Genetic Testing for Suicide Risk

Maria Bradshaw

March 9, 2013

A Colorado based company, Sundance Diagnostics, contacted me a few months ago to tell me about work they are doing to develop a genetic test to predict suicide risk when patients are prescribed antidepressant drugs. Their plan is to sequence the entire human genome of about 360 patients and controls to see if antidepressant drug risk can definitively be predicted.

After my son Toran died as a result of antidepressant-induced suicide, I asked the Coroner to order a DNA test to establish Toran’s metabolic status, he agreed and also agreed to have my blood tested as well.

The tests were conducted and I was advised they showed Toran was a ‘normal metabolizer.’

They did not.

They showed he was an intermediate metabolizer – a result which explains his adverse reaction to the antidepressant he was given. The incorrect information I was given reflects the level of ignorance around the genetics of drug metabolism amongst medical professionals and coroners.

About a year after Toran died, I took my cat, Bug, to the vet and was told he had to have surgery (yes I am telling a cat story, yes there is a point, J). I burst into tears and asked the vet if he might die as a result of the anaesthetic. Bug was my only companion at the time, my only reason for getting up in the morning and filled the need I had after Toran went to continue to ‘mother’ someone. I was so scared that I would lose him and knew I could not to handle yet another loss (yes I am slightly embarrassed at being the quintessential crazy cat lady and trying to justify my emotional reaction – just humour me).

The vet explained that if I wanted, she could conduct a blood test that would show whether Bug had any elevated risk for anesthetic complications.

That got me thinking.

Why was I offered a blood test to assess risk for my cat but not my son?

I geared myself up for a crusade to promote mandatory DNA testing before antidepressants could be prescribed.

Then I did some research and learned that the genes you are born with are one thing but the way those genes are expressed can be something completely different and alter according to your stress levels, smoking, diet, use of medications and a range of other factors.

I became concerned that a DNA test may give people a false sense of security in relation to their level of risk. That people would receive a result showing they were an extensive metabolizer (ie normal) and take the drugs but in fact may not metabolise them normally due to the influence of other  factors. Might the test results lead them to be less vigilant about monitoring changes in mood and behavior than they would be without the test?

So I abandoned my plans to campaign for testing and went back to working to ensure people had all the information they needed to make fully informed decisions about using antidepressants and pointing out that the risks outweighed any benefits.

Then Sundance contacted me.

They explained that what they were embarking on was a discovery project and that success could not be guaranteed but that if the project was successful, it may protect children from drug-induced suicide. They explained they hoped to identify anywhere from 50 to 200 markers and that the uncommon markers they identify are expected by scientists to be even more predictive that the common markers we already know.

My initial reaction to what Sundance are doing was to say I couldn’t support anything that might give people a false sense of security around taking antidepressants. That my work is around promoting the notion that environmental factors cause emotional distress and that environmental factors need ‘doctoring’, not the people who are impacted by them. That antidepressants shouldn’t be prescribed for normal human moods and behaviours.

Then I got real.

One in ten New Zealanders is on an antidepressant. Almost half a million people in a country of 4.4 million. Tens of thousands of antidepressants are given to children under 18 in this country despite the fact they are not approved for children. We give these drugs to babies under the age of one.

Of those who have killed themselves under the care of mental health services in New Zealand in the years 2007-2010, 83% were on a psychiatric drug.

What would I say to a mother whose child killed themselves on these drugs who asked me whether my taking the high road on the prescribing of these drugs was more important than giving her information that may have saved her child’s life?

The reality is that despite anything I or my peers do, these drugs will be prescribed to children today, tomorrow and for the foreseeable future. I will continue to advocate fiercely for a social, not medical approach to emotional distress. But I will also let people know that if, despite all the information I and others give them on risk, they choose to use antidepressants, there is a way of reducing their risk using the test Sundance is developing.

Yesterday Sundance sent me a press release they intend to issue on Monday, March 11. It contains the following paragraph:

If successful, the new tests will be available for each patient before a drug is prescribed.  The physician can then take action appropriate for the patient throughout the course of therapy.  Family members, who before now may not have been advised of antidepressant medications’ side effects, can be informed of the patient’s specific risk and can actively participate in ensuring the safety of the patient during treatment, choosing the level of monitoring warranted and making decisions on complementary therapies and alternatives to medication. 

I am pleased they acknowledge that the result of their test may be that people decide not to accept a prescription. I think the very fact that a test exists means that the number of people who take these drugs without knowing anything about the risks of suicide would reduce significantly.

I’ve asked Sundance to share their vision with me and they have said

“What if every mom and dad were to know about the test and would refuse treatment without testing and then really, really consider whether drug treatment is really best at all — considering that they are informed up, down, and sideways that the risks are there and can’t be fully ruled out– testing or not.

At the end of the study, if we have successfully identified predictive markers,   we will be saying to the doctor that we have important information for him about a patient that may be at higher risk but that he should never consider that a patient without the predictive genes is safe from antidepressant-induced suicidal ideation, that he must use his clinical observation, consider smoking, other medications being taken, any medical conditions and social stressors, etc., and still take every precaution imaginable with every patient — especially with a young patient with a growing and not completely matured brain.  We will be giving the doctor much more information than he has now—information that we hope will be critically important in identifying risk — but information that absolutely does not guarantee a patient’s safety. ”

Much of the genetic testing going on at the moment is about predicting who will have a therapeutic response to antidepressants. I think that identifying those at elevated risk for suicidal reactions is far more important.

I would really appreciate people’s thoughts about this.

Maria Bradshaw

DelusionNZ: Maria Bradshaw, who currently lives in County Wicklow, Ireland, writes of social models of suicide prevention, pharmacovigilance, and alternatives to psychiatric interventions for emotional distress.

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78 thoughts on “Genetic Testing for Suicide Risk

  1. I worry that the test, no matter how reliable it is, would be used as a distraction and a justificatoin by Big Pharma so as to continue current practice, or slightly ammended current practice.

    It might save lives, like getting rid of bull bars on 4 X 4′s reduces the number of people killed when they are hit by them, but it is not the same as taxing them off the road, or making them unfashionable, or providing good public transport and cycle lanes.

    I think Big Pharma is recieving quite a lot of threats at the moment (eg Ben Goldacre’s publication of Bad Pharma and his calls for sharing all the raw data from experiments so a more accurate view of drugs effects can be analysed by independent researchers). I hope this is making people have less faith in Big Pharma, though it may not have translated into differnent drug consumption and prescribing habits yet, the potential seems nearer than it has for a long time.

    So I’d think carefully before taking this on as a strategy. If you do go for it I’d think about using it as part of a bigger strategy which points out a larger range of problems with these drugs.

    It’s a long struggle.

    Good luck

  2. Thanks for your thoughts John. My focus will always be on giving people information on the dangers and falsehoods behind the practices of labelling and medicating people in distress. Some people however will always think this information doesn’t relate to them. My son for example would have (and did) say he would never kill himself even when he heard me discuss the clinical trial information with his doctor.

    Perhaps though if they had a test result showing their personal level of risk and information on how these drugs can induce suicide in people, they may realise they could be affected and make decisions either not to take the prescription or to ensure they are closely monitored by friends and family.

    In the end, I was devastated to learn of my son’s genetic risk of drug-induced suicide AFTER he died rather than before. I am angry that the people who knew these tests existed didn’t tell me and let me make a fully informed decision.

    For that reason, I don’t think it would be right for me not to let others know – while always continuing give them information on the fallacy of diagnostic labelling, the dangers of psychotropic drugs and the alternatives available to assist with emotional distress and behavioural issues.

    Again, thanks for your views which in general I agree with.

    • yes, I can understand your position on this.

      You maybe doing this already but I’d also suggest seeing if others are campaigning on the corruption of Big Pharma to see if you can work with them to get some more public exposure for your work.

      An awful lot of this is about challenging the power of Big Pharma and anything that undermines their influence is going to help chip away at their power.

      So I wish you luck with this.

  3. I really respect where you are coming from, but I don’t trust it, and I would never ever trust doctors. They know very well the side effects, but have ALWAYS, and continue to this day to tell me they are incredibly rare, that sucide has been taken way out of perspective, and that less than one in a million people experience any side effects. Of course it also depends on doctors offering the blood test.

    The DSM already requires ALL possible medical and environmental causes to be ruled out before diagnosing any of these conditions, yet no one has ever been offered any tests previously. Doctors do not do blood tests presently to ensure that nutritional and toxin levels are normal and that no other disease exists, before handing out drugs. I know of a woman who recently died from a brain tumor, which was found 7 years after she took herself to the doctor, in relation to signs of it. Instead she was given forced ECT, forced medication, forced hospitalisation and the like. A simple brain scan would have saved her life, as it could very easily have been removed, it started in a non important area of the brain, that was very easy to get to. Blood tests would also have shown up something being amiss. But doctors don’t do any of that stuff now, why would they bother doing a test in relation to side effects, when they barely believe in them to begin with. On top of that, how long will it take for the results of those tests to come back and what is the doctor going to do in the meantime. At presnt they drug them at the earliest opportunity. And I believe that even if they offered the test, they would still dish out the prescription first, give you a test slip to go and have the blood test and ask you to come back in a week with the results, but the person could already be dead, after a week on the drugs. I do not believe for one second that a doctor would wait for the results to come back and I also cannot see for one second why they would see these are results that need to be done urgently. Nothing is urgent about minising the risks of these drugs, and I for one would never believe that it would be.

    It is standard practice in human anesethics to have blood tests first to ensure that the best anesethic is used for the patient. It is also standard and has been for decades to have people on drips to have stablise blood pressure. Such things are now beginning to be offered in veterniary practice, which is good, but they are elective. Many people still consider them as some luxury that is not necessary. Human medicine consider such things unnecessary luxury’s when it comes to mental health treatment, and I don’t believe that will change.

    I understand the wish to get people to use these drugs more wisely, but I personally do not believe this will work. People believe these drugs are harmless and that they make you feel better than good and doctors believe that. The vast majority of antidepressents and growing numbers of antipsychotics are prescribed by GP’s in a 15 minute consulation, without them knowing anything about the drugs, or even worse the person. They have been pushed in this direction more by psychiatrists than drug companies. They used to refer to psychiatrists, psychiatrists have done huge amounts of education to say that is not necessary, these are incredibly safe and effective drugs. Psychiatrists are aware that these drugs are not approved for children, GP’s are not, but they are being pushed to prescribe them at younger and younger ages. The problem is the system and the whole practice of it. A blood test being available will not change anything, as it relies on it being done and people waiting for the results to come back before prescribing, which would never happen. It also requires people believing in side effects.

  4. I agree with everything you say Belinda, which is why I think this test is a good thing. Doctors cannot be trusted to care about patient safety before profit but they sure as hell care about managing legal and business risks because these go to the heart of profitability.

    One of the key’s to this test is to ensure the public are aware it is available and demand their doctor provides access to it. This serves two purposes. The first is that patients become far more aware that these drugs are clinically proven to cause suicide, the second is that doctors risk legal action and/or decreases in business if they prescribe without conducting the test first.

    Just as no one would accept a blood transfusion without some proof it was necessary and that the blood type being matched, and no doctor would fail to provide this information without being asked, I think if the public are aware of this test it will become the standard of care and we won’t be relying on doctors to do the right thing.

    • I think if it was part of a natinal campaign for a legal requirement that this teat be conducted, or a national campaign using TV and other media that was part of a larger campaign about the dangers and lack of efficacy of these drugs, and embedded in the message was to highlight the lies of Big Pharma I think it could potentially have a good impact.

