Editorial Note: When I raised the specter of the Science Media Center and Sense about Science recently, some of the Americans I knew fell about laughing, figuring we are still a long way off being as censored as the US of A is. After calming down, one of them Johanna Ryan wrote this post.
In June 2014 the BMJ published a study by Lu et al supposedly of teen suicide. This was a group of researchers at Harvard University. The study claimed to have found a “33% jump in suicide attempts” among US teens after the FDA placed a Black Box warning on antidepressants for young people.
It received an avalanche of publicity, none of which cast the faintest doubt on its alarmist conclusions. With a publicity machine like this, it was no wonder most American journalists (and most doctors as well) hesitate even to mention any downside to antidepressants, lest they be accused of triggering a wave of teen suicides.
Dozens of leading academics wrote the BMJ to pour scorn on the study. It is a good candidate for the most egregious article BMJ has ever published. It showed neither a major decrease in antidepressant prescribing, nor a rise in teen suicides. The increase in suicide attempts it claimed to find was actually a rise in insurance claims for “psychotropic drug overdoses”, many of which would not have been suicidal.
The “Clay Center for Young Healthy Minds” was founded at Massachusetts General Hospital in 2013 and immediately took a lead role in press coverage of teen depression and suicide. Gene Beresin and Steven Schlozman, two Mass General child psychiatrists, are its leading figures. Beresin went on ABC News to promote the “study” and its alleged finding of a 33% increase in teen suicides. He and Schlozman co-wrote an Op Ed calling on FDA to repeal the Black Box warning, which Beresin called “the next closest thing to prohibition.”
The Clay Center is not a treatment or research institute. It’s a media and communications project. Its dedicated to “educating” journalists, policymakers and the public about the virtues of the Mass General approach to childhood problems. Mass General is known for an aggressive use of psychiatric medication in children. In particular it’s known for the work of Dr. Joseph Biederman promoting the controversial diagnosis of “childhood bipolar disorder” and its management with antipsychotics in infants.
From the start it has forged a close alliance with the American Foundation for Suicide Prevention, an influential nonprofit whose leadership roster reads like a Who’s Who of American psychiatry. Dr. Christine Moutier, AFSP’s current president and chief spokesperson, worked with Beresin in the 2014 media campaign. Both are articulate, engaging and much more media-friendly than most leading academic psychiatrists like Biederman. Both are also sufficiently far removed from the world of drug-company clinical trials and “key opinion leaders” that no sticky trail of Pharma money adheres to them personally.
I’ve found it useful (and occasionally fun) to keep tabs on what they say to various audiences. Take this 2013 blog article, where they reassure everyone that the very small uptick in teen suicides in 2004 or so – which they allege was related to the Black Box warnings – was just a temporary blip, and suicide rates have re-stabilized. Very much at odds with their 2014 hysteria campaign!
And this more recent article, in which they report that more youth are getting mental health treatment, but the increases are occurring among kids who are either mildly impaired, or “not impaired at all.” They are nonetheless “delighted” that so many are seeking help! No downside whatsoever when your child psych clinic fills up with kids who are “not impaired at all” (though they do worry that more disturbed children may still be undertreated).
Occasionally their promotions verge on the ridiculous: In August 2016, at the height of back-to-school season, the Clay Center solemnly announced that 50-60% of college students had a psychiatric disorder.
The Clay Center owes its existence to two big, “transformational” philanthropic donations. The biggest was from Landon T. and Lavinia Clay. Landon Clay is a venture capitalist and head of a Boston-based investment fund called East Hill Management Company, LLC. He was formerly head of Eaton Vance and ADE, two other major investment funds. He’s an alumnus and major donor to Harvard University, and is (or was) on its Board of Overseers.
So why has this become the Clay family’s cause? I expected a warm fuzzy story about how one of their children had a mental-health condition, or how Mrs. Clay was a schoolteacher who worked with troubled kids, or something similar. I didn’t find it.
East Hill focuses on biotech ventures, and is advertised as investing in “disruptive innovations” developed at UK universities. Its offices are in Rhode Island and Oxford, UK. Landon Clay is a director of Plasso Technology Ltd., Glycoform Ltd., Arradiance Inc. and other biotech ventures in which East Hill invests. He’s also given millions to Harvard for telescopes, a faculty chair in mathematics and other high-profile science projects.
Jeremy R. Knowles, twice Harvard’s Dean, was on East Hill’s Board until his death in 2008. As Dean, Knowles was responsible for major expansions of scientific research, including the Harvard Brain Science Institute which is heavily involved in psychiatric research at Harvard and Mass General. Knowles also served on the boards of Vertex Pharmaceuticals, Biogen, Celgene and the Howard Hughes Medical Institute (HHMI).
East Hill’s business model is to finance startup companies to develop various drugs, devices, etc., and then sell them to major corporations. Their scientific advisory board also included Robert May, a “former President of the Royal Society” and Oxford zoology professor, now a member of the House of Lords.
East Hill has a link to Sense about Science, the British think-tank and media center: Oxitec Ltd., a company developing genetically-modified mosquitoes in a scheme to eradicate mosquito-borne tropical diseases such as dengue fever. Oxitec claims its technology is safer and more sustainable than pesticides, but this claim has been controversial. East Hill was a major investor, and Clay was on its board until it was sold in 2015. Oxitec’s press officer, Chris Creese, has also been employed by or affiliated with SAS, and SAS has publicly defended the Oxitec project.
The Clay Center’s other large donor is Elizabeth Hayden, billed as “an educator who has dedicated her life’s work to children and families.” She is also the widow of James Hayden, a tech millionaire. The Hayden Fund, set up in his memory, is administered by The Boston Foundation, an influential block of philanthropic capital with a finger in every political and economic pie in the Boston area. The Hayden Fund is one of its “Donor Advised Funds” whose funders are actively involved in their charitable giving.
Ms. Hayden’s professional career seems to have been as a teacher and administrator in a few of the small, wealthy private schools patronized by the Clays. She is also on the board of Stonehill College, a small Catholic college in Easton, Mass. where she and her husband both went to school. A student of the sociology of the U.S. ruling class could have a field day with Stonehill. Its board is 100% alumni, and amazingly influential for such a small place. It includes Wall Street bankers, university presidents, political fundraisers and corporate execs – including a former head of Johnson & Johnson’s pharmaceutical division and a key political advisor to both Presidents Bush.
Elizabeth Hayden is said to have worked with Gene Beresin for years to make his media center project a reality. She may have been the person who recruited the Clay family to the cause.
The National Alliance on Mental Illness (NAMI) is listed as a key “partner” of the Clay Center, along with AFSP as mentioned above. NAMI has played an enormous role in establishing the “chemical imbalance” concept of mental illness in the media and public discourse, and it has received six-figure donations from just about every psychotropic drugmaker in the market.
AFSP, in turn, has been involved in a retooling and expansion of official psychiatry’s support system in the past three years. It has played a key role in founding a broader organization called the Action Alliance for Suicide Prevention, which draws in U.S. military and govern-mental agencies as well as corporate heavy hitters to back the brand of mental health care favored by Mass General, Charles Nemeroff and Big Pharma.
Its Board of Directors includes the CEO of AFSP along with top execs from Kaiser Permanente and Universal Health Services, the giant for-profit behavioral healthcare chain. It also includes Thomas Insel of NIMH and Thomas Frieden of the CDC as Ex Officio members.
