Saturday, December 19, 2009
I have no personal knowledge, interaction, acquaintance with psychiatrist Dr. Mendez-Villamil. However, though this sounds fraudulent (which is why the fed likely pulled payment), how could this doctor personally benefit from all of these scripts? Doctors do not get paid by how many prescriptions they write (unless you count docs like oncologists who collect fees for administering chemotherapy). Drug companies are now forbidden to wine and dine doctors, so it is highly unlikely that some pharmaceutical rep is incentivizing this psychiatrist. Besides, these patients areMedicare and Medicaid, so they are likely getting generics in the first place.
So if there is no wrong doing or even an incentive to write all those scripts, is this even possible and why does it happen? If the good doctor is seeing patients every 10 minutes, and each patient needs 4-5 prescriptions (assuming an 8 hour day); that's 46 patients a day needing about 3 prescriptions on average to yield the 150 prescriptions a day that Dr. Mendez Villamil is "accused" of writing. Though this may not be good medicine, with that volume of patients, the numbers sound pretty reasonable, espescially since many chronic psychiatric patients are on multiple medicines. So it it possible that one psychiatrist sees almost 50 Medicare and Medicaid patients a day in 10 minute visits? If the psychiatrist accepts Medicare and Medicaid, then this is actually quite likely the case (and probably not the exception but the rule).
In a piece I wrote for KevinMd a year an a half ago, I described how there are two kinds of mental health care in the US: care for those who pay with insurance and care for those who pay out of pocket. The kind of care that you see in TV and movies where a patient talks to a psychiatrist and possible gets medication; that kind of care happens, but only if you are willing to pay out of pocket. In many cases fees for a regular sessions run over $200. For those paying with insurance, the experience is quite different. If a patient sees a psychiatrist, it is usually only for medication management and usually only in short (10 minute) visits. Any "talk therapy" is relegated to a psychologist or psychiatric social worker. I mean no disrespect to some of the excellent and well qualified non-physician therapist we have in the US. I am not even stating that having a short visit with a psychiatrist for medication management and counseling done by non-MD's is bad medicine. However, the public must be aware that this is how psychiatry is practiced in the US.
In the case of Dr. Mendez-Villamil, he probably is one of only a handful of psychiatrists in Miami that accepts Medicare and Medicaid. Patients probably wait months to see him. The Miami Herald makes him look like a criminal. However, think about the majority of his colleagues who only see patients who can pay $200 or more out of pocket per visit? Dr. Mendez-Villamil is probably a hero, and if he writes 100,000 prescriptions per year this should be seen not as a crime, but a sign of a broken system.
The piece I wrote for KevindMD was entitled, "As psychiatry goes, so will primary care." The reason why so many psychiatrist stopped taking insurance and the reason why those psychiatrist who accept insurance cram patients into 10 minute visits is because the reimbursement rate from insurers is ridiculously low. Many psychiatrist realized that accepting insurance just didn't make sense. The same thing is happening right now in primary care. More an more primary care physicians have stopped taking new Medicare or Medicaid patients, or any insurance altogether. Some have even gone beyond cash only, and started "concierge" practices which charge patients a retainer fee (sometimes well over the usual $1500 a year) in exchange for easy access to their primary care doctor.
Health care reform has focused on how to cover the uninsured and how to pay for this, but it has not focused on how to change the current reimbursement system that rewards "proceduralists" and punishes "congnitivists." If health legislation that covers the uninsured does eventually pass without addressing this fundamental crack in our health care system, there will likely be no primary care physicians to see all these newly insured patients (see what happened in Massachuesetts). The few primary care physicians that do accept the newly insured will likely have limited access and see more patients in less time....kind of like the good Dr. Mendez-Villamil. Whereas the typical psychiatric patient might be on 3-4 meds, the typical Medicaid and Medicare patient is on a great deal more medications. Primary care physicians, get your pens ready! 100,000 prescriptions a year will seem like nothing.
Tuesday, December 15, 2009
What's this about?
The FDA is reviewing the results of the JUPITER trial. I blogged about the results of the Jupiter trial a year ago. Basically this study looked at over 17,000 patients with relatively normal cholesterol levels, but an elevated CRP, which is a marker of inflammation and has been associated with elevated risk for heart attack and stroke. The study was planned for 4 years, but stopped just short of 2 years because they found a substantial benefit for patients taking Crestor. Crestor reduced the risk of heart related deaths, heart attacks, and other serious cardiac complications by 44%. These results are pretty impressive.
