I yawn every time I hear a Big Pharma rep tell me what a breakthrough their drug is. It’s like news about vitamins and just as often its too good to be true. New drugs are almost always “me too” drugs: cost a lot, do little more than their predecessors. Approved August 12, 2003, Crestor is the latest of the class of drugs known as statins. These drugs lower cholesterol by decreasing synthesis of cholesterol by the liver. So, let us take a look at Crestor, the latest, supposedly greatest, cholesterol drug.
This trial looked at carotid intima-media thickness (CIMT), a measure of the thickness of carotid artery walls, and the effects of Crestor on CIMT over time. Presumably CIMT correlates with coronary heart disease risk. CIMT varies widely among individuals and increases naturally with aging.
The result from the study reads:
middle-aged adults with Framingham risk scores lower than 10% and evidence of subclinical atherosclerosis, rosuvastatin treatment resulted in statistically significant reductions in the rate of progression of maximum CIMT during a 2-year period compared with placebo. Rosuvastatin did not induce regression overall.
Note that there was no regression overall. And, if you read the study or go here you will see how small the effect was. Dr. Michael Lauer, in an editorial to the JAMA article writes: “Should low-risk individuals undergo routine arterial imaging followed by statin therapy when evidence of asymptomatic disease is discovered? On the basis of current evidence, including the METEOR trial, the answer is clearly no.”
Finally, does CIMT measure anything important anyway? Doubtful according to the Rotterdam study published in the Journal Stroke. To quote their abstract: “Adding IMT to a risk function for coronary heart disease and cerebrovascular disease does not result in a substantial increase in the predictive value when used as a screening tool.” Another study, the APSIS study published in the European Heart Journal also found CIMT a weak predictor of events.
This trial was an utter failure. If you are physician you’ve probably never heard of it. Why? Because Big Pharma pretty much controls medical information these days. Unless you have time to read the Journals you’ll miss this kind of negative trial; it won’t be talked about.
In the CORONA trial 5011 patients of at least 60 years of age with ischemic congestive heart failure were randomized to placebo or Crestor. After 32.8 months there was no difference in nonfatal heart attacks, nonfatal strokes, death from cardiovascular causes or death from any cause. No differences between Crestor and placebo even though cholesterol levels and high-sensitivity C-reactive protein levels fell substantially in the Crestor group.
This trial, another failure for Crestor, investigated 2776 hemodialysis patients randomized to Crestor or placebo. After 3.8 years, there were no differences between groups in all cause deaths, cardiovascular deaths, nonfatal heart attacks or nonfatal strokes. Crestor did lower cholesterol levels.
JUPITER is an acronym for Justification for the Use of statins in Primary prevention an Intervention Trial Evaluating Rosuvastatin. This trial was reported as a great success.
The Jupiter trial was stopped early. This has been a trend in recent years. Ending trials early tends to exaggerate outcomes and several articles like this one have addressed this problem.
For a good start, how about a quote straight from the US Food and Drug Administration’s web site, the page titled Questions and Answers For Healthcare Professionals: CRESTOR and the JUPITER Trial. They state:
“There was no statistically significant reduction seen for cardiovascular death or hospitalization for unstable angina in individuals receiving CRESTOR compared to those receiving a placebo.”
That’s right, no statistically significant reduction in cardiovascular death. In fact look at table 3 in the NEJM article and you will see, subtracting nonfatal myocardial infarction from any myocardial infarction in both the Crestor and placebo groups and you will see there were 3 more fatal heart attacks in the Crestor group.
What other insights are found on the FDAs website? The FDA is very specific on the indication they have granted Crestor. Here it is:
This is the first time CRESTOR has been approved for use in the prevention of heart disease in individuals with “normal” low-density lipoprotein (LDL) cholesterol levels and no clinically evident heart disease . . . Based on the limitations above, CRESTOR should only be used for the primary prevention of cardiovascular disease to reduce the risk of heart attack, stroke, or arterial revascularization procedures in individuals without clinically evident coronary heart disease who meet the following criteria:
* Men > 50 years old or women > 60 years old, and
* hsCRP > 2 mg/L, and
* Presence of at least one additional cardiovascular disease risk factor such as high blood pressure, low HDL-C, smoking, or a family history of premature coronary heart disease.
