JAMA article reports dramatic reduction in hip fracture in stroke patients with b12 and folate

A recent article from Japan by Sato et al reported an impressive 80% reduction in hip fractures in a two year trial with B 12 and folic acid in patients with poststroke hemiplegia.Interestingly there were no fewer falls in the treatment group and no change in measured bone density. A reviewer ( Dr. Steven R. Cummings) in ACP Journal Club commented "The huge reduction in risk defies explanation by current paradigms of pathogenesis and prevention of fractures." Actually, we can always make up some pathophysiology to "explain" the facts. Certainty on the face of it, one has to ask why fewer fractures if no fewer falls and no change in bone density. It may well be that the treatment somehow (maybe collagen cross-linkage improvement) may strengthen bone without a measurable difference in bone density. It is well recognized that the bone density measurement does not tell the whole story about likelihood of fracture given a fall, it is just the typically used clinical measure. So should we give B12 and folate try in stroke patients with hemiplegia? It seems safe and after all a RCT resides on top of the EBM epistomologic hierarchy so why not?

retired doc back after phone cable cut and Rita

For the past week, I have been off line thanks to a cable cut incident with SBC and then Rita storming into east Texas. There is a lot to catch up with and please stay tuned.

American Heart Association and ADA disagree on significance of metabolic syndrome

Recently the ADA issued a position statement challenging the validity of the concept of metabolic syndrome. Their statement can be found here. The ADA authors said that the syndrome lacks a precise definition, is of dubious value and its underlying pathophysiology is in question.
The AHA/NHLBI panel on the other hand said that they "found the ATP criteria for clinical diagnosis of the metabolic syndrome to be a robust and clinically useful tool." and " in the absence of compelling scientific reasons for change, the AHA and NHLBI affirm the overall utility and validity of the ATP III criteria..." The executive summary can be found here. The timing of the two publications is such that it is unlikely that the AHA could have prepared a rebuttal to the ADA paper as they were published within several weeks of each other
The clinical management recommended by the two groups is very similar- more so that their seemingly disparate characterizations of the constellation of findings designated as comprising the metabolic syndrome. Everyone seems to agree that you should treat the various risk factors per se and that there is no specific treatment for metabolic syndrome, i.e. no single pharmaceutical magic bullet to fix or mitigate the underlying pathophysiology if there is one. ADA's statement indicates they are much more skeptical that there is a unifying pathophysiology than is AHA.

American Journal Medicine article paints alarming picture of current Internal medicine residency

The September 2005 of AJM features an article (Internal medicine residency training in the 21st century: Aligning requirements with professional needs, Charap MH et al. Amer J med. 118, number 9, pg 1042, sept 2005) in their APM Perspectives section that characterizes current IM residency training as an almost mission- impossible type situation. The authors from New York University Department of Medicine describe in detail changes made by the ACGME and Residency Review committees (RRCs) since 1980. In 1980, IM training was 3 years as it is now, although at some earlier date (when I trained in the 60s) training was an internship and then three years of IM residency so that total post med school education was 4 years. There was more time then and clearly less to learn . Now the total time in training is less and the amount of time "allowed" during that time frame (i.e. "duty hours") has been mandated to be less.
The entire article is worth reading if you are involved in teaching residents or interested in post graduate education.(I am sent the journal but am unable to download the articles on line so I didn't give the URL).
I found the article very troubling. Most disconcerting to me was that the following statement is no longer included in the current RRC documentation."Physicians must have a keen sense of personal responsibility for continuing patient care and must recognize that their obligation to patients is not discharged at any given hour or any particular day of the week. In no case should the resident go off-duty until the proper care and welfare of the patient is ensured." Previously the RRC-IM was careful to include this caveat that the authors consider it the " touchstone " of the internist's world. This admonition apparently went south when , in 2003, resident duty hours were further restricted by the ACGME. The RRC-Im Program requirements documents for IM residency is now 21 pages having been a single page in 1980. In the last year, training for 6 "core competencies" was mandated including training is "system-based" practice and " practice-based learning" and scholarly activity is also required. The authors make the following alarming statement : "the reality is that residency programs simply cannot satisfy these ever-increasing requirements other than as paper achievements responding to paper audits."
They make several recommendations which include : Restoration of the above quoted "touchstone" statement, not adding more requirements unless they are linked to equivalent reductions, convening a blue ribbon panel ( not affiliated with ACGME) to review all of the RRC-IM requirements, allowing more flexibility in the program to meet the diverse career interests of current day residents.The authors definitely believe that changes must be made because " there is simply insufficient time to educate internal medicine residents in the present regulatory environment"

If you thought medical school was hard before (katrina)...

