First, Do No Harm (Part 2)

What does Dr. Vertosick suggest is the cause of such snafus as the EC-IC bypass?

As the EC-IC bypass affair illustrates, experimental operations can jump into the medical mainstream long before anyone establishes their efficacy – or even their safety. Although ego and greed help keep unproved procedures in the operating room, it’s bad scientific judgment that puts them there in the first place.

Before new drugs can be marketed, they undergo three levels of testing. First, volunteers are given the drug to see how toxic it is and how well it’s absorbed and tolerated by the body. (This leads to specifically unexpected yet globally inevitable tragedies every once in a while, most particularly when one of the test subjects happens to be in a minority that has serious reactions to a drug that hadn’t been previously observed.) Then, once the obvious risks of the drug are known, it’s given to ill patients to see if they do better on it than previous, retrospective patients. Finally randomized trials are conducted to compare treated and untreated patients directly. Only when this last stage has been successfully completed is a drug considered for approval.

There is no such regulation on surgical procedures; although the FDA regulates surgical devices, it has no jurisdiction over surgeries. There is no legal obligation for surgeons to test therapies with the third stage of randomized trials. And since they can charge for any surgery, surgeons have no financial reason to put their therapies through expensive and difficult examination.

It is not unusual for surgical procedures to be widely implemented without rigorous testing – it is in fact quite standard. Vertosick offers the example of spinal fusion to treat back pain caused by degenerating disks. The disks can be removed “in a simple, two-hour operation”, or surgeons can remove the disk and implant a steel plate, which in theory helps to stabilize the spine, a procedure which is more involved and incidentally costs two to three times more. As Vertosick points out, “there’s no evidence that it’s any more effective than the simpler procedure”.

The reasons why so little testing is done are legion. It takes lots of money and effort to conduct randomized trials, patients don’t want to be assigned to “nonsurgical” groups – they want to be ‘treated’ when they go to surgeons, and that usually means undergoing surgery – and they go elsewhere for the surgery if they can’t get it in the study. Many doctors are not qualified to evaluate the statistical results produced, and often don’t believe the results when they arrive. Some of the critics of the NINCDS study initially complained that the best candidates for the surgery left and had the surgery elsewhere when they had been assigned to nontreatment, for example. But doctors often simply ignore studies, even when there aren’t potential confounding issues like that one, simply because they want to stick with what they “know” works.

What is known now is that the retrospective studies used by Yasargil did not accurately reflect the rates of stroke at that time. Too little was understood about how people’s health had changed between the time those studies were done and the time EC-IC was first being tested, and our assumptions that the two were comparable turned out to be wrong. As a result, Yasargil reached the wrong conclusion.

He didn’t even do something wrong – or at least, wronger than usual in medicine. He was in fact more careful than most such innovators, and certain more so than those who adopted his ideas without subjecting them to any testing at all. He was merely tragically wrong.

Other, equally tragic mistakes happen not through bad luck, but through incompetence, willful ignorance, and arrogance.

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2 Responses to “First, Do No Harm (Part 2)”

  1. Do you think it would be better for the FDA to regulate surgeries but not drugs, rather than the other way around?

  2. No.

    Not only would it not be better, it wouldn’t be good. Of course, it’s not good to have the FDA regulating the drugs, either.

    I’m hoping to get to a post about that, eventually.

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