Drug Development, “Lucrative Markets,” and the Future of Psychiatry

Sandra Steingard, MD
42
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A colleague sent me an article written by Dr. Jeffrey Lieberman that was posted on Medscape. It is entitled, “Psychiatric Drug Development: Hope Around the Corner?”  Dr. Lieberman is Chairman of Psychiatry at Columbia College of Physicians and Surgeons and one of the most prominent and influential psychiatrists in the United States.

In this article he describes the failed development of several new drugs, one for schizophrenia and two for Alzheimer’s disease.  These drugs were pulled from study – fairly late in the process – because they “failed to meet the desired endpoints on interim analyses” or in plain language, they were not effective.

Dr. Lieberman goes on to talk about why “novel drug development for central nervous system disorders is not for the faint of heart.”  He discusses the complexity of the brain and the difficulty in finding suitable animal models.  He asks, “how can lower species like rodents model the complexity of human behaviors and mental disorders that we are trying to correct pharmacologically?”

In his conclusion, he tries to rally his audience to his cause and this is how he does it:

  • He supports the NIMH so-called “fast programs” which are intended “to identify drugs that exist within the pharmaceutical industry and may no longer be under development, but can be repurposed for study for specific disorders(emphasis mine).”
  • He points out that “Anyone who works with psychiatric patients knows that there are tremendous unmet clinical needs… With these needs come tremendous market potential, so for those who stay the course and persevere, there will be very lucrative rewards. To me, this seems like a great opportunity, and I think our partners in the private sector should appreciate this” (emphasis mine).

And there you have it. We will once again try to fashion drugs to fit some construct that we have labeled as a disorder in order to target a potentially lucrative market. I am not sure I have ever seen this stated so baldly by an academic psychiatrist.

I wrote most recently about the work done in northern Finland. Some of us have wondered why the rest of Finland, let alone the rest of the world, has not taken more notice of this work.   We wonder why we are not studying the people who have recovered.  Why aren’t we putting more resources into understanding success and recovery?

I think I have an answer. There is no lucrative market for Open Dialogue.  There is no lucrative market for recovery.

I also have an answer to Dr. Lieberman’s title questioning whether hope is “around the corner”.  If he is talking about the future of psychiatry and if psychiatry’s leaders are unable or unwilling to disengage from the goal of promoting the financial welfare of the pharmaceutical industry, then my answer is no.

42 COMMENTS

  1. Dr. Lieberman is not alone amongst his peers in his hope for lucre. Dr. Joseph Biederman is the poster child of self-promotion for self-enrichment. The schizophrenia market is very small, but it drives the industry. There is no incentive to help people with schizophrenia recover without the use of drugs. If you lose the 1% (schizophrenia) the rest will soon follow. Bipolar – traditionally 1.5% of the population, but has expanded (thanks to Biederman)to about 4.5%. It is estimated that up to 13.4% of the American public is “mentally ill.” There’s lots of money to be made and everyone can grab a piece of the pie. Academics, drug companies, social services, the list goes on and on. Full recovery is a goal that only the most skeptical of individuals may be able to achieve.

    • You must be doing something wrong to only have 13.4% of the american population as mentally ill!!!!!!!!!!!!!

      In Australia we have a minimum of 20% of the population supposedlby needing treatment at any one moment in time (or so they tell the government and anyone who will listen!) and a lifetime prevelance rate of 50% of the population. Yep, they claim that 50% of the population will experience a mental illness at some stage, mainly anxiety and depression, which must be treated very early, otherwise they can never recover!! Most mental illnesses cannot be recovered from, well not without liftime maintaince medication!! Some mild cases of depression and anxiety, if they are treated early enough, ie, before a person is depressed, then they might be able to recover!!!!

      As you have so rightly put it is all about making money and no one makes money from people getting well. And this is not just drug companies, it is anyone in the whole mental health industry, including social services, psychologists, etc, etc.

  2. One of the issues making drug development hard is that there aren’t clear endpoints for clinical improvement. How do you define “better?” If you look up that sentence on You-Tube you’ll find a powerful video made by a certain church I that refuse to ally with.

    Is “better” working full time, debt free, off benefits? I guess 47% of Americans wouldn’t fit that. Is “better” lack of symptoms? Is “better” having a dog rolling on her back and itching herself and moaning and groaning, then chasing her tail, so I can laugh? Or a good life in general?