A section in the Tulane Medical student web site for comments for the now Katrina displaced(to be largely relocated in Houston) students has the title "'If you thought Medical school was hard before". A sense of humor doesn't hurt. The exploits of Dr. Tyler Curiel-head of heme-oncology at Tulane- could be called " If you thought doing medical research was hard before...". His lab, like so many other labs at both Tulane and LSU, continue to be without power and much research material has either been ruined or will soon be. Some his work was preserved by using liquid nitrogen to freeze valuable samples before the power went out. The nitrogen induced freezing is finite ( maybe two weeks) and his efforts to return to New Orleans and refreeze valuable material are explained here. The logistics of returning to the Tulane Medical center and applying liquid nitrogen to storage chests in a building without power is daunting but apparently Curiel will ( or perhaps at this writing already had) pull it off. He acquired the aid of Phazar Aerocorp who has donated jets and employees to aid in the mission. It will involve carrying 400 lb. tanks of nitrogen up various flights of stairs to the various labs and working in the heat and dark. He and his wife, Dr. Ruth Berggren, spent endless days and nights caring for patients in the Tulane University Hospital and Charity Hospital before being evacuated to Fort Worth. The exemplary behavior of many of Tulane's faculty in that time of unprecedented crisis focused attention of some prime time role models for the Tulane Med students who no doubt have some major challenges to overcome this year to continue with their medical education.(The above referenced newspaper article is now several days old, if any readers have learned more recent information, please let me know).

Texas Medical Association skeptical of UHC's "Premium Designation Program"

UnitedHealthCare representatives have met with the Texas Medical Association's (TMA) leaders to introduce their program designated as Premium Designation Program which will hand out stars to good doctors. I still remember the stars I was awarded on my grade school papers. Physicians who meet either the quality standards or the efficiency standards that UHC devises with be designated as either having one or two stars (two if both criteria are met) and a triangle will be the scarlet letter for those whose data is insufficient to analyze or if their specialty is not included in the program. Apparently the grading system will be based on claims data.UHC said that initially the program won't be used to penalize or reward physicians monetarily. Writing in the September 2005 issue of Texas Medicine , the senior editor quoted a 7/21/05 letter from the TMA General Counsel to UHC in which the TMA wanted to make it clear they did not endorse the program. Several physicians who attended UHC briefing sessions complained that UHC either implied or stated that their program was endorsed by the TMA. A program in which a star is given on the basis of claims reviews for "efficiency" is not a quality initiative. It is a cost containment mechanism. The program as currently touted by UHC seems to contain none of the AMA 's five requirements for a quality improvement type P4P program. Typically, TMA has been a strong advocate for physicians and patient care and so far it is willing to point out exactly how the emperor is dressed. The insurance industry's Trojan horse of quality seemed to have been welcomed within the walled city of the American College of Physicians (ACP) and perhaps other national medical organizations. While I continue to hope that national organizations can make a difference, I believe that meaningful resistance to this latest cost containment-profit enhancing- initiative of big insurance will be at the level of the state and local medical societies.

No reduction in GI cancers from antioxidant supplements-caraway extract for IBS?

The Sept. 6 issue of the Annals Internal Medicine reviews an earlier Lancet article ( Bjelakovic, G et al-Lancet 2004:364;1219-1228) which not only concluded that antioxidants do not prevent GI cancers but may increase the risk. The data clearly did not show cancer reducing benefit form the supplements included (various vitamins and selenium) but the conclusion of possible increased risk seems unwarranted as the Annals reviewer explains in his analysis. The increased risk (R.R=1.06) was found in a fixed-effects model which is said to be used if the data appear to be homogeneous but 7 of the trials seemed to be heterogeneous. The random effects model analysis did not show an increase in all-cause mortality and that type of analysis is usually what is employed with heterogeneous data.
The same review section ( Update in Gastroenterology and Hepatology) includes an article of a RCT evaluating the use of herbal preparation for the treatment of IBS. 208 patients were assigned to receive 1 of 4 regimens. An abdominal symptom score was the endpoint of interest. 2 of the 4 regimens were said to bring about significant improvement in symptoms scores.Both regimens contained peppermint and caraway fruit. The reviewer concludes that practitioners "should consider" these herbal preparations to their armamentarium for IBS. I know there is considerable energy in the efforts to make respectable complementary and alternative medicine but one small RCT seems to me inadequate evidence to include these herbs in your treatment choice bag just yet. (There are a few other small trials using the combination of these two herbs for treatment of "non-ulcer dyspepsia" but are we seeing a type of affirmative action for alternative medicine . FDA approval would not be granted for a prescription medication based entirely on one RCT.)

