When you read an article in a medical journal, all you have to go on is what you’re told in the article itself. If you watched Dr. Healy’s commentary [background music…], you know that this 11 page article represents 77,000 pages of data locked away in some data archive out of sight, a compression ratio of 7,000:1! And if you question an article, there’s no real way to answer your questions without that data. In this case, because of a legal challenge in 2004, the Clinical Study Report has been available on the Internet for a long time. It’s a 528 page document used to submit the paper to regulatory agencies. Over the years, many have read it over and over and found further things to fuel our contention that the original article reached an indefensible conclusion. But all that really did was further refine suspicions. It didn’t prove a thing:
In 2012, GSK finally posted the actual data [Appendices B, C, and D] as they had agreed to do in 2004, and so the numbers were there to see. So many numbers! And the only way to analyze them would be to hand copy them into some electronic format that could be input into a statistical program for reanalysis. I had a shot at that [cataloged in the lesson of Study 329: an unfinished symphony…], but there were so many numbers! Too many. I did enough to gain the conviction that this study was as far off the mark as it appeared. But it was only when we got the raw data in an electronic format that we could really do a complete analysis like the one we are publishing. I hasten to add that the form that data came in was a real challenge – a restrictive remote desktop that made the data manipulation very difficult.
The safety analysis required more data access. The transcribed numbers in the IPD tables for the rating scales were fine for the efficacy part, but the IPD version of the Adverse Events weren’t enough. We needed to look at the actual forms filled out during the study by the blinded clinicians and raters to approach the level of nuance needed to reach any conclusions about harms.
Our article isn’t really about Paxil Study 329. People like reporters Shelley Jofre of BBC’s Panorama, Alison Bass who wrote Side Effects, or legal actions from patients and governments brought it to the fore. The courts have levied punishments and record breaking fines already. And our group has been able to add a counter to the original article in the JAACAP which still sits in our libraries un-retracted.
The broader point of our article is that physicians and the patients we advise have an absolute right to look at the raw data behind the abbreviated proxies that appear in our literature as journal articles. When we have that kind of access, the playing field is level and the profession has the necessary means to join in the kind of checks and balances system that keeps people honest. Our paper is an example of how we think that information should be presented. Further, the medical profession has an absolute obligation to do whatever it needs to do to insure that the information we pass on our patients as scientific transcends other influences – including commercial profit or the academic advancement of the authors.
It’s a paradox that many of the authors who have lent their reputations and the reputations of their universities to these jury-rigged Clinical Trials preach a gospel of evidence-based medicine. And these questionable Clinical Trial articles are certainly filled with icons representing the tools of science – graphs, tables, p-values, standard deviations, etc. But they hide the only basic scientific tool we will ever have – the carefully gathered primary observations we call data. The real evidence never makes it into the courtroom…
We live in a society today where not only is cheating and deceiving tolerated, but rewarded, irregardless of business or industry.
Hillary Clinton, Tom Brady, and most KOLs in various specialties in medicine as examples up front.
Silence is complicity, period.
I don’t know if a fraud of this nature was considered shocking back in 1998-2001 when Study 329 was being prepared for publication. I was still in the dark about most of these issues myself. But it seems like it’s become the typical procedure for a medical research study now. This makes what you’re doing incredibly important.
I can’t stop thinking about the current trial (not the first) of a lawsuit against Janssen’s Risperdal for causing gynecomastia (growth of female type breasts) in a teenage boy. A first draft of a research paper on Risperdal in kids has emerged, with two data tables that were missing from the finished paper:
http://www.medpagetoday.com/Neurology/Autism/53288
The most appalling thing about this story is that the paper’s “lead authors” — a Johns Hopkins professor and a leading Toronto child psychiatrist — have only now asked Janssen for the original data, to see whether they signed off on a paper that misrepresents the facts! They never saw it before. Certainly they never saw the boys and girls they were “researching.”
Based on what they find out about their own study, they’ll decide whether it should be retracted, amended or let stand. (Actually one of them, Dr. Denis Daneman, already asked the journal to either retract the paper or take his name off it. The journal refused, saying they stood behind the paper because … it had been “peer reviewed.” No matter that Dr. Daneman was telling them, in essence, that the “peers” may have been lied to.)
