OPERATING UNDER THE RADAR
Desperate MS patients turn to a risky and unproven procedure for relief, but the doctors who do it stay in practice
In 2012, James McGuckin Jr. performed a risky, 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.
But such treatments had never been proved to relieve multiple sclerosis, had not been approved by the U.S. Food and Drug Administration and were being challenged by the medical community.
McGuckin is one of about 30 doctors who performed the procedure — with some requiring patients to pay as much as $10,000 up front. They say the procedure treats “chronic cerebrospinal venous insufficiency,” or CCSVI, a condition supposedly linked to MS.
Even after FDA warnings, doctors doing that procedure have been allowed to continue practicing in many states with clean li-
censes, a Milwaukee Journal Sentinel/ MedPage Today investigation found
Leipzig had been to McGuckin to have veins opened two times earlier that year. But less than two weeks after the procedure, a stent dislodged and traveled to her heart, requiring emergency open-heart surgery.
“I almost died,” Leipzig said. Looking back, Leipzig, 47, believes her 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 doctor’s words would turn into a life-threatening medical nightmare.”
One California doctor, Michael Arata, acknowledges doing the procedure 2,000 times and has been the subject of three FDA letters alleging violations of federal regulations. But no public action has been taken against his license by medical boards in any of the three states where he is licensed to practice.
The cases illustrate how an outdated regulatory morass allows problem doctors to continue to work without public disclosure of violations, putting patients at risk.
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. One potential risk the FDA cited: stents migrating through the body to places such as the heart.
“There is no scientific or medical legitimacy to it all,” said Steven Novella, 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 doctor Paolo Zamboni. But several studies in the years since have found no proof that it causes multiple sclerosis or that the treatment works.
Leipzig, who lived in South Carolina at the time, had gone to McGuckin to have the procedure at his clinic in Durham, N.C. She now lives in Burlington, Wis. She has been battling MS since she was diagnosed in 2008. A former salon manager, she has been unable to work since 2010 and now walks with a cane.
She said she felt more clearheaded after the procedures, though that only lasted a couple of weeks. In retrospect, she said, that feeling may have been because of how badly she wanted the procedure to be successful.
She sued McGuckin in 2015, and the case was resolved confidentially in 2017.
McGuckin is listed as CEO of Vascular Access Centers, which has facilities in eight states. He did not respond to emails, telephone calls or a registered letter.
But in a document filed in 2016 in connection with the Washington case, McGuckin noted an earlier study had suggested the procedure held promise for MS patients. He said he had relied on another doctor who ran the study to get FDA approval but acknowledged it was his responsibility to make sure that had been done.
McGuckin wrote that he acted with a desire to help patients. “I continue to live and practice under the daunting auspices of the Hippocratic Oath, which means more to me today than the day I swore it,” he wrote. “I am proud to be a physician treating patients daily while at the same time training students and fellow endovascular physicians.”
Arata, the California doctor, has claimed the procedure improves energy levels and cognitive ability and that improvements lasted as long as three years.
In a video on the Synergy Health Concepts website, Arata recalled a woman who could not move her legs or arms, could not speak and had difficulty eating. He said he walked into the recovery room 15 minutes after the procedure and the woman was holding a sandwich in one hand and talking to her family on the phone with the other.
Frank Lamb of Calgary said his wife, Maralyn Clarke, bought into the promise after seeing posters advertising a presentation by Arata to be held at a hotel convention hall in Canada.
Clarke, an X-ray technician, was diagnosed with MS in the 1980s. She had been unable to walk at times and wanted to stop the disease from progressing.
She and Lamb went to the meeting. The hall was packed.
“A dog and pony show is what it is,” Lamb said. “Give us your $12,000 and everybody will live happily ever after.”
Arata made it sound so positive, Lamb recalled, despite the cost and the fact the treatment would require surgery. MS is typically treated with medication. After much thought, Clarke decided to go ahead with the procedure and flew to Los Angeles.
At 11 a.m. on April 13, 2011, she went into the operating room. By 1 p.m., she was in a coma.
She never woke up.
Arata showed up a few times while Clarke was comatose, Lamb said. Eventually, Lamb took his wife off life support.
‘ “We’ll look after you. We’ll take care of you,’ ” Lamb remembers Arata saying. “They gave us nothing, not even a refund.”
In 2012, the FDA issued a warning letter to Arata saying 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 that the FDA had no jurisdiction to review the studies. The agency rejected that contention, noting its role is to protect research subjects from undue hazard.
That underscores the state-federal regulatory gap. The FDA could intervene in the cases of Arata and McGuckin because it had not approved their research. But doctors are able to perform the procedure 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 devices were approved for use in arteries, not veins.
In 2016, another FDA letter said Arata had repeatedly and deliberately violated regulations governing clinical studies, including failing to get approval for research involving people. The agency threatened to disqualify Arata from doing clinical research.
A follow-up letter in 2017 threatened to withdraw his eligibility as a clinical researcher to receive investigational products, such as drugs and devices that might be used in clinical trials.
In March 2017, the FDA issued a broader warning against one of the procedures, specifically citing Arata as one of its practitioners. In an email, the FDA would not comment on what, if anything, it has done since 2017.
Despite the FDA warnings, California has not taken any public action against Arata. A staff person at Arata’s medical office in California — Arata Medical — said the doctor would not comment.
In 2015, the state of Washington found McGuckin had performed the procedure on 233 patients in the state from 2010 to 2013. He was ordered to stop and repay patients who had used their own money. McGuckin remains licensed to practice in more than a dozen states, including New Jersey, New York, Indiana, Maine, Tennessee, Texas, Florida, Georgia, Louisiana, North Carolina, California, Maryland, Virginia and Pennsylvania.
John Fauber is a reporter for the Milwaukee Journal Sentinel. Kristina Fiore and Matt Wynn are reporters with MedPage Today.
This story was reported as a joint project of the Journal Sentinel and MedPage Today, which provides a clinical perspective for physicians on breaking medical news at medpagetoday.com.