Few Would Argue?

Few would argue that journalists should never be allowed to invest in companies they cover.

Okay, class. True or false?

If you answered true, you have failed journalism ethics 101 and you will never get one of the shrinking number of jobs in journalism (by the way, for an important analysis of the economic woes hitting the industry and what it means for our democracy, see Eric Alterman's excellent column in this week's Nation magazine). Every newsroom I have ever worked in has had a hard and fast rule that reporters may not invest in, participate in or contribute to any organization, public or private, which they cover during their working hours.

Now, let's turn to medicine. Here's a direct statement from the New York Times's Reed Abelson in an otherwise excellent expose of conflicts of interest in one corner of the superficially regulated medical device industry. The story involves a new replacement back disk used instead of fusion therapy (neither of which are very effective):

Few would argue that doctors should never be allowed to invest in promising new technologies. But when doctors are acting as researchers, they should not have money riding on the outcome, in the view of outside experts. . .

Why draw the line at research? Is it okay that the doctor prescribing a particular drug has a huge hunk of his or her retirement portfolio in the stock of the company that makes that drug? Isn't it possible that a physician with such a conflict of interest may ignore the signal from a new post-marketing clinical trial that suggests there are hidden dangers in the drug's long-term use (like the news this morning that Merck's Fosamax, the bone-strengthening drug that in a small number of patients also causes bone-weakening of the jaw)?

The same would be true for a start-up company -- that promising new technology. Isn't the surgeon more likely to use it once it comes on the market no matter what the evidence? In the device industry, in particular, this is a major problem since the regulatory barriers to entry for a new product are quite low (randomized, controlled clinical trials are almost non-existent in the field because sham surgery isn't possible; and loopholes in the law allow new devices considered minor variations of old devices to gain Food and Drug Administration approval with the most minimal of clinical trial testing).

Here's the description from this morning's story about the trial submitted to the FDA by the conflicted physicians:

In early 2005, when Synthes submitted the Prodisc study to the F.D.A. as part of the company’s application for approval, it used results for 162 patients who had received the device and 80 who had spinal fusion surgery.

The results did not include 50 Prodisc patients who were considered “training cases” — surgeries performed to let doctors learn how to implant the devices. Such training is fairly common in device trials.

An additional 21 patients, about 10 percent of those studied, were also excluded from the reported results.

That raised eyebrows at Medicare, which refused to pay for the surgery.

But let's assume for a moment that they approved payment for it. Now, back surgeons all over the country with investments in Prosdisc would be inserting this device in their patients and watching their investment portfolios grow.

If reporters need experts to question the "few would argue" assertion, I suggest they call Dr. Roy Poses and his colleagues at Brown University who write the Health Care Renewal blog. Or they can try Dr. Jerome Kassirer at Tufts University, author of "On The Take." They may have a second opinion.

Posted by gooznews at January 30, 2008 08:58 AM