Wednesday, September 30, 2009

We cannot trust drug company studies so we need a government panel,one that is not biased

I read the medical blog "The Last Psychiatrist" (TLP) regularly.Sometimes I think I understand it.I keep going back because at some level I just know he has a lot to say even if some(much) of it escapes me.

In this entry (see here) he takes on a recent commentary by Dr. Daniel Carlat.Dr Carlat gained some degree of name recognition when he renounced his lucrative life as a drug company paid speaker and has become an outspoken critic of many of the drug companies practices including those involving paid physician spokesmen.

TLP quotes Carlat making the point that people respond to incentives and with financial incentives at work how can you trust someone's analysis of the value of a given medication.How can you trust what a drug company's research or spokesman says?

Here is the passage from The Last Psychiatrist that really nails it: (my bolding)

This is the same error people make about the need for government intervention, e.g. that the "free markets" have failed and more regulation is obviously needed. Even if one were to agree on principle that people can't be trusted, the mistake is in forgetting that government is people. These people are subject to the same biases, cognitive errors and general prejudices as the guys at Goldman Sachs, albeit currently it in the opposite direction. We can argue that we prefer the government's biases, but one cannot argue that the government is less biased, self serving, or corruptible.

This may originally have been a country of laws, not men, but that's not the country most modern people want; they want to be able to alter the laws to suit the times. Fine, it's your country. But understand that if the laws are subordinate to men, then the enforcers of those laws will always have more power than you. Has anyone tried to get an anti-Depakote study published in J Clin Psych in the past decade?

It's excellent that Daniel Carlat thinks doctors like himself cannot be trusted to read and interpret their own studies, and that some other group of-- doctors? lawyers? what?-- with special bias-immunity rings need to be assembled to protect us. But those people are still people. This is why the NIH, with their incestuous grant reviewers, crazy politics and flavors of the decade philosophies is so dangerous-- they're just as biased as Pfizer except you think they are objective.

He captures the basic thoughts of the "Public Choice" school of thought. The people who comprise the government are just like the people not of the government in that they too are biased,self-serving and corruptible and respond to incentives and constraints just like everyone else.

His closing paragraph make it clear

People would do well to remember that at one point in our nation's history, "government" was George Bush. When you argue that government needs to be more involved, you are arguing that George Bush needs to be more involved. I do not trivialize this discussion by offering Barack Obama as an equivalent example of the government you want so desperately to supervise your lives.

Monday, September 28, 2009

See what Baucus bill has to offer in 2015 (just one little part)

A very grateful tip of the hat to Health Care Renewal for information about one of the things that lies in store after the next presidential election in regard to payment to the likely-to- be- far- fewer- physicians who are still seeing medicare patients. See here.

Page 80-81 of the Baucus bill has the following:
"Beginning in 2015, payment [under Medicare] would be reduced by five percent if an aggregation of the physician's resource use is at or above the 90th percentile of national utilization." Thus, in any year in which a particular doctor's average per-patient Medicare costs are in the top 10 percent in the nation, the feds will cut the doctor's payments by 5 percent."
The Washington Times (see here) has this to say:

This provision makes no account for the results of care, its quality or even its efficiency. It just says that if a doctor authorizes expensive care, no matter how successfully, the government will punish him by scrimping on what already is a low reimbursement rate for treating Medicare patients. The incentive, therefore, is for the doctor always to provide less care for his patients for fear of having his payments docked. And because no doctor will know who falls in the top 10 percent until year's end, or what total average costs will break the 10 percent threshold, the pressure will be intense to withhold care, and withhold care again, and then withhold it some more. Or at least to prescribe cheaper care, no matter how much less effective, in order to avoid the penalties.

This proposal is just another in the long list of "perverse incentives" that John Goodman speaks of here. This is another example of a situation in which the interests of the physician will be pitted against the best interest of the patient. In a way the proposed provision is blatantly straight forward; its aim is to save money and to do so without pretending that there will be an increase in quality plus there will always be 10% of docs who will have their fees reduced.

Friday, September 25, 2009

PPIs blunt effect of clopidogrel-yes they do,no they don't

Patients and physicians alike had to be a bit worried when this study suggested that PPIs decrease the efficacy of clopidogrel and could lead to more cardiovascular events. But the story continues and the results of the COGENT study discussed here said "no" : presumably offering some reassurance that the putative PPI inhibition of the desired beneficial pharmacological effect of clopidogrel is not really a problem.

What if the articles were published in reverse order?

Does the fact that COGENT was a randomized trial with placebo versus omeprazole in patients on clopidogrel and the Medco data study was more of a data dredge mean that we have no need to worry? Or does the fact that the COGENT trial was stopped ( the sponsor,Cogentus, filed for bankruptcy) before the planned number of patients were enrolled limit the power of the trial to find a real difference mean that we should question how much we should really be reassured? Can anyone tell me if the prematurely stopped COGENT trial was adequately powered to show a difference as great as that reported in the Medco study?

