Breakthrough govt.study-patients don't always take their meds

A report is out regarding a government study that demonstrated patients do not always take their medications as they should.Earlier work has suggested they do not always eat their vegetables. Not only do patients fail to take their medications regularly , they often take them incorrectly and stop medications that are supposed to be long term treatment, take them with food when they shouldn't and take them on a empty stomach when they should take them with food. There are even reports of patients not filling their prescriptions at all.

Dr. Carolyn Clancy, Director of the Agency for Healthcare Research and Quality , in announcing the results of the trial proposes an "in your face" campaign . Help seems to be on the way.

The success of previous government educational programs is the stuff of legends. Drunk driving,teenage sex, teenage use of drugs, to name just a few, have all been virtually eliminated.
Public Services Announcements have resulted in highways free of litter and it has become nearly impossible to find someone who does not floss or use sunscreen or a pregnant woman who smokes or drinks alcohol.A campaign to urge or cajole everyone to take their medications correctly will likely have similar impact.

Shorter, more focused CPR course sounds better

Kudos to these folks who tried out a shorter version of the CPR course and found it worked better in terms of retention of concepts ( and less wasted time). Waste of time was always the main thing in my mind as I went through these courses on multiple occasions.The Red Cross and American Heart Association have padded their courses with so much fluff that it gets in the way of learning what folks need to learn from these courses. The key to learning things is practice, practice, practice and these courses typically let the filler material take time away from potential practice time. The use of the AEDs involves very simple techniques and I believe the traditional courses are less successful because they try to say too much.

American Heart Association gets on band wagon for pumping weights

Even since I heard the term "sarcopenia" I began to worry about this muscle loss that accelerates as we get older. I began to counsel patients about the changes described when the sex hormones begin to fall and that their weight could stay the same but the muscles mass decreases and the subtle increase in body fat replaces the muscle weight and little net weight gain occurs .

I became convinced that we all-regardless of gender-should add some resistance exercise to the aerobic programs that we all advocate for general health and sometimes do. Now the American Heart Association has seen the wisdom of this approach.

The story of what goes on mechanistically as our muscles wither away is of course still being worked out but some interesting aspects have been investigated.

There is disconcerting evidence that at least one factor in the diminution of muscle mass as we age is loss of motor neurons in the spinal cord. Until I read this review I had not considered that the muscle atrophy of old age could be neurotrophic but there is considerable evidence suggesting just that. Details can be found in Dr. Lexell's review linked above.

At least two lines of evidence is presented. First, there have been a fairly limited number of morphological studies involving the human lumbosacral cord showing loss of motor neurons after age sixty. One such study demonstrated an alarming 50% decrement in motor neurons in some subjects while the average was only 25% and another study reported a more reassuring loss of only 5%. The small numbers of subjects in these studies limits the accuracy of percentages that are quoted and we have to wonder how much individual variation in this process occurs. Secondly, the histological pattern of muscle loss is of the type seen when nerve fibers or nerve cells fail. As motor units drop out a process of compensatory reinnvervation kicks in and interestingly there is a tendency to replace some of the fast twitch fibers units with slow twitch units, a process referred to a motor unit remodeling. The muscle loss with aging is both in number and size of muscle cell and the fast twitch fibers are disproportionately involved. The remodeled motor units are less efficient, slower and generate less force.

Data also point to decreased numbers of fast twitch muscle fibers even in regular joggers and swimmers at least in the thigh muscles which are those usually tested and biopsied. This is not surprising as the the quadriceps do little more than contract on foot strike to stabilize the patella when we run on level ground and swimming is more a shoulder activity that a quad workout. So jogging or swimming will not immunize against sarcopenia.

Decreased muscle protein synthesis and various hormonal decrements also characterize aspects of the aging sarcopenic process. Replacement of growth hormone-which declines with aging-has not improved muscle strength and function. Muscle protein synthesis does increase with regular resistance training even in the very elderly and muscle function improves along with muscle strength and fiber size.

