the 1boringoldman compromise…

Posted on Saturday 7 September 2013

In that video [a deal-breaker?…], Neal Parker of AbbVie, tells us that there are secrets in the Pharmaceutical Companies negotiations with regulators that might help the evil-doers in Bangladesh do a bio-equivalency study, clone his company’s product, and steal their business right out from under them. It might even be important to keep Adverse Effects secret from competitors for that reason. It wasn’t the best choice of examples for him to use, but that aside, let’s assume for the moment that outside the clumsiness and awkwardness of his presentation style, he has a point. Since I personally don’t think of Clinical Trials as research, it’s difficult for me to even understand what the things he’s referring to might be. Clinical Trials address two things – Efficacy as measured by some objective parameter, and Adverse Events, negative consequences of the drug’s use. But in the spirit of fair play, I’ll forgo those thoughts for the moment and proceed as if he’s referring to some unusual circumstance where the bad meanies could gain something of value from full access to the results of a Clinical Trial.

Is that a reason to keep the actual data for all Clinical Trials secret, proprietary, locked up in their vault or the vaults of the FDA or the EMA? Of course it isn’t. That’s like the 5th grade joke: A man stands on a corner in Birmingham clapping his hands. When asked why, he says, "To keep away the elephants." The inquirer says "There haven’t been any elephants here since the Ice Age!" to which he replies, "See, it works! Doesn’t it?" So even if Mr. Neal Parker has a real point that there are unusual circumstances where the information submitted to the FDA or EMA really might compromise his company’s product, that’s an exceptional situation – nowhere near the norm and certainly nowhere near a valid reason to hide the outcome data for all Clinical Trials. It looks to me like it’s a situation that calls for the 1boringoldman compromise.

The elements of the 1boringoldman compromise are as follows:
  1. The Pharmaceutical Company submits a request for some specific aspect of the trial they think they should be allowed to keep secret with a full rationale for their request, examples if necessary.
  2. An independent panel then evaluates their request and passes judgement based on the 1boringoldman compromise guidelines for such matters [no vague hypotheticals].
  3. The company then submits their drug, bound by that decision – a decision that becomes part of the public record.
  4. All other data from that Clinical Trial is fair game for the 1boringoldman compromise version of data transparency [which is that everything from the trial should be public and readily accessible].
Except for the name, I’m dead serious. Why should I have to prove to them that I deserve access to the raw data from a Clinical Trial used to approve a drug that I’m recommending to a patient? That’s totally backwards. The onus should be on them to prove that they have a genuine reason not to let me and my patients see it [and there aren't many of those]. That’s my final offer…
  1.  
    CannotSay2013
    September 7, 2013 | 10:37 PM
     

    Mickey,

    I am very thankful that you created this blog and that you let somebody like me to post his opinions on this matter. Now, seriously, I think you are missing the forest for the trees. In your own compromise, you say,

    ” Clinical Trials address two things – Efficacy as measured by some objective parameter”

    EXACTLY! The problem with all psychiatric drug trials is that there is no objective parameter whatsoever to be measured. No HIV antibody test (as in the case of HIV vaccines), no viral count/CD4 count (as in the case of HAART drugs), no cholesterol levels (as in the case of cholesterol drugs), no sugar levels (as in the case of insulin substitutes), etc, etc. All you have are nonsensical psychological questionnaires which, unlike IQ tests do not measure anything quantifiable, and the “opinion” of psychiatrists.

    You have made through the years excellent points as to why psychiatry is a pseudo science. You’ve done everything except admitting explicitly to this fact. Be courageous, and join the many of us who have reached precisely that conclusion.

  2.  
    Bernard Carroll
    September 8, 2013 | 10:06 AM
     

    Cannot: I think Dr. Mickey deserves better than that misguided and ill-informed attempt at gotcha. Laboratory tests are the servants of clinical science, not the other way around, and clinical science has a long history of successful progress in diagnosis and treatment before lab tests came along for diagnostic confirmation. You might ought want to take a look at this little discussion from a few years back.

  3.  
    CannotSay2013
    September 8, 2013 | 12:44 PM
     

    Bernard,

    That post is nothing more than a self-serving justification of psychiatry that repeats the same linguistic trickery which is as false today as it was then. A pattern of behavior disapproved by a DSM committee IS NOT a physiological symptom, which is what a migraine is. You can repeat the lie as many times as you want, it will not become true.

    My comment was not meant to be an attack or a “gotcha” for Mickey. Quite the contrary. I am very thankful for the many things he has exposed here. However, he has done everything but acknowledging that psychiatry js a pseudoscience. He has exposed its many pseudoscientific traits, but for some reason, he (and you) refuse to acknowledge the obvious.

