Posted by Michael Kennedy on July 5th, 2010 (All posts by Michael Kennedy)
First the WSJ points about Obamacare.
The act will reinforce the worst features of existing third-party payment arrangements in both the private and public sectors — arrangements that already compromise the professional independence and integrity of the medical profession.
Doctors will find themselves subject to more, not less, government regulation and oversight. Moreover, they will become increasingly dependent on unreliable government reimbursement for medical services. Medicare and Medicaid payment, including irrational government payment updates, are preserved (though shaved) and expanded to larger portions of the population.
The Act creates even more bureaucracies with authority over the kinds of health benefits, medical treatments and procedures that Americans get through public and private health insurance. The new law provides no serious relief for tort liability. Not surprisingly, various surveys reveal deep dissatisfaction and demoralization among medical professionals.
I’ve been posting about this for a couple of years and it is no surprise.
Now here is where it gets interesting.
On top of existing payment rules, regulations and guidelines, the new law creates numerous new federal agencies, boards and commissions. There are three that have direct relevance to physicians and the practice of medicine, and the nature and scope of the regulatory regime will be decisive.
Under section 6301, the new law creates a “non-profit” Patient-Centered Outcomes Research Institute. It will be financed through a Patient Centered Outcomes Research Trust Fund, with initial funding starting at $10 million this year, and reaching $150 million annually in Fiscal Year 2013, with additional revenues from insurance fees.
Don’t you think the “Patient Centered” touch is a nice one ?
In effect, the Institute will be examining clinical effectiveness of medical treatments, procedures, drugs and medical devices. Much will depend upon how the findings and recommendations are implemented, and whether the recommendations are accompanied by financial incentives or penalties or regulatory requirements.
Under section 3403, there will be an Independent Payment Advisory Board, with 15 members appointed by the president. The goal of the board is to reduce the per capita growth rate in Medicare spending, and make recommendations for slowing growth in non-federal health programs. It’s hard to imagine any other outcome other than continued payment cuts.
Now, we turn to the blog I mentioned. The author, a cardiologist mostly retired, discusses a recent randomized clinical trial. The way we decide on “clinical effectiveness” in an ideal world is randomized trials. They are the Gold Standard. So how was a recent randomized trial treated in a major medical journal? From the blog.
This week, the Archives of Internal Medicine published four (four!) articles assaulting the legitimacy and the importance of the JUPITER trial, a landmark clinical study published in 2008, which showed that certain apparently healthy patients with normal cholesterol levels had markedly improved cardiovascular outcomes when taking a statin drug.
Superficially, at least, the JUPITER study appears to have been pretty straightforward. Nearly 18,000 men and women from 26 countries who had “normal” cholesterol levels but elevated C-reactive protein (CRP) levels were randomized to receive either the statin drug Crestor, or a placebo. CRP is a non-specific marker of inflammation, and an increased CRP blood level is thought to represent inflammation within the blood vessels, and is a known risk factor for heart attack and stroke. The study was stopped after a little less than two years, when the study’s independent Data Safety Monitoring Board (DSMB) determined that it would be unethical to continue. For, at that point, individuals taking the statin had a 20% reduction in overall mortality, a dramatic reduction in heart attacks, a 50% reduction in stroke, and a 40% reduction in venous thrombosis and pulmonary embolism. All these findings were highly statistically significant.
This is a dazzling result for a randomized trial. Usually, you are looking at small changes and trying to calculate the “p value” to see if it is significant. Why would a journal publish attacks on such a dramatic study ?
If medicine were practiced the way it ought to be – where the doctor takes the available evidence, as imperfect as it always is, and applies it to each of her individual patients – then the incompleteness of answers from the JUPITER trial would present no special problems. After all, doctors never have all the answers when they help patients make decisions. So, in this case the doctor would discuss the pros and cons of statin therapy – the risks, the potential benefits, and all the quite important unknowns – and place the decision in the perspective of what might be gained if the patient instead took pains to control their weight, exercise, diet, smoking, etc. At the end of the day, some patients would insist on avoiding drug therapy at all costs; others would insist on Crestor and nothing else; yet others would choose to try a much cheaper generic statin; and some would even opt (believe it or not) for a trial of lifestyle changes before deciding on statin therapy.
This is the way we all want to practice. “Best Practice” they call it.
But in recent years, and especially now, as we bravely embark on our new healthcare system, this is not how doctors will practice medicine. Instead, they will practice medicine by guidelines. These guidelines (which, in modern medical parlance, is a euphemism for “directives”) are to be handed down from panels of experts, identified and assembled by members of the executive branch of the federal government.
And this makes the stakes very high when it comes to a clinical trial like JUPITER. For guidelines do not permit a range of actions tailored to fit individual patients (consistent with the uncertainties inherent in the results of any clinical trial). Instead, guidelines will seek to take one of two possible positions. That is, under a paradigm of medicine-by-guidelines, the results of clinical trials generally cannot be permitted to remain imperfect or nuanced or subject to individual application, but must be resolved by a central panel of government-issue experts into a binary system – yes (do it) or no (don’t do it). In the case of JUPITER, the guidelines must decide whether or not to recommend Crestor to patients like the ones enrolled in the study, at a potential cost of several billion dollars a year. It should be obvious that the answer which would be more pleasant to the ends of the central authority, and by a large margin, would be: No, don’t adopt the JUPITER results into clinical practice.
Well, we shouldn’t worry because all doctors, and especially well known academics are ethical. Right ?
Now comes the interesting part and I think he is absolutely correct.
This, DrRich submits for your consideration, is likely what instigated the almost violently anti-JUPITER issue of the Archives this week. DrRich theorizes that what we’ve got here is a bunch of wannabe federally-sanctioned experts, auditioning for positions on the expert panels. What better way to get the Fed’s attention than to let them know that you are of the appropriate frame of mind to assiduously seek out scientific-sounding arguments to discount the straightforward and compelling, but fiscally unfortunate, results of a well-known clinical trial?
Of the four papers appearing in this week’s Archives, three are more-or-less legitimate academic articles that make reasonable points, but do no harm to the main result of JUPITER. The fourth is a straightforward polemic, which has no place in a peer-reviewed medical journal, and whose very presence, DrRich believes, very strongly suggests that the editors of the Archives themselves must be auditioning for the Fed’s expert panel.
Most doctors resent guidelines unless they are obviously data driven. Most of that data comes from randomized trials.
What we are seeing here is the erosion of the ethics of those who publish and conduct such studies and who use them to establish guidelines. There is another type of guideline, called “consensus guidelines” in which a committee of “experts” debates the best practice. These are the guidelines most doctors distrust. Now we see the corruption of even the randomized trial as a source of data driven guidelines.