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"The medical community is currently trying to come to grips with the idea that much of the clinical trial literature has not been written by named authors, and, instead, has been written by medical writers employed by pharmaceutical companies who are not listed on the author byline. The success of virtually all of the blockbuster drugs has been tainted by charges of ghostwriting."
Ghosts In The Pharma Attic by Jonathan Leo and Jeff Lacasse
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It has been slow to dawn on me that virtually all of our psychopharmacological blockbusters in the last twenty-five years have achieved their widespread notoriety by routes other than safety and clinical efficacy – and ghost-writing has been a prominent player on their highway to success. Right now, I’m focused on Paxil Study 352 [paxil study 352 revisited…], a GSK production involving Sally Laden of STI [the editorial assistant for the infamous Paxil Study 329]. But I thought I’d weigh in on the "what’s ghost-writing?" question before continuing to try to parse this clinical trial and article further.
The "what’s ghost-writing?" debate can get pretty silly, sounding more like clinical examples for Anna Freud’s 1934 description of the adolescent defense mechanism called rationalization – the way teenagers flex their newly-found ability to use formal logic by torturing their parents with endless logical reasons that they should be allowed to do whatever they want to do. From my perspective, ghost-writing is more than the spell-checking, the grammar-checking, or the war on stilted language and run-on sentences often provided by the spouses of researchers. Just like authorship is more than edits and marginalia added to someone else’s draft. A ghost-writer is a hired writer who takes the data and creates the structure and arguments that will ultimately become the submitted paper – in other words, the author of the first draft. In that regard, Sally Laden, ghost-writer for Paxil Studies 329 and 352, is the prototype. Recall her testimony about Paxil Study 329 [Deposition of Sally Laden, 2007]:
ANSWER: Yes
QUESTION: Okay. Was it your responsibility alone to create the first draft of Study 329 or did you get help from some of your colleagues?
ANSWER: I believe I created it on my own.
QUESTION: Okay. Did Martin Keller tell you what to put in the first draft?
ANSWER: I don’t recall. I don t think I had any conversation with him until we were, you know, afterwards.
QUESTION: Okay. After you prepared the first manuscript?
ANSWER: To the best of my recollection, yes.
Medical Ghostwriting: A University–Sanctioned Sleight of Hand?
Society
by Jonathan Leo & Jeffrey R. Lacasse
May 2012
As we examined the results of the investigation, we were struck by the fact that the investigative panel seemed to confuse honorary authorship with ghostwriting. To be sure, both are problems in academia, but there are important differences. Honorary authorship consists of someone being placed on the authorship line who did not truly deserve to be listed as an author- often a department head or wellrespected senior researcher in the field. As we have recently argued, ghostwriting is a simpler issue to ascertain, by asking the straightforward question: Was there a writer who contributed significantly to the paper, who was not listed as an author? If the answer is yes, the paper was ghostwritten. This is not just our perspective. In a recent research article on ghostwriting, the editors of JAMA defined a paper as ghostwritten when, “An individual who was not listed as an author made contributions that merited authorship,” or “An unnamed individual participated in writing the article”…
The University of Pennsylvania has denied allegations made by one of its professors that several other academics – including his department chair – allowed their names to be added to a medical journal manuscript, but gave control of the contents to GlaxoSmithKline, according to his attorney. The study, which was funded by the drugmaker and the National Institutes of Health, looked at the impact of the Paxil antidepressant on patients with bipolar disorder.At the same time, the university has acknowledged a claim by the professor, Jay Amsterdam, that the 2001 study was ghostwritten by Scientific Therapeutics Information, his attorney tells us. However, he says the university is not planning on taking any action in connection with the ghostwriting. The study, which was published by the American Journal of Psychiatry [see here], did not mention that STI played any role.
“They said his allegations were not meritorius, although they did find that the publication at issue was ghostwritten,” says Bijan Esfandiari, the attorney, citing a letter and other documents he received from the university. “They acknowledged that a marketing firm was involved in drafting, and everything associated with, the issue. But in response to our complaint, they said that, at the time these events took place, which was between 1998 and 2001, ghostwriting was standard practice and everyone was doing this, so therefore, we’re not going to punish any individuals”…
On the other hand, Exhibit 9 of the Inquiry Committee Report displays draft one of the study 352 manuscript, which was prepared on March 1,1997, for Muriel L. Young, M.D. at GSK by Grace Johnson and Sally Laden at STI…Exhibit 10 of the Inquiry Committee Report displays draft two of the study 352 manuscript dated April 7, 1997, prepared for Muriel Young, M.D. at GSK by Grace Johnson and Sally Laden at STI…
In contrast, Exhibit 11 of the Committee Report displays draft three of the study 352 manuscript dated September 24, 1997, prepared for Muriel Young, M.D. at GSK and now displaying GSK-designated authors [Laszlo Gyulai, M.D., Gary Sachs, M.D., Dwight Evans, M.D., Charles Nemeroff, M.D. PhD, Muriel L. Young, M.D., Cornelius D. Pitts, RPh, William D. Bushnell, MS, Ivan P Gergel, MD]…
… in Exhibit 13 of the Committee Report, draft three [actually draft four] dated June 24, 1998 … was prepared for Cornelius Pitts, R.Ph. at GSK by Grace Johnson and Sally Laden at STI, and was assigned the following GSK-designated authors: Charles B. Nemeroff, MD, PhD, Dwight L. Evans, MD, Gary Sachs, MD, Laszlo Gyulai, MD, Charles L. Bowden, MD, Muriel L. Young, MD, Cornelius D. Pitts, RPh, William D. Bushnell, MS, Ivan P. Gergel, MD…
red = GSK employees & blue = STI employees
Nemeroff, the paper’s first author, says that the data used withstood rigorous peer review in a process that sent the paper back to the authors for revisions several times. "Right in the abstract under ‘results’ we report that ‘Differences in overall efficacy among the three groups were not statistically significant’," he says. "I don’t know how much more straightforward we can be than that. "He adds that "with a 2011 magnifying glass, obviously one would have included in the published paper the use of an editorial assistant". Still, he says: "All [STI] did was help collate all the different authors’ comments and help with references. We wrote the paper."
