The Physician Sunshine Act: Time for Hired Guns to Scatter

Obama's healthcare reform package was finally signed into law on March 23. And while Obamacare will have a huge impact (in my view, a positive one) on health care in the U.S. over the next few decades, one component, the Physician Payments Sunshine provisions, may improve medicine even more profoundly.

You might recall that the Sunshine Act was first introduced almost three years ago by Senator Charles Grassley. I've blogged about it several times before, here for example.

The Sunshine act is the culmination of a Herculean effort by Grassley, his staffer Paul Thacker, and many others to disinfect the culture of corruption and commercial influence that has permeated medicine. Click here for a series of links on Grassley's website offering a meandering trip down a memory lane of conflicts of interests. Almost all of the sights along the way pertain to my own field of psychiatry, which consistently provided the lowest-hanging fruit among ethically challenged researchers.

At any rate, now that the Sunshine Act is officially the law of the land, what, exactly, are its provisions, and how might it affect medicine? You can download a concise fact sheet on the act from the Pew Prescription Project website here. Essentially, the law requires that all drug and device companies report all payments made to physicians and teaching hospitals. This includes money for marketing activities, such as promotional talks and consultation, but also includes research grants, "charitable" contributions (which usually come with some promotional strings attached), and funding for conferences, whether CME or otherwise.

Given that so many drug companies have already published registries of physician payments, one might reasonably ask whether this act was actually needed, and whether it will really accomplish anything new. It was, and it will, and here's why.

As noted by Eric Milgram on his Pharma Conduct Blog, the existing company sponsored disclosures provide few details and are formatted in such a way that they are "translucent" rather than "transparent." As a patient, physician payment registries are important because they would presumably allow me to easily look up my doctor, and find out if he or she has been paid to push that new and expensive drug that was just prescribed for me. The current registries don't provide that level of detail, and they make it hard or impossible to conduct efficient searches.

The Sunshine Act fixes this problem. Companies will be required to report names, addresses, the amount of the payment, the date of the payment, and the precise nature of the "service" provided by the doctor. Not only that, but if the payment was for a promotional talk, the company will have to disclose the name of the drug the doctor was pushing. Thus, for example, Eli Lilly's current registry would allow you to find out that a doctor made $50,000 in 2009 performing what is vaguely (translucently) described as "healthcare professional education programs." But the Sunshine Act registry will tell you that your doctor made $50,000 for marketing Zyprexa in 2009. In fact, the Zyprexa speaker's payments will be broken down by date, so you might be able to discover that your doctor got a fat check exceeding your annual salary on the day before he wrote out a Zyprexa prescription for you.

It is this kind of granularity of information that will truly make doctors think twice before pursuing careers as hired guns.

Dr. Tom Insel, NIMH Chief, Scolds Psychiatry

In the latest issue of JAMA (the Journal of the American Medical Association), Dr. Thomas Insel, the chief of NIMH (National Institute of Mental Health) accuses academic medicine of having become a "culture of influence," in which drug industry marketing goals have pervaded the practice of psychiatry.

Insel's commentary is entitled "Psychiatrists' Relationships with Pharmaceutical Companies: Part of the Problem or Part of the Solution?" While acknowledging (as we all should) that some collaboration between physicians and pharma is a good thing, he concludes that industry influence has radically skewed psychiatric practice in favor of the most expensive drugs, even when evidence shows that cheaper generics work as effectively. He also bemoans the fact that effective psychotherapeutic techniques are "woefully underused and frequently not reimbursed."

In what I believe is an oblique endorsement of an APA Work Group's report on the relationships between psychiatrists and industry, Insel calls on organized psychiatry to lead the way to reform:

"The focus on financial conflicts of interest in psychiatry is an opportunity to take the lead in setting new standards for interactions between all medical disciplines and industry. Academic leaders, professional societies, and patient advocacy groups could turn the tables of public trust by developing a culture of transparency for psychiatry's collaborations with industry, including the clear separation of academic-clinical missions from industry marketing."