The Action Alliance does not seem to have a medical advisory board. It can always count on the AFSP’s, which still includes Nemeroff as well as Jerrold Rosenbaum of Mass General.
It can also count on the Anxiety & Depression Association of America. This group began as the humble Phobia Society in the 1980’s and became the Anxiety Disorders Association in 1990. In 2012 it took on its current name, and a much larger structure. ADAA is mainly a professionals’ organization, and its leadership is heavily stacked with Harvard, Mass General and Boston University faculty. The three groups – ADAA, AFSP and the Action Alliance – have collaborated on a survey of support for mental-health spending and other projects.
The Clay Center website names WBUR, the Boston affiliate of National Public Radio, as an affiliate. It also seems to have strong ties to WGBH, Boston’s PBS-TV channel. Despite the “Public” in their titles, NPR and PBS get less than 10% of their money these days from the taxpayer. About half is from corporate and foundation sources (the rest being from individual-donor fundraising). Affiliates are often high-profile pet causes for local corporate philanthropy, which can tend to put limits on their independence. WBUR’s CommonHealth health-reporting project handles the station’s work with the Clay Center and other powerful nonprofits.
The Clay Center can also draw on the considerable media networks already developed by NAMI and the AFSP. Both are regarded as prime sources for “responsible” mental health information by most media – and both have relied heavily on funding and hands-on public relations support from Pharma to achieve that standing.
Because of the Sunshine Act and the general low opinion of Big Pharma shared by most Americans these days, complex nonprofit arrangements like the Clay Center will likely play a larger and larger role in advancing both drug research and a Pharma-centric health care system. This may make it harder for most people to spot any conflict of interest. The fact that rich venture capitalists give you money doesn’t strike everyone as grounds for suspicion, and I can’t point to anything as naked and obvious as an investment by Landon T. Clay in pediatric psych medications.
However, it is biotech money flowing into Dr. Beresin’s beloved project, which is extremely helpful to the bottom lines of Harvard and Mass General. That may not be sinister, but it is kind of self-serving, to say the least. Sort of like Silicon Valley capitalists financing laptops for schoolchildren. You may think laptops for schoolchildren are basically a good thing, but you can’t help noticing how good it is for Silicon Valley as well. It also means that one particular viewpoint in medicine is being artificially inflated above others that might have more to offer troubled kids. When busy reporters or public officials want to know “what the science says” about mental health, nonprofits like the Clay Center help insure they hear no inconvenient facts.
There is an interesting story Bob Fiddaman points out on his blog recently.
On May 18 2017, Chris Cornell, lead singer for Soundgarden committed suicide. The media reported his wife’s hunch the Ativan he was taking had caused his suicide. WBUR ran an interview with Kelly Posner on May 25, the same Posner who headed up the Columbia Suicide Classification group FDA had turned to between the two PDAC hearings in February and September 2004.
Posner dismissed the link to suicide. When quizzed about the fact her group had reported the data that led to the Black Box, she responded that both FDA and she knew there was no link but they were stuck with trials that were not designed to look at the issue and FDA being very conservative and super-concerned about patient safety had been ultra-cautious and issued a Black Box Warning that was strictly speaking unnecessary. Posner was looking forward to a day in the near future when all the new and better designed research coming through the system would lead to the Black Box being removed, because it had had terrible unintended consequences – a drop in diagnoses of depression and a resulting increase in suicides.
This is presumably the work of Robert Gibbons and Lu for godsakes. And what about the fact there is no evidence the drugs work?
Thirty years before a certain D J Trump began talking about fake news, medicine had entered a fake world. Thirty years before Alt Right and Alt Left we had Alt-Medicine – as Study 329 makes clear.
Copyright © Data Based Medicine Americas Ltd.
Oh Johanna – I don’t know whether to laugh or cry! It reads like a warning for the future of the UK yet sounds so unfamiliar ( up to now) as to be quite hilarious in parts. The bottom line, as I see it, is that we ( the general inhabitants of whichever continent) are seen as idiots. Smoke screen after smoke screen set up to ‘hide’ the blatantly obvious – THAT THEY ARE ALL IN THIS TOGETHER! THEY are in it for the money and WE are ….we are, in their eyes, what matters very little. They suck the life out of us with all their high and mighty ways and ideas – when they finish with us ( that is, have ruined us beyond our coping abilities) they fail to have answers to our needs. Where will they turn then? They’ve already attacked adults, adolescents, children, toddlers, babies and the unborn – plus managed to make it quite impossible for many to breed. So, I ask again – where will they turn next? Will they decide that our pets need intervention as our skills of caring for them puts our beloved dogs’ lives in peril?!
We need to say that we’ve had enough! Enough of their meddling in every area of our lives. Enough of them deciding who, when and where can populate our world. Enough of them deciding that they can see, in our children, traits of ‘horrors’ for the future. Enough of them tempting our young adults to seek a better life by popping their pills. Enough of our elderly having very little say in how their lives are to end. In fact – just ENOUGH of ALL that they have to offer. Let’s return to the days when each and every one of us counted for something – not simply as a means to line someone else’s pockets but as real, thinking, healthy humans running the planet together and for each other. If only we could!
Eventually confidence in the pharmaceutical system will collapse as it did with the banking system, or over WMD. It is overdue and the game is ridiculously dependent on aggressive public relations by transparently thuggish agencies without a shred of integrity or responsibility. No doubt, as in the other cases the system will survive because that is where the capital and power lies but they will be on the defensive.
there to do ..
Mickey Nardo wrote posts on the subject, here, here and here.
Look at the first ‘here’ and this is what Mickey Nardo said:
It says that it’s something that can happen and people need to be aware of it, warn their patients, and keep a close eye. That’s simply the truth. If you’ve seen it as I have, you’re an immediate believer – epidemiology doesn’t matter in the n=1 world of caring for patients. The never-ending assault on the warning seems to me to be because it scares people who are seeing patients in a primary care setting where they can’t take the time to do what’s needed, and that impacts drug sales. That’s absolutely fine by me. It should scare them. Drug sales are not our concern. Isacsson and Gibbons have positioned themselves on the wrong side of this equation. One might legitimately question the warning if the antidepressant efficacy were a whole lot better – but it’s just not. That is absolutely clear. And even if they were more effective, the warning still ought to be there in my way of thinking to keep us vigilant.
The FDA is to be commended for finally issuing the warning, and is obligated to stand by it. It’s what the agency is there to do…
Several obvious, serious flaws to this study were adeptly exposed by previous posters. I contend this “study” and the BMJ’s publication of it may very well promote violations of the Hippocratic Oath.
Kristina K. Gehrki
to keep us vigilant…
I doubt that my fervor with blog posts or even all the very well framed BMJ Rapid Response replies will hold a candle to the impact of the immediate press alerts posted all over the country or the tweet to the APA President’s followers. One can’t help but wonder how these things get coordinated. The article was “Published 18 June 2014,” and the press blitz was on the same day. It was even on WebMD the day it was published in the BMJ. That same thing happened with other “anti-Black-Box” articles – notably the ones by Dr. Robert Gibbons [see smell a campaign…]. His media blitz was in high gear even before the second article that gave the source of his data was published [and Gibbons was commenting on this current article on, you-guessed-it, June 18th].
