"Last month, the Washington Legal Foundation, a pro business group, filed a petition with the F.D.A arguing that the agent was statutorily barred from adopting any of the report's recommendations, claiming the panel was biased because it did not include industry officials, investors or patients who had benefited from the devices."This is from the New York Times (7/30/11), a story about a particular metal to metal hip replacement which resulted in metal shavings enfilading the soft tissues of the hip and even possibly becoming blood borne. Pretty nasty stuff, which, as is so often the case with medical devices and with drugs, was not apparent until the product hit the wide open market and thousands of patients in the real world got exposed.
So the Institute of Medicine, a group of physicians and scientists wrote a paper warning against these devices, acting as part of the National Academy of Sciences, which is itself a quasi governmental organization which hopes to render opinions on issues of scientific importance without the influence of politics or vested money interests. The idea is that scientists ought to be able to evaluate certain things without considerations of who would be hurt financially, who might gain politically, just the science, please.
In the case of these devices the IOM suggested the unhappy experience of these particular devices is just the tip of the iceberg: The whole idea of the way in which medical devices like hip prostheses are approved for mass marketing is flawed; too few devices are evaluated in too few patients to be able to predict harm.
From the point of view of physicians, from medical school onward, you are always looking a ways of evaluating diagnoses and therapies in a way which eliminates biases, in a way which leads to the truth: Either a hip replacement device works well or it does not, or is limited; either it last a long time or it does not; it may wear out sooner than patients find acceptable; it may return the patient to full motion and function or it may not. All of these things need to be evaluated and in the process the eagerness of the patient to believe he did the right thing by having the device implanted, the eagerness of the doctor to believe he did the patient a good service, the eagerness of the device making company to believe they did good and no harm all have to be resisted and neutralized so you can make a decision not on what you want to believe but on the basis of what you really ought to believe.
In medicine., wishing does not make it so. Wishing for a drug which cures a particular type of cancer without harming the patient does not make a drug work. Wishing for a pacemaker which saves lives, does not save lives; wishing for a coronary artery stenting procedure which prevents heart attacks and saves lives does not save lives or prevent heart attacks.
Either these things work or they do not, and if you find problems, these have to be dispassionately evaluated. The whole idea of taking a side is antithetical to evaluation of drugs and devices.
But in commerce, you take the side of your device or your drug. You deny its risks and disadvantages and talk up its benefits. You sing the song of testimonials: Oh, this patient had a wonderful experience--never mind a year later he was crippled or dead. Your enthusiasm and product loyalty sells.
But scientists have to resist all those emotional forces and simply tell the truth.
What's wrong with hearing from patients who have been benefited? Isn't it the patient who is the one we care most about? Of course, but the patient trotted out by the drug company is not relevant. The fact a device has helped one patient does not diminish the concern over the hundred patients who were harmed by it. Thalidomide likely benefited many pregnant women, and the company that made it could have trotted out lots of mothers who would talk about the relief from nausea they got, how it changed their lives, but wait 9 months until their children were born without arms or legs and see how they feel then.
Diethyl stilbesterol (DES) may ( or may not) have saved some pregnancies from spontaneous abortion, but when the daughters of the mothers who took DES reached child bearing age, they discovered they had vaginal carcinoma.
Medicine is a litany of patients who were pleased with their therapy, only to find it harmed them later. And even if it did not cause harm later, if it caused no harm to some but devastating harm to others, that therapy ought to be thrown on to the trash heap.
So, forget the testimonials from satisfied customers.
What is really appalling is the contention the IOM and FDA ought to be rendering judgment about the safety and efficacy of devices and drugs taking into consideration the voices of those who stand to profit financially from these products (the "industry officials" and "investors.") The whole idea that would be a good thing to make this decision based on the testimony or interests of those who have a stake in the success or failure of a device is a very radical notion. What the Legal Foundation is saying is we ought to build bias is into the system.
Would the Legal Foundation urge judges to include in every jury a relative of the defendant, because they may have a stake in the outcome. Or how about allowing one of the defendant's lawyers on the jury? Or the defendant's wife? Or one of his investors?
This comes down to one of those "What were they thinking?" moments.
Here are people who are so accustomed to advocacy before anything else, before public good, before anything, they have lost their moral compass. All that counts is winning. All that counts is making money. All that counts is being able to get your way, the public be damned.
Is this a wondrous country, or what?
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