We need data for Data Based Medicine

One of the purposes of this blog is to invite colleagues to add to the knowledge base on drug groups. To submit a paper or to provide your comments, please do so on the form on the Share Your Story page.

I’ll start the ball rolling with the following draft Data Based Medicine (DBM) papers:

We have draft papers in preparation on: Mood Stabilizers, Antipsychotics, Stimulants, Dopamine Agonists, 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.

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

 


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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)

 

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Comments

  1. How about WBM (Wisdom Based Medicine)? “It takes a wise doctor to know when not to prescribe.” – Gracian.

  2. You are quite right, Jack, it does. However, my gp inherited me on Seroxat, thought herself they were not efficacious, but, on taking me off them equally did not realise that she almost killed me after eight weeks off Seroxat.

    So, where is the wisdom?

  3. My Gp told me to just take half a seroxat pill , then keep decreasing by half. It took 3 months. I have been suffering ever since now nearly 7 years. She has said to me in the past that maybe she should have taken it slower.
    Wiser now after the event !

  4. 18 years on most SS/NRIs, APs, TCAs, dopaminergics for what was fatigue/low energy in 1993. NEVER responded to serotonergics aside from bruxism/TMJ that coincided with Zoloft in ’93 (Rx Klonopin hs – still on). Tapered/ DC’d Pristiq (desvenlafaxine) over 10 months ending Spring ’11. Hellish protracted withdrawal and facing all of the life issues I didn’t attend to under the serotonin veil.
    Recent dx: premature ovarian failure, non-alcohol liver disease, several autoimmune disorders, MTHFR gene mutation (infertility, cardiac problems, depression in family).
    What could have been done differently–before jumping to the trashcan diagnosis of depression (to which all subsequent ailments have been attributed)??
    (Hashimoto’s thyroiditis diagnosed in ’96- treated w/Synthroid)
    Dr. Healy, I respect your work tremendously. I was, however, surprised to see that ruling out medical conditions/drug effects did not top your information to Prescribers. I hope you will reposition this key point in your treatment algorithm.

  5. “If a condition becomes more enduring, the treatment options become more complex and may vary all the way from changing work or relationships to a full investigation of contributing physical factors. Consideration should always be given to the role that current medications may have in stalling recovery – for every 9 people out of 10 who have the expected response to a drug, there will be 1 out of 10 who has just the opposite response. The only way to assess this is to stop treatment.”

    Dr. Healy, this needs clarification. As it reads in your draft, it appears you are recommending rule-out of medical conditions, drug effects, lifestyle interventions, etc. AFTER more invasive treatments have failed. Surely you can’t mean that?

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