More CME News, and an Important Correction

In a comment on the previous post:

http://brodyhooked.blogspot.com/2010/06/has-cme-pendulum-swung-too-far-or.html

--Dr. Michael Kirsch kindly calls our attention to a recent New York Times report by Natasha Singer and Duff Wilson:

http://www.nytimes.com/2010/06/24/business/24meded.html?scp=1&sq=university%20michigan%20continuing%20education&st=cse


--which in turn provides us with important news on the CME front as well as a critical correction to the comments I offered in that earlier post.


The news item is that the University of Michigan announced that as of next January, they will become the first medical school to accept no drug/device industry funding for any school-sponsored CME (continuing medical education) program. In taking this lead, Michigan follows its earlier trend in being one of the first schools to implement a strong "drug reps off campus" policy. (Somehow Stanford hired a better PR agent and so got tons of publicity when they did the same thing more than a year after schools like Michigan and Wisconsin had taken the first steps.)


In HOOKED I wrote that the average medical school, as of a couple of years back, received about 50% of overall CME funding from industry. That sum varied widely; some conferences had virtually no industry funding, which in turn meant that other conferences were funded almost totally by industry. Michigan estimates it will be giving up about $1M of funding annually by its new policy. That shows what most med schools have at stake in the relationship with industry.


Now for the correction. I ran my mouth last post about the different types of talks that industry speakers might give, and offered my concerns that by banning all talks by industry speakers, the recent rules of the ACCME might actually have gone too far. So I am pleased that the Times report corrected my misimpression. The Times reporters state that the rules are indeed designed to respect the distinction that I was worried about. That is, scientists or physicians hired full time by industry can speak all they wish to about any basic science research. What they cannot talk about is a product of their company. I think that's a reasonable dividing line. By the time a research idea or concept has gotten so far down the pipeline that there's an actual product being readied for the market, there ought to be sufficient published literature for a neutral sientist to be found who can assess its pros and cons. There seems little danger that physicians will be deprived of up-to-date but unbiased information merely because a company employee cannot give that talk.

Has the CME Pendulum Swung Too Far? Or Finally Far Enough?

Thanks to a long-time faithful reader for alerting me to this news story:
http://www.medpagetoday.com/PublicHealthPolicy/MedicalEducation/pda/20704

At issue is a new ruling from the continuing education (CME) poohbahs, the ACCME, on eliminating any industry scientists from accredited CME programs. The article quotes a number of my esteemed colleagues among the "Pharmascold" camp who are quite pleased with the ruling. It also quotes some standard medical society types who are going ballistic over it, as well as some level-headed folks like George Lundberg, former JAMA editor, who's fully attuned to the dangers of commercial conflicts.

My own view is quite conflicted and might fall under the heading of "hard cases make bad law." I think the problem is generalizing from specific cases to a general prohibition in all cases. I think if we had a set of case examples of industry scientists giving presentations at CME conferences, we could readily classify them into two piles, "ought to be allowed to speak" and "nothing of educational value lost if this dude is kicked out", for example:

• Case 1: A conference panel is looking at the future of pharmacologic management of diabetes. They begin by accepting the premise, that large-scale trials have failed to show patient-oriented benefits from tight control of blood sugar in Type 2 diabetes, so more drugs to lower blood sugar are a bad idea. An industry scientist familiar with the basic biological mechanisms of diabetes lists several aspects of the basic biochemistry of the disease that seem amenable to control by the right sorts of molecules. He makes no comment about any drug now nearing production, but rather sketches out the general principles clinicians need to know to be able to judge the value of potential future drugs.
• Case 2: A drug company is about to market a new drug for angina. A company scientist gives a glowing endorsement of the drug. He reviews a few published studies of the drug and admits that according to those data, the drug has little efficacy but causes some worrisome adverse reactions. He alludes reassuringly to as yet unpublished studies that show that the drug performs much better and has lower risks than the published studies show (but adds, when questioned afterwards, that presently those studies are not available for review outside the company).

I think we could readily agree that the first guy is adding something of real value to the CME and it would be a shame to preclude him from speaking; the next guy is a paid shill and adds nothing from a CME standpoint. If we could write a rule that the first person would be allowed in and the second not, then we'd be where we want to be. Sadly no such general rule that would include all the good cases and exclude all the bad ones is probably feasible.

