1 Boring Old Man

A Misfortune Not a Crime

Director’s Blog: NIMH

By Thomas Insel

April 11, 2014

… check out a new report  from the Treatment Advocacy Center on the treatment of people with serious mental illness. According to this report, there are now 10 times more people with serious mental illness in state prisons [207,000] and county jails [149,000] than there are in state mental hospitals [35,000]. The report includes a state-by-state assessment of treatment of people with mental illness in jails and prisons. In 44 of the 50 states, the largest single “mental institution” is a prison or jail…

How can this be possible? In the 1830’s Dorothea Dix revolutionized the care of people with mental illness by taking them out of jails and caring for them in asylums, later known as state hospitals. In the last 50 years, we have reversed this trend, resulting in a 90 percent reduction in public hospital beds for people with serious mental illness. While this reversal came about as the result of good intentions, it has resulted in unintended consequences. Many, but not all, people with serious mental illness can be treated effectively with the less restrictive care offered in outpatient settings. Sometimes patients with serious mental illness, just as with other serious medical illnesses, require hospitalization. In the absence of available public or private hospital beds, there are few options. Some patients are housed in emergency room holding areas; some return home, where family and friends struggle to provide care; and some—at considerable risk to themselves—become homeless. For those who do not realize they are ill and therefore resist treatment, or those whose behavior may be disruptive or aggressive, jails and prisons have become the de facto mental hospitals…

What should be done? Returning to the asylum system — which could be regarded as turning away from the goal of recovery — is not the answer. The new report suggests several remedies, including ensuring better treatment within the prison system, jail diversion programs, assisted outpatient treatment, and release planning. Surely our nation can do better than assigning the criminal justice system the responsibility for delivering care to the mentally ill. In an era of mental health parity and health care reform, how can we allow hundreds of thousands of people with a brain disorder to be treated in our justice system — if that can be called treatment — rather than our healthcare system? Abraham Lincoln, no stranger to serious mental illness, once lamented, “a tendency to melancholy… is a misfortune not a fault.” Our current system, if these new numbers are accurate, treats mental illness, for many, not as a misfortune but a crime, with little promise of recovery.

And I’m not going let go with a primal scream that those 350,000 people are not Myths. Their commitment was as criminals. They are receiving medications whether they want them or not [or whether they need them or not]. And, by the way, the TAC doesn’t need any biomarkers to know who they are or to count them. The prison guards know. The other prisoners know. The judges that sent them there know. It’s just not that hard to tell.

And I’m not going to advocate more medications, or less, or pray for future medications, or long for old Asylums, or blame psychiatrists, or anyone else. But there is something worth saying here. The National Institute of Mental Health is our government Agency that is tasked with thinking about the mental health of the country, and this is a problem that actually belongs at the very top of that problem list. There are countries all over the world that do a much better job with this problem than we do. There are social scientists and psychiatrists and social workers and psychologists all over this country that specifically care passionately about this topic and these patients. So why doesn’t the National Institute of Mental Health have a Task Force to look at this problem rationally, to travel the world looking at solutions, to figure out a direction for us to be moving in.

A wise observation. It looks as if they’ve worked out a pretty detailed system:

These concerns notwithstanding, we must collectively make a leap of faith and be prepared to make changes on the ground in the way that we as psychiatrists practice medicine. But this might be focused on specialty mental health care for the most complex patients, while primary care providers increasingly may conduct the first line of mental health screening and provide basic care. It is likely that the relationship between primary care providers and psychiatrists will expand exponentially with brief phone and “curbside” consultations replacing many of the more formal referrals for consultation.

Many psychiatrists will become leaders of multidisciplinary mental health teams providing coordinated services and, in some cases, may be located within large primary care practices. Conversely, we can expect to see primary care providers move into settings such as community mental health clinics to better provide general health care to severe and persistently mentally ill patients [SPMI].

