“We could have gotten this over with in 45 minutes.”
That’s what we overheard an unidentified panel member tell a colleague during the last break of the day at the FDA’s orthopedic advisory panel held on September 21.
The panel had been called together by the FDA to offer the agency recommendations regarding the classification of posterior cervical screws, including pedicle and lateral mass screws.
Surgeon Support
The panel heard the same message all day long from the Scoliosis Research Society (SRS), the American Academy of Orthopaedic Surgeons (AAOS), the American Association of Neurological Surgeons (AANS), the North American Spine Society (NASS) and the Cervical Spine Research Society (CSRS). That message was that pedicle and lateral mass screws used in the cervical spine have been the gold standard for the last decade and it was time to finally classify the screws so that they could be used “on-label” and the proper procedures for use could be taught by surgeons.
Cervical pedicle and lateral mass screws are components of rigid, posterior spinal screw and rod systems generally intended as an adjunct to fusion for the treatment of degenerative disc disease (as defined by neck pain confirmed by radiographic studies), trauma, deformity, failed previous fusion, tumor, infection, and inflammatory.
Currently the screws for the cervical spine are not classified and their use for anything other than use in the lumbar spine is considered off-label. The result is that surgeons can only teach the standard of care one student at a time during their practice of medicine.
OSMA Petition
For the first time in recent memory the FDA convened the panel to consider a petition, not from a particular company, but from the industry as a group through the Orthopedic Surgical Manufacturing Association (OSMA). The association had petitioned the FDA to classify the screws for the use in cervical as a Class II device.
The Panel had a jovial, yes, jovial time bantering over the value of screws over the previous standard of care, wires, hooks and cables. After the united medical society support of OSMA’s petition and an FDA staff recommendation for classification with tight controls, there wasn’t much science or clinical data to argue over.
“Ghost of Pedicle Screw Past”
After all that agreement and clear demonstration that the screws are the standard of care for certain procedures, it was a little baffling to figure out why the FDA even called this meeting.
Call it the “Ghost of Pedicle Screw Past”
Minneapolis attorney Bob Klepinski, a veteran of the pedicle screw lawsuits of the 90s said the agency was probably being particularly careful over any pedicle screw issue.
Over 3, 000 lawsuits were filed over pedicle screws in the 90s. NASS was sued over 400 times in 42 states after the society had sponsored five continuing medical education (CME) activities that mentioned off-label uses of pedicle screws. AAOS and SRS were also sued.
Physicians, manufacturers, societies that mentioned pedicle screws in their CME courses, and the individual faculty who taught the courses that included pedicle screws were all sued. Some called it a witch hunt against the spine industry.
Every one of the cases against the surgeon societies was dismissed by 1999 for lack of evidence.
To read a more detailed history of the development of the pedicle screw, read our April 3, 2007 story by Robin Young titled: When No Good Deed Went Unpunished: The First Decade.
FDA On the Hot Seat
In addition, the FDA has been through a lot of turmoil over the past few years, evidenced by the perplexing Regen Biologics actions that involved two panel meetings, political scandal reporting by the Wall Street Journal, the unprecedented revocation of the company’s 510(k) clearance and the departure of long serving top administrators.
This all happened while whistleblowing agency scientists went to Congress and the press and accused FDA political appointees of ignoring their scientific advice. They also accused the agency of retaliating because they exercised their right of free speech and assembly.
The agency, in turn, electronically bugged their own scientists by tracking their computer activities. The now former scientists and the agency are fighting each other in a whistleblower lawsuit.
Then came data from overseas registries and surgeon societies that certain large head metal-on-metal hips cleared by the FDA were failing in unacceptable numbers.
Jeff Shuren, M.D., JD, the agency’s current top device regulator, inherited a lot of FDA staff dysfunction. He’s been battered by patient advocates who accuse him of kowtowing cow towing to industry and not protecting public health. And, he’s been battered by industry and investors who accuse him of stifling innovation and failing to promote public health.
So the agency can be forgiven for the extra caution.
While support for bringing the screws under Class II of devices was universal, with some special controls, one patient advocacy group objected to the petition and urged to FDA to require manufacturers to go through the PMA (premarket approval) process for all devices implanted in humans.
Diana Zuckerman, Ph.D., president of the National Research Center for Women & Families testified that the FDA and OSMA reviews did not discuss a four-year study of 84 patients with 33 complications. She noted that the researchers found that 13% of patients had neurological damage after surgery, with palsy cited as the most common injury. Another 13% had implant failures. If 13% is considered low risk, then it has to be “looked at in terms of the benefits, ” she said. Patients who benefit have to be “counterbalanced by patients being harmed, ” she said.
When pressed for details of the study, she was unable to produce it.
Panel Deliberations
John Kirkpatrick, M.D.Panel member John Kirkpatrick, M.D., made it clear to industry that support for their petition was only for fixed stabilization and not for dynamic stabilization.
Raj Rao, M.D., from the Medical College of Wisconsin Milwaukee, agreed that all the screws and devices used in the posterior cervical spine are reasonably safe when used in the appropriate fashion for the appropriate indications, but cautioned that there should be a way to distinguish between pedicle screws C3 to C6 and lateral mass C3 to C6 for labeling due to the risks associated with the presence of vertebral arteries.
Raj Rao, M.D. Another panel member, statistician Brent Blumenstein, Ph.D., who is fond of telling his colleagues that he worships at the altar of randomization, was disappointed that there was no comparative data comparing screws to hooks, wires and cables.
Equipoise
John Heller, M.D., one of OSMA’s presenters, spoke of “equipoise” and noted that it is difficult to suggest to patients that entering a blind clinical trial offered equal opportunities for each treatment. He said he could not in good conscience offer that choice to his patients.
Recommendations
Ultimately, the panel offered the following observations to the FDA:
Available scientific evidence supported a reasonable assurance of safety for the use of cervical screw fixation systems in treatment of the proposed, indicated population. The panel did express concerns in the future regarding training and collection of long term data.
Available scientific evidence supported a reasonable assurance of effectiveness in the use of cervical screw fixation systems for treatment in the proposed, indicated population.
Support of the FDA’s proposed indications for use. Panel consensus supported inclusion of the specific screw trajectories presented by the FDA.
Reasonable evidence to support use of posterior cervical screws as an adjunct to fusion in the pediatric population. The FDA recognizes that this determination is based on modest level of evidence and lack of long term clinical data. It was emphasized by the panel that size of the osseous elements is more critical than chronological patient age.
Support of the non-fusion use of posterior cervical screws for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The panel emphasized that their discussions were limited to this narrow patient population and should not be extrapolated to other non-fusion applications or technology.
Other than the risks associated with the presence of the vertebral arteries, the panel did not identify any other unique risks, as compared to other spinal implants, which may be present in the cervical spine.
Confirmed the completeness of the FDA’s identified risks to health. In addition, the risk of iatrogenic foraminal stenosis associated with implant-related changes in spinal alignment resulting in neurologic injury was also raised.
Support of the adequacy of the proposed special controls. An additional recommendation was made with regards to the specific risks relating to C3-C6 pedicle screw placement.
Support of the requirement of cross-sectional imaging as part of pre-operative planning for procedures which utilize posterior cervical screw fixation.
After all was said and done, it was clear this really wasn’t about science. Perhaps the meeting served as a metaphor to exorcise the Ghosts of Pedicle Screw Past. Somewhere, Dr. Steffee must be smiling.