    I know clinicians have rating scales and some peer researchers have found those meaningless and have their own improvement scales. And SAMHSA had a huge debate on the definition of recovery. But pharma can’t make heads or tails of all this so they want to work on drugs with much firmer endpoints.

    • You can’t design a drug to treat something if you do not know what it is that you want to treat. What is psychosis?? Is it a disease of some sort?? In order to develop antibiotics, one first had to know what bacteria was. They had to be able to put bacteria into a test tube and then they could put in different substances until they could find something to kill it. One cannot put feeling sad, hearing voices or the like into a test tube. There are no brain scans or blood tests or anything else that can be done. The deepest of deepest brain scans and most intensive of blood analysis cannot find anything at all. Yet we are continually told that these are diseases and that we will find “better” medications to treat them. Can’t treat something that does not exist. At present ALL the medications simply numb you in different ways, all by shutting down half the body organs. Numbing a person to point of them not functioning is not a form of treatment for any disease. At most it is symptomatic relief, but I personally doubt that when it comes to these drugs.

  3. Yes indeed, it’s the organised greed of Capitalism Gone Mad verses friendship, support, talking things through, preventing child sexual assault, family violence, racism, homophobia and poverty.

    Dr. Lieberman tell us what and to some degree who the enemy is but he also points us towards our allies, and we will need them in order to win.

  4. Unfortunately, Lieberman is just embracing an idea that is mainstream and currently accepted as fact by a part of American culture: that the common good arises out of the fair competition between greedy and selfish instincts, and that as long as competition is fair (i.e. not biased by government), then greed, selfishness and lucre should be encouraged (aka Ayn-Rand-101).

    There is certainly some irony in proposing greed as an indirect cure for mental illness (rather than as a DSM diagnosis), but I do believe Lieberman is honest, and authentic with himself when making that proposal.

    Open Dialogue is a treatment that could justify itself even if it was a money-loosing proposition. But there should be no shame in pointing that in addition to the human values it conveys and to its scientific credentials, it seems a big potential money-saver in the long-term, especially since we might not be able to afford keeping those pharma companies on the welfare rolls of medicare/medicaid/government-assistance indefinitely.

    Some aspects of this discussion might be linked with one of the important thesis of Bob Fancher (or the starting point of postpsychiatry): that no school of psychiatric research can pretend to be purely scientific and culturally-neutral, any research about mind/behavior operates within a set of axiomatic cultural values, and the best that can be done is to be aware of those cultural assumptions.

    • Building on Stanley’s points:

      It’s important to point out that the financial savings from Open Dialogue, if they exist in the form of reduced hospitalization and medication costs, would accrue to state and federal medicare/medicaid budgets as well as to private health insurers. These savings would directly threaten pharmaceutical company revenues and would probably be a net loss for psychiatrists, as their billable time in the Open Dialogue model appears to be reduced (and their centrality to the team certainly reduces prestige and control over treatment regimens). So to get Open Dialogue approaches accepted in the U.S., one would first need to demonstrate that they can be effective here; that they produce significant cost savings compared to primarily pharmacological approaches; and then one would need to rally government and private insurers against pharmaceutical and medical interests in the inevitable lobbying battles that would ensue.

  5. This speaks to the larger social issue of our current form of government-by-marketing. As long as political campaigns can be funded and supported by corporate marketing interests, market benefits will be the primary value our government promotes. The “free market” (and I use quotes, because it’s clearly no such thing) will never promote something like Open Dialog – it will have to be the general community, in the form of government representation by people who actually give a crap about THE CITIZENS rather than their corporate masters, who promotes this healthy and money-saving alternative to a lifetime of dangerous and ineffective drugging.

    Sandy, you’re sounding more radical by the day!

    —- Steve

  6. “There is no lucrative market for Open Dialogue. There is no lucrative market for recovery.”

    Thank you for hitting the nail directly on its head and for pointing out this very important fact. And as long as the toxic drugs continue to be used on people there will be very little recovery indeed.

  7. Thank you for bringing this bald statement of greed by such a powerful psychiatrist to our attention.

    Others in this thread have said this also, but the practice of corporate welfare to folks like the drug companies is unsustainable. To the extent that there are any public officials who can see this, I think the successes of Open Dialogue and Soteria Houses should be persuasive. Why waste public funds on treating people in the expensive and destructive way they are treated now, when for a lot less money and a much better outcome, the state can provide real help?