There’s not the wealth of information for Paxil Study 352 like there was for Paxil Study 329, certainly not the raw data that was finally released for the 329 trial in adolescents this last August. But my own reading of the published Paxil Study 352 article [paxil study 352 revisited…] suggests that they took even deeper liberties with deceitful presentation and analysis than in the Keller et al Study 329. I’m going to start with the recent paper [The paroxetine 352 bipolar trial: A study in medical ghostwriting by Jay D. Amsterdam and Leemon B. McHenry] and chase the references to see what else I can find.
This is the point where my daughter might say, "This is why I named your blog, 1boringoldman. Who cares about an 11 year old article on an out-of-patent antidepressant?" At which point, I might respond, "I care. But hopefully I can get a few more people interested because this kind of thing is likely to happen again and again if somebody doesn’t wake up and realize how detrimental pharma driven ghost-writing and data secrecy in clinical trials can be." She’s pretty smart, so at that point she’d likely say something wise like, "Pass the Turkey, please" or "Nice Sweater!" to divert my attention. That might work at the dinner table, but not here. This kind of scientific misbehavior has gone on far too long unchallenged, and the damage done is all around us. There’s another meaning to the word boring…
There’s another meaning to the word boring…
Ah. Yes. Thank you.
How cynical we have become. The excuse “Every one does it,” is not acceptable.. Much harm might result, but they could run to the Bank and deposit their greedy money. And the Public be damned!
Who cares about an 11 year old article on an out-of-patent antidepressant?
Just kidding.
You sure did make me read a lot for the punchline though! And damnit, I learned something, too. I really am very proud of all of this. I just don’t have the right attention span to read all of it regularly.
This stuff really is shameful though. I can’t imagine this sort of scholarship flying in any of the academic circles I’ve been a part of.
The fact that the study was done some time ago is irreverent. There is every indication that these practices are widespread and continue. I is a perversion of scientific research. When physicians prescribe based on biased studies tailored to sell specific drugs, people are harmed. When institutions such as Penn fail to take responsibility, they lose credibility as sites of objective research and misuse public money. When someone with ethics, such asmDr. Amsterdam, tries to blow the whistle, he is harassed and hounded out of his position. This is a travesty of truth and justice. justice.
Look. I think the case against these GSK papers is clear. It is a revolting situation. Jay is to be commended, and so is 1Boring and others who know what is at stake morally and scientifically.
Just as a fine man among us once opened his remarks to me at a scientific meeting with “I don;t wan’ t to rain on your parade . . . but . . . ” , I will open this with: psychopharmacology is my baby; it doesn’t deserve to be thrown out with the bath water.
There is another side to the issue. While at Merck I was first author on 90% of my own papers. I did invite others as co-authors, some of whom who were outside OLs, who did work. In every case, even after exhaustive internal review of my work by Merck nitpickers being paid big bucks, those outside the company also tore my first draft to shreds. Sorry. Not a rubber stamp. At Merck I coordinated the first draft of a minority of papers on which I was not first author, First author KOL ‘s tore the drafts to shreds, often asking for (and receiving) additional data – not once but several times per paper.
The devil of this stuff is in the details.
Unless I am misreading it . . .entirely possible . . . the gist of this blog is that all or most drug success in psyhopharm is market driven by mostly bogus papers, objectivity didn’t exist at the companies; their collaboration with KOLs was contrived; KOLs are uniformly cheats and scoundrels.
Please! This is insulting. It is not correct. Sure I know who the narcissists and scoundrels are. But what of the others who are thoughtful, kind, beyond brilliant, hard working, and beyond reproach.
Yes, it could be that say 60% of ghostwritten papers were rubber stamped for phase III, and then 80% for phase IV and beyond. I do not know. If this is what you mean to say. Fine and disgusting. Maybe it can be documented.
Even so, you generally don’t get a medication to market unless it is efficacious and safe. For those who care, this information is freely available.
Paul Leber was hardly a slouch. He played by entirely logical/scientific rules in a field which has always struggled towards the quantitative.
There is no debate on whether drugs for Major Depressive Disorder are efficacious. They work: how well depends on the qualities of the diagnosed patient. If you’ve never seen an inpatient w/ major depression under treatment you cannot and will not understand. Most people do not get the history of the class and why the diagnosis of the disease got watered down. This is not immoral. Yet, what is unfortunate is that we do not yet have a biological test. The closest we came to it was Dr. Carroll’s DST. That might be worthwhile revisiting in the age of professional patients.
Finally, I am unhappy w/ the glib trashing, in Freudian terms no less, of the power of “everybody does it.” I do not know if everybody rubber stamped ghostwritten papers and called them their own. If everybody did, back then and nobody squealed, well . . . hello Nazi Germany.
But the way it was supposed to work was a Ms. Bin Laden wrote a company approved first draft which the KOL first author was supposed to tear apart and make his own. Ms. Ben Gay Laden was supposed to be credited. Just because a sociopath or two says this happened (and in their cases it didn’t) does not mean it wasn’t happening as planned – as mostly everyone was doing it.
I am sorry, but I take issue with fundamentalists posing as clear thinkers.
So, the challenge.is to get the internal first drafts by hook or by crook , and compare them w/ the published works. That is pretty much the tortured beauty of the present case. It is troubling. Just because it is documented as corrupt doesn’t mean that all were done that way. Does it?
To be clear even KOLs go w/ the pack sometimes. The practice of ghostwriting started when the first academic asked the research assistant to write a short draft. When the academic then tore that draft to near shreds/ threads – at what point in the deconstruction did it become his own vs. the ghostwritten draft? To this there is the answer of the fundamentalist and then there is the other answer. And so goes the real world.
Regards, Mark
Laden should be given some sort of posthumous award for excellence in literary fiction.
She seems to be more popular in spirit form than any other part of her life.
