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
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…
    Bernard Carroll
    April 7, 2014 | 10:29 PM

    When Bob Rubin and I made those exposés there was a scurrilous campaign to pooh-pooh their importance and to impugn us as malcontents, acting out an alleged vendetta against Dr. Nemeroff. Of course, they never made it clear why this charge held any water… it was a grand lie. No prizes for guessing who coordinated it. Overlooked at the time was our motive, which was to prevent patients from being harmed by bad clinical science in the guise of infomercials and experimercials. We look back on those days with a sense of real accomplishment. We made a difference… we forced many journals to change their policy on disclosures; we raised the awareness of COI across the board; an incestuous journal editor went out of business. And it didn’t stop there. Those who hector Dr. Mickey about patient harms on this site didn’t discover the patient harm issue – it has always been the subtext of what we do and say.

    Robert T. Rubin, MD, PhD
    April 7, 2014 | 11:39 PM

    The saddest part of all is that, in order to enrich themselves, these corrupt academics have tainted at least two decades of scientific literature, leaving the rest of the scientific community in limbo regarding which drug studies to take seriously and which to reject. Disclosures of conflicts of interest do little to help the reader decide if all the data were presented, if they were analysed appropriately, and if they were interpreted fairly. It will take a long time to rectify the reporting biases purchased by pharmaceutical companies and to produce a scientifically valid psychopharmacological literature.

    April 8, 2014 | 6:55 AM

    Well, what a treat – comments from the two principals. I think a lot of psychiatry’s critics see the focus on the misadventures of PHARMA and their academic allies as some kind of attempt to divert attention from the everyday prescribing psychiatrists who have perpetuated the inappropriate overuse and misuse of these drugs, and I have no inclination to argue with that because it certainly a justifiable complaint. But there’s another big factor that I wasn’t aware of myself that’s implied in your comments. I hadn’t realized how much the literature of medicine had to do with practice – both when I was an Internist and as a Psychiatrist. I guess it was so much a part of things that I didn’t even notice.

    That was true even when I was far along in my career and had an almost exclusively psychotherapy practice. I had drifted away from the main stream of psychiatric literature as it became so focused on psychopharmacology and neuroscience. It’s not that the ongoing literature ever receded in importance, I had just moved to another focus – another literature. Some five years after retiring and doing non-medical things, I’d gotten a good rest and was asked to help out in a local clinic. To my surprise, I immediately accepted. I guess I really had gotten my rest. I knew it would be a different version of psychiatry than I had practiced, so almost without thought, I ordered some textbooks and began to read the old journals I’d read in training and the early years – “boning up” on the new psychiatry. And I started seeing patients in the clinic, and found them on what seemed to me outrageous cocktails that I didn’t understand, It was about that time that Senator Grassley’s Investigations hit the news. The chairman of the department where I was affiliated was on the list.

    I had made the now laughable assumption that I could “bone up” and get up to speed, and what I found was that the “literature” that I had always counted on wasn’t there anymore, at least not the part I was looking at in 2008-2009 – and I was at sea. So I came into this story after your early exposures, around the time that Senator Grassley and Paul Thacker had gotten things to the front page.

    I can now see Bob’s point that much of our “literature” is an Augean Stable that has to be cleaned out. The medical literature doesn’t “go out of date” like the magazines in a doctor’s waiting room. It endures. That’s why the AllTrials campaign isn’t over when there’s a breakthrough like the growing availability of future RTC data or the recent EU decisions about transparency. Ben Goldacre and friends are right on to insist on extending it backwards in time to include all the drugs still in use. That’s why the fledgling RIAT project is so important and I’m so honored to be a participant.

    When I think about it, medical education lays a based locked in time. After that, we learn from each other, CME, our anecdotal patient experience, and the “literature.” CME and our “literature” are essential pillars, and with their contamination, we’re worse than lost at sea, we’re on a wrong course. And with the modern restrictions on patient contact, these “pillars” become even more important because individual patient contact is limited.