A possible variant of this is that some psychiatrists and allied mental health providers will assume some basic primary health care responsibilities for SPMI patients or may even become their principal caregivers in collaboration with primary care providers. There is an increasing emphasis on addressing health behaviors such as diet, smoking cessation, and exercise as the understanding of the link between mental health and other health behaviors has deepened. Psychiatrists are finding they need to counsel their patients on these issues and even provide more basic medical screening and care to patients or in consultation with primary care providers. Some psychiatrists are even taking refresher courses in primary care to be able to better address this patient need.

To reiterate, multidisciplinary mental health teams will also become more common within hospitals and local health systems. To meet the anticipated demand from more patients while reducing costs, psychiatrists as the team leaders will provide less direct care [again, focusing their direct care efforts on complex, high-risk cases] and more supervision of care, while monitoring and tracking patient progress and increasing their consultative role with other specialists.

That the system he’s proposing will ever fund what most people reading and commenting on this blog would like to see happen for less severe illness is a dream probably gone with the wind, so more important right now is to look at the Lieberman System of Collaborative Care for fatal flaws. As anyone alert and awake knows, the Managed Care system in place has relegated psychiatrists to the role of medication doctors focusing on symptoms. That has been true for some time, and psychiatry, particularly APA psychiatry, has essentially become a psychopharmacology specialty with what many of us consider an outrageous expansion in drug treatment. Let me remind you of the SAMHSA report I posted recently [a graph…]:

My concern in both the SPMI and the Collaborative Care models Lieberman is proposing is that the legacy of the Age of Psychopharmacology will be directly incorporated into both arms of the Lieberman System and perhaps even expand. This kind of medical model thinking for psychiatry is the stuff of managed care, perhaps its only stuff, and I’m reading the model as pure managed care. Likewise, the upper ranks of organized and academic psychiatry are largely people who have known little else, so the dangers of overmedication are multiplied. Finally, the notion of primary care physicians delivering even more of the mental health care is a further force for overmedication. So even if the pharmaceutical industry has abandoned CNS drugs, their golden years will be perpetuated and institutionalized in a healthcare system even without their "ask your doctor…" ads on television.

I was at a conference where a psychiatrist enthusiastically described her experience with collaborative care. Every morning, the treatment team would get together [the “huddle”]. She gave an example of why this was so helpful. One day, someone mentioned that someone’s PHQ-9 had gone up by a few points [this is a nine item screening for depression]. The presenter said something like, ”So we agreed to increase the fluoxetine from 20 to 40 mg and we were all set to go!”

In Psycritic’s post, he mentioned a situation from his experience in a Collaborative Care setting that will surely become endemic:

I thought that the vast majority of patients I saw would have benefited from psychotherapy, yet very few of the clinics employed therapists, and none had access to more intensive treatments like dialectical behavior therapy. Even in the clinics that did have therapists [usually LCSWs], they were usually full and could not readily see new referrals. Because of the therapist shortage, I often ended up prescribing a medication by default. And of course, other forms of integrated care may be much more compromised than what I experienced. For example, managed care organizations seem to focus much more on cost containment, screening using rating scales, and then using medications to get those numbers down.

I don’t think the APA’s initiative on collaborative care has anything to do with getting other doctors to see psychiatrists as real doctors. Psychiatrists who practice like real doctors are seen as real doctors without PR fluff form the APA. The emphasis on collaborative care by the APA is a function of their political ineffectiveness in supporting the current practice environment and it is also the way oligarchies function. Once managed care friendly contingents get a hold inside of the organization and "cost effectiveness" and "evidence-based" become buzzwords the resulting corporate approach is predictable. If Ioannidis has taught anything – it should be that anyone can come up with the evidence they want and there is ample evidence for that.

George Dawson, MD, DFAPA

Regarding the APA’s push for "integrative care" and more specifically about having psychiatrists embedded in internal medicine/primary care practices as the Brave New World. I was chewing the fat with my suite partner in my private practice, who is an excellent psychiatrist doing mainly medication management and consultation for psychologists and social workers. He’s a good guy with 35+ years of experience. After discussing Kupfer’s COI issues and the use of "computerized adaptive testing" for depression and anxiety, he shrugged and offered: "It won’t go anywhere. The Internal Medicine docs hate us" [meaning psychiatrists]. I laughed. APA at work for you! Not!