  4.  
    wiley
    September 8, 2013 | 12:55 PM
     

    I know I’m not being too good about being on topic, but I think this kind of financial motivation is not limited to the drug companies. The publication of the DSM-5 appears to be more about making money than contributing anything necessary to clinicians and clients.

    I’ve been looking for papers on class bias among psychiatrists/psychologists toward clients and its effects on diagnosis. Papers from 1997 and 1976 are still behind paywalls!

  5.  
    Melody
    September 8, 2013 | 3:00 PM
     

    Cannot,

    Wasn’t there a time when there were FOUR elements? Air, fire, water, earth? My, how things have changed. We now have a periodic table, with “new” (created) elements being added from time to time. Assuming we don’t annihilate our species with one or another of our scientific achievements, how will future humans look back on this epoch of science? Will they laugh and call all of today’s chemists, engineers, mathematicians, physicists, etc. pseudoscientists? I agree with some of what you say, but I believe people like Mickey and Bernard are trying to move the discussion forward.

    My husband is a plant scientists, and, like you, views the “science” of psychiatry with a jaundiced eye. But even he admits that his loving spouse has benefited from (is alive because of) antidepressants; and he has (perhaps unknowingly) served me well for many years as a talk-therapist.

    Without getting contentious with him, I’ve wondered how the early days of his “science” were measured. Application of fertilizer to a plant would (generally) make it greener. But ‘greener’ in whose eyes? What if I’m color blind and don’t see ‘green?’ Other metrics–size, disease-resistance, cold-hardiness, yield–I’m sure initially had no laboratory confirmations. But observations led to study, which led to science, which led to knowledge, which led to advancement. Rather than labeling psychiatry as a pseudoscience, I would be more inclined to think of it as embryonic science. Quite frankly, I think most of medicine fits that category–we know a lot more than we did once upon a time . . . but when you consider the human brain and the complexity and interconnectedness of the brain/body–we really don’t know very much.

  6.  
    CannotSay2013
    September 8, 2013 | 3:09 PM
     

    Bernard, Mickey,

    And I also have to say the following. This study http://www.nature.com/nature/journal/v318/n6045/abs/318419a0.html (which is behind the Nature pay wall but that I am sure you should have no problem accessing through your academic connections) is widely cited by skeptics and scientists alike to show unequivocally that astrology is a pseudoscience. That is in spite of numerous attempts by astrologers trying to refute it in peer reviewed astrology journals, very recently this http://www.astrologer.com/tests/carlson.htm .

    Perhaps it is because I don’t have my critical thinking biased by having made a living of (or by continuing to make a living of) psychiatry that I see the numerous similar studies, like Kirsch’s, made on antidepressants and other psychiatric drugs as equally indicting of biological psychiatry. Other very credentialed scientists have reached exactly the same conclusion http://whyevolutionistrue.wordpress.com/2011/06/25/is-medical-psychatry-a-scam/ .

    That is not to say that there isn’t people who genuinely benefit from psychiatric drugs. just as there are people who genuinely benefit from astrology or homeopathy, but with the evidence at hand, psychiatry needs to be presented as a pseudoscience, not as a scientific endeavor. And the reason psychiatric drugs seem to work for some people has to be recognized for what it is: the powerful placebo effect.

  7.  
    CannotSay2013
    September 8, 2013 | 3:10 PM
     

    Melody,

    I just published an elaboration of my views, in response to my other comment, that I think addresses your concerns. Let me know if that is not the case.

  8.  
    CannotSay2013
    September 8, 2013 | 3:13 PM
     

    Just to add (and sorry because there isn’t and edit button),

    “Rather than labeling psychiatry as a pseudoscience, I would be more inclined to think of it as embryonic science. ”

    That would have been plausible if psychiatry wasn’t a 200 year old specialty with a record of drapetomania, hysteria, insulin therapy, electroshock, lobotomy, homosexuality and the current 400+ insults made up of nowhere included in the DSM.

    Psychiatry, just as astrology, has been given more than enough opportunity to prove it self. It has failed “miserably” in every case. And by “myserably” I mean millions of lives that have been ruined by psychiatrists.

  9.  
    CannotSay2013
    September 8, 2013 | 3:28 PM
     

    Here I found a copy of the Nature study in astrology. I encourage those scientifically inclined, and trained, to read it carefully http://www.objectiveastrology.net/uploads/1/6/7/2/16726802/a_double-blind_test_of_astrology_carlsons_original_article_in_nature.pdf .

