THE LEDGER-STAR
Copyright (c) 1994, Landmark Communications, Inc.
DATE: Tuesday, December 20, 1994 TAG: 9412200510
SECTION: FRONT PAGE: A2 EDITION: FINAL
SOURCE: ASSOCIATED PRESS
DATELINE: WASHINGTON LENGTH: Medium: 72 lines
More than 1,000 Americans a week get steel screws implanted in their spines to fight back pain, although the devices are not government-approved and studies show they may cause more harm than good, a consumer advocate charged today.
Public Citizen petitioned the Food and Drug Administration to ban the screws, and accused the agency of negligence for not cracking down on allegedly illegal and unethical use of the devices.
``This has got to stop,'' said Public Citizen's Dr. Sidney Wolfe. ``It is a major and dangerous racket being perpetrated on patients in this country.''
At issue are orthopedic devices called pedicle screws, long hardware that is literally screwed into the bones of the back. Doctors think the screws may help heal spinal fractures or severe spinal degeneration, although the FDA has not approved them for use anywhere except in strictly controlled clinical trials.
But because screws are approved for use in leg and arm bones, doctors can buy them for other, unapproved purposes unless the FDA specifically bans it. So 50,000 to 70,000 Americans get the treatment every year, many for such common ailments as chronic low-back pain.
Complaints about the screws aren't new. More than 600 people who say they were injured or disabled by them have joined a class-action lawsuit, and the FDA warned seven manufacturers last year to stop illegally advertising the experimental devices.
The FDA also required manufacturers to say on the products' labels that they are not for spinal use, said spokesman Don McLearn. It wasn't immediately clear whether manufacturers complied.
But Public Citizen today released its own investigation of the screws, concluding they endanger thousands, that the FDA has been negligent in fighting their illegal promotion and that they are pushed by surgeons who received profitable stock shares in return.
``We found evidence of manufacturers' aggressive, illegal marketing of a dangerous device, often with the complicity of co-opted surgeons,'' said Public Citizen attorney Joanne Mott.
Her review of medical studies found spinal screws cause complications in a third of all patients and break off inside the spine in 10 percent. Also, screw recipients are twice as likely to need additional spinal operations as are patients who undergo traditional surgery to fuse their spinal bones without screws, she said.
Yet patients often aren't told the devices are experimental, Mott contended. She uncovered FDA records citing researchers who had not obtained informed consent before enrolling patients in pedicle screw trials, and her own survey of 101 screw recipients found only one who recalled being told the device was not FDA-approved.
The FDA never took any action against the seven manufacturers it warned to stop advertising spinal screws, so the promotion continued, Mott reported. She sent the agency copies of full-page ads for the screws, all from respected health journals, by seven different manufacturers.
The FDA last summer asked a panel of outside advisers whether spinal screws should be banned - and that panel said the agency should make it easier for the screws to gain approval to treat fractures and severe spinal degeneration. The doctors concluded people were only harmed by the screws if their doctors used them improperly and for treating minor ailments.
But the panel based its decision on manufacturer-funded studies that several internationally known spinal surgeons denounced as scientifically flawed, Public Citizen reported today. Wolfe blasted the FDA for not soliciting advice about the screws from critics as well as the industry.
KEYWORDS: FDA BACK SPINAL SCREWS by CNB