of anecdotal magic and noses…

Posted on Sunday 13 April 2014

I’m not much of a "twit", "twitterer", "social media" person. I like the idea, but it has never captured whatever part of the mind/brain dichotomy that controls such things. But the twitter icon is up there, and I hit it at times. I "follow" MedicalSkeptic who really covers the universe and is often a source for my musings when I click that little blue bird. Today, he posted a 2001 article that was perfect – a confluence of topics: the drug industry, antihistamines, allergy, and patents [Claritin and Schering-Plough: A Prescription for Profit]. MedicalSkeptic’s "tweet" says:
"Claritin and Schering-Plough: A Prescription for Profit bit.ly/Im6lLG 2001 article that should be read by all."
And I think he’s right ["should be read by all"]. It’s a study of the ins and outs of patent law and the games people and companies play. Be warned, it’s long and at times a little more detailed than one might like, but like some of those lectures after lunch in college when the sleepy dust descended, it’s worth staying awake for.

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].

So Claritin and Schering-Plough: A Prescription for Profit is a story about the life and times of Claritan, an average expectable antihistamine now among the many on the shelf in your local drugstore. The wheelings and dealings among Shering-Plough, the FDA, the competitors, and the generic manufacturers will all be familiar. NYT author Stephen Hall captured the absurdity of such stories, including the preoccupation with insignificant small differences. One wonders how many times we have to play out this scenario before we realize what an empty dance it is, and establish more reasonable priorities with checks on the anecdotal magic and an emphasis on the adversity. I’d lay out the article itself, but it’ll have to wait until May for now obvious reasons. My Allegra just isn’t that powerful…
Mickey @ 1:19 PM
Filed under: politics
your nose is growing longer…

Posted on Saturday 12 April 2014

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?

But one thing we do know right now. This is some remarkable copy written by the PhRMA PR department:
"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…
My mom would’ve said, "Pinochio, I think your nose is growing longer and longer!" I still wonder how adults can write things like that and deliver them with a straight face…

UPDATE: I couldn’t leave it alone. So here’s just one slide from the CHART PACK
Mickey @ 10:47 AM
Filed under: politics
being exposed…

Posted on Friday 11 April 2014

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.

I scrolled through my way-overly-simplified version of the Cochrane Collaborations’ efforts for a reason.
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…
The battle here was just getting the data to analyze, and it took them four years with major help from the British Medical Journal and others, including Ben Goldacre and the whole AllTrials community. It was a mega effort. The analysis was a walk in the park compared to the effort expended to get the data. They spent four years of their lives swimming upstream to produce these results. And now they have to listen to this:
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.
This is part science, but more comes under the heading of crime-fighting, the detectives at Cochrane using forensic techniques to get the data and analyze it. And what they found was plenty of evidence that a motivated crime had been committed, resulting in a few Billion Dollar haul. And now we’re going to hear the CYA responses of everyone concerned, and it’s unlikely that there will be much reprisal or policy change. To my way of thinking, this story is the payoff for the twenty years of effort expended to gather thousands of medical scientists together to do something good, something needed. And it must be discouraging for those involved to listen to those silly responses:
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.
But no matter what the concrete impact, this Tamiflu battle has already done a world of good as a paradigm that has driven the All Trials movement, the RIAT proposal, the recent legislative decisions in Europe, the rising momentum of the Data Transparency efforts. Fiona Godlee says, "The Cochrane review has made us aware of the very shaky ground on which clinical decisions have been made..." Ben Goldacre says, "This is a pivotal moment in the history of medicine. Trials transparency is finally on the agenda…" There’s little question that it will be a landmark in the medical history books, so there’s no need to be discouraged by the dancing of those being exposed. It’s the only dance they know… 
hat tip to the Cochrane Collaborations… 
Mickey @ 11:03 AM
Filed under: politics
losing your mind…