**Sticks tongue in cheek
Mark,
I appreciate your comment, actually more than you can know. I’m a psychiatrist too, retired, but feel good about my own career. I didn’t start writing about this stuff until I started reading the literature I had pretty much ignored after leaving academia in the late 1980s. But about this:
I know some of those people too. Actually a lot of them. But I still have to say, “So what!” It’s actually their job to write this blog – not mine. Why aren’t they talking about Study 352? or Study 329? or TMAP? or Sally Laden? We have grown a pretty large crop of real sleaze-bags in the last twenty-five years and they’ve filled our journals with enough articles like this one to have kept me busy for two or three years pretty much non-stop. No offense, but I feel kind of insulting towards the good guys for letting this stuff go on under their noses and tolerating it quietly. I take your Nazi Germany analogy seriously. It’s occurred to me more than once. In the paper under question, GSK/SKB didn’t “rip it to shreds”. They actually paid someone to write it.
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.
I’ve tried both methods. The only success is when there’s a court case and subpoenas involved. But hope springs eternal.
Absolutely not, and you won’t find the “all” on this blog. What you did find was “all” up there with the “blockbusters.” I only recently began to think about that, but I’m afraid that this kind of misbehavior pretty much spans the lot.
If you send me some good examples, I’ll be glad to write about them too. But if you’ve got some spare time, I’d appreciate it if you and your legitimate scientific colleagues would take a close look at the Clinical Trial literature over the last twenty five years themselves and speak up. So far, it’s a lonely business.
Thanks again for your comment. I’m serious. It’s the first one I’ve ever gotten from someone on the inside that I didn’t already know…
Dr. Kramer,
You also make some interesting arguments in your post and also here:
http://www.reportingonhealth.org/blogs/2011/09/26/full-disclosure-tighten-pre-publication-rules-eliminate-ghostwriting
However, you also write:
“I am sorry, but I take issue with fundamentalists posing as clear thinkers.”
“If you’ve never seen an inpatient w/ major depression under treatment you cannot and will not understand. Most people do not get the history of the class and why the diagnosis of the disease got watered down. ”
Are you referring to the author of this blog? If so, have you read him for long?
Dr. Kramer,
http://www.reportingonhealth.org/blogs/2011/10/07/full-disclosure-rewrite-ghostwriting-rules-focus-origination
To follow up further:
Dr. Kramer, you also say “The problem of ghostwriting will not be solved simply by blame, punishment, and tabloid journalism.” True, but the little of what non-insiders know of misdeeds came from journalists and lawyers. And sites like these. 1boringoldman is the one, along with Health Care Renewal, that combines both outrage with the sense that they come not to bury psychiatry but to save it. It doesn’t need saving?
Why are almost none of the thoughtful, kind, beyond brilliant, hard working, and beyond reproach advocating forcefully for these changes. I very much hope you address that. And, how to change that situation.
Off topic:
http://www.aacap.org/cs/56th_annual_meeting/
“AACAP has been a leader in managing disclosures and potential conflicts of interest that can and do interfere with objective conduct of science and clinical practice….We are now pleased to give you an update on the Principles, which meet or exceed the standards set by other organizations….While these Principles may prove to be inconvenient, at times, they are serving us well in terms of maintaining our scientific and clinical integrity. We hope you will take pride in our Principles and your participation in the process.”
Followed further down the page by:
“The reporting timeframe is a minimum of the past two years and imminent support. An obligation to report may exist for funds received prior to the last two years if it would be commonly perceived to have impact on that particular presentation, e.g., funding for a study which ended prior to two years ago but is now being reported must be disclosed.”
So, the only hard rule is 2 years and it does not require actual relevant dollar amounts. The slide is here: http://www.aacap.org/galleries/AnnualMeeting/Conflict%20of%20Affiliation%20Slide.ppt
Now see this:
http://www.pharmalot.com/2012/11/one-stop-shopping-proposed-for-conflict-disclosure/
“In a bid to simplify increasing demands to report conflicts of interest held by physicians and researchers, a leading group of academics, policymakers and ethics experts are proposing the creation of a centralized data repository to house all disclosures and increase transparency in medical research and practice.”
“And Thacker cautions that industry lobbying will attempt to influence the final outcome. “My fear is that they’ll go for the most watered-down version and only require disclosing conflicts in the last two years, or not require actual relevant dollar amounts,” he says.”
So:
“My fear is that they’ll go for the most watered-down version and only require disclosing conflicts in the last two years, or not require actual relevant dollar amounts,” – Paul Thacker
“We hope you will take pride in our Principles and your participation in the process.” – AACAP
“Even so, you generally don’t get a medication to market unless it is efficacious and safe. For those who care, this information is freely available.”
“There is no debate on whether drugs for Major Depressive Disorder are efficacious. They work: how well depends on the qualities of the diagnosed patient. If you’ve never seen an inpatient w/ major depression under treatment you cannot and will not understand. Most people do not get the history of the class and why the diagnosis of the disease got watered down. This is not immoral. Yet, what is unfortunate is that we do not yet have a biological test. The closest we came to it was Dr. Carroll’s DST. That might be worthwhile revisiting in the age of professional patients.”
Yet:
http://hcrenewal.blogspot.com/2012/11/what-if-institute-of-medicine-wrote.html
Is this the same Dr, Mark Kramer in comments here? discussing ghostwriting and Merck in disclosure in his comments?
GSK paid KOL
http://projects.propublica.org/docdollars/search?utf8=%E2%9C%93&term=mark+kramer&state%5Bid%5D=
No wonder he’s defensive
Corrupt KOL’s defending even more corrupt KOL’s…..As if anyone would be surprised….. Just follow the money as they say Mr. industry apologist Mark Kramer…by the way; say “Hi” to your pal Nemeroff for us, next time you get together to chat about your GSK extra income over a cigar… 🙂
Let’s take as an example:
ATOMOXETINE (STRATTERA FROM ELI LILLY) AND ADHD
The CMAP (CHILDREN’S MEDICATION ALGORITHM PROJECT)
suspended back in 2008
http://www.pharmalot.com/2008/08/texas-suspends-psych-drug-program-for-kids/#more-15077
Here is the disclosure section from the related 2006 JAACAP paper:
Disclosure:
Dr. Pliszka serves a consultant for and is a member of the speakers’ bureau for Shire Pharmaceuticals and MacNeil Specialty and Consumer Products; he has received research support from ELI LILLY, Cephalon, and AstraZeneca.