Disease Mongering-One more obstacle in the search for medical knowledge?

Recently, the American Diabetes Association (ADA) issued a statement casting doubt on the validity and usefulness of the concept of metabolic syndrome and suggesting that physicians not make that diagnosis. One of the news articles about this statement used the term disease mongering.I had not previously been aware of that term. Mongering has two dictionary definitions:
1) to deal in a commodity 2) to promote something undesirable or discreditable. A 2002 BMJ article deals with disease mongering which describe as follows: " Some forms of "medicalization" may now be better described as " disease mongering"- extending the boundaries of treatable illness to expand markets for new products.
A 1992 book entitled "Disease-Mongers" by Lynn Payer, health editor of the New York Times, provides an early application of that characterization.Two years earlier, Ivan Illich's often quoted "Limits to Medicine" had dealt in part with that subject.
The BMJ article speaks of disease awareness campaigns that are linked to companies' marketing strategies and company sponsored advisory boards, risk conceptualized as diseases and disease prevalence estimates constructed to maximize the impact and importance of a given medical issue.
Osteoporosis was given as a example of a risk conceptualized as a disease. A diagnosis of osteoporosis can be made on the basis of a bone mineral density (BMD) test if the patients' test results vary sufficiently from that of a normal young woman. BMD is one of the risk factors for osteoporotic fractures but in this formulation a low BMD becomes a disease worthy of ICD coding, prescription medication and continuing followup with more BMD determinations. The authors reference the role of drug companies in sponsoring meetings where the disease was defined, and funded studies of therapies and patient groups and and disease foundations.There has definitely been a paradigm shift, patients at some higher level of risk for fracture have been defined as having osteoporosis and there is widespread knowledge of the test, the new definition and patient acceptance of prescription medication.
All of this has to give a physician some cause for concern. Have we been bamboozeled by Big Pharma, have patients and physicians been sold a bill of goods? The authors would say yes, but I do not believe it is that simple. Trying to disentangle the facts from drug company hype and spin in a literature so often highly influenced by those drug companies is no easy task.
The treatment of osteoporosis has a sound foundation. 25 years ago we had no treatment for the painful complications of osteoprosis, we do now. That is not the issue. The issue is are we preemptively " treating" a low BMW to prevent clinical osteoporosis because we have been convinced that this is the appropriate thing to do by pharma hype. Maybe so, but that does not necessarily mean we shouldn't do it. Risk of fracture is clearly reduced by bisposphonates. Bisphosphonates appear safe and effacious and for a patient at an increased risk of osteoporotic fracture it is reasonable to offer that patient the option of prescription medication to mitigate that risk even though we may have not reached that point if not for the promotional efforts of drug companies. With the spotlight that has been focused on Pharma's antics, I want to believe there will be less disease mongering and both physicians and patients will be more skeptical and immune to influence.
Specifically in regard to the metabolic syndrome and relevant to disease mongering discussions, at least one drug company cannot be pleased with ADA's recent statement challenging the validity of the concept. I read today a two page ad from Sanofi Aventis in which "a newly discovered physiologic system" is highlighted, namely the endocannabinoid system which is alleged to be overactive in the metabolic syndrome Their drug, rimonibant is an antagonist of this system and FDA approval for treatment of the metabolic syndrome would be more valuable than treatment for obesity alone an application for which it has demonstrated some usefulness.
Fox Mulder believed the truth is out there somewhere.Physicians typically do as well, but it is harder to grasp the truth when we have serious doubts about the veracity of the data underlying our practice decisions.

The doctors and Nurses of New Orleans Charity Hospital

Fox News interviewed a nurse at New Orleans Charity Hospital last night. She and her fellow nurses and the physicians had been fighting against everything for the last few days, disease, injury, diminishing supplies and food and water living and working in a island without outside help.
She said they kept it all going because that is what doctors and nurses do and what they accomplished was done without help from the city, state, FEMA or anyone else. That dedication and focus on patient care is what doctors and nurses are all about. Making patient care and welfare first is what was imprinted in my limbic cortex at the same institution over 35 years ago. My wife and I became doctors there at LSU and Tulane Medical School and "Big Charity" and our hearts are breaking as we sit glued to the TV and Web absorbed in the misery as memories flood our minds of a time of youth and promise as we underwent the transformation from young adults in our early twenties to physicians. We are so proud of the current generation of faculty and students at the two med schools fighting the good fight in the face of impossible conditions and risk to themselves. Dr. Roy Poses and others on their web sites do a great service by pointing out and fighting against the outside forces that erode the core values of physicians but , by God, when the chips are down, the core values are there as the actions of the doctors at Charity and other N.O. hospitals illustrate so heroically.