Editorial Note: This is part three in a sequence of posts that began with Outsourcing Fascism and continued last week with Not Our Nomination.
Our Nomination
The RxISK nomination for the SAS JM Prize is Lisa Rosenbaum from the Brigham and Women’s hospital in Boston. Dr Rosenbaum has courageously stood up for the mainstream of science on a range of fronts including moral outrage about conflict of interest or excessive medical care – she’s been against those who are against conflict of interest or massive medical inputs. She has as a result had to put up with the snide remarks that all worthy SAS JM Prize winners have had to contend with.
Research Parasite
Rosenbaum came onto many radars in 2015 when she had a series of articles in the New England Journal of Medicine about conflict of interest. She figured everybody had gone mad – the best of the brightest clinicians and scientists will have links to industry and if we get too worked up about this we will simply be shooting ourselves in the foot. Grow up in other words.
Some wondered if this was a joke.
It wasn’t. Her first article was one of three, with a supporting editorial from Jeff Drazen, the NEJM editor who made clear he fully supported her point of view.
In his covering editorial, Drazen trotted out Selman Waksman, whom he said was the discoverer of streptomycin, and who to “realise” his discovery had approached Merck to help produce it. Waksman had in short order been given the Nobel Prize for this work. The BMJ published a famous streptomycin RCT and invited Waksman to write an article about the breakthrough treatment – something Drazen said they would not be able to do today because of his links to Merck.
[One reason why Waksman was picked for this illustration might be because there is an ongoing war between BMJ and NEJM who regard BMJ as holier than thou].
There are multiple ironies to this account. One is that Waksman was not the discoverer of streptomycin. It was Albert Schatz. Waksman spent his life writing Schatz and everyone else who had anything to do with streptomycin out of the script. That said there were grounds to award a Nobel Prize to both Schatz and Waksman although the drug turned out to be much less effective than initially hoped.
The BMJ RCT about streptomycin was similar to streptomycin – not up to much – it added nothing to our knowledge of streptomycin other than what had already been established in clinical practice.
As regards Waksman’s links to Merck, this was not an innocent link to a company willing to mass produce a drug that might save lives but rather was an exercise aimed at taking out a product patent on a compound naturally available in soil. In the course of the patent application, Waksman lied. The granting of a first patent for a product rather than a process, as had been the norm prior to streptomycin, may have done more than anything else to encourage pharma to hype the benefits of their products and hide their harms ever since.
Drazen’s choice of Waksman seems therefore nicely symbolic, and much more a Freudian slip than deliberate. That said, one can take his point that Waksman had sufficient background to warrant being asked to write an article for a leading journal. But his idea that such a man wouldn’t get asked to write a comparable article today is nuts. The only circumstances that I can imagine in which a Waksman would be debarred today is if they decided to include material about the harms of the product – something they would have been encouraged to do in the 1950s.
The irony comes with Drazen using Waksman to frame the conflict of interest articles he commissioned Rosenbaum to write. Its difficult to imagine any other journal of significance asking her to write anything in that there doesn’t appear to be anything in her background of any substance or interest that would warrant such an invitation.
One option is that like the BMJ, the NEJM see their future in journalism rather than science. It is easier to manage legal and other risks it would seem when staff or semi-staff writers do the writing than in the case of articles from researchers whose contents cannot be risk managed in the same way.
The reaction of many researchers reading Rosenbaum’s articles is likely to have been – is this a black joke? We spend decades working on real problems in the hope of an article in the NEJM which could make our careers, which we’d frame and put on the wall. Here is a nobody getting three articles – none of which say anything – and many more since.
A short while later, just after the publication of Study 329, Drazen labelled some of us who figured access to clinical trial data was important as research parasites.
This was consistent with a stance the NEJM had taken over a decade before anyone had heard of Fake News, which was that they had no interest in the integrity of the data. You’re claiming companies run trials in Russia and the patients don’t exist – we ain’t checking.
Its one thing to say conflict of interest has been overdone – as I have – but then to say its wrong to insist scientists should keep to the norms of science that do not permit claims to be made in the absence of data opens the way to a dictatorship.
It also seems odds to label people who are at least working with the data as research parasites and not to do so for people who are offering views outside their area of competence.
Morcel from the Rich Man’s Table
The following year, Rosenbaum had another feature in NEJM on N of 1 Policymaking, in which she decried the demise of morcellation.