Tom

Just saw this article by Jeffrey Lieberman today on integrated care. Some real gems in there, including this:

There is a historic and exciting opportunity for psychiatrists to influence the future of medical care and occupy our rightful position in the field of medicine.

"Occupy our rightful position." Doesn’t that smack of insecurity and wanting a more "medical" identity for our profession? What do you think, Dr. Dawson?

Psycritic

^{If you read this blog much, you will recognize that I have
recycled this image from other posts on Insel’s campaign
for Clinical Neuroscience.  It was originally an old Soviet
propaganda poster.}

My original specialty was Internal Medicine, something I enjoyed  doing, and I think I’ll put on my Internist hat to respond. Dr. Dawson is right on the money here. This is all some kind of garbled system theory talk that reads like a power-point presentation from a Managed Care or governmental think tank meeting where they use the word impact as a verb, where evidence-based and cost-effective are synonyms, and where if there’s a doctor in the room, it’s not a practicing physician.

As an internist, I didn’t hate all psychiatrists, only some psychiatrists. The ones I liked were the ones that did their jobs. They saw the patient, and took care of the problem that I couldn’t handle myself. You could tell that because the patient either disappeared into their care, or when they came back, gave a report like, "We’re working on it." That’s what doctors want from a referral. Internal Medicine really is frequently algorhythmic – psychiatry as I understand it, not so much. The proof is readily apparent in the last twenty years of psychiatry giving the straight medical model the old college try, a bust in my book. Internists, primary care physicians, medical physicians in general spend their life with algorithms and guidelines. If mental illness could be approached that way, back in the day, I would have simply learned the rules just like I learned them for diabetes or heart disease. But I could see that there was something else, and I saw how a decent psychiatrist could approach those patients in a very different way, and do the job I couldn’t do.

I don’t hear any medical physicians, or any psychiatrists, or any psychologists, or any social workers, or any patients clamoring for Collaborative Care. Tom’s partner in the second comment sounds to me like he has a reasonable take on what the internists of the world might say if they read Jeffrey Lieberman’s piece. He’s creating a whole new profession based on the vision from a third party way of thinking about medicine that will surely go absolutely nowhere. So why are he and Dr. Summergrad [new APA president] talking it up so much? As Psycriyic pointed out, that’s what the whole theme of this year’s APA is really all about:

 

1. In my last post [reason enough…], I interpreted the theme of this year’s APA meeting [Changing the Practice and  Perception of Psychiatry] as some recognition that psychiatry’s reputation is in the tank. But, alas, Psycritic gently informed me that I’d missed the boat:
   I don’t want to a total downer, but when the APA says “changing the practice and perception of psychiatry,” with the “practice” part they are referring to increasing use of evidenced-based treatments and integrated care, and the “perception” part is wanting the public, other doctors, and med students to see psychiatrists as “real doctors” and scientists. Alas, it has nothing to do with the the reasons for change that most of us reading this website believe are important.
   Alas indeed! I could perhaps blame the pollen count, but that’s not the only time that my wishes have overwhelmed my rational thinking recently. To wit:
2. In early March [before the Spring pollen came], the APA published a preliminary schedule for this year’s meeting. Looking through it, I ran across this:
   
   That was about a month after Dr. Kupfer’s Conflict of Interest with this company became clear. I thought maybe this had been put together before and they might need alerting, so I wrote the program chairs:
   Drs. Muskin and Carter,
   I’m a retired Psychiatrist and Psychoanalyst who blogs as 1boringoldman. Looking over the preliminary APA Annual Meeting Program, I ran across this:
   [above graphic]
   The presenters are shareholders in a commercial venture [Adaptive Testing Technologies] marketing these very CAT tests. The details are well documented:
   [open letter to the APA…, credibility…, ludicrous!…]
   Is it really appropriate for them to be presenting their products in an educational forum like this? Did they declare this obvious Conflict of Interest to your program committee? Don’t we have enough Conflict of Interest problems already?
   And was answered the same day:
   All presenters disclosed.
   Thank you for your message, I will consider the matter closed.
   Philip R. Muskin,MD
   And sure enough, when the definitive program was published, the disclosures [and symposium] were there:

   
   [reformatted to fit screen]

   
   [reformatted to fit screen]

   So it’s listed as NIMH Research [Gibbons grant to develop his tests]. It’s disclosed as a coming commercial product. But at the APA convention, it’s a session. How that’s anything but a huge conflict of interest and using the APA meeting to roll out a new commercial product disguised as an educational symposium is beyond my understanding. But back to the wish it was a clerical error – no cigar there.
3. The third wish interfering with my judgement should be obvious. I apparently still wish the APA would stand up and firmly acknowledge the problems and make some kind of ethical stand about COI, or just about anything else. So I keep acting as if that’s possible. But I’m afraid that’s the most irrational wish of all. They’re not going to do that. They didn’t do it through the DSM-5 process, or at the time of the Grassley investigations, or any time since or in-between. And my continued attempts to view the American Psychiatric Association as anything but a big part of the problem is going to have to accede to Freud’s Reality Principle – and fade away.

A judge ruled in February that as a state agency, the university and its IRB are immune from the lawsuit. The legal ruling didn’t allow questions to be explored about who’s ultimately responsible for the safety of research subjects and whether the university did everything reasonable to protect Markingson from harm. According to the U’s human subjects protection guide, the IRB’s first charge is "to protect human subjects involved in research at the university from inappropriate risk"…

The lawsuit by Markingson’s mother, Mary Weiss, alleged that the IRB’s trust was misplaced in the so-called CAFE study, led by Dr. Stephen Olson, a U psychiatrist. A central allegation was whether Olson had too much power over Markingson, and too many conflicts that obscured his clinical judgment. Olson recruited Markingson into the study at the same time he served as Markingson’s treating doctor and advised a Dakota County judge on whether Markingson should be committed to a psychiatric hospital.

Had the IRB followed its own guidelines, it would have discouraged Olson from recruiting his own patient. The IRB Web site states that "doctor-patient relationships between the investigator and participants should be avoided, when possible, to eliminate any power-based coercion"…

In some ways, the way the University of Minnesota has tried to deal with the Markingson case [refusing to let it to see the light of day, denying all allegations, trying to limit any investigation to the present corrections] turns out to be a microcosm of how American Psychiatry is dealing with the overall problem of corruption in the ranks in the specialty. If you look at the APA Convention program for next month’s meeting, none of these unpleasant and shameful topics made it to the program. Yet the theme for the meeting addresses them:

So we’re interested in Changing The Practice and Perception of Psychiatry, but we’re not mentioning why it needs to be changed? Like the President of the University of Minnesota, the APA is saying "look at us now, not then." For that matter, the pharmaceutical industry is doing something similar. They’re finally giving in to Data Transparency but presenting it as a magnanimous act rather than a position they’ve been forced to occupy.

Psychiatry head to receive major award

University of Minnesota

Medical School News

by Sarah Hansen

04/15/2013

S. Charles Schulz, M.D., head of the Department of Psychiatry, will receive the esteemed Stanley Dean Award for Research in Schizophrenia in 2014. For more than 50 years, The American College of Psychiatrists [ACP] has issued this award to “a group or individual that has made a major contribution to the treatment of schizophrenic disorders.” The award will be presented at the next annual meeting of the ACP in February 2014. As part of the award ceremony, Schulz has also been asked to present a brief lecture on his work.

Schulz is the founder of the Schizophrenia Program at the Medical College of Virginia and, previous to his coming to the University of Minnesota, was the Medical Director of the Schizophrenia Module at University of Pittsburgh. He has contributed to the National Plan on Schizophrenia Research and with his colleague Dr. Carol Tamminga, started the International Congress on Schizophrenia Research. Schulz was featured as an expert in the 2011 Academic Health Center informational video The Value of Academic Medicine: Confronting Psychiatric Illness. Watch to see him discuss relevant psychiatric issues including schizophrenia.

hat tip to altostrata…   

The outcome variable in the study was voluntary continuation of medications. Patients with a diagnosis of Schizophrenia regularly stop their medications. The CATIE and CAFE studies hypothesized that the side effect profiles of the drugs were a major factor in the poor adherence rates, thus the outcome variable. In truth, side effect profiles are only one of many factors involved in this complex issue, and the naive notion that these drugs are the solution to the problem of Schizophrenia for either patients or society has long passed. But those larger questions aside, in this case there was ample evidence of fundamental research misconduct. Dan Markingson’s adherence to medication was not a function of side effects – it was legal repercussions. His semi-freedom to live outside an institution was predicated on staying on the medication.