  10.  
    Melody
    September 8, 2013 | 4:29 PM
     

    Cannot,

    I might argue that unknowable—but large—numbers of lives have been ruined by doctors who think they understand how to correctly treat diabetes. Are those who study diabetes and/or treat diabetics pseudoscientists, too? After all, they’ve been working at this for almost 100 years.

    There are those who would credit Frederick Banting (discoverer of insulin) as a scientist of the first order. Think of all the lives saved because of insulin. On the other hand, once insulin was discovered, the true cause of (Type 1) diabetes has never been unearthed. Likewise, once the ‘treatment’ solved the problem of imminent death, the search for a cure exists today primarily as a fund-raising talking-point. Treatment has become the be-all, end-all. Today’s scientists continue to search for a me-too, latest/greatest insulin-like formulation. Or they create new gadgets (monitors, meters, pumps, specialty foods)–that will improve ‘quality of life.’ And because we now have laboratory results (bG’s, A1c’s, c-peptide’s, etc.) that can measure certain values, we consider all these advancements as scientific because they’re objectively quantifiable.

    Is the glass half full, or half empty? You might believe that wonderful diabetic specialists give hope and life to diabetics; I see them as impediments to the search for both cause and cure. Are diabetic specialists really only pseudoscientists, guiding uneducated patients through the maze of today’s treatment paradigms? Their livelihoods depend on ‘treating’ patients–not curing them. We have the means to measure all sorts of disease parameters and patient compliance. These measurements are indeed objective—but is that the only criteria dividing science from pseudoscience? I don’t think so.

    (Cannot, I’m not trying to be contentious with you either. I do understand that mental illness or mental health is, in so many ways, a different animal . . . and more easily manipulated by both patient and practitioner. I just think that labels get in the way of progress. Hubby and I have interesting conversations regarding pseudoscience vs. science; he sees only black and white while I continue to be awed by current and historical shades of gray.)

  11.  
    CannotSay2013
    September 8, 2013 | 4:47 PM
     

    Melody,

    Even you concede that so called “mental health” is a different thing from genuine diseases, so this reference to “diabetes/insulin” that has been used by psychiatrists ad nauseum is irrelevant,

    “I might argue that unknowable—but large—numbers of lives have been ruined by doctors who think they understand how to correctly treat diabetes”

    What is relevant in a discussion about “ruining lives” is the coercive nature of psychiatry. Insulin treatment for diabetes cannot be imposed (although “insulin therapy” for so call “mental illness” could at some point, like it happened to John Nash). HAART cannot be imposed to newly diagnosed HIV patients even though these patients pose an arguably higher risk for the public health than any subset of people identified as dangerous by psychiatrists (just in 2010 15000 people died of AIDS http://www.cdc.gov/hiv/statistics/basics/ataglance.html ). The overwhelming majority of HIV transmissions in the US are preventable but we don’t preemptively lock in HIV positive people (the only country that has done it has showed that such a strategy would be extremely beneficial to put the HIV epidemic under control http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2688320/ ). A similar argument could be made to preemptively lock in black teenagers living in the inner cities. However, none of that is, thankfully so, legal in the US.

    The reason you have those arguments with your husband is because he is a scientist and you probably aren’t.

    Science is indeed black and white. If you want “gray areas” go to the arts, the humanities, or astrology. If you, however, are going to call something “science” you better have testable falsifiable predictions (which the theory consistently predicts well) or you’ll have something that might be worth studying, but it will not be science.

    And here is the thing. If both Mickey and Bernard were to join me, and the survivor movement at large, in fighting for making psychiatry a 100% voluntary endeavor as in ALWAYS, not except in case A, B, C, I might be more sympathetic with their position. But as long as they continue to defend coercive psychiatry, I have no recourse other than continue to fight psychiatry itself.

  12.  
    CannotSay2013
    September 8, 2013 | 5:40 PM
     

    Elaborating further (and sorry for the extra comment, but again, there is no “edit” button) I have to say that it is my experience that non scientists have in general a distorted vision of what “science is” vs what it isn’t.

    I don’t blame these non scientists entirely because the media is full of references to a mythical, non existent “scientific consensus” on so many vital issues that people might have come to believe that indeed science works by “consensus”.

    In science there is no such a thing as “consensus”. Science presumes a regular, totalitarian order in the universe/nature and uses the scientific method to discover such order. Applied scientists/engineers use that scientific knowledge to develop applications or, “cures”, as they are called in medicine.