    I do think we should talk more about outcome research though. I would like to think such alternative approaches are the wave of the future, but they won’t be adopted if we don’t have some hard facts to back up what we say.

    • Your quite right Ted, outcome research for psycho-social approaches are really useful when taking on the psychiatric community (service providers, commissioners and politicians). They are the other side of Whittkers evidence on the dangers and limitations of the drugs. It important to have this information and if possible the economic analysis to back up the argument when trying to influence these people directly.

      It is one part of a successful strategy – along with large scale demonstrations, sit ins and such like

    • Long-term outcome studies are critical, but I agree, there are many already extant that simply need broader publication (or maybe not so simply, as the media bias toward supporting drug company propaganda is clear).

      For instance, we have been studying stimulants in “ADHD” kids for over 50 years now. All of the summary reviews have shown the same thing: kids exposed to stimulants long-term do no better than those who have no such treatment or take stimulants only briefly. These include the MTA study and the Oregon State University Medication Effectiveness Study, the latter of which reviewed every piece of extant literature on stimulant research, and found no evidence for any improvement in any long-term outcome, except for a slight reduction in the likelihood of a motor vehicle accident. Delinquency, school completion, test scores, college admission rates, self-esteem, social skills, and eventual employer satisfaction with their ADHD employees were all unaffected by stimulant treatment.

      This kind of research already exists for “depression” and “schizophrenia” as well, as Bob documents in the book. I think the big question is how we get this information to be published broadly enough to undermine the Joseph Goebbels strategy (the Nazi propragandist who famously stated that “if you repeat a lie often enough, it becomes the truth) pursued by the pharmaceutical companies and their allies in the psychiatric profession.

      —- Steve

  8. Lucrative Market?

    There’s no money in what works.
    Never has been.
    Never will be.

    Because it can be succesfully done with non-professionals, peers, safe environments, good food, exercise, meditation, community.

    No need for psychiatrists.
    No need for hospitals.
    No enormous financial investment.

    But very little return (profit).

    Lots of saved lives.
    But not a “lucrative” market compared to conventional psychiatry (a “dead” profession).

    Duane

    P.S.: Psychiatry is *dead*.

  9. “I think I have an answer. There is no lucrative market for Open Dialogue. There is no lucrative market for recovery.” Correct.

    666 – “sickness & sex sells”.

    People freely express their disdain for and lack of Faith in heterosexual marriage, calling people “fools” and “stupid” for “believing” in the fraudulent and dreadful bondage, but I dare anyone to not support gay marriage and watch what happens – they WILL attack you (verbally). Up next on the Human Rights love & sex relationships agenda: polygamy. It’s ALREADY in the social landscape (television show). Can anyone guess what comes after polygamy?

    How are America’s foster kids doing today? Miley Cirus said to teach kids that sex is “cool and magical”. She said they’re learning about it on TV “anyways”, so might as well just drug ’em and lust ’em! America has to stay alive SOMEHOW.

    Rich, Sexy, Hot and FKD UP.

    What do people cry about in Open Dialogue, anyway? Chemical warfare fears? The ground will cave in, the sky will fall? Did a spouse cheat? Can’t pay the bills, terrified of homelessness?

  10. The line “so for those who stay the course and persevere, there will be very lucrative rewards” reads sounds like a recruitment effort aimed at psychiatrists and other prescribers who are or may be questioning the standard of care that is promoted by the APA and the AACAP. It is a standard of care that serves the marketing agenda of the pharmaceutical industry; and is without a evidence base to support it, which is WHY it has failed. “Stay the course” is Tom Insel’s rally cry for Translational Science—he fails to understand (apparently) that there must be science available to translate…

    Jeffrey Lieberman is one of the “research psychiatrists who was added onto the TEOSS drug trials late in the game—as near as I can tell, once it was apparent the TEOSS trials had failed, NIMH determined to shore up this colossal failure up by adding Harvard, and Lieberman to the list of investigators. I wonder if Lieberman’s willingness to go along with the charade was rewarded by becoming President-elect of the APA…

