foul…

Posted on Monday 14 January 2013

Pharmagossip has a post up that links to a post by Peter Breggin about some discovery documents from Eli Lilly in a time when the world was young. This from Dr. Breggin:
The sealed Prozac data from Eli Lilly also came from my investigations of the company as a medical expert in product liability suits. The British Medical Journal [BMJ] recently obtained the sealed documents from an anonymous source and released them to the FDA and the U.S. Congress.
I got really lost following the timeline and their exact path from sealed into the public domain, and promise to try to get that in order soon. But for now, I just want to mention the two emails that Jack Friday points to on Pharmagossip. They’re from 1990 [Prozac was launched in 1987 and the first FDA hearings on SSRI suicidality were in 1991]. An Eli Lilly employee, Claude Bouchy, is writing to his superiors, apparently responding to a request from another corporate group asking that he change the physician reported identifier of adverse events on several subjects in a Prozac Trial. The documents are from another era – before there was a world wide web – so they’re printed by teletype, fading and marked up with notes and underlines. They’re pretty challenging to read so I’ve transcribed them below for convenience [link to the originals]:


This is message #1 from: BOUCHY CLAUDE
November 13, 1990 10:49
To: THOMPSON LEIGH, WEINSTEIN ALLAN J, ZERBE ROBERT L
CC: MAYR GERHARD, TAUREL SYDNEY, WEBER HANS J

RE: ADVERSE DRUG EVENT REPORTING-SUICIDE FLUOXETINE
Hans Weber and I have problems with the directions our safety people are
getting from the corporate group (Drug Epidemiology Unit) and requesting that
we change the identification of events as they are reported by the physicians.

- GEB-FLM039(DEN #GE90100350A). On this one, our safety staff is requested to
change the event term "suicide attempt (as reported by the pshysician) to
"overdose".

- GEB-FLM025(DEN #GE 90090427A). On this one, it is requested that we change
from "suicidal ideation" to "depression".

Hans has medical problems with these directions and I have great concerns
about it. I do not think I could explain to the BGA, to a judge, to a reporter
or even my family why we would do this especially on the sensitive
issue of suicide and suicide ideation. At least not with the explanations
that have been given to our staff so far. I am quoting "When an overdose
is taken in a suicide attempt, our Research Physicians prefer to list the
event term overdose" even if "when tracking suicides, we always look at all overd
ose and suicide attempt reports".
This issue has been argued back and forth for about a month between Bad Homborg
and Indy, therefore I am bringing it to your attention and await your
directions.
Regards,

Claude.


November 14, 1990 06:47

To: THOMPSON LEIGH
CC: MAYR GEHARD, TAUREL SYDNEY, WEBER HANS J,
      WEINSTEIN ALLAN J, ZERBE ROBERT L

November 14, 1990 05:58
RE:ADVERSE EVENT REPORTING – SUICIDE FLUOXETINE
Thank you very much for your prompt answer and your detailed explanation. Hans
and I rediscussed the issue in depth.
Our point is the following: the physician has reported a suicide attempt. Do we
have the right to change it to some terminology which we may consider to be more
specific e.g. overdose, but which is not free from ambiguity and could be
regarded as inaccurate or misleading?
The term overdose is not free from ambiguity because there are clearly forms
of overdose which are not related to suicide attempts, for instance wrong
dose prescribed or dispensed error on the part of the patient etc … In fact
and perhaps more importantly, the dictionaries we have looked at [medical
dictionaries and non-medical] fail to associate [not to mention equal] the
concept of overdose with suicide attempt.
In addition, it can be argued that the event term overdose is inaccurate or
misleading because in this case the patient attempted suicide by taking
an overdose of barbituates and tricyclics and not, I repeat not, of fluoxetine.
Finally, on a very simple and non-scientific basis, I personally wonder whether
we are really helping the credibility of the excellent ADE system by calling
overdose what a physician reports as suicide attempt and by calling depression
what the physician is reporting as suicide ideation. We fully realize that there
is no code in our DSM system for suicide ideation but it could be argued by
people who have little sympathy to the company or by regulatory authorities
that it is not a responsible way to deal with an issue which is getting so
much attention in the scientific and in the general press. It could also be
argued that the term depression is not specific in this case.
Of course, at the end of the day, we will do what we are told to do but Hans
and I felt that we had to bring these points to your attention.
Regards,