In short, the only thing to date that can mitigate sarcopenia is resistance training (RT). There are no data to indicate that we can stop motor neuron death but RT is all we've got.

Still more on house staff duty restrictions-faculty angst

I have written before about the changes in house staff medial education in the post duty hour restrictions era and evoked some critical comments by house officers. Also, more recently I commented on articles in the Annals of Internal Medicine which seemed to provide some reassurance that at least there had been no negative effects on patient safety with the restrictions (some had feared that increased hand offs might lead to fumbles and more patient risk).

Well, the wheel is still in spin and now we have a different slant on the issue, one that is less reassuring in regard to the effects on resident education and medical school faculty job satisfaction which could affect faculty retention particularly in the already waning area of general internal medicine.

The July 23, 2007 issue of the Archives of Internal Medicine has a very interesting and I believe important article discussing the views of a number of medical school faculty members who have a list of what they believe to be significant negative aspects of the new resident educational landscape in internal medicine. Th WSJ medical blog covers this article here.
(Effect of Residency Duty-Hour Limits, Reed DA et al. Arch Int Med/Vol167 (no 14),p 1487)


140 key clinical faculty at 39 internal medicine residency programs were surveyed and 111 replied. The article give the results of that survey.

While no evidence of patient safety problems were presented the faculty reported worsening communication with patients and diminution in overall quality of care ( I am not sure how quality was defined). While there was said to be lower levels of resident fatigue and improved personal-professional life balance the faculty believed generally that resident education suffered as did the accountability of the residents to their patients along with decrease in the resident-patient relationship and according to some faculty there was worsening professionalism among the residents. As faculty did more work while house staff did less work, faculty satisfaction decreased. There seemed to be less time for teaching and learning.

This is not a hard data article but a presentation of the impressions of IM resident training program teachers most of whom trained in a era that was very different. One difference is that many faculty likely grew up medically with their limbic cortices branded with the concept that as a professional obligation they should place the needs of the patient above their needs and the primacy of that directive seems no longer to hold the same exhaled position in the medical ethical scheme.

The authors say this:

...with the increasing focus on safety and the advent of duty hour restrictions, our understanding of professionalism may be evolving to include greater valuation of personal needs.

I am still trying to figure out what that means but I do not think the major driver in the sea changes that have taken place in the medical education of residents is concern about work-life balance on the residents. As to what is, I hope to say more later.

ABIM proposes certification in "comprehensive internal medicine"

The American Board of Internal Medicine (ABIM) is proposing still another piece of sanctified paper for internists to strive for and jump through hoops to obtain.

According to a news article in the July 1,2007 issue of Internal Medicine News, ABIM's Board of Directors has approved the concept and is moving forward awaiting the report of a committee,due in Feb. 2008, charged with the development of requirements.

This certification is to be optional and is called a Recognition of Focused Practice.

Apparently the board has endorsed the idea that "comprehensive internal medicine is different from what is recognized by the underlying general internal medicine certificate."

We get little information about exactly how this differs from what internists do typically.The article gives few hints. We are told that preliminary discussions about this certification lead to, according to Dr. Richard Baron, a "remarkably consistent vision". But as to specifics we are told only that the comprehensive internist should communicate effectively and have a deep knowledge of medicine and the patient.So far it sounds like what we thought we trained to do as internists and what I still think internists should do. So we need a specific certificate for that? There must be more to it. A Google search for "certification comprehensive internal medicine" lead to no useful hits. I could not find any further details on the ABIM's website. I guess if we approve of "bribing doctors" to do their job ( AKA P4P) we might as well give them an extra certificate for knowing their business and talking to patients.

This along with a similar certification for hospital medicine still awaits approval from the American Board of Medical Specialists. I don't know what the final requirements will be but I'll bet we will heard about performance indicators, electronic medical records and more hype about the "advanced medical home" and a team approach.

Great source for Travel Medicine reference

CDC has recently made available its "Yellow Book". This is free and is on line and is an invaluable source of authoritative information regarding travel medicine. For a number of years I did my fair share of travel medicine for several international companies and this publication is a necessity.