There is another underlying assumption in such studies. The "non-compliance" is viewed as a paradox. Here is a medication that can rid the patient of psychotic thinking and symptoms, yet they stop taking it. How-come is that? While it’s another naive question, in Dan’s case, there’s none of the usual evidence that it helped him in any way. We’ve not seen a detailed case report [if there is one], but the observations of his mother and the staff at the Halfway House don’t confirm that it was helping. He was seclusive, grandiose, remaining in his private world that we don’t know about. If anything, the outside view suggests continued psychotic processes. The point being, there’s no concrete evidence that suggests that he responded to the medication in the first place.

A research program that condones or allows that kind of recruitment and inclusion deserves thorough investigation, and perhaps shutting down. The University wants to limit the investigation they have been forced into to remain limited to the program now – not what happened then. That allows Dr. Olson to continue to aver that they did "nothing wrong" and Dr. Schultz to make tapes like the one above selling that academic programs [his academic program] as the right places to do clinical trials. That should be true, but in this case, it wasn’t. This was not research misconduct lite – this was the real deal and what has been happening is, by any measure, a cover-up extraordinaire.

There’s another part to this story that isn’t the stuff of courtrooms or investigations. Dan Markingson was an Object, not an encountered person – a Subject. He was a Schizophrenia Object for the study. He was a Dangerous Person Object for the courts. He was a young adult taken out of the course of his life by a show-stopping illness we’ve known since the dawn of time. There’s no guarantee that he could have been helped, but if that had been possible [and it often is], it would require that the Subject Dan Markingson be encountered. Anyone who has ever worked with these patients knows that with such cases, that’s not always easy, and sometimes impossible. But in this case, it doesn’t seem that anyone gave it a shot. They didn’t even seem to register how sick he remained during the six plus months he was in their care.

As long as I’m at it, the next chart in the pack has a rather ominous background message:

Plus Pill: A Shift in Pharma’s Mindset

eye for pharma

By Zuzanna Fimi?ska

Apr 11, 2014

The 21st century pharma company is no longer solely a provider of molecules. To survive in the new reality, the industry must change its mindset and offer services, putting the customer at the center of their activities. In an uncertain climate, big pharma must understand its customers and deliver what they really need: value beyond the pill. While many companies have begun to do this in earnest, others hesitate and question whether patient services are warranted or appropriate. However, it is increasingly apparent that the industry has a role to play in patient support, and that much is at stake for the industry itself.

The importance of treatment adherence

According to the World Health Organization [WHO[ improving adherence would have a greater impact on health than any potential discovery in medicine. Even if the pharmaceutical industry one day discovered the much wished for “cure for cancer,” it is likely that it won’t be taken properly [oral anti-cancer therapies currently run about 60% adherence].

In addition to being potentially lethal, non-adherence is expensive. While there may have been a tendency in the past to assume that not taking prescribed medicines provided some degree of savings, the U.S. Congressional Budget Office (CBO), which serves as an independent, official scorekeeper of the fiscal impact of federal policy and proposed legislation, changed its stance on medication adherence in 2002, recognizing that the evidence of a direct connection between medication use and healthcare spending was sufficient to “score” a medical cost offset in its budgetary forecast. The CBO’s budget forecasting now assumes that medication adherence can lead to reductions in doctor visits and hospitalizations, and impact the rise of healthcare costs.

