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Friday 17th of October 2008 11:05:49 AM
What with the downtime imposed by a hurricane and the confluence of a bunch of other family and personal stuff, I think it best to-at least for a while-take blog writing off the table.I probably can't resist posting a few wonderfully cogent comments on some of my favorite medical blogger sites but little more than that for a while. I have beaten to death a number of my favorite themes and I need to re-fire the belly. I promise not to reappear in a new role as a political pundit.That market is super saturated anyway. So for a while, so long and thanks for all the fish.
From by james gaulte Research This Blog Entry
Thursday 25th of September 2008 11:25:37 AM
Now 12 days since Hurricane Ike and still no power to my part of the Houston area. So no blogs for a while and for a short while to come. I only have access to a friend's computer or the wi-fi at a mall. Maybe next week things will be up and running again. Hopefully, my three readers will be patient.
From by james gaulte Research This Blog Entry
Tuesday 09th of September 2008 03:36:45 PM
Every time I mention there may possibly be some problems with the work hours restriction regarding house officers, I receive a barrage ( OK, 1 or 2 comments) from folks who consider me to be a old jerk who just wants a return to the good old days and that I want nothing more than to deny house officers time with their families so to better achieve the nebulous work life balance.
Thanks to Kevin for alerting me to this news item. In part, it seems like some surgery residents have been caught working too much in their misdirected efforts to try and learn to be good surgeons. Shame on them.
To disabuse these rebellious surgeon in training from their anachronistic aversion to shift work for physicians, efforts should begin earlier, i.e. in medical school. Rules should be implemented to limit the hours of study allowed for medical students.
From by james gaulte Research This Blog Entry
Saturday 06th of September 2008 10:39:58 PM
Sometime in the 1980s the term "work-life balance " ( which I will abbreviate as "wlb" to save key strokes) began to seep into the universe of conversational and literacy discourse. I suggest the term itself may be a bit of a self contradiction or at least a poorly constructed notion. Work for the great majority of human adults is part of life so would not "work-non-work balance" be more to the point.
And the point seems to be basically that there is said to be some appropriate distribution of the hours in a week or day so that the proper of amount of time is spent working and in the other various domains of existence, which would including family time,recreation,and you fill in the blank with religion or community service or duck hunting.WLB had become a buzz word particularly in the business world wherein it is widely believed that companies must make some highly visible effort to help their employee achieve this wlb or at least appear to do so.
It is a modern concept and a concept that makes sense only when folks achieve a certain degree of affluence. It would have made no sense to talk to our ancestors who worked the land from dawn to dusk and then collapsed in bed to talk about balance. Pretty much every thing was work. Similarly millions of people who eek out a barely adequate living in those parts of the world now call developing (formerly known a underdeveloped) are not too concerned with discussion about the best way to balance their lives. In the 1970s and before medical students and house officers did not lobby their trainers, teachers and exploiters for a better balance in the work and non work lives.I don't know why we didn't , maybe we just were not that evolved yet or maybe we thought we could not get away with it.
When I did consultation work for a large international corporation, I frequently did examinations for overseas travel and executive physicals for the top small percentage of the employees. One such person was tasked to consult with high level managers to work out ways in which those managers could make it to happen that their employee would achieve this wlb. This individual traveled around the world visiting various general managers and vice presidents and noted that most could be fairly described an "workaholics". He told several of them that they would never achieve the alleged goal of more wlb without the leaders serving a role models. Almost to a man (or woman), the reply was basically : Look if I slow down or work less, some sob will take my job." The wlb manager soon retired early and moved to a ranch in Montana ( I am not making this up ).
Government officials and politicians who get into some type of hot water such as accusations of wrong doing often decide to retire and give as reason " spend more time with my family". Nothing like getting caught to convince one to balance their work and life.
