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Why Negative Medical Studies Are Good

This is a guest column by Ivan Oransky, M.D., who is executive editor of Reuters Health and blogs at Embargo Watch and Retraction Watch.

One of the things that makes evaluating medical evidence difficult is knowing whether what’s being published actually reflects reality. Are the studies we read a good representation of scientific truth, or are they full of cherry-picked data that help sell drugs or skew policy decisions?

That question may sound like that of a paranoiac, but rest assured, it’s not. Researchers have worried about a “positive publication bias” for decades. The idea is that studies showing an effect of a particular drug or procedure are more likely to be published. In 2008, for example, a group of researchers published a New England Journal of Medicine study showing that nearly all — or 94 percent — of published studies of antidepressants used by the FDA to make approval decisions had positive results. But the researchers found that when the FDA included unpublished studies, only about half — or 51 percent — were positive.

A PLoS Medicine study published that same year found similar results for studies long after drugs were approved: Less than half — 43 percent — of studies used by the FDA to approve 90 drugs were published within five years of approval. It was those with positive results that were more likely in journals.

All of that can leave the impression that something may work better than it really does. And there is at least one powerful incentive for journals to publish positive studies: Drug and device makers are much more likely to buy reprints of such reports. Such reprints are highly lucrative for journals. Read more »

*This blog post was originally published at Gary Schwitzer's HealthNewsReview Blog*

Spinal Fusion Device: “From Revolutionary Advance To Public Health Alert”

There are many stories journalists could report on about conflicts of interest and questions about evidence in the treatment of low back pain, perhaps especially with spinal fusion. We talked about many of these with journalists from the American Society of News Editors in a workshop at the Foundation for Informed Medical Decision Making in Boston in May.

John Fauber of the Milwaukee Journal-Sentinel hammers one of these issues, looking at how Medtronic’s Infuse product “went from revolutionary advance to public health alert.”

Here’s his story on MedPageToday: “Spinal Fusion Device: A Bone of Contention for FDA.” 

His entire series entitled “Side Effects: Money, Medicine and Patients” is indexed on the Milwaukee Journal-Sentinel website. The image below is from the Journal-Sentinel’s online story:

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*This blog post was originally published at Gary Schwitzer's HealthNewsReview Blog*

Pharma Discloses Physician Relationships – Now What?

This was the year that Pharma disclosed the names and payments of their physician consultants.  Look here for physicians speaking and consulting with Merck, GlaxoSmithKline, Lilly, and Pfizer.

Physician disclosure of conflict is important.  It helps put a physician’s opinion and point of view into a context. Disclosure has long been the standard in the academic world.  This represents the first time that such information has been made available to the general public.

But how will patients use this information and how will it affect care and outcomes?  Should patients flatly avoid physicians or others who have a relationship with a pharmaceutical company?  And should patients routinely screen physicians for conflict?

I don’t know the answer to these questions.  I’m not sure patients know the answer to these questions.  I suspect patients may not like the idea but would be willing to overlook a pharma connection when the reputation of the physician is impeccable.

Transparency is all the rage.  Expect more. But I’m wondering how the average health consumer will practically process the information.

*This blog post was originally published at 33 Charts*

Physicians Are Biased About Healthcare Reform

From the department of “Credit where it’s due,” in the comments of my post on the Lewin Group, Nurse K pointed out the following:

Come on Shadowfax, you’re blogging about this stuff and you stand to make A TON of money if it goes through…for awhile…until insurance companies decrease your compensation since you’re making more per patient. I know you mentioned this before in like a comment or something, but ER docs stand to benefit (temporarily) probably more than anyone else. HUGE bias on your part.

Much as I (really, really) hate to admit it, she’s absolutely right.  In fact, I’ll go one further: I first got interested in this part of medicine policy because I was mad that I was seeing all these uninsured patients and wasn’t getting paid a thing for my efforts.  I started keeping track of the number of uninsured I saw every day, just as a pet obsession.  It was a sobering number.  After that I started getting a little perspective, talking to patients and seeing their bigger picture, understanding why they were uninsured, learning the particular challenges they faced getting health care, etc.   For me, this cause became something beyond the personal a long time ago and became a moral imperative.

But K is right to note the potential for bias, and it’s fair for me to acknowledge it.  I hope that my integrity on this point is evident.  The fact that I argued in the New York Times for an increase in primary care compensation, with an attendant decrease in the compensation of specialists, including Emergency Medicine, should speak well for my ability to see beyond personal self-interest. (God knows it didn’t make me popular in EM circles!)

This is something which struck me yesterday, reading the med blogs reaction to Obama’s presser.  Quite a few docs mounted their high horse and with great indignation denounced this:

Doctors are forced to make decisions based on a fee payment schedule that’s out there. So they’re looking… if you come in with a sore throat or your child comes in with a sore throat, has repeated sore throats, a doctor may look at the reimbursement system and say to himself, “I’d make a lot more money if I took this kids tonsils out.” Now that might be the right thing to do, but I’d rather have that doctor making those decisions based on whether you need your kids tonsils out…

Now it’s a clumsy clinical scenario written by someone who has no clue about medicine.  But it’s a damned fair point.   Bias comes writ large, as in the Walter Reed orthopod who pocket $850K and falsified his research to benefit Medtronic, and it comes writ small, as in the ER doc who sees a small lac and has to decide whether to use a band-aid or a stitch, knowing that the stitches will pay 10x more.  It comes with the cardiologist who has to decide whether to take a low-grade troponin leak to the cath lab.  It comes with the surgeon seeing a patient with unusual abdominal pain and a slightly enlarged appendix on CT (you can observe or just take out the appy; guess which pays more).

Whether there’s a “fix” for that in the current reforms is debatable.  It harms our standing, however, to deny the possible existence of bias and to claim a moral purity that, as a profession, is not justified.  I think and hope that most of us in these ambiguous situations are able to come to the right decision for the patient the vast majority of the time regardless of our economic interests.  The best way to remain credible is to acknowledge the mere potential for bias and move on and debate the salient point.  Making counter-factual arguments that biases do not exist or that we physicians are too awesomely altruistic to ever be influenced by them does nobody any good.

*This blog post was originally published at Movin' Meat*

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