      Goverments need to reculate and monitor all medicines and Big Pharma in general and this could be an important part of that message.

      But like others I am worried it would be coopted by Big Pharma or not taken up enough to seriously raise the dangers of these drugs. So you would need to think about how to ensure a big enough take up with a good press and PR strategy for it to have the kind of impact you are looking for.

      • I’m in Australia and given our medical system I just cannot see that happening. First and foremost no such test would ever be allowed to be advertised here, just like no one medication can be advertised here.

        We have no legal right to know the person blood transfusions have come from. We do know that all dontated blood has basic tests done on it, but that is public knowledge, not something one has to ask for. We also know that people are voluntarily asked to dislcose other information, but most of that is not tested for. What we do know is that no one on any form of psychotropic medication is prevented from dontating blood, and one would have to guess that those coctails are being passed onto many unsuspecting people. No country would be willing to remove a potential 10% of blood donors on the basis of them being on psychotropic medications.

        I also don’t believe that they really care about the suicide factor enough to actually offer the test, let alone actively encourage and support its use.

        It also does not answer the question of what a doctor is supposed to do with someone while awaiting the results of such a test. It will at a minimum take a few days for the results to come back. That is assuming the person even goes to the clinic to have the blood withdrawn immediately. What happens in those few days – doctors will be sued for not doing anything, which is why they are so happy to prescribe them so early now, so they can’t be sued for not doing anything. Do you seriously believe that people are going to be happy to be told that sorry, nothing I can do, have to do a few blood tests first, you will need to the collection centre to have the blood withdrawn – which is exactly what happens here with ALL blood samples taken in the community, and the results will be forwarded to me in a few days time. You really need to give them at least a week to be sure, so I can see you next week and we can discuss then what we should do – just don’t kill yourself between now and then??

        We are always required to allow at least a week for results to come back on any test ordered by any doctor in the community, after we have had the test done. There is no way at all doctors will wait a week before putting someone on these drugs. It would be way, way, way too risky to do so.

        I would also add that doctors really do not care about being sue, it is the medical insurers who care, but they just as concerned, if not more concerned about being sued for not doing something. The vast majority of them sued in terms of mental health are for not doing things early enough. Now you propose to ask them to do absolutely nothing for EVERYONE for AT LEAST a WEEK.

        I personally do not believe I will ever see every doctor never prescribe any form of antidepressent until someone has had the required blood tests and the results have come back in. If anything I can imagine doctors being struck off the medical board for not intervening. No medical board is going to kick them off because they decided to treat while awaiting the outcome of the test results. What happens in that period of time.

        I will also add, that to my knowledge how blood tests are done in Australia is not to my knowledge any different to anywhere else in the world. Even in hospitals they take time for them to come back. No one will ever consider such tests are life threateningly urgent and so they will be placed in line with everything else. Do you seriously believe that you will be able to convince doctors and the public that no one should be placed on any medications ever without the results of these tests being known, even if it means a week or more of awaiting those results. What do you want to be done during that period of time, or do we just ask them not to kill themselves??

        I hate these drugs and do not believe they help anyone, but a test alone is going to do nothing, when nothing else is offered by the system, and the only thing a person has is to be told to wait until the results come back and then what, sorry can’t take them you might be adversly affected by them, nothing I can do.

        Most people if offered something else, will not keep taking them, as the side effects are so horrible. They keep taking them, as they have nothing else. Money does not grow on trees, asking for the health system to fund this, means nothing else is funded, and so it becomes even harder to get support of any meaning.

    • Hi Maria. Thank you for this thoughtful post, as well as your critically important voice here at Mad in America. I have extraordinary respect for you, your experiences, and the work you’re doing.

      The topic of genetic testing in the context of predicting antidepressant response is one I’ve been interested in since my postdoctoral fellowship at the Mayo Clinic. Mayo is a hotbed of biological psychiatry, and numerous psychiatrists were actively researching the clinical applications of genetic testing. Of particular interest was testing for polymorphisms of the cytochrome P450 gene, which as I understand it determine the kind of “metabolizer” of antidepressant medications one is. Some people are normal metabolizers, some are slow, some are ultra-rapid.

      The clinical relevance of such testing with regard to antidepressant efficacy and adverse effects seems obvious. The former chair of the psychiatry department dreamed of being able to individualize the dose and type of antidepressant for each patient based on their cytochrome P450 test results. At the time I worked there, Mayo Clinic psychiatrists routinely administered the cytochrome P450 test to patients taking antidepressants for a cost of approximately $2000.

      Unfortunately, it appears that psychiatrists’ enthusiasm for this test is not based on adequate scientific evidence for its utility. In 2007, the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group published a report on the scientific status of the cytochrome P450 test in the scientific journal Genetics in Medicine. The report states the following: “…CYP450 genotypes are not consistently associated with the patient outcomes of interest, including clinical response to SSRI treatment or adverse events as a result of treatment. No evidence was available showing that the results of CYP450 testing influenced SSRI choice or dose and improved patient outcomes, or was useful in medical, personal, or public health decision-making. In the absence of evidence supporting clinical utility, it is not known if potential benefits from CYP450 testing will outweigh potential harms. Potential harms may include increased cost without impact on clinical decision making or improvement in patient outcomes, less effective treatment with SSRI drugs, or inappropriate use of genotype information in the management of other drugs metabolized by CYP450 enzymes.”

      The article concluded: “The EGAPP Working Group found insufficient evidence to support a recommendation for or against use of CYP450 testing in adults beginning SSRI treatment for non-psychotic depression. In the absence of supporting evidence, and with consideration of other contextual issues, EGAPP discourages use of CYP450 testing for patients beginning SSRI treatment until further clinical trials are completed.” The full report can be accessed here: http://www.egappreviews.org/docs/EGAPPWG-CYP450Rec.pdf.

      I post this here not to discourage research on biological tests for predicting medication response, but rather to highlight the disappointing reality that there is precious little scientific evidence to suggest that biological tests of any kind (e.g., genetic testing, brain scanning) are useful in making psychiatric diagnoses or predicting response to psychiatric medications. And this is not for a lack of looking. Indeed, research on such tests has been a central pursuit of biological psychiatry for three decades, supported by billions of dollars of taxpayer money.

      I’m not saying that genetic testing won’t ever prove useful in predicting adverse reactions to psychiatric medications, or that it’s not important to study this. Rather, I’m pointing out that given present knowledge and a long track record of failure, there is little reason for optimism that useful tests will emerge in the near future. And there is certainly an insufficient basis to charge people large amounts of money for genetic tests will no established clinical utility.

      Best,

      Brett

      • Dear Dr. Deacon,
        I appreciate your response regarding the very interesting history on P450 enzyme testing.
        I was a guest speaker at the National Press Club along with EGAAP when they presented their findings. I also personally know the director of the diagnostics division of Roche Diagnostics who was responsible for developing the Amplichip – test for P450 enzymes. He personally told me that Roche had made the decision to market the test and not do studies first to show clinical utility– hence the EGAAP conclusions. Roche was far from alone. The belief I had was that EGAAP was asking for un-realistic data as regarding clinical utility and that the same standards to be applied to all of the other genetic tests being developed, would be burdensome, and unnecessary except for standards of safety of the patient. You notice that EGAAP has not been heard of for years. And that Roche did do some studies for clinical utility.
        It is also interesting that Mayo went beyond CYP450 testing to test for drug response with a serotonin transporter marker- the 5HTT-LPR. I believe some testing for clinical utility was done, but not the kind of studies that would have satified EGAAP.
        Now, Mayo has launched a for-profit diagnostic company that is providing genetic testing for drug treatment response.

        Where I am going with this is to say that genetic testing is advancing quickly. And, with the new technology of whole genome sequencing the possibility exists that extraordinary new discoveries may now be even more likely. After all, before we could only identify fewer than 10 million genetic markers, now we can identify 3 billion basepairs (6 billion total nucleotides). We think that drug side effects is an area of pretty excitig potential, given this new technology.

        After all, the FDA website lists over 100 medications for which genetic testing is recommended before the drugs are prescribed. And, in 2009, the FDA quietly told drug manufacturers to bring in serious testing for suicidal ideation with each new drug application. Dr. Kelly Posner at Columbia, who had developed a highly regarded new test to identify if patients were experiencing suicidal thinking when they took medications, was swamped for copies of her test and training of clinical trials doctors in how to use it.

        To my knowledge, pharma companies are genotyping all patients in new drug trials now. Their hope is that if their drug fails, there will be a group of patients for whom it does not fail and that they can market their drug to that set of genetically defined patients for whom the drug is effective and not harmfull. Lets hope that the profit of providing a safe drug that does not harm people–even a small group of people–is compelling. Abuses potentially? Sure. But it is a lot harder to mess aroung with DNA data than vague questionnaires, unreported data and mislabeling of side effects and misreported deaths. At least I surely hope so.

        Dr. Deacon, respectfully, we may be witnessing the dawn of an era that will take leaps and bounds ahead to that which we all would like to see– safe medication for those who desparately need it to save their lives, and for everyone else, no casual prescribing without knowing if the patient will be put at risk. And, best of all, Maria’s plan of education, awareness and great strategies to keep everyone possible from taking drugs in all of those cases where there are better strategies for maintaining wellness–especially when it is for the children.
        Best regards,
        Kim Bechthold, CEO, Sundance Diagnostics, Inc.

        • Hi Kim. Thanks for your thoughtful reply. I do think this kind of research is interesting and important, and I remain open-minded to what the science reveals here in the years to come. At the same time, I wonder how much clinical utility may ultimately be found in genetic tests to predict responses to medications that, as a whole, have little if any efficacy beyond placebo for the vast majority of people who take them. One might argue that the value of such tests can be found in their ability to predict who will be able to tolerate antidepressants, but it’s not clear to me that testing to identify people who can adequately tolerate relatively ineffective medications is marketing gold. Perhaps we will see.

          The real message I want to convey is this: “show me the data.” I’m sure you are excited about this technology, and you may have good reason to be, but I have heard variations of “we may be witnessing the dawn of a new era” from biomedical proponents for decades now. Robert Whitaker has written eloquently about this. Such pronouncements of faith in the potential of biomedical research are par for the course among biological psychiatrists. To pick one of many recent examples, see this blog post (and my comment) by Washington University psychiatrist Eugene Rubin: http://www.psychologytoday.com/blog/demystifying-psychiatry/201303/bipolar-disorder-and-schizophrenia-similar-and-different. Rubin ended his post by stating, “Years ago, this would be considered science fiction. Now, it is a matter of ‘when’ not ‘if.’” Another new era, about to dawn.

          Yet, the new era never seems to arrive, although its arrival has been eagerly anticipated and predicted to arrive at any moment for more than three decades. Biological psychiatry’s relentless quest for the new era has produced an extraordinary, tragic, and unconscionable waste of resources that could have been better invested in less quixotic pursuits. I hope your work turns out differently, I honestly do. The clinical utility and importance are plain to see. Until then, I will remain an open-minded skeptic, waiting for you to “show me the data.”

          Best,

          Brett

  5. Maria

    I have serious doubts that this approach could be helpful in exposing and defeating Biological Psychiatry. Just as you make clear that Psych drugs end up doing far more harm than good, this testing approach may end up with the same result. A few may be saved from potential harm but more people in the long run may be harmed. I am afraid that this may just give more fuel to Biological Psychiatry’s genetic determinist theory and practice.

    Biological Psychiatry will find ways to work around the obstacles presented by these tests. There are several categories of antidepressant drugs. They will end up claiming that perhaps only one category creates a risk for the patient; if it’s the SSRI’s then they will prescribe the older trycyclics. If that doesn’t work they will end up promoting antipsychotics or some other category etc. etc.

