Why I plan to continue prescribing Zetia and Vytorin

I have received many phone calls from concerned patients about their continued use of Zetia or Vytorin, following the announcement earlier this week of the results of the ENHANCE trial, and the public furor that has resulted from the misguided comments of a prominent Cardiology thought leader. Here are my thoughts on it. I must add that the study has not yet been presented, even in abstract form. The only credible information describing the results of the study comes from the Merck web site.

The study looked at patients with heterozygous familial hypercholesterolemia, a disorder of LDL metabolism. These patients have half the normal number of LDL receptors and as a result their circulating levels of LDL cholesterol tend to be in the 300-400 range. Of course this disease is associated with accelerated atherosclerosis, and all of the manifestations of such (premature MI from CAD, stroke from carotid vascular disease, etc).
The study examined the effect of Vytorin 10/80 vs Zocor 80 over a 24 month period. Baseline LDL cholesterol was 318. LDL was lowered by 58% in the Vytorin group and 41% in the Zocor group. Thus, the LDL cholesterols were 133 and 187 respectively. This is a dramatic lowering, but an LDL cholesterol of 133 still results in progression of atherosclerotic disease. While one might expect that there would be more rapid progression at the higher LDL, one would only expect to be able to see this after many years. In fact, based on Framingham risk scores, at the higher level of LDL, a 40 year old man, with normal blood pressure and an HDL cholesterol of 40 would have a 3 % 10 year event rate, while a man with the lower level would have a 1% event rate.
The ENHANCE study measured carotid intimal-medial thickness. This is thought to be a surrogate marker for other vascular disease. The thicker the intima and media, the more atherosclerosis. In patients with hyperlipidemia, carotid intimal thickening progresses with time. Other studies with other medications (Lipitor, Crestor) have shown that aggressive treatment of hyperlipidemia for CAD ( to LDL less than 70) is associated with regression of carotid intimal-medial thickening. The thickening is caused by deposits of cholesterol as well as scar tissue stimulated by the deposit of cholesterol. The measurements are very exacting. The differences in the ENHANCE study are vanishingly small- (5 thousands of a millimeter, or 5 microns) and I would venture, probably much less than the limits of resolution of the vascular ultrasound equipment.

The study therefore does not apply to the vast majority our patients. The base line LDL was astronomical, and the LDL cholesterol in both treatment groups was still much higher than what evidence based goals for primary and secondary prevention of heart disease aim for. For primary prevention, it takes a very long time to see a difference in long term outcome for patients with an LDL of 190 vs 130. The study result (measurements of carotid intimal-medial thickness) was not different between the two groups.

Thus, I plan to continue prescribing Zetia and Vytorin in anticipation of outcomes data for the development and progression of coronary artery disease. I believe that there is very strong data supporting the lowering of LDL cholesterol to under 70, and until it is clearly demonstrated otherwise, I plan to continue to use these medications where appropriate.

NEJM whining again

This week’s complementary articles NEJM Dec 27 “Comparing Physicians on Efficiency” by Milstein and Lee, and “Is quality Improvement Improving Quality” by Vonnegut, are timely. As we head in to a presidential election year, with healthcare finance reform at or near the top of the agenda, we need to be asking just what do we want to see at the other end. There are multiple competing interests, which need not be summarized here. It seems obvious however that while we as physicians can complain about the details, several apparent facts need to be considered
1. Reimbursements per unit time will continue to decline.
2. New technology will supplant old technology (anyone order a phonocardiogram recently?)
3. New practice models will emerge and evolve to treat patients “better, faster, and cheaper.”
Physician lobbies are impotent in preventing this, not because of the antitrust laws which prevent more organized lobbying, but because, while not entirely free, the market place is still largely free. While we may yearn for the good old days, we have to remember that, as across the US economy, standing in the way of market forces has been futile. Since there are great asymmetries in knowledge between the various stake holders (patients, physicians, and payers), a truly free market may not yield the desired result of quality healthcare for all, even if it does yield healthcare for all. Despite this, a market that is as free as possible probably has the best chance of delivering the most innovation at the lowest cost. Since healthcare is a rapidly evolving field, a system with too many constraints may prevent us from achieving our ultimate national goal.

State Medical Boards to "pile on" older physicians

An article in this weeks American Medical News alertted my you yet another challange to physicans (See Stricter Requirements sought for Relicensure by Damon Adams(Am Med News Dec 24/31 P1).
Before ~1990, many specialty boards did not require periodic recertification for physicians who had successfully completed the existing training requirements and passed the board exams. Thus many practicing physicians in their early 50s and older (including, not coincidentally, myself) have not sat for re-exams, and have not spent the time to formally recertify. While I have been a strong supporter of maintaining my CME requirement and have typically done much more than asked by my home state, the additional several hundred hours required to take these board recertification exams in order to continue an active medical license is simply not how I want to spend my precious little vacation time. I believe this proposal, along with pending Medicare reimbursement cuts, will cause a wholesale exodus of late middle aged physicians from the ranks of active practice. Before state medical boards add this requirement to their re-licencing process, they MUST do a cost/benefit analysis, to determine:1. How many excess physician retirements will there be? Will the harm to patients caused by the loss of these physicians be made up by the purportedly greater competency held by the remaining physicians?