    Take AIDS as an illustrating example. Science tells us that it is caused by HIV infection. Science didn’t “decide” by consensus that to be the case. What the scientific community did was to accept as scientifically valid the work by Luc Montagnier and Robert Gallo that established the HIV virus (discovered by the former) as the cause of AIDS (something established by the latter). This theory was further validated when drugs were developed (David Ho) that attacked the chemistry of the HIV virus that took many AIDS patients from the gates of death to regaining their lives back. There is still a minority of patients for which HAART drugs do not stop the progression to AIDS but that in no way invalidates the general theory that AIDS is caused by HIV. Many AIDS denialists have learned the hard way the perils of denying the AIDS/HIV science http://www.aidstruth.org/denialism/dead_denialists .

    In some other areas of human knowledge, consensus does play a role, arts being the most prominent example. What is “good art” vs “bad art” is highly subjective, nonetheless, there are people who are respected for their taste and can make a living out of being “art critics”. Even though, as it happens in the film industry, art being highly valued by these critics is not always highly valued by those buying the art. But it is understood that this is highly subjective, and here there is room for “gray areas” and “consensus”.

    Science is not like that. Science is totalitarian and undemocratic. Any complains about the non democratic nature of science should be directed to God (for those who are believers) or to the rules of nature (for those who are unwilling to acknowledge the existence of a creator but recognize the structure existing in the universe) :D.

  13.  
    wiley
    September 8, 2013 | 6:46 PM
     

    Are you an engineer, CannotSay?

  14.  
    tom2
    September 8, 2013 | 7:12 PM
     

    Cannotsay2013, are you indicting neuroscience as well? Psychiatry seems to be a practical discipline that responds to specific conditions (people hearing voices, etc…) Now, are you saying that these conditions simply don’t exist, that patients are lying or confused when they state they suffer from what are currently considered psychiatric or psychological ailments? Are you saying that these conditions are rather purely intelligible in terms of social, or dare I say, spiritual factors? In other words, are you contending that depression is a socially constructed concept that has no biological referent? I ask this because it seems that the charge that psychiatry is a “pseudoscience” requires that these psychiatric conditions have no biological component whatsoever. Moreover, this charge also requires that current psychiatric diagnoses be utterly unintelligible and completely useless.

    If a “mental disease” is a definite phenomenon, and if a “mental disease” has any definite and reliable molecular referent, then psychiatry is obviously not a “pseudoscience.” It is, rather, a discipline that responds to some of the most complicated processes in the universe, and is therefore woefully incomplete. But psychiatry’s inadequate and incomplete knowledge base does not make it a pseudoscience. For it to be a pseudoscience would require that it’s CURRENT foundational principles be simply false.

    Tip of the hat if you can decisively refute the claim that “mental illnesses” don’t exist and that behavior has no molecular component whatsoever.

  15.  
    tom2
    September 8, 2013 | 7:15 PM
     

    Pardon that last sentence, which makes no sense at all.

    I meant to say that I would be very impressed if you can refute the claim that “mental illnesses” do exist, and (moreover), that behavior has at least some molecular component.

  16.  
    CannotSay2013
    September 8, 2013 | 7:43 PM
     

    wiley,

    I have a PhD in hard science, so I am going to be hardly impressed by pseudoscientific psychiatric constructs. Simple put, if my field worked as psychiatry, or astrology for that matter, there would be no LHC, no Space Shuttle and no probes sent to Pluto. As a matter of fact, there would not be any cars, computers, or the internet.

    tom2,

    As a way of introduction, I ask you to read this fabulous essay by Jeffrey A. Schaler which deals with the matter of what I believe “mental illness” is http://www.cato-unbound.org/2012/08/06/jeffrey-schaler/strategies-psychiatric-coercion . The essay deals with the matter of coercion, but at the beginning explains the notion of mental illness vs actual illness. I agree with Schaler’s (actually Szasz’s) view. He express it very clearly there, so I am not going to repeat it myself.

    I am bringing here an analogy that has been brought other times to answer your question about neuroscience and how it is relevant to psychiatry. Your question fails to acknowledge the fact that neuroscience deals with the hardware of the brain (cells, brain tissue, etc), while psychiatry claims to deal with the “mind”. These are two different things. The sw/hw analogy, while far from perfect, helps illustrate the difference (and also explain why psychiatry is a failed discipline).

    An operating system, like Windows or MacOS X, needs the CPU, RAM and hard disk to be executed, to “run” so to speak. However, Windows/MacOSX IS NOT the billions of rapidly switching on/off bits that you would be able to see with a microscope if you were able to see a CPU/RAM running either.

