Welcome to Data Based Medicine

Adverse drug events are now the fourth leading cause of death in hospitals.

It’s a reasonable bet they are an even greater cause of death in non-hospital settings where there is no one to monitor things going wrong and no one to intervene to save a life. In mental health for instance drug-induced problems are the leading cause of death — and these deaths happen in community rather than hospital settings.

There is also another drug crisis — we are failing to discover new drugs.

Companies are sawing off the branch on which they are sitting.
Doctors are failing to recognize the most treatable cause of death today.

These two crises may be linked in that detecting adverse events on drugs is still the best way to discover a new use for a drug, and new drugs. But there are fewer and fewer incentives for anyone to recognize adverse events. Companies are blocking efforts to detect problems and in so doing are sawing off the branch on which they are sitting. Doctors are neutering themselves by failing to recognize and treat what should be the most recognizable threat to life and moreover the most eminently treatable cause of death in the world today.

Part of the problem is cultural

A century ago Freud drew our attention to the many ways in which speech could be biased. Half a century ago clinical trials drew our attention to the biases that both doctors and patients bring to therapy. Just as Freud’s insights once made it difficult for anyone to accept things that were said at face value, so clinical trials and evidence-based medicine have created a culture that makes it increasingly difficult for doctors or patients to spot what is right in front of our own eyes. Ultimately Freud ended up being used to explain away or deny claims of abuse that we now know were happening, and in much the same way companies and doctors are now using trial data, or the lack of it, as a drunk uses a lamppost — for support rather than illumination. Just as a point came at which claims of abuse could no longer be denied, we may be nearing a point where treatment-induced problems will have to be recognized.

This blog aims at raising the profile of this interlocked set of problems and the need for Data Based Medicine.

It will do several things:

1. First — the key thing is to pave the way for RxISK.org, a website for doctors and patients to enter reports of treatment related problems. For reasons outlined below and in my latest book, Pharmageddon, having another talking head is not a way to solve problems. It’s time to do rather than talk or write, and RxISK.org is about doing. It will be the only site on the web where patients and patient-doctor teams on a global basis can enter the details of what happens on treatment and can discover both new things about treatments and also whether a particular treatment is actually producing a problem for this patient.

It’s time to do rather than talk or write, and RxISK.org is about doing.

2. Second — I will post a set of questions and mysteries for which I have no answers. These are not questions without answers, or mysteries that cannot be solved, but some will likely remain unanswered and unsolved. Some because they are quite old and the trail may be going cold. Others because they are enduring. But some because the answers are hidden behind barriers of attorney-client privilege – a barrier that few people are aware of. The best response to these questions and mysteries will be data or documents that provide answers to the questions or information that sheds light on the mysteries.

The best response to these questions and mysteries will be data.

The style in which these questions are raised will often be quite stilted and the posts will not come thick and fast. There is a reason for this. Several years ago I put in a Freedom of Information request to Eli Lilly. The 103rd document that came back read as follows:

103             “Healy long term strategy.
Thank you for the message outlining your strategy to counteract Dr David Healy’s claims re: Prozac and violence.
Send a letter to Healy designed to get him to stop discussing a study that he has never done. Have a third party expert in the audience at BAP to ask Healy questions when he presents.
Just last Thursday Healy was quoted in a Cincinnati paper saying Prozac causes violence and suicide…X has asked that we go back to legal and determine if we can sue Healy under UK law.”
 

Anyone responding to this blog therefore needs to take care with their choice of words. 

Anyone responding to this blog therefore needs to take care with their choice of words and ideally needs to stick with data, and documents. This is not a forum for prejudices or unsupported opinions; it’s for moving questions forward or solving mysteries.

(Note Post Hoc: Some colleagues have wondered if I am or was being sued by Lily. The answer is No. If you want to read more on this episode, see the Academic Stalking section on HealyProzac.com or download this article on Academic Stalking.)

