Friday, March 29, 2013

The Increasingly Hard Life of a Drug Rep

I manage to get on some strange e-mail lists, partly because I used to write a regular newspaper column on medical issues, and partly because I am now identified as having something to do with Pharma. As a result I get unsolicited "cold calls" via e-mail, some of which shine a light indirectly on issues related to this blog. A recent message seems to suggest that the campaign us pharmascolds have launched is having success, making life harder for drug reps, and driving the companies to look for new ways to influence physicians.

A nice publicist wanted me to know all about Activate Networks:

This outfit will help drug marketers get more bang for the buck by mapping the local physician social network, and picking out the docs who have the most influence over their peers. These docs, the firm points out, may not themselves be the heaviest prescribers of the drug, and so might initially escape notice from the data usually generated by drug firms that focus on prescribing volume. Yet (they argue) if you go after these docs, using the methods kindly supplied for you by Activate (I assume for a hefty fee), you can get a lot more payoff from your detailing efforts, as is explained in detail:

Why bother? The e-mail lists the woes faced by today's reps, that make it mandatory that they'd use whatever new technology they can:

The Changing Face of Pharma Detailing

Pharma companies are battled for physicians’ time:

• One out of four physicians work in a practice that refuses to see reps

• Sales reps are never seen by the doctor in 43% of calls

• Two thirds of medical schools and a quarter of private-practice physicians have limited sampling in some way

• For every 100 reps who visit a practice, 37 place their products in the office's sample cabinet, and only 20 speak to a physician in person

Of course from my own point of view this is all good news, and signs that some progress is slowly being made.

Wednesday, March 13, 2013

Latest on the Markingson Case at U-Minn

I have previously reported on this case:

A recent update is provided by Dr. Judy Stone on the Scientific American blog:

My own views on this case are very nicely summarized by Dr. Stone so I will simply quote her conclusion:

It is difficult in this case, as with much of life, to tell with total certainty “where truth lies.” The reluctance on the part of the Office of Research, the Office of the President, the Office of the Counsel, and the Board of Regents of UMN to fully and transparently examine new evidence is extremely troubling, though. Without such a transparent examination, there is no guarantee that the clinical investigational staff did not commit breaches of research ethics and of law, and has not continued to do so, perhaps putting other vulnerable patients at undue risk.

When I started reading about this case, it was as an academic endeavor, seeking a case study for my blog. I did (and do not) not know any of the parties involved. Yet the more I have learned, the more outraged I have become.

I am angered by the thinly veiled threats towards Dr. Elliott (e.g., Mr. Rotenberg’s “What is the faculty’s collective role in addressing factually incorrect attacks on particular University faculty research activities?”

I am saddened by what appears to me to be violations of the trust of vulnerable patients and of research ethics. As I have become immersed in the case, it has become clear that it provides a lifetime of study and discussion about what not to do during the course of a clinical trial. It is also clear to me that more patients than Mr. Markingson likely were harmed at the UMN by: enrolling participants with contested ability to consent; having financial incentives that encourage keeping someone on a trial when it appears they are not responding well; approving and supporting protocols that have seemingly disproportionate risks....
And, unfortunately, it appears that UMN believes, as do many other institutions, that protecting itself from scandal and its consequences comes first and foremost and that, like the big banks, that it is too big to be punished.

All I would add to this apt summary is that U-Minn appears to have adopterd the strategy of stonewalling, and by doing so successfully evading initial investigation into their possible lapses. Then, as more and more information accumulates that there really was a fire to explain the smoke, they continue to point back to the fact that the initial, incomplete investigations exonerated the U. as a reason not to inquire into any new concerns--as well as to keep insisting all this is water under the bridge. Meanwhile they continue to place pressure on Dr. Carl Elliott as the faculty member who has refused to be silenced.