Claude

It’s apparent that Claude has been asked by the Drug Epidemiology Unit to change several reported Adverse Events from the way the physicians reported them [suicide attempt -> overdose, suicidal ideation -> depression]. So already we know a lot:
  • they’re messing with the medical reporting in a clinical trial
  • they’re worried that Prozac will look like it causes suicidal thinking
  • they’re manipulating the outcome of the study to hide serious adverse events
Claude is calling foul on this kind of obvious falsification of data, though he doesn’t quite say it outright. Claude and Hans actually lay out a pretty good argument about the wages of sin, and seem to be recommending the high road [even though there's a hint of some CYA in there too]. They go on to warn about the particular danger of this kind of sheenanigans on such a controversial and public issue. But just as we’re about to canonize Claude and Hans, they go over to the dark side, "Of course, at the end of the day, we will do what we are told to do."

My reaction to these emails is mixed. On the one hand it’s disillusioning to see this kind of blatant corruption so early in the game. On the other hand, after so much speculation about what went on in the background, it’s confirming to read it there in black and white – almost a relief. But mainly, these people were messing with reporting suicide attempts – the worst side effect of all. They knew what they were denying, what it meant, and their reflex was to hide it in the word-play of reporting – change the data. A crime is being contemplated, one actually soon committed. And all of this is going on less than a year before the FDA Hearing on Prozac and suicidality in September 1991 where the freshly appointed Chairman of Emory Psychiatry, Dr. Charlie Nemeroff, will testify as Eli Lilly’s star witness – making his debut with a lie:

September 20, 1991

"I would suggest to you that I have as little confidence in these anecdotal reports as I do in the anecdotal report of Teicher, and that, in fact, there is no substitute for controlled prospective double-blind clinical trials…"

"In conclusion, there is simply no scientific evidence whatsoever, no placebo-controlled double-blind study that has established a cause-and-effect relationship between antidepressant pharmacotherapy of any class and suicidal acts or ideation."

"As Drs. Potter and Fawcett have suggested, limiting the availability of antidepressants could have a very profound adverse effect in terms of increasing the morbidity and, in fact, mortality associated with untreated depression."

    Dr. Charles Nemeroff, Professor and Chair
    Department of Psychiatry
    Emory University, Atlanta Georgia
hat tip to Pharmagossip and Peter Breggin  
  1.  
    Evelyn Pringle
    January 14, 2013 | 11:09 AM
     

    I was happy to see that you picked up on how early Chuck Nemeroff was shilling for the SSRI makers. From the start you might say.

  2.  
    January 14, 2013 | 12:59 PM
     

    Two things I have said before, and after this post, feel worth repeating:

    Lilly is one of the most corrupt in the business, first with Prozac, then with Zyprexa, and now with Cymbalta… What will be the latter’s poisons to learn?

    and, the only way to enact change is to make felony charges, not just on pharma, but, on the APA too.

  3.  
    January 14, 2013 | 1:26 PM
     

    What filtered down to the folk at that time was that the people who had committed suicide on an antidepressant were just too depressed to do it before taking the medication. If psychiatrists were warning patients that they might start feeling good enough on an antidepressant to commit suicide, then I missed it.

  4.  
    January 14, 2013 | 2:44 PM
     

    A psychiatrist I know said that Smith Kline Beecham (later acquired by GSK of Paxil fame) was run by “psychopaths.”

  5.  
    Fid
    January 14, 2013 | 3:35 PM
     

    Old Charlie “Bling Bling” Nemeroff doing what he does best

    bling
    ‘ Nemeroff

  6.  
    berit bj
    January 14, 2013 | 3:51 PM
     

    40 % of the patient groups in 56 countries surveyed by PatientView at the end of 2012 rated the pharmaceutical industry reputation as “poor” on price fairness and transparancy, according to FiercePharma today. Only 4 % of the respondents marked the business as “excellent”. Two-thirds of respondents from Europe,11,5 % in the USA.

    I’m an optimist. Bio-bio-bio-psychiatry will be history, and take with it the psycho-pharma- dominated toxic psychiatry, ruining lives and environments. Wiser, more careful and honest voices are being heard. Robert Whitaker is making the rounds in Europe. His and Ben Goldacre’s books are being translated and read.

