Thursday, February 28, 2013

DSM-5 and the Sorry State of American Psychiatry

If you think I've been underproducing blog posts lately, you can lay the blame at the doorstep of Rick Bukata and Jerry Hoffman of Primary Care Medical Abstracts. Being a lazy cuss, I often don't know that an article of interest has been published until they include it in their monthly literature updates, and their January edition was quite late in coming out. But when it arrived it did include two papers that shed a bright light on a topic we've addressed in the past, such as:

The first article is an opinion piece that fires a broadside at the new DSM-5 and the "psychiatric oligarchs" who wrote it:

Scottish GP Des Spence notes the new CDC figures showing that based on the expansive way we now define mental illness, about a quarter of the US population is mentally ill. Now, if a group had a tiny sliver of scientific curiosity, this statistic would be a matter of dismay and demand immediate and thorough study--either something horrible has been added to the US water supply, or else the way mental illness is defined and counted has become totally disconnected from any form of medical reality. Yet the psychiatric community can apparently look on these figures with satisfaction.

Spence lays the blame clearly at the feet of conflict of interest, noting that 75% of the authors of DSM-5 are awash in COI. Spence avers that the new, broader definitions of mental illness in DSM-5 "defy common sense and will serve only to undermine psychiatry’s professional standing. It is yet more industrial mass production psychiatry to serve the drug industry, for which mental ill health is the profit nirvana of lifelong multiple medications."

By way of illustrating what this means, we can turn to the second article:;jsessionid=40498050C908CBC4C63E2D01A0C0B731.d03t03

Dr. Herschel Jick and colleagues from Boston University looked at how methylphenidate (Ritalin) was prescribed for children aged 5-14 in the US vs. Britain. They found out by the way that equivalent supplies of the drug cost about 4 times more in Britain than here. But much more worrisome is the evidence that more than 4 times as many kids in the US were being prescribed this drug, supposedly for attention deficit disorder, than is true in the UK. It seems that our threshold for deciding a kid has a major mental disorder, with all the implications of carrying that label for life, is much lower than it ought to be. And Spence for his part notes that in the new DSM-5 the criteria for diagnosing ADHD are loosened substantially.

I'll go back to my previous post on Robert Whitaker's important book--
--as well as to my previous post on the antipsychiatry movement:
--to remind anyone just joining us that I have not joined the scientologist crazies and that I agree with Whitaker that there is a group of folks (he estimates about a fifth of those now taking psychiatric medications in the US) who suffer miserably without their meds and who are vastly more functional with them. But when we decide that a quarter of the US population is mentally ill and probably ought to be on drugs, then what used to be a thoughtful and helpful medical specialty seems to have turned into nothing more than a marketing agency for Big Pharma.

What to do? There is probably a simple step that could well be effective. We usually figure that a medical specialty group can be trusted to tell us how to diagnose conditions that fall within their specialty. So, for instance, if cancer specialists tell us that such-and-such is what make a cancer of the prostate Stage 2, then other specialists use those criteria and the Stage 2 label for that form of disease. So it has been logical that other specialties that treat patients with mental illnesses, such as family physicians, pediatricians, internists, etc., have routinely used the DSM's earlier editions as their guide to diagnosing and labeling mental illness.

Therefore, the American Academy of Family Physicians, the American College of Physicians, and all other specialty groups ought to declare officially that they reject DSM-5 and will advise their members not to employ its terminology or criteria. Unless and until the American Psychiatric Association can come up with a scientifically more valid manual created by people free of conflicts of interest, they should not be able to foist their commercial product (off which they make huges sums in sales) on the wider medical community.

Paying Thru the Nose for Journal Reprints--For Whose Benefit?

In HOOKED, I noted that one of the biggest income makers for major medical journals, besides ads, is the sale of reprints to drugmakers. Drug reps like to hand out glossy reprints to docs to create the charade that what they say is based on hard science, and to further create the charade that the doc is a careful scientist and so of course will take the reprint back home and study it line by line. It's a much better charade if the reprint carries the byline of a highly respected journal.