Change in paradigm

According to eyeforpharma’s "The Importance of Patient Services" Whitepaper, the estimated impact from non-adherence ranges from $30 billion a year to $560 billion a year, although it must be pointed out that patients who do not adhere to a given treatment often end up on a different treatment, so the higher figures are undoubtedly not representative of the impact on the industry as a whole. This is not lost on the pharmaceutical executives. In 2011, business intelligence firm Cutting Edge Information conducted a survey of 18 drug companies. The study concluded that 25% of overall sales were diminished by patient adherence, while 31% of revenue can be preserved by patient support efforts. Nevertheless, offering patient-support services is often met with skepticism and fear. “People in pharma are scared,” said Isler. “Everyone agrees that the traditional model is broken, but nobody really knows the answer,” he admitted.

Entering into a dialogue with customers requires a shift in organizational structure. Companies need the right people with the right skill set, including experience in services and with customer interaction. “Pharma are mostly scientists and physicians, who are happy in their labs, but not talking to customers. It’s not natural for pharma to be a customer-focused industry, but now we need to be there, talking to our customers, instead of being this prescriptive black box that tells them what is good for them,” Isler concluded.

The days when pharma could safely build their business on a molecule are now gone and efforts must be made to ensure a shift in thinking necessary for the industry to remain relevant. To achieve this, companies need to overcome fears that have so far been crippling the revolution of pharma.

• expanding target populations by lowering threshholds
• encouraging polypharmacy
• staying on medications longer
• following guideline recommendations fully
• following up patients to insure medication compliance
• PHARMA getting into the business of dealing with patients and theiradherence

Back in the dawn of time [early seventies], I was an Internist on an Air Force Base in rural England – a posh assignment considering the alternatives. England has an allergy season from hell and my wife was then its major target. So at work, I spent my days with asthma and hay fever, and I came home to the same affliction. I had all the pills [I’ve forgotten their names]. We called them by color – the red ones, the green ones, the blue and white capsule, etc. I tried all the tricks [kind of like the KOLs with the antidepressants]. I sequenced them, combined them, augmented them with anti-inflammatory drugs, etc. I don’t know that any of that made much difference. We ended up believing that rotating them was the secret, but I don’t even know if it really mattered or was just a myth-to-keep-us-busy.

After we came back to the States, my wife got desensitized, and was one of the only total cures I’ve ever seen from allergy shots – a miracle cure by any measure. But cruel fate intervened and as the years passed, I gradually became the poster child for seasonal allergies, having been spared until my 40s. And I went through the same drill as before. Rotating did nothing for me. By then, the non-sedating antihistamines were around, and so I settled into taking too much Claritan, which worked pretty well for the three or four weeks of my discontent each Spring. I changed to Allegra for unrecalled reasons, and was delighted when it became OTC. I still take it. Periodically, I try the old sequencing, combining, augmenting, rotating methods, always ending up with the myth-to-keep-us-busy conclusion.

Last Spring, I was on a trip during the season, and my Allegra [now fexo-fenadine] got lost in the shuffle. A fellow sufferer produced Claritan. It was fine [too much Claritan, I might add]. That has happened before and the ancient Chlor-Trimeton [too much Chlor-Trimeton] is a fine substitute too. If this topic comes up at a party, we allergy types light up and the various personal regimens begin to flow – doctors and non-medical people alike. I think of it as antecdotal magic, but I admit that I join in with gusto – and I even talk aloud to the direct-to-consumer ads about allergy medicines that show up on television, arguing with the beautiful people that skip merrily through fields of flowers and camp in the forests. When they get to the inevitable, "Ask your doctor if … is right for you," I sometimes become postal. I’ll spare you the rants.

There’s only so much that a symptomatic medicine can do by blocking histamine release, and we want so much more. Yearly, we go through the ritual of asking more from the medicine than it’s capable of giving us. My head is filled with myths and anecdotal magic, but in the end, I really think that just about any of the mainstream antihistamines will do, and the cure for my April miseries is the coming of May. I think the same thing about the antidepressants. They are symptomatically helpful to some people if they don’t ask for too much. Too much antidepressant is no solution. There are side effects and dangers that need careful attention: akathisia, libidinal problems, suicidality, flatness, withdrawal, etc. – much more than with antihistamines. Our tainted KOLs spent years obsessing on the anecdotal magic side of the equation, and not giving patients or even fellow physicians the necessary information about the side effects and dangers [information they knew].

