FDA Approves New Mammogram with 100% Radiation Increase, Only 7% Detection Improvement.

The detection improvement applies only to distinguishing cancerous from noncancerous tumors. Does that mean fewer biopsies? It's just pie-in-the-sky guesses right now.

by Heidi Stevenson

15 February 2011

Just in time for Valentine's Day, the FDA has a new present for America's women: a 3-D mammogram, produced by the Selenia Dimensions System machine made by Hologic, Inc. It provides double the dose of radiation for a gain of 7% in ability to distinguish between cancerous and noncancerous breast tumors.

Jeffrey Shuren, the FDA's Director for Devices and Radiological Health, states, "Physicians can now access this unique and innovative 3-D technology that could significantly enhance existing diagnosis and treatment approaches." Were I a radiologist, this development might thrill me. Wow! A new toy! However, as a potential patient, my take on the device is...well, less sanguine.

In the face of reports that even very low doses of x-ray radiation increases the risk of cancer and documentation indicating that breast cancer rates are increased enough by mammograms as they exist to negate any value received—without any documentation to support its claim—the FDA blithely states:

There is uncertainty for radiation risk estimates; however, the increase in cancer risk from having both a 2-D and 3-D exam is expected to be less than 1.5 percent compared to the natural cancer incidence, and less than 1 percent compared to the risk from conventional 2-D mammography.⁽¹⁾

Based on what? Absolutely no documentation is provided to support the claim of less than 1.5% increase in cancer. But the story is even muddier than that.

Notice that the improvement is only 7% to "distinguish between cancerous and non-cancerous cases as compared to viewing 2-D images alone". It doesn't increase the chances of finding cancer or tumors by 7%—No! It merely increases the ability to determine whether they're cancerous or not. Will this even decrease the number of biopsies performed as a result of mammograms?

Nonetheless, Bloomberg reports that Leonard Glassman, an FDA panelist who helped bring this decision, stated, "This, that I've seen today, is probably the tool that I've been looking for for the last 37 years."⁽²⁾

Now the Real Testing Begins

So now that it's been approved, the radiologists' new toy is being put into action to do tests about whether it's effective and safe.

University Hospitals Case Medical Center in Ohio is about to start a trial of approximately 450 women to see if it's of any real value⁽³⁾. According to Cleveland.com, University Hospital's Dr. Donna Plecher, stated:

I don't know that we have enough data to say which women would benefit [from the 3-D mammography machine]. We see its biggest impact as a screening tool. The hope is that it will detect cancers earlier. We will be picking up more cancers at an earlier stage. And our recall rate should go down.

In other words, the FDA has absolutely no idea whether the product they've approved will provide any actual benefit. In the computer world, such products are called vaporware. The fact that a program didn't actually do what was claimed didn't necessarily stop sales—but in most cases, there wasn't a lot of concern for whether people might die of its effects. Apparently, the FDA and Hologic are thinking much the same way, and they don't seem terribly concerned about the potentially fatal effects of their product.

Does it really do what it says on the tin? Who knows! Who cares! There's money to be made! Let's go get some!

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