    Maria, I appreciate your writings and your passion. I could be wrong in my perspective but I am trying explore some different angles on this subject.

    Richard

    • I’m exploring Graffitti-in “Anti-Depresents Kill” on phramacies – although only in my mind.

      Or pop up withdrawal and information clinics outside GP offices.

      I’m wondering what you are exploring Richard?

      Big Pharma wins by using massive PR and Marketing campaigns. What tactics would help us win?

    • Richard, from my experience that is already happening. People here are routinely told that only SSRI’s are a suicide risk that SNRI’s are not only a more superior medication, but also pose no suicide risk!! They are also told that antipsychotics will improve the drugs antidepressent response, which is how they get people hocked on them as well!!!

  6. Maria,

    I’d be *for* these tests – for genetic biomarkers, suicide risks, etc. if we had any indication that the drugs actually did some good – more harm than good for the vast majority.

    But we *don’t*.

    We have the opposite.

    Antidepressants are not ready for prime time.
    In spite of 10% of the population (in some countries) being on them.

    A sane approach would be to focus of helping millions of people get *off* these drugs.

    The lesson seems to be to *not do this again* – not wildly market drugs that aren’t ready for prime time; only to look for suicide risks *afterwards*.

    Duane

  7. Maria,

    I support the need for any testing that can help build a scientific base for diagnosing and treating depression, including DNA testing.

    Right now, the lives of millions of people are left up to the expert opinion of doctors and psychiatrists who too often only seem to know what Big Pharma wants them to know. In addition to your tragic suicide story and similar losses to many other families, there are also people in prison for antidepressant-induced homicides.

    I understand this first hand. I recently uploaded a video called “Paxil-Induced Homicide” to YouTube based on my own family tragedy in 2004 in Canada. But, unlike Americans, I have my freedom back, have reconciled with my wife and daughter and have been rebuilding my career.

    I also filed a lawsuit in 2011 against GlaxoSmithKline based on my own 2009 DNA test results from Australia. I have been off all prescription drugs for more than 2.5 years.

    Psychiatry needs to have a scientific base. We cannot afford, in many ways, to leave diagnostic and treatment decisions up to opinion. CONGRATULATIONS to Sundance Diagnostics for providing leadership in this area.

    David

  8. I don’t think anyone is really giving this a chance yet, remember this test is still in its infancy. Nobody, not even Sundance Diagnostics, are claiming it works.

    As far as I can make out this is not a test to determine whether it’s safe for certain patients to take antidepressants, I don’t think Sundance or Maria are saying that.

    It’s more about informed consent, having all the facts opposed to the theories of healthcare professionals and pharmaceutical companies.

    Yup, SSRi’s are about as effective as placebo but they are still here, still being prescribed. I can’t see a major push to ban them.

    Pharma often create blockbusters. The money spent on marketing is obscene.

    Now, we could all sit here and bitch about safety and efficacy [I've been doing that for the past 7 years] – In fact, many people having been calling for the safety and efficacy issue to be looked at… alas, they are still prescribed.

    So, you chip away.

    This test, if proven, should, at the very least, make people stop and think.

    Black box warnings and advocates are up against a huge industry here.

    Irving Kirsch’s findings should have been global news. Leaders should have asked questions, there should have been debates in parliament. Instead we got people opposing the findings of Kirsch, these people basically threw water on the fire.

    People have nothing to lose by taking a genetic test – I’ve never heard of anyone suffering withdrawal because they had a pin-prick of blood taken or a hair on their head pulled off.

    I guess the proof is in the pudding… just give the pudding a chance to rise before throwing it in the bin.

  9. Thanks for your comments everyone. In my view, the market for antidepressants is, as with all economic transactions, a matter of supply and demand.

    Many of the people I work with who want, like me, to see antidepressants off the market, focus on restricting supply. They do this by advocating for greater regulation and attempting to undermine supply by challenging pharmaceutical companies through the legal system or other avenues. This is important work and I’m involved in it too.

    My key focus however has always been firmly on the demand side of the equation. Like any other product, if demand reduces or stops then there is no profit in the product and suppliers will stop producing it.

    In my view, the value of this test is primarily in the impact it could have on demand. Its easy for those of us who work in this field to forget that the vast majority of people prescribed these drugs have no idea they can cause suicide, homicide, mania, psychosis etc. Particularly in my country where there are no Black Box Warnings, no patient information leaflets – and informed consent is a joke.

    Taking an antidepressant in NZ is seen as no more risky than drinking cola. Not necessarily good for you, but not life threatening and certainly less harmful than the scaremongers like Maria Bradshaw would have people believe. Everyone knows someone on Prozac and they are just fine.

    Imagine if there was a major advertising campaign that told people Cola can kill you. If there was a warning on every bottle. If you had to show evidence you were over 18 and to be tested for diabetes before buying it. Might you reach for a bottle of water instead? Might you hesitate before giving it to your children? Might Coca Cola take enough of a hit that they could not justify continuing to produce the product to their shareholders?

    I think this test has the ability to ensure that people are informed of the risks. I think it will encourage more people to select Play Therapy rather than drugs for their child. I think at the very least, it will make mothers like me more vigilant in watching for the signs of suicidality in their kids.

    If we all stopped demanding these drugs — doctors and patients – there would be no money in supplying them. If liability ensurers required that doctors run the test before prescribing in case stroppy mothers like Maria Bradshaw dragged them through the courts, they may be forced to disclose the risks to their patients.

    Sundance have been very clear that this is a discovery project. It may not, as has been suggested, produce useful results. Equally however, the results may be not in the ability of the test to identify risk but in the impact such a test has on demand for these drugs.

  10. Maria

    I first want to congratulate you on an excellent post. You have started a discussion that should have begun long ago by the people who develop pharmaceutical drugs.

    You have touched upon a couple of important issues – P450 genetic polymorphisms and some of the environmental issues (e.g. drug-drug interactions)that can affect how these genes may be expressed or transcribed – i.e. epigenetics.

    Although more than forty (40) P450 enzymes have been identified in humans, there are six (6) that are responsible for about 90% of all human Phase I drug oxidation.

    There is also the issue of genetic polymorphisms regarding metabolic transporter enzymes involved with Phase II metabolism – i.e. ABCBI and SLCO1B1. The ABCB1 enzyme is thought to be important in the regulation of the concentration of drugs which cross the blood-brain-barrier (e.g. psychotropics) by pumping out toxic compounds. Surprisingly, these metabolic processes are poorly understood.

    In this regard all modern pharmaceuticals are considered toxic by these wonderfully ancient metabolic processes encoded in our DNA*.

    Having said this, I do not believe that P450 polymorphisms and associated epigenetic issues will alone explain the severe side-effects some people experience. Much work is now underway to understand the polymorphisms associated with the transporter and receptors genes associated with the neurotransmitters (e.g. serotonin, norephinephrine, dopamine etc.).

    In this regard, I believe that the Sundance Dx initiative will attempt to determine all of the genetic factors that may be involved. If we wait for the pharmaceutical industry, it will never happen.

    We wish Sundance Diagnostics Godspeed.

    Neil Carlin
    Toronto, ON

    *Clinical Manual of Drug Interaction Principles for Medical Practice – Wynn, Oesterheld, Cozza & Armstrong – APP publishing 2009

  11. Thanks Neil. I agree this is a discussion / debate we need to be having and cannot think of anyone who is better qualified to comment than you. In my view, lived experience of the drug-induced suicide of a child and the committal of all ones waking hours researching its etiology, combine to produce people who bring the perfect combination of pragmatism, vision and knowledge to suicide prevention.

  12. Maria

    Thank You. Coming from you, this is an honour.

    In the end, it will be about the scientific discovery of why people (Toran & Sara) are driven to such severe agitation, while on these medications, as to kill themselves violently.

    In my view it is about the severe, internal akathisia. Not the mostly benign movement type, most doctors are taught about, but the severe drug-induced internal type that drives people to kill themselves, violently.

    The prescribers of SSRIs and other psychiatric drugs, need to wake up from their pharma-marketing-induced coma.

    Neil Carlin
    Toronto, ON

    • Not so simple. Many people take the drugs and will say they feel better. But a smaller subset of people will go off the rails and become so extremely agitated as to kill themselves & perhaps others. The medical/scientific literature supports the issue of increased risk of suicide re adolescents -> FDA Black Box Warnings.

      Neil

      • I think there is room for all sorts of discussion here:

        What is the science behind the dangers of these drugs.

        What is the evidence of their effectiveness.

        What effective campaignigning tactics are available to those who wish to campaign about the dangers.

        These all seem worth discussing.

        The power of Big Pharma and how to combat it is one question that keeps arrising and that seems to me to be the thing that underlies most of the debates on this website.

        Whether invetigating the genetic risks of SSRI induced suicide is a fuitful avenue to undermining Big Pharma’s power is surely worth debating.

        • I agree John. In New Zealand, Heroin was a very widely prescribed treatment for a range of illnesses in the 1950s and a recent report from our Law Commission recounted the fact that despite a growing body of evidence the drug was harmful and addictive, the medical profession refused to accept that its risks outweighed its benefits.

          Clearly that situation changed and Heroin became an illegal drug whose harm is now not disputed.

          What will it take for the same to happen with SSRIs, antipsychotics and other drugs that cause serious harm? What would we need to do to make regulators and prescribers stop endorsing these drugs and patients stop requesting them?

          Would an advertisment for a suicidality test that played alongside advertisements telling people to ask their doctor if Effexor is right for them, make a difference?

          Would people who say “I would never be stupid enough to kill myself” pause if they saw DNA results showing they have a genetic profile that makes them susecptible to suicidality on the drugs?

          If science is the new religion – the thing everyone now has faith in – how could the science of genetics contribute to a new set of beliefs around the wisdom of messing with the brain?

          • Re: “…*wisdom* of messing with the brain”

            This is not about just about being *smart*.
            It’s about being *wise*.

            We’ve already tried just *smart*.
            Look what happened.

            Duane

          • What happened with Heroin was that they simply found another drug to replace it. SSRI’s have already largely been replaced by SNRI’s and they now claim they are 100% safe and not related to suicidality!! Of course they always have the triclics or the ones before that. And very very easy to just create some other wonder pill, look how easy it was to market Prozac.

            While the community believes that feeling said is a brain disease, and that we have medications to cure it, they will keep taking these drugs. This test could well do the absolute opposite, people will be even more convinced it is safe and effective and take it even more readily. Afterall, we now have genetic tests to support its use.

            Problem is one cannot develop a drug to cure something that does not exist. In order to develop antibiotics one first had to put bacteria into a test tube, and then find a substance to kill it. One cannot and nor will they ever be able to put feeling sad into a test tube. Spending billions of dollars trying to promote the use of these drugs by claiming there are genetic evidence to prove they are not toxic to some people, is not going to help people to face the real issues, instead it will simply encouarge a much more widespread use.

            I also believe that are many many more things than simply genetics that predict how someone will respond to said medications. The level of depression they feel would be the first on my list. Suicidality is not something one can measure it is a very personal experience, despite what many may believe. And there will never ever be a drug that can cure it. I also do not believe that suicide and depression are related, and I am not alone in that. David Webbs work details that in much more detail. He was acutely suicidal and had numerous very seious attempts, he was never depressed though.