There’s obviously a “pipeline” for getting the word out. It would make a good project for some young investigative reporter to flesh out this pipline and locate its origin…
So many hidden hands, and vested interests in the psych/pharma industrial complex and so many agenda at play. It really is quite sinister. There are a lot of people making a lot of money from the ‘mental illness’ industry. Not surprised to see Joe Biederman and Posner thrown into the mix. Seems some folk like to live parasitically off the suffering of others…
The Authority are so great at blaming individuals that they themselves destroyed. Their game is manipulative and deceptive and all for the gain of monetary value (this is a crime).The damage they have caused is unforgivable but even worse the denial and blame of the victim is just pure EVIL!
Captain Gustav M. Gilbert, U.S. Army Psychologist at the Nuremberg War Trials
(1945 – 1949) wrote:-
“I was searching for the nature of evil and I now think I have come close to defining it. A lack of empathy – its the one characteristic that connects all the defendants. A genuine incapacity to feel with their fellow men.
Evil, I think, is the absence of empathy”.
The palpable absence of empathy in main stream psychiatry, experienced by those of us who comment on David’s blog; those of us who had our loved ones lives terminated or destroyed by this absence, differentiates this alleged medical discipline from the approach to medicine in other specialities and their multidisciplinary teams.
We often felt that amidst the arrogance, bullying, lies, coercion and forced drugging, there appeared to be a perverse professional pride in this absence of empathy and the ability to devastate lives without remorse.
Yes Anne-Marie, “EVIL” is the appropriate word for this whole complex (second)
industrial “Axis of Evil”.
By Gilbert’s analysis, the “medicine” that we and our lost souls experienced and endured is truly evil.
Evil, brilliantly and relentlessly marketed as “medicine”.
No wonder the smiling assassins strike out at D.H. so viciously and punitively.
Tim this is absolutely brilliant; the explanation of how lack of empathy equals evil, and inflicted evil equals the hell that so many of us and our loved ones have undeservedly found ourselves enmeshed in.
One goes around in circles trying to give psychiatry and lethal medications the benefit of the doubt, trying to be fair to them, trying to see the best side of things, because it seems just so unbelievably awful that they could EVER intentionally ruin our lives. But yes, it’s their lack of empathy, their total reluctance to stand in our shoes and imagine how their treatments are affecting us, that causes the hell. Being mentally unwell is bad enough by itself, without being pitch forked into utter desperation when fear of malign behaviour by those we expected to be able to trust, sabotage our recovery with this form of EVIL.
Your quote from Captain Gilbert puts our situations perfectly. Thank you.
I think people are very malleable. People may have empathy but they can switch it off: sometimes it may be necessary to act effectively, sometimes unfortunately it is just convenience. Nietzsche remarked on this somewhere, that having stopped off in the street to administer artificial respiration to someone that had collapsed in front of him that empathy would not have been much use in performing the action at that critical juncture. I suppose if these characters were just deficient in their ability to have such an emotion they might actually be morally less culpable than if they could: they would just be malevolent beings, rather than people who were responsible for acting in an evil way. Ironically, we are also confronted with this problem with people who may have diminished responsibility and act in obsessive ways under the influence of pharmaceutical agents.
No doubt, however, the people in the dock at Nuremberg were much more preoccupied with their own fate than what they had done: the gallows awaited and they can’t have been a pretty sight.
Brilliantly perceptive comments from both Heather and Tim here in relation to the complete lack of empathy from many in mainstream psychiatric services. The legacy of drugs like Zyprexa and Seroxat, and other psychiatric drugs, lingers long in the minds and bodies of those unfortunate enough to have been prescribed them. Drugs like Seroxat are not medicine. Medicine is sage, thyme, Echinacea, Garlic, Ginseng- herbs, plants, whole foods, deep tissue massage, yoga, walks in the woods with friends, happy memories with loved ones, stress free summer holidays. That’s medicine. Seroxat, Zyprexa and the other poisons that the psychiatrists peddle to us have destroyed countless lives, and when people harmed by these poisons speak out, mainstream psychiatry ignores, deflects and denies our experiences. This is outrageous. The lack of empathy in mainstream psychiatry borders on sociopathy, and I do not use that word lightly…
I think you’re wrong. Medicine is not sage, thyme, Echinacea, Garlic, Ginseng- herbs, plants, whole foods, deep tissue massage, yoga, walks in the woods with friends, happy memories with loved ones, stress free summer holidays. This all my contribute to healing but its not something you need a doctor for. The specific thing medics now do for you is poison and mutilate you. Good can be brought out of the use of Zyprexa and Paroxetine but only if there is a decent relationship between the person proposing a poison as an option and person considering taking it and then taking it. The proposals can only be genuine if the poisoner really knows what she is giving and commits to monitoring for the poisonous effects.
It is wonderfully useful to have lack of empathy highlighted as a major part of the problem Tim. It explains the feeling of frustration when intelligent people can never the less display a ‘denseness’ which is so hard to deal with. It is also useful as obviously those lacking in the ability to change their mind…much less ‘heart’ will not be amenable to debate or listening to challenging views even when provided with evidence. So different strategies must be used to get messages across by avoiding those known to be ‘dense’ lacking in compassion or have superficial caring attitudes. They do tend to be charming, often charismatic and attract followers both out of admiration and fear which makes progress to change within institutions even more difficult. Apologies that I cannot use links but on google ‘Disruptive and Distressed Doctors; The Relevance to Personality Disorders’ . Courses were given both in USA and UK Unfortunately the referrals to retraining were in relation mainly to medics at the lower end of the ladder – psychiatrists were claimed to have higher levels of pathology which must have gone down well with colleagues,, some found it humiliating and obviously resentful of the cost out of their own pocket, £1500 up..what is missing though is any intention to assess those at the top of hierarchies where they tend to dwell in any organisation. Who would dare to suggest it though and would they comply?
You might think I’m wrong, or perhaps you are misunderstanding me. You said that medicine is not Sage, Thyme, Echinacea, Garlic, Ginseng- herbs, plants, whole foods, deep tissue massage, yoga, walks in the woods with friends, happy memories with loved ones, stress free summer holidays. I said that they are. Medicine should heal, that is what the vast majority of the public expects it do do. It should be a good thing. The vast majority do not expect it to poison them. Most people’s understanding of something ‘medicinal’ is of something ‘good’, something goo for them, something that will help them, heal them, make them better. Seroxat and Zyprexa are not useful drugs because the very basis of the paradigm that they are used for is built on sand and illusions…
There are a myriad of natural, side effect free real medicines (not poisons) that can help, heal and aid people in recovery from mental health problems. Ayurvedic medicine, herbs etc…
We’re going to have to disagree. Ayurveda is not medicine as that word is now used. Part of the problem with Ayurvedic and other related approaches is they were so open to con-men making a killing that it was a relief when medicine got on a progressively stronger footing in the nineteenth century and especially after 1950. There was an opportunity to cut back on quackery and lethal conmen and hucksters.
My hunch is if business practices hadn’t corrupted medicine as much as they have done so that the marketing of drugs like Zyprexa or Prozac differs little from the hucksters and conmen of yesteryear, we wouldn’t be having this argument.
