Children is one of several closely related books due out in the next few weeks including Paul John Scott’s The Malcharist and Jon Jureidini and Leemon McHenry’s Illusions of Evidence Based Medicine.
It would be wonderful if everyone reading this could buy a copy and one also for some doctor near you. Samizdat will publish all reviews you care to write and send in – even hostile ones. We would love if you could tweet or email or otherwise spread some of the “soundbites” below or others of your choosing – even hostile ones.
Now is the time for soundbites, in contrast to Tony Blair’s claim from one side of his mouth, when he flew in to take credit for the Northern Irish Good Friday peace agreement, that now is not the time for soundbites while claiming to feel the hand of history.
Children of the Cure tries not to take a position. It tells a story that can do with being scrutinized – for the hidden positions/motives of its authors as much as for anything else.
Children of the Cure
It’s a story that makes clear that motivation and common sense can be worth more than “expertise.” It is also a true story. Truth is stranger than fiction because fiction has to make sense. It’s a true story about lies.
After Black Box Warnings stained the SSRI antidepressants, Lady Macbeth like, senior FDA figures, working closely with trusted experts, spent over a decade trying to wash the stain away, in a manner that suggests the apparatus you think is there to look after you has no interest in truth, and many of those involved would prefer to see you dead than admit they got something wrong.
FDA to GSK
Please provide your rationale for coding suicide attempts and other forms of self-injurious behavior under the term emotional lability
We agree that the results of Study 329 failed to demonstrate the efficacy of Paroxetine in paediatric patients with MDD… we agree that it would not be useful to describe these negative trials in the labelling.
GSK to their Staff
If you are depressed who should you consult? A TV presenter or a doctor?
Judge Paroxetine on clinical trials not trial by media.
Internal GSK Document
Target: To effectively manage the dissemination of these data in order to minimise any potentially negative commercial impact.
Proposals: Positive data from Study 329 will be published
The question for every reader is: How could a journalist with no medical training, Shelley Jofre, spot the problems that the authors and reviewers of Study 329 failed to detect?
In 2016, we got fake news but as events were to reveal, medicine has been operating with fake science for thirty years. The trials we see bear as much relation to the data as what we get from politicians bears to the facts.
New York Attorney General Spitzer held a press conference at which he claimed his office’s action would change the course of medicine for ever. All pharmaceutical companies would be pressured into making their data available to doctors – as it should be.
GSK’s response “We believe that GlaxoSmithKline’s initiative to launch this register is a responsible step in ensuring transparency of our clinical trial data” left Spitzer furious.
A sensational document leading to a successful fraud case that was going to change the face of medicine, a document that opened up the prospect of investigating ghost-writing, a Black Box Warning slapped on antidepressants after nearly 15 years of campaigning, might all sound good but it didn’t feel at the time like much was really changing and it’s not clear there has been any change for the better since.
Black Box Meeting
Perceptions of the February 2 Black Box Meeting may have also been coloured by an event a few days later. On February 7 Traci Johnson, a 19-year-old college student taking part in a healthy volunteer trial for duloxetine, which Lilly was trying to rush to the market as Cymbalta to fill the void left by Prozac, was found hanging by a scarf from a shower rod in the testing facility. Her story and photogenicity became front-page news.
When researchers and the press started asking about duloxetine, the FDA didn’t scour its database and go public. It kept quiet. The FDA gave a legal rationale for its silence. Some clinical trial data are considered “trade secrets,” … and thus are exempted from release under the Freedom of Information Act
1boringoldman describing Marty Keller lead author of Study 329
There’s a deposition of Martin Keller about Study 329 available on the Internet. It’s 125 pages long, but easy to summarize: “If you think I did something wrong, you’re wrong because I’ve never done any wrong things, and I don’t specifically remember anything I’ve ever done.”
Ivan Oransky, of the Retraction Watch blog, put it trenchantly:
“GSK agreed to pay a $3bn fine and you’re [Editor of JAACAP who published 329] saying you had completely different results? Great. Show me.” Oransky described the journal’ silence as part of the “typical scientific playbook.” “It has been our experience that journals and researchers and institutions can be incredibly stubborn about failing to retract a paper”.
Now the profession itself is under attack in Congress, accused of allowing this relationship to become too cozy. After a series of stinging investigations of individual doctors’ arrangements with drug makers, Senator Charles E. Grassley, Republican of Iowa, is demanding that the American Psychiatric Association, the field’s premier professional organization, give an accounting of its financing. NYT July 2008
The BMJ’s mission is to lead the debate on health, and to engage, inform, and stimulate doctors, researchers and other health professionals in ways that will improve outcomes for patients. We aim to help doctors to make better decisions.
