A front page, above-the-fold Chicago Tribune story from late May begins like this:
If you have a faulty heart valve and decide to get it replaced, a surgeon will implant an artificial one that has undergone rigorous examination by the Food and Drug Administration.
But if you choose the option recommended for most patients — repairing your valve with an annuloplasty ring — there are no such guarantees, even though both devices are permanently stitched into the heart and considered life-sustaining.
That's because, a decade ago, the FDA downgraded the regulatory class of the rings. Instead of being grouped with heart valves and implantable pacemakers, annuloplasty rings were put into a class with most catheters, sutures and hearing aids, which allows the medical device industry to gain approval for new rings without clinical studies.
"It's absolutely ridiculous. How could something that is permanently implanted in the heart be regulated this way?" said Diana Zuckerman, president of the National Research Center for Women & Families, a think tank that has fought for stricter oversight of medical devices. "The first question is: Who petitioned this change and what financial interest did they have?"
It appears the author omitted the “..and puppies!” (or the “…and NOT you asshole men!”) from the tail end of Ms. Zuckerman’s organization, but there you have it: Annuloplasty rings are regulated like sutures and hearing aids instead of heart valves. And the Chicago Tribune is pissed.
The rest of the article reads like a combination of…well you remember that scene in Wedding Crashers when Isla Fisher throws a temper tantrum because Christopher Walken won’t let Vince Vaughn and Owen Wilson come back to the family compound? Yeah. It reads like that. With a good dose of your stereotypical college newspaper rant-icle that throws evil corporations, words like “linked to,” “associated with” and “loopholes,” and pleas for the government to do something into a blender and sees what comes out.
Here’s the crux of the Tribune’s complaint:
A Tribune investigation found that the FDA rubber-stamped the group's petition, allowing the invasive devices to make their way into the hearts of thousands of patients with virtually no scrutiny.
Today, annuloplasty rings have had more deaths associated with them during the past five years than any other device in their class, according to a Tribune analysis of FDA data on adverse events. Although there are many flaws in the way the FDA gathers its data and there is no way to tell if the deaths are directly related to the rings' performance, the analysis raises questions about whether the agency erred in reclassifying the device.
That last paragraph sounds pretty scary – more deaths associated with these devices than any other in their class. Of course, we’re not told how many – is it significantly more? Just a couple? Within the range of random chance? And the vague “associated with” is slipped in there. What the hell does that mean? Directly caused? Possibly caused? What’s the criteria? And we’re told that these things have more deaths associated with them than “any other device in their class.” Which sounds scary. Until you realize that – and this is pretty much the entire point of the article – their “class” consists of catheters, sutures, hearing aids, and joint replacement devices. Gee…I can’t imagine why a device implanted in the failing hearts of elderly folk has more deaths “associated with” it than a fake knee. Gotta be inadequate regulation!
Seriously though, that’s the closest this article comes to exposing any harm associated with these rings. Maybe people are dropping dead from these things left and right, but you wouldn’t know that from the article. I was even waiting for the inevitable human interest section – you know, the one where they interview the poor single mother of five who lost her husband to a faulty, unregulated ring – and all the Tribune could muster up was this:
The surgery was an ordeal Al Edwards, of Lincolnshire, dreaded. He had known about his regurgitating mitral valve since he was a teenager and had no symptoms. But the problem was getting worse as he grew older, and he had developed an irregular heartbeat that required surgery. So Edwards decided to have his valve repaired as well, hoping to avoid further surgery down the road.
Edwards, 61 at the time, chose to have the operation in February 2007 at Northwestern Memorial Hospital in large part because of Dr. Patrick McCarthy, a world-renowned heart surgeon there.
Two years after the surgery, Edwards received a letter from Northwestern's CEO, Dean Harrison, addressing media reports that the ring inside Edwards, a model called the Myxo ETlogix, "was experimental and not cleared by the FDA for use." The reports, Harrison said, were wrong.
