Showing posts with label conflicts of interest. Show all posts
Showing posts with label conflicts of interest. Show all posts

Friday, October 28, 2011

COI Update from the ASLME--Capsules

I'm in Pittsburgh just having attended the conference, "Conflicts of Interest in the Practice of Medicine," sponsored by the American Society of Law, Medicine and Ethics, which you can read all about at: www.aslme.org/2011COIconference
ASLME also plans to publish all the papers from the conference in its journal.

So what's new in the field? The quick answer for regular readers of this blog is, apparently not much. There were few new issues and virtually no possible solutions raised that have not already been discussed here and elsewhere. The presentations were nevertheless interesting and the interplay between the legal and medical viewpoints was illuminating. I have listed a few capsules below of possible interest and will do at least one more post on a particular issue.

>>The conference began with the usual ceremony of the highly placed official welcoming everyone, and in this case it was the Dean of the Pitt School of Law. She began by saying that COI is "almost impossible to eliminate" and that the conference would address the "challenge of managing" COI. At that point I was getting worried that we were going to hear a rehash of really old ideas. Fortunately the subsequent sessions all paid appropriate attention to the desirability of eliminating and not merely managing COI.



>>Christopher Robertson, JD, PhD of U-Arizona law school was given the task if laying out the evidence for the seriousness of COI in medicine. He began by reviewing the evidence relating to physician self-referral (e.g., sending patients to the imaging center that the physicians' group owns instead of to get their scans at the local hospital x-ray dept.) and said what we all know, that evidence shows that the rate of ordering tests and procedures jumps astronomically with self-referral. I had generally not thought to connect the self-referral data to issues of COI at the medicine-Pharma interface. But I think Robertson raised a good point. Physicians commonly deny that they overorder tests and insist that when they send patients to the testing center they profit from, that either the patient benefits greatly from the test, or they have saved the patient a trip across town or to another city, etc. So we have clear evidence that 1) money changes physician behavior (duh) and that 2) physicians commonly rationalize that association away. I think one can reasonably argue that such is presumptively relevant to other money-laden relationships, until proven otherwise.



>>Bernard Lo MD from UCSF, a chair of the IOM panel that wrote their report on COI in medicine, was first to raise this issue but it was echoed by other speakers. As we enter the era of heightened, required disclosure, many physicians fear the liability of multiple, perhaps inconsistent disclosures, as different forms and bodies have different rules (such as whether to report relationships for the past 2 years or 5 years or whatever), and then providing fodder to investigative journalists who can check out all these disclosures on line and play "gotcha" with any inconsistencies that are revealed. Now the extreme pharmascold might say, so much the better, yet another good reason to divest oneself from these conflicted relationships. But the point the speakers made seemed very reasonable, that it would be far superior to have a single, uniform and common disclosure process so that each individual had to disclose in one place only for all purposes.



>>One of the most appreciated speakers was Sunita Sah, MD, PhD of Duke, who has co-authored several well-designed studies of how disclosure practices might impact physicians and patients. During the Q&A the point emerged of how reluctant patients are to appear to criticize their own physician's COI, assuming the relationship to have been established before the COI becomes known. Some studies that are cited to show that COI is no big deal for patients and does not decrease their trust are studies in which patients are basically asked about their own physician's COI. A fairer study design would be to get patients to imagine that they are seeking a new physician, and can choose among several physicians on a panel, some of whom are disclosed to have COI. The outcome of interest would be how willing patients are to select the physicians with COI, and at least some preliminary data, I understand, would suggest that they'd be less likely to select those docs.



>>A couple of speakers commented on the recent pullback at NIH in backing off proposed COI policies, that would have required academic medical centers to post faculty COI on accessible websites (http://brodyhooked.blogspot.com/2011/08/nih-conflict-of-interest-rules-weakened.html) Blame was placed on the White House, feeling under fire to do something about the supposedly out-of-control government regulations that the Republicans are raising Cain (no pun intended) about. The timing was bad; the time that the NIH stringent guidelines would have gone into effect was precisely the moment that the White House decided they had to make a show to scaling back on regulatory load.

Monday, November 8, 2010

From Health Care Renewal: Logical Fallacies in Epstein's Denunciation of COI Reg

Just a quick cross-post to our colleagues at the Health Care Renewal blog:
http://hcrenewal.blogspot.com/2010/11/there-you-go-again-richard-epstein-says.html

Dr. Roy Poses discusses a recent blog posting by Prof. Richard Epstein of the University of Chicago and New York University law schools (funny thing; as an academic I have always found it as much as I could manage to work for one institution at a time; I never tried working for two). (Link to Epstein posting is in URL above) Prof. Epstein is a strong defender of the so-called free market and believes that undue restrictions on financial conflicts of interest are stifling important innovation in Pharma. (What else would you expect? The blog on which he posted his comments is called "The Libertarian.") One of Dr. Poses' special hobbies, which warms my philosophical heart, is to analyze people's arguments in search of logical fallacies. He finds a whole raft of them in Epstein's recent post and lists them all for your edification.

For earlier mention of Prof. Epstein in this blog, see http://brodyhooked.blogspot.com/2007/08/epstein-vs-relman-debate-to-overlook.html

Sunday, April 19, 2009

"You're Another"--Not a Very Good Answer to Pharma Influence

This is getting tiresome.

The ploy du jour for those who wish to deny or to distract attention from the fact that the drug industry has a near-stranglehold over the medical literature regarding pharmaceuticals seems to be "you're another."

