Long gone genie
Have you ever tried to get a genie back in the bottle? I haven’t either, but I hear it’s very difficult. Apparently genies like their freedom about as much as powerful corporations like their enormous uninterrupted profits.
Now, let me be clear that I have no problem with people or corporations making money. (Or corporations who are people, for that matter.) And if it grows from thousands to millions or billions, all the better.
It’s the ability to do that that makes America so great.
But when huge sums of money are made with little or no regard for the health risks to untold numbers of people — no. That’s cruel and deeply immoral…and America at her worst.
Last week I told you how General Electric promoted two radiological devices that were approved by the FDA over objections of nine experts in the field.
And now that those official approvals are out in the world, it will be nearly impossible to get them back in the bottle.
So today I’ll do what the FDA whistleblowers tried to do, and what agency officials should have done — I’m going to give you fair warning so you won’t be duped into agreeing to the use of an “advanced” medical device that could do much more harm than good.
Compression obsession
If you asked a woman to design a state-of-the-art mammogram device, you can be absolutely certain there would be no painful compression of the breast. And she would be a hero to women everywhere.
But when GE designed a new way to mammogram, they came up with a state-of-the-art digital device. That is, it uses digital imaging. The breast still gets compressed.
This technique was approved by the FDA in 2000, making it a true 21st century apparatus, except that it’s not an improvement — it’s a step backwards.
With the digital device, radiologists examine a digital image rather than an x-ray image. And while that sounds like an improvement, FDA scientists (the ones who later became whistleblowers) concluded that the new computer-assisted technique wasn’t safe or effective, and that it might harm women by prompting unnecessary biopsies and too many callbacks for further imaging.
No doubt, those issues are huge concerns for every woman. But there are two more concerns that are just as big: 1) compression, and 2) radiation.
Over the past 20 years, researchers have developed mammography alternatives that require no compression or radiation exposure. But just as those techniques were gaining some ground, the digital machines arrived.
This was a serious setback for the non-radiation devices. When clinics “upgraded” to the computer-assisted machines, many of them spent millions of dollars on the new machines. So having made that huge investment in the “future” of mammography, they’re going to be much less likely to try out any other new technology.
So radiologists win. GE wins. We women lose.
But we only lose when we agree to stick with conventional compression/radiation techniques. You can find more information about mammogram alternatives here.
Dangerous tradeoff
In 2009, GE asked the FDA to approve the use of CT scans for colon cancer screenings.
This one was easy to sell to patients. The CT scan was dubbed “virtual colonoscopy” because it produces images of the colon without inserting a camera into the colon. As you may know from firsthand experience, many patients love the idea of avoiding the dreaded insertion.
But when something seems too good to be true, it usually is.
First of all, the bowel-clearing prep required for colonoscopy is also required for a CT scan. And as many people will tell you, this super-laxative prep is much more unpleasant than the insertion. At least with the insertion you’re under twilight anesthesia.
Secondly, there IS insertion. The bowels need to be filled with air. This is minimally invasive, but from what I hear, it’s fairly uncomfortable and FEELS invasive.
Then there’s the polyp problem. In most cases, polyps found during colonoscopy can be removed on the spot. Not so with a CT scan. So if the scan detects polyps, you have to come back again for a colonoscopy so the polyps can be removed.
And finally — most importantly — there’s the radiation issue. CT scans expose the patient to 400 times the radiation dose you get with a chest x-ray. For the FDA whistleblowers, this was the key issue: the possibility of putting many patients at higher risk of cancer from this very powerful dose of radiation.
Both of these procedures — digital mammography and CT scans for colon cancer — are performed thousands of times each day. So don’t let a doctor or radiologist talk you into using one of these new “advanced” technologies. In both cases the alternatives are much safer.
Just don’t expect to ever hear that from the FDA.
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