Not all wags see Insel's commentary as optimistically as I do, of course. Bernard Carroll, over at Health Care Renewal, believes that Insel went soft on some of the poster boys of corruption, such as Charles Nemeroff, who resigned his chairmanship of Emory after it became clear he deceived the university regarding his promotional work with industry. Carroll points out that Insel might have considered disclosing his history of close ties with Nemeroff:

"Though Dr. Insel spoke in platitudes about the need for transparency as a solution, the spirit of transparency did not move him to disclose that Nemeroff is his former boss at Emory; that Nemeroff found a position for him when Insel was departing the intramural research program at NIMH; that Nemeroff lobbied for Insel’s appointment as NIMH Director; and that Insel appointed Nemeroff as an advisor soon after he moved to NIMH. These are pertinent conflicts of interest that readers of JAMA deserve to know about."

If this is true, this is interesting information that is new to me. Nonetheless, in my opinion it does little to detract from the power (and courage) of the country's chief psychiatrist calling his own profession out on the carpet for bad behavior. Bravo to Dr. Insel!

Psychologists Prescribing: The Best Thing That Can Happen to Psychiatry

First, I apologize to readers of my blog for the paucity of posts lately. The reason has nothing to do with my health (I had a mitral valve repair surgery at the end of March and have recovered uneventfully). I’ve been too busy with a bunch of things, all of which are coming to fruition this May. These includes a book called Unhinged: The Trouble with Psychiatry; an article to be published in the New York Times Magazine; launching a new newsletter called The Carlat Child Psychiatry Report, to be edited by Dr. Caroline Fisher; and new blog columns for both Psychiatric Times and Psychology Today.

So I won’t be able to keep up the twice weekly pace that I think is truly minimal for a good blog, but I’ll do the best I can.

Today I want to touch on what is probably the hottest topic in psychiatry: whether psychologists should obtain prescription privileges. This is topical because Oregon just overwhelmingly passed a law authorizing prescriptive privileges for psychologists, although it is unclear whether the governor will sign the bill.

I endorse psychologists prescribing, and here’s why: it would be the single best thing that could happen to psychiatry. Yes, I know it sounds ridiculous, but here’s my reasoning. Psychiatry has boxed itself into a tiny corner of medicine called “psychopharmacology.” It’s a silly way to practice our craft, because the essence of what we do is to understand the mind and to help people live better lives. Drugs are effective but only one of the tools available to us, and we have largely ceded psychotherapy to psychologists and social workers. The result is a fragmentation of care. You see your “p-doc” for your meds, and you see your therapist for your mind. Each professional is far too busy to communicate with the other.

While there are plenty of patients out there who do so well on meds that they don’t need therapy, the majority of patients do best with both meds and therapy. But psychiatrists rarely provide the full package of treatment, because we are trapped in a system of incentives that discourage integrative care. Insurance companies pay more for med visits. Drug companies throw the full force of their marketing machinery into pushing medications. The top psychiatrists find that the road to academic glory lies in psychopharm research. And our anachronistic training system, which requires that psychiatrists attend medical school, selects for practitioners who see people in terms of discrete diagnoses, and who are rarely psychologically minded.

Enter psychologist prescribers. These are professionals who went into their field because they are fascinated by the human mind. From early in their training, they learn about psychiatric diagnosis, psychological testing, psychotherapy, interpreting behavioral science research, neuropsychology, etc…. They don’t go to medical school, so they learn nothing about such crucial psychiatric topics (being sarcastic here) as gross anatomy, histology, pathology, or the physical exam, nor do they have clinical rotations that psychiatrists draw upon daily, such as Ob/Gyn, surgery, internal medicine, radiology, and others. Thus, psychologists don’t learn how to deliver a baby or how to tie a surgical knot, but they do learn how to get at the root of anxiety and how to keep patients coming back for treatment.

Psychologists first obtained prescriptive privileges in the military through the Department of Defense demonstration project, and since then have been awarded privileges in both New Mexico (2002) and Louisiana (2004). The lengths of the training programs vary, though they are typically two year programs incorporating both didactics and a clinical practicum. Many have charged that these two year mini-programs cannot possible produce safe prescribers. But the evidence contradicts this position. There have been no adverse events reported in any of the programs operating thus far.