Dr. Crismon has received research grants or unrestricted grant funding (through the University of Texas at Austin) from AstraZeneca, Bristol-Myers Squibb, ELI LILLY, Forest Laboratories, Pfizer, and Shire; at present or during the past 3 years, he has served on the speaker’s bureau or has been sponsored for lecturing or developing continuing education materials by AstraZeneca, ELI LILLY, Forest Laboratories, and Pfizer; and he has served as a consultant to or on advisory boards for Janssen, Pfizer, ELI LILLY, Bristol-Myers Squibb, AstraZeneca, and McNeil Specialty and Consumer Products.
Dr. Hughes has received research support from GlaxoSmithKline.
Dr. Conners has served as a consultant to or been a member of the speakers’ bureau for Novartis, ELI LILLY, McNeill Specialty and Consumer Products, Shire, and GlaxoSmithKline; he is also on advisory committees for Shire and ELI LILLY.
Dr. Emslie receives research support form ELI LILLY, Organon, and Forest Laboratories. He is a consultant to or a member of the speakers’ bureau for ELI LILLY, GlaxoSmithKline, Forest Laboratories, Pfizer, Wyeth-Ayerst, and McNeil Specialty and Consumer Products.
Dr. Jensen receives research support from Janssen, McNeil Specialty and Consumer Products, Pfizer, ELI LILLY; he has served on the speakers’ bureau for Janssen, UCB Pharma, and Novartis; and he holds stock in Lilly Pharmaceuticals.
Dr. McCracken receives research support from ELI LILLY, Shire, and Bristol-Myers Squibb. He is a consultant to or has received honoraria from Shire, ELI LILLY, McNeil Specialty and Consumer Products, Janssen, Cephalon, Abbott, and UCB Pharma.
Dr. Swanson has received research support from, had an advisory board membership in, and participated in speakers’ bureaus for McNeil Specialty and Consumer Products, Cephalon, UCB Pharma, Shire, Novartis/Celgene, ELI LILLY, and Abbott.
Dr. Lopez has no financial relationships to disclose.
I.e. 2/9 had not received money from Eli Lilly.
It’s pretty easy to google and find Figure 1 from that paper and review where atomoxetine sits on that algorithm. Would most ADHD experts try one methylphenidate formulation, then one amphetamine formulation, and then proceed directly to atomoxetine? NOT attempt further stimulant formulations past those first two (those these are possibly “optional”). Would for them augmentation of stimulants with alpha agonists be stage 6? And, atomoxetine stage 3?
Here is the disclosure section of the 2007 AACAP Practice Parameter:
Disclosure:
Dr. Pliszka receives or has received research support from, acted as a consultant to, and/or served on the speakers’ bureaus of Shire, McNeil Pediatrics, and ELI LILLY.
Dr. Bukstein receives or has received research support from, acted as a consultant to, and/or served on the speakers’ bureaus of Cephalon, Forest Pharmaceuticals, McNeil Pediatrics, Shire, ELI LILLY, and Novartis.
Drs. Bernet and Walter have no financial relationships to disclose.
From that Practice Parameter:
“Atomoxetine has been studied in the treatment of patients with ADHD and comorbid anxiety (Sumner et al., 2005 [rct]). Patients with ADHD or an anxiety disorder (generalized anxiety, separation anxiety, or social phobia) were randomized to either atomoxetine (n = 87) or placebo (n = 89) in a double-blind, placebo-controlled manner for 12 weeks of treatment. At the end of the treatment period, atomoxetine led to a significant reduction in ratings of symptoms of both ADHD and anxiety relative to placebo, showing the drug to be efficacious in the treatment of both conditions. This study is of interest because treatment algorithms for ADHD with comorbid anxiety have recommended treatment of ADHD first with stimulants, then addition of a selective serotonin reuptake inhibitor (SSRI) for treatment of the anxiety (Pliszka et al., 2000). Recently, however, the SSRI fluvoxamine was shown not to be superior to placebo for the treatment of anxiety when added to a stimulant in a small sample (n = 25) of children with ADHD and comorbid anxiety (Abikoff et al., 2005 [rct]). This small study does not invalidate this practice, but the above results of Sumner et al. (2005) suggest that using atomoxetine for the treatment of ADHD with comorbid anxiety is a viable alternative approach. “
&
“However, atomoxetine may be considered as the first medication for ADHD in individuals with an active substance abuse problem, comorbid anxiety, or tics. Atomoxetine is preferred if the patient experiences severe side effects to stimulants such as mood lability or tics (Biederman et al., 2004). When dosed twice daily, effects on late evening behavior may be seen.”
1BOM, given your experience in your current clinic and your background as a psychoanalyst (hell, as a clinician), I would very strongly recommend you carefully read through recommendations #2 and #5 (they would make this comment too long to copy in full here). Note that this is the ONLY reference to trauma history in this section on careful evaluation (or the entire practice parameter for that matter):
“Information regarding any physical or psychological trauma the patient may have experienced (including multiple visits to the emergency room) should be gathered as well as any current psychosocial stressors.”
That’s it.
Then there is this:
Computer-Assisted Management of Attention-Deficit/Hyperactivity Disorder in Pediatrics in 2011. From Dr. Dulcan’s department.
Would also note this post:
http://claudiamgoldmd.blogspot.com/2012/03/behind-scenes-look-at-adhd-treatment.html
Finally, might note this in “lessons learned”:
“4.Researchers who study drug therapies and accept financial support from drug companies should have a clear sense of mission. According to former RWJF President Steven Schroeder, M.D., who first oversaw the TMAP project for RWJF, pharmaceutical companies have become a “lightning rod” for negative media attention. Because articles like the New York Times’ “Making Drugs, Shaping the Rules” may be published, grantees who accept drug industry support should make sure that “their motives are pure.” In the case of TMAP, RWJF saw an opportunity to improve treatment of a vulnerable population — seriously mentally ill patients in public mental health systems. (Former RWJF President/Schroeder)”
http://pweb1.rwjf.org/reports/grr/039931.htm
Mark Kramer, what an interesting background http://www.3daudioinc.com/3db/showthread.php?10921-Talk-about-irony-Antidepressants/page9 tbis page leads to lack of credibility, and a reminder that being a GSK paid speaker is probably the only reason he showed up here in comments re the PAXIL 352.