A group at Oxford decided to try to get some of the quantitative data that I did not have access to when I wrote HOOKED, as this area had been little studied:

The authors approached the two big British journals and three top US journals (New England Journal, JAMA, and Annals of Internal Medicine) for data on their most widely reeprinted articles. The three US journals refused to play ball. JAMA and NEJM claimed proprietary privilege and Annals said the data would be too hard for them to compile. I'll let you draw your own conclusions as to what we might have learned had these folks provided the data. So the analysis was restricted to the British journals and also included data on some subsidiary journals published by BMJ and Lancet.

The authors compared the most-reprinted articles with a comparison set and decided that the reprinted stuff was about 8 times more likely to have been drug-industry-sponsored, which is hardly a news flash. Of greater interest, I think, is the data on what it can mean to a journal to score big with a sale of reprints to a major drug company.

It turns out that BMJ is small potatoes compared to Lancet, with the biggest sale of reprints for a single article by the former being a bit over $200,000 while the latter hit $2,436,000. Of course you don't do that well every day; the median take for BMJ was a bit less that $20,000 and for Lancet, $451,000. But it does hint at what sorts of sums are at stake.

The authors are careful to note that they cannot prove and won't allege that these sums in any way influence the editorial decisions of journals. They clearly have the worry however that if an editor is faced with accepting or not accepting a questionable paper extolling the efficacy of a new drug, knowing how much reprint sales could amount to might be a factor that could sway the decision.

Here is my perhaps paranoid reasoning in support of the authors' worry. As best as I can figure out from the somewhat opaque tables provided in the article, the Lancet's top sales for a single article was as noted $2.4M. Elsewhere it's reported that the maximum number of reprints sold by that journal was 835,100. Let's assume that the journals charge per copy for reprints and don't have a sliding scale based on factors such as article contents, which drug company is buying, etc. If we assume that the largest selling reprint was the same as sold the most copies, that works out to about $2.92 a copy.

Let's think about this for a while. The average journal article for a major research study is perhaps 8-10 pages max. Even figuring in the glossy paper and good quality printing, what could it cost the journal actually to print that reprint (in these large quantities)? It would seem that the charge of nearly $3 a copy has to be quite excessive. If the drug companies were trying to keep their costs down, you'd think they could have bargained for a much more economical rate--after all, who else buys reprints in that quantity besides them?

Back in the early days of this blog:
--I argued that while most of the literature uses terms like "gifts" to talk about money and things of value that change hands between drug companies and physicians, you might as well call it what it really is, which is a bribe--we pay you these things and expect you in return to prescribe more of our drugs. So what is it when drug firms knowingly overpay for reprints of articles in major medical journals? Doesn't that suggest that at least in the minds of Pharma, they are actually paying a bribe rather than buying goods at the market rate? Maybe they will influence editorial opinion in their favor, maybe they won't, but it seems worth it to them to take a chance and invest a certain sum of money in the possibility of influence. And this is not an industry known for making a lot of stupid investments.

Hat tip to Primary Care Medical Abstracts for pointing out this article.

Thursday, February 21, 2013

The High Prices of Drugs and Devices

I know this blog is not about health policy generally, but for anyone even vaguely concerned about health care and its costs, which ought to be all of us, a must-read is Steven Brill's piece in Time:

Mostly Brill focuses on ridiculous hospital charges and obscene profits, being careful, every time he mentions a hospital, to tell us how many millions of bucks its CEO is paid, even though these are mostly supposed to be nonprofit hospitals. I have to imagine the American Hospital Association is now in full damage control mode. My favorite is the hospital spokesperson who told Brill, when the reporter inquired about a hospital bill with outrageous overcharges, that the hospital was prevented by law from talking about its billing practices (which is, of course, a flat-out lie).

