The life sciences have fostered an environment that can get pretty crazy, but let's face it: That's one of the things we like about the life sciences. Below are two stories that rival the tallest tales told of the Old West, but these two stories happen to be true stories.
Hamburg; clinical trials for Ebola
The latest outbreak of Ebola has generated a few rhetorical whoppers by elected and appointed officials. One of the weirder among them is a remark by FDA Commissioner Margaret Hamburg, who said in a recent blog at FDA Voice that the agency “strongly” supports clinical trials for Ebola vaccines and treatments.
Color me chicken, pardner, but there is no way in the world I'm going to consent to be randomized in a trial for a vaccine or a treatment for a cold-blooded killer.
However, the idea of a non-randomized trial for Ebola doesn’t make much more sense than a saddle without stirrups, either. For starters, the current outbreak will be well past done by the time any trial has a chance to make it out of the barn. Then you have to ask yourself whether the next outbreak will present a virus with the same surface proteins and other characteristics as the current outbreak. If the answer is no, any diagnostic, treatment or vaccine currently in development mightn’t lasso the critter.
Care to sink your hard-earned coin into that kind of ranch? I wouldn’t.
Cook Medical’s warning letter
Cook Medical is a big wheel in the device business, and certainly has the pockets for a top-notch compliance staff. But as we have seen in the past, even big companies with deep pockets sometimes don’t ride their herds very well.
The September 16 warning letter to Cook addressed the plant that manufactures catheters and other devices, stating that the company had identified more than 700,000 non-conforming livestock "across all device families" over a stretch of about two years. Among the problems were labels that seemed to fall apart, and a process that did not do a particularly good job of bonding catheter tips to the catheters.
There was one recall of the company's devices that took place during the period in question, the Zilver PTX stent for the peripheral vasculature. The company said in its May 2013 statement that the rate of catheter tip separation was 0.043%, which to the greenhorn sounds like a good rate.
Still, Cooke had to trash more than half a million devices due to the non-conformities, which can't have been cheap.
However innocuous these problems might have been, device makers have to understand something about Sheriff Jeff Shuren. He and the rest of the agency have no breathing room (from the media or from Congress) when it comes to problematic medical devices. If a device maker has a problem that seems a minor problem, the real question might be "would this be a problem for Johnny Law?"
If the answer is “yes” – even if it’s just a problem of optics where the townfolk are concerned – then it's a problem for the device maker, too. If you’re in the device industry, you simply cannot let wild horses run loose in your corral. Your ranch is regulated. Tightly. And please, no excuses. It’s not as if you didn’t get the flyer.