Glen Steinkopff says a medical device known as the pedicle screw all but saved his life. A 1990 skiing accident crushed a vertebra in his lower back and ruptured two disks. Now 25, he's back at work with the ski patrol at a Tahoe City, Calif., resort. The framework of screws and rods that holds three of his surgically fused vertebrae left Steinkopff with only occasional soreness in his back and enviable flexibility. "I can touch my toes," he says, though "I can't put my palms on the ground."
Gloria Perdue says the same device ruined her life. The apparatus loosened in its moorings after her 1992 operation, and "I could feel the screws in my back going clank clank clank,' " she said. After three additional surgeries, Perdue, 39, depends on a combination of prescribed narcotics, muscle relaxers and antidepressants to get through the day. Perdue, who lives near Roanoke, says, "My pain is so bad that if I weren't a Christian, I'd have blown my brains out."
At least 300,000 patients in the United States have received some combination of pedicle screws, rods and plates, many to repair serious problems such as crushed vertebrae but sometimes for lesser ailments. Like Steinkopff, most appear to be pleased with their operations, which generally cost between $8,000 and $10,000. But some 7,000 patients have sued manufacturers, alleging injury from the devices, which surgeons fasten to the bony struts, or "pedicles," that connect the front and back of the vertebrae along the spine.
That could be the story of any medical invention sold in this country. No device or operation is free of risk. But the pedicle screw's path from drawing board to operating room has implications even for people who have never felt a twinge of back pain. Behind this simple piece of hardware is a tangled regulatory history that both patients and manufacturers cite -- for opposite reasons -- as proof that the federal Food and Drug Administration needs to change the way it regulates medical devices and drugs.
For patients who say the device caused them injury, the pedicle screw is a case study of how companies can exploit loopholes in the rules that the FDA has made to protect the public from dangerous devices. For the manufacturers, however, it is a prime example of their contention that companies have to scale needless FDA roadblocks to bring promising new treatments to market.
The pedicle screw also has become a key prop in t he raging debate in Congress over the FDA. The Republican majority is pushing legislation, now in committee, that would speed up the FDA's approval process. Opponents of the legislation, including consumer advocacy groups, contend that the agency's safety net already has too many holes in it.
Fifteen years ago, the pedicle screw was merely an idea in the head of a Cleveland orthopedic surgeon named Arthur Steffee. Today, it is the foundation of a $100 million industry and a popular treatment that many spine surgeons regard as a true advance in orthopedic medicine. Last October, after years of opposition, the FDA recommended that the industry be allowed to market the screws for spinal surgery.
How the screws became so widely used, and whether the FDA intended that to happen, are matters of dispute. Twice in the mid-1980s, the FDA rejected applications from Steffee's company, AcroMed Corp., to market the device for spinal operations; the second time, the agency cited the risk that the screws could cause nerve damage and bone fractures.
The pedicle screw had not been proven safe or effective for spinal surgery, and it had not received formal FDA approval for use in the spine. But the company was able to make its pedicle screw device available anyway through what AcroMed's co-founder, Edward Wagner, once called a regulatory sleight-of-hand done with the FDA's blessing.
Instead of asking for permission to "label" the device for lower back surgery, AcroMed filed a new application in 1985 to sell the device for general bone surgery -- such as in arms and legs, where bone plates and bone screws already were being used. FDA gave the go-ahead.
Once the product was labeled for general use, physicians were free to try it for other surgeries. FDA permits such "off-label" uses -- indeed, it has become common to experiment with off-label drugs in treating cancer -- as long as companies and doctors don't advertise or promote the product for these unapproved purposes. FDA officials deny that AcroMed had the agency's approval to pursue this backdoor strategy.
Whether AcroMed and a half-dozen competitors violated the FDA's rules is an issue in the bitter legal battle being fought in federal and state courts. The patients' lawyers, who stand to make millions of dollars in contingency fees if they win, have a nine-member committee to manage the mounting number of cases being heard in courtrooms throughout the country.