The article goes also after drug and device manufacturers and repeats the charges detailed here and in HOOKED about their excessive prices--how they lobby Congress to get exemptions from competition and price negotiation, how their claims that they need the extra money to do their research don't match the math, and so on. Brill does a nice job on implantable devices, showing how the devide company first charges at least 2-3 times what it costs to make the device, and then the hospital that sells the device to the patient marks it up an extra 2.5 times on top of that.

For us the one bit that struck me as newsworthy was Brill's recounting of testimony before a Senate committee in 2008 by Gregory Demske, an assistant inspector general at HHS.He told the committee,
“We found that during the years 2002 through 2006, four manufacturers, which controlled almost 75% of the hip- and knee-replacement market, paid physician consultants over $800 million under the terms of roughly 6,500 consulting agreements."

We've reported instances of individual orthopedic surgeons, for example, walking home with more than $1M in consulting fees over a 1-2 year period; but this is the first time I recall seeing these figures reported for such a large chunk of the industry as a whole. Think about what this means. If these 4 companies find it in their own interest to pay what really amounts to $200M per year in bribes to docs just to get them to use their devices, think about what their profit margins must be.

Tuesday, February 19, 2013

More from ACRE: It's Us, or Those Evil Insurers

I'm grateful to my colleague Dr. Roy Poses from Health Care Renewal for this link:
(You have to register to enter the site but it's free.)

Medscape features an interview conducted by Dr. Henry R. Black, an internist and clinical professor at NYU, with his colleague Dr. Michael A. Weber of SUNY Downstate/Brooklyn. Dr. Weber is one of the mainstays of ACRE, whose new guidelines on relationships between industry and medicine we recently reviewed:

The ostensible purpose of the brief interview (you can watch the video or read the transcript) is to introduce you to these guidelines, which as I already noted are not all that bad. Mixed in with this announcement, however, is something of a new rationale for why we should ignore conflict-of-interest concerns and applaud physicians' financial ties with the drig industry as part of continuing medical education.

Dr. Weber, in common with the rest of the ACRE leadership, cannot fathom why people like me (a.k.a.pharmascolds) are not wildly impressed with the fantastic, lifesaving and lifeprolonging medicines produced through private enterprise and the entrepreneurial spirit--they see only the upside and never the downside of these developments. As Dr. Weber paints the picture, docs have two chioices when it comes to CME. Either they can embrace folks like him who freely take money from drug and decvice companies, who of course will tell you completely objective information about these marvelous life-saving new products, that you'll then use to dramatically improve your patients' health.

The other alternative is to let other people run CME, and according to Dr. Weber, this would inevitably be insurance companies who want to save a buck and don't care whether or not patients die as a result of their skinflint practices. They'd make sure that the CME program contained little if any information about these marvelous new drugs, for fear docs might prescribe them and run up the tab. 

So let's see if I get this--conflict of interest is wonderful when practiced by industry CME sponsors and their physician partners, because it means that we'll more speedily adopt more life-saving medicines. On the other hand, conflict of interest is terrible when practiced by third party payers, because all they want to do is save money and they don't care if patients are harmed. This of course assumes that patients are always harmed by using an older or cheaper drug, or no drug at all, and are never harmed by using the latest brand name, expensive drug. It also assumes that the only reason one could possibly be against conflicts of interest between medicine and the drug industry is a desire to cut costs--that it has nothing to do with quality of care or the integrity of the scientific process. Or that thing called "professionalism" which ACRE folks have said does not exist.

Dr. Poses is a sort of expert on argumentative fallacies so I'll let him decide which category of fallacy this argument falls under.