Dr. Elliott informs me that the latest step on behalf of the Markingson family is an on-line petition, which can be found here:

A brief reminder as to what all this is doing on this blogsite. The initial charge against U-Minn is that their psychiatry department was getting a lucrative grant from a drug company to do an investigation of several antipsychotics, and to "prove" that the company's drug was the best. The company complained that the U was enrolling subjects too slowly and therefore threatened to end the grant. Under this pressure, it appears, a person who could not give valid consent was enrolled in the trial, was kept on one of the drugs despite continuing to deteriorate, with protests from his mother repeatedly ignored, till he finally committed suicide. If the facts are as alleged, and as further supported by information subsequently released, this seems an especially egregious case of academic physicians being distracted from their duties toward patient care and medical science by the lure of industry funding.

Monday, March 11, 2013

Update from Dollars for Docs, ProPublica: Is Transparency Having an Impact?

Tracy Weber and Charles Ornstein at ProPublica have issued an update on the newest data posted on the Dollars for Docs website:

The investigative reporting group launched this site in 2010 to gather in one convenient, searchable place the various disclosures of payments to physicians that some drug firms had been forced to issue as part of legal settlements and in some cases voluntarily. Next year, such disclosures will be legally mandated by the Sunshine Law provision of the Affordable Care Act, so we can hope that some of the current limitations of reporting will be overcome.

In general, Weber and Ornstein's report shows that many docs are still making a killing off speaking and consulting for drug companies, with the highest rollers being psychiatrists--but other docs are seeing their take diminishing, and some drug companies are investing less money in these contracts. How much of these changes is cause-effect relationship with increased transparency is anyone's guess.

The top dog in the story is Nashville psychiatrist Dr. Jon W. Draud, who took in more than $1M between 2009 and 2012. Close behind was a neighbor of mine, psychiatrist Dr. Rakesh Jain from Lake Jackson, TX, who scooped up $582,049. Dr. Jain seems a good example of somebody who doesn't yet get it: “'I am not a marketer, I am an educator,' Jain said. ...[He] acknowledges the excesses of the past and said he does not excuse them. But he said he sees real value in the new brands because they give psychiatrists options if their patients are not responding to older drugs. ... Having the financial support of drug companies does not lessen the value of this teaching, he said." (Weber and Ornstein note that Drs. Draud and Jain probably make more money than they list, as some of the firms who pay them are not yet disclosing.)

Another psychiatrist, Dr. Gustavo Alva of California, stated, “I actually enjoy the aspect of educating my counterparts about developments in the field.” I admit that I would probably enjoy it too if it netted me $663,751 since 2009, as it did for Dr. Alva.

But a different picture emerges from the experiences of Dr. David Rizzieri, a Duke cancer expert:

"Ten of the doctors dropped from making about $100,000 a year to less than $20,000 in 2012. Some doctors whose payments declined spoke about drugs the companies are no longer pushing. Others, like ...cancer expert ...Rizzieri..., faced new restrictions from their employers.

"Rizzieri had been a speaker for Cephalon, GlaxoSmithKline and Novartis in 2010 and 2011. But after Duke restricted participation in speakers’ bureaus, his speaking pay dropped markedly in 2012, the new data show. All told, Rizzieri has received at least $567,300 in speaking and consulting payments since 2009.

"Dr. Ross McKinney Jr., director of the Trent Center for Bioethics, Humanities and History of Medicine at Duke, said university officials 'had multiple discussions' with Rizzieri, who 'is getting more restrained.'

"McKinney said Duke physicians can deliver paid talks about diseases, but only if they use their own slides and presentation materials. 'The general tone is a little bit more distant and less cozy than it used to be,' he said.

"In an email, Rizzieri said he still did some paid speaking that is allowable within Duke’s new guidelines, but has focused his attention on a series of educational talks developed by the Division of Cellular Therapy at Duke."

Also, some of the companies profiled by ProPublica have dropped their reported payments. GlaxoSmithKline, for example, spent $52.8M on physician speakers in 2010, $24.1M in 2011, and $7.6M in the first 3 quarters of 2012. But all companies who were willing to talk to ProPublica claimed that any reductions were strategic business decisions, depending on how many new drugs they had in their pipeline at any given time, for example. No one was willing to say out loud, at least, that transparency had discouraged any spending. Overall, Dollars for Docs has logged in more than $2B in payments since it began in 2010 reporting 2009 figures. If estimates of annual US Pharma marketing spending as high as $57B are to be believed:
--then this almost for sure lowballs the true figures.