As the federal courts have done in other large product liability cases, one judge has been assigned to supervise pretrial discovery. The lawsuits, which allege that pedicle screws are defective in design and pose unreasonable dangers to patients, are coordinated in Philadelphia under a single name: In Re: Orthopedic Bone Screw Products Liability Litigation.
The patients' lawyers, in pushing their lawsuits, have unleashed a broad attack on the manufacturers. They allege that the industry subverted FDA's rules by using physicians as a kind of sales force. According to the lawyers, the companies recruited doctors to serve as advisers and consultants, bought the loyalty of some physicians with financial incentives and sent them to teach their colleagues how to use the device in the spine.
The lawyers also allege that patients became human guinea pigs. They contend that companies and surgeons tried out their products on thousands of patients instead of testing them through rigorous clinical trials that involve a limited number of patients who give their informed consent.
The industry and the surgeons vigorously deny these charges. The companies say they are victims of a vague and ever-changing FDA process that provides them with little guidance on the difference between education and promotion. The surgeons say they have found the device to be a necessary and vital option, and that's the only reason they choose to use it.
"I think it's state of the art' for certain indications," said Neil Kahanovitz, an Arlington orthopedic surgeon. Kahanovitz, who said he has received no industry money for pedicle screw research, has implanted pedicle screws and plates in about 75 to 100 patients who had fractures, instability of their spines or tumors that required removal of bone. "When those indications present themselves in my office, I have no hesitation about doing that operation," he said.
But some doctors say the pedicle screw has been used too often for general lower back pain of unspecified origin -- a condition about which there has long been debate about whether surgery is effective.
The FDA, before making a final decision on pedicle screws, is required by law to seek public comment. On March 1, the committee of plaintiffs' attorneys weighed in with a 231-page response. They took this unusual step, the lawyers said, to forestall the FDA action, which they said manufacturers could exploit as support for their position that pedicle screws are safe for spinal surgery. "You fight the war on all fronts," said John Coale, one plaintiff lawyer.
Drawing on industry documents recently unsealed in Philadelphia, the attorneys accused the FDA of basing its recommendation on sloppy science, much of which they said came from doctors with financial ties to the industry. The devices came into widespread use "not because they were a good medical idea but because they were a good business idea," wrote attorneys John Cummings III of New Orleans and Arnold Levin of Philadelphia on behalf of the plaintiffs' committee.
In 19 volumes of supporting material filed with the FDA, the lawyers included an electronic mail message that they said shows the industry mentality. In the May 1994 message, a salesman at Synthes (U.S.A.), a Paoli, Pa., device maker, reported to his colleagues after observing a medical team as they implanted the device. "Well I did my first case the other day and the patient died on the table" for reasons unrelated to the screws, he wrote. "Second case went better, the patient lived."
The representative included a p.s. to another sales rep with a good track record for selling the devices: "It sounds to me like you're on a gravy train!' " Industry officials reject the notion that this message symbolizes anything other than one man's colorful language. AcroMed's Wagner said no medical company can survive by putting profits before patients' safety. "I didn't want to build an airplane that wasn't going to fly," he said. "You don't build a company making bad products." Getting to the Marketplace
Before the pedicle screw could turn the first penny of profit, it had to get to the marketplace. Steffee, an orthopedic surgeon with an entrepreneurial bent, formed AcroMed with Wagner in the early 1980s to sell a "spinal fixation" system Steffee had developed. The device acts as an internal splint, holding the vertebrae in place until the bones' own healing mechanism can bring about fusion. Surgeons consider Steffee's approach an improvement over existing spinal stabilization techniques that depended on hooks and wires.
In a mid-1980s demonstration video, Steffee described his trial-and-error development of the device. The early design, he says on the video, "proved to exhibit a number of imperfections." In some 160 early procedures, 21 screws broke, and he had to redesign the system, he said.
In 1984 and 1985, AcroMed twice asked the FDA to clear the device, saying the implant was substantially equivalent to bone plates and bone screws already in use. The FDA turned down both requests, saying the device was not equivalent. The agency's second rejection cited "potential risks," including nerve damage and fractures.