Monday, February 18, 2013

At Long Last Data: Reducing Trainees' Exposure to Marketing Makes a Difference

We can start with this nice summary piece by Kevin O'Reilly in American Medical News:

We've had a problem for some years now. After decades of howling in the wilderness, the pharmascolds started to win battles around 2005-2009. We now have many more policies in place to limit the influence of pharmaceutical marketing on medical education and practice--not the least of which is PhRMA's own code of conduct from 2009, which is why, when I recently asked a mostly-medical-student audience how many of them were carrying pens with drug firm logos, no hands went up. If I had asked that question of a similar audience in 2005, the response would have probably been, on average, half a dozen branded items per person.

So what if anything has actually changed? There have been very few published data to answer that question. At first, the reforms were obviously too new to allow careful study of effects, but as years have gone by, we naturally wonder what the record is.

Now the article above notes two recent publications, one addressing medical school, the other residency.

First, Marissa King and a team headed by Dr. Joseph Ross of Yale:
--did a very clever study of the impact of medical school policies discouraging contact with drug reps on later physician prescribing. They set about doing their study the same way drug reps market drugs--they bought the IMS Health database on practitioners' prescribing and the AMA masterfile that allows those data to be linked to individual physicians. Only instead of name and address of the doc, they wanted to know which med school he/she graduated from and the graduation year. They then looked at three psychotropic drugs that entered the market in 2006-8, that in their opinion represented me-too drugs that had no major advances over older, often cheaper drugs-- lisdexamfetamine (Vyvanse), palperidone (Invega), and desvenlafaxine (Pristiq). They compared prescribing of these drugs between two groups--those attending schools that had instituted policies to exclude drug reps by 2004 and those that had not. Essentially they tried to figure out the lag time between attending a school that had a certain policy, then completing an average residency, and then being out in practice and prescribing drugs independently.

King et al. noted two reasons to predict that they'd find no significant differences. First, the schools that implemented policies back in 2004 often had pretty weak and tentative policies; it was quite normal for these policies to be substantially tightened as the decade progressed. Second, they were unable to control for the residency experience, so for all they knew, when med students who had seen no drug reps as part of their MD education then proceed on to residencies where they were awash in marketing, the effects of the med school policy would be washed out.

Theredfore it is notable that King et al found significant differences for two of the three drugs they studied, where graduates of the schools with strict policies prescribed significantly less of the expensive but hardly better new drugs. The authors admitted that they had no data on whether this would carry over to really useful new drugs--would they prescribe less of those too? But in any event we have some tentative and preliminary data to suggest that med school policies make a difference.

What about residencies? The next study is out of a team headed by Dr. Andrew Epstein at Penn: (subscription required). These folks looked specifically at psychiatrists prescribing antidepressants, and asked how often they prescribed three different groups of drugs--heavily promoted; reformulated; and brand name. (Arguably, smart docs would prescribe less of all three groups.) They looked at two variables--what year the psychiatrist graduated from residency, and whether the residency was located within an institution that had a strict, moderate, or loose policy restricting drug marketing (based on the AMSA scorecard). They found that merely graduating at a later date did not substantially effect prescribing, but the degree of policy restriction did.

We have no evidence to show that overall, pharmaceutical marketing is less a part of the overall medical environment today than it was a decade ago.  In the commonly cited statistics of Eric Campbell's group, the number of docs reporting contact with drug industry sources went from 94% in 2004 to 84% in 2009 (see: That's hardly a major decrease. In such an environment, many would imagine that a med school or residency banning reps and drug lunches is a prely symbolic and ineffective gesture; and the argument is still heard that instead of banning these activities, a smart residency director would encourage them and use the contacts with reps as a teaching opportunity for the "real world." So these new studies, while hardly definitive, are nonetheless major steps toward showing what actually happens when one implements such policy changes.

(Hat tip to good friend and fellow blogger Alice Dreger for the link to the O'Reilly piece.)