    The TEOSS trials were seeding trials conducted with the intent to gain FDA approval for pediatric use. Drugs were subsequently approved for pediatric use by the FDA for limited use; but as is Standard Practice in psychiatry, the drugs are prescribed off label, the cost is fraudulently billed to Medicaid, in the vast majority of cases. As 1 Boring Old Man and I, among others– have pointed out, the rampant Medicaid fraud—which is ongoing despite multiple illegal marketing lawsuits—could not have been done without the cooperation of the APA and AACAP, which makes both of these organizations complicit in an ongoing criminal enterprise. I have no doubt that the treatment protocols, treatment algorithms and practice parameters which are written by members of the APA and AACAP, and are without empirical support serve the purposes of pharma primarily. These standards are marketed by the APA and AACAP as CME and are disseminated in “peer-reviewed” journals and recommend using psychotropic drugs off label in spite of the lack of evidence for prescribing the drugs in this manner. The only logical conclusion, is that they were written in order to support the marketing agendas of pig pharma… Psychiatry has re-defined “Standard of Care” to mean plausible deniability. Psychiatry’s standards are meant to serve as a defense for medical malpractice. The standards were written to support the marketing agendas of pig pharma and serve as a legal defense for the rampant medical malpractice that results from their use.

    This is what Lieberman and Insel are urging professionals to, “stay the course” on…and the hope of new drug discovery “around the corner” is also used by Insel–and these discoveries have been claimed to be “around the corner” longer than I have been alive…enough is enough! To quote Grace Jackson, M. D. “No one is really paying attention to what’s going on. . . The issue is how many Medicaid kids are being drugged to death, not how many kids in fostercare are being over medicated.”

    I would add that no one should be medicated because a lack of medical ethics has become acceptable in mental health ‘treatment.’

  11. Hi Sandra as a fellow blogger on MiA I have at times been skeptical about some of the professionals writing here. For though they have not been the true incarnate believers of the biogenetic psychiatry and probably consider themselves radical compared to fellow peers it is your journey, represented in your blogs, which has been the most interesting to follow.
    For me, MiA’s purpose is to participate in the global move for not just changing psychiatry but radically changing psychiatry dismantling the power of pharmaceutical and corporate greed which allows for blatant human rights abuses on a select group of people. This can only occur if the people who are subjected to the will of psychiatry cease to be just a label or a number in a randomized control trial and become humanized beings again.
    Your willingness to explore other avenues and especially open dialog where it becomes very difficult not to see the person behind the distress, appears to have profoundly touched you and this evolution in your outlook is visible on these pages.
    For me that makes this whole site worthwhile. I have always operated on the principle if I can reach just one person in the audience whom I can inspire to start their journey even if it’s years down the line then my talking was not in vain. For me you are that visible sign here on MiA. Of course I don’t know if it is MiA that has played a part in your journey or if you can place it to one person or event or a concatenation of it all, but I do know that your journey, to use my boss’s words of ‘professional recovery’, will be supported here!
    The whole recovery movement arose through the power of people’s narratives that they can and do recover. Often they come into psychiatry with horrific life stories only to be re-abused and yet still they rise up out of the dust and tell their stories. It is these stories of meaning and hope that humanize those labeled people and challenge psychiatry. That is why, though we live in an era where quantitative research is the only valued research, it is the qualitative which is the most powerful.
    The Dr. Lieberman’s of this world can only succeed if dehumanization combined with corporate greed is allowed to occur. Quantitative research with its randomized trials etc, etc, opens the door to that possibility. Our stories, your story, the qualitative research can shut those doors be they those who recover as victims of psychiatry or professionals who recover from the indoctrination of the medical model.
    Thank you for being one more person who inspires hope in me that trying to reach people working in psychiatry is never in vain.

  12. Hi Sandra,

    This is a problem that is affecting all industries at this point in history, not just medicine. It is a sign of a deeper malaise spreading through out the advanced capitalist world, but in particular the United States which has by law protected shareholder interests above other groups such as a company’s employees and customers in many instances.

    No amount of advocacy work will change the profit motive of large pharmaceutical companies. Instead, the focus must be on requiring full disclosure of risks (both by the drug manufacturers and by doctors prescribing to patients) to ensure there is fully informed consent before choosing to take any medication. The fact that drug companies are easily able to manipulate the FDA to bypass this disclosure process is the biggest concern we should be focused on at this time. Patients also should be required to sign a disclosure of side effects form in a doctors office before they are handed a prescription.