  13. Dear Belinda,
    I am Kim Bechthold, CEO of Sundance Diagnostics, Inc. We appreciate your comments very much. We reached out to Maria and other persons, and medical experts in the field, in order to learn how medication-induced suicide and acts of violence were triggered, how they occurred and what was needed by families and patients in order for us to help curb theses serious drug side-effects. We are receiving very important information and advice, for which we are truly grateful.
    Before our quest, however, we knew that the subject you brought up was one of the most important issues for which we needed a solution–almost immediate test results, if the test to be developed was to be of value. Lukily, technological advances are amazing and more are coming daily. As it stands right now, the cheek swab for our test (yes, just a cheek swab) can be in a mailer in the doctors office. The mailer is sent over night to a testing laboratory. When received, the results can be faxed to the doctor within 48 hours and we think soon it could be within 24 hours. More exciting though is that desk top DNA analyzers are being developed for the doctors’ offices. Affordabililty and reliability is key and that is being worked on. It is a little hard to predict as to when the desktop analyzers will be available, but we doubt it will be too far away. There is another intersting point to think about. Psychiatrists make very little extra money from insurance providers in the United States because they have few tests for which they can draw blood and interpret results (reimbursed actions)as other medical like other doctors do. A genetic test, that can be taken in their offices, cheek swab or desktop device, brings in new revenue. This may add to their desires to perform the test.
    The biggest issue, however, in the U.S. will be medical liability insurance carriers. Depending on how strong the test is in predictive value, the insurers may require the test, and/or the doctor may not want to risk prescribing without the test. He may not wish to fail to tell his patient that there is a test. We can’t predict any of this until we know how the test will turn out, but we are certainly employing the current best technology on the planet to try to find the markers that can predict the risks. Thank you again for your comments.
    Best regards,
    Kim Bechthold

  14. Dear Belinda,
    I didn’t mean to be boastful about the sequencing technology. It is not our technology but has been developed by 5 different companies, four in the United States and one in China. We are just excited to able to use it for the study. It is a monumental scientific achievement to have developed machines that can identifiy over 3 billion base-pairs of DNA in an individual in hours. Ten years ago, the Human Genome Project took over a year and millions of dollars to sequence two genomes.
    Best regards,
    Kim Bechthold

  15. Seeing your the post of the person developing the test worries me even more. It could be spending even more money on something that should, in most cases junked. Spendng good money after bad as they say.

    Irving Kirsch’s research found SSRI’s to be slightly more effective than placebo. Why spend more money on something that a sugar pill would work just as effectively as but have nowhere near as many dangers?

    Maira has a good answer in that it might reduce the sucicide risk about these pills and make the general public question the safetey and possibly the efficacy of them. But there is also a risk that it legitimises this treatment even more by adding yet another level of mystifying science, which tends to add to placebo effect, ie the faith people have in medical treatments

    • One of the things I like about Sundance’s approach is that they don’t pussyfoot around suicide and violence with medical terminology. They name these drug reactions for what they are rather than talking about suicidal ideation or agitated depression they just say these drugs cause suicide and violence.

      Personally I’m glad a corporation is fronting up with some money to confront the reality of what these drugs do to people. Its criminal that individual activists, many of whom have been financially devastated by their experience of psych drugs, sell their homes and assets and work for nothing to mount this challenge.

      Why spend more money on something no better than a sugar pill? That’s a question for Regulators who in my country fund 16 different antidepressants, none of which work, all of which cause harm.

      Why spend money raising awareness of the dangers of these drugs? Because people will continue to use them until they understand there are safe, effective alternatives and continue to be harmed.

      Personally I hope Sundance spend a fortune on this and more importantly make a fortune on it. Because then they will develop tests around antidepressant withdrawal and drug use in pregnancy and in specific ethnic groups being targeted by pharma and a heap of other areas that need exposing.

      • I think it is a gamble Maria, but one that it looks you are prepared to take. So I hope you have a well thought out strategy to make the most of this and minimse the risk of Big Pharma coopting this.

        It is a long struggle and this may prove to be a contructive initiative.

    • John I totally agree. If anything this test will only encourage even more use. And it will give psychiatry what they have always wanted, a biological test. Now they can it simply and have a justification for putting people on toxic coctails that do absolutely nothing other than destoy lives.

      I was never and nor are most people ever suicidal or homicial on these and other drugs. We are also never ever helped by them. Instead I lost over 15 years of my life in drug induced fogg, which is the whole purpose of these drugs to simply sedate someone. I still experienced many other horrible side effects and especailly withdrawl effects.

      These tests may help to save one in a million from dying and I’m not saying that is bad, but it is not going to do anything at all to help the billions of people whose lives are destroyed by these drugs, it is not going to do anything to reduce the growing levels of disabiltiy caused by these drugs, etc. What it will do is to promote the use of these drugs even more than is already happening, by saying we now have biological proof they are safe and effective and that you will respond to them!!

      When people are spending thousands of dollars on such tests they are not going to be able to afford other treatments, or in my case our government would not fund other treatments, when a simple DNA test can give them the drug to cure them!!

      I believe wholeheartedly psychaitrists will love the test, it will simply legitimise the cult they are the leaders of.

  16. John, you rightly state, “Irving Kirsch’s research found SSRI’s to be slightly more effective than placebo. Why spend more money on something that a sugar pill would work just as effectively as but have nowhere near as many dangers?”

    If people (doctor’s and the general public) are ignoring the work of Kirsch then what hope do we, as critics, have?

    We can argue until we are blue in the face regarding the efficacy of SSRi’s. I’ve been writing about this for 7 years, there have been many, more distinguished authors, that have gone before me.

    Journalist’s such as Robert Whitaker have won awards for their work yet it’s still the pharmaceutical company CEO’s that get the knighthoods.

    If you think shouting from the rooftops about the lack of efficacy is the only way to warn people then more power to you. Experience tells me something completely different.

  17. Something that Belinda stated caught my attention. Until we convince the general public that these drugs are toxic we are waging a losing battle. Many of us keep attacking the drug companies for pushing their poisons, and we attack biopsychiatry. Perhaps the real target of our attention and effort needs to be the public that goes around believing that “sadness is a brain disease, and that we have medications to cure it, ……”

    How do we go about mounting a media campaigne to address the truth? I think that doing anything else is just spinning our wheels. You’ve got to convince the consumer of the product. If there is no demand the drug companies won’t be able to sell the toxic poisons. Unfortunately, such a media campaigne requires tons of money and some concentrated leadership to sustain things. Our movement seems to have neither.

  18. Agree with what you say Stephen except the bit about it needing tons of money. Major marketing campaigns were not needed to abolish slavery or to give women the vote. Public education can be achieved in lots of ways and we can’t let a silly thing like being broke stand in our way.

    • Tons of money did not get woment the vote or abolish slavery. It did take years of well thought out campaigning (and in the case fo UK suffragettes an awful lot of smashed windows – they might not have practise violence towards people but they weren’t overse to quite a bit of violence towards property).

      A bit of money helps but not huge ammounts and there are people who give grants to social/political campaigns such as this. I only know the UK situation but there must be people who fund this in other countries.

      • I guess we need to start smashing a lot of windows then! Perhaps we need to start at the offices of the APA.

        Of course, this would get a lot more of us who’ve been in the so-called “mental health” system into the legal system as well. We’d end up in the 9/11 system, which takes five years to get out of in my state. This program is stricter than the usual parole system. Perhaps this is another reason why our movement doesn’t move forward more swiftly. Frankly, one time in the dreaded state hospital was enough for me. I’d really have to think hard about doing something that got me smack dab into both the “mental health” system and the legal system, all at the same time.

  19. My personal strategy for educating the public about the risks (and lack of benefit) of these drugs is to share my son’s story, run free public education sessions, get in front of key opinion leaders and politicians in my country and conduct research. I believe I make a difference but I don’t believe for a minute that the average person is going to take as much notice of me as they are of their doctor. I believe that while for some people Toran’s story is compelling, the majority believe it couldn’t happen to them.

    While I do my little bit, I support everyone else who is doing their little bit too. Sundance and their test are not the key to abolishing SSRI harm. They are one part of the multi-pronged approach to this issue.

    Doctors will never tell their patients my son’s story but they will give them test results that include information that clearly states the drugs carry a risk of suicide. And people who think that what happened to all the suicide victims couldn’t happen to them will see their own personalised results and realise that it could.

    Yes there are risks associated with this process but there are risks in not implementing new strategies too. Antidepressant prescriptions are increasing by 10% per annum in my country. We have the highest rate of youth suicide in the english speaking world. I think we have to be pragmatic as well as principled and for me, saving lives will always have priority over winning against pharma.

    • I think one of the assumptions being made here is the only reason people will commit suicide is if they are on these drugs. Fact is that is not the case. I personally know of 15 young people who have killed themsleves, NONE of them were on ANY sort of psychotropic medication. I also know of a child psychiatrist who did not prescribe medications, as they felt that therapy was better. But after loosing 6 clients in one year, she started prescribing them to some, with parents well informed of the side effects, told to monitor the child more, more regular appointments, etc, etc. She has lost no client since.

      Sure these drugs do raise the chances of suicide, but that risk is in the scheme of things, very very minor. At most less than 5% of people taking these drugs would be at risk of such a thing. What happens for the other 95% who have no such issues. 95% will be shown to have no risks, take the drugs and many will still kill themselves. People have been told then via a DNA test that they are now 100% safe to take and everyone will believe that.

      This company is doing this, because they believe totally that these drugs save lives and that we need to actively promote and encourage there use. They do acknowledge that a very small percentage of people react to them. So for them it is quite simple, we can remove that very very small percent of people from them, and then actively promote and encourage the use of these drugs as a first line treatment for everyone else, without any questions at all, as they make people better than well.

      Problem is there is NO evidence that these drugs work any better than placebo. Better off just giving everyone a suger pill, than shoving toxic substances down there throats. The aim of this company is to get the other 95% of the population who do not react to them, onto these drugs, but there is no evidence at all that that will reduce the suicide toll, if anything it will increase it, becasue a pill cannot stop people from wanting to die. Unless you address the underlying reasons why someone wants to die, nothing will change. A drug cannot do that, despite what this company might want to believe. There WHOLE purpose of developing this test is to get MORE people onto these drugs, not less. Simple really, just take a really small percentage off them, which is estimated to be less than 2% and then we can put everyone else on them, and convince them via DNA tests that they are 100% effective.

      I cannot see how this test will do anything to really reduce the numbers of people them. 99% of people will be given a test and then told by a doctor that we now know for 100% certainty that they are safe for them to take. Hence everyone will take them. Sure the other 1% or so might be directed to talk therapy first, but for that small percentage, it really is not going to make any difference at all. If anything it will increase complaince and the length of time people take the drugs. Doctors always tell people who complain of side effects it is a part of your illness getting worse, not the medication. Now they have done a DNA test which siad it was safe for them to take. Hence they have even more reason to increase th dosage, write multidrug coctails and the like. Has anyone considered what the multidrug coctails do when they all interact with each other.

      Are suicide rates and rates of depression increasing, sure they are, because we have a society convinced that these are brain diseases that can be very effectively treated with a pill. Sure we have a very small percentage of people who have killed themsleves while on the drug, but most people show no such issues. No problem taking a very small percentage of people off the drugs, when we can get the rest of the population on higher doses and multidrug coctails, thanks to DNA tests, that supposedly prove they are safe to take.

      NO ONE is depressed for no reason, no one commits suicide for no reason, until people are willing to address those reasons, nothing will change. Convincing the population that 99% of people will not be adversly affected by something is going to increase its use, not decrease, from my way of looking at things, while they continue to believe that these are brain diseases and that we have drugs to treat it.

  20. I run a suicide prevention organisation Belinda and am certainly not under the illusion that everyone who kills themselves is taking an SSRI.

