Medical Device Daily Washington Editor
Now that the Center for Devices and Radiological Health at FDA has jettisoned two examples of what many in industry believe were employee baggage – namely Robert Smith, MD, and Julian Nicholas, MD – the clinical community and device makers both seem to be more optimistic going forward about the CDRH review process. FDA declined to respond to queries regarding the circumstances that led to Smith's departure, but he and Nicholas acknowledged in a hearing earlier this year that they were among the signers of the letters to the White House and Congress about alleged malfeasance at the Center for Devices and Radiological Health (Medical Device Daily, April 1, 2010). Nicholas found FDA unwilling to renew his service contract, and Smith parted ways with the agency in July under circumstances FDA has declined to explain. By at least two accounts, however, Smith will not be missed.
Last week, Medical Device Daily interviewed Bob Rusk of Giotto USA (Wichita, Kansas), during which Rusk asserted that Robert Smith, MD, was perhaps the principal thorn in the side of industry on some settled points of FDA's regulatory approach. Rusk said Smith had made remarks to the effect that Smith had “changed the rules per his view of things,“ and also said, “it seems that as he's less in the picture, things move more smoothly“ (MDD, Aug. 24, 2010).
Medical Device Daily interviewed Etta Pisano, MD, of the University of North Carolina School of Medicine (Chapel Hill, North Carolina), for a different perspective on the tenure of Smith, but her remarks did not seem to offer a sharply contrasting view compared to Rusk's. Pisano, who served as the principal investigator in the definitive DMIST (Digital Mammographic Imaging Screening Trial) study that investigated the reliability of full-field digital mammography (FFDM) compared to film mammography, said in the interview that she found Smith's positions on some issues “strange.“
Pisano told MDD that she has “had no conversations with the FDA since“ the November meeting on 510(k) applications for FFDM (MDD, Nov. 19, 2009), but that prior to the meeting, “I talked to them about it, trying to get them to get on the stick,“ Pisano said. “I was encouraging them to do it and was giving them feedback on what they'd written, telling them that if they wanted to sub-contract the writing of the document to someone like me,“ that she would be willing, adding, “I'm sure there are lots of people who would be happy to help them.“
Pisano said that in some of her communications with FDA in 2006 on the FFDM guidance, “I was always assured it was right around the corner, and obviously it wasn't,“ but when the agency published the draft in 2008, “I replied publicly to the guidance documents and told them I thought they were overly burdensome.“
Pisano said she had conveyed the view that “requiring a clinical trial was too burdensome. I thought they should do reader studies or small group studies of fewer than 50, where they could demonstrate substantial equivalence with an already approved device. I still think that's the thing they should be doing.“ She said that any of the devices used in DMIST would serve as a capable benchmark for such studies. “If you could show substantial equivalence to one of the machines that was in DMIST, that should be sufficient to get approval at this point.“
Reiterating a point she made at the November hearing, Pisano said, “I really have a question whether its ethical at this point to double expose women“ in a trial designed to establish substantial equivalence unless the issues run toward basic physics. Given that those issues had been settled by DMIST, she said, “I just don't understand why they held it up.“
Pisano said she had met with a number of individuals at CDRH on the issue, and that while some of the names and faces are not particularly memorable, “I remember Bob Smith,“ noting that she had “met with him over and over“ regarding the guidance. She said his conduct led her to believe he was inexperienced in the field.
“I think he was not experienced in mammography or breast imaging,“ Pisano mused, although she acknowledged that she was not sure about his occupational background. “I know he was very, very anxious about what led people to conclude that equipment was equivalent based on physics results,“ she said.
Pisano remarked that Smith seemed to experience substantial distress upon discovering that his views of the appropriate standards for determining substantial equivalence were not universally held at FDA. “I think he felt that when people above him in the chain“ expressed the view that physics results were sufficient, “he thought he was being unduly pressured. He took it as 'how dare you question my judgment',“ which “I think is an odd thing.“
“I think that's a strange claim that people above you“ have no right to disagree, she said.
Pisano pointed out that the letters to Congress and the White House were more geared toward what Smith felt were issues related to computer-assisted detection (CAD), but Pisano asked: “How could a CAD system really be dangerous to patients? Radiologists are trained that they shouldn't use it as a primary screening tool, that they need to use it in conjunction with their own interpretation.“
“Rational people can disagree about [some of] these things,“ Pisano observed, but argued, “in fact, that particular topic – whether we should approve devices based on technical parameters – is something that was laid to rest dozens of years ago. To claim that puts people at risk is a strange claim.“
“I'm an advocate for rigorous FDA standards,“ Pisano said, but “I think his view cost patients money because we didn't get more devices out there, more competition,“ which she said would have exerted a downward pressure on prices. Furthermore, “I'm not sure it protected a single patient from any kind of harm,“ she said.
Pisano said that Smith's remarks at several public hearings, during which he spoke as a citizen rather than as an employee of FDA, augmented the comments he made during earlier hearings to convey a distinct impression. “I heard what he had to say“ at the public hearings, Pisano said, adding that based on those comments, “I think he was the primary obstacle to any kind of change in the [FFDM] guidance document.“
“I think there's a little bit of strangeness going on there“ with Smith's objections, she said, adding, “I really don't understand the guy at all. I'm glad he's gone.“
Mark McCarty, 703-268-5690