Nobody in this closed world seems to even get how Orwellian or just plain bizarre the situation is. Maybe you guys can offer them some guidance…
“It’s a paradox that many of the authors who have lent their reputations and the reputations of their universities to these jury-rigged Clinical Trials preach a gospel of evidence-based medicine.”
When the *evidence* that points directly to their lacking skills to interpret and validate RCTs is presented, a remedial action plan should be immediately forthcoming! Maybe all who lend their names and the reputations of their universities should be thinking about specific, new credentials? The RIAT team as instructors in the method for analyzing all of the clinical data would be a formidable first step.
Maybe our prestigious professional journal editors and review teams should follow suit and sign up for RIAT team lessons?
Maybe proof of competency in the review and analysis of all clinical data should be required of all who are lending their names to a RCT before an article is published?
To me, the response of those who have [possibly] been duped into endorsing jury-rigged Clinical trials is key to defining: “The real evidence never makes it into the courtroom…”
Or rather, is it just the data that is missing?– or is there a stronger case to be made for what many [me included] have cited as lack of concern for the patients who have been and will be harmed ? There is already a curious lack of interest expressed by a very long list of noted scientists/doctors, who completely ignored the case reports , preferring to scurry back to their conference rooms and look for *evidence* of their innocence. Study 329, for instance,had a second review by a prestigious group of doctors, who went on a mad hunt for statistical evidence to support the safety and efficacy of Paxil, while seemingly dismissing the critical information at the heart of each reported harm/death of a child/adolescent who was prescribed this drug. Odd, but consistent with the worship of statistical evidence and self justification?
To date, the response to criticism of RCTs that began when things went terribly wrong in clinical practice, has been to discredit the complaining doctor and put forth more statistical evidence– from a variety of sources as far removed from the cases that prompted the complaint as is humanly possible to achieve—
IF there is not an immediate response, replete with initiation of an immediate *corrective*action plan to correct what has to be acknowledged as the
most serious risk to patients everywhere, then we can infer that the *real* evidence that hasn’t made it to the courtroom, is willful negligence,
willful deceit- for financial gain–.That would change a wrongful death verdict to second degree murder– (depraved heart murder) in some states.
The best news is the public access feature of Study 329– and evidence of the state of the art credentials of the RIAT team — whom, I refer to as, “david”– in relation to “Goliath”– . The lower case ‘d’ stands for the small number of scientists required to discover the weakness of this giant– (and I don’t mean just securing all the data…)
Dr. Hassman,
Hmm, Tom Brady was not involved in a drug study where benefits were overstated and harms were minimized affecting god knows how many kids.
And by the way, a judge did rule he hadn’t done anything to warrant a 4 game suspension which you may not agree with living in Baltimore. 🙂
Good points, AA. & thanks for the reality check on Tom Brady being labeled as a “cheater”:-)
To your comment in response to Dr. Hassman, I would add a strong affirmation to his last statement: ” Silence is complicity, period.”
Seems like a pivotal moment is at hand for psychiatrists who have a good command of our political system to speak to the critical need to make the example of the RIAT report on Study 329 a political issue– as we head into the upcoming presidential election campaign. I would imagine the support of many other ethical psychiatrists would be a given.
The point is pervasive acceptance of cheating and deceiving. The fact that above commenters defend the Brady matter reinforces my point, the judge who ruled against the NFL suspension never said anything about Brady being innocent, just the punishment was not fair.
As long as people rationalize there are some who are above the law, well, then why have a damn law in the first place.
You can’t have it both ways, punish psychiatry without hesitation and give one’s heroes or partisan political interests a pass. No, you punish cheating and deceiving like one learned in kindergarten. But, do we even teach that these days?!
“The point is pervasive acceptance of cheating and deceiving. The fact that above commenters defend the Brady matter reinforces my point.”
The point is that Tom Brady received excessive punishment for violating a NFL guideline! one that was apparently not a big deal until the New England Patriots won another Super Bowl . It was a professional football players guideline– not a law– and it did cause harm to anyone- nor did it have much effect on the outcome of the Super Bowl–.
I am not advocating acceptance of cheating and deceiving, nor rationalizing that there are some people above the law. But I am trying to make a point, in support of AA’a comment, that the significance of the cheating and deceiving evident in the Paxil Study 329 Study is the harm caused to children.