For some, their work is their life even though their position is such that they could opt to fish more, be ushers at church or have regular meals with their spouses. For them the balance is heavily shifted to the work side. Consider the degree to which physicians in their training shift much of their lives to the studying and working for a prolonged period of time. Do they accumulate a great unmet need for other activities so that when they finally finish training they are ready to catch up and re balance their wlb ratio, in part by becoming shift workers? Maybe so. Or since the income rewards are getting less and less and the prestige of physician work is diminishing and the autonomy is getting harder and harder to even find and when the pride of being physician gets to some personally determined tipping point maybe it is more politically correct to say you need more time on the life side of work life balance than to say screw it.
From by james gaulte Research This Blog Entry
Tuesday 26th of August 2008 06:40:36 AM
A tip of the blogging hat to DB's Medical Rants for this reference.
This article by Ian Shrier and others from McGill investigated the subjectivity of meta-analyses and concluded the following:
The interpretation of the results of systematic reviews with meta-analyses includes a subjective component that can lead to discordant conclusions that are independent of the methodology used to obtain or analyse the data. And things get even more mushy when the statistical experts differ as to what methodology should be used.
In their discussion this paragraph says it well :
Our results suggest that a systematic review with a meta-analysis must be viewed with the perspective that it represents one study conducted by specific investigators with a specific methodology. At each step of the methodology (defining the general criteria, search strategy, inclusion/exclusion criteria, data abstraction, and analysis), subjective decisions are required that could affect the validity of the study; the relative importance of each will likely depend on the topic of inquiry and the data acquired. Our study demonstrates that disagreements in the conclusions of systematic reviews with meta-analyses can also be due to subjective interpretations of the results and not only of the methodology. The inclusion-exclusion criteria often are determinative of the outcome.Meta-analyses can be thought of as observational studies in which the subjects are trials.
Of course meta-analyses involve subjective judgment calls and various type of personal bias that the investigators bring to the table. How could it possibly be otherwise?
This gives me still another opportunity to reference the classic editorial in the Annals of Internal Medicine by Steve Goodman of Johns Hopkins which I discussed at some length here. To sum it I can do no better than to quote Goodman:
Judgment determines what evidence is admissible and how strongly to weigh different forms of admissible evidence. When there is consensus on these judgments and the data are
strong, an illusion is created that the evidence is speaking for itself and that the methods are objective. But this episode should raise awareness that judgment cannot be excised from the process of evidence synthesis and that the variation of this judgment among experts generates uncertainty just as real as the probabilistic uncertainty of statistical calculations.
I never tire of repeating my rant that meta-analyses should never have been placed at the top of the evidence based medicine evidence hierarchy.And for that matter biological plausibility should never have relegated to lower rings of the ladder.
From by james gaulte Research This Blog Entry
Wednesday 20th of August 2008 07:18:26 PM
Dr. Jonathan M. Edelman, Director of Scientific affairs for Merck, has offered this reply to the charges leveled in the Annals of Internal Medicine article which had characterized the Advantage trial as a "seeding trial".
Dr. Edelman denies that it was, in fact, a seeding trial and that it was designed to answer a significant, scientific question describing the trial as one in which Vioxx was compared with a widely used drug Naproxen in a "real life" setting and involving patients who were allowed to take aspirin as well and - as such- answered questions that were relevant and pertinent to practicing physicians. He also denies that participants were not properly informed about the purpose of the trial.
Edelman also says that the trial "was designed, conducted, analyzed and interpreted by the scientific department of Merck." I had implied otherwise in my comments in an earlier entry on this subject perhaps inappropriately embellishing this following statement from the Annals article, "Merck's marketing division, ...handled the scientific and marketing data including collection, analysis and dissemination." However, which group or groups within the company designed the trial does not settle the question of if this a seeding trial or not.
Dr. Carlat has also taken up this topic and interviewed one of the authors of the Annals article.See here for the interview. The WSJ.Com Health Blog also writes about this issue here. The Med Page Today bl og tackles this topic also.
Details of how much and what was disclosed to the patients and the participating physicians is not made clear by either the Annals article or the Merck reply.