    I’m not as bothered by the “hectoring” as I once might have been. As an old guy, I spend some time as a patient myself, and I can see that these problems aren’t limited to psychiatry, though I think we lead the pack. These days, the out-of-date magazines in the waiting room are often supplemented by a big television with medical infomercials playing on its rented screen. But all of Medicine is way too big for the likes of me, so I’ll stick to the part I know best.

    And a hearty thanks to both of you for getting the ball rolling ten years ago, keeping at it, and helping me and others wake up to the “slings and arrows.”

    April 8, 2014 | 1:55 PM

    dr mickey,

    when is someone going to address the elephant in the room: namely that obamacare has allowed unqualified medical professionals (i.e. non-MDs/MBBSes) to write prescriptions at pharmacies.

    I really believe the Gerson Lehrman Group has gone too far. please see article here:

    “No appointments are needed at the clinics and most insurance is accepted. Most locations offer care to patients 18 months and older and are open seven days a week with evening hours, making convenience a big part of their lure. Services are usually provided by nurse practitioners or physician assistants, who are qualified to write prescriptions, according to the Convenient Care Association, a national trade association. Many clinics collaborate with local physicians who can be called upon for consultations, if necessary.

    dr mickey this is very concerning to me. as it shows america’s disregard for the medical profession. the fact they allowed such unqualified people to prescribe drugs is both disconcerting and representative of the rot in the medical system.

    someone needs to do something. this is absolutely ridiculous.

    April 8, 2014 | 2:51 PM

    “Non-MDs/MBBSes” prescribing isn’t the elephant in the room. The elephant is that their uninformed prescribing isn’t any worse than MDs/MBBSes!

    While I understand the discomfort prominent psychiatrists such as Dr. Carroll and Dr. Rubin might have regarding “hectoring” about the poor quality of clinical care, from the point of view of the patients, the “subtext” in criticism of the field is not good enough.

    Conflict of interest could disappear from psychiatry tomorrow without affecting quality of care for a generation. In fact, COI could disappear and clinical psychiatry never know it’s been practicing in error. This could go on forever.

    Concern about the sullied dignity of the profession while leaving the clinical quality subtext unspoken permits the erroneous “few rotten apples” argument. Sadly, while rotten apples are as repugnant to patients as they are to concerned physicians, it’s the corps of clinical psychiatrists that is the immediate danger to us.

    Decrying COI is a top-down solution, while bringing quality of clinical care (how about looking at outcomes and injury???) into the foreground is a bottom-up solution.

    Bernard Carroll
    April 8, 2014 | 4:14 PM

    Alto, what is this last comment about? Who are you saying left issues of harm to patients unspoken? Who do you think blew the whistle on the reckless impetus to use antipsychotic drugs for non-psychotic depressed patients? That was Bob Rubin and me. Who do you think blew the whistle on risk of tardive dyskinesia with the new antipsychotic drugs, especially in nonpsychotic depressed patients? That was me. Ditto for risk of metabolic syndrome in nonpsychotic depressed patients. Who do you think has been calling for a pause in the prescribing of antidepressant drugs for all nominally depressed patients because most of it is futile or harmful? That was me. Who do you think has pushed back against the commercially motivated sidelining of lithium because patients will have better outcomes? That was me. We have done much more than just decry COI, in your words. Do your homework, for goodness’ sake, and quit acting like you alone have been concerned with outcomes and injury.

    April 8, 2014 | 5:07 PM

    Your contribution is profoundly important and wonderful, Dr. Carrol; but many of these “critics” who “hector” didn’t need to be told by rarefied psychiatrists that something was really wrong with the diagnosing, prescribing habits, and ineffectual to harmful drugs we were given. For many of us we were at the mercy of state paid psychiatrists and whatever other low cost options there were. I thought I’d have better luck when I made enough money to pay for a private psychiatrist. I was wrong. He was the third psychiatrist I saw that prescribed lithium to me (which is what I asked for) while saying nothing about blood testing. I took lithium for four years without ever having the levels monitored.