I was interested to know whether the reader should just believe that the Keller 2001 paper was ghost written or whether there is some kind of proof of this? How did the authors find this out/know?
If you publish this covering letter, GSK will be put in an interesting position. If they don’t already realise it, every effort on their part to draw attention to mistakes we have made on the basis of publicly available data that others can view will draw attention to the benefits of data access and the role of companies in denying access.
“It is no longer clear to us if you still wish to publish the paper. If you are going to reject the paper, we want to know that within a week.”
In reply to BMJ claims about our “claims” made about adverse events:
Please identify any claims that we make that are not supported by the data, and we will be happy to review
In reply to BMJ claims about “the tone of the paper”:
“We think we have been extraordinarily neutral in the circumstance, but if you indicate each episode of non-neutral language, we are prepared to have a go at flattening the tone further — from pancake to Kansas. (Kansas is flatter).”
BMJ ask that we specify what was done to make the coding reliable, unbiased and reproducible … There is not a single other article about a clinical trial in the published literature that specifies these steps. BMJ have a primary concern — shielding the journal from a legal action …
BMJ have understandably been very careful about any perceived conflict of interest on the part of our team, given that some of us have previously criticized GSK’s Study 329. We now have concerns about BMJ’s links with GSK.
New England Journal of Medicine
The aerial view of the concept of data sharing is beautiful, Jeffrey Drazen, editor of NEJM wrote.. [but] there is concern among some front-line researchers that the system will be taken over by what some researchers have characterized as “research parasites.”
The term research parasite was quickly hashtagged and became an academic social media hit. Lots of people identified as research parasites, perhaps just to annoy Drazen.
Iain Chalmers, Ben Goldacre and Sense about Science
Today’s GSK has shown moral and scientific leadership that puts to shame many in the academic community.”
Study 329 Restored
As with most scientific papers, Keller and colleagues convey an impression that “the data have spoken.” This authoritative stance is possible only in the absence of access to the data. When the data become accessible to others, it becomes clear that scientific authorship is provisional rather than authoritative.”
Superficial scratches or suicidal?
He has cut himself in response to the voice on three occasions in the past six days. On the back of his hand he has carved a cross with small adorning cuts. On his forearms he has made 10–15 cuts each about six inches long. On his upper arm are three additional cuts.
“Nothing was ever pinned on any of us,” despite various trials and investigations, he said. “And when I say that, I’m not telling you we’re like the great escape artists, that we’re Houdinis and we did something wrong and we got away with the crime of the century. Don’t you think if there was really something wrong, some university or agency or something would have pinned something on us?”
“We merely supplied the patients”. This statement on the disclosure form by one of the authors of the notorious Study 329 pretty much sums up exactly what is wrong with today’s industry sponsored research.
The Bitter End
Against a background of over 30 negative RCTs, including 7 negative Prozac trials, and no positive trials, prescribing antidepressants to distressed teenagers should have come to a full-stop but, while antidepressant use for teenagers briefly stalled in 2004 by 2018, aside from contraceptives, antidepressants had become the most commonly prescribed drugs in adolescent girls generally.
Study 329 is a story of the greatest failure in medicine. But the same story can be old about almost all drugs and for people of all ages.
Pharmaceutical companies make chemicals. We are the laboratories in which medicines are made. Medicines are chemicals used for a social purpose — to treat conditions that we define as diseases. Drugs cannot come into being unless we as healthy volunteers and later as patients in clinical trials agree to take them to see what happens. Without our participation, there is no drug.
But the research in which we once participated has morphed from scientific studies whose data were in the public domain into company trials where the data have been sequestered. We are never informed about this sequestration of our data. We assume that we are participating in science, and that the data arising from the risks we take are broadly available to scientists, as they once were.
This is not just about the legal consequences of hiding data. Faced with a choice between believing you when something goes wrong on treatment or believing the scientific evidence, nine out of ten doctors will believe the “science.” And possibly because they know there is something wrong somewhere, they will get nasty with you — sometimes extremely nasty. Many of us sense this and don’t dare to raise the fact that the treatment is not suiting us. When you come up against it, it’s like the Great White shark in Jaws appearing right beside your boat – a real shock.
At present, things are getting worse, not better. It’s something doctors need to realize because if drugs work marvellously well and have no side effects, there are cheaper prescribers even more likely to keep to the guidelines. Unless doctors can make a case that their job is to bring good out of the use of a poison and that this requires a good and honest relationship between us and them, they will soon be out of business in all but name.