It would be very nice if we could say, "Look, just write down the general principles and rely on the good judgment of the CME meeting organizers to make the fine-grained, case-by-case judgments." We tried that and the result is the present-day CME mess where commercialization has completely taken over.

So, if throwing out the bath water with an across-the-board rule assures that some babies will be tossed out as well, what do we do? One reaction is to say that so few babies will get the heave-ho that it does not really matter. Supporting this argument is the fact that we must decide what it is that inside company scientists are likely to know about, that neutral outside experts do not. I have a very hard time imagining that this will have a great deal to do with the clinical side of drug development. I would suspect rather that the inside folks will clearly know a lot more about some technicalities of the molecules and the mass production of same, which frankly is the sort of information that puts CME audiences promptly to sleep.

On the other hand I feel badly about a rule that is obviously an exercise in overkill, for baldly political reasons--it feeds into the Pharmapologist accusations that all that we are doing today is an exercise in some "politically correct" hyper-reaction to a basically non-existent problem.

I have always had what I suspect now is an overly simplistic view of the world--that the real problem in the conflict-of-interest realm is not the industry scientist, the guy who has the drug company's name on his business card and on his paycheck, who is known by all and sundry to have been bought and paid for. This person knows to whom she is responsible and can, with perfect integrity, do her job. The problem, I have always assumed, is the presumably "independent" academic physician who claims to be from Harvard or from Stanford or from U. Miami, but who actually takes such a substantial portion of income from industry that he's largely forgotten where public health concerns leave off and industry sales figures pick up. This latter person, who thinks he can walk on both sides of the street without tripping, is the real threat to professional integrity. It's the latter and not the former who should be banned from CME.

Making Female Lack of Sexual Desire a Disease, for Fun and Profit

This post is to recommend to readers of this blog that they check out the New View Campaign, http://newviewcampaign.org.

The focus of this effort is Boehringer-Ingelheim's new "female viagra" drug, Flibanserin, which is to be discussed by an FDA advisory committee on June 18. A petition asking that committee not to approve the drug is being circulated and New View will be testifying as a lay group against approval.

I apologize for not being able to follow this particular debate as closely as I would have wished in recent weeks. The major points stressed by New View are:

• Flibanserin was discovered accidentally as part of a search for new antidepressants. It is said to work by modifying several neurotransmitters. So far, drugs that alter neurotransmitter chemistry have been frequently shown to cause severe adverse effects, many of which were not evident in the initial approval trials.
• B-I is taking full advantage of the FDA rules that to be approved, a drug has to be shown to be better than placebo in a few trials, and that is all. The actual amount of improvement shown by subjects in the trials B-I is submitting to the FDA is marginal at best.
• The larger societal issue is the medicalization of female sexual desire and the idea that if a women has low sexual desire, it must be because her brain chemistry is whacked out; it cannot be because she's stressed out of her mind or her boyfriend never bathes or any of the various environmental causes of low sexual desire. According to New View, the marketing campaign that B-I has launched for its new drug pushes all these buttons.

Dr. Thomas Insel and the Rehabilitation of Charles Nemeroff

A while ago I blogged approvingly about a paper by Dr. Thomas Insel, director of the National Institutes of Mental Health: http://brodyhooked.blogspot.com/2010/03/nimh-director-on-industry-influence.html. I noted in that post that Dr. Bernard Carroll had a more jaundiced view than I did, based in part in his psychiatrist's-insider's knowledge of the longstanding relationship between Dr. Insel and the disgraced chair of psychiatry at Emory, Dr. Charles Nemeroff, who shortly thereafter became undisgraced enough to be snapped up as the new chair at Miami. (Carroll's views were to be found at http://hcrenewal.blogspot.com/2010/03/dr-pangloss-as-nih-institute-director.html.)

Recent events seem to demonstrate that Dr. Carroll was right all along. I was about to post several sources in this past week's debacle at NIMH, but Dr. Carroll has saved me the trouble by masterfully pulling the threads of the story together while also identifying exactly the key issues at stake in this mess-- so save time and just read his post, http://hcrenewal.blogspot.com/2010/06/public-trust-at-nimh.html, which also includes links to most of the critical background documents.