PhRMA: Sunshine Not Driving Docs Indoors

MedPage Today

By David Pittman

Apr 10, 2014

Doctors haven’t disengaged from drug companies in the months since the tracking of financial relationships between them started, several pharmaceutical executives here said. The Physician Payments Sunshine Act required drug companies to track gifts and other payments to physicians starting August 1, making them public later this year – leading to fears that public shame or misunderstanding might come of doctors’ relationship to pharma.

But those ties have pretty much stayed put, different leaders of the drug industry said at the annual meeting of the Pharmaceutical Research and Manufacturers of America [PhRMA]. "We’ve seen virtually no change in the way we interact with physicians," Pfizer CEO Ian Read said at a press conference. Celgene chief Bob Hugin, who doubles as PhRMA board chair this year, said his company has seen the same thing, and the law has had "no impact on the way we deal with physicians."

Each man shook his head "no" when asked directly if doctors seemed more hesitant to interact with pharmaceutical companies now that the law was in place. The Centers for Medicare and Medicaid Services (CMS) will make public on Sept. 30 payments and other "transfers of value" drug companies report giving doctors. With a handful of exceptions, drug companies and group purchasing organizations must report payments or gifts in excess of $10 made to physicians on a yearly basis. The first year will include information collected between Aug. 1 and Dec. 31. CMS will allow physicians to review and protest inaccuracies starting this summer.

"Who wants to go to a doctor that is not the most well informed, the most aware of what’s happening?" Hugin said. "We really want to make sure that this act, which is designed to make things more transparent, does that but doesn’t change behavior because people misuse the data and apply in a way that implies something inappropriate." He suggested that the Sunshine Act may become an issue when and if people mischaracterize the data when it becomes public. That’s why companies and doctors must be proactive later this year when the data are released to make sure it is presented accurately and fairly, he indicated.

"We welcome the transparency, and I think physicians will welcome the transparency because the relationships are highly ethical between the industry and physicians," Read said. The Justice Department last year accused drug-making giant Novartis of kickbacks it paid to doctors by holding "educational events" on fishing trips and at Hooters restaurants that were little more than parties.

hat tip to Alto…

I always wondered what they talked about at a Pharmaceutical Research and Manufacturers of America meeting [PhRMA]. Besides the Sunshine Law, the image on the left from their website addresses another such topic – the academic·pharmaceutical·NIH Axis. Actually, when I followed the link on their site, there was an even bigger picture slide that included many other elements – almost all of the usual subjects:

It’s an impressive universe they have there. I noticed that they left out the ghostwriters. Maybe they’re the ones walking around outside on their virtual campus. On the site, there’s something called the CHART PACK with a number of charts which make the case that the PhRMA world is an unfairly oppressed place. Looks like an Insel blog. My editorial comment is the graphic on the right, but take a look yourself.

Well, what about the claim in the article that the Sunshine Act is having no effect on the doctors in the PhRMA service? Is it true? Or is this more spin to launch a campaign against the Sunshine Act itself? With this crowd, one can never know. I’m sure that for some doctors who have banked on PhRMA pay [another pun intended], losing some patients because of reporting is immaterial in the face of their PhRMA earnings. But the overall impact won’t be felt for some time. Who knows?

"Who wants to go to a doctor that is not the most well informed, the most aware of what’s happening?" Hugin said.

"We really want to make sure that this act, which is designed to make things more transparent, does that but doesn’t change behavior because people misuse the data and apply in a way that implies something inappropriate." He suggested that the Sunshine Act may become an issue when and if people mischaracterize the data when it becomes public…

"We welcome the transparency, and I think physicians will welcome the transparency because the relationships are highly ethical between the industry and physicians," Read said…

The Cochrane Systematic Reviews were new to me, though they’ve been around for twenty years. The group is made up of a network of thousands of independent scientists who donate their time to do in-depth and comprehensive reviews of clinical trials using structured meta-analytic techniques – many of which have been developed by the Collaboration themselves. So beside bringing their scientific background to their work, reviewers are trained to use the many structured tools to make their reviews the gold standard in the world of clinical trial analysis.