Posted on Friday 11 April 2014

In the Field of Dreams, James Earl Jones reminds of those recurrent seasons that help us mark the passage of time. For him it was baseball season. For many, it’s Christmas, or hunting season, or even Spring. Something that just shows up year after year – the rhythm of life. Then again, for some of us, it’s something else – something forgotten that makes its presence known whether we want to acknowledge it or not:

And so here it is once again. And rather than singing oldies like "Those April Showers, May come your way…" we hear the dark refrains of Eliot,
April is the cruellest month, breeding
Lilacs out of the dead land, mixing
Memory and desire, stirring
Dull roots with spring rain…

and count the days. As I say every year, "Even when there’s no cure for an illness, it’s helpful for the afflicted to know what’s wrong – why they’re having trouble thinking." It’s another kind of "losing your mind…"
Mickey @ 9:49 AM
Filed under: politics
something really huge…

Posted on Thursday 10 April 2014

Something really huge just happened. Something that just might change medical science altogether. In medical school, we read some of the best mysteries you can imagine. Things like the story of Typhoid Mary and how they tracked her down. But this is one with a twist, and it happened just this week. It’s about Tamiflu, and here’s Ben Goldacre, a master story teller to tell you all about it…
  • The Guardian
    by Ben Goldacre
    April 9, 2014

    Today we found out that Tamiflu doesn’t work so well after all. Roche, the drug company behind it, withheld vital information on its clinical trials for half a decade, but the Cochrane Collaboration, a global not-for-profit organisation of 14,000 academics, finally obtained all the information. Putting the evidence together, it has found that Tamiflu has little or no impact on complications of flu infection, such as pneumonia.

    That is a scandal because the UK government spent £0.5bn stockpiling this drug in the hope that it would help prevent serious side-effects from flu infection. But the bigger scandal is that Roche broke no law by withholding vital information on how well its drug works. In fact, the methods and results of clinical trials on the drugs we use today are still routinely and legally being withheld from doctors, researchers and patients. It is simple bad luck for Roche that Tamiflu became, arbitrarily, the poster child for the missing-data story.

    And it is a great poster child. The battle over Tamiflu perfectly illustrates the need for full transparency around clinical trials, the importance of access to obscure documentation, and the failure of the regulatory system. Crucially, it is also an illustration of how science, at its best, is built on transparency and openness to criticism, because the saga of the Cochrane Tamiflu review began with a simple online comment… [click here to continue]

and here are the articles in the BMJ:
It’s a great story, and the reason we have to have Data Treansparency for all clinical trials…
Mickey @ 7:46 AM
Filed under: politics
“Munchausen’s by Proxy”…

Posted on Wednesday 9 April 2014

The post made in america… was about Peter Parry’s paper, Biologism in Psychiatry: A Young Man’s Experience of Being Diagnosed with “Pediatric Bipolar Disorder”. It’s a case study written as an interview of the patient himself about his lost adolescence as a Bipolar Child patient, with Peter’s thoughtful analysis of the case and the whole issue of Pediatric Bipolar Disorder. In the comments, Sandra Steingard and I were discussing the difficult topics of Projective Identification and “Munchausen’s by Proxy.” Then we we got some help from an unexpected source, the patient himself identified in the paper by the pseudonym Adam.  His comments are quite clarifying, located on-line here.
Mickey @ 6:12 PM
Filed under: politics
a graph…