Unlike most patients, Edwards knew a thing or two about FDA regulations. He has a doctorate in pharmacy and spent two decades working on drug approvals, including three years with the FDA. He filed freedom of information requests with the FDA and soon discovered that the agency hadn't cleared the device.
"I had to pick my jaw off the desk," he said. Although the ring he received apparently fixed his mitral valve, the fact that the FDA hadn't cleared the device — or even known that it existed — left him feeling betrayed.
Are you kidding me? I’m calling bullshit. I don’t think Al Edwards exists. Or maybe he does, and the reporter twisted his words. Because I have a really hard time believing that when a world-renowned heart surgeon and a little ring save your life, your first thought is, “I am so pissed that the FDA classifies this as a class II device!”
I honestly have no idea what the point of this article is, besides serving as an outlet for some weird government-regulation fetish. The problem doesn’t seem to be that these things are dangerous and unregulated. It just seems to be that they are unregulated. Which apparently bothers somebody over at the Chicago Tribune. There’s also some amateur “evil corporation!” angle in there – so perfectly set up by the not-at-all suspiciously convenient quote in the lede - but I don’t really understand it.
But here’s why I got really incensed by this particular article:
When medical device laws were first put on the books in 1976, panels of medical experts placed every device on the market into one of three classes. Annuloplasty rings were in the highest-risk class, known as Class III, because "the device is implanted and life sustaining."
The FDA was supposed to write regulations outlining what manufacturers must do to gain premarket approval, or PMA, for each Class III device. In the meantime, Class III devices on the market before the laws were enacted could be sold through the less rigorous Class II process, known as 510k.
That had huge implications for manufacturers. Going through a PMA costs hundreds of thousands of dollars and can take years, but the 510k process can be completed in a few months and costs companies as little as a few thousand dollars.
I mean, my first thought is why on earth the FDA is still using the same classification system it developed in 1976. But anyway…
The final ‘graph there is designed to show the reader that these manufacturers are trying to cut corners by getting their devices classified in class II as opposed to class III. Apparently, the Tribune would like to see these rings placed into class III because then…well, I’m not really sure why. But that would supposedly make people safer, since the drugs would receive a more rigorous review.
It would also make people more dead. Lost amidst the Tribune’s Gloria Cleary foot-stomping routine is the fact that when you make live-saving treatments more expensive to produce and delay their production, people will die. Now, maybe we've found the perfect middle ground between preventing dangerous products from coming on the market and allowing sick patients access to lifesaving treatments – although there are plenty of reasons to be skeptical – but the Tribune doesn't even acknowledge this trade-off.
The Tribune story closes by returning to their oh-so-perfect quote dispenser:
A month afterward, Al Edwards received a second letter from Northwestern saying his Myxo ring had been cleared by the agency — two years after his surgery.
"It really boils down to your mother, your father, your son or daughter, and whether you would want them to go through this," he said. "My answer is no, I wouldn't. I would want an approved device."
Jeez, Al. I thought I was the most cynical guy to get a new lease on life.
Anyway, my answer is: I want to be alive. And I want my mother and father and sons and daughters to be alive. I don’t give a hoot about whether the thing that saves my life was approved by the FDA, FTC, SEC, or the GAO. I don’t give a damn about whether it was class II or class III or whether the manufacturer was “linked” to whatever. And if your calls to regulate things for the sake of regulating things costs me a lifesaving drug like Rituxan, that doesn’t make you a champion of the public interest. That makes you an idiot. And a dangerous one at that, especially when you engage in this sort of crap on the front page of a major paper.
I recognize the public interest in not allowing cyanide on the market. That’s fine. So long as everybody else recognizes that when we regulate things to the point where they are insanely expensive and take forever to produce, people are going to suffer and die. That could include your mother, your father, and your son or daughter. There is a trade-off. You can believe you’re on the right side of that trade-off. But you can’t pretend it doesn’t exist.