Don’t think this is a *punish psychiatry* issue, but a *where is the integrity in psychiatry?* challenge. Seems like you are rationalizing when you use extreme unrelated analogies that make this huge violation of ethics and law (as in fraud), just one more dig at psychiatry. By that I mean, you seem to be saying that unless the cheating and lying in politics and professional sports are death with like “one learned in kindergarten”, psychiatry should get a pass.
In other words, what’s the big deal if kids are exploited, harmed even killed by the lying and cheating going on in academic psychiatry and Pharma? – Look at what Hillary is getting away with —
There are differences in the crimes, their victims and a pressing need to prioritize a political agenda around issues that directly threaten the well being, health and safety of children. Hillary’s deleted emails don’t make it into the final cut.
Correction: Tom Brady’s under inflated football did *not* cause physiological, psychological or emotional harm to anyone. Call him a cheater if you like, but he is not a criminal. A kindergartner probably would see no reason to punish him.
Kind of minimizing cheating, no issue that meds are more harmful than a football game, but, how many people walk away from watching this debacle that are the New England Patriots and are seeing that cheating has benefits?
How do you know that cheating and deceiving from other aspects in society empowered these doctors and pharma executives to be more brazen, if not just consider it after watching health care be disrupted from other perspectives?
Again,the basic point is simple: why do people minimize, deflect, and just pathologically rationalize basic antisocial traits?
These days, goes along easily with the societal narrative of doing what is popular, easy, and convenient.
Pun intended here, kind of a deflating moment to realize, eh?
I end my comments at this thread simply with this: I truly think that at least 85% + (wish I could say 95%, but that number is not realistic in the past 20 years) of people who graduate medical school do not inherently have an agenda to cheat or deceive their patients and colleagues, but, what do they learn once into residency or out on their own afterwards?
First Medicare by the late 1960s created an environment of abusing the system of insurers for physician private gain, then private insurers in the 1990s made it obvious that profiting was the prime agenda and not any real clinical gains, Big Pharma then showed their true colors of profiting grossly by the 90s as well, then growing government intrusions in the past 15 years to attack any physician who would even remotely try to do something that often wasn’t even really a violation, all of these elements chipped away at those who just could not maintain integrity and responsibility.
Obamacare was the final shot at the bow. Yes, Study 329 preceded Obamacare, but, I think the above trifecta of these Non clinical entities that just wanted to take advantage of the health care system paved a way to reinforce that cheating, deceiving, and plain malfeasance have a greater likelihood of reward than real effective punishment.
Besides, this study above is just a tip of a hideous iceberg of corruption that is not melting, but growing. Because too many stay silent and either uninterested, uncaring, or just plain intimidated. So, we can rail away about 329 ongoing, or, find creative and effective ways to marginalize, ostracize, and criminalize what is going on now, today, and not 10 plus years ago?!
Yeah, as long as we applaud the Clinton/Trump/Brady/ and multiple examples in the business arena (a link to educate?: http://bizshifts-trends.com/2015/09/09/cheating-cheaters-its-global-business-societal-phenomenon-it-works-it-rewards-its-boundless/) –and other typical stories of late, oh, and allow the Deceiver-in-Chief in the Blight House down in DC to continue his blatant efforts to cheat and deceive, where is the example to do otherwise? Yes, in my opinion, what goes on in politics, business, and celebrity culture is related to what goes on in medical circles as well.
It, as in America, is a culture of deceit and selfishness, and it won’t end in any aspect of American professionalism until people stand up as a united sizeable majority and say in so many words, “I am mad as hell and won’t take it anymore”, and show the cretins to the door.
A door hopefully at the edge of a cliff, in my opinion.
Thank you for the opportunity to comment, be safe and well, folks.
Joel is right, but just like me he wants the naive ‘perfect’ World.
And where I want unbiased RCT’s and fair courtrooms, there are none.
I’ve been absolutely ran over by GSK’s drug Paxil, stripped of family, friends, job, economy and any hope. But I still can’t go to Court, GSK can deny deny deny and get away with it. Despite 25 years of evidence of their fraudulent play.
I live in a country where lawsuits aren’t used all that often, and the cost of sueing GSK would be equal to approx. 100 years of net income for me, just to get a lawyer on my side working my case.
Perhaps whatever happened to that football Before the game wasn’t such a big deal in the World as a whole. But I sure get what you mean by how people just let cheating of all kinds pass, it’s become the new normal.