Posted on Wednesday 9 April 2014

There is a SAMHSA [Substance Abuse and Mental Health Services Administration] Report now available for free download on-line [National Expenditures for Mental Health Services and Substance Abuse Treatment, 1986-2009] that is, in my opinion, a must-read for interested parties. That said, I hasten to add that it’s hard, because it’s written for policy wonks, and the graphs and tables are all corrected in unfamiliar ways – so one has to read what the scales are to see things accurately. The upper part of the figure below [my recoloring for clarity] is the relative overall US spending for each of the categories in per cent, regardless of the amount for each year – which has itself been a variable [from page 43]. Those big picture amount numbers are in the report in some mega-tables in the Appendices [page 67+ of the 108 page report] for the hearty. The middle piece of my figure was traced from rescaled graphs I had made of the patent life of the big named psychiatric drugs from various FDA  sites [so accuracy is more like the right year but nothing more]. The bottom graph is straight from the report [page 38]. Again, the ordinate scale can be deceptive. It’s the percentage growth. So the fall from 1999 to 2004 doesn’t mean less was spent, rather that spending was plateauing, no longer growing like a weed.
hat tip to Jamzo…     

A commenter recently mentioned she noticed a change in psychiatry [for the worse] around 1994. I said maybe a little earlier, but agreed that it was in the right ball park. Looking at these graphs, it looks as if the guesses were on the money [pun intended]. The bottom graph shows a five fold increase in the rate of spending from 1993 to 2001 and the upper graph shows the resulting three and a half fold increase in the drug share of overall spending. Looking at the last five years on the graph, it looks as if we’ve settled into a new equalibrium – a stability in a new system. From a cost perspective, these numbers will probably even fall as the drugs go generic and cost much less. But that doesn’t fix a thing because from the perspective of our system of delivering care, the damage has been done and is likely to be self perpetuating.

A friend of a friend called yesterday with a very sticky child custody problem. In trying to get the family the help they needed, I called a child advocacy lawyer I know in Atlanta  who mercifully agreed to try to help this woman through the thorniest mess I’ve heard in a long time. In talking to the lawyer, I said that if the child needed psychiatric care or evaluation and I could help her find someone suitable, to let me know. I was actually thinking of a psychologist who has spent her career amid the impossible situations that custody cases can be. But my lawyer friend understood my phrase "psychiatric care" as meaning "psychiatrist" and said, "Oh I doubt we’ll need a psychiatrist. They’re for medicines and …" adding "and they’re more expensive." I guess that’s the sad-but-true reputation of psychiatry these days, something that’s hard to add to the graph, but implied.

This is all retrospective data, ending five years ago – now part of history. Like all of history, there were no road signs broadcasting these numbers, their meanings, or their ultimate outcome along the way. But even in my cloistered office, you could just feel it, like you can feel a front passing through before the rainstorm that will soon follow. And there’s one other important thing that’s not on those graphs, something once called transinstitutionalization, moving people from one institution to another – in this case from the mental institutions of the pre-1960s to the prisons of today. In my mind, this is the biggest tragedy in the story, because we have the where·with·all to do a lot better than that. And in this case, I don’t think the blame falls on psychiatry, or pharma, or any of the usual suspects. I blame whatever drives the attitudes in society as a whole, or at least American society, that avoids looking at and caring about the people we can’t "cure," but can damn sure do a better job of taking care of, mostly outside of any institutions, if the funds [and the will] were to be available…
Mickey @ 2:08 PM
Filed under: politics
if you’ve got a spare minute…

Posted on Wednesday 9 April 2014

A message from Carl Elliott:

In early December, we delivered a petition signed by over 3,500 of you to Minnesota Governor Mark Dayton, calling for an investigation of the death of Dan Markingson in a University of Minnesota psychiatric research study. That same week, the Faculty Senate at the university also overwhelmingly approved a resolution calling for an investigation.

Yet four months later, we still have seen no results. The president of the university, Eric Kaler, has indicated publicly that any review he commissions will not include an investigation of Dan Markingson’s death. Governor Dayton has not even acknowledged our petition.

In the meantime, evidence is accumulating that Dan Markingson was not the only patient who died or was seriously injured in psychiatric research studies at the university. Two investigative news reports have appeared with evidence of misconduct involving other patients. A confidential letter has emerged indicating that the Institutional Review Board was aware of ethical problems with psychiatric research at the University in 2009, and that it was concerned enough to request an external investigation. And for over six months, the university has stonewalled our open records requests for reports of deaths and serious injuries in psychiatric research studies.