Example: Here's a posting on the "Placebo Journal" blog, which purports to be a humorous site, though I am missing the humor in this particular situation: http://placebojournal.blogspot.com/2009/04/right-way-to-influence-someone.html

This post cites with approval the "Pharmascold" article by Shaywitz and Stossel that I recently skewered: http://brodyhooked.blogspot.com/2009/04/pharmascolds-strike-back-latest-from.html

The writer of the post then somehow manages to turn into a semi-justification for not getting excitedabout conflicts of interest with Pharma the following news account of political COI:
http://online.wsj.com/article/SB123914567420098841.html

The politics story reveals that Gov. Ed Rendell (D-PA) received campaign contributions from a big Houston law firm, and then handed that firm a juicy contract to try a civil suit on behalf of the state against Janssen regarding their drug Risperdal. This looks very fishy because the contract with the Houston law firm somehow was handled through the guv's office directly, bypassing the state AG who you think would be expected to handle such business. Of course there was the routine denial that the campaign contributions had anything to do with this.

All right, so we agree that this stinks. What are we supposed to conclude? The article about Rendell and his shenanigans notes in passing that the substance of the lawsuit against Janssen was not the point (of the motion filed in PA court by Janssen to protest the way the lawyers were appointed). The substance involves the claim we have investigated at length in a number of previous posts--that Risperdal and its fellow "second generation" antipsychotics were heavily marketed as being safer than older drugs in that class; and that when we actually run the real numbers it turns out that these drugs are not safer, and that the companies engaged in all sorts of underhanded stuff to conceal the actual adverse reactions associated with the drugs. No company could have pulled this off without the active participation of medical investigators beholden to them who willingly did the bidding of the marketers, and who proceeded to conceal the true risk profile of these drugs from their fellow physicians and thus subjected millions of patients to undue and inappropriate risks. These are all physicians who presumably once swore an oath to do what would benefit the patient rather than what would advance their own careers or line their own pockets.

According to this post we are supposed to give these docs a free pass and stop berating them for their conmflicts of interest, all because Ed Rendell is reportedly a scumbag. To which I reply that I utterly fail to see the logic of that so-called reasoning.

Friday, January 9, 2009

An ABG Campaign for Surgeon General?

There seems to be something of an ABG campaign brewing with regard to rumors of President-Elect Obama's pick for Surgeon General of the U.S.

Anybody But Gupta.

At first there seemed to be generally positive reviews of CNN's Dr. Sanjay Gupta, based on his proven abilities as a public communicator regarding medical information.

Then protests began to be registered--but interestingly, mostly on what I'd regard as less important issues.

Rep. John Conyers (D-MI), for one, has objected to the possible nomination on the grounds that Gupta did a hatchet job on Michael Moore's movie Sicko, despite the fact that Moore had his facts straight and Gupta didn't. See http://www.pnhp.org/news/2009/january/conyers_obama_shoul.php

Gupta also later presented a report on John McCain's health reform plan that didn't square with the facts and seemed heavily biased in the plan's favor. He also has no administrative experience that would seem to qualify him to lead the U.S. Public Health Service.

So far, however, it has been only an e-mail from the Physicians for a National Health Program that has nailed Dr. Gupta on what seems to me to be perhaps the strongest reason to oppose his nomination. After discussing his clear lack of enthusiasm for a single-payer health plan, the pet goal of PNHP, the e-mail went on: As a media figure, he has been disturbingly cozy with Big Pharma. He co-hosts Turner Private Networks' monthly show "Accent Health," which airs in doctors' offices around the country and which serves as a major conduit for targeted ads from the drug companies. Another example: In 2003, despite mounting evidence to the contrary, he publicly downplayed concerns about the dangers of Vioxx. It was removed from the market a year later by its manufacturer, Merck. (Full disclosure: I am a PHNP member and am sympathetic with the call for single-payer.)

The candidates that the Obama Team have been rumored to be considering for FDA commissioner generally have been known for their strong stance of skapticism or criticism of the pharmaceutical industry (though as to whether those reputations are deserved, see Shannon Brownlee and Jeanne Lenzer, http://www.huffingtonpost.com/jeanne-lenzer-and-shannon-brownlee/a-new-years-resolution-fo_b_156571.html). It would seem a major contradiction to put somebody with those credentials in the FDA post and then pick Dr. Sanjay Gupta, who doesn't seem to know a conflict of interest when it bites him in the whatever, to be Surgeon General.

Saturday, May 17, 2008

Must Read Paper of the Month: Is COI a Red Herring?

The "must read" paper of the month is a short commentary by David Healy in World Psychiatry:

http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=17342217

Healy is responding to a paper by Fava that ordinarily one would expect to receive approval from critics of industry and medicine's too-cozy relations with it--calling for reforms to correct current conflicts of interests that are rampant in psychiatric research (as well as all other specialties):

http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1805729

Healy, however, never seems to go in the front door if climbing in the basement window will serve; so he takes issue with the entire question of whether what is the problem with shoddy, misleading research in psychiatry is conflict of interest at all. He notes that if you in fact adhere to the scientific method, then you should be able to have several dozen major conflicts of interest and still come up with an experimentally plausible answer. Over the centuries, for instance, that has allowed scientists of all different religious persuasions and degrees of religious fervor nevertheless to discover scientific conclusions that disagreed with religious dogma.

If conflict of interest is not the real problem in the current morass of suppressed data and spun results, then what is? Healy suggests that it is really simple: the industry-sponsored studies are not science at all and so do not adhere to the scientific method. He uses the SSRI antidepressant track record as his case in point. The "science" supposedly showed that SSRIs are safer than the older antidepressants and at least as effective; but now we are realizing that once we eliminate the company spin, SSRIs are hardly effective at all and have many major adverse effects. It is to our shame, Healy charges, that we in medicine never figured this out. Had journalists and lawyers not gotten on the case, the shenanighans with the data would never have been revealed.

I realize that when all is said and done, this may be nothing more than semantics, but I still think that Healy's piece is a great read.