If i get AIDS, or when I broke my collar-bone some years ago, I would send anyone who approached me with echinacea or anything remotely Ayurvedic packing. The problem I have is I am now faced by a mega-huckster who has happened on some real cures but who rather than trading on hope as the old-time charlatans did, says if you don’t hand over all the money you have I will stop doing research for new AIDS drugs and stents and you will die.
l expect we will have to disagree about this
I mentioned Ayurvedic because I believe that these ancient systems of health can be useful. I also mentioned herbs, and diet etc because herbs and diet have helped me more than SSRI’s ever did. Of course you would not send someone with a broken collarbone or with Aids to get some echinacea. That’s ridiculous and not what I was suggesting at all. Of course there are great drugs out there that help people enormously, I have no problem with that. I think that psychiatry is missing the point when it comes to mental ill-health though. The person is holistic- Monica Cassini touches on this on her blog- beyond meds- everything matters. The key is in ‘everything matters’ – holistic- the ‘whole person’. Often if you gave some depressed people a million euro – I guarantee you you could probably ‘cure’ their depression in some instances with money. What does that tell you? Depression is often circumstantial, but psychiatry is still looking to brutalize it out of the person with ECT of psych-drugs as if the ‘depression’ itself is some kind of virus or disease that can be ‘fried’ out of the persons head… wrong approach- bad paradigm… needs to change… respectfully disagree if you will…
I do disagree. ECT, SSRIs, antipeychotics and benzos are immensely useful. But part of knowing how to use them means knowing when to use them. And they should not be used for distress. There are real psychiatric diseases but these are extraordinarily rare compared to the vast amount of distress that is out there. The problem is not the treatments – its the shrinks who should not be involved in distress. If family doctors were left to get it right without threats of legal action is they get it wrong, they’d do a better job
But both they and you face a problem. Distress is not going away anytime soon with holistic talk or whatever. Holistic therapists can usually pick and choose who they take – and its often people with money. GPs have to take everyone who comes in through their door. This is something no-one else has ever had to do.
You say ECT, SSRI’s, Benzos and Anti-psychotics are immensely helpful. I don’t have direct experience of Anti-Psychotics or ECT, but I do with SSRI’s so I can only speak from experience in regards to those two approaches. I agree with you that SSRI’s and Benzos can be useful (in the sort term as ways to numb people as that could be what is neede din some cases of depression/anxiety etc), however they are not used as ‘useful’ approaches, they are used as first line treatments for distress, and yes GP’s and psychiatrists should not be treating people with distress, but they are, and they have been doing so in immensely large numbers for at least 20 to 30 years now so surely something is wrong with this paradigm of care? It is clearly not working, and in many cases it is harming people. A new paradigm of care is needed and I don’t think that psychiatry can be trusted to lead it…
I think you are making my point. Its not the job of medicine to sort out distress. That’s for politicians, revolutionaries or whatever. Until they do many people will turn to a variety of hucksters. And will also turn to family doctors who face vastly more distress than anyone else on this planet. Its unquestionably the case they dish out things they shouldn’t do in the face of this – but this is partly because pharma companies threaten to get them sued or fired if they don’t.
Something needs to change but the medical model for treating disease rather than distress is not what needs changing
I agree with TM that some other than conventional treatments can be classed as medicinal when used by those with proper knowledge of what compounds are contained in the plants . Many are still used these days , research , not by cranks,is being carried into the use of eg daffodils – fields of them are grown in parts of wales, leeches are used in university hospitals. Obviously conventional medicine is necessary in any modern society as DH says for most conditions but when the risks as with anti depressants is so high that people are not being told of them because they will decline to use them , no wonder the rich look elsewhere – they are the ones with access to information, the less priviliged will still be prescribed the most from lack of knowledge not just because they live in deprived areas and so experience greater ill health. Am not just partly but wholly in disagreement with DH regarding GPs – being stressed, having too little time, fear of pharmaceuticals etc is no excuse to commit immoral acts. GPs could speak out or commit to not prescribing unless proper information /consent is honestly given and follow up is guaranteed. A famous poem was written by Pastor Niemoller who was incarcerated in a concentration camp for speaking out against the Nazi atrocities in WW2 ‘First the came for the socialists and I did not speak out, I was not a socialist. Then they came for the Trade Unionists…….the Jews….then they came for me and there was no one to speak for me’ Most activists are speaking out on behalf of others after terrible experiences of their own. This shouldn’t be happening in a ‘civilised’ country.
“… family doctors who face vastly more distress than anyone else on this planet. Its unquestionably the case they dish out things they shouldn’t do in the face of this – but this is partly because pharma companies threaten to get them sued or fired if they don’t.
Something needs to change but the medical model for treating disease rather than distress is not what needs changing…”
I agree that family doctors have a tough enough job, but I have never heard of a doctor being ‘threatened with a lawsuit by Pharma, or get fired if they don’t dish out things they shouldn’t.’ If this is the case, then I think it needs wider exposure, and perhaps you should do a blog post on it, because that is truly a despicable state of affairs. I understand that the contemporary medical model that family doctors work under is pressurized towards prescription for distress, but surely family doctors can bound together and challenge this pressure? I have always thought that doctors need to form a union of force against undue influence from pharmaceutical companies. The individual family doctor has huge power, if that power was harnessed with others, because it is the family doctor who holds the prescription pad and pen- not the pharmaceutical company or the regulators. The doctor decides on the brand, or the generic, etc. They could choose- if they wanted to- to boycott certain pharmaceutical companies that misbehave or withhold data on drugs for example. I’m sure it wouldn’t be that difficult to form a guild-type union for family doctors whereby they connect with each other to fight for their autonomy against nefarious forces and pressures? In my experience with family doctors, (and I have had dealings with several) they are very much in favor of the prescription pad, and very quick to prescribe psychiatric drugs, in particular SSRI’s. I don’t think that family doctors generally keep up with the information that’s out there, or the various scandals, debates about transparency, drug trials, ethics etc. Of course, you could argue that they are way too busy to keep up, and perhaps that’s true, however something we do agree on is- the paradigm needs to change…
This requires more than a blog post. It needs a book – am working on one.
Korea Biomedical Review
GSK Tops Clinical Trial Transparency
GlaxoSmithKline said it ranked No.1 out of 46 pharmaceutical companies in clinical trial transparency, according to the AllTrials Transparency Index
expert reaction to the life sciences industrial strategy
Experts react to the new Life Sciences Industrial Strategy.
August 30, 2017
Science Media Centre
Phil Thomson, President of Global Affairs, GlaxoSmithKline, said:
“The UK is a powerhouse for life sciences and GSK welcomes the vision set out today by Sir John Bell for the sector’s future. At the core of this new industrial strategy is a stronger and deeper level of collaboration between industry, government, the NHS, academia and funders. Working together, we can make the UK internationally competitive in life sciences for the long-term, capitalising on the country’s world-class science base and realising innovation to drive economic growth and improve patient care. As the UK’s largest life sciences company and one of its biggest investors in research, we look forward to contributing to this effort.”
It’s mainly UK citizens/NHS users who will be used as fodder for the research/trials – a captive population who will be sold the altruism mantra without knowing how the research will be used in future.