What's the FDA have to do with this?
Why is the FDA weighing in on a year old study for a drug that is already on the market? Because Astra Zeneca, the maker of Crestor, is asking the FDA to give Crestor and indication to use Crestor in patients with normal LDL's but elevated CRP's. Currently, all statin medications are only indicated to treat high cholesterol in order to prevent heart attacks and strokes, not to actually prevent heart attacks and strokes irrespective of cholesterol.
I have previously discussed the meaning of "indication" in a post called "An indication for change." Basically, even though Crestor has been proven to prevent heart attacks in patients with elevated CRP and normal cholesterol, the company can not share this information with doctors or advertise this information with patients until it gets the indication. You may notice that a recent Crestor commercial shows a woman over time who states that while she was building a family/career, atherosclerotic plaques were building up in her arterties. The reason this is a focus of the commercial is because Crestor recently got an indication to prevent the progression of atherosclerosis. Since it is the only statin with this indication, the company likely wants to use this as a competitive edge over other statins. It it gets the CRP indication, it will likely use this in advertising messages to doctors and patients.
What does this mean for me?
Actually, the study results have been out for over a year, so this is not really anything new. However, if the FDA does go forward with the panel's recommendations, you will likely hear more about testing for CRP, and your doctor may even recommend this test.
Should I use a statin to treat an elevated CRP?
The jury is still out. This may change though, as the Adult Treatment Panel IV (ATP4), a NIH sponsored group, will soon make its new cholesterol treatment recommendations. They will have to address the CRP issue. The US Preventative Health Task Force (the same government group that recently told younger women to stop getting mammograms) recently stated that they felt there was insufficient evidence to recommend this. This is true, because though there are numerous studies associating CRP to cardiovascular risk, only the JUPITER study shows that treatment works. That being said, the JUPITER study is a very large, randomized trial with substantial differences between treatment and placebo groups, so it should not be ignored. If you don't want to wait until the APT4 weighs in, I would discuss this with your physician. If you are very worried about heart attacks and strokes (possibly a strong family history), but have a normal cholesterol, treating an elevated CRP might be a reasonable option for you.
What do the nay-sayers say?
There are many that will come out against this, regardless of what the ATP4 decides. In addition to stating that there isn't enough data they will say:
- "The patients in the JUPITER study taking Crestor developed diabetes". This is true, but most of the patients in the study were at risk of developing diabetes. Even though there were statistically a few more patients taking Crestor that developed diabetes, it is very unlikely that this was real, and other markers of diabetes were the same
- "You are taking medications that have side effects." It is true that any medication has side effects. However, one interesting thing that came out of the JUPITER study was that there were really no difference in side effects between the placebo group and Crestor group. Given that the 20mg dose used in the study was a relatively high dose, this is pretty impressive. Groups like Public Citizen warned of the dangers of Crestor, but this drug has proven to be quite safe.
- "The patients in JUPITER did not exactly have normal cholesterol levels, and their risk was high." This is a valid criticism. In order to really prove that treating elevated CRP levels with a statin prevents heart attacks, you would need to find patients with an otherwise low risk for heart disease (i.e. not pre-diabetic) and an ldl cholesterol below 100. However, the patients in JUPITER were very representative of the normal population of patients (60% of the country is overweight or obese and many a pre-diabetic) that would not usually get a statin medication.
Do I have to take Crestor to treat an elevated CRP?
This is actually a very important question. Currently, simivastatin is a generic cholesterol medicine and much cheaper then Crestor. Though simvastatin has not shown it can reduce heart attacks by lowering CRP, many physicians will assume a "class effect" and believe that all statins will do this. The problem is that a dose of 20mg of Crestor was used in the JUPITER study, and no amount of simvastatin will lower CRP or LDL by that much. In most studies that have measured CRP lowering with statins, it is the very potent statins that seem to work. In addition, though all statins have shown prevention of heart attacks and strokes, only the more potent statins (Lipitor and Crestor) at high doses have shown to prevent the progresssion and even shown reversal of plaque build up. This will become an even more important issue when Lipitor goes generic.Bottom Line:
The FDA will very likely approve Crestor for treating elevated CRP levels, and you will hear about this in the media and in advertisements. Though based on one study, the results are compelling enough to discuss this with your doctor and consider CRP testing.