Saturday, February 16, 2013

More Deja Vu: Why KOLs Don't Blow the Whistle

The text for today's sermon is:

Barry Meier reports in the Times that Johnson & Johnson's orthopedic device subsidiary, DePuy, had numerous warnings from its own paid consultants about the dangers of its Articular Surface Replacement artificial hip implant, a couple of years before they had to take it off the market and now face 10,000 patient lawsuits. As usual, it's only when lawsuits are filed and the legal discovery process leads to release of internal company documents that we discover what was actually going on.

Meier has been around this block a few times-- see HOOKED for a discussion of his book, Pain Killer, about how Purdue Oharma bought out national pain experts in defense of their drug OxyContin. But surprisingly, Meier sounds surprised when he writes: "It might not be surprising to find that executives acted to protect a company’s bottom line. Still, the Johnson & Johnson episode is also illuminating a broader medical issue: while experts say that doctors have an ethical obligation to warn their peers about bad drugs or medical devices, they often do not do so."

Well, both HOOKED and this blog have reported repeated instances of this very phenomenon. Indeed, if you want to read some really snippy comments, hunt up the e-mails among marketers in the drug company when one of their "consultants" starts making public statements about the dangers of a drug. You can see the logic--we bought and paid for this guy; so how come he's now cut the marionette strings and is dancing to his own tune?

Which, by the way, ought finally to put full stop to the commonly heard rationalization among docs who take large wads of industry cash and still proclaim their independence: I'm a scientist, you can't buy my opinion. Well, Johnson & Johnson did, and they are hardly alone.

The artificial hip episode replays a couple of techniques that we've seen before, as ways to keep docs docile and not likely to spread the word about a newly discovered danger of a profitable product:
  • It's only you: A company may be getting reports from all over about patients having adverse reactions, yet still reply to each reporting physician that they were shocked to get his note because he's the only one who has seen this happen. Physicians who can be persuaded that they are seeing something none of their peers are seeing are much more likely to doubt the accuracy of their own observations than to pursue a disclosure strategy. (This ploy goes all the way back to the way Chemie Grunenthal pushed thalidomide back in the late 1950s in Europe.)
  • Smear campaigns: The industry is not above retaliation against its KOLs. Meier reports, "For example, when Dr. Lawrence D. Dorr, an orthopedic specialist, warned fellow surgeons in an open letter in 2008 that a hip implant made by Zimmer Holdings was flawed, he became the subject of a whisper campaign that questioned his skills as a surgeon. ...'The first thing that a company does is to put out a campaign that a surgeon does not know how to operate,' said Dr. Dorr, who was a consultant to Zimmer when he wrote the letter. 'It hurt my practice for a year.'"
 Incidentally, if you thought that J&J were newcomers to shady behavior, check out previous posts:

Hat tip to one of my most faithful and helpful readers for the Meier article.

Monday, February 11, 2013

On Lack of Moderation of Comments on This Blog

The one (of 6) legitimate comments to a recent post says:

Uhh. Whatever happened to moderated comments? I used to come to this blog for insightful posts, AND DISCUSSION IN THE COMMENTS.

No longer, in the second aspect (I still read very interesting blog posts!). Instead, in the comments section, I see almost entirely spam-like "comments" having nothing to do with the post, and pushing some other website or other.

And the interesting comments only seem to come to surface because Dr. Brody knows the commenter.

What's up with this?

Here's what's up. When I started this blog in 2007, there was very little problem with spam comments. I accordingly created the blog with rather generous settings to allow comments simply to go up without prescreening. (I can, if I wished, allow no comments at all, or require that I approve all comments before they appear.)

The volume of spam comments has since become immense. When I just now logged on, I had a stack of 69 comment awaiting my review, all of them spam so far as I could tell. (I am asked to review any comments that show up for posts that are older than a certain specified limit.)

If I reset the blog settings so that I moderated all comments before they went up, I am frankly not sure where I'd find the time to do the blog. I have a more-than-full-time job and manage to do this blog only in odd moments. As I trust is abundantly clear, I make no profit off any aspect of the blog. Blogspot has some sort of spam filter which is supposed to weed out the worst automatically but as you can tell, these low-lifes are adept at finding ways around it. Exactly what is in it for them, to get their links posted in a comment where it is virtually guaranteed that no one will click on them, escapes me, unless they somehow get paid extra for everyplace on the Internet that their link appears.

