If the Doctors Don't Speak Out, Who Will?

I hadn't planned to write anything about the first trial -- of what is likely to be several -- of Johnson & Johnson for the failure of the artificial hips manufactured and sold by its DePuy Orthopaedics division.

For one thing, I've written about J&J and DePuy before (e.g., here). For another, it was just too damn depressing.

Two years ago, I wondered whether the DePuy complaints were evidence of systemic problems at J&J. I'm not really wondering any more.

The news from the courtroom has been pretty bad. Late last month, in a New York Times article, reporter Barry Meier wrote that J&J's own internal reviews had "found that the company had not adequately assessed the device’s potential risks before it was used in more than 90,000 patients" (full article, here). More damaging still:

DePuy conducted the post-mortem review of the A.S.R. in November 2010, just three months after it recalled the all-metal implant, but it never released the analysis.

The metal-on-metal "Articular Surface Replacement" (ASR) device failed within five years in about 40% of patients who received it. Among other problems, the metal-on-metal format resulted in the release of minute metal fragments into the patient, causing, in some cases, serious internal damage. Problems with the DePuy device began to surface shortly after its release;

In previously recorded testimony presented in court on Wednesday, DePuy’s president, Andrew Ekdahl, was shown an e-mail in which he was warned about the A.S.R.’s problems nearly three years before it was recalled.

But what really got me thinking was an analysis that Meier wrote in the "Sunday Review" section of the 17 February New York Times, titled "Doctors Who Don't Speak Out." (full article, here).

It might not be surprising to find that executives acted to protect a company's bottom line. Still, the Johnson & Johnson episode is also illuminating a broader medical issue: while experts say that doctors have an ethical obligation to warn their peers about bad drugs or medical devices, they often do not do so.

Meier quotes a Yale School of Medicine professor: "Questioning the status quo in medicine is not easy."

To be fair, questioning the status quo is rarely easy -- whether you're talking about medicine, politics, academia, credit default swaps, or nutritional guidelines.

Meier outlines several reasons why doctors would be reluctant to "warn their peers about bad drugs or medical devices": fear of a lawsuit; belief that a problem is really an anomaly; aversion to reporting; and (I believe most importantly) financial ties to a drug or device manufacturer.

I've written before about the overly-cozy relationship between doctors and drug and device companies, about dental-device manufacturers who underwrite an entire issue of the Journal of the American Dental Association (here), about pharmaceutical companies writing entire textbooks (here), and about plans to require drug companies to disclose payments made to doctors for research, consulting, travel, and entertainment (here).

It's everywhere, and it needs to stop. And doctors need to develop a culture where -- to borrow a phrase from high-quality assembly-line manufacturing -- it's more important to stop the line for a possible problem (that turns out not to be one) than to let a real problem roll by. Because the patients are the ones who are suffering from their doctors' silence.

What ever happened to, "First, do no harm"?