    And like in any other industry, the best way to get the attention of a company that has behaved in a socially irresponsible way is simply not to buy their products! Both doctors and patients can play that role.

    As for the lack of interest in alternative programs like peer respites etc. – this why we have such a large and active not-for-profit sector in the U.S. They can take on these roles. If there is a broad enough interest in them by clients/consumers and they are financially viable, they will sustain themselves on their own, irregardless of whatever ‘lucrative’ products big pharama wants to pursue next.

  13. Sandra,

    It seems to me that in the end the final decision comes down to the patient (consumer) whether or not to take medications that are suggested or prescribed. Perhaps the focus should not be on changing the profit motives of the pharmaceutical industry or the ‘biological psychiatry ideology’ of the doctors. It should be on creating more educated and savvy consumers. A more mainstream platform needs to be launched — not with a message of ‘anti-psychiatry’ but rather a ‘need to know facts’ for users of psychiatric drugs that explains what is known about their benefits and side effects/long term effects in plain English, questions to ask a doctor, etc.

    Patients in other areas (cancers, heart disease, etc.) are very well organized, well read and informed on their treatments, side effects, efficacy levels, survivior rates, alternative and complementary treatments etc. There is no reason that patients of psychiatric conditions could not be the same.

    Most successful public health campaigns have focused primarily on changing consumer beliefs and behaviors (smoking, fast food, etc.). And in turn the ‘producers/providers’ tend to adapt to the changes in demand – although not without a lot of resistance to such change – as we have seen already in reactions to things like Soteria in the 70’s.

    But ultimately, the power is in our hands, not theirs.

    • I agree with you, but part of the problem of uneducated or mis-educated consumers is that the pharma companies are allowed to do direct to consumer advertising, as well as being allowed to market illegally to doctors, who also seem to believe their lies. Additionally, the APA, NAMI, and other groups who support pharmaceutical interventions need to be restricted in their ability to lie for Big Pharma. Lawsuits don’t seem to be enough – I think criminal penalties for illegal marketing would be a great place to start. Additionally, I agree that written informed consent should be required, including written statements to the effect that this drug is being administered in the absence of clear evidence that there is anything physiologically wrong with you, and that the long-term effects of this drug are not fully known but appear to increase in riskiness the longer you take the drug.

      Which brings me back to my earlier point: we need politicians who aren’t bought off by corporations, which means we need to arrange it so corporations are not able to contribute any money to political campaigns. It’s a long road, but I hope places like MiA can help educate people in the meanwhile and build some momentum.

      Sandy, would love to hear you getting involved with some advocacy at the APA!

      —- Steve

      • @Steve

        When I was a kid they made my parents sign liability forms for receiving prescriptions, an irony because my parents were only complying with them because of a custody battle with the state over refusing to drug me in the first place. When I was 17 I saw a psychiatrist voluntarily while getting stuff together for SSI and he had me sign such a form before prescribing me ativan. On the form I remember it saying that the treatment may be dangerous and I had a right to a second opinion and blahblahblah and by singing I took full responsibility for what happens.

        I’m not sure if or when they did away with these forms.

    • “Patients in other areas (cancers, heart disease, etc.) are very well organized, well read and informed on their treatments, side effects, efficacy levels, survivior rates, alternative and complementary treatments etc. There is no reason that patients of psychiatric conditions could not be the same.”

      The problem is that (voluntary) patients of psychiatric treatments are often supporters of the lies. They’ll twist logic to support their opinions no matter what — “Well duuh, of course antidepressants only work for 10% of people because only 10% had the real disease (like me)” — They want to believe that their brain is broken and they want to believe that the answer lies in drugs. Educating them is pointless. They’ll ignore you at best, viciously attack you at worst. Rarely ever will they go “Wow, there are problems with psychiatry and it’s treatments? I never knew! Thank you so much for the literature!”

  14. Hi Dr. Steingard,

    Do you perceive their being a trend in mental health institutions forcibly drugging people who have successfully tapered off medications in communities across America due to the rise in this “lucrative [drug] market”? Or would this sector of the population still be protected in the absence of a crime or hurting one’s self or others?

    Thanks,

    SickTryingToGetBetter (But doing MUCH better now! :-))