Light bulb moment
You might check to see if pigs are flying past a blue moon, and maybe a certain warm place is freezing over, because today I’m going to express my deep admiration for the FDA.
Well…not the entire FDA. Specifically, I want to share my admiration for a group of FDA employees who are known within the agency as the “FDA 9.”
In a sense, these nine FDA doctors and scientists tried to take a bullet for us. They risked their careers, and even risked jail time by attempting to block the approval of potentially dangerous medical devices.
And not only were they pitted against top FDA officials, they were also saying “No” to one of the wealthiest and most powerful corporations on earth.
Would you like to guess who won?
Here are two hints: It wasn’t the FDA 9, and it wasn’t you and me.
We bring good things to…us
Here’s what you may have heard on the evening news…
The FDA 9 recently filed a lawsuit against the FDA, charging that agency officials secretly tapped into their personal e-mail accounts and installed spyware on their computers.
This was after the notorious nine turned whistleblowers and informed Congress and the President that senior managers at the FDA had “ordered, intimidated and coerced” them in an effort to get them to “modify their scientific reviews, conclusions, and recommendations in violation of the law.”
Just imagine how tense things would be at your workplace if you took a grievance with your boss to two branches of the federal government. Awkward!
Now, here’s what the newscasters didn’t tell you…
The FDA 9 strongly recommended to deny approval of several devices that were eventually approved. So it’s very likely that you or a family member or a friend has had a medical procedure using one of these devices.
For instance, in 2008 I told you about the serious problems with digital mammograms. But the Associated Press reports that long before 2008 the FDA 9 had determined that digital mammography was not safe or effective, that it might harm women and result in unnecessary biopsies and other procedures.
The FDA went ahead with approval, of course, which led to a harrowing description of a digital mammography clinic. This comes from the New York Times — a quote from the director of breast imaging at the University of Cincinnati Medical Center…
“Our whole group is kind of pulling our hair out some days. You struggle and you struggle. It’s just so much harder. These are really experienced, qualified radiologists who are wringing their hands. It’s where the increase in callbacks and biopsies is coming into play. It happens every day.”
Just as the FDA 9 had predicted, digital mammography was a fiasco.
They also warned against the use of CT scans to screen for colon cancer. Two years ago I told you about this so-called “virtual colonoscopy” which is appealing to many patients because it’s less invasive than conventional colonoscopy.
But many of those patients are shocked to learn that when a CT scan detects polyps, a colonoscopy is then required to remove the polyps. Meanwhile (and this was the key point with the FDA 9), CT scans produce an extremely powerful dose of radiation — 400 times greater than a chest x-ray!
It’s absurd. But the procedure received FDA approval.
Now, why do you suppose senior FDA managers would refuse to recognize these clear dangers that their nine experts warned them about?
The answer might be found with a silent player in this tense drama. And for once, it’s not a drug company, although this player certainly rivals any drug company for corporate world domination, while also managing to fly way under the radar.
General Electric received the first FDA approval for digital mammography — a very lucrative technology, with some machines costing more than half a million dollars.
And the Times reports that GE also pressed the FDA to approve CT scans for colon cancer screening. By the Times estimate, the rapid increase in scanner use would be worth “hundreds of millions of dollars annually.”
With hundreds of millions and much more at stake, you don’t let the opinions of a few scientists stand in the way. And if they start making trouble, complaining to Congress and the President, well…it’s a moment’s work to troll through their computers, gathering juicy bits for some good old fashioned personal intimidation.
For a change, someone at the FDA was looking out for us. But they just couldn’t overcome the diehard system that always goes where the money flows.
Sources:
“Lawsuit says FDA monitored e-mails” Nedra Pickler, Associated Press, 1/31/12, ap.org
“In Shift to Digital, More Repeat Mammograms” Denise Grady, The New York Times, 4/10/08, nytimes.com
“Scientists Say F.D.A. Ignored Radiation Warnings” Gardiner Harris, New York Times, 3/28/10, nytimes.com