As the safety data gradually accrues, I predict that psychologists will attain prescriptive privileges in most states over the next 10 to 20 years. We saw the same pattern in the 1970s with nurse practitioners—psychiatrists and other physicians engaged in bitter turf wars initially, arguing that they didn’t have enough training, but large scale health services research studies eventually demonstrated that NPs operated competently and safely, and now they are accepted as independent practitioners in most states. As it turned out, there is so much business to go around that psychiatric nurse clinicians have not eaten into psychiatrist’s practices or incomes. On the contrary, since NP’s must receive regular supervision, many psychiatrists have developed side gigs supervising nurses, charging $200 to $300/hour—more than you can make seeing patients.

According to some psychologists I have spoken with, the early experience in New Mexico and Louisiana is that psychiatrists and medical psychologists (that’s what they are termed in Louisiana) are accommodating to one another and that psychiatrists are not losing business. But as more and more states approve prescribing psychologists, this will probably change. I predict that patients will vote with their feet and preferentially see prescribing psychologists once they realize that such practitioners provide one-stop shopping—meds and therapy combined.

And herein lies the great opportunity for psychiatry. As psychologists gradually become serious competitors for our patients, we will have to re-evaluate how we practice and how we are trained. We will have to take a close look at our catastrophically inefficient medical school-based curriculum. We will have to decide which medical courses are truly necessary and which are not. I suggest that the process begin with a work group created jointly by the American Psychiatric Association and the American Psychological Association. Yes, let’s get psychiatrists and psychologists in the same room, and create an ideal curriculum for integrative psychiatric practitioners. Let’s face it, going to 5 to 7 years of psychology graduate school, then capping it with 2 years of psychopharmacology is not an efficient use of training resources. It’s almost as inefficient as going to four years of medical school, one year of medical internship, then three years of psych residency.

There must be a middle path—perhaps a five year program that would interweave coursework in physiology, pharmacology, and psychology from day one. The specifics would require much thought and discussion, and would best be done by reverse engineering. Start with the ideal psychiatric practitioner, list the core competencies such a person requires, and then figure out the very best way to teach those competencies.

On the other hand, organized psychiatry can continue on its current path, which involves throwing millions of dollars into lobbying efforts to fight psychologists. The money is being wasted, I can guarantee that. At the end of the day, we will be on the sidelines as patients flock to prescribing psychologists and our professional sphere constricts further and further into a narrowly defined neuropsychiatry role. We can do much, much better than that.

WebMD's Big Lie

In order to provide quality web-based health content, you need money. The question is how you choose to make that money. WebMD, like many web sites, makes money from advertising, but it consistently goes several steps further, allowing its content to be transformed into one long stream of stealth advertising.

The incredibly successful company was just caught red-handed by Senator Chuck Grassley, who saw a WebMD television commercial encouraging viewers to log on to the site in order to take a depression screening test. When Grassley navigated over to the test, he found that it was funded by Eli Lilly—information that was apparently omitted from the TV commercial.

What's the big deal? At first blush, this looks like business as usual. I read through the test, which appears to simply go through the DSM-4 criteria for depression, one at a time. Nor is the test actually written by Lilly. In fact, at the top of the page is the statement “This content is selected and controlled by WebMD's editorial staff and is funded by Lilly USA.” So it would appear that Lilly paid WebMD staff to encourage people to discover whether they have depression, and to seek appropriate treatment from their doctors. Yes, some of these patients might end up on Lilly’s antidepressant Cymbalta, but others would be prescribed competing antidepressants. Looked at this way, this isn’t particularly deceptive or nefarious. In fact, it might be interpreted as a public health service--enhance awareness of depression, and everybody benefits.

But of course this story isn't quite that benign. Let’s take a closer look at Web MD’s depression screening test. DSM-4 lists nine possible symptoms of depression, yet WebMD’s test lists ten. Here is WebMD’s extra item:

“I'm having frequent headaches, stomach problems, muscle pain, or back problems.

Yes

No”

Now, nobody would insist that the nine DSM criteria are the be-all and end-all of depression. Depressed patients often experience problems that are not specifically included in DSM-4’s list. These include symptoms and behaviors like lowered sex drive, irritable mood, excessive use of drugs or alcohol, and, yes, various physical aches and pains. There are many more. So why, out of the dozens of possible depressive symptoms not listed in DSM-4, did WebMD decide to ask about one, and only one, in particular: aches and pains?

