The NYTimes had a recent article on real world testing of drugs. This raises questions, such as how are consumers to be informed today?
There are limited head to head
trials, and almost all of the data comes from highly selected groups of
individuals under conditions that are nearly impossible to replicate in
the real world. Ivory tower medicine indeed, giving us the best case
scenarios only…but far from the outcome impact for all the spend and
utilization occurring in very different ways out in the real world.
It’s an interesting question as to which should be the better gold standard in addressing the patient before a physician: randomized clinical trials with non-matching study populations or outcome databases with real world utilization of patients matching her symptoms?
This used to be a hypothetical question and rationale for the quest
for the holy EMR (the one to unite them all). However, recent advances
in social networking using pools of individual experiences in places
like Patients Like Me and Sermo bring tantalizing “wisdom of the crowds” potential in evaluating the effectiveness of various treatments.
As medical tools increasingly help us to personalize and segment
populations, it forces a pause in how the delivery of the appropriate
data and heuristics will occur. In a world where we ask individuals to
make choices, is our ivory tower approach to group statistics relevant
to individuals who want the best for them?
Vijay Goel is a doctor and former McKinsey & Co. consultant based in Los Angeles. He blogs regularly at Consumer-focused Healthcare.
Over the last 25 years, clinical research has been largely privatized. The overwhelming majority of clinical studies published in the three most respected medical journals (NEJM, JAMA and the Lancet) are commercially funded. As a result, our medical knowledge grows not in the direction that best improves our health but toward corporate profits, the way that plants grow toward sunlight.
Before 1980, most medical studies were publicly funded, and most academic researchers scorned industry support. Now, the vast majority of clinical trials are commercially funded, and with the financial stakes so high, there is so much mounting evidence of individual scientists and corporations manipulating their findings.
Even our most trusted journals are dependent on drug-company money. Drug makers don’t just buy advertising in their pages. According to Richard Horton, editor of the Lancet, they also pay up to $1.75 million for reprints of articles favorable to their drugs, which sales reps then hand out to doctors.
And many journal articles are biased in favor of their sponsors’ products. So many times, the type of sponsorship that is available for randomized controlled trials is strongly linked to the results and conclusions of those studies, even when other factors are taken into account.
A 2003 report in the Journal of the American Medical Association found that clinical studies funded by drug companies are three times more likely to conclude that the sponsor’s drug is the treatment of choice, compared to studies of the same drug that were not commercially funded.
Sometimes drug companies may deliberately choose lower dosages for the comparision drug when they caryy out head-to-head trials, making the company’s product do better in the trial. And sometimes trials produce unfavorable results that are not published, or that unfavorable outcomes are suppressed.
The disturbing conclusion is that most of the evidence in what doctors believe to be “evidence-based medicine” is more infomercial than dispassionate science.
Real-world studies are not being performed under real-world conditions. Patient outcomes need to be reported in real-time, so patients and physicians can learn immediately if and how patients are benefiting from new therapies.