Other documents show that at least one public relations agency linked to Lilly was tasked with developing a Healy management plan. Given that the marketing departments of each pharmaceutical company employ several PR agencies and I’ve given several marketing departments an incentive to manage me, this seems a reasonable way to explain for instance getting an email from a colleague in Japan who had just met psychiatrists from the US who on hearing he knew me advised him to have nothing to do with me as I was trouble and I would soon be in trouble. The interesting aspect of this was that the American psychiatrists he named had never met me, and had never engaged with me in any way.

A UK PR rep told me I was doing more for sales of Prozac than anyone else!

But the picture is complex. Many years ago a woman who claimed to be responsible for PR for Prozac in the UK introduced herself to me at a meeting saying she was really pleased to meet because I was doing more for sales of Prozac in the UK than anyone else.

This is not a simple picture with the good guys (the clinicians) on one side and the bad guys (industry) on the other. Most of the grief I’ve experienced has come from clinical colleagues, as the website healyprozac.com, especially the academic stalking section, shows. The solid help I’ve had has mainly come from within industry.

A Japanese colleague was advised to have nothing to do with me by an American psychiatrist who had never met me.

The challenge in this world managed by public relations agencies and marketing departments for both scientists in industry and insurance companies and the rest of us is to find a way to turn this dynamic around and use efforts to hide problems as a way to make things safer. If there are just two boxers in the ring, it’s possible to try Muhammad Ali’s rope-a-dope strategy, but there are at least three in this case. The third party is organized medicine — doctors. The fact that medicines are available on prescription only has made doctors, rather than companies, the chief deniers that a drug might be causing problems. Insurance companies, regulators, and others are also parties to these events and their interests in the outcome shift around from time to time.

3. Third — this site will in due course have a category of posts for people who have been through the system, people who have had partners, parents, children, or friends injured by treatments and who have found themselves trapped in a Kafkaesque world when they have sought help from doctors, regulators, or others who seem to be there to help us.

Their stories will highlight the lunacy of the system but will also show how we can change everything. 

Their stories are aimed at highlighting the lunacy of the current system but also showing how someone who is determined can change everything. These stories will likely migrate to RxISK.org when it is up and running.

4. Fourth —the site will have a myth-fable-fairy tale slot. Academic lectures or articles seem to make little difference, perhaps even increase sales of whatever drug is being discussed. But very often people trying to describe the issues turn to fairy-tales or myths to explain what’s going on. If the Emperor’s New Clothes turns up once, it does so hundreds of times. This suggests trying to pull together a collection of alternate ways to describe things. I’ll take a stab at posting one or two examples as starters over the next few weeks and then throw the slot open to others.

If the Emperor’s New Clothes turns up once, it does so hundreds of times. 

5. Finally — the main theme of the early posts is missing data and how impossible it is today to practice Data Based Medicine. If the data on which we base our treatments is missing, what might data-based position papers on various treatments look like? I will post a draft position paper on the Antidepressants. The principle underpinning these position papers is a set of questions to which the answer will commonly be: We have no data. It would be excellent to have input from anyone who can provide comparable statements for other drug groups or who can see ways to improve on what has been done here for the antidepressants.

If the data on which we base our treatments is missing, what might data-based position papers on various treatments look like?

 


RxISK: Research and report prescription drug side effects on RxISK.org.

Search. Report. Contribute.


You and your meds. Give the real story. Get the real story.

Pharmageddon

Pharmaceutical companies have hijacked healthcare in America, and the results are life-threatening.

 

Dr. David Healy documents a riveting and terrifying story that affects us all.

 

University of California Press (2012)

 

Available on Amazon.com

 

Comments

  1. Dan Abshear says:
  2. @Tianeptino says:

    This is absolutely great news, David, not only for all of us followers of your outstanding work, but also for the entire medical community (and beyond!)

    I have hope and faith that these initiatives will contribute to a most necessary turn in the History of Medicine, for the sake of all.