Excuse me Mickey, but I just had to comment on this, my BS meter went on overdrive when I saw Kramer’s comment.
This question is for Altostrata:
http://claudiamgoldmd.blogspot.com/2012/04/psychiatric-medication-in-children.html
Any references in the literature that you would particularly recommend re sexual side effects that don’t abate with withdrawal?
Thank you in advance for any information.
Actually, rereading my comment it’s the lack of the reference to trauma that’s most concerning.
I try not to comment on the time of other comments, but I think that both Dr. Kramer’s post and some of the replies engage in over-generalizations that may weaken attempts to establish a broader alliance to address the problems being discussed on the blog.
Someone who works with industry wrote a piece I particularly like. Pharma is onerously but in certain ways not effectively regulated. Academicians bear responsibility and have driven some of this while opposed by those within the research branches of pharma companies. The money grubbing KOLs vs the opportunistic journalist and lawyer jackals caricatures are at times of limited value.
Academicians and professional societies, and pharma, have largely taken rear guard actions. If Dr. Kramer, or others, can point to examples that parallel the effectiveness of journalistic, legal, and legislative attempts to reveal these machinations I would welcome them. Point to a parallel in psychiatry to the 2011 Spine Journal editorial referenced in earlier comments.
Amongst the concerns is when in one form or another a physician is provided hundreds of thousands to millions of dollars by a drug company and that same physician is involved in research and/or education and/or consensus development and/or committees …etc that in turn impacts millions to billions in profit for that same company.
I wouldn’t necessarily argue that it’s more concerning than in other areas of human endeavor, but would find it hard to understand why it would be less so.
In Study 329 McCafferty comes off sounding a lot more concerned about the presentation of the suicidally data than Dr. Ryan. If you look Dr. Ryan’s disclosure in 2008/9 he could list “nada,nothing.” Wouldn’t Dr. Carlat have had to list monies from being a speaker for Effexor. Between the three who would be more likely to be smoking a cigar with Nemeroff?
Couple of issues raised by Mark Kramer are interesting.
Firstly, it’s good to see debate here.
Kramer wrote:
“Sure I know who the narcissists and scoundrels are.”
Then maybe you should name them, it is they who are tarnishing the very same argument you are putting out here.
Kramer wrote:
“Even so, you generally don’t get a medication to market unless it is efficacious and safe.”
Hogwash! Medications are put to market normally after an 8 or 12 week clinical trial. Two years down the line and a whole host of side effects reported that show the drug isn’t safe highlights how thoroughly misleading your statement is. Many of the SSRi’s cause facial tics and severe withdrawal problems and suicidal ideation… not to mention completed suicide, many do not work – How is this safe and effective?
Kramer wrote:
“There is no debate on whether drugs for Major Depressive Disorder are efficacious. ”
Then you must have been living on the Planet Zog for most of your life, either that or you are one of the many professionals who bury your head in the sand when a patient complains of side-effects to you.
Kramer wrote:
“…what is unfortunate is that we do not yet have a biological test. ”
In other words you have no proof that these ‘disorders’ exist yet you and others willingly prescribe powerful drugs that alter brain chemicals – way to go!
Kramer wrote:
“So, the challenge.is to get the internal first drafts by hook or by crook”
Cases against pharmaceutical companies, more often than not, see settlements on the proviso that all items of disclosure are kept sealed. It’s an attempt to stop further litigation against pharmaceutical company ‘A’ and their product. The evidence is kept away from the public. 329 and 352 are not the only studies ghostwritten. All pharmaceutical companies hire PR firms to draft studies, they also target KOL’s to endorse them.
It’s been suggested [comments in this thread] that you have been paid by GSK. Can you enlighten us as to why GSK paid you?
Forgot to include the links:
http://www.pharmafile.com/news/175798/goldacre-right-greater-honesty-needed
http://www.spine.org/Documents/TSJJune2011_Carragee_etal_Editorial.pdf
In the case of Dr. Pliszka above, who was involved in both the Texas algorithms and the AACAP treatment parameters (both published in JAACAP) I don’t think that classification schemes of “scoundrel,” “narcicist,” “slouch,” or “sociopath,” nor of “thoughtful, kind, beyond brilliant, hard working, and beyond reproach” to be of great usefulness. I don’t know him to necessarily be any of those things. Nor whether or not his “motives are pure” as Dr. Schroeder would say.
Find a scientist you know and say to them that to participate in science they should make sure that their “motives are pure.” See how they look at you.
We don’t need “choir boys.” Amongst other things, we need something that addresses how a group of child psychiatrists writes a practice parameter about ADHD evaluation whose only reference to past trauma is the quote above, and is not listed among possible comorbid issues.
Food for thought:
http://edzardernst.com/2012/11/yet-another-homeopath-wins-the-nobel-prize/
Annonymous stated: “I try not to comment on the time of other comments, but I think that both Dr. Kramer’s post and some of the replies engage in over-generalizations that may weaken attempts to establish a broader alliance to address the problems being discussed on the blog.”
Lies are lies, fraud is fraud, greed is greed, and a crime is a crime after all….that is not over generalization….it is actually a dire warning volley being shot across the bow of our society…unfortunately…..I can only assume nothing will change as these so called conversations continue running off into relative obscurity…I can already hear those precious “open dialogue” folks who believe in redemption without confession or accountability; continuing to sit around on their hands, running in endless circles while twiddling their futile intellectual masturbation thumbs until someday history bestows upon them all the “Neville Chamberlain” capitulation award of achievement.