    Sundance has been very clear to say that regardless of the risk rating returned by their test, these drugs carry a risk of suicide for everyone who uses them. Here’s a link to an interview with the test developer if you want to see what they are saying publicly http://fiddaman.blogspot.co.nz/2013/03/antidepressant-suicide-gene-solution.html.

    I think you will find that your statement that “This company is doing this, because they believe totally that these drugs save lives and that we need to actively promote and encourage their use” is completely incorrect. If that were the case, they would be developing a test showing genetic markers for therapeutic response, not suicide risk.

    Currently available DNA testing would not show that “99% of people will not be adversely affected” so I’m not sure why you would think that this test would lower, rather than raise the percentage of people shown to have elevated risk.

    You have every right to be skeptical about this and to challenge and question it. As I said in my blog, I had many reservations initially too. I’ve been fortunate to have months of being able to ask them questions directly and one of the reasons for blogging about this was to give other people the opportunity to do the same. As you’ve seen, Sundance CEO Kim is happy to respond.

  21. Dear Belinda,
    I posted a comment to Dr. Deacon just under his reply and so I am not sure you would have been able to see it. I am copying it below in case you would like to read it.

    And just a few items from our communication with you earlier. The test, when completed, will not be a blood test, just a cheek swab that is performed in the doctor’s office. Also the test will only tell the doctor if his patient is at heightened risk for suicide. It can’t and we won’t tell the doctor that the patient is safe from risk of suicide. Plese see the Fiddiman interview that Maria suggested.

    Also, finally, we will not be promoting antidepressant drug use or safety. We are owned by private investors, not pharma.

    We appreciate you sharing your thoughts and we are listening.

    We would like you to know also that we are mothers and fathers and partners and a number of us are living with a loved one with a mental illness or have lost a cherished friend to a drug side effect. We understand, too, losing years of one’s life that you describe and the heartbreak that brings.

    “Dear Dr. Deacon,
    I appreciate your response regarding the very interesting history on P450 enzyme testing.
    I was a guest speaker at the National Press Club along with EGAAP when they presented their findings. I also personally know the director of the diagnostics division of Roche Diagnostics who was responsible for developing the Amplichip – test for P450 enzymes. He personally told me that Roche had made the decision to market the test and not do studies first to show clinical utility– hence the EGAAP conclusions. Roche was far from alone. The belief I had was that EGAAP was asking for un-realistic data as regarding clinical utility and that the same standards to be applied to all of the other genetic tests being developed, would be burdensome, and unnecessary except for standards of safety of the patient. You notice that EGAAP has not been heard of for years. And that Roche did do some studies for clinical utility.
    It is also interesting that Mayo went beyond CYP450 testing to test for drug response with a serotonin transporter marker- the 5HTT-LPR. I believe some testing for clinical utility was done, but not the kind of studies that would have satified EGAAP.
    Now, Mayo has launched a for-profit diagnostic company that is providing genetic testing for drug treatment response.
    Where I am going with this is to say that genetic testing is advancing quickly. And, with the new technology of whole genome sequencing the possibility exists that extraordinary new discoveries may now be even more likely. After all, before we could only identify fewer than 10 million genetic markers, now we can identify 3 billion basepairs (6 billion total nucleotides). We think that drug side effects is an area of pretty excitig potential, given this new technology.
    After all, the FDA website lists over 100 medications for which genetic testing is recommended before the drugs are prescribed. And, in 2009, the FDA quietly told drug manufacturers to bring in serious testing for suicidal ideation with each new drug application. Dr. Kelly Posner at Columbia, who had developed a highly regarded new test to identify if patients were experiencing suicidal thinking when they took medications, was swamped for copies of her test and training of clinical trials doctors in how to use it.
    To my knowledge, pharma companies are genotyping all patients in new drug trials now. Their hope is that if their drug fails, there will be a group of patients for whom it does not fail and that they can market their drug to that set of genetically defined patients for whom the drug is effective and not harmfull. Lets hope that the profit of providing a safe drug that does not harm people–even a small group of people–is compelling. Abuses potentially? Sure. But it is a lot harder to mess aroung with DNA data than vague questionnaires, unreported data and mislabeling of side effects and misreported deaths. At least I surely hope so.
    Dr. Deacon, respectfully, we may be witnessing the dawn of an era that will take leaps and bounds ahead to that which we all would like to see– safe medication for those who desparately need it to save their lives, and for everyone else, no casual prescribing without knowing if the patient will be put at risk. And, best of all, Maria’s plan of education, awareness and great strategies to keep everyone possible from taking drugs in all of those cases where there are better strategies for maintaining wellness–especially when it is for the children.”

    Best regards,
    Kim Bechthold, CEO, Sundance Diagnostics

  22. Belinda,

    You wrote, “This company is doing this, because they believe totally that these drugs save lives and that we need to actively promote and encourage there use.”

    This kind of baffles me. I’m left wondering if I’ve been reading the wrong press release. Are there two diagnostic companies both with the name Sundance?

    Can you point me to where Sundance claim that they believe that these drugs save lives and that we need to promote the use of SSRi’s?

  23. Antidepressants are not the only psychotropic drugs which cause akathisia and increase risk of suicide and homicide due to genetic differences in metabolizing psychotropic drugs, I find it very troubling that only the SSRIs are the focus even though they are not the only drugs known tho cause akasthisia, suicide and homicide…I’d be willing to bet the SSRIs are not killing as many as people as the neuroleptic drugs are…But then when a neuoleptic drug is the cause it’s usually a person with a diagnosis of schizophrenia schizo-affective, or bipolar disorder; people with these diagnoses are the most marginalized of psychiatric patients. I can’t help but notice that the other drugs known to cause the same fatal adverse effects are not a part of this discussion on suicide prevention through genetic testing; which is disturbing since those who die from the adverse effects of other classes of drugs are just as dead and leave behind family members who mourns them. I wonder why the sole focus for this effort appears to be on the SSRIs? It seems like eugenics to me.

  24. I hope the comment from Sundance diagnostics, posted elsewhere and copied here, explains the initial focus on SSRIs

    “The reason to start the project with SSRI’s is a scientific one. It is imperative that the first whole genome sequencing study for heightened drug risk is successful. If the science is questionable, studies for genetic prediction of drug risk with other drugs will be hampered. The critical need in this type of study is to find exceptionally well diagnosed patients with extensive and complete medical records. With such, we can defend the results of our research. Well diagnosed patients with complete medical records are much easier to obtain for suicidal ideation than for any other drug side effect at the moment. That is why we are starting with the risk of suicidal ideation. We have the DNA prepared and ready to sequence for the first SSRI we will study. The cost of the study and the confirmatory trial will be anywhere from $12 to 20 Million. With success we will move to the next drug. Predictive genetic markers may be consistent througout all drugs in the SSRI class. If we find that to be true, our research with SSRI’s may go much more quickly and we can move on then to other drugs.

  25. Hi Maria,

    Interesting opportunity you have here. One of the lessons publicized on this site and on blogs like 1boringoldman is that much of the harm associated with psychotropic drugs has been caused by scientific fraud instigated by capitalist incentives. In some cases it’s outright misrepresentation and hiding of negative findings, in others manipulation of study design and statistical analysis to produce desired outcomes. Invalidating and biased methodologies in statistically complex studies can even be inadvertent on the part of well-intentioned researchers following the prevailing practices in their fields. So you may want to dig into the fine print of how your data will be used after you submit it to Sundance. What commitments have they made to you, in writing, that the data underlying their claims will be open to critical review by independent researchers? I personally would not be satisfied with the position that they will meet the standards of the FDA and other regulators, since those agencies have often proven to be captive to business interests.

    From your comments and research it seems like individuals at this company are sincere and have a good balance between optimism and realism. But having worked at an investor-funded startup myself, I can tell you that when the money is running out, and the positive results you hoped for aren’t there, and the livelihoods of you, your friends and colleagues are on the brink of disappearing into bankruptcy within 2-3 quarters, it’s very hard to resist that temptation to make the data look better than it is – if only, you may tell yourself, to give you the time and resources to make that really important discovery that will save so many lives and justify everything.

    Evaluating a data transparency policy for a company like Sundance is way outside the scope of my background, but there are other writers on MIA like Jay Joseph (for his knowledge of genetic studies) or David Healy (on clinical SSRI trials) who may be able to advise you on what is an acceptable data use policy for a company like Sundance.

  26. Thanks Rachel, wise advice and I appreciate it. I understand sundance have been in contact with David Healy and are hoping to engage him in reviewing the data. I am hoping they can make this happen. Those of us who are cautiously optimistic about this research have also talked to David who I believe supports the idea of testing for adverse reactions (rather than testing for therapeutic response)as does Dr Dee Mangin who we at CASPER also work with. Their professional opinions are ones we respect completely and whose views will influence our own.

    I have discussed with Sundance providing my son’s post mortem blood sample for this project and would not do so without fully exploring all the issues you raise and obtaining clear written agreements around data transparency and independent review. I would be devastated if Toran’s DNA was used to perpetrate any fraud or harm.

  27. I have read this thread with interest, and I probably come here from a different perspective. I have a son with bi-polar, but when the meds work, he stabilizes on the depressive side of the continuum, which is a double whammy: 1. he has the challenges of a depressed person, 2. the danger of suicide is elevated for someone with bi-polar, compared to most people with depression.

    What is of interest to me, as someone who loves him, is to find that which works without endangering him. To that end, I recognize that genetic testing will eventually help him find the right cocktail of medications.

    One of the challenges of pharmaceuticals is that they are quite imperfect–a bit like using aspirin for blood-thinning because Plavix and warfarin and the like have not been discovered. Another challenge is our expectations: we expect an Rx to fix a problem–sometimes it can only manage a problem or improve it slightly without fixing it, much like dulling a pain instead of eliminating it. That does not mean it doesn’t work, just that it doesn’t work as well as we would like.

    Maria, my heart goes out to you–you have lived my nightmare. My son has a potentially terminal illness, and that is a reality I live with daily. With medicine of any kind, we play the odds–no intervention, pharmaceutical or surgical or whatever, is fool-proof, 100% guaranteed. I think of the vaccinations against smallpox (I still have a faint scar on my upper arm). People died from the vaccinations, but millions were saved and smallpox was eliminated (small comfort to the families of those who died of side-effects.)

    So, for me, in medicine as in life, I see us in a casino, playing the odds, hoping it won’t come up craps. I have more confidence in board-certified psychiatrists than in general practitioners when it comes to SSRIs and other psycho-pharmaceuticals. I recognize that there are people who get prescriptions who should not and people who do not get prescriptions but who should. And, I look forward to the day when genetic testing can tell us with greater precision (not 100% precision) who should get what and when. This sounds like one more step along the road. I am glad that Sundance is taking it.

  28. Dear Sam,
    I have passed your comment on to the men and women who have made investments in Sundance and the many who have contributed their time and hard work so that we could take this “one more step along the road.” Thank you for them and for me, personally, for your comment. It means a great deal to us, more than you might know.

    For two reasons in particular: one is that the United States Congress passed a law last year to make it easier for early-stage companies like ours to raise necessary funding for medical research and development and the Securities and Exchange commission has refused to set forth the rules to enact the legislation. This means that companies like ours face losing control of our endeavors to the wrong kind of angel and venture capital investors and that we have to work very hard to raise funding in a way to be able to hang on to our goals and remain committed to the good of the patients.

    The second reason is that Sundance made a very difficult decision last year which meant that we would have to work even harder. We had to choose whether to put together a test with a limited number of known markers, and take it to market, or whether to “walk out to the edge of the gang plank” and invest in very expensive whole genome sequencing so that we could find every known marker for genetic high risk rather than just a few. We knew the latter would be far and away the very best for the patients. Our investors bravely backed management in its decision to make the leap and invest in the sequencing–something not done before in psychiatry that we know of. The risk to finance such a large program therefore grew larger.

