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The Inadequacy of ADHD Research Methodology

November 22, 2011

By Umesh Jain

This is the third in my series of Dr. J’s Rants. You’ve seen Rick’s Rants. This my version of the same. You may have already seen Part I and Part II but if you haven’t, you might be interested in my general beefs.

Science. Evidence-based. Randomized double-blind placebo controlled trials. These are the terms that reflect the gold standard of research. It means that something doesn’t exist by chance. Lots of people have a belief of what they think is evidence (usually anecdotal) but very few people, organizations or institutions can afford the true scientific challenge of proving their beliefs. Drug companies, for example, have a vested interest in doing research to prove to the Federal Regulatory Agencies that all is well. Others aren’t as rich as drug companies but if they could, why would they want to spend the money and simply find a negative result suggesting what they thought an association was found to be irrelevant. And if was irrelevant, would you have heard about it anyway? But having done many contract research trials for pharmaceutical companies and for government research, here are some of the methodological errors that I found (in my opinion):
a) What may be research evidence is not necessarily generalizable into community practice. For example, when research was being done on antidepressants, the reported rate of sexual dysfunction was around 10-15% where in clinical practices it was seen to be higher than 60%. Well, no one asked and if you did have a problem, you wouldn’t say. One wonders what gets missed then.
b) When clinicians do contract research outside of a hospital setting (you might be surprised to know that a lot of drug research is done in private offices whose major incentive is the huge dollars for patient recruitment), not only do they not have to universally submit to a University-based Ethics accreditation (private firms do this type of ethics review), but one wonders about their likelihood of passing on a negative finding and have to face the risk of their funding dropped.
c) A patient can easily tell the difference between a placebo and real medication (at least when it comes to ADHD medications). Their responses are likely to be influenced as a result. It is not a true placebo if you can tell.
d) And don’t even get me started on the recruitment problem. Sometimes, patients are recruited into studies that don’t meet criteria and are just pushed through. The drug company assumes that the doctors are doing it correctly but are they? More patients, more money. What is the incentive, science or money?
I think we have to concede that the best that “evidence-based” research tells us is that something is happening and the only way to truly determine if this is fact is to have others replicate the study by those who are not vested financially in the outcome. This is where governments have to step up and where the University-based hospitals have a role. At the end of the day, consensus-based guidelines are often more practical because they reflect the nature of what clinicians in the community actually see. But my word of caution is this: don’t believe everything you read that sounds like science! Healthy cynicism is a good thing.

4 Responses to “The Inadequacy of ADHD Research Methodology”

  1. Tea says:
    January 1, 2012

    Just knowing that ADHD has to do with brain chemistry, plus the variations on ADHD we each have, and it would be unlikely that anyone can do more than guess. I also learned about how to make statistics perform selling mutual funds.

    I realise that I have to try the drugs and report any reactions, even though on Straterra that involves taking it daily for 8 weeks or so at $140./3 weeks.with no discount, and no job.

    What I find difficult is that there is very little information about Side Effects … are we meant to try to cope with them or do we stop at the first sign of turning blue? Straterra’s urine retention may be something that can be coped with by drinking more water… lots more. I wish there was more information available .. what would signify that the drug is working? Not the end of my ADHD/Anxiety/Depression. Perhaps that is also subjective .. but I havent seen anything as yet
    that gives me a clue as to what to look for.
    .

  2. caper says:
    November 22, 2011

    When the doctor can’t see what’s going on in your head (and I don’t expect them to go that far given the cost of an fMRI), the patient has to take an active role in order to get effective treatment. My GP has been good to let me experiment with ADHD medication to figure out what works for me.
    However one of the CADDAC practice guidelines authors wanted to give me Epival to fix the tics I developed. I found out that tics is a side-effect of MPH overdose, so I cut my daily dose of MPH from 80mg to 40mg

  3. kc5jck says:
    November 22, 2011

    Squeeze the numbers hard enough and they’ll say anything.

  4. no_dopamine says:
    November 22, 2011

    One of my favourite books when studying for accounting was “How to Lie with Statistics”. There was even a brief news clip about it on the radio last night.

    Who really checks up? We find out years later that such and such drug or cancer treatment/screening is life threatening, how are we as individuals supposed to make sense of it all? Who do we trust?

    RANT here: I would like to see docs do more short-term trials with their patients. Yes, refer us to specialists who can formally diagnose and offer expert treatment. But what is the harm in seeing what a med will do for a patient? (provided there aren’t any contraindications, like a sedative in case you might have sleep apnea). Med trials diagnosed my asthma and narcolepsy/ADHD. One was doctor-supervised and the other wasn’t. In one case, the specialist mis-diagnosed, and in the other case, the GP missed the boat. But the med trials supported diagnosis and saved some time. Why couldn’t we get doctor-supervised meds treatment while we are waiting to see the specialists? What needs to change there? grrrrr

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