Re Ketamine – is it a new kid on the block? am out of touch on this
but article in British Journal of Psychiatry Open has published ‘Ketamine; a Stimulating Antidepressant ‘ May 2016. There are approximately 40 references by the authors to pharmaceutical companies ,named in Declaration of Interest. ‘Reasons to be fearful’? as the song goes….Newer article in Psychology Today August 20th 2017 has openly warned of the potential for serious adverse effects. Who will be the winners and losers? Answers on a fag paper.
Referencing your paper, Susanne ..
Depression: What About Ketamine?
Ketamine for depression encouraging, but questions remain around long-term use
University of New South Wales
A world-first systematic review into the safety of ketamine as a treatment for depression, published in the prestigious Lancet Psychiatry, shows the risks of long-term ketamine treatment remain unclear.
Led by researchers from UNSW Sydney and Black Dog Institute, the review examined all prior published studies of ketamine treatment for depression, and finds few existing studies effectively report the safety of repeated doses or sustained use.
Ketamine research leader UNSW Professor Colleen Loo, who is based at the Black Dog Institute, said these major gaps in the literature must be addressed before ketamine is widely adopted as a clinical treatment for depression.
Just for interest’s sake –
Sir John Bell has been a non executive director of ROCHE since 2001. ROCHE marketed RoAccutane-isotretinoin.
Today we mark and remember the death of another youngster who died from the effects of their drug in 2010. This fine young man, who helped people with autism and has had a Centre named for him in his memory where he worked, died in 2010 aged only 19. His dermatologist firmly assured his mother when questioned, that he had never ever known any problems with this drug, that it was perfectly safe.
I’ve often wondered about writing to Sir John Bell to ask him how he feels about all these deaths, almost one a month by the MHRA’s reckoning (pretty conservative figures anyway, in our opinion). He’s a genetisist. It will be ‘interesting’ (perhaps not the most well chosen word) to see in the next generation how the genetics will have been affected by ROCHE’s drug. If, as we suspect, the damage IS passed down genetically, and eventually shown to have done so, one wonders how Sir John Bell will stand on that? He can surely, as a non exec director of ROCHE with all his scientific knowledge and background, be unaware of these ghastly possibilities?
– as Study 329 makes clear.
“Given the potential for life-threatening events in young children and adolescents, understanding the extent to which these medications pose a genuine risk to youth is urgent.
This need would allow future research to deviate from the current line of studies estimating the magnitude and differences between drug and placebo effects and focus more on precision medicine-driven questions, such as which treatment or combination thereof may be most advantageous for certain patient subgroups in certain clinical settings.”
Question Is there a scientific justification to prescribe selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors for children and adolescents, based on what is known about their efficacy and safety?
Our study has some limitations. First, none of the randomized clinical trials included directly compared effectiveness across disorders. Accordingly, we could only make indirect conclusions with regard to disorder specificity. Second, although our meta-analysis included unpublished trials, reporting bias could lead to an overly positive representation of findings in the literature.82
In this regard, many concerns have been raised about the accuracy of the data of 1 study in particular: Paxil Study 329. A reanalysis of the original data found that paroxetine did not show efficacy for MDD in adolescents and that the initial study underplayed the drug’s potential to increase suicidal thoughts among adolescents.
Keller MB, Ryan ND, Strober M, et al. Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry. 2001;40(7):762-772.PubMedArticle
Paroxetine is generally well tolerated and effective for major depression in adolescents.
GlaxoSmithKline Clinical Study Register. Study ID: 112487; clinical study ID: PIR112487. A randomised, double-blind, placebo controlled, parallel group, flexible dose study to evaluate the efficacy and safety of Paxil tablets in children and adolescents with major depressive disorder; post-marketing clinical study. https://www.gsk-clinicalstudyregister.com/study/112487#rs. Updated August 29, 2013. Accessed August 21, 2016.
Le Noury J, Nardo JM, Healy D, et al. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ. 2015;351:h4320.PubMedArticle
a bespoke novel ranking ..
GlaxoSmithKline Japan Selects SciBite Semantic Platform to Enhance Pharmacovigilance Capabilities
To kick-start the project, the team created a custom-built thesaurus of GSK drug terms (or VOCab). Additionally, the pharmaceutical giant made use of SciBite’s TERMite Expressions (TExpress) module to search for phrases within texts suggestive of pharmacovigilance events.
“SciBite is absolutely committed to our Japanese clients and is extremely pleased to welcome GSK Japan to our international group of customers,” said Rob Greenwood, Chief Executive Officer, SciBite. “Our highly flexible technologies are proven by life science companies the world over to offer new, innovative opportunities to change the way they achieve their pharmacovigilance activities. We look forward to seeing how GSK Japan combine our market-leading technology and their internal human-centric expertise to evolve their pharmacovigilance capabilities.”
Why are prescriptions of antidepressants at an all-time high?
Prescriptions of antidepressants are at an all-time high, with almost eight million being issued a year in London alone. Are we over-medicating? And why is demand so great? Hannah Betts, who has been on them for seven years, investigates…
Professor Carmine Pariante of King’s College, London, tells me: ‘The action of antidepressants is more complex than that and involves stimulating the birth of new brain cells and regulating stress hormones.’
Professor Wendy Burn, president of the Royal College of Psychiatrists, says ‘the pills do work… The effect can be instant, although we say two weeks to see an improvement, six weeks for full benefits.’ and ‘despite the hysterical headlines I’ve never seen anyone become either a zombie or a killer.’
SSRI critic Dr David Healy maintains: ‘Children’s mental health services have become a horror story with youngsters even more likely than adults to end up with a plethora of gateway diagnoses leading to shocking cocktails of treatment.’
Robert Whittaker, ‘The day will come when we look back and think: “What in God’s name were we thinking?’
“Hysteria ensued. One paper produced the headline, ‘A dribbling, suicidal mess — until I kicked the kill pills’, to coincide with a BBC Panorama episode entitled ‘A Prescription for Murder?’ The programme asked: ‘Is it possible that a pill prescribed by your doctor can turn you into a killer?’ (Answer: probably not, given that the reaction it was describing afflicts a ‘tiny minority’, if any.)”
It is apparent that one who hasn’t seen it does not mean that it doesn’t happen and this is the problem with those who haven’t seen it .. and truly it becomes a closed mind with extremely dangerous consequences for the increasing numbers who lived it and died by it ..
“The effect can be instant” ..
The Tragic Consequences of Prescription Pills
…financially hobbled ..
GlaxoSmithKline Is Wasting Money Paying a Dividend
It’s rarely a good idea to spend money you don’t have.
Sep 1, 2017 at 6:02AM
Glaxo should pay down its debt.
………………………………………………………..And its legal bill…………………………………………….
On abuse of a dominant position
GSK agreed to plead guilty to a three-count criminal information, including two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and one count of failing to report safety data
“Today’s multi-billion dollar settlement is unprecedented in both size and scope. It underscores the Administration’s firm commitment to protecting the American people and holding accountable those who commit health care fraud,” said James M. Cole, Deputy Attorney General. “At every level, we are determined to stop practices that jeopardize patients’ health, harm taxpayers, and violate the public trust – and this historic action is a clear warning to any company that chooses to break the law.”
$488 million in China
$1 billion of Paxil-related case settlements that have not involved birth defects.