    So you see how important your comments are for our people.

    We have had incredible assistance from the day we first started speaking with parents and families who live as you do with the risks of these illnesses and the medications available, and the parents and families who are living with the unbelieveable, crushing, never-ending pain of the loss of a child. We sought to understand their experience and learn from them and we are–incredibly, every day, and we are so grateful.

    Thank you so much again for your comments. We will keep everyone posted with our progress through CASPER, the Seroxat Sufferers Stand Up blog, Leonie Fennel’s blog, the Crespi Family Hope blog and any others that wish us to report to them.

    Kim Bechthold, CEO, Sundance Diagnostics

    • Hi Kim,

      Thank you for taking the time to write here and share with us some of the challenges a company such as yours face.

      If I understand it correctly Sundance Diagnostics is carrying out its own GWAS (or Whole-Exome?) studies into anti-depressant suicide risk? I looked through Sundance’s website but could not find any information on this.

      I did however find these texts on Sundance’s website:

      “The labels on all antidepressant drugs warn of the risk of suicide, causing a parent to worry about whether to seek treatment for a child who is depressed, a partner to worry whether to seek treatment for his loved one, a son to worry whether to seek treatment for his parent.
      This worry can cause delay while the depressed person’s life may be hanging in the balance. The genetic safety testing we are developing should give the patient and the family more confidence in proceeding quickly with treatment.”

      “When a drug makes a patient feel worse rather than better, he is likely to discontinue treatment. Untreated depression results in higher medical costs, hospitalizations and loss of job productivity, and can affect the ability of a mother or father to care for the family.”

      I wonder if you are familiar with research that shows that the effectiveness of all anti-depressants can be accounted for by their placebo effect, and that their active ingredients (which will be likely to play a significant role in the increase of suicide risk in children and adolescents) play little or no part in their anti-depressant effect. For an accessible review and explanation of this research I would refer you to Irving Kirsch’s excellent “The Emperor’s New Drugs” (ISBN 9781847920836).

      In light of this it would seem clear that the most effective way to prevent child suicide would be NOT to administer anti-depressants to children, and yet that does not seem to be the aim of your company, which does not seem to focus on preventing at-risk children from being prescribed anti-depressants but rather on “giv(ing) the patient and the family more confidence in proceeding quickly with treatment.” Which I presume refers to treatment with anti-depressants.

      This comments column is not the right format to go into a lengthy discussion as to why I think “genetic safety testing” for anti-depressant induced suicide is misguided, but I will go as far as to say that if you see this testing as a way to make people who would otherwise have had reservations about putting their children on anti-depressants “proceed quickly with treatment”, then your test will without a doubt contribute to an increase, rather than a decrease, in child suicide.

      • What happened to the question: “Have anyone in your family committed suicide?”

        I like your arguments and it helps me not feeling a lunatic.

        I have no reason to believe is anhy ot these especially when medicine is in a crossroad: adding genetic “treatments” to the existing. In the future they want everything to be treated with genetical approach.

        They are already helping couples to choose what kind of children they want to have and it is not only the color of eyes and hair.

        It seems to me that it is very difficult to some people to lose faith in doctors and their intentions.
        So we are in a Stockholm syndrome situation because with all that has been published showing how… dear Lord, receiving money from the Pharma to prescribe?7

        Having patients who kill themselves because of drugs they prescribed…

        It’s me. I’m too pessimist.
        I’m done with these subject.
        I get too angry and sad. That is one of the reason it is so hard to raise awareness. Some people trust Big Pharma.
        THEY ARE ALL THE SAME PEOPLE.

    • Kim, I just realized I misread your post. I didn’t notice the “known” when you wrote “invest in very expensive whole genome sequencing so that we could find every KNOWN marker for genetic high risk rather than just a few”.

      So of course you are not engaged in GWAS research, which would’ve been very odd, that was stupid of me.

      I think the reason I was confused by your statement is because I’m not sure why you need to sequence the whole genome in order to look for already known markers for “genetic high risk”. I can see how it might be a good marketing ploy since “whole genome sequencing” sounds impressive but I don’t see the scientific rationale behind it, since whole genome sequencing is not going to give you any more accurate predictions that only looking at the specific known markers. But of course I don’t know exactly which specific markers you refer to – may I suggest that you should perhaps include this information in your website, as well as links to the relevant studies that claim to have established an association between those markers and higher suicide risk? Because of course the efficacy of your test in predicting suicide risk will only be as good (or as bad) as those studies.

  29. Hi Maria,

    I hope you read my reply to Kim Bechthold above. Please forgive me if I’m blunt, and of course this is only my personal opinion, but I feel this is too important an issue to not speak clearly: it seems to me that Sundance Diagnostics are taking you for a ride in the most unprincipled way imaginable.

    I hope I’m wrong, and I’m sorry to be so blunt; if I speak like this is only out of genuine concern for you and the great work you are doing through CASPER.

  30. Hi, Morias,
    I had never read anything about Irving Kirsch, so your posting stimulated me to do so. Interesting guy-certainly more brilliant than I am–maybe you, too. And, the person I thought of first was Linus Pauling, equally brilliant but ultimately misquided. But when I read something of his, something struck me. BTW I went to the wikipedia on him first and then found this: http://psychrights.org/Research/Digest/CriticalThinkRxCites/KirschandSapirstein1998.pdf

    1. His research field is basically that of placebo that morphed into study of anti-depressants. There is the bias, and I don’t know the name, of being a hammer and seeing every problem as a nail. Back in the day, if there were alternative medical treatments and you went to a surgeon, he would recommend surgery. Same thing.

    2. Wikipedia describes one of this contributions as: Response expectancy theory
    Kirsch’s response expectancy theory is based on the idea that what people experience depends partly on what they expect to experience.[2] According to Kirsch, this is the process that lies behind the placebo effect and hypnosis. The theory is supported by research showing that both subjective and physiological responses can be altered by changing people’s expectancies.[3] The theory has been applied to understanding pain, depression, anxiety disorders, asthma, addictions, and psychogenic illnesses.

    Now, the interesting thing about that is that if it is true, it applies to you, me, and Irving Kirsch as well. If you expect that anti-depressants don’t work and read Kirsch, who works with placebos and expects things to be placebos, (or if I expect anti-depressants to work), then we are all guilty of confirmation bias.

    3. The introduction to his article, and I confess that the statistics are beyond me, even though I work with statistics as a non-statistician, reads: EDITORS’ NOTE
    The article that follows is a controversial one. It reaches a controversial conclusion—that much of the therapeutic
    benefit of antidepressant medications actually derives from placebo responding. The article reaches this conclusion by
    utilizing a controversial statistical approach—meta-analysis. And it employs meta-analysis controversially—by
    meta-analyzing studies that are very heterogeneous in subject selection criteria, treatments employed, and statistical
    methods used. Nonetheless, we have chosen to publish the article. We have done so because a number of the
    colleagues who originally reviewed the manuscript believed it had considerable merit, even while they recognized the
    clearly contentious conclusions it reached and the clearly arguable statistical methods it employed.
    We are convinced that one of the principal aims of an electronic journal ought to be to bring our readers information
    on a variety of current topics in prevention and treatment, even though much of it will be subject to heated differences
    of opinion about worth and ultimate significance. This is to be expected, of course, when one is publishing material at
    the cutting-edge, in a cutting-edge medium.
    We also believe, however, that soliciting expert commentary to accompany particularly controversial articles
    facilitates the fullest possible airing of the issues most germane to appreciating both the strengths and the weaknesses
    of target articles. In the same vein, we welcome comments on the article from readers as well, though for obvious
    META-ANALYSIS OF PLACEBO http://journals.apa.org/pt/prevention/volume1/pre0010002a.html
    1 of 16 3/11/2009 2:51 PMreasons, we cannot promise to publish all of them

    So, not merely the conclusions but the methods are controversial.

    4. Finally, and here is where I am in over my head a bit, I note that:
    a. It is meta-analysis of many studies, not as strong as the double-blind, control studies required for individual pharmaceutical products.
    b. Many of the 1500 studies found were eliminated from consideration, perhaps justifiably,but perhaps selection bias.
    c. The authors lump together pharmaceuticals from very many different drug classes, including several kind of anti-depressants, and lithium as well. It would have been more convincing to me if it had concentrated on SSRIs alone, as it may have introduced cross-effects statistically that would hide rather than reveal true differences. It is a bit like having +100 from one and -100 from another and concluding that there is 0 effect when they are seen in aggregate.
    d. I wondered what his analysis would have shown about beta blockers, heart drugs that are among the oldest used–would they too have had a majority of their effect from placebo? Or aspirin?
    e. His study looked at research with durations from 1 to 20 weeks, but it is well known that the full therapeutic effect of SSRIs requires 6 weeks, so why would he include studies from 1 to 5 weeks? Could he be putting his thumb on the scale?

    After all of this, with every advantage to debunking the therapeutic effect of anti-depressants, he and his co-author conclude that that 25% of the effect is therapeutic, not due to placebo (50%) or natural effects (25%).

    So, the conclusion is that anti-depressants work alongside a huge placebo effect. That’s great, if he is right. It explains why drugs plus therapy are better than either alone. It might be sufficient to get a person paralyzed by depression to the therapy he/she needs. Concluding that something does less than claimed is not the same as concluding it does nothing.

    If Kirsch contends in his 2009 book that depression is not a matter of brain chemistry imbalance, then what is it? And without reading the book, I hope it is not something like a chiropractic adjustment, something unscientific that cannot be falsified, just something that can be “lost.”

    • Hi Sam,

      First of all let me tell you how sorry I am to hear about your son.

      I’m more or less familiar with those criticisms of Kirsch’s work and I don’t think they have much weight. Kirsch’s work consists mainly of analysing clinical trials conducted by the anti-depressant manufactures themselves (mostly the clinical trials used to get the drugs approved) so criticism like: “His study looked at research with durations from 1 to 20 weeks, but it is well known that the full therapeutic effect of SSRIs requires 6 weeks, so why would he include studies from 1 to 5 weeks?” can hardly apply. Whatever the shortcomings of the studies, they are in fact the shortcomings of the manufactures’ clinical trials which, if anything, raises even more questions about the efficacy of anti-depressants.

      I’m afraid I don’t have the time to go through the criticisms one by one, so I’ll just say please read the book, or if you are used to reading research papers (as it sounds you might be), then I would encourage you to look at Kirsch’s actual research – the book comes with a very complete bibliography. At the very least I can assure you that it is all pretty mainstream scientific analysis; no “chiropractic adjustment”s anywhere in sight.

      Also, since Maria Bradshaw mentions that “I understand sundance have been in contact with David Healy and are hoping to engage him in reviewing the data” (March 16, 2013, at 5:16pm), it might interest you to read David Healy’s praise for “The Emperor’s New Drugs” (printed on the inside of the front cover of the edition I have). He writes:

      “Irving Kirsch brilliantly documents a grim scandal of regulatory and clinical failures concerning antidepressants but also holds out hope in one of the most profound meditations for 50 years on the nature and role of the placebo effect in clinical care.”

      I’m glad to hear you use the word “falsified”; not a lot of people seem to be aware of Popper’s criterion of demarcation these days. I know some people still question de validity of falsifiability, but in this I’m a staunch Popperian – and I certainly feel psychiatry would benefit enormously from applying falsifiability a bit more strictly (such as for example to “genetic safety testing”).

