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Did FDA officials ignore warnings about radiation risks of routine CT screening for colon cancer?

I expect there will be some heated exchanges this week at the Food and Drug Administration’s public meeting on how to reduce unnecessary radiation exposure from medical imaging.

According to an article published Sunday in the New York Times, at least two government experts intend to speak at the meeting about how FDA officials ignored their warnings about the risks associated with using CT (computed tomography) scans for routine colon cancer screening.

As Times reporter Gardiner Harris indicates, a paper trail appears to support those scientists’ claims:

Scores of internal agency documents made available to The New York Times show that agency managers sought to approve an application by General Electric to allow the use of CT scans for colon cancer screenings over the repeated objections of agency scientists, who wanted the application rejected. It is still under review.

After an agency official recommended approving G.E.’s application, Dr. Julian Nicholas, a gastroenterologist who trained at Oxford University and the Mayo Clinic and worked under contract with the agency, responded by e-mail that he felt strongly that approving the application could “expose a number of Americans to a risk of radiation that is unwarranted and may lead to instances of solid organ abdominal cancer.”

Dr. Robert Smith, a former professor of radiology at both Yale and Cornell and an F.D.A. medical officer, wrote that he agreed with Dr. Nicholas because “the increased radiation exposure to the population could be substantial and would raise a serious public health/public policy issue,” documents show.

How did the FDA managers respond to these concerns? Writes the Times:

Minutes of a May 12, 2009, meeting, for instance, reveal that an agency manager, Joshua Nipper, dismissed the scientists’ concerns by saying, “We don’t need to be reinventing a big bugaboo about radiation.”

Nicholas told the Times that he refused to back down — an action that may have resulted in the termination of his contract with the agency.

“I was first ignored, then pressured to change my scientific opinion, and when I refused to do that, I was intimidated and ultimately terminated,” Nicholas said. “And I’m going to tell the committee exactly that at the meeting.”

Best interest of patients?
No one, of course, is saying that CT scans do not save lives. But they are often used in situations when their value isn’t proven.

As I reported last August, a New England Journal of Medicine study raised serious questions about the quadrupling of the use of CT scans in the United States during the past two decades. That study reported that as many as 2 percent of all cancers may be attributable to the radiation from CT scans. A single CT scan can deliver radiation equivalent to more than 400 chest X-rays.

And, as reported here last December, a study in the Archives of Internal Medicine estimated that as many as 15,000 people may die from cancer over the next two decades as a direct result of CT scans received in 2007 alone.

About 70 million CT scans are performed in the U.S. each year.

As the Times article notes:

For decades, scientists at the F.D.A. approved many radiological medical devices with minimal oversight, declaring them modest improvements over older devices and thus not needing extensive reviews or clinical trials to prove their safety and efficacy. But these devices now play a central role in American medicine, helping not only to diagnose a wide array of ailments, but also to treat cancers.

And the agency has done little to asses whether the rapid proliferation of scans is in the best interests of patients, and whether the machines themselves properly protect patients or are beneficial for all of their now-routine use.

We’ll have to see what FDA officials recommend as a result of this week’s public meeting, which is part their recently announced initiative to “reduce unnecessary radiation exposure from medical imaging.”

Stay tuned.

Comments (4)

  1. Submitted by Don Schuman on 03/29/2010 - 11:24 am.

    On April 20 2008 I went to the emergency ward complaining of appendicitis. I clearly had a ruptured appendix. I was given THREE CT scans, which the doc claimed showed conclusively that I had colon cancer. He removed my ascending colon as well as my appendix. I did NOT have colon cancer, just appendicitis! Now I get to fear colon cancer because of the CT scans!

  2. Submitted by Bernice Vetsch on 03/30/2010 - 02:20 pm.

    Has Congress been able to confirm an Obama nominee to head the FDA yet? (I see no evidence at the site.) S/he’ll have a big cleanout job to do.

  3. Submitted by Don Schuman on 03/30/2010 - 04:48 pm.

    Hi! This is not a post. I just copied my previous comment into Word. It showed up WITH my edress! Would this happen to anyone who copies a comment? You say in bold type that edresses will not be published. Are you actually secure in this? An answer would be appreciated. Best regards!

  4. Submitted by Gregory Lang on 04/03/2010 - 02:50 pm.

    First off, medical radiation. Around 2000 I had a dislocated shoulder that required a few X-ray attempts. Around 2007 I had a bad tooth that required a few X-rays. One dental specialist had a computer color X-ray. I had to ask for a lead blanket. More recently my dentist got the new color computer X-ray. The first time the lead blanket was optional. Now my dentist uses all the time it even with the newer lower radiation X-rays even though the manufacturer claims the lead blanket isn’t needed anymore. I take the view that medical radiation should always be reduced to the lowest practical levels.

    Last summer I had a REAL colonoscopy. I wouldn’t call the fifteen minutes wasn’t “fun” but it was “interesting” at least in reporter wannabee mode. The doctor or tech doing it said I did a very good “prep” but there were still small bits of feces. (for weirdness they let you watch it live on color TV, nice to see all pink.)

    I didn’t consider a virtual colonoscopy but researched it out beforehand. Last summer I found almost nothing on the radiation risk online! With the bits of residual feces I saw in my REAL colonoscopy I wondered how the “virtual” would handle this.

    Complete with errors that got by spellcheck here is a “reporter wannabe” report on Minnpost on my REAL colonoscopy. The actual procedure was a lot easier than the prep or recovery, which is also present (or worse) with the virtual.

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