Can We Trust Evidenced-Based Treatment When We Only Get SOME of the Evidence? Financial Incentive, Publication Bias & Meningitis Crisis

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Science is science, right?  We shouldn’t have to worry about good vs bad results, just objective findings and how they can be used in providing safe, quality care.  But what happens when there is a bias on publishing research results, so that we only get part of story?

“Positive findings are around twice as likely to be published as negative findings. This is a cancer at the core of evidence-based medicine”, states Ben Goldacre in his 14 min Ted Talk,  What doctors don’t know about the drugs they prescribe.

Dr. Goldacre talks fast and admittedly, for me, is a little hard to follow at times, but he’s making some critical points about a phenomenon called, ‘Publication Bias’ and in an age where there is a push for ‘Evidence-based practices’ in healthcare, we have a responsibility to understand this concept.  After all, research is supposed to guide best practices for treatments, drugs, surgery and related decisions about what gets covered by insurance, yet according to Goldacre, “Positive findings are about twice as likely to be published as negative findings’. 

In one striking example, he cites a review of all trials submitted to FDA as part of drug approval process (i.e. for marketing authorization) for antidepressants over a 15 year period.

Results showed both:

  • 38 Positive studies
  • 36 Negative studies

BUT, BUT, BUT, what got published in peer review literature was misleading!  What got published in the peer reviewed journals?

  • 37 of the positive studies
  • 3 of the negative studies

That’s right, one of the positive studies and  thirty-three of the negative studies did not make it into the peer reviewed literature!

He calls this “research misconduct’ and likens it to tossing a coin 100 times but only telling us about the fifty times it comes up as “heads” implying that coming up “heads” is the most likely outcome!

Goldacre’s solution is:

“1.  Publish all trials in humans, including older trials for drugs still in use.

2.  Tell everyone you know about this problem.  info@alltrials.org”

And I’m adding this one:

3.  Make financial incentive secondary to providing safe, compassionate care in the vision of health care in the USA.

There are points of correlation in one of today’s healthcare crisis’ involving meningitis deaths from tainted drug supply for treatment of questionable value.  First, the financial incentive to use the cheaper drug, second, a high number of folks treated,  and third, a review of the literature indicating that there was no strong evidence for or against the injections being used to treat back pain.

In NY Times 10/7/2012 piece by Denise Grady, Andrew Pollack, and Sabrina Tavernise called, Scant Oversight of Drug Maker in Fatal Outbreak:

  • Dr. Micheal J. O’Connell, Chief Executive of PainCare, a medical practice with 12 locations in NH,  discusses the financial incentive to use cheaper drugs when Medicare reimbursement offers fixed amounts states, “If you are using a more expensive product, there would be less left over”.
  • In 2011, 2.5 million medicare recipients received epidural steroid injections.
  • In 2011, the Cochrane Collaboration, an international group of medical experts reviewed the data last year and found there was “no strong evidence for or against” the injections.

With Medicare reimbursing about $300 for an injection and a little multiplication we get 750 MILLION Medicare dollars spent in 2011 for a procedure of questionable value and ultimately responsible for at least seven deaths and untold stress for patients who received or may have received the tainted drug in 23 states!

Can we see the bigger picture here and wonder about what drives our healthcare system?  Is it providing care? Is it making money? Gaining prestige? We can do better, can’t we?

 

 

beth improvOD Consultant and Author, Beth Boynton has been trained in the Professor Watson Medical Improv Curriculum at the Feinberg School of Medicine Northwestern University.  Please contact beth@bethboynton.com or 603-319-8293 to learn more about how a program can be adapted to your healthcare team, students, or organization.

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