      As for your question: “If [...] depression is not a matter of brain chemistry imbalance, then what is it?” I wish I could go into it but as I said I’m afraid I don’t have the time at the moment, and in any case this is not really the ideal format to go into such a big question in detail. I’ll just say that it isn’t so much whether depression is a “brain chemistry imbalance” or not , but what the etiology of that “imbalance” is, and how it can be best corrected (“imbalance” is not a very helpful term, it would be better to speak of “atypical physiology” or “atypical morphology”). Without getting into it I can only point you in the direction of neuroplasticity and activity-dependent plasticity, which explains how environmental experiences (such as trauma or psychotherapy) can lead to changes in “brain chemistry” and even brain morphology. It is really a question of which is the cause and what the effect; a chicken and egg sort of thing. The field of neuroplasticity is still in its infancy but it is already ringing the death-knell of biologically-determined psychiatry.

      By the way, and please don’t take this the wrong way, but isn’t it funny how if you look at your first post and the timing of Kim Bechthold’s reply to it, and now your reply to my reply to Kim’s reply to your post, it almost looks like you could be Sundance’s “plant” in this thread? Like you could almost be working for them… you aren’t, are you? (Just kidding!)

  31. Morios,
    Thanks for your response. To me the word “falsifiable” distinguishes science from superstition as well as pseudo-science. I don’t know how Popper uses the word. And as for the rest, uhhh, if you or Sundance or anyone wants to pay me for my opinions that I freely express, sometimes too freely, I’m interested. Hasn’t happened yet so I am not holding my breath. :) I’m not smooth enough to be a troll.
    Sam

    • Karl Popper was the man who came up with the notion of falsification as a way to distinguish between what is a scientific statement and what isn’t. He developed this concept in his 1934 book “The Logic of Scientific Discovery” (well, the original is of course in German, “Logik der Forschung”). Popper himself, being a philosopher and not a scientist, was not dismissive of all unscientific statements, he was simply interested in finding a criterion of demarcation for scientific statements.

      By the way, Sam, I have to say I really admire your quick thinking. Considering that at 5:16, when I posted my mention of Kirsch’s book, you had “never read anything about Irving Kirsch” it is very impressive that by 6:05 you had managed to find so many arguments against Kirsch research, and that you were able to read through all that material and make up your mind about it, let alone write the actual post. Truly impressive – I must say I’m humbled.

      Oh! And of course I never said you were a troll, I hope you didn’t get the idea that I resented any of what you said. I said you might be plant, but of course you know I’m only joking.

      Give my best to your son. I hope he is doing well.

  32. Dear Morias,
    I received your update by email but it does not appear above. Perhaps it will. I apologize for the confusion I have created in my reply. Instead of mistakenly saying “every known” marker, I should have said, “every possible” marker.
    The uncommon markers that are yet to be identified, and can only be identified by whole genome sequencing, are suspected by a number of scientists to contain a wealth of information regarding psychiatric disorders. GWAS discoveries for antidepressant drug risk have, in the most part, not been confirmed by independent groups. When we are working to prevent the loss of life, we need the best that science has to offer. Sequencing is not a “marketing ploy” but a dedication to finding the best that can be found for patients and their families. Sam is also not a “plant.” But we honestly do respect your desire to get to the heart of the matter and ask important questions. Thank you.
    Kim Bechthold

  33. Morias,
    No offense taken, and I guess there is a difference between a troll and a plant that should be recognized. :)

    As for the response to Kirsch, we live in an ever accelerating world where search and quick response are the new paradigm that has replaced knowledge–fortunately for me I am better at searching than knowing, so I have come into my element as I embark on the last stage. The arguments against Kirsch were my own–as I work with data, I have to be aware of potential pitfalls and fallacies, so applying some of that experience to that which I read quickly and which I did not have to analyze in depth–merely raise the questions, it was a simple trick.

    So, are you a fan of More, Erasmus, Folly, or some combination of the above?

    Sam (not a pseudonym) :)

  34. Gee, Kim and Morias, seems to me that “Is Sam a plant?” could be a whole new thread in http://www.madinamerica.com. And it brought to mind Brendan Sullivan’s remark during the 1987 Iran-Contra hearings in the US: I am not a potted plant.

    And the whimsy of a business card that listed my position as either Plant or Paid Plant, along with a new entry in my resume such as: Paid Plant, Sundance Diagnostics, 2013- will get me through the rest of the afternoon with a smile.

  35. Dear Sam,
    We are looking over our benefits package for “V.P Paid Plant.” We may have to amend our enployee handbook to cover watering, fertizing, sunlight.
    Thanks Sam and Morias for the smile here, too.
    Kim

  36. Kim, Sam,

    Please stop it, you are embarrassing yourselves.

    Maria,

    I hope this exchange helps you see what you are dealing with. If you still have any doubts please consult with any independent person who knows anything about genuine genetic research.

  37. Kim, Sam, Please stop it, you are embarrassing yourselves.

    ??????????

    Morias, up until now I thought we were having a genial exchange of differing views. And what Maria is dealing with are intelligent people with differing views, 2 of the 3 seems to be able to laugh at themselves and the world they live in, taking the subject but not themselves so seriously. And, as I gently pointed out, I am using my real name, as is Kim along with her last name. So, please, let’s keep this genial and not pretend that any of us is the shaman with the key to the secret knowledge. These are complicated questions without definitive answers at this stage of our knowledge. I’m still chuckling–why aren’t you?
    Sam

  38. Agreed. And still chuckling.
    Morias, I kind of thought you might not be joking about the “plant” and I kind of thought you might have been being sarcastic about Sam’s ability, even though you said you were “impressed.” Now I see, you really are joking, this time about “genuine genetic research.” I’m just joking, Morias, just joking. But, hey, we would like to hire Sam.

    Putting the fun aside for a moment for something important.

    You both may wish to know that today marks the 5th anniversary of Maria’s son, Toran Henry’s tragic death. The fact that we are all talking speaks volumns of the work that Maria is doing in his honor. Thank you, Maria, his short time on this planet has graced us all and has brought us your advocacy, your brilliance, and your determination. We are in your debt and in debt to your enduring, towering love for Toran.

  39. Thanks Kim and Sam. The last couple of days, and yesterday in particular have been difficult to say the least. My heart is broken. I yearn for my son with an intensity I can’t describe. I spent most of the day in bed yesterday, unable to face the world which without Toran feels so lonely and empty. Today I was out doing a suicide prevention education session in his memory. So…I have missed this exchange and having read it quickly now, need to read it again before I can make any sensible response. But not tonight. Tonight I am going to do absolutely nothing :)

  40. I find it more than strange as well as inappropriate for the CEO of Sundance to be using this comment thread to do public relations and marketing for Sundance a commercial medical testing company on the mad in Americal site. Even stranger, is the fact that she directs interested parties not to the company website for information, but to the blogs of activists who are invested emotionally (if not financially) in Sundance’s commercial enterprise being marketed here as if it is an altruistic cause not a commercial endeavor.

    Most telling, is this contradictory comment
    “GWAS discoveries for antidepressant drug risk have, in the most part, not been confirmed by independent groups. When we are working to prevent the loss of life, we need the best that science has to offer. Sequencing is not a “marketing ploy” but a dedication to finding the best that can be found for patients and their families.”

    The best scientific “discoveries” are based on scientific data that is readily available for independent examination; i.e. show your work. The research that a discovery is based upon must be replicable by others; i.e. verifiable. I’m alarmed to say the least that the absence of this information is attributed by the CEO of Sundance Diagnostics to the importance of the project/mission, “preventing loss of life.” How does this explain why there is no open access to data, or studies; nor have the results/claims made been independently verified. Given the mission of this endeavor, this information is obviously important, Nonetheless, the CEO seems to imply in her comment that the goal, “preventing loss of life” means open access to data and research results being independently verified is not important, neither is explaining the absence of this information respectfully, in a forthright manner. The “marketing ploy” seems to consist of recruiting the enthusiastic support of bereaved families, and bloggers market Sundance Diagnostics on blogs, perhaps as training for marketing the end product.

  41. Dear Srsly,

    Thank you for your comments.

    Many new companies these days are combining an altruistic cause with a commercial endeavor. It is being called, “social entrepreneuralism.” The logic is that with a commercial success a company will have the financial means to contribute more to its chosen field of altruistic endeavor. That is Sundance’s goal.

    Respectfully, this thread was not initiated by Sundance Diagnostics. We are replying to comments to the original story to answer questions and clariy our work.

    Also, respectfully, bloggers we have referred to have no financial interests in the company whatsoever.

    Also, respectfully, the research that has been published by others is available from PubMed or from the authors. There have been many. A list of several of the publications is available from Sundance, at your request. We have carefully explained that we have not completed our own research, so there is no publication as yet. If and when there is a publication at the end of our study, it will be made available to everyone.

    As a last note, a commercial company such as ours, with an altruistic goal, needs to be advised by and learn from persons who have suffered terrible losses due to medication-induced side effects. We could think we know everything we need to know, but we would be mistaken. So we have reached out to a number of persons to help us more fully understand the problem and be sensitive to the issues. Of greatest importance is our need to undertand from patients and their families how to approach patient awareness and education, if our test successfully predicts risk.

    Also, even a commercial company can use someone to “protect their back.” Or a lot of someones. Especially in light of commercial entities that may have a lot to loose if the company’s work is successful.

    Finally, in the United States, non-profit patient organizations have contributed large sums of money to commercial companies doing research in their disease. The organizations have not resented the company’s profits because their goal was to cure a disease and sometimes they also share in the profits. By and large, it takes a commercial entitity over $780 million to develop and get approval for a new drug. Rarely is this done by a non-profit organization and never is it done by a government agency in the U.S.

    A locking of arms by a commercial company and patient organizations and families that all share the same goal can be a very powerful and a very good thing, we believe. That is our hope for Sundance DX.

  42. It’s true that Sundance’s research is not available yet. Anyone interested can however check out the research on which NeuroMark Genomics, Kim and Wayne Bechthold’s previous company (Wayne being now the president of Sundance dx), based their Mark-C test, also designed to identify suicide risk linked to anti-depressants.

    Research here:

    http://ajp.psychiatryonline.org/data/Journals/AJP/3834/07aj1530.PDF

    A very informative and unbiased article about Mark-C here:

    http://www.dreamfigure.org/entry/mark-c-test-reduces-antidepressants-related-suicide-rate/

    And an interesting side-story here with links worth checking:

    http://neurocritic.blogspot.co.uk/2007/09/on-your-neuromark-get-set.html

    I have to say that from all this literature the Mark-C test sounds very impressive, I wonder what happened to it or to the “Mark-C Outcomes Database”?
    Or to NeuroMark Genomics (their website seems to be down at the moment).

    • In case it is not very clear:

      The study is a very limited study which looks at just one particular type of anti-depressant. As far as I can understand it – which I admit is not very far at all – it is not badly conducted, although of course it looks at suicide ideation rather than actual suicide, and makes no claims as to the link between those two things. As the authors of the study themselves conclude: “Until functional alleles are demonstrated or replication is shown in an independent sample, these findings should be viewed as preliminary.” Let me emphasize that: preliminary.

      And yet NeuroMark Genomics – a company whose CEO was Kim Bechtold and where Wayne Bechthold was listed as Vice President of Administration and which, like Sundance DX, is or was located at Boulder, Colorado – made this announcement on September 27, 2007, that is to say, on the very same day the research paper was published online:

      “NeuroMark, a Boulder, Colorado company, announced today the immediate availability of a genetic test to identify people at risk of suicidal ideation – thoughts of committing suicide – when prescribed an antidepressant drug. The test, called the Mark-C™ test, is expected to help restore public confidence in antidepressant medication and help to reduce a recently announced spike in suicide rates among U.S. youth. “This is an exciting example of the power of genetics to address a critical need and make important drugs safer for patients worldwide,” stated Kim Bechthold, NeuroMark’s CEO.”