More on medical house staff work hour restrictions

I evoked a good deal of rather strong comments when I wrote about the ACGME mandated resident work restrictions. Let me go on the record and say I am not an advocate of having residents perform important medical tasks while in effect stoned from sleep deprivation. Sleep deprivation is a bad thing and when folks have to make decisions when they are fatigued and sleep deprived bad things will follow.

Medical educators all of whom have thought more and more deeply about it than I have expressed some of the same concerns that I did in a previous post. Simply put-will there be unintentional consequences and will some of those consequences not be a good thing. This would included errors involving hand offs, less educational opportunities for house staff, disruption of the typical work routines for other hospital personnel,even more fragmented patient care .

Two articles and an editorial in the recent issue of the Annals of Internal Medicine provide some reassurance for the older generation of physicians who in the twilight of their careers live mainly to ensure that the current generation of medical trainees suffer at least as much as they did during training. These two investigations found no evidence of significant harm to patients and while saying there is no evidence of harm is not equivalent to saying there is no harm, the editorial writers seemed convinced that the Hippocratic oath maxim of doing no harm had not been violated.

The editorial mentioned a new "ist" that I had not previously heard about. The term is "noturnalist". This seems to refer to attending hospitalists and moonlighting senior residents who fill in at night on the teaching service to make up for the restricted work hours of the house staff. This development is one probably of many to come as the residency programs and the institutions continue to adapt and make the new ACGME rules work better for all concerned.

Eugenics-an idea whose time has (hopefully) gone

The July 9, 2007 issue of AMANEWS (subscription required) features a two page piece on the eugenics movement in the United States, highlighting the sterilization practices in the state of Indiana which has the unfortunate distinction of being the first state( and the first government entity in any country ) to enact a eugenic sterilization law. This may come as a surprise to some that the U.S. did this before Nazi Germany did.

Those who were complicit, directly or indirectly, included several past presidents of the AMA who were described by the article as being "affiliated with the ..movement" and Justice Oliver Wendell Holmes who in his opinion upholding the 1927 Indiana law stated " Three generation of imbeciles are enough."

A key element in the Nazification of German doctors was the acceptance of the notion that they were the physicians of the Volk and that their loyalty and duty was to the collective and not the individual. Once the idea that the individual should be sacrificed for the good of the group, there is no limit to the atrocities that may follow.

2,400 persons from Indiana were sterilized without their consent as well a total of 64,000 throughout the country as some 31 other states passed similar laws.

The article's author states:

"One important brake on a resurgence of eugenics, experts agree, is physicians' insistence on putting the welfare of individual patients before society's interest"

Also quoted is Dr. Paul. A. Lombardo who has written about the eugenics saga:

"The ethical grounding of the medical profession is in treating disease and caring for people,not caring, as the Nazis did , for the state or the larger collective."

A no-insurance practice works for one internist

I attended a dinner "CME"talk a month or so ago. Across the table was a physician who I knew as an oncologist with whom I had patients in common 10-12 years ago. He was a partner in a local clinic at the time but now he had changed to a solo private practice.

"I ain't gonna work on Maggie's farm no more"

He still sees some oncology patients, some left over from his old practice which he had left 3 years ago but basically he does general internal medicine which he said he enjoys a great deal. He said he accepts no insurance at all including Medicare.He spends as much time as he needs/wants with each patient.Typically one one hour plus with a new patient and typically 30-45 minutes with an old patient but often an hour if he hasn't seen them for a while. He tells me he gets almost no calls at night or on the weekend. He has a receptionist and a nurse and the receptionist collects most of the fees at the time of the appointment and for the rest he has a contract with a local accounting company to do the followup billing.There is no back room of three clerks calling insurance companies which my dermatologist needs to run his practice.Almost all of of his new patients are referred by former patients or their families.

The clinic where he had formerly worked had progressively restricted the time he could spend with a patient.It was down to fifteen minutes but right before he left the administrator and the executive committee agreed to require three additional patients per 9 hour day.

