A Food and Drug Administration scientist blocked the approval of potentially more precise digital mammography machines for several years, a pattern that is coming under scrutiny after recent revelations that the man's computer was being monitored by the agency.
Robert C. Smith is being criticized by some breast-cancer doctors as well as some in the FDA for not approving the new machines during his nearly four-year tenure as a medical officer in the agency's radiological-devices branch.
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The WSJ notes
Five mammography machines using digital technology were approved by the FDA's radiological devices branch before Dr. Smith joined it. None were approved during his tenure. Six were up for approval in that time. There is no way of knowing whether any women had cancers advance because of the delays of digital technology
Smith's actions were especially frustrating for breast cancer specialists like Dr. Etta Pisano. Pisano noted of Smith, "He began putting in obstacles to approval that were unreasonable" once he had the bureaucratic power to do so.
(Dr. Pisano was co-author of a 42,760-patient study that appeared in the 2005 New England Journal of Medicine that demonstrated the reliability of digital mammography and showed that it was "'significantly better' than film in finding cancer in women under 50 and those before or during menopause".)
Dr. Smith's lawyer claims that Smith was merely following proper FDA procedure. Smith's contention is that too many medical device manufacturers have an improper "cozy relationship" with FDA regulators, whereas Smith was merely being "an honest and rigorous regulator".
If that's true, that's alarming. It would be bad enough if Smith were a rogue, overzealous regulator. It would be even worse if Smith represents how the system is supposed to work.
As one breast cancer survivor noted in an online comment
I just realized that if this particular bureaucrat had continued in his position, I probably wouldn't be here. My 3 year anniversary is coming up, so perhaps I should send him a "thank you for moving on" card.
But how many more Dr. Smiths are still at the FDA, delaying other vitally-needed medical innovations for American patients?