RxISK Papers

Data for Data Based Medicine

— One of the purposes of this blog and of RxISK.org  is to invite colleagues to add to the knowledge base on drug groups.To start the ball rolling we have prepared the following draft papers.

They all come with a health warning:

DBM papers:

Two of these also come in Swedish
The following papers deal with dependence and withdrawal

The following chapters from Psychiatric Drugs Explained relate to issues of abuse and consent.

We also have draft papers in preparation on: Stimulants, Statins, and Hypoglycemics.

We need papers on: Treatments for Asthma, Hypertension, Osteoporosis, Antibiotics, Anti-Ulcer Drugs, Contraceptives, Analgesics, Anti-inflammatories, Drugs for Sexual Functioning, and others. (See Principles underpinning DBM papers.)

To submit or comment on a paper:


Principles underpinning DBM papers

The emphasis is on highlighting missing data. This may be:

  1. Hidden data: data from trials hidden through miscoding, ghostwriting, etc. (see recent posts)
  2. Missing data because of trial design: e.g., flawed design, too short, or surrogate outcomes
  3. Missing data because the right studies have not been done: as in adverse events
  4. Data that is hidden by statistical sleight of hand

The questions used in the current drafts are almost more important than the answers. We want questions that reveal our uncertainties and lacunae in our knowledge rather than questions that falsely reassure. The emphasis is on highlighting the unanswered questions where doctors and patients have poor information on which to make therapeutic judgments.

We encourage anyone writing, editing, or contributing to a paper to resist the temptation to advocate for a treatment, in particular a non-drug treatment, and to resist the temptation to denigrate the use of drugs for what they see as lifestyle or trivial purposes.

The aim is to appraise doctors and patients of the state of the data — in contrast to the state of what is called evidence — and to encourage them to observe previously unreported or poorly documented effects of drugs and to contribute these observations to the pool of data that helps guide decisions.

The aim is to make doctors and patients aware that the current state of the data at best permits guidance to supplement therapeutic judgments and does not mandate guidelines to replace clinical judgment or patient values.

Data Based Medicine believes that controlled trials are extremely important but have come close to being made into a fetish. They are, moreover, probably not the best method to reveal treatment related adverse events (see posts).

Authors are encouraged to return to the original definition of evidence based medicine which was an “integration of the best research evidence with clinical expertise and patient values” (Sackett & Rosenberg 1995).

This will result in papers that will have a judicious mix of best evidence and consensus view that may in some instances have a “return to the 1990s” quality to them.  The best example may be pregnancy and antidepressants: it was so much received wisdom in the 90s that women should avoid drugs in pregnancy that there is almost nothing saying this.  This has left a gap through which companies and other interest groups have been able to march – claiming that all the evidence points to the need to use antidepressants in pregnancy.  Going back to the 90s will mean apparently going against what purports to be evidence.

Justifying such papers will be an interesting  exercise that may need to tap all the resources this approach can mobilize.

David Healy
February 2012

 

 

Comments

  1. Hi David
    Antidepressants for Prescribers is very interesting, do you intend to publish it outside this blog?
    Christophe
    editor with Prescrire

    • Christophe – I would be very interested in any thoughts you have about how to draw attention to tqhis approach. It would be good if there was anyone from Prescrire who might be able to do something similar for another drug group – David

  2. Hi David,

    what you and your team are doing is truely great, thank you.
    just a quick question if you have the time to answer.

    I was misdiagnosed 3 yrs ago for bipolar because of severe akathisia/ agitation, and took seroquel, ssris and valproic acid for 3 yrs.
    I am worried if the seroquel in medium-high dosage which i took all togather for about 8 months had done some brain damage? if so, do you think I can reverse it by learning and using my brain more?
    thank you :)

    • David_Healy says:

      Physical activity is a great way to use your brain – the more you can get fit the better.