    After I enrolled with the V.A. and saw one of their psychiatrists, he took me off the lithium and I started on a rotating cocktail regimen. Later I found that the depression that terrified me so much that I submitted to drugging was an iron deficiency that was corrected with high doses of iron and vitaming C, but not before months of trying psychoactive drugs that didn’t help at all. He quit the V.A. because he was frustrated with the limitations of short visits— he was an old school psychoanalyst who was a pioneer in the creation of the diagnosis of PTSD for combat veterans. I adore and respect the man, and if he were reading what I write here, I’m sure he would notice everything I say and remember it, instead of focusing only on the criticism and framing is as something that’s above my station and all that I do.

    No one has to go out of their way to find a psychiatrist who will see them for less than half an hour on the first visit and fifteen minutes or less thereafter, while doing nothing but writing prescriptions without giving any indication that “side effects” should be a concern and looking at the patient askance when they report side effects.

    Your tendency to lecture lay people, even to the point of screaming at me in allcaps as if I were too stupid to understand text alone is not very becoming. The fact that you’ve made a significant contribution to harm reduction doesn’t entitle you to tone-police whomever you please. If you’re so sensitive to criticism of your field, and feel that you and others you consider to be quality psychiatrists must, at every turn, be credited, then perhaps the issue is yours. If, as Alto said, the problem is just “a few bad apples” then it wouldn’t take monumental efforts to challenge obvious bad and harmful practices, would it?

    Too many people have never seen a psychiatrist who doesn’t practice in just the way we “critics” describe. Your efforts to shut us up doesn’t reflect well on you. I often qualify my criticism and refer to the most problematic aspects of biological psychiatry as the “it” of it— a term Dr. Nardo used. If you like, I’ll put a # with every post to indicate that it’s not about you. You’ve not criticized Joel for saying what we “critics” say in far more strident and unqualified terms than I do. If you insist on denying the legitimacy of criticism from patients and former patients, it pretty much puts you in the camp of psychiatrists who show little respesct for their patients and who refuses to listen to them and grant their objections any validity to you, and to themselves in their own lives and experiences with psychiatry.

    Gagan, nurses are able to prescribe psyche medicine now. The ACA also requires and rewards evidence-based medicine. So, this is the perfect time for critical psychiatrists and other mental health specialists to organize and to lobby for better and more evidence-based diagnoses and treatment in psychiatry, pschology, drug treatment programs, and alternative recovery programs.

    Bernard Carroll
    April 8, 2014 | 5:43 PM

    Thank you for recognizing what Alto didn’t.

    April 8, 2014 | 8:32 PM

    Decrying COI is a top-down solution, while bringing quality of clinical care (how about looking at outcomes and injury???) into the foreground is a bottom-up solution.

    I doubt anyone on this page disagrees there there is a big problem with the quality of care, outcomes, and injury. I don’t, nor do my colleagues above. Watching the “top” problem fester for a quarter century has, indeed, been painful. Worse, it was untouchable, in part because it was supported heavily by another “top” – the third party carriers who actually pay people to do exactly what Wiley is talking about. As I saw it, one of the unmentioned forces in this story is that group which has essentially relegated psychiatrists to being prescribers in brief meetings where context isn’t in the picture. It remains the nightmare for many. I decry that too.

    On the other hand, I take your comment about “decrying COI” as a discounting of how much that was a force up and down the whole system and how much of a problem it still is. I think that it’s the thing that I can personally do to get at the root of things. I didn’t know it until it was already a cancer. Drs. Carroll and Rubin knew it long before I did. But it was a force that justified the creation of a system that’s no good for any of us. I certainly decry COI, problems of outcome, harm, injury. But it’s not decrying I see myself trying to do. I see myself as trying to expose as much of it as possible. That was not even possible until recent years. I intend to keep at it as my contribution until I can’t see this screen. That’s not going to change.