Read you blog briefly, and in a 2-party system (democrats and republicans), I can tell you as an outsider that republicans look stir crazy no matter how poorly the democrats perform. But I would probably lean to a 3rd or a 4th option if I was ever faced with those 2 candidates… off topic, but just saying that Donald Trump reaches european media too..
Joel,
Here in Boston the media has examined this *recent* issue of cheating under a microscope-., covered every detail starting with The Pat’s owner putting up a million when allegations were made, not admitting guilt, but hoping to contain the campaign to smear Brady and his team. Didn’t work. Brady’s punishment was heavily publicized, so the overturning of that decision was news. and then there is the NFL’s appeal… I agree it is a debacle , but it reflects the NFL’s overinflated value in our society. This is news. go figure. On the other hand, the local psychiatrists who were caught cheating and committing fraud by Sen. Grassly were barely mentioned in mainstream media news –. Where was the outrage? So, I agree that psychiatry doctors and pharma executives were emboldened to become more brazen in their cheating, though it is directly linked to the positive reinforcement they have personally received. Tip of the hat to their wealthy influential bosses, who have consistently protected them from legal consequences of the crimes they most assuredly committed.
Psychiatrists & pharma becoming more brazen has nothing to do with examples from other aspects of society– they have nothing in common with the rest of us to start with–. We are their market, not their peers. They have amassed the wealth that em*powers* them to trample on our laws. Society provides the money— and this is the thanks we get?
You may have missed the basic points outlined in this series of blog posts. One of the points is the effect this jury-rigged clinical trial and the heft it got from the AJCAP, has had on society– namely children. This was achieved, in part by the psychiatrists who breached the trust society has granted them. Your arguing that psychiatry is simply using the play book created by the masses -pun intended here, is deflecting the more salient issue of how society, itself has been used by psychiatry. We have been indoctrinated with fabricated science, drugged like guinea pigs and pathologized in every conceivable fashion– which not so coincidentally, has made psychiatry & pharma execs richer and more powerful.
Could be that psychiatry and Pharma has imagined that the narrative making their crimes popular,easy and convenient has come form society? But then, how could that be at the root of their reasoning, when their greatest efforts and feats of daring have been predicated on their ability to completely dupe society??
No. Can’t be. Who would follow the play book of a society that has no clue where its power lies? Certainly not those whose aim is to control and exploit society.
Tom plays football- excels at his role. Consistently gives fans our money’s worth– rain or shine, through scandals and bad press, Tom Brady stuns, amazes, entertains us– which is what we had in mind when we bought the ticket in the first place. As a Patriot’s fan, I can’t complain.
As a former psychiatric nurse I haven’t even started complaining!
“It’s a paradox that many of the authors who have lent their reputations and the reputations of their universities to these jury-rigged Clinical Trials preach a gospel of evidence-based medicine.”
Karen Wagner & Evidence-Based
https://aacap.confex.com/aacap/2015/webprogram/Session14434.html
http://mghcme.org/faculty/faculty-detail/karen_wagner
http://www.utmb.edu/newsroom/article3003.aspx
…etc.
Mickey, you once wrote:”I’ll be glad to stop writing about these jury-rigged Clinical Trials when either I get to the end [which appears to be far in the future] or the legitimate scientists, our journals, and the pharmaceutical companies begin to police our scientific literature as they should’ve been doing since all this started.”
Clinicians who believe in the legitimacy of our work (including judicious pharmacotherapy for children), to which the actions of Wagner (and the active silence of Martin) are a betrayal, need to speak up too.
1boringyoungman [et al],
In my mind, this paper isn’t much about Study 329. We all know it was mis-reported. It’s about exactly what you address – speaking up. RIAT represents a new possibility for us to begin to reclaim the knowledge base of medicine and I appreciate the BMJ giving us a place to make that statement…
Ove,
If you start from the premise that the power of our society lies in our ability to influence our elected leaders, which extends beyond electing them, you have to wonder how we wound up at the bottom of the food chain?
In 2012, a demonstration of the power of *the people* was displayed when the SOPA bill was defeated. ( see link to tutorial)
https://youtu.be/Fgh2dFngFsg
Wealthy constituents nearly succeeded in enacting a serious threat to our freedom to connect on the internet. The people waged the campaign that stopped it. Internet is central to every phase of this win.