Thursday, September 24, 2009

The villian is fee for service-of that we can all agree?

Health care costs too much and it will cost more and we are told that a major cause of this is the fee for service system (apparently obesity is the other cause) that rewards volume and not quality.So to bend the cost curve ( I presume they mean bend it downward),we must do away with physician fee for service and pay for quality. Quality is nebulous and floating and if Congress has its way the definition will be whatever the secretary of HHS says it.

What does this really mean?

I think Dr. Wes nails it cleanly here when he says"

"Perhaps I'm too cynical, but I think the subliminal message coming from Washington so far is really this: doctors should be happy becoming salaried employees of larger health systems. This way, the government can pay the health system a bundled fee and the doctors can fight for their share of the kitty."

The larger health care systems, the vertically integrated systems, that some allege will save us from the old-fashioned and very harmful fee for service is a topic that I spent some effort ranting about two years ago.
see here. Not only will it save money but it will further the ubergoal of social justice. Those systems offer a chance to employ the utilitarian ethics to the cost curve bending exercise.

Monday, September 21, 2009

Dr. Richard Cooper's views get aired on major economic blog

Arnold Kling is one of the economists whose blogs I have begun to read lately ( lately being since the stock market tanking in 2008 scared the heck out of me ) In this entry he gives well deserved blog time to the thoughts of Dr. Richard Cooper who- is among other things (quite a few other things)-an outspoken and well spoken critic of the Dartmouth studies on regional variation in Medicare expenditures, a study that Mr. Peter Orszag and others in the Obama administration seemed to have taken as gospel truth.

Dr. Cooper points out several flaws in the widely quoted Dartmouth studies and their conclusions and the purported remedies based on that work. I have blogged about Dr. Cooper's views before. He argues , in part, that just looking at Medicare expenditures, which is what Dartmouth did, gives a false impression of what is really going on. One should examine total costs and when one does a different picture emerges, one in which more expenditures does correlate with better outcomes which is certainly a conclusion more consistent with common experience.

Monday, September 14, 2009

So what do tires and a tariff on Chinese tires have to do with health care?

The United States has moved to impose a tariff on imported tires from China.See here for WSJ article.

With the stock market swoon of 2008 and dire predictions of another great depression blaring from just about every "news" source and while I watched some significant percent of my retirement assets drop, I morbidly began to try and educate myself about the great depression. One thing I learned was that tariffs are not a good thing from an economic point of view.

While admittedly much ( but not all ) of what I read was more to the Austrian and Monetarist economic sides of the aisle there seemed to be agreement about at least two factors that took a severe recession and made it great; monetary actions of the Federal Reserve in reducing the money supply and the Smoot-Hawley tariff.

As best I can tell, economists of almost every stripe agree that free trade is a good thing and tariffs are not. A tariff is a tax on imports. The following is a quote from a text book on Macroeconomics by Paul Krugman and Robin Wells. Dr. Krugman has made it very clear than he is not of the Austrian School of economics and seems to be more in agreement with at least some of what Keynes said.

[A tariff] raises the domestic price above the world price,leading to a fall in trade and domestic consumption and an increase in domestic production. Domestic producers and the government gain , but domestic consumer loses more than offset the gain leading to a dead weight loss. ("Dead weight loss" is a term of art in economic circles and you can read about here without a graph or here replete with a graph and cogent comments by a real economist-Dr.Mark Perry of University Of Michigan- who discusses the issue in the context of the recently imposed tariff.)

Since the President has access to a number of highly educated and intelligent economists who would, if asked, would be likely to tell him that from an economic of view a tariff is not a good thing to impose,it seems unlikely his actions are being done in a belief that it will the economy. Perhaps political motivations are more likely.What could that be?

The United Steelworkers union supports the action. Could the tariff move be another gift to the unions from which the Obama administration might reasonably expect support for their health care reconstruction plans, particularly in regard to putting pressure on the Blue Dog Democrats who may have reason to worry about reelection and whose vote may be crucial to the health care bill passage.

Tuesday, September 08, 2009

Is Roflumilast the next drug for obstructive lung disease?

The answer seems to be a firm "maybe".

Remember aminophylline.Once a mainstay in the treatment of asthma and COPD exacerbations as well for longer term therapy in the form of various oral preparations, it now generally considered a third line medications almost about as likely to be used as the 12th man on the NBA bench in a close game.

Interestingly, one of the purported ways that aminophylline was thought to exert a therapeutic effect was its inhibition of PDE3 and PDE4. Now a new drug, roflumilast, is being studied to treat obstructive pulmonary diseases is also a phosphodiesterase inhibitor.

Recently four phase 3 clinical trials were published in the Lancet.See here for a brief summary.

The four trials involved 4500 patients;two lasted six months and two for one year. A decrease in exacerbations was shown as was a slight increase in some parameters of lung function.These statistically significant outcomes occurred in patients who were already taking a long acting beta agonist or an anticholinergic ( Tiotropium). Nausea was the most common side effect.