Ironically, some of the new transparency actually aids the drug companies themselves, according to Dr. Susan Chimonas of the Center on Medicine as a Profession at Columbia:

"At a recent conference, Chimonas said she heard that pharmaceutical companies themselves are using the disclosures about payments to 'push back on doctors who are greedy.'

“They can say, ‘No. We see you’re taking this amount of money from our competitor. Why should we give you more than that?’ she said."

Saturday, March 2, 2013

More on Diabetes Being Misunderstood

Again thanks to the most recent issue of Primary Care Medical Abstracts, I learned of a study of screening for adult-onset (Type 2) diabetes that further stresses the position I have been arguing for here for a good while, that it's basically a misunderstanding of the disease to imagine that the answer is better control of blood sugar. The study in question is by a group at Cambridge, UK headed by Rahman:

The question Dr. Rahman and colleagues set out to answer, using a large population cohort that they followed for 12 years, is how much earlier you learned somebody had diabetes if you did population screening for the disease, rather than waiting for symptoms to develop that led the individual physician to do the tests that led to the diagnosis. The authors concluded that you "gained" 3.3 years through population screening. As all these people (being Brits) had good access to care by their general practitioners, who were informed of screening results, the mantra that we all devoutly believe, that early diagnosis is always better, would lead you to expect that those whose diabetes was detected by early screening would do better than the comparison group who were diagnosed only through actual symptom development.

And you'd be wrong, as the study showed no differences in a large number of important complications of diabetes.

Dr. Rahman and colleagues conclude that there is at this time no good evidence for population screening of asymptomatic patients, which happens to be what the U.S. Preventive Services Task Force had already concluded based on other evidence. The point I want to draw is somewhat different. If our old model of diabetes as a disease of out-of-control blood sugar, which should be made better (and complications prevented) by tight control of blood sugar, were valid, then we'd expect screening to be effective in delaying the onset of complications. The fact that screening had no measureable effect is just one more bit of evidence that the old model is flawed.

If the old model is flawed, why does it remain so influential? Well, the old model sells drugs and devices (specifically, all the test strips for those nice glucose monitors that are so heavily advertised on TV). So long as so much money can be made from the incorrect model of diabetes, don't expect that those who control the airwaves are likely to work to educate us on a better model.

Friday, March 1, 2013

More on DSM-5: An Irrelevant and Perhaps Incoherent Defense

To supplement the previous post on DSM-5, I thank Dr. Bernard Carroll for calling attention in his comment to psychotherapist Gary Greenberg's blog:
--which in turn refers to a paper in JAMA extolling the virtues of the soon-to-be-published DSM-5 from some of its authors:

I am not acquainted with Mr. Greenberg or his blog and would not ordinarily cite his work under those circumstances, but I have for a good while followed Dr. Carroll's excellent work and so will take a chance on relying on his endorsement of the post.

As a very minor introductory point, sticklers for accuracy might have noted that in previous posts I prevaricate between calling the new manual DSM-V and DSM-5. The JAMA piece uses "DSM-5" but also includes mention of the previous editions of the manual, which were designated by Roman numerals. Thinking they planned to be consistent, I started using the designation DSM-V a while back, and it now appears I was in error. And if using "5" instead of "V" was the only quibble about the new edition, we'd be in great shape.

Mr. Greenberg focuses in on one questionable statement in the JAMA "advertorial" as he puts it.  The American Psychiatric Association folks state, "Many of the revisions in DSM-5 will help psychiatry better resemble the rest of medicine, including the use of dimensional (eg, quantitative) approaches." Two points here. First, it's not clear at all why it should be so important that "psychiatry better resemble the rest of medicine," except for psychiatry's own inferiority complex, for which there is no doubt an expensive drug that they can take. Second, and much more important, is Mr. Greenberg's main response: "...there are no dimensional measures in the DSM-5. They tried to develop and implement them, but the effort was hurried and chaotic and poorly planned and ultimately soundly rejected by the membership of the APA. The dimensional approach was going to be the signal achievement of the DSM-5 (that is, after the first signal achievement, the tying of neuroscientific findings to DSM disorders, had to be abandoned for lack of evidence); it didn’t pan out. The APA leadership is understandably reluctant to own up to this fact."