    Software is an independent reality of hardware even if you need the latter to execute it. You could burn a PC running Windows, but Windows would still exist in a DVD. You could burn all PCs running Windows, and all DVDs having a copy of Windows and you still not have finished Windows. Windows could still be, at least in theory, reconstructed by putting together the thousands of programmers who created it (assuming these programmers remember everything they coded).

    So what if the mind needs the brain biology to exist or that it is theoretically possible to establish correlates of certain behaviors with brain activity? The concept of “disease” applies to tissues while what psychiatry calls “disease” is patterns of behavior that, by definition, cannot be linked to genuine brain diseases like Alzheimer’s or genetic diseases like Down Syndrome.

    Again, I am not opposed to the idea of people voluntarily engaging in pseudo science (and my stance is as good for psychiatry as for astrology). However, from where I stand, psychiatry is a pseudoscience and its promotion by the government is a violation of the violation of the Establishment Clause ( https://en.wikipedia.org/wiki/Establishment_Clause ) of the first amendment even in cases of non coercive psychiatry. With psychiatry, our government is affirming the veracity of a particular religion and promoting it.

  17.  
    CannotSay2013
    September 8, 2013 | 7:47 PM
     

    For those without the stomach tor read the whole thing, I put here the part of Schaler’s essay most relevant to this discussion.

    Disease versus Behavior

    A disease refers to a histological (tissue) lesion, wound, or cellular abnormality. Mental illness is not included in standard textbooks on pathology because it refers to behavior, not cellular pathology. This distinction between behavior and disease is important because people tend to confuse the one with the other. Behaviors can be influenced by disease, and vice versa, however behaviors are not diseases, and vice versa. Smoking is a behavior. Lung cancer is a disease. Drinking alcohol is a behavior. Cirrhosis of the liver is a disease.

    Diseases are found in a cadaver upon autopsy. Behaviors cannot be found in a cadaver during autopsy for obvious reasons. Disease is something that a person has. Behavior is something that a person does.

    When I say there is no such thing as mental illness, I mean the following: The mind, consciousness, and thinking is not susceptible to disease. “It” cannot get sick or diseased. That represented by the pronoun “I” cannot get sick or diseased. The mind cannot be diseased because it is not a biological entity. Strictly speaking, there is no such thing as the mind. Since there is no such thing as the mind, it cannot be ill or diseased. Put another way, the mind can be sick or diseased in a metaphorical sense only. Since the mind cannot be sick or diseased, it also cannot be healthy.

    The brain can be diseased, just as any part of the body can be diseased. The human body is susceptible to literal disease; the human mind is not. I can tell you a sick joke and you know what I mean by “sick joke.” I cannot give antibiotics or any other literal medicine to a sick joke. I can’t treat a sick joke. Since the mind cannot be diseased, or, since the mind can be diseased in a metaphorical sense only, like a sick joke, it cannot be treated, or given medicine, to make it healthy, except in a metaphorical way.

    None of this is to state or imply that people labeled or “diagnosed” as mentally ill are not engaged in certain behaviors that others may find disturbing. A person plucks out his own eyes; another amputates his penis; another injects saliva under her skin to deliberately create infection. Mental health professionals and laypersons alike “diagnose” or label the persons engaging in such disturbing behaviors as mentally ill. The behaviors clearly exist. They are sick only in the sense that a joke is sick, that is, they are sick in a metaphorical sense, but not in a literal sense.

  18.  
    wiley
    September 8, 2013 | 10:58 PM
     

    No one has a degree in “hard science.”

  19.  
    CannotSay2013
    September 8, 2013 | 11:25 PM
     

    wiley,

    Your attempts at a) ad hominem, b) unmask my anonymity will go nowhere.

    If you have any smart thing to contribute to this debate, please do so, but please do not deviate the attention to irrelevant tactics that only contribute to decreasing your and psychiatry’s credibility.

    Psychiatry is a pseudo science. It shares with other psudosciences its inability to make falsifiable predictions. It shares with homeopathy and astrology than when it propositions are tested in controlled, double blind UNBIASED studies, it is unable to perform beyond placebo/chance. I have put unbiased in capital letters because there are very few of those studies. When it comes to SSRIs, I only know those of EH Turner and Irving Kirsch, both of which reached the same quantitative result even though EH Turner was more generous to psychiatry than Kirsch.

  20.  
    a-non
    September 9, 2013 | 6:34 AM
     

    I’m not here to debate the validity of psychiatry. I’m here to debate the use of psychiatry as justification of research abuse, including spinning clinical trials.

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