Friday, September 04, 2009

Why are placebos thought to be getting stronger?

I read the blog Wired from time to time to make some slight attempt to keep up with really cool innovations and products in the land of the wired.In doing so I came across an excellent essay on placebos. See here .

Here is one sample from the article:

"Two comprehensive analyses of antidepressant trials have uncovered a dramatic increase in placebo response since the 1980s. One estimated that the so-called effect size (a measure of statistical significance) in placebo groups had nearly doubled over that time."
[Unfortunately, no references are given in the article].

If the placebo effect is getting stronger, why would that be?

One thought is that the direct to consumer drug company advertising has had effect(s) greater than simply promoting sales for a given medication.Perhaps it could generate greater belief in the effectiveness of pills in general which has stirred up a greater expectation of something good happening to people who take medications.Drug company advertising is just one force pointing in that direction;so do the activities of various disease promotion organizations (some of which are thought by some cynics to really be put-up jobs by the drug companies) and the general trend that seems to make almost everything a medical problem.

The "expectation effect" is a topic of relevance to the placebo effect. A patient can expect the announced beneficial effect of a pill and this has been shown in some experimental settings to increase the release of endogenous opioids. This article from Scientific American gives some detail and background regarding this issue.Areas of the brain that deal with weighting of events and threats seem to be activated by placebo through this mechanism of anticipation. Some studies have indicated that subjects who sign up a drug study may experience beneficial effect even while they are put on the waiting list.

Harriet Hall offers a detailed discussion of various issues related to the placebo effect here in the May 20th 2009 issue of the blog "Skeptic".

She outlines 4 possible ways placebo might work;

2.Motivation (folks want to get better and often sign up for clinical trials)
3.Conditioning ( maybe all of us have become somewhat conditioned to believing pills make us better is in no small measure due to the effect of drug company and disease promotion groups advertising )
4.release of feel good substances such as endogenous opioids.

Wednesday, September 02, 2009

Do resident work hour restrictions transform professionals to shift workers?

The answer according to Dr. John D. Rybock,from Johns Hopkins School of Medicine, is "yes". Dr. Rybock in a letter to the editor published in the August 27,2009 issue expresses the opinion that the duty-hour rules of 2003 have "taken away their(residents) control" and prevent them from making decisions that characterize a professional.

In regard to limiting work hours he says:
"We now force them to leave a patient with whose treatment they are intimately involved or to cease the observation of an instructive surgical procedure midstream.It did not take long for this system to produce residents who would either walk away when their time" had expired or else lie in order to violate the rules.Although we added "professionalism" as a training goal, we began giving our trainees the choice between abandoning a patient and lying."

As pointed out in another letter to the editor in the same issue of NEJM: It has now been six years since the implementation of the 2003 ACGME regulations and there still is no consensus or clear cut evidence on whether the work-duty hours changes have improved safety and the debate continues on the effect on residents' medical education.

I continue to be amazed at how much impact the pronouncements of the IOM have and how there seems to be so little questioning and criticism of their recommendations.The IOM recommendations regarding further limitation of work hours seems to be taken seriously by ACGME.

An editorial in the NEJM presented the voice of reason.(Blanchard,MS, et al, To nap or not to Nap.Residents' work hour revisted .NEJM 2009,360,2242-4). That editorial recommended careful studies on the impact on the new IOM recommendations regarding patient safety and other relevant end points before widespread implementation of further restrictions.

Tuesday, September 01, 2009

Closer and closer to a new oral anticoagulant (dabigatran)

Actually, there already is a new oral anticoagulant available in Europe and Canada at least for the application of clot prophylaxis in hip and knee surgery patients.Dabigatran is an oral direct thrombin inhibitor that is taken twice a day and requires no blood test monitoring .In Canada, the trade name is Pradax and in Europe,Pradaxa.

Data from the large RELY trial were presented in Barcelona in August 2009. Some details can be found here and the entire article is available on the NEJM web site for free.

18,000 patients with non-valvular atrial fibrillation were randomized into three groups:warfarin titrated to an INR of 2-3, dabigatran 110 mg twice a day and 150 mg twice a day.The lower dabigatran does was associated with a slightly lower rate of bleeding while the higher dose and warfarin had similar rates. With a median followup of 2 years there was no increase in abnormal liver function tests in either dabigatran group.

Liver function test is an important issue as an earlier another oral thrombin inhibitor (ximelagatran) was withdrawn from the market after it had been approved in several European countries because of liver problems.

One possible bump in the road to FDA approval is the finding of a small increase in heart attacks in both dabigatran groups. I can't guess how an anticoagulant could cause an increase in heart attacks but perhaps warfarin is better at reducing risk of myocardial infarctions. Even so, with the battles and bad press that the FDA has had in recent years with real or purported increase risk of myocardial infarctions with certain prescription drugs an anticipated 2010 approval might be overly optimistic.