You can find more information about these issues at:
So we need your help. We are organizing a series of actions beginning this week with a call-in campaign to Governor Mark Dayton and University of Minnesota Board of Regents Chairman Richard Beeson. We are asking you to make a phone call as soon as possible to the offices of Dayton and Beeson and leave a message asking for action. Here are phone numbers [and if you need it, a suggested script for your call.]

Please make your voice heard. And let us know that you called by leaving a comment at www.danmarkingson.com.

Thanks,

Carl Elliott

Richard Beeson
Office of the University of Minnesota Board of Regents
Phone: 612-625-6300

Gov. Mark Dayton
Phone 651-201-3437
Toll Free: 800-657-3717
[see also the academy itself…]. I’ve mused at times about why my radar lands on certain cases in the sea of stories about the misbehavior in psychiatry and the pharmaceutical industry. Paxil Study 329; The TMAP related cases; and this Dan Markingson case are always on my front burner. Each is a travesty that involves both psychiatrists who ought to know better, pharmaceutical companies manipulating things they ought to keep there noses clear of, and great big cover-up operations that need to see the light of day. But the Dan Markingson case is on top of the list, though it’s not the one I talk about the most, because it has a champion of its own that I could never equal for patience and single-mindedness, Carl Elliot.

Dan Markingson died by his own hand, a victim of an illness that dates to antiquity. He became a part of a study he should never have been enrolled in – a study that had no medical indication but was rather an experimercial. He was put on a maintenance dose of a blinded medication that wasn’t working. He languished in a treatment facility that did not adjust his treatment to his illness for six months as part of a legal double bind. And not long after hearing that his commitment was to be extended, he killed himself in a bizarre way – consistent with his untreated illness. All of that in a Trial that shouldn’t have been.

The kind of paranoid psychosis Dan had is a big time illness – it can be a lethal illness. Dan’s lethality was there the day he was admitted. He could have succumbed with the best of treatment, but we’ll never know because he didn’t get it. This may even be a case where, in spite of the dominant view of these medications, he may well have been grossly undermedicated, at least early on. But we don’t know that either. All we know is that he was adjudicated to a treatment he never received. Rather, he became a pawn in a marketing chess game.

Carl Elliot, Mary Weiss, and Mike Howard have been able to engage the Minnesota faculty and much of the mental health community in keeping this case on the front burner only to be repeatedly blocked by the very people who should be supporting their efforts. If you’ve got a spare minute tomorrow, leave a message or two to support Carl, Mary, and Mike in trying to make this thing go the right way…
Mickey @ 12:30 AM
Filed under: politics
kudus…

Posted on Tuesday 8 April 2014

While I have no business in the details of legal matters, I was really glad to read this article. It’s part of the fallout from the TMAP scam that has been dragging on now for ten long years:
The Associated Press
By Andrew Demillo
April 7, 2014

Arkansas Attorney General Dustin McDaniel asked the state Supreme Court on Monday to reconsider its decision tossing out a $1.2 billion judgment against drugmaker Johnson & Johnson, saying justices did "significant harm" to the state and broke from 170 years of precedent. McDaniel filed a petition for rehearing over the high court’s decision last month that the state misapplied the Medicaid fraud law in its lawsuit against New Jersey-based Johnson & Johnson and its subsidiary Janssen Pharmaceutical Inc. over the marketing of the antispyschotic drug Risperdal. McDaniel said last week that he would ask the court to revisit the ruling. "The court’s rejection of the state [Medicaid fraud] case does significant harm to the state and its citizens," McDaniel wrote in the filing. "It deprives the state of a critical tool to protect the integrity of the Arkansas Medicaid program and the vulnerable poor, sick and elderly who depend on Medicaid as a literal lifeline."