I'll try to police more recent entries more carefully in the future to eliminate spam comments. Meanwhile, my apologies to the serious readers who would like to see this plague depart.

ADDENDUM 2/11: After publishing the above post I went and checked the comments for the last 5-6 posts, and I note that compared to the last time that I did this, the Blogspot automatic spam filter is apparently letting a lot more of the obviously spam comments slip thru. I appreciate Anonymous calling this to my attention and promise to work harder in the future to police this.

Sunday, February 3, 2013

New Sunshine Regs--While CME Remains in the Dark?

Just to prove me hopelessly behind the times, no sooner do I get around to posting about the LA Times editorial bemoaning the delayed release of Federal regulations to implement the sunshine provisions of the Affordable Care Act (see immediately previous post) than I hear from my esteemed bioethics colleague Dr. Alice Dreger at Northwestern about a post at Forbes:
--in which medical journalist Larry Huston reports that the regs are finally out, but that they contain a notable gap for continuing medical education programs.

Let's look at both sides of the controversy Huston hints at. In support of the decision made by the Feds, a CME program that follows the appropriate guidelines from their accrediting body (the ACCME) is supposed to assure that the committee that selects speakers functions independently of any fund donor. So if the good Dr. Kol is chosen to be a CME speaker at a particular conference, and if Carter's Little Liver Pills paid money to support the conference, then Carter's giving money should have in no way influenced the decision to pick Dr. Kol. It would therefore be highly inappropriate to have Dr. Kol listed, on the public website identifying drug company payments to docs, as being in the pay of Carter's.

What about the opposing argument? As Huston points out, it's not as if either the CME planners or the drug firms are dolts. The drug companies support CME programs out of their marketing budget, as a rule--not out of some charity fund. (duh.) If they use marketing $$ for this purpose, it means the company sees some sort of ROI, which to us non-MBA types is "return on investment." If they plow bucks into CME, it is supposed to pay off in increased revenue from drug prescriptions.

Now, what if they give money to a CME program and they don't see the sorts of ROI they were counting on? Do you think they'll be as eager to give money for the next CME program those planners propose? Of course not, and the company knows this and the CME planners know this. That's "independence" for you.

So is it fair that Dr. Kol ends up on the "sunshine" web site personally named as having taken company cash? Well, if he is, then maybe CME speakers will be happy to have their true role in this shell game called by its right name. If not, then the Dr. Kols of the world can start letting CME planners know that they need to run their programs without commercial sponsorship--as the American Psychiatric Association, for one, has already recommended:
--and as the Institute of Medicine report on industry influence also has called for:

Saturday, February 2, 2013

Waiting for the Sunshine, only 15 Months Late

As Ground Hog Day approaches, it's naturally a topic of conversation whether or not the sun will shine. The Los Angeles Times, coming from a city where the sun usually shines, is worried about the lack of sunshine across the country in DC:,0,1445349,print.story

We've previously noted how the Sunshine Act, to require federal reporting of drug company payments to individual physicians, got folded into the health reform law:

The Times notes that the final regs to implement this part of the health reform law were due out in October 2011, but they have yet to see the light of day (no pun intended). Their editorial advice is to get on with it speedily.

At intervals we have noted how some pharmapologists have insisted that folks like me who worry about financial conflicts of interest between medicine and the pharmaceutical industry are way off base because there's no evidence whatsoever that the public's trust in medicine or physicians is compromised by these financial ties. These folks may be right or they may be wrong, but they won't find any support for their position on the LA Times editorial page. The editorial makes its view clear that trust in medicine has been severely eroded and only as good dose of full disclosure can reverse the process.