FDA Screwing Around with Device Approval

January 01, 1996  ·  Michael Fumento  ·  Fda

Why is it that whenever the FDA quickly approves a drug or medical device, you always read about it in the first few pages of the newspaper, but when it delays approval of something that could prevent death and suffering, you usually only hear about it in the opinion pages — if at all?

Case in point: this column. Subject: The FDA’s delay in approving something called a pedicle screw to treat serious spinal injuries, a delay that is encouraging terrifically expensive litigation against the screws’ manufacturers and making doctors hesitant to use them.

Originally pedicle screws were only used to fasten leg and arm bones, and the FDA approved them for this purpose. But orthopedic surgeons found they were also excellent for fusing bones of the spine which had broken or degenerated. There are other ways of doing this, such as using wires, rods, or hooks, but once physicians tried the screws, the other techniques pretty much fell by the wayside.

The FDA has never approved the screws for this express purpose. Nonetheless, FDA policy wisely allows a drug or device which has proven safe and effective for one thing to be used for another. It’s called "off-label" use. Virtually everybody reading this column has probably received a drug or treatment that hadn’t been approved for that specific purpose, yet doctors had decided it was a good thing to offer their patients.

Over 300,000 times, doctors have used these on patients’ backbones, in the belief that it was the best treatment. But, of course, operations aren’t always successful and not everybody received complete relief. Sometimes it’s the doctor’s fault and sometimes that’s just the way it is. But in this litigation-happy country, nothing ever "just happens." Somebody had to pay and pay dearly, and that’s where the trial lawyers come in.

About 7,000 patients who have received spinal treatment with pedicle screws have filed suits with an estimated total liability of $1 billion. Their lawyers’ chief weapon: That the FDA has been steadily dragging its feet on the approval of the technique. You can just hear the plaintiff’s lawyer booming at the doctor on the witness stand: "You mean to tell us that you inserted these screws even though you knew for a fact that the FDA has not approved them for that purpose!"

The best answer to that is: "Yeah, but so what?" But you can see how an uninformed jury might feel otherwise.

FDA approval of pedicle screws for use on the spine would "take the wind right out of the trial lawyers’ sails," one industry insider told me. Naturally, the trial lawyers are desperate to see the screws remain unapproved and have enlisted the lobbying and legal support of Sidney Wolfe’s Public Citizen advocacy group, which often works hand-in-hand with plaintiffs’ lawyers. Back in 1994 an FDA panel of medical experts voted unanimously to ease regulations on the use of the screw. The following year, the FDA declared it produced "significantly higher rates" of relief than "other existing devices."

Yet not only is the FDA dragging its feet on granting approval (except for one extremely rare form of back surgery), one of its top officials has actually sabotaged the case for approval.

The sabotage arose out of something generally called the Cohort Study, a major evaluation published in the medical journal Spine which concluded that pedicle screws were at least as safe and more effective than previous methods of treatment.

As such, the study is devastating to the trial lawyers’ position, prompting their typical reaction of trying to intimidate and harass the doctors who worked on the study. The FDA knows about this tactic and so flatly told the lawyers it would not release the names.

These sharks are back-biters.

But FDA Deputy Associate Commissioner Mitch Zeller nonetheless turned the names over to a group associated with the trial lawyers. He says he did so accidentally, not having noticed that they were marked as confidential.

Rep. Joseph Barton (D-TX), claims Zeller isn’t telling the truth and is demanding that the Justice Department investigate. In the meantime, subpoenas issued to doctors who worked on the Cohort Study have risen nearly five-fold since their names were released.

FDA Commissioner David Kessler has apologized for the release, but has rushed to his employee’s side in saying it was inadvertent. Barton is right; that’s a question for Janet Reno, not David Kessler to answer. In the meantime, the way for the FDA to undo some of the damage is to give its approval to pedicle screws for spinal use. Get a backbone, commissioner, and do what’s right.