    I can’t do the bottom up, except as a volunteer doctor. Alto, you seem to see those efforts as trying to divert attention away from the everyday problem, or avoid the problem as you see it, some attempt to preserve the dignity of the profession, or blame someone else – a misguided, self serving endeavor that’s either misdirected or not good enough. If that’s what you think, there’s nothing I can do about that. But I’m tired of your saying it over and over. Your complaint was registered a long time ago.

    I have no problem with bottom up solutions to this problem. From my perspective, meeting in the middle would be the most desirable outcome of all. But over time, you seem to have decided that I and the people who comment here are part of the problem. that our efforts are either inadequate or worse. I think you’re preaching to the choir myself, but if you think otherwise, that’s your business. But you’ve forgotten what the heading on that box above the comment section says.

    Frankly, If you decide to leave, I’ll miss you. I’ve learned from your insights and your efforts about withdrawal and passed them more places than just here. But people interested in trying to work on the “top” are now emailing me rather than commenting here because they feel attacked. Please don’t do that anymore. Please.

    If you think we’re misdirected, leave us to it.

    April 8, 2014 | 8:51 PM

    Thank you, wiley, you said it better than I ever could.

    Dr. Carroll, I have immense respect for psychiatrists such as yourself, Dr. Rubin, Dr. Frances, Dr. Nardo, Dr. Healy, and others who have risked the ire of your peers by speaking up about conflict of interest and dangerous prescribing.

    If you don’t mind, I’m going to refuse the role of identified anti-psychiatrist. There are some who say “all psychiatrists are bad,” but not me. What I say is “a good psychiatrist is very, very hard to find.” I know this very well, I spend hours every week trying to find sympathetic psychiatrists for referrals.

    With all due respect to those congregated here — I assume the psychiatrists reading are interested in the critiques of their profession — yes, there are exceptions, and you are among them.#

    Psychiatry still is in big trouble, though. How is change going to come about in clinical practice?

    April 8, 2014 | 10:39 PM

    wiley — well they’re psychiatric nurses. in canada they require slightly more education/training (1 to 2 years on top of their RN, which is a BScN). i wouldn’t be opposed to these individuals being able to prescribe, as i’d call them the “soldiers in the trenches”.

    what a bigger mess psychiatry would be without the nurses who help mental health professionals “deal” with these patients.

    Bernard Carroll
    April 9, 2014 | 1:31 AM

    Alto, you have a knack for reframing the issue tendentiously to suit yourself. You just did it again. Dr. Mickey didn’t offer you the role of identified anti-psychiatrist. He said he is tired of your saying the same thing over and over… with an unwelcome condescending and dismissive attitude, I might add. All that hectoring hasn’t moved the ball down the field. Enough already. It is hard enough for folks like Dr. Mickey, Bob Rubin and me to change a complex and entrenched system. Your kind of airy, ill-informed pot shots at us are no help at all. I agree with Dr. Mickey’s bottom line.

    April 9, 2014 | 11:55 AM

    I’d offer that colleagues who practice responsible, caring, and well documented standards of care dish out as much shame and humbling of these other colleagues who are just interested in what is popular, easy, and convenient, but, shame and humbling/humility got buried next to morality and ethical standards probably about the same time. So, great concept, lousy application for this example.

    We live in times of “excessive lies and misdirections are misguided truth, so shut the hell up trying to confuse us with the real truths” not only from psychiatry, but it is pandemic in all aspects of our society, be it politics, business, hell, even the homeowners association psuedo fief-doms that are out there in neighborhoods.

    People who clamor for us to bring about this alleged change for the profession of psychiatry, well, how do you bring down corrupt and inefficient leadership? Start with your politicians who you vote for as example A?

    If the APA has no real foundation of credible membership, the organization falls from the weight of the huge and lame egos at the top. If the APA is made irrelevant, where are these corrupt losers going to scurry to next?

    Academia most likely, and that is now starting to develop fault lines there, perhaps some are microscopic, but isn’t crumbling sometimes slow and steady? Besides, WHEN psychiatry training programs can’t attract credible medical school candidates as they already are witnessing now, maybe the overall residency programs leaders above the academic cretins in the departments of psychiatry might have some reaction to evoke change.