There you have it. A very specific indication. Note that if a patient’s one additional risk factor were smoking, if you could persuade them to quit smoking you could forgo the Crestor, save vastly more money and no doubt improve their health to a greater degree!
The FDA also reported a safety concern: “An unexpected safety finding in the JUPITER trial was an increase in the number of individuals receiving CRESTOR compared to those receiving a placebo who developed diabetes.”
The FDA also admonishes physicians to interpret the results of the Jupiter trial with caution:
The results from the JUPITER trial do not support the use of CRESTOR in all patients with an elevated hsCRP. For example, there was no evidence that CRESTOR provided benefit in individuals with an elevated hsCRP but no traditional cardiovascular risk factors, which include high blood pressure, low HDL-C, smoking, or a family history of premature coronary heart disease.
The best analysis of the JUPITER trial I have read is by Dr. John Abramson, a family physician, Robert Wood Johnson Fellow and member of the clinical faculty at Harvard Medical School. Here are some key points he makes:
* 170 people had to be treated for 1 year to prevent 1 event at a cost of $270,000 for the Crestor alone (doctors visits and labs add to costs)
*400 people had to be treated for 1 year to prevent 1 death at a cost of $580,000 for the Crestor alone
*41% of the patients had metabolic syndrome and 15% smoked, yet there was no counseling on diet and exercise or smoking cessation
Well I hope this was enlightening. I am not trying to disparage Crestor. In fact I like the drug. I prescribe it in certain situations. It lowers LDL better than any other statin and raises HDL better than any other statin. But it is no miracle drug. Statins in general have been over-hyped and their effectiveness exaggerated.
President Lyndon Johnson signed The Social Security Act of 1965 into law on July 30, 1965. President Harry S. Truman was the first beneficiary. Detractors of the plan warned it would become prohibitively expensive and accused President Johnson of hiding the true costs. Just as it does today, the government in 1965 underestimated the costs of their programs. How much? Well, in 1965 the government projected Medicare spending on hospital care would be $9 billion in 1990. They were off by a factor of 7 and actual costs in 1990 were $66 billion. Medicare is in deep financial doo-doo. The medicare program has somewhere between $50 and $100 trillion in unfunded liability. Let’s put this in perspective; the entire federal budget for 2010 is $3.55 trillion. Or let’s put it another way. If you made $50,000 a year, but were in debt $1.4 million, you would be in a similar situation as the government. And don’t forget, that’s just Medicare. Social Security is another pile of unfunded liability.
Something has got to give. I suppose it might as well be physician’s fees. There were other choices. Here are some examples: diabetic shoes, scooters, wheel chairs, vacuüm erection devices, drugs that don’t work (there’s a list of them), futile end of life care etc.
But I never intended to argue in favor of cutting something else to save my hide and keep my income. Actually, I favor the cuts. Perhaps it’s time for doctors to wean themselves from the government teat. Perhaps if these cuts stick, doctors will stop accepting Medicare. Medicare is a bureaucratic nightmare. Doctors might find it liberating to drop Medicare. They would find that they needed fewer staff. Paperwork hassles would drop. They would no longer have to comply with ambiguous rules and regulations. Coding guidelines commandments could be ignored.
Still, I have not made my point. Perhaps the government does not owe doctors a living. Perhaps there is no place for the government in the doctor-patient relationship. I think it is time for a return to the free-market in medicine. I think prices would fall in such a system (yes I know, they’re going to fall anyway). Surely in a free market system, 30 tablets of Clarinex, a drug used to treat allergies would not cost $133. Who would buy it? Likewise, fees for professional services would fall. If no one can afford your fee to take out you gallbladder, then either you lower your fee, or you find another job; someone will do it for less. In fact, surgery text books written in the days of cash payment talked about negotiating fees and giving price breaks to low income people. Did you know that Medicare rules forbids physicians giving price breaks? The Government considers it theft if you do not give the same price break to Medicare patients. Back in the days of cash payment, here is an example of the cost of health care.
