Friday, September 7, 2012

A Clash Over Vertos Medical’s Promising Procedure -

Dr. Daryl F. Fourney's role as a lead researcher in a clinical trial for a device to treat back pain began normally enough.

Under his agreement with the device maker, the neurosurgeon was supposed to report on how patients had fared six months after undergoing the treatment, which involves removing tissue that is compressing the spine.

The trial started well and by the six-month mark, most patients had improved. But then he began hearing from some patients who, beyond six months, were experiencing pain again — so severely, in fact, that they had to undergo the type of back surgery they had hoped to avoid.

That's where Dr. Fourney's experience stopped being routine. What happened next provides a glimpse into the sometimes contentious world of medical testing and the federal rules that allow device makers to market new products with little or no data about their long-term effectiveness or safety.

Unlike prescription drugs, many medical devices are cleared for sale by the Food and Drug Administration without extensive studies in patients. In recent years, some of those devices, which seemed effective at first, have gone on to fail catastrophically.

Last year, when Dr. Fourney told the device maker, Vertos Medical, that his report would describe the problems that patients experienced after the six-month trial, the company filed a complaint with the University of Saskatchewan, where he is a professor. In that complaint, Vertos accused Dr. Fourney of scientific misconduct and violating "research ethics" by failing, among other things, to follow the study's original protocol and by independently deciding to follow his patients for added time without seeking agreement from Vertos.

Vertos and its medical allies have kept up the pressure, contending that Dr. Fourney's report, which was recently published in the medical journal Neurosurgery, is flawed. For his part, Dr. Fourney said he had a duty to report what he had found.

"I don't blame industry for wanting to promote a product," said Dr. Fourney, who has worked on other studies. "But we have an obligation to our patients."

Vertos says that more than 10,000 patients nationwide have undergone its procedure and insist it is safe and effective. It is one of several treatments for lumbar spinal stenosis — a common condition of aging that can make standing or walking painful.

In what is considered a minimally invasive procedure, a small opening is made in the back and a special device is then used to scrape away spinal tissue that has thickened, reducing pain and increasing mobility.

Vertos says the treatment, which it markets under the brand name Mild, is intended for patients who do not yet need back surgery. Often cortisone shots are used to control pain in such patients, but Vertos says that its treatment, which costs about $5,000, is better and longer-lasting than shots, which have to be frequently repeated.

The company's chief executive, James M. Corbett, also called Dr. Fourney's findings an outlier, adding that other studies had positive results. "We have good evidence that these patients can have extended relief of their symptoms," he said.

As with many newer products and procedures, there is limited data to judge such claims. A Vertos consultant, Dr. Bohdan W. Chopko, said he expected to publish a report soon showing good results in 45 patients he has followed for two years.

In 2010, Dr. Chopko published a positive, short-term report on some 75 patients who had undergone the Vertos procedure. But he said that apart from the 45 patients mentioned in the coming report, he did not know what happened to the 30 other patients from his 2010 study, adding that it was not unusual for patients no longer to be followed because researchers lost contact with them or because they did not respond to subsequent inquiries.

One spine expert, Dr. Eugene J. Carragee, said it was not surprising to see device producers like Vertos laud studies that supported their product and denounce ones that did not. But the intensity of the complaints by Vertos about Dr. Fourney reminded him, he said, of a time not that long ago when a manufacturer could prevent a study with negative results from being published.

"Either this company has a poor or odd understanding of what the ethical responsibilities of a researcher are or this was a naked attempt at intimidation," said Dr. Carragee, who is a professor at Stanford.

Dr. Fourney said he became involved with Vertos in 2008 because he knew one of the developers of the company's procedure and believed it held promise. And initially, the 10 patients he treated experienced relief.

But some patients contacted Dr. Fourney after their time in the study was over to complain of returning pain. Since he was also the doctor who regularly treated those patients for back pain, he kept tracking them, he said.

By 2010, he had performed traditional back surgery on six of those 10 patients to relieve their pain, a failure rate that he deemed "unacceptably high."

"This raised a red flag," he said.

By then, he had also stopped enrolling patients in his study. Last year, after he sent a draft copy of his report to Vertos, the fireworks started. Mr. Corbett, the company's chief executive, told the surgeon in a letter that his findings were a "gross misrepresentation of the facts." Vertos also filed a formal complaint of misconduct against him with the University of Saskatchewan.

The company argued, among other things, that Dr. Fourney had violated his agreement by expanding the study's term. It also argued that the patients he chose for the study were ill-suited since they were already surgery candidates. The surgeon said that Vertos had initially promoted its procedure to doctors as an alternative to surgery and added that the study's protocol did not bar patients who were surgery candidates.

In an interview, Mr. Corbett said the company was not trying to suppress Dr. Fourney's study but was only interested in making it accurate. "Fundamentally, we had a disagreement about the science, and we attempted" to resolve it, Mr. Corbett said.

In a letter to Neurosurgery, Dr. Chopko, the Vertos consultant, said Dr. Fourney's study was undercut by several methodology flaws.

In response, Dr. Fourney noted that Dr. Chopko's positive 2010 report failed to disclose his financial ties to Vertos; Dr. Chopko, who is Vertos's director of physician education, described the omission as a "clerical error" and said it would be rectified.

The company is currently running a 100-patient trial comparing the effectiveness of its procedure to the effectiveness of cortisone shots.

Dr. Carragee said that what he found most striking about the episode was how Vertos and its allies were attacking Dr. Fourney about the quality of his research when the research being used to promote the company's procedure was also limited and of questionable value.

"The thing that gets me about this is the double standard," said Dr. Carragee, who is also the editor of a medical journal, The Spine Journal. "The positive findings are pushed far beyond their scientific merit and the limitations of it are being ignored."