Because Lilly markets Cymbalta as the "go to" antidepressant for patients who have both depression and physical pain. This is not really a "depression screening test" at all. Instead, it is a "Cymbalta-requester" screening test.

WebMD is telling the public a big lie. The say that “this content is selected and controlled by WebMD's editorial staff” when in fact the crucial aches and pains questions was selected by Eli Lilly’s marketing team to encourage patients to ask their doctors for Cymbalta.

The company's blatantly deceptive techniques are particularly ironic given that WebMD's CEO, Wayne Gattinela, likes to talk up "transparency" in interviews about his company. Clearly, WebMD would never allow transparency to get in the way of an Eli Lilly payday.

DSM: The Everlasting Gobstopper of Psychiatry

The DSM is the Everlasting Gobstopper of psychiatry, providing a seemingly endless store of material for bloggers, journalists, academics, and other commentators.

I looked through the comments on my last post and was impressed by how articulate they were. I'll spend the next few posts commenting on some of the comments. How's that for narcissistic exploitation of one's own blog?

S pointed out that “a reasonable, experienced, compassionate doctor will not be bound up by DSM diagnoses,” and accurately followed that up with “but I suspect all of us here know that there are plenty of doctors who can't see past rigid categorization or have a two-dimensional view of their patients.”

I agree. Michael First, who was the editor of DSM-IV, once told me, “We used to joke that DSM should come with a combination lock and you can only open the book if you agree to really explore what is going on in the patient’s minds.” I think of DSM is a map into the mental world. It allows us to locate a patient in a general region, but not much more than that. To truly make the diagnosis, we have to do the messy work of talking with the patient and exploring what’s going on. In fact, the term “diagnosis” is a misnomer and should probably never have been borrowed from the rest of medicine, since it implies a precision utterly lacking in psychiatry circa 2010.

Dr. Peter Huang likes the new dimensional aspects of the DSM-V, but is concerned that the new disorders being proposed "will serve as an even bigger seed that Big Pharma + the APA + the FDA will use to increase further the insanely vast quantities of psych meds that are prescribed.” This is also Dr. Allen Frances' main critique in his essay, Opening Pandora’s Box: The 19 Worst Suggestions For DSM5. I agree that this is an inevitable consequence of elaborating the DSM, but only if we psychiatrists acquiesce. Some of these "changes" represent little more than a shuffling around of criteria from one label to another. The two risk syndromes (for psychosis and dementia) are potentially more insidious and might be exploited by drug companies for commercial gain. For this reason, I find it rather unlikely that both will make it into the final version--I predict that mild dementia (in the new vocab, "mild neurocognitive disorder") will make it through the gauntlet, but not "risk syndrome for psychosis."

Dr. Joseph Arpaia points out that DSM is mute when it comes to how the environment produces psychiatric symptoms: “The minimizing of the environmental effects means that the brain's attempts to adapt to the environment are seen as inherent brain pathology. This is as absurd as stating that an immune response to a bacterial invasion is an inherent immune pathology.”

However, the reason DSM does not mention environment is that it attempts to be “agnostic” when it comes to statements of causation. Yes, depression can be caused by many things but DSM simply runs down the list of symptoms. This speaks to the issue of how the document is used. If someone invented a DSM robot (perhaps in Freud's likeness), such a machine would, indeed, simply go through the lists and makes a bunch of diagnoses divorced from context. But thoughtful clinicians, whether psychiatrists or psychologists or social workers, don’t use the manual this way. Don't expect DSM to be more than it is, which is bare-bones descriptive psychiatry. At this point, we know too little about causation to do anything more than describe symptoms.

That's all for now--stay tuned for our next installment of "Commenting on the Commenters."

DSM-5's Rough Draft: The Carlat Take

In a prior post, I observed that the process of hammering out the DSM-5 had degenerated into a bar room brawl. Major figures in the development of past DSM versions, such as Allen Frances (the DSM-4 chairman) and Robert Spitzer (DSM-3 chairman), had both severely criticized the DSM-V process for lack of transparency and for a headlong rush to get the thing done too quickly in order to start making the APA some money.