The writing is already on the wall that this unsavory marriage of between corporate greed & academic tyranny will eventually collapse in upon itself; and yet not before it’s gets horribly bloody for innocent & guilty alike…
“I wouldn’t necessarily argue that it’s more concerning than in other areas of human endeavor, but would find it hard to understand why it would be less so.”
I would have to say that the arguing is actually pretty much over….and the grave digging has already commenced…to even vaguely point toward those other evils of “human endeavor” is quite honestly using a straw mans approach to avoid the inevitable reckoning.
“In Study 329 McCafferty comes off sounding a lot more concerned about the presentation of the suicidally data than Dr. Ryan. If you look Dr. Ryan’s disclosure in 2008/9 he could list “nada,nothing.” Wouldn’t Dr. Carlat have had to list monies from being a speaker for Effexor. Between the three who would be more likely to be smoking a cigar with Nemeroff?”
I could quite honestly see them all around sitting around some lavish table spread blowing cigar smoke up each others arses…I know there are those that believe Carlat & his hand chosen notorious minions are somehow better than the Nemeroff’s of the profession/academia world….I would recommend those mislead believers chart a course of serious self reflection about what ethical behavior and personal integrity entails…
As much as it is distasteful to fathom, I must ponder that far to often the fumbling appeasers are as destructive & present a greater obstacle than the greedy charlatan oppressors themselves…
Re the lower-case annon author asking Altostrata a question (whom I do not see here in this thread ) about sexual side effects… it is an interesting twist that Mark Kramer’s study on a Merck med vs GSK’s PAXIL appeared to show LESS sexual dysfunction side effects, and that is why it is interesting that Kramer is paid for consulting by GSK (dollars for docs database) because he used both companies pills against the other yet seems to have ties to both companies monetarily….isn’t that conflict of interest? Who reads studies anymore and actually believes the data?
I am not a Phyc Doctor or any Doctor as a matter of fact….I am just a simple victim or better stated a survivor of the Paxil debacle….. Please excuse me, as I do not write as eloquently as the above do, but I will try to explain the horror that one goes through with an ill studied drug (ghost written) or ill written studied drug such as Paxil ….I can’t state it any simpler then, it was a living hell…. before and after. I was not a part of the above stated study, but I was prescribed the drug back in late 90’s for PTSS. I, due to the grace of god and only god ….I am here today. I knew then when coming off of this horrific drug, knew, that there was a huge problem with this drug, as simple as I am. It took me 2 years, to get my life back in to somewhat of an order (mildly speaking). Paxil is not only a bad drug for the study above 352…..it is just a bad drug period. I believe….. not shame on you all involved….. but God help you all involved! You took an oath…to practice medicine ethically and honestly and due to your greed and arrogance went for the holy dollar…. As far as Penn goes… they just might be purposely setting a precedence on how easy they are on the up for payoffs, for getting sub-standard drug on today’s market. (Very lucrative). In my neighborhood we call them drug dealers…. It’s a shame they can’t be prosecuted. I say when a drug is instituted all included…. should be held accountable to the fullest…. extent of the law (if there were a law), (there needs to be a law) and then and only then would we get decent drugs in the market place. The studies need to be triple blinded……that means, no one knows who, or what just the why…. I know there are a lot of good guys out there……but, It’s the bad one’s that make you all look like asses (nicely stated). We all need to go after the bad guys. Dr. Jay Amsterdam…..kudu’s to you…God bless you. Thank you from the bottom of my heart! it’s about time that someone brings this to the surface, we need more Dr. Amsterdam’s in this world.
Wow! his is terrific. Where to begin.
First of all I am very busy just now, but I love Jay and a few others posting here as themselves. I also love my medical research field. Not what it has become. And yes, I am a jazz musician primarily; have recorded on major labels, and learned a lot about fundamentalism on 3db audio.
And what am I busy doing? What would I rather be doing? My first love beyond family and friends is music, followed by science. See – I worked in industry because it was the place where I thought I could make a real difference in the world and at the same time be a patron to my family and art. And while at Merck I had a real creative scientific spark. It was just like a great jazz solo. I followed it to the end of what was possible – as an idealist – nothing more nothing less. And then when I left Merck for Music, without a safety net, because following my dream was no longer possible there, I still wished that I could bring into the world what I knew to be true. So, what I am doing just now is following my original discovery and helping it along. It is my legacy, and it is also the first really interesting mechanism in neuroscience for the past 60 years.
I was hurt when someone said their BS meter went up. I guess I hurt you first or someone close to you. And yes because of 2008, and b/c I follow my dreams, I do need to work at science at times. So why did Glaxo pay me? Not to write a bogus paper. They paid me to follow my dreams on my original discovery. So, I am glad you friggin’ asked. And make no mistake about it I am pissed at you. (Like I said it was me who started it, OK?)
It was a scientist at Glaxo – and I mean a really fantastic scientist and humble man – who replicated my discovery and Nadia’s – not once but twice – as did Pfizer – not once but twice. I replicated it 3 times. So how do you think I felt after being invited to talk at Nobel Hall, when I read in 2006 a Merck – ghost written paper (at Chris Lines got the credit) first authored by people whom I loved, but whom I can no longer can respect – Keller and Montgomery and a host of losers – who don’t know why they are so – from Merck. It was a paper proudly claiming that Merck using a hyped technology disproved what I considered an important discovery for humanity. This is not the right forum to debate my work. But in time there will be debate on the science of all this. You think things have been quiet here.? When Keller et al came out with its BS, and Nemeroff added a disclaimer about in the journal I published my formal replication – how do you think I felt? . Stephanie – I am sure you are great – but you need to change the battery in your BS meter
Of everything I wrote to Micky the only thing that excited me was ” . . . Fundamentalism posing for clear thought!” It took me 12 years to formulate that – and it just popped out. Thank you.