Mike Huckabee's healthcare plan

Mike Huckabee’s emphasis on prevention as the financial engine for his healthcare reform plans may be a Faustian bargain. Prevention comes at a price in the United States. As a practicing interventional cardiologist, I and my fellow practitioners have seen a 20% decrease in procedural volume in the past 2 years, driven, we believe, by the more aggressive use of (branded and expensive) “statins” to lower cholesterol, and the use of drug eluting stents (each at 4 times the cost of their earlier brethren). Have we saved money? Perhaps very little. Have we improved the quality of life by reducing the need for invasive procedures? Most definitely. But when I tell my patients that there is something that has been proven to prolong their life, proven to make them feel better, takes minutes a day, and costs nothing, they are all very excited until I tell them that this something is exercise. This is the true prevention that Mr Huckabee speaks of, which would, like closing all fast food restaurants or placing a tax on food calories, be true primary prevention. Exercise and weight reduction is the third rail of medicine, much like what raising taxes is to politicians. Patients (read Americans) don’t like to hear it, and Mr Huckabee, perhaps better than anyone running for office, knows this well. Yet this is the best way and the least expensive way for Americans to save money. Having said that, there is probably such a burden of subclinical cardiovascular disease in the US, that even if we all started eating right and exercising tomorrow, the needed savings would likely not become manifest for a generation. Also working against this is the general consensus in the US that its OK to spend 50,000 USD to save one life per year. After the renal dialysis services were made widely available in the late 1960s, this number has been used to define the cost-effectiveness of any new procedure or medication. In the cardiovascular realm its been the yard stick applied to defibrillators, antihypertensive therapy, beta blockers for heart failure, and other therapies. Even taking an aspirin a day has a cost, although by comparison, its cheap. All of this adds up. To quote the late Senator Fullbright, a billion here and a billion there, and soon your talking real money. And that’s when a billion USD was worth something.
Mr Huckabee’s idea is an excellent one, and should be an important component of any national healthcare plan. I believe it will pay off in the long run. It will not pay for itself in the short run however.

Another unfunded mandate

Laura Landro’s article in todays Wall Street Journal entitled “Keeping Patients From Landing Back in Hospital” (WSJ 12/12/07 p D1)highlights one of the paradoxes of modern healthcare. As we move away from the personal physician model (Marcus Welby Medicine), the doctor who admitted you to hospital, treated you, and followed you thereafter, we see the lack of coordination of care hurting patients more and more. To a large extent this results from several phenomena. The first is the fact that a rapidly dwindling number of primary care physicians actually follow their patients when they are admitted to hospital. It’s simply not cost effective anymore for them to do so. The work is left up to “hospitalists”, an emerging hospital based subspecialty of Internal Medicine. The second is the fact that as medical practices merge and grow, the chances of an after-hours call from a patient reaching their physician, who has knowledge of their condition, grows smaller. The third is the lack of a sophisticated, unified information technology infrastructure being available to provide knowledge support to anyone (physician, extender or even someone familiar with the patient) that might avert a visit to the emergency department. ( I know, for example, that Mrs. Schwartz likes to eat more herrings than she should, or Mr. Smith is fond of barbeque and biscuits, and that’s the most likely reason they developed recurrent heart failure, not something more sinister, and can be treated with an extra dose of medication that she already has on hand). Once a patient presents to the emergency department, the obligatory admission almost always occurs, because there is no one with direct understanding of the patient willing to take responsibility. The current tort environment is also partly to blame for this.
So who should be financially responsible for providing the extra staffing to make sure the follow up appointments are scheduled at times convenient for the patients care givers (be it parents, children or in-laws)? Who should be financially responsible for paying for the home visits necessary to make sure that the patients filled their prescriptions and have removed the herrings from the fridge, and thrown out the cigarettes? And how long should they be responsible? Unfortunately Ms. Landro’s article did not address this. I suspect this argument is headed the same way many other arguments are- we will save money by preventing admissions. If our new technology and systems were doing such a great job of improving healthcare and saving money, than why are our costs escalating faster than can be accounted for by demographics without measurable improvements in overall outcomes? We will almost certainly never know if “Marcus Welby” medicine did a better job statistically at keeping patients out of the hospital than our current and evolving corporate model of medicine. What is almost certain however is that some of the expense to pay for the fall out of this new paradigm will come from the pockets of physicians in the form of lower reimbursements. This further demotivates physicians from going the extra mile (or even step) that might help prevent a re-admission.

Does size matter in health care delivery?

An article entitled "Bigger Practice, Better Quality?" appeared in the American Medical News, dated Nov 26, p 11. This article is as well balanced as could be. However it is an example of how history is written by the victors. The article addresses the increasing body of evidence suggesting that larger practices provide better care based on protocol driven medicine. However, its much like the tree falling in the forest. As a solo practicioner with an EMR I can provide quality data, but I have not encountered a payer willing to look at it. The gap between big groups and small groups will only grow wider, based on the quote from Don Fisher, the President of the American Medical Group Association, who implies that solo practicioners are more likely than those in large groups to be concerned with the bottom line. The American Medical News, and similar publications such as Medical Economics are replete with instances of financial profiling by large groups, and the negative consequences to hapless physicians. Just like in movies of a certain genre, bigger may be better, but small practices will never be able to, nor will be given the platform with which to prove this wrong.
This is, however a separate issue. This, and other articles should call small groups and solo practicioners to electronic arms. You dont go to a gun fight with a knife.

Microsoft Healthvault may have it locked up

Finally someone has recognized the fact that it will be years before all health information is available in a standardized digital format that can be sent by command to your personal health account. With Microsoft's new Healthvault, I believe the most powerful and useful feature is the ability to upload files, especially PDF files. PDF is the lingua franca of cross platform communications. My EMR can make PDF files. I can create PDF files from documents printed out from the various sources from which I recieve patients health records. I can do it now.

This is a great opportunity for people with complex medical problems who travel to assure the availability of some of their most important records.
Truckers will find this particularly useful. Contract workers who spend only a few months in any given location will also find this invaluable.
Physicians can add value to their office visits by charging a fee to post documents on Healthvault.
3 cheers for Microsoft.