From by james gaulte Research This Blog Entry
Monday 18th of August 2008 04:36:00 PM
A number of e-mails and other internal Merck documents became fair game for analysis and critique when they became available as part of the discovery process of a civil suit involving the cardiovascular safety of Vioxx and this analysis is published in the August 19,2008 issue of the Annals of Internal Medicine . (The Advantage Seeding Trial: A review of Internal Documents, Hill KP et al, Annals Int Med. 2008;149;251-258).
The documents discussed in this article are concerned with a trial called ADVANTAGE which was said to assess the differences between Vioxx and Naproxen regarding side effects and effectiveness in the treatment of osteoarthritis.The trial involved 600 investigators and 2785 patients and was ultimately published in the Annals of Internal Medicine giving the results of a 3 month followup.
The current Annals article(needs subscription) takes the reader into the real life example of the world of a clinical trial that is designed and executed by the marketing ( not the research) division of a pharmaceutical company. This type of trial has been referred to as a "marketing trial" or a "seeding trial". The term " seeding trial" is actually used by involved employees although one company e-mail advised against the use of the term even in in-house writings.Although it has been suspected and alleged that drug companies sponsor these marketing trials this article is said to be the first documentation of at least some of what goes on in the company as the trial is planned and carried out.
Perhaps new to some physicians the seeding trial is nothing new at all in the world of marketing as explained in great detail in this reference which puts the idea in the context of opinion leaders, the Hawthorne effect and the tipping point. (for some reason I could only pull up the cached version.)
If the idea worked for Post-Its-as the above reference explains-why not for prescription drugs?
Psaty and others have decried the use of these low quality ( from a scientific or statistical point of view) trials and I wrote about in 2006 with some fairly unkind words about the physician opinion leaders who participate and make these marketing trials possible.
Doctors Harold Sox and Drummond Rennie wrote the editorial in the August Annals entitled "Seeding trials: Just say "no" " They wrote that the key to a successful seeding trial is deception. I would like to believe that many or most of the physician investigators were deceived as the alternative is that they knew it was wink-wink-nudge-nudge pretense of a trial and the term co-conspirator would apply.
Sox and Rennie said the Annals published the trial because no one told them it was a seed trial.One has to wonder why the editors had to be told. A 1994 NEJM special article made clear the characteristics of such trials and the Advantage trial was published in the Annals in 2003.David Kessler and co-authors in their NEJM article said the following about these marketing trials.
Features that distinguish such trials from scientifically rigorous studies include the use of a design that does not support the stated research goals, the recruitment of investigators not because they are experts or leading researchers but because they are frequent prescribers of competing products in the same therapeutic class, disproportionately high payments given to "investigators" for their work (although the only work may be to write prescriptions for the drug), sponsorship of the studies by the company's sales and marketing division rather than its research department, minimal requirements for data, and the collection of data that are of little or no value to the company. Typically, these trials involve introducing a new drug in a crowded therapeutic class. The success of such a new product may depend on undoing physicians' comfortable habits of prescribing a competing, more established product.
Hopefully with the spotlight of the current Annals article and editorial, editors,review boards and potential physician investigators will be less likely to be deceived and will "say no"and protect the real victims of these trials namely the patients who often in good faith thought they were furthering science and helping other people with the disease under study while in fact they may put themselves at risk for side effects for no reason other than increasing the sales of the medication.
From by james gaulte Research This Blog Entry
Friday 15th of August 2008 11:52:08 PM
Enticed by pizza and promotional pens and mugs, enchanted by attractive, tricky drug reps and hoodwinked by cleverly crafted medical articles that have been funded by Big Pharma the woefully undereducated and incredibly gullible and naive medical doctors may look forward to having help from the government . At least that is being proposed, see here for news about that.