  7.  
    Terry Bearden
    January 14, 2013 | 4:58 PM
     

    We were told that our son’s illness was so severe that the pills (Effexor XR and Seroquel) gave him the strength and energy to do what he was going to do anyway. He committed suicide in 2003. He had never been “weak” or lacked “energy.” If I had to describe the issues he was struggling with that led to him seeking “professional” help, I would use the term “anger issues.” His diagnosis was MDD. We immediately pushed back but were rebuffed by a psychiatrist who assured us he need about 3 months for his body to “level off.” He died after 7 weeks.

  8.  
    Mark
    January 15, 2013 | 8:37 PM
     

    Altostrata - low-road.

    Is your forum officially a non-profit?

    You realize that it is probable that your account will be frozen if you accept donations through PAYPAL. It makes no difference whether you are operating at a loss.

    Adios. Mark

  9.  
    Mark Kramer
    January 15, 2013 | 9:11 PM
     

    “I’m an optimist. Bio-bio-bio-psychiatry will be history, and take with it the psycho-pharma- dominated toxic psychiatry, ruining lives and environments. Wiser, more careful and honest voices are being heard. Robert Whitaker is making the rounds in Europe. His and Ben Goldacre’s books are being translated and read.”

    Crap as spoken by a Luddite.

    Be sure to follow these “wiser voices” to their banks. An anti-bio book by Ross and Lam caught my attention in the 90s. Now in 2009 Ross is nothing more than a shabby cabby – a driver of his own non-medicine cart. Primitive snake oil.

    You’ll see how fast you turn around when (or if) a substantial medical discovery is made in the field.

    The problem is knowing which horse to back.

  10.  
    Catalyzt
    January 16, 2013 | 11:43 AM
     

    Mr. Kramer, what’s up with the name calling? Most blogs where the intelligence level is this high have a policy against ad-hominem comments.

    “You’ll see how fast you turn around when (or if) a substantial medical discovery is made in the field. ”

    And now, precisely, is that going to happen if research protocols are so badly compromised? This is the larger point, I think. The field, like so many others, in the past half century, is moving backwards.

    In psychopharm, I think the low-hanging fruit has been picked. Clear thinking and unbiased research will be essential if there are any new discoveries to be made.

  11.  
    mark Kramer
    January 17, 2013 | 11:54 AM
     

    And now, precisely, is that going to happen if research protocols are so badly compromised? This is the larger point, I think. The field, like so many others, in the past half century, is moving backwards.

    No. I am working on a new strategy. It’s a draconian version of a cumulative N of 1 approach. Clinical trials are a crapshoot these days unless I personally oversee them.

    In psychopharm, I think the low-hanging fruit has been picked.

    Correct.

    Clear thinking and unbiased research will be essential if there are any new discoveries to be made.

    Absolutely. So you are not a luddite. Whitaker and Goldacre are off the chart bright journalist/activists. Like all other parasites they do not produce what we need. Their opening light is spectacularly blinding. Subsequently, their followers are in darkness.

  12.  
    berit bj
    January 18, 2013 | 8:24 AM
     

    Mark Kramer. I find your comment most revealing. If this is a passable level of discourse among your equals, I decline the decent downhill.

    But I’ll respectfully point to what the industry itself is doing, as reported in business pages of major MSM. There is as little hope in scientific breakthroughs in psychiatric drug research as in brain research. What honest researchers (for instance Steven Rose) have found and reported points to awsome complexity of the human brain, and Nancy Andreassens et al. found progressive brain shrinkage in rodents fed neuroleptics, reported even in theNYT, though the Scripps Institute in Ca sticks to their script, skipping this vital factor when they search preordained, prepaid answers in order to keep biological psychiatry afloat long enough so that the whole industry can get precalculated gains from another round of me-too toxic drugs. But business is gloomy except for injectable Abilify with a lease of life as “new” and patent- protected. The lucrative “schizophrenia-market” is expiring, as ever more informed patients and doctors are discarding the diagnosis as unscientific, because it is an invalid construct and, in spite of a hundred years of effort, still unreliable.

  13.  
    berit bj
    January 18, 2013 | 8:44 AM
     

    Sorry, I meant to write “downhill descent”, but writing decent instead, while keeping my hot temper in check, is funny.

    As for the Luddites, they had every reason to worry. The Industrial Revolution made riches for the few, generations of misery for the many, till the working people got themselves organized. New technologies, new industries, globalization, history repeating itself?

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