A Power Morcellator is a tool introduced into the body to shred tissue, such as a uterus, with the bits then being extracted by suction. It became popular in the last decade. The downside was that if the organ being shredded contained cancer cells, morcellation risked spreading these.
One unfortunate case, in which a woman named Amy Reed, had her uterus removed in this way, only to find soon afterwards that it contained a cancer and she now had a stage 4 leiomyosarcoma, close to ended morcellation as a technique. Unfortunately for the companies making morcellators and for the morcellating surgeons, Amy Reed was a doctor as was her husband, Hooman Noorchashm. They sued the hospital where she was treated and did an extraordinary amount to raise the visibility of the risks of the procedure.
This was the N of 1 case that Rosenbaum was complaining about. This hard luck case had driven policy, she claimed.
Her article ended up being much discussed. The issue discussed was had she managed to inappropriately access Dr Reed’s medical file. She had certainly misrepresented Dr Reid’s original problem.
What was less discussed was that Rosenbaum works for Brigham and Women’s, the hospital that Reid and Noorchashm were suing. It was very odd that the NEJM should offer Rosenbaum and Brigham a platform like this.
More or Less
Ever one to take on issues that might make her unpopular, Dr Rosenbaum has most recently taken on the Slow Medicine, Less is More, Right Care movement.
Whatever one’s differences might be with the general thrust behind these approaches, Dr Rosenbaum doesn’t get to grips with the sense that healthcare is in crisis that has motivated a wide range of people to grapple with the issues and try to both improve care and control costs.
Her default seems to be that healthcare is just fine thank-you. If doctors order all kinds of tests rather than make judgment calls this is probably for the best. This is all wrapped up in an “I used to believe Less is More until I grew up” bouquet.
There has predictably been a number of scathing comments – all of which increase Dr Rosenbaum’s chances of carrying off the SAS JM Prize this year or next.
What’s going on? Well one possibility may be that Dr Rosenbaum somewhere in her career, perhaps around the time she was transitioning from LM to ML took or at some party had PharmArmorin slipped into her drink. This was a drug made and marketed by Pfizer in 2006 that caused the taker to think the pharmaceutical industry were the saviours of the universe. But it was withdrawn extraordinarily quickly and so comprehensively that Google Imaging it throws up nothing.
We hope you will tweet this image and the link above so that we can restore the PharmArmorin star to its rightful place in the firmament.
NEYM
So why would PharmArmorin have been whipped off the shelves so rapidly when all the data suggested it would have made all doctors as right thinking as Dr Rosenbaum now is?
While all this has been happening Neymar moved from Barcelona to Paris St Germain (PSG) for a world record fee – $250 million – Euro 225 million. No one needs to know who Neymar is other than he’s a pretty boy who plays football (soccer). His arrival in Paris seems to have killed French football. PSG are owned by the Qataris and are now, along with most major football clubs, a marketing vehicle. So much money has been pumped into PSG that most of their league matches are now exhibition matches rather than the real thing. The tension is gone. The result foregone (there may be bribery as much as skill involved in this). Paradoxically it may wreck Neymar as a footballer as there is nothing left to help push him and others to step up a level – see Here .
Looking at the evolution of both NEJM and BMJ, the squabbling sibs, you’d have to wonder if something similar is happening. They are becoming celebrity journals, with celebrity writers and celebrity managers but a lot has been lost. If keeping people safe is one of the criteria for a medical journal then neither fit the bill anymore – other than tokenistically.
In the midst of this, Celebrity Prizes like the SAS JM Prize, offered because someone has been in a twitterstorm or features in the media, rather than because someone has made an actual contribution to medical knowledge or patient care, makes all the sense in the world. The more froth the better.
We’re perverse. Froth sells things more than plastic perfection. What better than to sit down to a squabble over the merits of flat whites, lattes or cappuccinos – after that we can sort out the serious business of who should get the 2018 SAS JM Prize, now that JC has put himself out of the running.
Johanna says
You may have missed it – if so, lucky you! – but Dr. Lisa Rosenbaum has done a star turn as a psychiatry expert, too. Last year she wrote a series for the New England Journal of Medicine to explain why treatment for the “seriously mentally ill” is so lousy in the USA, and their life expectancy is so poor. American society, you see, is way, way too hung up on freedom. Worse yet, we love a pat, feel-good narrative, so we’re currently infatuated with the “recovery” movement.