There are barriers to enacting our power, the biggest one is lack of unity. But I can name multiple divisive forces that are the signature tactics of the 1% that perpetuate this divide and conquer scenario–. And then we have the specific tactics of industries that have eroded the confidence we should have in regulatory agencies, even our criminal justice system. Our fault?No way. You see, it does not matter who we elect– the leaders don’t work for us– until we rise up and demand it.
How much has psychiatry contributed to factors that weaken our faith in our power as a society, who is now in crisis? A no brainer- pun intended here. Right down to our basic identity , psychiatry has dehumanized us. Is there a society in a developed country more pathologized than ours?
We as a society should be steering the direction of our political campaigns with with our needs, issues and welfare in the forefront. That’s the ticket we can’t afford to buy these days?? No, it is the one we don’t have to buy– but who believes it?
Galvanizing the majority of our society around one slam dunk issue that turns the spotlight where it belongs- the crimes of the ruling class, is what democracy can look like.
Paxil Study 329 fits the bill–when the public education campaign is ignited, try to imagine anyone rationalizing this threat to our children — and all of us by extension, — Cheating in the NFL??
study329.org is not simply a tool for filing lawsuits— you’ll see 🙂
Mickey,
Totally. Focusing on the shared knowledge base of medicine, especially psychiatry, as something meant to serve the best interests of individual patient-clinician shared decision making is key. Those who view themselves as pro-psychiatry and view psychiatry as a positive force on balance have in some ways the greatest stake in doing this. We need to speak up to counter the ill effects on our shared knowledge base that have been brought about by the kind of actions, over the past 2 decades, the handling of Study 329, epitomizes.
Looks like it comes out late Wed/early Thu this week. A singular opportunity for front line child psychiatrists to speak up and begin to reclaim our knowledge base. Whatever the outcome, my thanks to you for your voice on all this.
Katie, I watched the video earlier when you linked it. (On DH’s blog I Believe)
And the story surrounding Aaron is thrilling to say the least. I’m not very read up on freedom of speach and information, but of course I understand the fundamental in it. My native Sweden is (more like was, now) in the forefront of the right to have information and the right to be able to speak up. And I’ve grown up with a belief that we have the right to organize and freely speak our minds.
But things aren’t as good as I was taught to Believe (yes, from early age we are taught in school that Sweden is a free society, virtually free from corruption)
Because just as we want to keep our neutrality from NATO, we have built our society post WW2 with “democratic socialism”, socialism that is almost a curseword in America from what I understand. But the times has caught up with us, we have “had” to conform with the World around us. And unfortunately, the “World around us”, is in fact the American way. We’ve looked to you and bought the idea of “the Dream”.
But just as socialism in it’s hardcore form is filled with flaws, just the same comes with the commercialism that we imported from America.
I’m not blaming America though, humans are greedy everywhere, but to me it seems as if the U.S. embraces it and allows it.
What struck me totally surprised was that we are just as corrupt as I could imagine the FDA or other American regulatory agencies are.
Swedish “FDA” uses the same revolving doors.
In 1991 John Virapen bribed them to speed up their approval of Eli Lilys SSRI with just 19’000 dollars.
In the late 1990’s Anne-Liis von Knorring undertook some study of some SSRI for Lundbeck/Forest labs.
Heck, even Arvid Nilssons Discovery of neurotransmittors (or whatever he was responsible for..) led us to the invention of SSRI’s and the discussion we are having today.
And me? Well, I don’t wanna sue anyone. I can’t be bothered wether Obama is better than Bush. And as long as there aren’t any drones in the Swedish skies it’s OK that you sacrifize your own sons and daughters all over the World. But when commercialism has influenced what drug I should take, when marketers sold Paxil to me through my naive psychiatrist. The same psychiatrist that gave me a speech of how safe and benefitial Paxil was. How it would treat my panic anxiety and leave no trace.
Then, I will sue, but just because it was forced upon me. And if that means I will have to become my own lawyer, so be it. The record will state that I did not accept being used as a pawn in a profit-based game. And 30 years from now, I will be proven right. (when the next generation of brainaltering drugs is out there)
The study 329 is not the reason, or my solution, but it’s a part of me. I am Paxil, I became Paxil, I wanna tell people I was betrayed by Paxil and GSK!
BIWX WELL done!!!!!!! I am reading the report now, and will actually buy a copy of BMJ………… Congratulations!