That will do for now…$3m for Wendy seems like chicken feed in the great scheme of things and it might be years before she gets it so I hope she gets it with interest ..
In any court case the patient is on trial and even felonies, it seems, does not count against those who make crime pay .. they carry on doing what they’ve always done and is it possible to find a way round it…?
I doubt in a million years GSK will offer 105 UK Seroxat claimants a settlement and admit liability for Seroxat – why would they?
Where is the Data giving the edge to either side?
There are a number of withdrawal services running including one at Camden Mind run by a person who had experience of withdrawal herself. It sounds semi official which may or may not be a good thing. But there must be a lot of data held by different groups by now – if this was pooled it would be possible to identify which drugs are the main problem and even if certain areas or clinics are over-diagnosing. A drawback being withdrawal services are not widespread or even known about by individuals so data would be limited – it is simply not possible to rely on GPs help when they are doing the bulk of prescribing. Does the NHS have any obligation to collect such data?
Would have thought that it was in the NHS’s interest TO collect such data to cut down on money wasting – but I bet no-one sees it as being ‘in their interest’ nor ‘an obligation’. ‘Saving’ seems to be a forgotten word – both in view of money and patients.
Thanks Mary – I tried contacting the UN/UK Commission on Rights of People with Disabilities and the Equality advisory group to ask they pay some attention to the issues….surprise! returned unanswered. To get a response at all these orgs use web forms which are simply a waste of time. They have just held another ‘jolly’, sorry ,conference , enjoyed by selected attendees but it was worth trying . So instead have contacted email@example.com to ask if they would consider doing some research. There are withdrawal services with as you say important stats but the NHS is so convoluted who knows if any of it is recorded. Any medics out there know? Probably be too revealing to be ignored, so close eyes it’s not really happening or what can ‘they’ who suffer from mal treatment do about the massive denial machinery at the disposal of pharms and medics.
“With the right data and the right technology, you can turn any problem into a data problem.”
ICAPTS 2019: 21st International Conference on Antidepressant Prescribing, Trends and Statistics
May 18 – 19, 2019
The ICAPTS 2019: 21st International Conference on Antidepressant Prescribing, Trends and Statistics aims to bring together leading academic scientists, researchers and research scholars to exchange and share their experiences and research results on all aspects of Antidepressant Prescribing, Trends and Statistics. It also provides a premier interdisciplinary platform for researchers, practitioners and educators to present and discuss the most recent innovations, trends, and concerns as well as practical challenges encountered and solutions adopted in the fields of Antidepressant Prescribing, Trends and Statistics.
This sounds like no small beer …
The quantity of paroxetine prescribed decreased by approximately 0.78 per cent a year.
EXASOL analyzed 774 million rows of data released by the Government’s NHS Digital and sourced from the NHS Business Services Authority2. The data captures every GP prescription dispensed at all pharmacies across England in the past six years. The data was analyzed by data scientists at EXASOL, using the world’s fastest in-memory analytic database.
Sean Jackson, chief marketing officer (CMO), EXASOL says: “When analyzing the data, we can see that the prescribing of antidepressants has increased by a large amount in recent years. However, this is only one part of the story: when we delve deeper, we find that the data can uncover further information such as geographic differences across the country.
“With the right data and the right technology, you can turn any problem into a data problem. People suffering from mental health problems need support and respect, these insights can direct help to the right places and it highlights where more resources are necessary. By uncovering insights using big data, it shows the factual reality of the problem. However, to be able to analyze such enormous data-sets requires the right tool for the job. We hope the findings will help to raise awareness of this important issue.”
Thanks very much for the great research you carry out . Looking through the links you provide it looks extremely promising? Should rightful cynicism be suspended until the conference has been held? – see what it comes up with and hopefully more from UK will be attending including GPs who do the bulk of prescribing. The conference though is three years in the future by the time anything comes of it that’s probably more like 5 years at least. In more useful detail it does describe what the Yellow Card was showing – massive more prescriptions in deprived areas. That is known already and prescribing drugs is not solving the problem of appalling inequality between quality of life and provision of services. My post probably seem quite naïve but am learning a lot from the blogs –
Bob’s ‘Data’ ..
Bob Fiddaman: Taking on the Pharmaceutical Regulators and the Seroxat Scandal
September 2, 2017
“All these factors have seen a welcome increase in prescribing treatments for this illness not only in the UK but worldwide.”
The Evidence, however, is clear .. .. .. the Seroxat scandal ..
our blood stained scarlet
Kristina Kaiser Gehrki September 3, 2017 at 9:43 am
Thank you for this outstanding podcast series: Sharing personal experiences and accurate data helps inform, inspire and build collaborative communities of global citizens dedicated to others’ well-being.
Akathisia is a serious ADR causing much suffering and death. It is buried under the rug by regulators, Pharma, doctors, and “mental health” organizations because if drug consumers knew more about akathisia, they would be less likely to consume. This systemic concealment led to the burial of my child who was destroyed by akathisia and unnecessary prescribing. Since Natalie’s death, I’ve been fortunate to meet dedicated people who productively advocate for drug safety and transparency. Bob is one of these tireless activists and undoubtedly a “rock star” in my book.
“Mental health” and “suicide prevention” organizations with strong pharma ties don’t want akathisia awareness. They’d prefer to see mothers of dead children buried in grief and shame, hanging our heads on the sidelines wearing a scarlet A for Anonymous. But blogs like Fiddaman’s empower parents to publicly share our blood-stained scarlet A for Akathisia.
My teen’s prescribed demise is at:
Akathisa the most serious, common and destructive side effect there is. Along side Increased energy, blunted emotions and detachment is a recipes for disaster.
My brain has been so destroyed by antidepressants it took me ten minutes to find out how to spell recipe.
If anyone who reads my post thinks I’m thick well I can honestly say “Yes thanks to SSRIS I am now”. I apologise for any spelling mistakes I make but my brain is not the same anymore. I can only cope with simple words. If they get to intelligent my brain is in melt down trying to figure out how to spell it and what it means.
I was not this bad before SSRIS although I wasn’t a rocket scientist either.
it doesn’t take 93 years ..
If you improve as a result of lowering the dose or stopping altogether, ‘that’s a pretty good clue the drug is linked to the problem,’ says Dr Healy.
GlaxoSmithKline sets up first team for acquisitions in 93 years
As govt increasing price control over branded generic medicines has affected its profitability
Abhineet Kumar & Aneesh Phadnis | Mumbai Last Updated at September 4, 2017 02:07 IST
…more or less sorted…with the support of a cash-rich parent ..
Someone from …
In this week’s solo talk on IAI Player, we’re joined by outspoken psychiatrist David Healy as he examines the risks of indiscriminate drug use and marketing by the pharmaceutical industry.
Adverse effects of widely-prescribed drugs are often overlooked because there is so little truly independent academic evidence, while pharmaceutical companies wield an unprecedented amount of power through marketing and ghostwriting scientific literature. Could widespread integration of big data and data capturing-technologies provide the evidence to free us from the yoke of big pharma companies?
In Doctors and the Danger Industry, Healy reveals the market forces that threaten our health.
Can big data prove the effectiveness of drugs?
For the first time in a century, today’s treatments may be less effective than before.
Sign in required otherwise you get stopped short after 20 mins ..