Looking at the just-released proposed DSM-5 criteria, I'm pleased to say that the APA leadership has apparently been listening. They've pushed the planned publication out two full years to 2013, giving everybody time to review the proposal and to do some field testing. They have made the process far more transparent by posting task force reports on the DSM-5 web site. And they have avoided trying to pretend that DSM is ready for a paradigm shift in which diagnoses are based on neurobiological criteria (here's a secret--they don't exist yet in psychiatry).

Here's a quick Carlat-tour through some of the the main proposals.

--Temper dysregulation with dysphoria (TDD). A much more accurate way of categorizing children with explosive temper tantrums so that they don't get misdiagnosed as having bipolar disorder. This is a response to the fact that the diagnosis of bipolar disorder in children has increased 8,000% over the past decade.

--Addiction and Related Disorders. No more having to deal with the confusing terms "substance abuse" vs. "substance dependence"--both will be jettisoned in favor of the catch-all term "addiction." Currently, "dependence" is supposed to be a more severe problem than "abuse" but there was no good way of distinguishing the two in real patients. When someone has a problem with drug or alcohol craving, it's an addiction, pure and simple, and DSM-5 will acknowledge this.

--Autism Spectrum Disorders. This makes a lot of sense. No longer do we have to figure out: "Is this mild autism? Or is it severe Asperger's?" Now we can describe such patients as being somewhere on the spectrum of autism and spend more time understanding them as people rather than coming up with just the right label.

--Binge Eating Disorder. Some might see this as a form of disease mongering--that is, expanding the definitions of diseases to label more and more people as mentally impaired. But in fact I see patients with BED (as it's abbreviated) in my office with some frequency. These are not just overeaters, but rather patients who compulsively binge and have lost all sense of control.

--Risk Syndrome for Psychosis. This is a bit more iffy a proposal in my opinion. The idea is that you can diagnose people who have milder symptoms of psychosis before they develop full blown schizophrenia. Then, maybe you can prevent a more severe disease by starting them on prophylactic antipsychotics. But the research is debatable. Only about 35% of patients who qualify for this "pre-psychosis" end up developing true psychosis. I doubt this will make it into the final DSM-5 as an official disorder.

There are others potential disorders to examine, but I'll look at those in future posts. We all have a few years to comment on these proposals, and I think they are offered in the spirit of healthy conversation and debate. Thumbs up to the DSM Task Force.

Lilly: "Execute the *%#&*! out of them"

A new paper, written by Glen Spielmans and Peter Parry and published in the journal Bioethical Inquiry, shows how various drug companies, particularly Eli Lilly and AstraZeneca, manipulated science and lied to doctors in order to sell their drugs. While this is not exactly news, the intriguing aspect of this article is that the authors reproduce e-mails and slides that are the smoking guns of deceptive sales practices. And let me tell you, these gun barrels are hot and you can still smell the gun powder.

"The data don't look good."

That's what John Tumas, an AstraZeneca publications manager, wrote in an email to a brand manager and a scientist. He was referring to an AstraZeneca-funded study showing that Haldol was superior to Seroquel (oops!). The fact that AZ officials knew about this data didn't prevent them from sending one of their hired guns to an APA meeting two months later to claim that Seroquel was "significantly superior" to Haldol.


When AZ didn't have the stomach to lie about unfavorable study results, they did the next best thing--they buried them. "Thus far," wrote Mr. Tumas in a different email, "we have buried Trials 15, 31, 56 and are now considering COSTAR."


Zyprexa and Weight Gain: "Don't introduce the issue!"

Eli Lilly knew that Zyprexa caused enormous weight gain as far back as 1995, and knew that it was worse than competing atypical antipsychotics as of, at the latest, 1999--we know this because Alan Breier (now Lilly's Chief Medical Officer) admitted to senior executives in an email that "Fact: the order of weight gain among antipsychotics is: Clozapine>olanzapine [Zyprexa]>seroquel>risperidone>traditional neuroleptics."



But in 2001 Lilly sales reps were being trained to "neutralize" physicians' concerns about weight gain by pushing what managers were calling a "comparable rates message." Most of all, reps were instructed to follow the "don't ask, don't tell" policy favored by the U.S. Army regarding a different inconvenient issue.

There are many other zingers in this comprehensive description of what the authors call "Marketing-based Medicine" as opposed to "Evidence-based Medicine." The entire paper is required reading for those interested in the realities of pharmaceutical marketing in the modern age.