So what's new, exciting, and innovative about DSM-5 is offering quantitative, dimensional measures to diagnose mental illness, to please nonpsychiatrists by making psychiatry better resemble the rest of medicine, except for the fact that there are no quantitative, dimensional measures in DSM-5. To which a third point could have been added. If there had been quantitative measures in DSM-5, that would not have made it so much different from older versions of the manual at least as far back as DSM-III. What made DSM-III special for its day was precisely that it demanded quantitative criteria, e.g. before you could diagnose a patient with depression, you had to have so many out of the following list of criteria for at least so many weeks. So the idea of having easily agreed-upon and measured criteria that would appeal especially to non-psychiatrists is hardly all that big a departure. Admittedly, demanding that a person have (say) 6 out of 9 criteria for a given mental disorder, when each of the 9 is described qualitatively, is not as quantitative as having something like a blood pressure cuff you could wrap around the patient's head and read a number off the dial. But it's the number-off-the-dial that (Greenberg tells us) the APA looked for and failed to discover.

Greenberg focuses on the illogic of the case as stated by the DSM-5 committee, but the larger issue may be trying to change the subject. As I have followed the issue, the main complaints about DSM-5 have not been the lack of quantitative measures or making psychiatry look different from the rest of medicine. The main recurrent concerns have been 1) the serious conflicts of interest among the panelists, and 2) the creation of new categories of illness that will vastly increase the number of patients susceptible to a diagnosis. The article in JAMA does not address the first concern at all, and addresses the second only glancingly.

To illustrate how wonderful the DSM-5 is going to be, the authors give us glimpses into the new criteria for autism spectrum disorder, binge eating disorder, disruptive mood dysregulation disorder, posttraumatic stress disorder, and the removal of the bereavement exclusion for diagnosis of major depression. They state that the new criteria for autism "is not expected to significantly alter prevalence rates." Others have looked at the new criteria and disagree, I gather, so I don't know who's right. In none of the other examples did they address how many additional people might be diagnosed. The concern about conflicts of interest, of course, is that if you're in the pay of the drug companies, you naturally want to see more people being prescribed drugs, which means they should all have psychiatric diagnoses for which drugs can be recommended. After that one comment that say nothing more about how many more patients might receive the other diagnoses.

The discussion of bereavement and depression seems especially disingenuous (see my earlier post on this, The DSM-5 folks make it sound like this is first off, a very minor issue that affects only a few patients; and second, the problem for those few patients is that they may suffer terribly under present guidelines and DSM merely fixes things for them. Specifically, while grief is common and can last a long time, it is also possible for people who have just lost a loved one to have an unrelated major depression. By the old guidelines, they say, these people would have been denied proper treatment for their major depression, and with DSM-5 removing the exclusion for diagnosing depression in the face of grief, now these people can get proper treatment.

Now, if the goal of DSM-5 is to make psychiatry more like the rest of medicine and make it easier for nonpsychiatrists to handle psychiatric diagnoses, maybe somebody should point out to these folks that if a patient has, for example, congestive heart failure and kidney disease, you don't deny them treatment for the kidney disease because you are treating them for heart failure. The possibility that a person can have two diseases at the same time is one that most physicians can figure out, and they therefore know that guidelines that tell you how to diagnose any one of the diseases must be modified when a second disease may be concomitantly present. That's called clinical judgment and guidelines cannot totally replace clinical judgment. So we can be forgiven if we think that the real reason to remove the bereavement exclusion is to make a lot of people with uncomplicated grief reactions candidates for antidepressant drug therapy--and to be very skeptical that any significant number of patients who actually have major depression rather than grief are today being denied proper therapy.

Bottom line-- this paean of praise for DSM-5 in JAMA appears to reinforce rather than remove concerns about the new edition. My advice in the previous post, that other specialties should boycott this product, stands.