And so, allegedly, science-based efforts to actually help (i.e. medicate) people with mental illness are hamstrung by all sorts of do-gooder liberals who insist on “freedom of choice” for poor wretches who cannot make a meaningful choice about anything. What a tragedy, huh? Condemned to disability and death by too much freedom!
http://www.nejm.org/doi/full/10.1056/NEJMms1610124 “Liberty vs. Need”
http://www.nejm.org/doi/full/10.1056/NEJMms1610125 “Closing the Mortality Gap”
If only it were half true. In fact, coercive forced-treatment schemes are on the rise, to the extent that several states allow even alcohol and drug addicts to be “treated” against their will. And ideas like Rosenberg’s, far from being iconoclastic, are the received conventional wisdom in psychiatry.
It’s a quintessentially American tactic. No matter how powerful you are, position yourself as the gutsy underdog. And paint those who rebel against you, no matter how small and powerless, as some sort of crushing tidal wave of fashionable public opinion. Poor billionaires. Poor white male Harvard graduates, despised by everyone. Poor America, bullied and dissed by all these s—thole countries. Above all: poor doctors, scorned as greedy drug-company shills by an ignorant public.
Dr. Lisa does mutter a few words of concern about the current crop of antipsychotic medicines. While “highly effective,” she says, they may have some tendency to cause “obesity and diabetes” and thus may “increase the cardiovascular burden.” But that’s about it. They’re a risk factor, maybe, but only in the sense that Dunkin’ Donuts are a risk factor. What’s really dangerous is all this naive well-meaning political correctness, standing between the Patient and the Cure.
The fact that the drugs are not a cure—they do not vanquish psychosis like Prilosec vanquishes stomach acid—gets lost here. Not to mention the depressing outcomes for those who take them long-term. Even in the current pro-drug and pro-coercion climate, it would be hard for a psychiatrist to write stuff like this in a major journal. You’d have to present at least a modicum of evidence.
That’s the magic of a Lisa Rosenbaum article. It’s published by a real M.D. and bears the seal of America’s most respected medical journal—yet it can be less fact-based than a column in USA Today or the Huffington Post. Best of both worlds.
annie says
Guardian of the establishment’s corruptions.
Hooman Noorchashm @noorchashm 7h7 hours ago
Replying to @LisaRosenbaum17
.@jenniferlevitz .@TheCancerLetter .@NEJM You don’t seem to have that problem from your NEJM bully pulpit Lisa. Sad and Pathetic! Not a physician! Guardian of the establishment’s corruptions. https://davidhealy.org/celebrity-science/
https://davidhealy.org/celebrity-science/
Tweets are my own
https://twitter.com/LisaRosenbaum17/status/955476017593962496
Lisa Rosenbaum @LisaRosenbaum17 10h10 hours ago
That uncertainty is often viewed as weakness seems like a major problem for the culture of medicine, but also so hard to change. Has anyone worked in medical environments where it’s more acceptable to be uncertain?
Dropped in the lap from – Hooman ..
http://cepuk.org/2018/01/22/appg-camdenccg/
Caroline Montagu 22/01/2018 at 4:59 pm #
Withdrawal from prescribed medicines such as benzodiazepines and ssris is often frightening and painful for the person and it is also frightening for the family. A centre such as REST takes some of the fear away and coincidentally helps the family. Keep it open. It is very valuable.
mary H. says
Yes, withdrawal from ANY medication is probably far from easy. Withdrawal from antipsychotics is extremely frightening and painful – and so is withdrawal from benzodiazepines and ssris no doubt BUT FAR MORE FRIGHTENING IS THE LACK OF ACCEPTANCE OF THE NEED FOR WITHDRAWAL. Throwing your weight around about ‘a return of your mental health problems’ or ‘ no problems coming off 800mg of Quetiapine’ ( when you’re struggling on 400mg – you want to reduce; they want to increase) – those are the REAL STRUGGLES those who dare suggest withdrawal so often face.
Withdrawal takes a long, long time and has to be done slowly. No one knows better than the patient at which speed they can cope with reductions. A centre which supports withdrawal must be a godsend for any patient lucky enough to have access to such a service – but, more than this, it should be an absolute right for those unfortunate patients who have no family or close friends to fall back on for support during withdrawal.