Steffee, who declined to be interviewed for this story, met with FDA officials on Dec. 12, 1985, and was "very aggravated," one agency official later wrote in a memo. Steffee "badgered the FDA staff at length demanding the right to immediately sell" the device, the memo said.
AcroMed and FDA officials do not agree on what happened next. During the meeting, AcroMed officials say, an FDA representative suggested the company change its vocabulary: AcroMed should apply again and should call the devices "bone plates" and "bone screws" and ask permission to use them for general bone surgery. A few weeks later, the company filed a third application using this approach.
The FDA says it never coached the company on how to bend the rules. Wagner, who retired in 1991, retorted in an interview: "They knew. They've known from day one. There was nothing secretive. We weren't meeting in tunnels in Chicago in the dark."
The contemporaneous record reflects some evidence for AcroMed's version. On Jan. 16, 1986, Wagner wrote to a surgeon on the company's advisory board that "we have acceded to FDA's position that we refer to the plates as bone plates' and the screws as bone screws,' a labeling slight-of-hand {sic} that satisfies the agency's regulations but in no way changes the intended use of the plates and screws." The FDA then gave the green light. Soon after, it also approved a separate AcroMed request to conduct clinical trials that would determine whether the device was safe and effective.
Now the company could distribute the device to a surgeon who wanted to employ it off-label -- in this case, in the spine. But the rules prohibit companies from promoting off-label uses, limiting them to presenting scientific papers and demonstrating the device.
The plaintiffs' lawyers have alleged, and some FDA officials believe, that the company crossed the line by turning education into a form of promotion. The lawyers assert that AcroMed formed an advisory panel of physicians, sponsored training sessions for hundreds of spine surgeons and offered videos, catalogues and brochures.
At least five other pedicle screw manufacturers adopted the same strategy, the lawyers allege. The industry developed financial ties with about 200 spine surgeons and these doctors provided services that ranged from consulting work to spreading the word about the pedicle device's utility, the lawyers allege. According to their FDA comment, surgeons made more than 1,000 appearances at some 230 professional meetings where pedicle screw devices were demonstrated.
All told, the lawyers allege, the industry paid out more than $29 million in cash and gave out stock or stock options. The firms also donated $5 million to medical institutions where these doctors worked, their FDA comment asserts.
In the early 1990s, the FDA warned the industry that its sales and training practices were a form of illegal promotion and told manufacturers they faced administrative sanctions if they did not stop, FDA documents show. The FDA investigated AcroMed and referred the case to the Justice Department for prosecution. But the case went nowhere; one internal FDA memo suggested a jury might decide that the agency had full knowledge of the company's tactics, and therefore shared any blame. AcroMed officials say the case was dropped because there was no merit to the allegation.
Former AcroMed executive Wagner said his company followed FDA rules -- at least so far as company officials could understand them -- and didn't improperly advertise or promote the device for spinal use. The FDA never drew a bright line for the company describing where training ended and promotion began, Wagner said. FDA officials seemed reluctant to give straight answers, according to Wagner. "Everybody ducked and bobbed and weaved and avoided," he said.
The surgeons also dispute that what they did could be called marketing and say their loyalty could not be bought. "I see what appears to me to be a very useful procedure, and then those doctors want to learn how to do that useful procedure. Is that promoting or is that science?" said Steven Garfin, a spine surgeon at the University of California at San Diego who has acted as a consultant for three pedicle screw companies. "I'm instructing; at least that's what I see my role as."
AcroMed and other companies say their consulting doctors always gave honest information to their colleagues. "They are out there talking about the risks and benefits," AcroMed lawyer Richard Werder said. "A number of the doctors AcroMed was associated with did nothing but talk about complications."
In their FDA comment, the plaintiffs' attorneys also criticize the industry's clinical trials, saying the data were flawed. The FDA also has questioned the data. In 1990, the agency withdrew its approval for one AcroMed study. AcroMed defended the study, saying it generated valid, useful information.