    Nah, what the hell am I thinking?! Psychiatry is already being replaced by NPs. PCPs, psychologists in some states, and wait for it, even LCSW-s will continue to press to get prescribing privileges. And who played a role in this to a sizeable degree? The APA, again!

    idiots, we are ruled and led to the cliff edge by idiots!!!

    If interpreted as proselytizing, I accept the charge, the APA must be made irrelevant as the first step, and I genuinely hope to not have to repeat this any longer.

    Joel Hassman, MD

    April 9, 2014 | 4:58 PM

    The APA could collapse into a steaming heap overnight, and it wouldn’t change a thing about who funds research.

    April 9, 2014 | 5:50 PM

    Sigh. No medical training here. Just can’t understand why Nemeroff continues to be the dean of psychiatry at Univ of Miami, continues to be featured as a presenter at APA conferences, continues to serve on the boards of suicide prevention organizations (thus preventing any contribution from me to their support), etc., etc. Why? Why? Why? I don’t understand why the guy isn’t in jail.

    April 9, 2014 | 8:30 PM

    Perhaps the greatest mystery, Peggi, is that it’s a mystery. Cronyism, nepotism, group-think, etc. are automatic and self-reinforcing. Someone usually has to knock the king off the mountain to establish a new reign. That’s the game, and it isn’t exactly too aware of itself or amenable to challenge when enormous piles of money and prestige are in the kitty. Who’s gonna kick the top dog down a notch while they’re riding on his coattails?

    April 9, 2014 | 9:28 PM

    Mickey, I had not seen your comment of April 8, 2014 | 8:32 PM, it was posted while I was composing my comment of April 8, 2014 | 8:51 PM. My comment was not in response to yours.

    Of course, let’s meet in the middle. Clearly, all of us are concerned about the quality of care in psychiatry.

    April 9, 2014 | 10:12 PM

    Alto, the first I heard about hypomanic and manic reactions to discontinuing an antidepressant was when you brought it up recently. It had never crossed my mind. I also ran across it today reading an editorial linked to in Philip K. Hickey’s post that he put up on Mad in America yesterday. It addressed the hypothesis of tardive dysthymia. It links to a copy of an editorail written by Giovanni A. Fava —
    Do antidepressant and antianxiety drugs increase chronicity in affective disorders?—= which, I could not help but notice, was published in 1994. So, just as the overzealous use of psychotropic drugs was going into overdrive, a significant number of rich questions were raised about the relationships between antidepressants and anti-anxiety agents and depression and anxiety, respectively.

    I think in our technocratic society with it’s demand for instant gratification and/or monetization, “actionable” answers— and answers that have the appearance of being “actionable”— too often have more cache and funding than questions that require a broadening of the scope of possibilities or other perspectives and a willingness to sit quietly without reaching for confirmation bias or closure for the purpose of settling doubts, anxieties, ambiguities, and getting published— an unfortunate byproduct of the commodification of everything.

    Now that I know about this particular danger of amitriptyline causing mania I’ll make a special point of not running out— I take 150 mg a day for nerve pain and sleep, and if it effects my mood beyond being in less pain and able to sleep better, it’s hiding that from me. I have also once again been reminded that amitriptyline causes cognitive impairment and problems with memory. I have a new disorder— the side effects of some of the medications I take make me forget about the side effects of some of the medications I take. I’m not alone, which is more of a symptom of contemporary medicine than a reassuring platitude.

    It’s not easy to speak of most topics with the tentativeness and complexity they deserve in our society. It’s often seen as equivocating or talking too much instead of getting right to the point— it defies the economic values embedded in our culture.

    Time is money.

    Personally, I don’t believe I’ve ever been “depressed” and most of my anxiety has been quelled by the fact that I have thousands of dollars in my savings account now. No drug can do that, unless it’s a blockbuster you own stock in.

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