The plan is for the government to hire unbiased docs who will go forth and detail the office docs but this time the detailing will be done by folks who know the truth. It has become very difficult for someone with only a college degree, four years of med school and from 3-8 years of further education to sort the truth from the hype in regard to medication use. Fortunately, once the government hires someone with similar educational background to disseminate the unbiased truth they apparently- through the magic of government funding- become able to pluck the nuggets of truth from the dung of pharma manufactured propaganda and the razzle-dazzle of the traveling hired guns.
There are some cynics who believe that government decisions themselves have an unfortunate but predictable tendency to be biased, confused and self interested but the high-school civics class notion of the governmental agency or agent who is free of self interest and serves only the public good has considerable currency in spite of overwhelming evidence to the contrary.
As suggested by "The Last Psychiatrist" blog -does it not worry anyone that Congress believes or claims that physicians are so clueless that the government has to send out "academic detailers" to instruct the docs as to proper patient care?
I also wonder how have they been able to practice medicine before without that help?
Were not the "academic detailers" hired by the medical education companies hired by the drug companies thought to be part of the problem? Well, with a different source of funding things will change.
From by james gaulte Research This Blog Entry
Tuesday 05th of August 2008 07:29:05 PM
In a recent Medscape edition (July 1,2008) we find a disturbing essay by a practicing academic pediatrician who expresses concern about some of the unexpected consequences of the restrictions placed on medical house staff work hours. I find it disturbing in part because what the author describes could not be further from the notion that the physician (house staff) should not leave until his patient is taken care of.
Dr. Jane R. Gilsdorf, from the University of Michigan Medical Center, pulls no punches with this sentence:
The current system is creating a legion of shift-worker physicians who leave when the clock strikes a certain hour rather than when the job has been completed.
In discussing this with a former partner, who taught internal medicine residents for over 30 years and retired one year after the work rule changes were implemented, he had this cynical comment to make:
"Maybe it is good that the residents learn that approach early on because it seems that most docs are becoming shift-workers. Consider how things often work. You have a primary care doctor who has defined office hours and when you call his number after hours you either get a "triage nurse" or a recording that basically says call back tomorrow if it is not an emergency or go to the ER if it is an emergency. At the ER you see an ER doc who is working a shift and if you are admitted you are likely seen by a hospitalist who also is a shift worker. The notion of a personal physician whose role transcends duty hours is dead in the water."
Dr. Gilsdorf opines that more funds are needed to help correct the problems brought about by the ACGME work restriction rules. Basically, someone needs to be paid to do much of what the house staff used to do and now cannot. Dr. R. Centor discusses some of the problems brought about by the ACGME work rules and suggests with good planning,teaching and hard work many of them can be at least to a significant degree mitigated and I believe he is probably right.
However,how the broader "shift-workerization" of physicians can be reversed is another matter.Major shifts in the economic forces regarding physician and hospital compensation have brought that about and that big ship will be hard to turn around.
From by james gaulte Research This Blog Entry
Thursday 31st of July 2008 02:45:42 PM
Dementia prevention and statins are again in the news with this study. Previous studies offered contradictory data , some showing an benefit in risk reduction in the development of dementia from statin use while others did not.
The current study is a bit more robust than some of the previous ones as patients were followed over time and periodic tests of cognitive ability were performed and the statins users scored higher.
Another study (a meta-analysis-and thanks to Dr. RW for that reference) offered evidence that post operative onset of atrial fibrillation can be reduced by statins. I guess we could use something new now after those unpleasant, unintended consequences noted from giving almost everyone beta-blockers pre op.
I have marveled before about how many good things can be attributed to statins all of which make me feel good about taking one of them even though my LDL wasn't all that high anyway.
I have written before about the contradictory results regarding statins and risk of colon cancer and commented that another case-control study will not settle that issue (for that matter,any issue) but that is exactly what the NEJM published in the face of previously published dueling case controls studies addressing that issue.
The story of dementia and statins is still being written but maybe in the meanwhile we can keep exercising in the hope that it will keep our hippocampi big and healthy and our frontal lobes relatively free of white matter bright spots.Anyway it would be nice to think so.
From by james gaulte Research This Blog Entry
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