Docs, Medical Boards Ignored FDA Warning Letters on CCSVI

In 2012, James McGuckin Jr., MD, performed an unproven procedure for multiple sclerosis on Theresa Leipzig at his North Carolina medical facility.

It was not the first time McGuckin, who holds licenses in more than a dozen states, did the controversial procedure.

In one state alone, Washington, he performed it more than 200 times.

As McGuckin snaked a catheter from Leipzig’s leg to a kidney vein, he placed a stent that propped open a blood vessel. Then he placed another stent in the jugular vein in her neck, all with the intent of relieving her multiple sclerosis.

But such treatments had never been proven to work, had not been approved by the U.S. Food and Drug Administration and were already being debunked by the scientific community. Indeed, McGuckin was already under investigation for performing the procedure by regulators in the state of Washington.

It was the third time in a year Leipzig had been to McGuckin for venoplasty in vessels serving the brain.

This time, there were problems.

Less than two weeks after the procedure, a stent migrated to her heart, requiring emergency open-heart surgery.

“I almost died,” said Leipzig, 47. Looking back, she believes the condition left her vulnerable to persuasion.

“Then comes a shred of light: doctors performing a procedure that shows promise and hope,” she said. “No one would ever imagine the physician’s words would turn into a life-threatening medical nightmare.”

McGuckin is one of about 30 physicians, some with licenses in multiple states, who performed the unproven procedure — often requiring patients to pay as much as $10,000 up front. They say the procedure treats what is termed “chronic cerebrospinal venous insufficiency,” or CCSVI, a condition supposedly linked to MS.

Even after FDA warnings, physicians were able to continue practicing in many states with clean licenses, leaving patients in the dark about their troubled pasts, a Milwaukee Journal Sentinel/MedPage Today investigation found.

One California physician, Michael Arata, MD, acknowledges doing the procedure 2,000 times and has been the subject of three FDA letters alleging violations of federal regulations. But to date, no public action has been taken against his license by any state medical board.

The cases illustrate how an outdated regulatory morass allows troubled physicians to continue to work, with little disclosure. Often, malpractice histories are shielded from the public in online listings and ignored by state licensing boards.

In some cases, the Journal Sentinel/MedPage Today investigation found, it took years before any licensing action was taken. Some states have not acted at all.

One reason: A lack of communication between the FDA, which oversees medical research, and state medical boards, which regulate the practice of medicine.

The day after the stent was placed in Leipzig’s kidney vein in May 2012, the FDA issued a safety alert saying the procedure was linked to serious injuries and deaths.

It also said there was no reliable evidence of its effectiveness and that promotion of it may lead people with MS to make treatment decisions without being aware of the risks.

One potential mishap the FDA cited: stents migrating to places such as the heart.

“There is no scientific or medical legitimacy to it all,” said Steven Novella, MD, an assistant professor of neurology at Yale School of Medicine. “I think it is completely unethical to offer a treatment to a patient that is not valid and gives them false hope.”

The supposed underlying condition — CCSVI — was identified in 2009 by Italian vascular surgeon Paolo Zamboni, MD, but several studies conducted in the years since have found no proof that it causes multiple sclerosis or that the treatment works. Neurologists specializing in MS were initially cautious and then turned overtly skeptical when Zamboni’s findings proved impossible to replicate.

In a follow-up trial, Zamboni and colleagues found the technique was largely ineffective and should not be recommended for people with MS. It was published in November in the journal JAMA Neurology. […]

In 2012, the FDA issued a warning letter to Arata saying that he had failed to obtain FDA approval before allowing patients to take part in clinical research that used devices posing the potential for serious risk and ordered him to submit an application to the agency.

A firm representing Arata argued the FDA had no jurisdiction to review the studies. The agency rejected that contention, noting its role is to protect human research subjects from undue hazard.

That underscores the state-federal regulatory gap.

The FDA could intervene in the cases of Arata and McGuckin because they were calling their procedures research, over which the agency has jurisdiction. However, the procedure can be done without federal scrutiny if there is no research involved. It is viewed as akin to the “off-label” use of a drug, in that the stent devices were approved for use in arteries, not veins. At the same time, they are not permitted to claim effectiveness in marketing materials that the FDA hasn’t verified.

That loophole has existed for years, said Diana Zuckerman, who has done research on the FDA and its regulation of medical devices.

Even when the FDA does act by sending warning letters, often no action is taken, said Zuckerman, president of the National Center for Health Research.

“That’s par for the course with the FDA; they don’t enforce,” she said. […]

Read the original article here.