Most of us don't get it that in theory, no professor ever gets a grant from NIH; a university gets the grant. So when the Emory Nemeroff was banned for two years from getting any NIH or NIMH grants due to his blatant nondisclosure of industry funding, that was not really Nemeroff that was being punished, it was Emory; and so technically the Miami Nemeroff is blameless as the proverbial newborn babe and can start taking home NIH grants by the dozen any day. Admittedly that's how the rules were written and so Insel as NIMH director cannot change those rules. And so, again by the letter of the law, Insel did no wrong when he privately advised the Dean at Miami that Nemeroff posed no liability to him whatever as a new hire, in terms of NIH funding potential.

Dr. Carroll then goes on to identify the really most egregious bit of behavior-- the fact that Insel then proceeded to appoint Nemeroff to two NIMH study sections. That was purely a matter of discretion and there was no requirement in any book of rules to make such appointments. The fact that he made them seems to demonstrate beyond a doubt that Insel does not get what's wrong, and that his real priority is to go to bat for his good ol' pal Nemeroff whom it now seems he believes was unfairly punished. In the process, if the integrity of academic psychiatry and of the NIMH goes into the toilet, then so be it, appears to be his motto. Indeed a sorry state for the director of an NIH institute, and an indicator that whatever Insel wrote about in his JAMA article, he has no clue what it means.

More on Trial Registries: Any Impact on Journal Publication?

A while ago I posted about a study by Mathieu et al. in JAMA that appeared to suggest that registering clinical trials was not having the hoped-for benefits on the transparency of journal publications of trial results: http://brodyhooked.blogspot.com/2009/09/registering-clinical-trials-less-than.html. Another paper published shortly after that one by Robert Ewart and colleagues from Southern Illinois U.--
http://www.annfammed.org/cgi/reprint/7/6/542

--adds to our level of concern that trial registries are not having the impact we had sought.

Ewart and friends looked at 158 reports of randomized clinical trials published in high-impact journals in 2008. They were able to analyze 110, including only trials that had been registered. Comparing the trial as described in the registry entry with the final report in the journal, they discovered that 31% of the time, a primary outcome had been changed, and in 70%, a secondary outcome had been changed, without these being mentioned in the publication.

Unlike the earlier paper, Ewart did look at trial sponsorship, but they found no difference related to industry vs. non-commercial sponsorship in whether an outcome had been altered.

Ewart and colleagues suggest that at least some of this problem may result from investigators' lack of familiarity with the registry process, but agree that a serious problem with the interpretation and integrity of trial results arises when changes are made but not explained in the methodology section.

I go back to the same point I made in the previous post--where are the journal editors or reviewers? What is the appropriate division of labor here? Is the reviewer supposed to be the one to check the trial registry, or is the journal editor? Do the instructions to reviewers make clear which is the case? Information is being made readily available now on the internet that is designed to allow us to have greater reassurance that what we read about a clinical trial is kosher--yet people responsible for the journals and their content are ignoring that information. It's ridiculous to say that each journal reader is responsible for going to the web to look up the trial on the registry. If a manuscript is submitted to a medical journal, and something has been altered without explanation from when the trial was first registered, then the editors should demand an explanation or else refuse to publish the paper. What is going to change, and when?

Drugs for Kids: Biggest Growth in Pharma Sales

According to Reuters:
http://www.reuters.com/article/idUSN1924289520100519?type=marketsNews

...The pharmacy benefit manager Medco reports that the fastest growth sector in pharmaceuticals is chronic-use drugs for children. Increase in presciption drug use was four times higher in kids than among the general population, with one in four kids overall, and 30 percent of adolescents, now taking some sort of medication chronically.

The big areas of growth were drugs for diabetes (blamed on the obesity epidemic) and antipsychotics (due in part to a cutback in the use of antidepressants among children with FDA black box warnings about antidepressants in kids, and an apparent felt need to switch the kids to different medicines rather than use non-medication approaches to behavior problems). Drugs for ADHD actually grew more in young adults than in kids.

The Medco folks expressed surprise at these figures and warned of increasing health care costs in the future as these kids reach adulthood--and presumably continue to need their drugs.

Warning: This Blog Is Not About Personal Medical Advice

Readers: I just took down a comment posted by "James" in response to the recent posting on the Whitaker book. James was asking for assistance in coming off a psychiatric drug that he has been taking for many years.

I wish James all the best for his future health. But I must remind all readers that this blog is about ethics and health policy. It is not designed to offer anyone personal medical advice and it would be highly irresponsible to interpret anything said on this blog as personal medical advice. You must consult the appropriate health professional to get personal medical advice. Everything discussed on this blog is general background information and cannot be applied to any specific individual's care without expert interpretation.