    Thank you and best of lucks,

    @Tianeptino
    Psychiatrist (Chile)

  3. THANK YOU. The website ssristories.com literally saved my life. I was going through the suicidal thoughts, so i quit, then I had a psychotic withdrawal. All before the “black box warning” was in place, so I could not get any doctor to treat me like I was having a reaction to the drug, even though I KNEW that was the problem. (I did clinical research for Ely Lily in my career.) The ONLY place I could find confirmation of what I knew was happening to me was that website, and it literally kept me fighting when my own brain was trying to kill me.
    I am very excited to see this being taken to the next level. I cannot thank you enough, and I KNOW you will save lives by this effort.

  4. If anyone is doing a news item or story about Antidepressants and Violence stories – I want to tell my story. mrktmavens@gmail.com KENCYBNYC

  5. Karen Thorpe says:

    Hello, I am trying to find out how I can get help for my son, who has been on two anti psychotic drugs for some time (clozapine tablets 700mg daily and a fortnightly injection of clopixil) he has started experiencing a strange side effect about two months ago it started, which I have discovered is called ‘ocular gyric crisis. I notified his careers and they have told his doctor and key worker over a month ago, but nothing has been done to change his medication. It is my belief that he is on too much medication and that he is a poor metaboliser, and a lot of his symptoms and health problems stem from being over medicated. I feel that his health is in danger. If you or anyone would like to reply to me via my private email address, with any advice I would be happy to hear from you. Sincerely Karen Thorpe

  6. Hello David. I am surprised I haven’t found you before today, as I tend to do a lot of internet research into healthiness. But now we are meeting. That is good. I run two blogs that are in many ways related to your stated mission, and in some ways, very different. The two sites are http://personalhealthfreedom.blogspot.com/ and http://healthicine.org/

    Our goals are similar, but my strategy is different. I believe we need a new point of view.

    The medical systems, the medical paradigms, the medical doctors and researchers use a medical technique to focus their energy on a medical issue – usually creating a ‘drug’ solution, with medical side effects.

    I believe we need to use a health paradigm, from a healthiness viewpoint, to research healthiness and ways to improve healthiness. Along the way we will learn that healthiness has symptoms, and side effects too. But today, healthiness is missing…

    I call this Healthicine: the arts and sciences of health and healthiness.

    maybe we can work on this together?

    to your health, tracy
    Founder, healthicine.org

  7. While I am in agreement with the accumulating data on the topic of violent adverse reactions – is there also data on how much comparable violence occurs that is NOT associated with adverse drug reactions? Seems that for a really tight case there needs to be that side of the story also??

  8. Judy Turner says:

    I have taken Prozac and had absolutely no bad effects from it. In fact, I first took Prozac in 1988 and was on it for 3 years during a period of very dark depression. Prozac is not a diazapam which means it is not a mood elevator. Very slowly over a period of about a month I realized I was feeling less depressed, more in control of my thoughts, more in control of my emotions and by the end of the second month I was no longer depressed, I was happy, I was enjoying my life again. I was going to a clinical psychologist as well, and with the help of Prozac gained a new perspective. I stayed on it for over a year, slowly withdrew and periodically when I feel myself spiraling down the black hole of depression again I schedule an appointment to see my doctor and when I am taking Prozac I have to schedule a monthly appointment with him or he will not prescribe it. I do not believe that children and teens should be prescribed drugs because they are a little hyper. My brother was the original hyper kid and my parents nearly went nuts raising him but he turned out great. On the other hand, his son was given drugs and he is not okay today. He is in his 40s and he still needs drugs to deal with his problems. I was helped by Prozac and think it saved my life when I was constantly thinking about ending it. It is not for everyone however, and doctors who prescribe these drugs for the first time to a patient should keep the patient under close supervision, such as scheduling monthly or more frequent appointments and getting the pharmacy to refuse to dispense the drugs to the patients who ignore appointments.

  9. https://petitions.whitehouse.gov/petition/begin-research-corelation-between-shootings-and-anti-depressantsssris/TJJGc6NT

    Me and my daughter both had psychotic thoughts after being put on anti-depressants. She had been the victim of a school hostage/ shooting situation. I was recovering from the abuse of one of my children by my husband. Both of us felt the impulse to take a gun or knife and kill people. We immediately stopped taking ( zoloft, and prozac) and never before or since has this happened to us again.
    We think that they need to look hard at the current medicines used to treat emotional trauma, and maybe consider softer and less dangerous alternatives such as St. Johns Wort and cognitive therapy. Please guys we need help. I have never tried to get signatures on anything. How do I start?