McDaniel said justices broke with years of precedent by ruling on grounds not previously raised in filings. Justices ruled that the state Code Revision Commission "substantively altered" the meaning of the Medicaid fraud law when it was codified and that it was originally intended to regulate health facilities. The commission is responsible for making technical corrections to state code. McDaniel noted that the 1993 law remained unchanged for 21 years despite other amendments and attempted amendments by the Legislature over the years. "By improperly transforming a well understood and accepted interpretation of the law, this court has arrogated to itself powers not conferred by the Arkansas Constitution or the General Assembly," he wrote.

The drugmaker said in a statement Monday that it didn’t violate the Medicaid fraud law. "After a thorough review of the case, the Arkansas Supreme Court agreed with our position. We believe that the record speaks for itself and are prepared to vigorously defend our position," the company said. Risperdal was introduced in 1994 as a "second-generation" antipsychotic drug, and it earned Johnson & Johnson billions of dollars in sales before generic versions became available. The drug is used to treat schizophrenia, bipolar disorder and irritability in autism patients. An Arkansas jury found the New Jersey-based companies liable in 2012. Pulaski County Circuit Judge Tim Fox then ordered the companies to pay $5,000 for each of the 240,000 Risperdal prescriptions for which Arkansas’ Medicaid program paid during a 3 1/2-year span.
In champagne around…, I wrote:
After their settlement in Texas, J&J lost a number of similar suits – Louisiana, South Carolina, Arkansas. Having sat through the Texas trial, it’s hard for me to imagine how they could win. The off-label marketing, hiding side effects, giving out perks, etc. It was just rampant. I think they settled in Texas because they could tell [as could everyone in the courtroom] that if they let the trial proceed, they stood the chance of getting massacred. But in the other suits, they went to the end – losing the verdicts. Now, they’re neutralizing their losses one at a time on technicalities
To my way of thinking, the TMAP epidemic which had taxpayer money diverted into the J&J Bank Account based on an orchestrated fraud was the most cynical of the many underhanded marketing schemes in the world of psychopharmacology. To have hard won juried decisions thrown out on clever legal technicalities just adds insult to injury. I didn’t go to the Arkansas Trial, or to South Carolina, but I went to Texas, and what I heard there made me ashamed of medical care in general. Doctors, Administrators, Pharmaceutical Companies, and their paid sales force – everybody was behaving in a way I can only see as criminal, antisocial. These settlements are our only recourse, and I want them to stick instead of getting lost in the details of legalisms and clever argument. "… 240,000 Risperdal prescriptions for which Arkansas’ Medicaid program paid during a 3 1/2-year span!" Kudus to Arkansas Attorney General Dustin McDaniel!
Mickey @ 11:24 PM
Filed under: politics
the whole industry…

Posted on Monday 7 April 2014

Fierce PharmaMarketing
By Tracy Staton
April 7, 2014

GlaxoSmithKline [$GSK] says it’s rolling out sales and marketing reforms around the world. Apparently, the changes come none too soon. The British drugmaker opened another bribery investigation, this time in Iraq, to check out allegations that it paid government-employed physicians to promote its products. And Glaxo hasn’t yet finished working through the scandalous Chinese bribery allegations that kicked off an industry-wide corruption crackdown.

So, CEO Andrew Witty and his team sound a bit … conflicted. On the one hand, Witty sounds the perfectly contrite corporate leader. He apologized for the marketing allegations that ended with a $3 billion Department of Justice settlements. He’s promised good behavior and touted those worldwide sales reforms. But on the other, the company is digging into at least two sets of corruption accusations, and faces related repercussions at home and in the U.S. Two bribery probes in two different geographic divisions? That’s a systemic problem.

When the Chinese bribery scandal hit, Glaxo’s U.K. headquarters was quick to say that head-office executives didn’t know about any malfeasance in its China subsidiary. That may be so. But if HQ didn’t know, that means HQ was either turning a blind eye or failing to pay enough attention. Either way, that’s not a good thing for a company trying to clean up its image.