With no Medicare (or third-party payers) would the average family physician make $160K per year and the average non-invasive cardiologist $284K per year? In 1949 the Department of Commerce reported the average family doctor’s income as $8,835 per year. Adjusted for inflation that would be $78,660 in 2009 dollars. You can see what other specialties made in 1949 here and plug the numbers into an inflation calculator. You will find all physician salaries have outpaced inflation quite nicely. The reason is Government intervention, specifically Medicare and to a lesser extent, licensing and education requirements and other measures to limit competition (other professions do the same thing).
So, I say bring on the cuts. Physicians stop accepting Medicare. Let’s go back to cash, no insurance for routine care, no Medicare and no Medicaid. Our country will be better off. After the upheaval, so will the doctors, nurses and patients. But what about the poor you say? The poor too will be better off after prices fall. And after prices fall we will be better able to set aside some funds to help those who need and deserve it.
I leave you with a quote from Grover Cleveland:
I do not believe that the power and duty of the General Government ought to be extended to the relief of individual suffering which is in no manner properly related to the public service or benefit…. The friendliness and charity of our countrymen can always be relied upon to relieve their fellow-citizens in misfortune. This has been repeatedly and quite lately demonstrated. Federal aid in such cases encourages the expectation of paternal care on the part of the Government and weakens the sturdiness of our national character, while it prevents the indulgence among our people of that kindly sentiment and conduct which strengthens the bonds of a common brotherhood.
When I was a resident in family medicine evidence based medicine was just getting started. Expert panels were publishing guidelines for treating various medical conditions. Some physicians found the idea insulting. “Cookbook” medicine they called it. But it was hard to argue with the idea. Most physicians, especially generalists like myself, simply cannot cover enough ground reading medical journals to stay current. Guidelines were the answer. They summarized the best evidence and provided algorithms (decision trees) for treating patients. Of course, if circumstances dictated otherwise, the guideline could be modified or ignored.
I love clinical guidelines. I think they help me practice better medicine. I read them and I study them. But exceptions are common. Guidelines are a starting point, but often need to modified or ignored. Reasons are many: drug interactions, polypharmacy, multi-system disease, patient’s age, another treatment would be more effective, patient’s income, patient preferences, the guideline is wrong or not up to date etc.
Over the years clinical guidelines have become clinical constraints. Physicians are often “graded” and pay determined by how closely they follow guidelines. Known as “pay for performance” or P4P, it is electronically tracked. Hence we have the push for physicians and hospitals to adopt electronic health records (EHRs). If you want to read in depth what a bunch of crap P4P and “quality” indicators are go here and here.
Now family medicine is rapidly evolving into a specialty of rote application of clinical guidelines, checking off boxes of quality indicators and coordinating care among specialists. No one enjoys it and it does not take a medical degree to do it. And for my nurse practitioner friends out there, you too are over qualified for this type of work.
Now it comes down to this: 10 to 15 minutes on average to see a patient (if you are lucky). Are you, the physician, going to listen to your patient, examine your patient, and develop a plan customized for that patient; or are you going to follow your guidelines, check off your boxes and get your extra pay for being a “quality” physician, I mean, provider.
As noted above, exceptions to guidelines are common. But the bean counters are not interested in the exceptions. To them it’s like a light switch, either on or off, black or white. Take two physicians. The first sees his patient, makes the diagnoses, then consults the guidelines and simply follows them. The second considers the full context of the situation and then may or may not follow the guidelines in his customized treatment plan. Which physician would you rather see? Which will follow the guidelines more often? Which will rate higher on the bean counter’s quality scale?
What intelligent medical student would choose Family Medicine as a specialty? Eleven years of higher education to follow guidelines, coordinate care and check off quality indicators is preposterous. Is it any wonder that half of all primary care physicians want to quit? Family medicine will die as surely as the sun sets.