One thing is for certain, many a journey can be faced alone – withdrawal is NOT one of them
John Stone says
Of course, there are plenty of candidates – in the field of vaccines Brian Deer, Dorit Rubinstein-Reiss and Seth Mnookin immediately come to mind but I see Emily Willingham has already made it, which scarcely adds to the award’s prestige.
http://www.ageofautism.com/2014/04/emily-willingham-dorit-rubinstein-reiss-and-the-barmy-army.html
http://www.ageofautism.com/2013/09/emily-willingham-and-the-cdc-criminal.html
Willingham’s crude little column has always been an exercise in flannel.
annie says
Professor Wendy Burn, of the Royal College of Psychiatrists, added: ‘Addiction is a serious mental illness and the rising number of deaths by opioids make this review timely.’
http://www.dailymail.co.uk/health/article-5304945/Urgent-review-launched-prescription-pills.html
‘Growing problem’ of addiction to prescription drugs probed
http://www.bbc.co.uk/news/health-42787958
Prescription drug addiction: what are your experiences in England?
As the government launches an investigation into the growing problem of addiction to drugs such as painkillers, we want to hear your stories
A colleague, Sarah Boseley, is at hand .. ?
https://www.theguardian.com/society/2018/jan/24/prescription-drug-addiction-what-are-your-experiences-in-england?CMP=Share_iOSApp_Other
Now we have it – loud and clear – your addiction is your mental illness – twice labelled – one on top of the other –
The PROBE will take a year
while little eight year olds have little voices
https://www.9news.com.au/national/2018/01/23/12/45/nsw-dads-antidepressant-warning-after-eight-year-old-son-tries-to-take-his-life
John said parents needed to be told in no uncertain terms about the potentially dangerous side effects of antidepressants.
“You are brought up to listen to the doctor and believe everything they say. You’re told they know what they are talking about and you don’t. If they say you do something then you basically go and do it. You trust them implicitly,” he said.
“This has been a very rude education in that in fact that’s not really the case.”
“We took the doctor’s advice and it was only when everything went wrong that we realised that actually we should have taken more care in that. We didn’t appreciate the risks involved.”
https://www.theguardian.com/science/2015/sep/16/seroxat-study-harmful-effects-young-people
David Healy, professor of psychiatry at Bangor University in Wales, said it was hard to see how so many suicidal children could have been overlooked. “We think if you were to go in and look at this data, anyone without training will find there are at least of the order of 12 children becoming suicidal on this drug out of about 93 [who were given it],” he said.
“This is a very high rate of kids going on to become suicidal. It doesn’t take expertise to find this. It takes extraordinary expertise to avoid finding it.”
annie says
Science Media Centre
expert reaction to drug trial protocol redactions by industry sponsors
http://www.sciencemediacentre.org/expert-reaction-to-drug-trial-protocol-redactions-by-industry-sponsors/
Dr Gillies O’Bryan-Tear, Chair of the Policy and Communications Group, Faculty of Pharmaceutical Medicine, said:
“From the outset, in the title, it’s clear what the authors have set out to prove in this review of industry sponsored protocols: that the industry conceals its study designs and in so doing, is harming patients. Nothing could be further from the truth.
It is surprising that there still exists in academia the view that the pharma industry is trying to hide important safety and efficacy data from public scrutiny.
Prof. Tony Fox, Professor of Pharmaceutical Medicine, King’s College London, said:
“I should also point out that the UK has a reputation for transparency of clinical trial protocols.
Glaxo (now GSK) actually began publishing long before Clintrials.gov (etc)
See: Sykes R Being a modern pharmaceutical company BMJ 1998; 317: 1172. As for law, the EMA does have a guidance and a policy on what can be legitimately redacted.”
Tetchy and Touchy ..
annie says
The world and his dog are talking Mental Health @Cheerful Podcast ..
https://twitter.com/CheerfulPodcast
Simon Wessely Retweeted
Ed MilibandVerified account @Ed_Miliband 18h18 hours ago
Delighted to announce that our live show of @CheerfulPodcast on Sunday is on mental health with very special guests @Rubywax , @george_ezra , @ayeshahazarika and @WesselyS. If you’re coming see you there. If not, listen soon…
Meet the Real Celebrities ..
https://twitter.com/shanecooke/status/956865272849321991
Me and my mum are starting a prescribed medication withdrawal peer support group
Noel Hershfield says
In my Province,there is an epidemic of drug addiction and death from narcotics.Last year over four hundred deaths mostly due to “elephant sized Fentanyl !Now the experts in our Public Health have legalized Cannabis!Wait for the young overloading our emergency rooms! My colleagues in emerg call it a FLOOD!