“Big Risk is what you need to worry about – not just big pharma”
September 7, 2017
expert reaction to study looking at antidepressant use in pregnancy and psychiatric disorders in children
Science Media Centre
Prof. Carmine Pariante, Professor of Biological Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, said:
“This is an important paper, but it remains virtually impossible to fully disentangle the effects of antidepressants from the effects of the underlying mental disorders for which the drugs are prescribed.
“Many studies have found that untreated depression in pregnancy increases the risk of mothers drinking alcohol and smoking during pregnancy, seeking less antenatal care, and developing postnatal depression, as well as the risk of their offspring being exposed to a harsh childhood and developing mental disorders in adulthood. Based on this, the risk of discontinuing antidepressants in pregnancy, for mothers with moderate to severe depression, continues to outweigh the potential risk (if any) uniquely associated with antidepressants.
“Clinical guidelines already recommend a high threshold for prescribing antidepressants in pregnancy and the importance of an individualised discussion with mothers, and the authors rightly acknowledge that this paper does not change these recommendations.”
Prof. Carmine Pariante: “I have received research funding from pharmaceutical companies developing novel antidepressants, but not for research related to the perinatal period.”
Antidepressant use during pregnancy and psychiatric disorders in offspring: Danish nationwide register based cohort study by Xiaoqin Liu et al.
Published: September 7 2017
The Cochrane Centre is one reliable source of data analysis. Prof Peter Gotzshe of Nordic Cochrane Centre has published a response 4th Sept to a previous rr providing data which in any scientific community should not be ignored – in TheBMJ ‘Anti depressants and Murder – Case not Closed’ by Gwen Adshead member of Coll of Psychs Ethics Cttee. Gwen was practicing at Broadmoor some years ago – there is a high risk of violence and suicide in such institutions – it would be useful to know what drugs were being given, often compulsorily ,to people then? There is no useful data included in the piece. That post was a response to ‘Antidepressants Increase Risk of Suicide and Violent Homicide at All Ages’. The Cochrane Centre is open access and has a free newsletter – as all publications should be when data provided by citizens is involved.
September 8, 2017
hacking the immune system, bioelectronics and the mind-body interface
Science Media Centre
Prof Sir Robert Lechler FMedSci, President of The Academy of Medical Sciences and Vice-
Principal (Health) and Executive Director of King’s Health Partners Academic Health Sciences Centre
Prof. Kevin Tracey, President and CEO, The US Feinstein Institute for Medical Research
Prof. Ed Bullmore FMedSci, Vice-President Immunopsychiatry, GlaxoSmithKline and Head of the Department of Psychiatry, University of Cambridge
‘The Notorious Past and Bright Future of Psychiatry’
“Thankfully, we are well past that. We now have scientifically developed and proven efficacious treatments that are safe and are changing and, in many cases, saving lives”
‘information that I will pass on to the many people who write to me every month cataloging the truly dreadful experiences and outcomes that they have had at the hands of psychiatry. I’m sure that they will be comforted ..
Wheels within wheels ..
Hits ‘go’ ..
GlaxoSmithKline hits ‘go’ on Adaptimmune’s SPEAR T-cell program
Axel Hoos, SVP of Oncology R&D at GSK, added: “The aim of GSK’s R&D is to develop medicines with transformational potential for patients.
In this regard, there may be a snag. The drug is being studied alongside Merck’s Keytruda (pembrolizumab), an anti-PD-1 inhibitor, but a safety scare and deaths from a recent trial of the marketed medication has halted its studies, along with a series of PD-1 and PD-L1 combo trials, in the multiple myeloma setting.
“It seems a specific issue, and we’re something completely different.”
You can say that again…and we’re something completely different ..
“The only thing different this time was that he had started Paxil.”
“Antidepressants prevent more suicides than they cause, probably by a large multiple,” said Dr. Peter Kramer, a psychiatrist and clinical professor emeritus at Brown University and the author of several books about antidepressants, including “Listening to Prozac.”
Dr. Kramer, who was not involved in the Dolin litigation, said he urges patients to contact him right away if they have a bad reaction during the first weeks after starting treatment with the drugs — and especially in the first five days.
“When I put people on medication for the first time, I say we’re going to be very cautious in the early going,” he said.
In the early going…in his book, Peter Kramer would have single handedly saved Stewart Dolin’s life .. ironic his book is called Ordinarily Well ..
The Lancet weighs in: review of Ordinarily Well by Stephen Ginn (@psychiatrist): “a paean to clinical pragmatism, as opposed to evidence-based absolutism … persuasive … often fascinating … convincing”
“If that is the process by which antidepressants work, it does patients an enormous disservice to avoid discussing it entirely, which this book does.
A Fitting End for Wendy and Team ..
No New Trial for GSK and Paxil Death of Stewart Dolin
No New Trial For GSK In Suit Over Reed Smith Atty’s Suicide
Law360, Los Angeles (September 14, 2017, 9:30 PM EDT) — GlaxoSmithKline can’t have a new trial after losing a $3 million case over the suicide of a Reed Smith LLP attorney, an Illinois federal judge ruled Thursday, concluding among other things that an expert on stress at international law firms wouldn’t have changed the outcome.
A jury in April awarded Wendy Dolin $3 million in her suit claiming her husband Stewart committed suicide after taking the generic version of GSK’s antidepressant Paxil and that the drug company had failed to disclose the risk. GSK sought a new trial, arguing the verdict wasn’t borne out by the evidence the jury had seen, court records show.
For example, GSK had argued its case was undermined when the court excluded testimony by an expert on the nature of international law firms, but U.S. District Judge William T. Hart disagreed, saying information about the stressful nature of the work had been discussed in the case.
“The jury would not have been helped by hearing an expert on law firm structure, procedures and stressors,” Judge Hart wrote. “The topics were extensively covered by several law firm witnesses.”
Judge Hart also found that the jury was allowed, for example, to favor Stewart Dolin’s doctor Martin Sachman’s testimony despite “vigorous cross-examination” by GSK’s attorneys at trial.
“The jury was entitled to accept Dr. Sachman’s testimony that he relied on the statement that the risk of adult suicide did not extend beyond the age of 24 when he prescribed paroxetine for Mr. Dolin,” the judge wrote.
Dolin sued GSK in 2012, two years after her husband stepped in front of a train in downtown Chicago. Stewart Dolin had struggled with anxiety and depression off and on, and had begun taking generic Paxil just a few days earlier.
Her case had been unique in that she sought to hold the brand-name drugmaker accountable for labeling even though her husband had been taking a generic counterpart.
After the judge ruled that GSK is liable for the labeling on the generic versions of its drugs, Dolin argued the company had failed to alert the U.S. Food and Drug Administration to data that showed an increased risk of suicide in adults who take Paxil. The suit said the potential for suicide in adults was mostly left off the drug’s label, leaving doctors uninformed.
A jury agreed with Dolin, awarding her $2 million for Stewart’s wrongful death and $1 million for the pain he suffered in the days before he took his own life.
In its bid for a new trial in May, GSK said that, from Sachman’s testimony, it was clear he was aware of the risks that accompanied Paxil’s active ingredient, paroxetine.
But regardless of the strength of Dolin’s evidence, Judge Hart repeatedly blocked GSK from answering her allegations over the course of the five-week trial, the company said.