Wow and then I jyst saw Steph at it again. In the studies I conducted at Merck Paxil was used as an active control An active contro is used to benchmark the study. If Paxil doesn’t work in the study, the the study doesn;t work. Do you see? It just so happened – and I did not know about this before the study I published on MK869 that there my drug had so many fewer side effects truly, and that it lacked sexual dysfunction. It was amazing. But that wasn;t what was amazing. What was amazing was the principal of a very old survival meachanism – being involved in affective disorders. Don’t you see? What turns me on is not the business side. It is the creative side. That’s why most people go into science. Why can’;t you see that? And also most people go into medicine to help people. Why is your BS meter upo so high? It is a shame. Enough of you.
As far as the withdrawal effects – oh – they are horrible. That’s also why I was excited about the NK1 blockers. They didn’t seem to have any. It’s crazy – but I never personally ever met any evil doctors. .
The person who wrote in interesting prose about appeasers is a fundamentalist binary thinker who maybe doesn;t realize that his dishwasher works through fuzzy logic. . It took a while – but thjose who will argue like that guy are wired that way, and those who are more like me are wired my way. I like the way I’m wired. And many of my pals are fundamentalist/binary thinkers. Of what you – YAdda – are is a yadda Yadda Yadda ypurself . This means you like to talk too and maybe wish you could do more without losing your cool/ You said one thing though that rings right. There is now a sensitivity to what has happened, maybe because of Jay and also many others inclusing a lone blogger like 1Borig or moire prominent ones like Silverman. You have to be careful though. Left and Right wing media are businesses. And yes Corporate-academic greed. The world is in decay. I am getting older. I am sure this is what my grnadfather said too. Only problem is he was right.
I just can’t follow the business about Dr. Pliszka. He had to have been related to one of the qualifiers I used. I think we do need creative and good people in medical science. Jay is a good example; I really do think I am too and so many I know. And while we are at it, I did smoke a cigar with Charlie. I liked Charlie, way before I understood Charlie. I don’t like Charlie now. It still isn’t persona. I donlt like him because the F’ker brought down my field. I just didnlt know this crap was going on. Honestly. He was totally outrageous – on the phone while he was supposed to advising! Charlie lost a child – talk about severe justice. I don’t know what what makes him – or those of his lose network – tick. I never had the choice to join. .
And Jane I don’t feel like an ass. And you are right when a profession does not police itself then there are problems.
So what am I to do? Become a policeman now, a musician and a scientist. As I see it, Dr. Professor Jay is doing some heavy lifting. But you know it has always been that way. Groups of wanna bees don’t write symphonies. Most significant actions are from a combo of grace and ability, and most people don’t know why they are called to do what they do, anyway -so I think. .
Now Fid is one of those who is running his own little thing. I do like what you do. You should drop the tone, though. I don’t think you found my comments interesting – I think you saw an easy target to punch rhetorically. Firstly we all know the scoundrels – they are those in the headlines of Grassley and Thacker: Nemeroff, Keller,and others whose extent of potential criminality I do not know. But I do know a lot people like Ranga Krishnan, who you’d be advised to understand. It would take away some of the cynicism. There are still good people left. As far as your arguments against the regulatory process: you are being naive and talking as the uninformed. It’s interesting that nobody here has called you out. That’s maybe because I’ve stepped into a right wing leftist room? Every med I worked on had one to two years of long term data. I should know because I was the one who created the tables, did the work not for the faint of heart. Only terrific epidemiology can dissect truly troublesome problems with the meds over time. Again, Many of us are now taking life saving medications. Try not to throw the baby out w/ the bathwater. The conundrum is the tension between tort and treatment. You have to do your thing; I need to do mine – wh is mainly to finish this thing and get back to work. Nobody disputes the need for post market awareness. My understanding is that things have improved, not gotten worse. I could be wrong.
Many of the SSRi’s cause facial tics and severe withdrawal problems and suicidal ideation… not to mention completed suicide, many do not work – How is this safe and effective?
“There is no debate on whether drugs for Major Depressive Disorder are efficacious.”
Efficacy is way different from side effects. Whether side effects are tolerated gladly or not. depends on the severity of illness. To be blunt if you are concerned about a little nausea, sexual dysfunction, constipation, you shouldn’t be on the frigging medicine. It is likely you have a personality disorder, can’t cope with life, and ought to see your closest friend or minister. Stop your crying’ Medicine probably isn’t the answer. Ever hear of talk therapy? Talk about fraud! I’ve been living on the same planet as you have Mr. Fid. If you or yours have ever had side effects, and still think you need a psychotropic then you just have to keep trying them all – hopefully while you are supported by a good friend or doctor. Unfortunately the latter are also treated like cattle bu 3rd party insurers. I don’t have the answer. Life sucks.except when it doesn’t. Why were you born anyway? To do exactly the crap you are doing!
“””” In other words you have no proof that these ‘disorders’ exist yet you and others willingly prescribe powerful drugs that alter brain chemicals – way to go! “”
That was rich. Tell that to your favorite clergyman., your favorite healer, your favorite, whatever. Here is what I know Oh ye argumentative Fid man for way down yonder:
Serious severe depression is as stereotypical as a piano with strings that have all been unwound. It nearly always has 88 keys, never goes out of tune, but doesn;t make much of a sound. The piano cannot restring itself string. When it gets cold ad the humdity changes the strings may begin to tighten, and often after 9 months the piao is playable. But for most pianos, in that condition if you hire piano technician, he can get the string back in shape in maybe three weeks to the day. And you know the instrument will sound better according to the variation in barometric pressure daily.
Serious depression is that way. I want to deal with you with compassion. But you already know that you have blocked that approach. So, let me give you a recommendation if you wish. Go to the inpatient hospital as a volunteer and see it. It also exists as outpatient but not so prominent as in yesteryear. Please stop bashing. It’s so foolish.
” 329 and 352 are not the only studies ghostwritten. All pharmaceutical companies hire PR firms to draft studies, they also target KOL’s to endorse them.” Of course. But you really missed my point. Just as this bashing goes, keep an open heart to what might be right in medicine. I do know.
“It’s been suggested [comments in this thread] that you have been paid by GSK. Can you enlighten us as to why GSK paid you?” I hope you understand me a little better now. Even after all this if you still point your finger of blame towards me, I would say to you this: (the same thing I said to Elmer Gantry” 1 finger forward, 3 back. If you do not understand what I’ve said about myself, and those closest to me who are actually great playing it straight doctors and scientists, then . . . there is nothing more to say to you . . .you’ve been hurt along the way. I am sorry.