Their logo shows their most characteristic graph – the forest plot with the mean and Confidence Intervals of a number of trials of the same thing. The size of the mean box in the center is proportional to the size of the trial and the horizontal line shows the 95% C.I. The bottom diamond is the weighted trial mean. The horizontal axis varies depending on what’s measured. The top graph is from the Tamiflu meta-analysis and shows the time to first alleviation of symptoms between Placebo and Zanamivir. One can see the means, the intervals, the significance [does it cross the vertical null line], and the sum of all studies at a single glance.

But that’s not all. One easy way to deal with studies you don’t like is simply not publish them, maybe even not even register them. In this Tamiflu story, there were many such missing studies, so the Cochrane authors spent almost four years along with many allies fighting to get their hands on the data from all the studies done. And Cochrane goes another step – they grade the quality of each clinical trial for signs of any number of sources of bias, and discard the uninterpretable trials from the dataset. In the case of Tamiflu, rather than used the data printouts, they used the CSRs [Clinical Study Reports], the actual forms where the data was being recorded because they felt they couldn’t trust the published results. Here’s their flow chart:.

I’ve only mentioned the broad strokes of the techniques they’ve developed to gather their data for analysis. It’s an obsessive and impressive process from start to finish. Is all of this necessary? If you’re a psychiatrist trying to make sense of the psychopharmacology trials of the last three decades, it’s a godsend. And as we’re seeing today, in the case of Tamiflu, a beyond-blockbuster success in the public health market, it was essential. Cochrane looks to be exposing Billions of dollars wasted, flowing into pharma coffers for no real public health gains. Now Roche and GSK having resisted this process as long as they could, is contesting this recent meta-analysis that counters their claims. So, I expect that we’ll be hearing about this one for some time.

Study Questions Tamiflu’s Effectiveness Against Pandemics

Governments Have Spent Billions of Dollars Stockpiling the Antiviral Drug for Use in Flu Outbreaks

Wall Street Journal

By Hester Plumridge

April 9, 2014

A new study into the effectiveness of one of the world’s leading flu-fighting drugs concludes it isn’t proven to reduce the spread of flu or flu complications, like pneumonia and hospital stays, raising questions about the medicine’s use against pandemics. Governments have spent billions of dollars stockpiling Roche Holding Ltd. ROG.VX -2.86% ‘s antiviral drug Tamiflu. The drug is used to treat flu, and to prevent pandemics and seasonal flu outbreaks. It is approved in more than 100 countries. The new study—conducted by the nonprofit Cochrane Collaboration, a global network of health-care academics, and published Thursday in the British Medical Journal—doesn’t question the drug’s ability to treat symptoms of flu. But in examining earlier trials and studies of the drug, the study found there is no indication it is effective in stopping the spread of flu or reducing complications—both key components of fighting a widespread flu outbreak…

Roche said it disagreed with Cochrane’s conclusions and criticized the decision to use data from just 20 of its trials and exclude real-world data from seasonal use and from the 2009 swine flu pandemic. "I believe our studies were run to a very high standard," said Barry Clinch, Roche’s global development leader for Tamiflu. Glaxo said it continued to believe the data from Relenza’s clinical trial program support its effectiveness against flu. The U.S. Federal Drug Administration said it considers the clinical trial data submitted for both drugs adequate to support their approval to treat and prevent influenza. The EMA said the review’s findings didn’t raise new concerns.

Cochrane reviewers fought for over four years to gain access to all the trial data from Roche and Glaxo, after their reviewers found in 2009 that the majority of the data on Tamiflu trials was unpublished. The reports’ authors call the current system of drug evaluation and regulation "deeply flawed," since even regulators may not have all the trial data. "The Cochrane review has made us aware of the very shaky ground on which clinical decisions have been made," said Fiona Godlee, editor of the BMJ. "We need the full data from clinical trials made available for all drugs in current use." The European Parliament earlier this month passed a law requiring drug companies to publish all clinical trials related to a drug, but it only covers drugs approved since January 2014. Roche and Glaxo both say they are now committed to publishing all clinical study reports on all their drugs.

hat tip to the Cochrane Collaborations…