      • thank you so much!! I cant believe you replied so soon !!! thanks for all the work you have done and I am a great fan of several of your books :)

      • thank you again for answering my question out of your busy schedule! I was treated in China for this condition 3 years ago and I think the mental health system there is terrible however doctors were so confident at their knowledge claiming there are no lags behind the western system. Drugs are massively prescribed and you get it from the hospital the very doctor works at, most of them are from the original companies, GSK, Eli-Lilly. Maybe you can look into give a talk in China in the future if you think it’s possible because the system is so drug-based and terrible.

  3. I would really like to see something on the prolonged benzodiazepine withdrawal, the one that lasts for years. Information and recognition of it screams by it’s absence.

  4. Lisa Coppeta says:

    I want to know when, or where there will be more information on the lives lost to suicide during the time of the older RX drug before Prozac hit the market in the U.S? (1950′S – Early 1980′S) ?
    (Imipramine) the generic form of Tofranil.

    As you know I have contacted you before about my sister Lori’s Story (1956-1981)
    My family was decades in the dark until 2009.

    If not for the black box warnings 2004, and families coming forward, listening to the warnings on TV commercials for the advertising of these RX drugs that we so often here today say… “may cause change in behavior” or “may cause suicidal thoughts in some people” or “if worsening depression that leads you to suicidal thoughts or actions” please contact your doctor!!
    The missing Link has now been made.

    Some families like mine never knew why their loved one took their life. Why suddenly they changed!
    Now they too can have the answers if the older RX Drugs were involved as well.

    This is a HUGE break through for the families who lost their loved one in this sudden way so long ago…. they need to be accounted for, and not labeled suicides, but RX Induced suicide was the cause.
    One is by choice, the other is not!

    In 1981 WE DID CONTACT THE DR. WHO GAVE HER THE RX DRUG.. IT APPEARS FROM MY RESEARCH, THAT THEY MAY OF NOT KNOWN AS WELL THAT THE RX DRUG THEY GAVE HER FOR “SITUATIONAL ANXIETY” OF DIVORCE WAS INDUCING HER SUDDEN SUICIDAL THOUGHTS, AND BEHAVIOR!
    That she did NOT exhibit before this RX Drug was given to her!
    These dates say it all:
    Prescription bottle dated: Aug. 18, 1981.
    Sept 22, 1981 she lost her life AGE 25!
    If anyone wants to read her story you can contact me at the email above. I thank you all for listening to my comment.

    • David_Healy says:

      Lisa – It is highly likely that there are many people out there who have lost loved ones because of the effects of an older antidepressant or related drug. Just because someone did commit suicide on a drug that can cause suicide doesn’t prove the drug caused it – but the timeline you offer is very suggestive – David

  5. Sorry – I DID NOT FIND ANY E-MAIL ADDRESS AT YOUR WEBSITE….

    VERY IMPORTANT DATA ON BRIBERY OF PHYSICIANS IN USA – NAMES OF INSTITUTIONS AND DOCTORS MENTIONED IN FULL DETAIL
    http://projects.propublica.org/docdollars/?utm_source=et&utm_medium=email&utm_campaign=dailynewsletter

    ‘pro Publica’= journalism with a public interest.
    Dollars for Docs
    How Industry Dollars Reach Your Doctors
    From http://projects.propublica.org/docdollars. © Copyright 2013 Pro Publica Inc.
    By Eric Sagara, Charles Ornstein, Tracy Weber, Ryann Grochowski Jones and Jeremy B. Merrill, ProPublica, Updated March 3, 2014
    In recent years, drug companies have started releasing details of the payments they make to doctors and other health professionals for promotional talks, research and consulting. As of 2012, 15 companies published the information, most because of legal settlements.
    ===============
    LvdH: very detailed maps of many states of the U.S. with details about names of doctors and institutions involved.
    In Florida alone $ 214.234.452 were spent …it contains 719 pages with 25 names on each page… total entry’s are nearly 18 million!
    This is really amashing!
    ==================================

  6. If the translator who translated those manuscripts into Swedish is in any way involved in pharmacovigilance then I’m interested in establishing Contact with him/her!

    I have suffered extremely from SSRI, but I am all alone it seems here in Sweden.

    Not one single person with authority has had the guts to talk to me.

    David Healy must be able to provide my email through this site.

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