There are no insurance company clerks to call to approve a test, he feels no pressure to report to Medicare his quality indicators and he does not worry that one day he will be told by one of his patients that he has been delisted by their insurance company because of quality issues.

He tells me that every day for the last five or six years in his old practice he went to work mad and came home madder as third party payers demanded more and paid less and as his partners tried to adapt to it all by making more demands on everyone. Now he goes to work and looks forward to the day much as he did fifteen or more years ago.

His practice is not the concierge practice in which patients may pay a yearly fee to have ready access to their physician rather his is all pay per encounter.

His practice may not be for everyone but he seems to have made it work.More power to him.

"Well, he hands you a nickle
he hands you a dime
he asks you with a grin
if you're having a good time" ....

"No I ain't gonna work on Maggie's farm no more."

Quoted Lyrics are ,of course, from Bob Dylan ( copyright 1965)

Clinical trials-another aspect of their complexity

The randomized clinical trial proudly sits atop the evidence based medicine (EBM) epistemological hierarchy. The RCT's ability to minimize known and unknown confounders suits it well (when done well) to identify efficacious treatments and to identify common side effects.

However ,subtleties lurk under the surface.One seemingly simple issue turns out to be more complicated and nuanced that it seems at first analysis. that issue is "when to stop a trial"? If the treatment under study is shown to be efficacious before the trial's planned end point, is it ethical to continue the trial while depriving those who receive the placebo for the test drug's benefit? Is it ethical to stop a trial early- possibly before there has been enough experience to find out about common adverse reactions? Will "premature" conclusions prematurely limit future research into that topic? Will any harm from premature erroneous conclusions be amplified by over-reaching ,zealous guideline authors leading to economic sanctions to those physicians who shun the dogma of the day?

Two articles in the June 19, 2007 issue of the Annals of Internal Medicine explore this issue.Dr. Mueller et al have written a Perspective piece entitled "Ethical Issues in Stopping Randomized Trials Early Because of Apparent Benefit" and Steven Goodman offers an editorial that provides a counterpoint.

Like other issues that seem to be on the front burner in current medical care discussion the underlying theme is the conflict between the individual's benefits and the benefit of the group or the collective.

Mueller and co-authors in presenting the theme that early stopping of a trial may give an overestimate of the drug's benefit use the example of a RCT using bisoprolol in patients undergoing noncardiac surgery which was stopped early because of an apparent large relative risk reduction in the treatment arm.The AHA and American college of cardiology jumped on the finding and issued recommendations. Subsequently two larger trials failed to show any cardiac risk reduction.

Mueller also quotes a systematic analysis that demonstrated that early stopped trials often lead to a significant overestimation of benefit. Goodman ,however, in his rejoinder states that the analysis only looked at that trials that stopped early whereas he contends that the proper denominator should have all trials that used stopping rules and when that is considered much of the overestimation of benefit seems to evaporate.

Rather than simply not stopping trials early Goodman believes that proper use of Bayesian analysis would go a long way to mitigate the problem raised by Mueller.The Bayesian approach basically is using prior experience and context to help decide if a trial should be stopped .

There is much more to each side that I have presented so far; the issue is complex.On the one hand, we have the issue of doing what is right for those trial participants and on the other what would be right for future patients .

Goodman ( Goodman, SN, "Stopping at Nothing?Some Dilemmas of Data Monitoring in Clinical Trials", Annals Internal Medicine, 2007;146:882-887) states it this way:

This is an extraordinarily difficult question, as scientists will differ in their assessment of both how much we have learned and how much we need to learn. There is no clear ethical guidance on the matter;the utilitarian perspective will put more weight on future patients ,whereas ethical theories that place more value on obligations and individual dignity will favor the interests of patients in the trial.

Even when my caffeine titer is maximized I have difficulty sorting out conflicting arguments of the epidemiologist-statisticians. I read Goodman and he seems right , I read Mueller and his arguments are also convincing even though his are more Utilitarian based and those ideas fare less well with my libertarian biases. My simplistic conclusion is that I need to be even more skeptical ( if that is possible) when RCTs are stopped early.