If Witty really wants to reform GSK, then he and his top managers need to move beyond plausible deniability. They can’t just launch new quota-free sales-rep compensation and promise to stop paying speaking fees to doctors in the U.S. and beyond. Painful follow-through has to happen.

We need to see Glaxo execs take out their brooms, and move into global operations to sweep out misbehavior. If they don’t, whistleblowers and government investigators will. And that makes all those the sales-and-marketing changes look like little more than window-dressing.
Just a fluff piece to fill a column? I don’t think so. I think Tracy Stanton is on to something that Sir Andrew Witty and others need to listen to carefully. I don’t think the time honored method of putting a few platitude band-aids on a problem and waiting for the news cycle to pass is going to work very well. We’re onto that maneuver – a lesson learned in the school of hard experience. I was looking over some old posts and ran across any number of excuses, press releases, and statements in response to accusations in years past, and most of them would be laughed at these days or at least send eyes rolling. And plausible deniability is on top of the list of worn out spinning wheels. Two early versions came from my favorite bad example, Dr. Charles Nemeroff, when he was busted for leaving out conflict of interest declarations:
New York Times
By MELODY PETERSEN
August 3, 2003

Two scientists are raising concerns about an article in a medical journal that described experimental treatments for depression because an author did not disclose his significant financial ties to three therapies that he mentioned favorably. The executive editor of the journal said it had not required disclosure of the potential conflicts, but was considering changing its policy in light of the criticism. The ties between pharmaceutical companies and researchers have come under increasing scrutiny in recent years.

The lead author of the article, Dr. Charles B. Nemeroff, chairman of the department of psychiatry and behavioral sciences at the Emory School of Medicine in Atlanta, said he would have reported the conflicts of interest, which include owning the patent on a treatment he mentioned, if the journal had asked him to. ”I have always been totally compliant, probably gone overboard, with disclosure,” Dr. Nemeroff said. ”If there is a fault here, it is with the journal’s policy.”
The Wall Street Journal
By David Armstrong
July 19, 2006

Charles Nemeroff, one of the nation’s most prominent psychiatrists, edits the journal Neuropsychopharmacology, which this month favorably reviewed a controversial new treatment for depression. But Tuesday, the journal said it plans to publish a correction because it failed to cite the ties of the article’s eight academic authors to the company that makes the treatment, including the article’s lead author: Dr. Nemeroff.

The journal’s nondisclosure of the financial ties of its own editor as well as those of the other authors highlights the failure of many respected medical journals to identify relationships between academic researchers and medical companies that may benefit from positive research reports. A spate of recent lapses is prompting calls for more journals to ban offending authors from publication. In addition, medical schools are being urged to regulate relationships between their researchers and industry more closely…
His excuse that second time – clerical error. It didn’t work so well as the first one and he decided to step down as editor shortly thereafter. We can thank Drs. Bernard Carroll and Bob Rubin for both of those exposures. They came early and got the ball rolling. The investigations of Senator Grassley and Paul Thacker came next, and then the epidemic of suits against the Pharmaceutical companies with the release of enough incriminating documents to convince any doubters. So we’re now veterans of ten years learning that plausible deniability simply equaled a lie, and we’re not likely to buy such things anymore, almost by reflex.

I was a retired person before I was capable of believing that Doctors, Academic Department Chairmen, and Pharmaceutical Companies named after long-dead men with handle-bar mustaches were capable of the kind of deceit we’ve all seen in recent decades – but our naivety has given way to, at the least, a careful suspiciousness, even paranoia about such matters. And GSK has placed itself in a goldfish bowl that’s going to be hard to escape.

So when Tracy says, "We need to see Glaxo execs take out their brooms, and move into global operations to sweep out misbehavior" she’s not just moralizing, she’s giving GSK an appropriate heads up they really need to hear – not just GSK, the whole industry. We’re veterans now…
Mickey @ 6:19 PM
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