The plaintiffs' attorneys also attacked the body of scientific literature about pedicle screw devices, alleging conflicts of interest. Of 206 journal articles the FDA reviewed, about 90 were by authors with financial relationships to pedicle screw companies and fewer than a dozen disclosed those ties, the lawyers alleged.
In one case, AcroMed advised Marc Asher, a University of Kansas orthopedic surgeon, that he did not need to disclose his company ties in an article he had written for the Journal of Bone and Joint Surgery, even though he had been receiving royalties from AcroMed for his work in developing a pedicle device. The company told Asher that because his article dealt with a different AcroMed device, he could state on the medical journal's conflict of interest form that he had received "no benefits in any form" from "a commercial party related directly or indirectly to the subject of this article."
Asher decided to disclose his ties anyway. Werder, the AcroMed lawyer, said the company still believes Asher's disclosure was unnecessary.
Spine surgeon Garfin, who helped supervise an industry-sponsored study requested by the FDA, said the industry's support has not tainted the research. "That's where the money came from. I can't hide it," he said. "But they didn't influence anything. I'd like to think I'm above that." A Uniquely Valuable Device'
In early 1993, representatives of the American Academy of Orthopedic Surgeons met with FDA officials to discuss the growing use of the device -- and the increasing numbers of lawsuits and the much-criticized clinical trials. Some surgeons argued that the pedicle screw "is a uniquely valuable device for certain diagnoses, but probably not for the general usage it now enjoys," according to notes of the meeting included in the plaintiffs' FDA comment.
The FDA asked orthopedic professional societies to conduct a new study, funded by the industry, to gather data about past pedicle screw operations. In July 1994, an FDA advisory panel, citing that study and other evidence, voted unanimously to recommend that the pedicle screw be reclassified as a less risky device that did not require premarket studies. It said the devices had become the standard of care for certain spinal operations in the lower back and merited approval.
The plaintiffs' lawyers fault the FDA's reliance on the study, asserting that its methodology was weak and that it was overseen by doctors with conflicts of interest. The industry and the doctors contend the study was a thorough, untainted review based on the records of 314 surgeons in operating on some 3,500 patients.
FDA spokesman Jim O'Hara said the agency is reviewing the plaintiffs' allegations as it weighs a final decision. "Is this a case of bad science being sold to the agency?" O'Hara said. "A lot of charges are being made on both sides of this issue. The agency is committed to getting answers to all of the questions." USING BONE SCREWS IN THE SPINE
Bone plates and screws are cleared by the Food and Drug Administration for use in general bone surgery, such as in arms and legs. U.S. surgeons also have used them in about 300,000 operations for lower back problems, such as crushed vertebrae and spinal instability, to hold the vertebrae in place until they can fuse naturally. About 7,000 lawsuits have been filed by patients claiming injury. One spinal device is shown below: THE HARDWARE
Plates: 44 to 196 millimeters in length, with one to five slots. Curved "nests" allow flexibility in placing the screws.
Screws and nuts: Screws generally are 70 mm in length with a nut already attached. A second nut, added at the end of the procedure, secures the plate. THE SURGERY 1. Screws typically are inserted into the pedicles, bony struts along the vertebrae. The attached nut helps anchor the screw and stabilize the plate. 2. Plate is bent to fit thecurvature of the spine and then fitted over the screws. Long openings allow more flexibility for screw placement. 3. Final nuts are screwed down to lock plate in place. CAPTION: AcroMed's Edward J. Wagner displays plexiglass vertebra with two pedicle screws in it. "You don't build a company making bad products," he said. CAPTION: A 1990 SKIING ACCIDENT crushed one of Glen Steinkopff's vertebrae and ruptured two disks. He's back on the slopes, left, with a framework of screws and rods attached to his spine. Some 300,000 patients have had such procedures, although the Food and Drug Administration twice rejected it for spinal use. CAPTION: AFTER A 1992 OPERATION, Gloria Perdue says the spinal implant loosened in its moorings, leaving her in unremitting pain and forcing her to wear a brace much of the time. She is one of 7,000 patients who have sued the device makers, alleging the device posed unreasonable dangers.