the pipeline paradigm…

Posted on Thursday 31 March 2016

It really does sort of look like a pipeline. It’s the SSRis, SNRIs, and Atypicals graphed by the  year of their FDA Approval. The first time I ever heard that term, pipeline, I thought it was a joke of some kind. But I found out it was in wide usage in the business and KOL worlds. I wonder if there was a similar chart for the First Generation Antipsychotics? for Tricyclic Antidepressants? or for the Benzodiazepines? some string of "me too" drugs that stretches all the way back to the 1950s?

I know that when I showed up for a psychiatric residency in 1974, I thought there was sure a lot of chatter about  only a few categories of drugs. In internal medicine, I can’t recall anything similar. Admittedly, I spent those medicine years in public facilities that had more limited formularies, but I doubt that there was anything like what I encountered coming to psychiatry. There was a difference back then. We talked about the differences among ourselves and picked the best choice for the situation. I for one didn’t even know which company made which drug or what was new and what was old. Now, the patients have often already tried many of them, and sometimes made a choice based on what they’ve heard about from somebody or seen on television before they show up ["ask your doctor if kerfunkeltine is right for you"]. In fact, that’s why they’ve come. Here are those drugs labeled:

I may have missed a few or added one or two that ought not be there, but I was aiming for a Gestalt, and I think it comes across. And alongside the flow of new drugs, there were lots of other things for Key Opinion Leaders [KOLs] to talk about: Sequencing; Combining; Augmenting; Indications; Statistics; XRs; StereoIsomers; Genetics; Receptors; Neurotransmitters; etc.

In my own mind, I saw classification like I later learned Karl Jaspers had: Brain Disease, the Major Syndromes [Psychotic Illness]; and Other. The Biological Psychiatrists were focusing on the Major Syndromes with treatment and etiologic research. And there were any number of disciplines and approaches in the fuzzy Other group, presumed to be psychological in origin and treatment. The DSM-III was an attempt to get the theories [specifically psychoanalytic theories] out of diagnosis, which made sense. But it also ablated the border between the Major Syndromes and the fuzzy Other group in the process.

Over time, there was a new boundary: Mainstream Psychiatrists treating with medications and researching the brain, and other disciplines focusing on psychotherapy and matters social. But for my purpose here, that pipeline now emptied onto the entire domain  of mental health treatment. PHARMA and Managed Care institutionalized this new way of looking at things. There were many who didn’t follow along, but were basically working off-the-grid. New Industries rose up [Contract Research Organizations, Medical Writers]. Old Institutions waned [mental hospitals, community mental health] or changed [jails-as-mental-hospitals]. And in the last decade the whole thing has turned into what could only be called one mell-of-a-hess.

I originally constructed that pipeline graph because in spite of all the hoopla about it drying up, it looked to me like it was still dripping. But I didn’t have much success in locating what else is under development [other than the Ketamine dreams]. And as I looked at it, I began to have another thought. It’s obvious that right now, we’re all in a period of paradigm exhaustion in this whole corner of the healthcare world. The focus is on what’s wrong with all the models instead of what each has to offer. The drugs are weak, over-used, more toxic than advertised. CBT’s effectiveness is waning, and no other specific psychotherapy fits the bill. Neuroscience, Genomics, and Technology have let even their biggest cheerleaders down  [Clinical Neuroscience? bah humbug!]. PHARMA is turning off CNS research. Guild Wars are reviving with an old familiar fire-in-the-belly and name calling. Even Managed Care is having trouble showing results.

As I mused about what paradigm is it that’s so exhausted?, I had the thought "you just drew it." I don’t mean the individual drugs, or even their classes. But the idea of a pipeline that would just keep on flowing and bringing the hope of something newer, something better. It was the pipeline that sustained KOL psychiatry. The other disciplines had gained access to third party coverage and practitioners worked to have a connection with a prescriber. Managed Care thrived on the existence of a pipeline of future hope and built a reimburement system around it. Researchers fought to do the Clinical Trials that sustained it. PHARMA milked it for all it was worth. Even the failings of the drugs kept people busy and things moving along. Nobody gave much thought about the fact that there were only two [maybe three] basic themes playing out in these drugs and that the main advantage was that they were better tolerated. The pipeline itself, or what it implied, is the paradigm that lasted for three decades – so long that for many, it’s all they’ve ever known. And when it started running dry, all hell broke loose. The rest of the universe may have already known that the pipeline is the paradigm, but I didn’t…

    April 2, 2016 | 4:55 PM

    The paradigm that is exhausted is what I call the antibiotic paradigm: The way to treat any condition is to pound it into extinction with a drug or combination of drugs.

    After only 86 years, the antibiotic paradigm itself has been made obsolete by bacterial resistance — nature’s revenge.