The judge’s rulings “gave plaintiff free rein to violate basic rules of trial, while precluding GSK from responding and unreasonably restricting the presentation of its case,” GSK said.
Wendy Dolin pushed back in July, saying the company’s arguments for a do-over ignore evidence that does not fit its narrative.
Representatives for the parties didn’t immediately respond to requests for comment on Thursday.
Baum Hedland Aristei Goldman PC
in his ruling, Judge Hart noted:
“The testimony of all of the medical experts who testified reveals that it is recognized in the medical community that some patients treated with SSRIs may be more likely to attempt or commit suicide. An SSRI may activate patients with suicidal ideations or induce symptoms of emotional volatility leading them to attempt or commit suicide in order to escape intolerable feelings.” Order, p. 6.
Judge Refuses GlaxoSmithKline Motion for New Paxil Suicide Trial
Judge Hart: $3 Million Verdict Against GSK Stands
Judge William T. Hart rejected all of GSK’s arguments for a new Paxil suicide trial.
“There is … no basis to set aside a jury’s finding that Mr. Dolin’s death was caused by the ingestion of paroxetine.” Order, p. 17.
Hot ‘Chocolate’ ..
‘Dolin Wins Again’ …..
Glaxo loses bid for a new trial in an unusual Paxil suicide case
By Ed Silverman @Pharmalot
September 18, 2017
In a setback for GlaxoSmithKline (GSK1), a federal judge upheld a $3 million verdict in a closely watched trial that involved a highly contentious issue — whether consumers can successfully sue a brand-name drug maker if they suffered harm after taking a pill made by a generic rival.The verdict was issued last spring in a lawsuit that was brought by Wendy Dolin, the widow of an attorney who committed suicide after taking a generic version of Glaxo’s Paxil antidepressant. The federal court jury decided the drug maker failed to properly warn about the risk of its medicine.
On Monday, a Glaxo spokeswoman wrote us that the company plans to appeal the decision.
Ex-GSK CEO, R&D chief Andrew Witty and Moncef Slaoui are jumping into the biotech VC game
by John Carroll — on September 19, 2017 06:05 AM EDT
“Andrew Witty we believe brings the highest level of understanding about the pharma industry as a whole,” Hatteras General Partner Bob Ingram tells me, counting off Witty’s leading roles in the global commercial as well as R&D side of the business.
Witty is landing in a group where he already feels quite comfortable.
Endpoints News ..
Never one to rest on his laurels ..
Former Glaxo boss Sir Andrew Witty takes on his second role in as many days
This is money ..
Data Based Medicine @RxISK 3h3 hours ago
Data Based Medicine Retweeted Law360
GSK aims to reverse its defeat in #Paxil suicide case–and preserve a wicked legal Catch-22 for victims of generic drug harm. To learn more: @MISSDFoundation
Law360, Springfield (September 27, 2017, 3:57 PM EDT) — Drugmaker GlaxoSmithKline said Wednesday it will appeal an Illinois federal judge’s decision denying the pharmaceutical company a new trial as it continues to fight a jury’s award of $3 million to the widow of a Reed Smith LLP attorney who committed suicide while on a generic version of the company’s antidepressant Paxil.
GSK is also asking for a stay of the judgment, and notified the court that it posted a “supersedeas bond,” also known as an defendant’s appeal bond, for $3,037,400 in order to delay payment of the $3 million judgment awarded to Wendy Dolin in April. Dolin is the widow of former Reed Smith LLP partner Stewart Dolin, who ended his life by jumping in front of a train in downtown Chicago in 2010, six days after beginning to take paroxetine, the generic name for GSK’s Paxil.
“We are excited to get the brand name immunity issue — that is, GSK’s claim that it cannot be held liable for injuries caused by a drug label that it had exclusive control over — briefed and argued before the Seventh Circuit. We are confident that the Court of Appeals will see the wisdom in both Judge Zagel’s and Hart’s well-reasoned opinions,” Wisner said. “Mrs. Dolin is proud to have her case leading this important legal issue, one that affects over 80 percent of all prescriptions.”
The never-ending saga between the multi-billion dollar pharmaceutical corporation, GlaxoSmithKline, and grieving Chicago widow, Wendy Dolin, has taken yet another twist, one that was anticipated yet it shines a deplorable light on Glaxo and their hired attorneys from Atlanta, King & Spalding.
Judge tosses U.S. lawsuit against GSK from private eyes imprisoned in China
by Carly Helfand |
Oct 3, 2017 8:45am
GlaxoSmithKline has worked hard to put 2013’s China bribery scandal behind it. And a U.S. judge just gave it an assist in that department.
U.S. District Judge Nitza Quiñones Alejandro in Philadelphia tossed out a lawsuit from a husband-and-wife team of former private eyes, Reuters reports. Peter Humphrey, of the U.K., and Yu Yingzeng, of the U.S., claimed the British pharma giant had misled them into probing a whistleblower in China, an investigation that led to their arrest.
The reason Judge Quinones Alejandro threw out the case? Humphrey and Yingzeng sued over injuries that occurred entirely outside the U.S., meaning they “lack standing” to assert civil claims under the federal Racketeer Influenced and Corrupt Organizations Act (RICO), Judge Quinones Alejandro wrote.
GSK, for its part, is “pleased that the Court agreed with our view that this case should be dismissed,” a spokeswoman said in an emailed statement.
RELATED: Private eyes imprisoned in China sue GSK for bribery-scandal damages
The suit came years after Humphrey and Yingzeng were first implicated in the GSK scandal, which sparked marketing reforms across the company and chilled Chinese sales for many multinational drugmakers. In the suit, they said Glaxo had hired them to gather information on Vivian Shi, then the drugmaker’s government relations head in China; GSK believed she was the source of the bribery allegations. But the pair of sleuths also said they were hired with the understanding that the bribery allegations were false.
Instead, they wound up with an assignment to pinpoint the source of a clandestine sex tape involving former GSK China head Mark Reilly, which executives received alongside a whistleblower’s corruption allegations. And they claimed in the suit that GSK had hired them to create a “dossier” on Shi to “frame her as a vindictive former employee.” Ultimately, they were arrested in 2013 for illegally obtaining and selling personal information about Chinese citizens, and through the lawsuit they sought to collect damages for the lost business and physical and emotional stress their prison sentence brought.
RELATED: GSK hands SEC $20M to put China bribery charges to rest
Glaxo, meanwhile, is hoping the saga won’t rear its ugly head again. Last fall, the company agreed to pay $20 million to wrap up SEC charges that it violated the Foreign Corrupt Practices Act by using travel agencies to funnel $489 million in bribes to local doctors and healthcare professionals.
US Supreme Court Refuses to Restrict Personal Jurisdiction in Landmark Paxil Case
Today, the U.S. Supreme Court allowed to stand an appellate court decision stating that a product manufacturer is subject to personal jurisdiction for product-related claims in a state where development or testing occurred, dealing a huge blow to the well-funded big pharma legal teams who may well now find themselves defending their drugs and medical devices in all fifty states.
Today, the U.S. Supreme Court chose to let that case stand by denying the defendant’s petition for a writ of certiorari, which is a written request for the U.S. Supreme Court to review a lower court’s ruling. The denial of a petition for a writ of certiorari by the U.S. Supreme Court means the decision of the lower court stands as the final decision.