will carry out the billions of dollars in research can be nothing but positive and will answer many “which is best” questions. Unfortunately, or fortunately, whatever the case may be, medical research is much more complicated and involved than the proponents of CER would have you believe.
ARRA sets aside a large amount of money to create a new government research organization that would carry out CER which will then be used to help physicians use more scientific, evidence based or “effective” treatments. The idea not expressed in the language of the bill but verbally communicated during the writing of the bill was that this research would also form the basis of what the government would pay for in terms of treatments. The ultimate bottom line as seen by many is that CER is a way to control costs by rationing care.(2) Put another way, you and your physician would no longer decide what is best; a government agency would make the decisions by limiting what treatments would be covered.
There is a considerable amount of objection to the idea of another government body to do what is essentially the work already carried out in the private sector and by the FDA. There are no arguments against CER per se, CER produces valuable scientific information.(1) It is the use of CER data as a “gatekeeper” for introduction of new drugs, or as the standard used to approve payment for one procedure vs. another that brings out the red flags. The arguments against government sponsored CER fall into the following categories:
1. It is a waste of taxpayer money. These studies will not produce the information the government wants.
2. No CER study ever done has had any impact on clinical care (1). Medical protocols are developed over a series of studies each affirming a small discretely measurable aspect of a drug or a treatment procedure. What develops through the years is a mosaic of information from which physicians make their clinical treatment decisions.
3. CER can’t possibly answer all the questions that arise with any given disease and its treatment. There are just too many variables in real clinical practice. The two very large CER studies already completed by the government in recent years, one studying the use of blood pressure reducing medications and the other studying which medication was more effective for psychotics provided a large amount of useful information. In both studies the conclusions were that the older forms of medicine worked just as well as the new ones. But in both cases, follow-up studies proved the government research wrong. Again, it wasn’t that the studies weren’t useful and productive; they just failed to do what they set out to do, i.e. set the standard for which treatment is best, X or Y?
4. CER studies are often “systemic reviews” which simply summarize older studies and to make judgments based on a compilation of previous research. Critics point out that this type of CER doesn’t add any new clinical insight to the problem being studied.
5. The European models of CER are used to determine which treatments are used for which people. In short, it is their tool for rationing health care. All the single payer government run plans have budget limitations that mean they simply do not pay for certain kinds of care. CER is used to help rationalize these decisions when the citizens become angry about the lack of coverage. (3)
6. CER will stifle the creation of new medications. There is considerable reservation regarding the government studies being used to evaluate newer medications which have to be clinically tested over years to see how well they work and what impact they have at different dosage levels, and at different stages of a disease. To compare a new cancer medication with little or no widespread clinical use with an older mediation would end up stifling the creation of new drugs. Why would anyone make a new drug since it couldn’t possibly pass the CER test?
7. The FDA strictly prohibits CER. (1) Companies may not perform head to head research on their product vs. a competitors’ since the products are essentially the same and any differences are too small to make a real treatment difference. So what will happen when the FDA or the new agency both have to rule on a new medication? Will we see the end of the FDA in deference to the CER agency? As John Parker would say “Interesting Times”. Indeed.
It is clear that CER research can lead to helpful information. It is already a part of the ongoing mosaic of research findings that go into determining what treatments used in our health insurance system works best. Critics of Government run CER point out that when done by private entities, the research can be done more properly, I.e. without the government restricting the studies to studies based on the of cost. If cost becomes the only criteria for CER research, our health care system will suffer greatly, we will see a slowing of the advances in health care. And do we really want the Government to tell us what is best when it comes to health care? For myself I am still advocating the consumer driven approach which will put my doctor and I at the center of the process. Not some Government lackey.
PS A Bit About Government Decision Making Expertise
In my readings in preparation for this commentary, I came up with the fact that CMS has no Oncology expertise on its staff, no physician, no nurse specializing in oncology, no pharmacist. Despite having no medical staff, CMS has made 165 rulings in regards to Medicare payments for cancer services. These are not individual cases, they are 165 guidelines or rules. Just think what some Poly Sci major will do when setting up payment rules for open heart surgery!
(1) What Are the Promises and Pitfalls of a New Federal Effort?
By Scott Gottlieb, M.D. American Enterprise Institute (AEI)
http://www.aei.org/publications/pubID.29310/pub_detail.asp
(2) Comparative Effectiveness’ Research Sparks Concerns over Access to Health Care;
By Mary Agnes Carey and Alex Wayne, CQ Staff. The Commonwealth Fund
(3) Comparative Effectiveness in Health Care Reform: Lessons from Abroad
by Helen Evans, Ph.D. Backgrounder #2239 The Heritage Foundation
http://www.heritage.org/Research/HealthCare/bg2239.cfm
Kirby V. Nielsen
Delaware, Ohio