    Certainly in the “mental health” field, where conditions are so vaguely defined (and resolution of symptoms ambiguous), this paradigm never had any validity. It also has been undermined by the placebo effect — what’s doing the work, the drug or the patient’s belief in the drug?

    Which harm is worse, the condition or the drug?

    We very much need to shift to a paradigm that recruits the body’s resources to combating physical disease and the mind’s resources to combat “mental” conditions, rather than looking for more silver bullets to shoot.

    April 3, 2016 | 12:30 AM

    “After only 86 years, the antibiotic paradigm itself has been made obsolete by bacterial resistance”

    “We very much need to shift to a paradigm that recruits the body’s resources to combating physical disease”

    That would seem to describe the vaccine paradigm.

    “and the mind’s resources to combat “mental” conditions”

    So switching over to a vaccine paradigm for “mental” conditions?

    Bernard Carroll
    April 3, 2016 | 1:14 AM

    Altostrata’s broadsides against medical therapeutics are ill-informed and tendentious. In fact, they are Luddite overstatements. Note first the sleight of hand in reframing the discussion from infectious disease to physical disease generally. The antibiotic paradigm is not obsolete, and there are hundreds of millions of people alive today who would have perished without those drugs. Bacterial resistance is just an expected phenomenon that is being addressed – it is not a cause for mean spirited, Luddite satisfaction. The advice to “shift to a paradigm that recruits the body’s resources to combating physical disease” is irresponsible – it is regularly followed by fringe sects, with disastrous results. Once again, I do not disagree that antibiotics, like psychotropic drugs, are often prescribed inappropriately, but we would not want to throw out the babies with the bathwater.

    April 3, 2016 | 1:57 AM

    The pipeline may have slowed. The power gained by having participated in the process with a paucity of questioning, that persists.

    April 3, 2016 | 2:27 AM

    1boringyoungman ,


    April 3, 2016 | 3:52 PM

    Rather than paradigms that apply to treating physical illnesses, perhaps a different paradigm altogether would be best for “mental health” conditions — as Mickey himself has often explained, at great length.

    April 3, 2016 | 5:09 PM

    1bom, I know you moderate comments these days. If you feel that what I’ve written below will paradoxically contribute to contentious interpersonal dialogue, even though this is not my intent, then please feel free to not pass it through to post. Thanks, 1bym.
    Alto, 1bom’s lengthy explanations can be interpreted in a variety of ways. My interpretation continues to be that no single paradigm is going to a silver bullet for “mental health.” To me that leads to shifting away from “shifting of paradigms” thinking, shifting away from definitive rejection of particular paradigms. Psychoanalytic thought was not an exhausted paradigm that had been made obsolete and had to have a stake driven through it, as a number of prominent psychiatrists have tried to do. Perhaps it was overly dominant and ossified and had become too close minded. To my reading, the psychiatrists who were looking to forge a new path back in the 70s and 80s, one they felt had much good to offer, viewed psychoanalysis as having such a stranglehold on mental health care that overthrowing its hegemony was paramount. To some extent this fueled black and white thinking and led to an underestimation of the value in that paradigm. I think that “obsolete”, “nature’s revenge”, “never had any validity”, run the real risk of falling into the same kind of traps that have driven a single brained use of a biological frame for defining “treatment” of mental health “problems.” Just as 1bom has pointed out with the document that BPS put out a while back about psychosis.
    I am also not sure how much value add one gets out of the antibiotic example. It’s difficult to imagine how the use of antibiotics could be defined as obsolete. But the suggestion that one not value antibiotics, figure out how they can be used judiciously and their benefit be preserved, that one define them as obsolete in favor of a paradigm (unless you are referring to vaccines) that would seem to be vaporware…. That sounds a lot like Insel’s position. Let’s throw the baby out with the bathwater while we await vaporous approaches waiting for us just over the horizon.
    These issues we confront appear to be very nuanced. Where the question of the value of a medical, a disease/syndrome based model, seems to come most to a head is around what 1bom refers to above in the “major syndromes” (which I guess might also include melancholia). One of the most interesting disagreements I’ve seen discussed here has been between Carroll’s position of individual instances of schizophrenia and melancholia clearly falling under the “major syndromes” and Steingard’s position that there are enough difficulties with using those definitions to guide treatment and prognosis that a more drug focused, rather than diagnostic category focused approach, might be better. The former I guess you could call a more medical model and latter less so. To me a lot of what Carroll argues is that the problems Steingard describes are shared with a lot of syndromes/diseases that fall under physical health and that syndrome/disease approaches in “mental health” and “physical health” are no more or less useful, and no more or less fraught with problems. I don’t think I can do justice to Steingard’s arguments, but I myself tend to find them of value, though with the caveat for me that I find them I think of not significantly more or less of value for “physical” illness than “mental” illness.
    Alto, while Dr. Carroll’s appears to have chosen a contentious response to your tendentious post (and I chose both of those descriptors carefully), I hope that my response does not come across as suggesting in any way that you should not be posting your commentaries. I find Dr. Carroll’s comments of immense value. And, strangely enough have come to think that he accords everyone’s opinion (not just MDs’) respect and so equally deserving of opprobrium depending on the content. However, I do wish sometimes that the responses could be tempered a bit. I do feel that the “broadsides” description from Dr. Carroll is a fair one. Fewer broadsides, on a personal or pardigmatic level, might be helpful. I don’t mean less focus on the truth, even if uncomfortable, or mincing of words, because that mistake (especially among our academic nobility) has done much harm. But, maybe just less broadsides.

