Monday, October 04, 2010

"Evidence-based" Needs Good Evidence

I’ve written before about evidence-based medicine.  As a general principle, I believe in it.  I certainly think we ought to be reviewing, studying, and evaluating our health care interventions and discarding those that don’t work or, worse, actually do harm.

So, I was certainly interested when my Best Beloved directed me to Huffington Post and this article by Mark Hyman, MD.  Dr. Hyman lays out serious problems with some of the evidence on which our recent medicine has been based.  And he’s not simply expressing an individual opinion, however informed.  Instead, he points to recent reviews of research in JAMA, the Journal of the American Medical Association; the Archives of Internal Medicine; and the New England Journal of Medicine.  So, there’s evidence that the evidence has been distorted on which some important medicine has been based.

Much of this has long been a concern.  Research has been directed by those pay for it.  Now, it can be a small issue in choosing the direction of research.  People choose to research what funders will pay for.  One result is that practical, potentially profitable research gets funded, and basic research – fundamental research that may stimulate something potentially profitable, or may not - doesn’t.

It’s a much more serious issue when the interests of the funders drive the results of the research, or the way the results are reported.  There has long been a complaint that when pharmaceutical research shows a study drug doesn’t work, or doesn’t work better than competitor drugs, the results don’t get reported, or get distorted.  Now there are reviews like those Dr. Hyman points to that say document instances of this.

And then there are the issues of drugs sold and prescribed “off market” – that is, to treat conditions for which the drugs haven’t been tested.  Granted, sometimes those “off market” applications can appear to offer benefit; but that benefit hasn’t been documented, or documented well, and the risks specific to the “off market” use haven’t been determined.  That’s why it’s illegal for pharmaceutical companies to market drugs for the “off market” use.  Unfortunately, as Dr. Hyman documents, the costs of those violations in terms of fines are nothing compared to the profits.

I will also note that Dr. Hyman shares my feelings about reports of research in the news media.  He notes that often reporters focus on headlines that misrepresent the study results, or amplify a study’s importance all out of proportion.  If on top of that the research has been badly done, and/or the reports in the peer-reviewed sources are distorted, it becomes not only more difficult but perhaps outright hazardous to trust a news report on any given study.

Dr. Hyman has seven steps we can take, and I think they bear repeating.

How to Protect Yourself From the Spin Doctors

1. Follow the money: Be a detective and look up the articles mentioned in the news. Find the study, see who wrote it, and determine what financial conflicts of interest they have. Also check who funded the research.

2. Do your homework: Be suspicious of media reports of scientific findings. Does the finding make sense in the context of other studies and is it the best possible approach. Educate yourself by learning to use PUBMED (the National Library of Medicine) and reviewing different perspectives.

3. Does it pass the "sniff test": Is the treatment suggested just a "me too" drug that has not been proven to be any better than existing treatments? Does it make sense to you or does something smell rotten? Trust your intuition.

4. Advocate for an arm's length relationship between industry and academia. Write your Senators and Congressmen to develop new regulations and legislation that will build a fire-wall to protect us. Grants are fine, but Pharma should have no participation in study design and should not be allowed to interpret or publish results.

5. Demand a no revolving door policy between industry and government regulators. Former drug company executives should not be on FDA committees or involved in regulation or legislation.

6. Advocate for comparative effectiveness research. Preventing this research allows Pharma not to play fair.

7. Campaign for finance reform: If done effectively, can limit the influence of industry on government.

I think these are all steps well worth taking as individuals, and worth requiring of both those who provide our health care and those who pay for it.

So, take the time to read Dr. Hyman’s article.  It will give you pause.  But, if we can press researchers, health care practitioners, payers, and community leaders to change, work like his can also give us all better health care.

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