  10. Home Health Care Worker says:

    I have a client who had a seizure due to the drugs he was prescribed by 5 different doctors with no one communicating…he went to the hospital…they release him to only take out one drug and put him on another…that is making him more manic then he already is…and the pain in his legs and the open heart surgery drugs…
    I chewed the ER doctors good saying “well it’s no surprise with all the CRAP he is on” and literally ordered them to check on the vitamin and mineral levels, MRI, CAT…
    Now he is suicidal and I left work not knowing if he will eat a gun for dinner instead of supper…good little guy…66…5’2…Grumpy Old Men…funny most of the time…
    Any suggestions? I am trying to get him into a husband-wife psychiatrist team to get him into DETOX – and he wants to go – so I hope it works for him…
    They need to stop doping up Gran pa and Gran ma for God’s Sakes…sorry for venting folks but this really pisses me off…
    I got some books from another husband-wife team “Rare Earths – Forbidden Cures” and the handbooks…talks about what our bodies need to keep in sync and the problems with some of the pharmaceuticals dispensed…interesting read…
    Well send me suggestion if you have them and I printed the page for him to read tomorrow…link him to the site so he can tell his story…in it’s entirety…

  11. What a fantastic illuminating ( thanks for that word) article David—-thanks so much. I especially like this statement because its so true and so well said—

    “companies and doctors are now using trial data, or the lack of it, as a drunk uses a lamppost — for support rather than illumination” —
    Brilliant- Paints the picture perfectly.

    just like unnecessary and oppressive– long term forced drugging –

  12. “103 “Healy long term strategy.
    [....]
    Just last Thursday Healy was quoted in a Cincinnati paper saying Prozac causes violence and suicide…X has asked that we go back to legal and determine if we can sue Healy under UK law.””

    Hmm, looks like a pretty major paranoid hallucination there. You need to start taking your meds again David!

  13. Anne Watmough says:

    I am a long time schizophrenic and user of anti psychotics and am currently on a psychiatric ward! I have the proud description of “Survivor” to add to my lifelong struggle within psychiatric “Care”. And find I continue to protest fighting in my little world against a system of coercion in medicating and misguided concepts of the madness I find I have suffered with all my life! My current diagnosis is that of schizoaffective disorder which describes my symptoms as partially schizophrenic and partially bi polar these two labelings I personally reject! With a view to my release I allowed them to dose me with Depakote and the impact on my body and mind was horrific! I felt in myself I was being poisoned and I thought deeply about death and ending my life soon. I refused it came to and now will not take any oral medication whatsoever! But I have no choice but to allow them to inject me with Haldol Deconaote and am given 78mg a week! The withdrawals I am expecting will be horrific once being reduced and I know that it is actually harming my brain! I meet people every day who have been prescribed these toxins and would advise don’t ever allow them into your body ever! There are no quick fixes for the consequences of traumatic events in your life! Or for that matter madness!

  14. At last some rationality in our liltte debate.

Trackbacks

  1. [...] Although SSRI Stories only features cases which have appeared in the media, starting March 2012 there will be a Website:  http://www.rxisk.org/ which will allow personal stories to appear in a different Website from SSRI Stories.  This is the work of Dr. David Healy  http://davidhealy.org/welcome-to-data-based-medicine  [...]

  2. [...] are unsupported or injurious to the reputation of its product, as happened to Prescrire. (See also Welcome to Data Based Medicine). It is against this background that I am saying that antidepressants such as Cymbalta or Pristiq or [...]

  3. […] we have Evidence Based Medicine, Science Based Medicine, Data Based Medicine, Instinct Based Medicine, Patient Based Medicine, Experience Based Medicine, Functional Medicine, […]

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