      So Kim’s company already had a test developed and ready to go based on a study which describes its own findings as “preliminary” and in need of further confirmation before any conclusion can be drawn from them. In spite of which Kim had no trouble saying that a test based on that preliminary study “is expected to help restore public confidence in antidepressant medication.”

      Perhaps it’s just me, but I just cannot see these as the actions of people genuinely concerned with saving lives. To me these are the actions of opportunistic individuals whose only concern is making money, no matter what the consequences might be for others. I repeat my question: what happened to the Mark-C test which Kim Bechthold was marketing with such enthusiasm only a few years ago?

      I will not continue posting on this subject; I will resist the temptation to list all the details which give “Sam” away as Sundance’s plant (just a hint, Kim: no CEO would ever say when posting in her professional capacity, no matter how jokingly, “we would like to hire Sam”)

      I will just say this to Maria:

      Maria, if you are still considering giving some kind of endorsement to Sundance DX, please, please at the very least wait not only until they have published the results of their research but until their test has been in use for some time and they can provide you with reliable statistics on the accuracy and usefulness of that test – statistics that can be independently verified. Please do not rush into an association which could so easily destroy everything you have worked so hard to build when there are still so many questions unanswered.

  43. Morias,
    I have been reading this thread, and I was content to just read, until you slandered me. You write intelligently but your otherwise healthy reservations step over the line into unhealthy territory. For the record:
    1. I wandered in here
    2. I do not know Kim
    3. I did not know she was married
    4. I did not know she had a prior company
    5. Indeed, you have read ALL contact I have ever had with Kim or her company or her agents.
    I hope that is helpful to you–if you want a bee in your bonnet, it shouldn’t be me–choose someone prettier.
    As for the substantive points you make, many of which I am ignorant, I would suggest two thoughts:
    a. we have light bulbs and cholesterol drugs because someone wanted to make a buck–that’s not disqualifying
    b. entrepreneurs at start-ups, both successful and unsuccessful, let their ideas get ahead of their reality. (One reason I have never been nor wanted to be an entrepreneur.) Bill Gates sold an operating system before he had one to sell–the result is Microsoft. Obviously, having started 2 companies, Kim is entrepreneurial.

    So, while your skepticism is helpful and necessary, you might put a leash on it, and also consider that entrepreneurs and scientists think differently–both are necessary.

    Sam

  44. Morias, I endorse two things

    1. universal awareness of the risks of SSRIs
    2. fully informed consent to their use

    I am far more interested in these things than I am in whether Sundance’s test works or not.

    I will take any opportunity to raise awareness of risk and promote fully informed consent to as broad an audience as possible. Those who dismiss Toran’s story as anecdotal or as an idiosyncratic response and CASPER as an anti-psychiatry lobby group may be less quick to dismiss the science discussed in this discussion.

    To sit back and wait for anything, including the success of Sundance, condemns more children like Toran to a horrible, lonely, painful death so waiting is not an option for me.

    I am not endorsing Sundance, I am endorsing science and business recognising the harms of these drugs and working to reduce those harms. It makes a nice change from science and business promoting their use and denying they cause harm.

  45. What strikes me is that the lessons were not learned.
    Many ethical physicians and researchers are fighting the “genetic euphoria” some people are promoting.
    According to the new genetic-panacea whores we are all saved not only because the numerous incredible treatments already available and about to appear but also because of the tests.

    I found this article at… OMY! CNN:

    http://edition.cnn.com/2011/10/27/health/brca-genetic-testing-ep

    Excerpt:

    “Doctors and genetic counselors interviewed by CNN say that Myriad Genetics in Utah is doing something very similar with tests that determine if a woman has a potentially dangerous genetic abnormality linked to breast cancers.

    Most breast cancers do not seem to be genetic. Instead, they’re the result of cells gone wild for no apparent reason. However, some women get breast cancer because a bad gene runs in their families. When testing shows that a woman carries such a gene, she has a much higher chance of getting breast cancer. These women usually then get more frequent MRIs, ultrasounds and mammograms to detect a cancer, and sometimes even choose to remove their breasts to prevent a cancer from growing in the first place.

    Myriad owns the patent on breast cancer genes and so is the only company that can test for them. It offers one test that catches most, but not all, abnormalities, and then charges nearly all patients $700 for a second test that catches the rest.
    If a woman can’t afford the $700 fee, she may miss an abnormality, which could mean the difference between life and death.

    “What Myriad’s doing — charging extra for this test — is really sleazy,” Matloff says. “They’re collecting blood money off my patients.”
    Myriad defends the $700 charge for its second test, called BART, even though many patients can’t afford it and insurance won’t pay for it..”

    The “A pill for every ill” is over,
    They are not even searching for new drugs the way they did,

    Cant you see that the genetics is the new industry?
    I really do not understand how those who learned a lot from the evils these people can do for money DON’T SEE that those who are in charge of the genetic treatments, screening… all the panacea ARE THE SAME!

    I left this comment at another blog where a long discussion about this test took place.

    I’m appalled that some people can trust these people.
    Please! They don’t care about health. They want MONEY.

    The research I did about the the way medicine is being done. some aspects are at my first blog, justAna, was enough.

    Fortunately I never received an e-mail from any of these bastards.
    Isn’t it strange that they are asking for those who are raising awareness about the harms of SSRIs to say that these tests are state of the art science?

    Science? No, there is no real science behind any of the available treatments or screening tests.

    I would not be surprised if genetic tests become mandatory to a prescription. How much does the test cost?

    Don’t we have to make numerous tests to some medical specialities?

    Why not a test for psychiatry?
    Wow! They will make a lot of money because it will be worldwide.

  46. What about the other side effects? Will they also have a test?
    Funny because suicide is under “Violent behavior” that can turn against others or self.

    Will they test for genetic testing for: drug-induced homicides; birth defects – the mom would test if the child has a genetic possibility of having any problems; addiction – the body cannot reuptake serotonin in the presynaptic gap without the antidepressant; sexual problems that can persist after quitting the drug – PSST;… you all know the list of side effects.

    ANd what about the withdrawal? A test to check if the genes of the person will make it harder to withdraw?
    It seems that most people cannot stop antidepressants SSRIs like they aspirin.

    ANtidepressants SSRIs don’t help even those who are clinically depressed.

    Did we forgot that? That the chemical imbalance theory is not valid?

    Usually those who are clinically depressed starts with one antidepressant that works for a while and stop helping. It is changed for another antidepressant, and another and another and… ad infinitum.

    Some patients end up with . electrodes attached at their heads to the ECT.

    What about 5, 6 7, 8 years of treatment and nothing helps?

    The real issue is: for how long will antidepressants be at the market?

    Antidepressants: “more lives taken than saved” claims Dr. David Healy

    “Isoniazid, reserpine, imipramine, atropine, stimulants, benzodiazepines, antipsychotics, fluoxetine*, ketamine – all have antidepressant credentials. The word coined by Max Lurie has lost meaning; it’s a basket for acronyms. Psychiatry was the first branch of medicine to have specialist hospitals and journals, the first to adopt controlled trials, rating scales, and guidelines. The antidepressants beckoned us toward clinical neuroscience but have led to myth, hidden data, ghostwriting, more lives taken than saved, womb to tomb consumption, and an increased incidence of “depression” from 1 per 1,000 to 1 in 5 of us.
    Knowing when not to prescribe is the greatest art in medicine.”

    “womb to tomb consumption”

    http://hellaheaven-ana.blogspot.com/2012/12/antidepressants-more-lives-taken-than.html

    Amitriptyline, one of the first antidepressants tricyclic, is prescribed for poor people.
    They are lucky!

    • Well said Ana.

      Antidepressents have you have so clearly said “don’t work”. They are not approved for use in children and adolescents, not just because they cause such a high rate of suicide, but because even drug companies can’t create carefully designed studies, to even have ONE study that shows people get better.

      It is well known that if they were required to prove that on average these drugs work for adults, NONE of them would be on the market. They are only approved for short term use and only in profoundly depressed people, the ONLY thing they test for. Even then they have to put EVERYONE on placebo for a month first to wipe out those that naturally recover. One does not put everyone with cancer on placebo before trialling a new chemotherapy agent, to see which ones naturally recover, so why do it with depression. They do it because if they did not the placebo rate would be too high and there would be absolutely no chance of getting any drug approved for anything.

      One cannot design a medication to treat something that does not exist. One actually has to know what you want the medication to do, before you can desgin a substance to treat it. In order to develop antibiotics one first had to know what bacteria was and to put it into a test tube, then and only then could they put in different substances to see which killed it. One cannot put feeling sad in a test tube, one cannot even define what feeling happy means. Even in clinical trials, they did not even use patient self reports to decide if the drugs were working or not. They decided that patient self reports were not reliable. How do they diagnose them – on the basis of patient self reports, but they will not use the same self reports to decide if the drugs work??

      Everyone, even when feeling really down experiences some things that are not totally bad, that could be as simple as eating a nice meal or the like. Sure one requires much more when they are really down, but they still experience somethings that are not totally bad. Antidepresents numb the person. When a person is really down feeling number is not all bad, BUT it comes at a cost, feeling numb means you cannot experience a few things, like a nice meal or a funny movie, as good as they are now numb. They numbness, numbs, and that is everything, including the good things. Therefore the person gets more depressed, the dosage is increased, and the cycle starts again. Then they add on another drug, and another one, then they fry the brain with electricity, cut it open and remove parts of it, and it keeps going on and on and on. People don’t get better, they get worse, as no one has actaully looked at WHY they were feeling down to begin with!!

      Anyone that has read Whitakers work, or actually knows the history of treatment for depression, knows that it used to be an incredibly rare condition. In 1980 the standard advice was to do nothing. They had found that antidepressents did not help, psychotherapy did not help, ECT did not help, long term. The best thing one could do is to push through it, because sitting at home doing nothing only gave them things to dwell on and made them worse. MOST people had a single episode for a few months and recovered totaly without treatment to never ever relapse again. Then media advertising came in and made out prozac to be something that not only made a person not sad, but it made them better than well. They made out depression as a brain disease, that needed life long medication. Suddenly for the first time in history we had people who became disabled for life by this condition and the best treatments in the world were not helping. They were so bad, they could no longer work and now require disability benefits for life, they are now incurable. How can a drug that makes people better than well, create a situation in which for the first time in history we have people become permanetly disabled by feeling sad??

      And these people want to put more people on these drugs, at earlier intervals and for life. How is that going to help anyone. They cannot even provide ONE scienfitic study that says the drugs keep people well. ALL the research is on a 6 week medical trials. If you want people on them for life, need to provide at least one study of a year or longer duration. Problem is ALL such studies have shown people get worse, not better. But they still promote it.

      And yes what about all the other side effects. It was the other side effects that made me want to give up on life. I was not that bad, but I was told by doctors that my life was not worth living if I was not on them. When the side effects, every single one them became too overwhelming then I decided I couldn’t cope. The drug itself did not do that, the piles of side effects, and being told life would be even worse without them, made me want to give up. But they are not testing for that. I would add, I know of thousands of people who felt the way I did. But they want to believe that the drug itself does it, not other things going on and above all else they want to believe that these drugs can cure a fictional brain disease. As others have said, this test will increase the numbers on the drugs, and the rate of sucide, not lower it.

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