    April 3, 2016 | 6:01 PM

    No fighting please. This comment deserves thoughtful responses.

    I’ll start. Psychoanalysis, particularly institutional psychoanalysis, deserved to be slammed in the 1970s. The notion that insurance should pay for a treatment that extensive, that optional, was absurd. Many analysts had generalized theory meant for a specific application well beyond rational limits. And the sequestering of psychoanalysis to the medical profession [psychiatry] was a uniquely American thing. Even Freud thought that was a bad idea [he wasn’t a psychiatrist]. Actually, probably the biggest mistake was separating classical psychoanalysis from its derivative dynamic psychotherapy as if the latter was less than blocked a healthy evolution that has now slowly happened in the shadows over the last 30 years. Psychoanalysis should never have been mixed with psychiatry, but it was. All of that said, of all of my training programs, it was the most important to me [then and now]. I don’t talk about it here because people always want to talk about Freud’s theories and I’m as capable of debunking them, actually probably better at it than most. I stuck with it, because I could see that there were people there who could hear things I couldn’t hear, and they taught me how in as much as that can be taught. So I’m not a psychoanalytic psychiatrist as many were in the 1970s. I’m two or more things, and that’s fine with me. But specifically addressing 1980, being seen as a dinosaur at age 40 was mighty painful and there was nothing I could do about it. I’m sure my history and that part shows in what I write, but I try to stick to the task at hand.

    I lament that the psychiatric traditions in relation to the Major Syndromes were reduced down to Kraepelin. There were so many more important people all along the way to the present. I would include Dr. Carroll and the biological psychiatrists of the earlier days in that mix, along with others still in the dialog. My fight is with the “carpetbagger KOL set”. As for the Schizophrenia versus many psychoses dilemma. I still think Schizophrenia for the classic cases, but am impressed that the borders are not nearly so distinct as I once thought or was taught. The relationship to trauma and life experience is going to have to become a lot more solidly grounded for me to accept it as etiologic, but of course it matters. Until then, it’s one case at a time for me. I don’t know the “etiology” and anticipate never knowing.

    I think one perspective my Internal Medicine years gave me is that the dichotomy of Medicine, solidly scientific versus Psychiatry, the great unknown is an illusion at best. We know a lot and almost nothing about both.

    Bernard Carroll
    April 3, 2016 | 10:10 PM

    1BYM, I don’t mind copping to the moniker contentious – it can be part of being rigorous when a firm response to nonsense is needed. Sometimes it takes a broadside to deflate a broadside. As you say, there is no point in mincing words.

    April 4, 2016 | 4:05 PM

    My April 2 comment is not a broadside, it’s my opinion as an observer, student, and recipient of all kinds of medical care.

    A careful reader will have noted I was using antibiotic treatment as a metaphor for the cultural attitude of “a pill for every ill.” I did not advocate that antibiotic treatment should be abandoned. (That our use of antibiotics is in trouble and other approaches to infection must be found is not an uninformed, unknown, or even controversial position.)

    As you say, 1boringyoungman, Mickey’s long essays about contemporary psychiatry’s underpinnings may be interpreted in a number of ways. My interpretation is “less reliance on drugs and more integration of other approaches.” You can call this a paradigm or an anti-paradigm, as you wish.

    Out of respect for Mickey, I forbear from responding to Dr. Carroll in kind. He and I agree in our dislike of fools and bullies.

    Bernard Carroll
    April 4, 2016 | 7:36 PM

    Altostrata now wants to prevaricate. I thought she penned a broadside. 1BYM thought she penned a broadside. I’ll leave that point right there. Nothing in her original comment suggested graceful metaphor. She did indeed call the antibiotic paradigm exhausted. She did not leave the door open for combining therapeutic approaches. No, it was black and white language – an irresponsible Luddite call for an outright paradigm shift. She seems now to want to walk that back but she surely owns what she first wrote.

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