A type of chiropractic device mired by lawsuits and controversy is again under investigation in Florida.
This time, the FDA’s focus is Spinetronics, owned by Coral Springs chiropractor David Bass. FDA says Bass over-stated the treatment capabilities of a spine-stretching device he invented, the Antalgic-Trak.
Sarasota-based Axiom Worldwide and Melbourne-based Vax-D have also run into trouble in recent years for misrepresenting similar “spinal decompression” devices.
Although each company made something a little different, all the devices required patients to recline on a table as acomputer-controlled machinestretched the body in different ways.
Some chiropractors say the treatment is valid, but sales have led to lawsuits and accusations of fraud.
Medicare and major insurers, such as Blue Cross & Blue Shield of Florida, consider the treatment experimental and do not cover it.
In fact, BCBS-FL started a task force to investigate providers suspected of billing for spinal decompression under codes meant for other procedures. It's unclear whether Bass has been a focus of the task force because its records are not public, said BCBS-FL spokesman Mark Wright.
The FDA warning lettercites Bass’ failure to control the manufacturing quality of the machines, adhere to FDA advertising requirements or respond to customer complaints.
The letter, dated July 25, says that Bass did not adequately respond to “observations" sent by the agency months earlier regarding the company's manufacturing and marketing practices.
The agency accuses Spinetronics of failure to maintain proper design control procedures and to test the device's embedded software for medical risk. The letter also accuses Bass of marketing the device without FDA clearance and not notifying the agency that he would be distributing the product commercially.
Bass declined to discuss specifics, but said, “Our team is working to address and resolve (FDA concerns).”
The Florida Department of Health consumer information website says Bass has a clear and active license.
Though Spinetronics’ current website doesn't have any blatant FDA violations, says Dr. Stephen Barrett of Quackwatch.com, it still seems to test the agency's limits.
For example, a video on the site shows testimonials from patients with herniated disks, scoliosis and bladder cancer. The patients said Antalgic-Trak helped them restore full functioning.
“Today, ten months later, I don't have a pain in my body,” said the man with bladder cancer.
Yet, Spinetronics’ claims are mild compared to those of Sarasota-based Axiom Worldwide, which went under after advertising a similar product, the DRX 9000, as “NASA approved” and “The eighth wonder of the world.”
The company was being sued by several chiropractors, who said they were tricked into buying the hundred-thousand-dollar machine.
The Florida Attorney General's office filed suit against Axiom in 2009 and the case is still open, spokeswoman Jennifer Davis said.
Then-Attorney General Bill McCollum barred Axiom from continuing to market under false pretenses and asked Axiom to repay $100 million to chiropractors around the state.
Several chiropractors contacted by Health News Florida who bought the Axiom machines said they have not received any compensation.
The company's CEO, Jim Gibson of Tampa, could not be reached for comment.
Even though the reputation of spinal decompression devices has taken a beating, the devices are useful for some patients, said Dr. Ronald Wellikoff of Lauder Hill, chairman of the Florida Board of Chiropractic Medicine. He doesn't speak for the board, he said.
Similarly, Deland chiropractor Jeremy Gordon said he's seen the procedure relieve pain for hundreds of his patients.
One patient, 62-year-old truck company owner Allen Paquette, said he was in crippling pain from four bulging disks in his neck and had started losing feeling in his left arm. He began treatment with Gordon after reading a newspaper advertisement and "hasn't felt better in years" since his 24 sessions with Gordon's Axiom machine, he said.
His treatment, which ended two months ago, cost just under $4,000, he said.
"I horseback rode five hours this morning," he said. "It was worth every penny."
---Health News Florida is an independent online publication dedicated to public-service journalism. Reporter Brittany Alana Davis can be reached at 954-239-8968 or by e-mail.