Whoever wrote this is really thoughtful: “Academicians and professional societies, and pharma, have largely taken rear guard actions. If Dr. Kramer, or others, can point to examples that parallel the effectiveness of journalistic, legal, and legislative attempts to reveal these machinations I would welcome them. Point to a parallel in psychiatry to the 2011 Spine Journal editorial referenced in earlier comments.”
Why not give your name and what you do? I completely agree with you. There are no other effective remedies. When I first became aware of Medicare fraud I was in Medical School. My thought was , “where is AMA, the PMA, where are my future peers? It was 2 or 3 guys who were the bad actors. Now, it seems this kind of fraud can’t be stopped. So yes. BTW legal, tabloid, and legislative methods are all corruptible as well.
One thing that just occurred to me is that “doing what is right” is not so easy. It is a huge commitment to clean up this mess. As a friend once said to me when I bean to tilt at a mill, “Mark, simply try to bring less evil into the world.”
Only thing I am doing here is avoiding work, and also saying to those of you trashing the whole field, “stop the nonsense, but continue the hunt.” I just can’t – and won’t do it – except to add some balance. That’s my job. I do not see it as appeasement – as I’ve already agreed with the main premise. I mean what the hell so some of you?
And now for the principal reason- 1BOr’s thoughtful comments – NExt
So. Yes. I approve – FWIW – of what you are doing, and mainly because Jay loves you – and I love Jay . And yes if you wish – and you do – you will keep it up, b/c someone needs to do it. As far as our peers not stepping up: that is right – I think. I’ll tell you what caught my eye is the person who showed all the COI statements at the end of an article! What a hoot. It is theatre. Whoever said the marketing arms of Pharma need a kick in the backside – they are right.
I knew Llynn Crimson. Not well. But when I read that stuff I always wondered how a pharmacist could get so involved w/ big Pharma. Big pharma puts candy in front of these people. It is their weakness and greed, and Corporate overreach that provides the sweets. How many of those who’ve been corrupted had the impulse control and sensibilities of 2 year olds. How many are sociopaths? I don’t know.
Years ago I tried to devise a for profit Good Seal of . . . “any product you could name” I tried to devise ways in which it could not be corrupted. I gave up.
To wax even more philosophical: Sometimes I think the only thing that will shock humanity into awareness self regulated conscience is either the real second coming . . . an alien invasion . . or either as staged by Dreamworks.
As I wrote in my very first post – there are probably high percentages of papers in phase II and IV/V – but I really do not know how many are entirely ghostwritten for KOLs, or how many of those KOLS did any work. As importantly – I wonder how many have just restated the obvious, or were review papers that caused harm?
I certainly agree that ghostwriting is ghostwriting if the original draft is not shredded to threads.
I can’t do what you say, so you will keep doing it. But rest assured, I’m no shrinkin’ shrink. However my central message to detractors of medicine . . it is still a young science. Look how far we’ve come. At least we know the brain is not a muscle (except that it mostly is.) I also feel that the fight between the north and the south has ever been resolved, nor the psychoanalysts and biological psychiatrists.
I think you are helping me articulate my greatest concern. Corruption is blatant, paraded more openly than ever before. Having been on the inside I do know that hard to find place where corruption is not; where that is, is a wonderful place. Havig been a student of the street too as world traveled musician, I do know that hard to find place where corruption is not; where that is, is a wonderful place.
My bias is towards friendly people as healers. But for the really mentally ill I favor biological Psychiatry practiced by friendly people. I applaud those people in industry who never cared much about marketing, and who invented some of the most spectacular medicines we have. I don’t think they could have done what they did and fought the predators in the other building. Maybe it is why – at some level – I left the corporate world. However, perhaps I should have done more to call out the KOLs I suspected of gaming us. You’d be surprised at what I’d done anyway. Not your typical corporate type./
After all these years I still do not understand our species or our planet. But I know how (on my own terms) to play jazz piano as good as anyone who ever played. I know how to do the calculus of pharmacokinetics and to analyze whether a drug will be able have a chance at being therapeutic, I know pretty much how to manage a group of 100, and I know that the issue under discussion – too – will come to pass, just as each and every one of us will. And I know how to tyoe typos and ru n on sentences.
Nobody can do much better than we are. And that is revolting, funny, and touching. It is a taste of our creator’s psychology. Of course, some don’t believe in that God stuff – well because there is no scientific basis?
Best regards, Mark
Well Dr Kramer, I don’t think Nemeroff “brought down your field” as you write in one of your long comments above. He, as you are–still is in the biz and making money the same as ever–no sanctions get past that guy, he is alive and well as you know in Florida still promoting himself and psychiatry.
I felt the need to add your GSK payments from the Dollars for Docs database here because you, in a thread abt GSK and Paxil conveniently left out the fact that they paid you in 2010 as the data states—and the follow your dreams thing is a nice touch but I for one live in the harsh reality that yes, my adult child is now disabled due to the harm from psych meds and I do not need to see the inside of a locked down psych unit–as a volunteer—you fail to understand just who you are writing to here, and maybe it is not all for me.
No further engagement will be coming from me here, I predominantly like to write and read about the transparency of the psychiatric /pharma world. That won’t change, and writing about it won’t change things either, Nemeroff is proof of that.
Perhaps from an entertainment pt of view you can consider some of us a “hard audience” to please
Bravo!!Bravo!!
Thank you for that rambling nonsensical narcissistic tirade (I haven’t laughed so hard in ages) especially when coming from a self proclaimed “worlds greatest whore house piano player”. 🙂
It’s so unfortunate that your true self aggrandized appeasement colors have shown through brilliantly for all the world to see here Mr. Kramer…..
In bidding us a fond farewell; would you like to now play us your bastardized jazzed up version of your favorite Nemeroff/GSK dedication love song just for old time sake http://www.youtube.com/watch?v=mOcU40jqToQ LMAO