Despite FDA warnings, state boards lag in taking action on controversial MS treatment
By John Fauber of the Milwaukee Journal Sentinel and Kristina Fiore and Matt Wynn of MedPage Today. March 28, 2018.
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.
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 being challenged by the medical community. What’s more, McGuckin knew he was under investigation for performing the procedure by regulators in the state of Washington.
At the time, interest in the purported treatment was fueled by social media, with hundreds of testimonial videos posted by patients on YouTube and shared within the MS community. In some cases, doctors did their recruiting seminar-style in hotel ballrooms.
Multiple sclerosis, which has no cure, affects an estimated 400,000 people in the U.S. Symptoms can include trouble walking, loss of balance, vision problems, fatigue and tremors, all of which generally worsen over time. The disease leaves some patients desperate for hope.
Yet experts say there is little reason to expect the vein-opening procedure would work. After all, multiple sclerosis is considered an autoimmune and neurodegenerative disease, not one caused by a lack of blood flow through veins.
It was the third time in a year Leipzig had been to McGuckin to have veins opened. This time, there were problems.
Less than two weeks after the procedure, a stent dislodged and traveled to her heart, requiring emergency open-heart surgery.
“I almost died,” said Leipzig, 47. Looking back, she 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.”
McGuckin is one of about 30 doctors who performed the unproven procedure — with some 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, doctors have been allowed 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 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 troubled doctors to continue to work, putting patients at risk. Often, malpractice histories are shielded from the public in online listings and ignored by state licensing boards. Some doctors continue to collect money from Medicare even after being cited by the FDA.
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 of 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 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 treatment to a patient that is not valid and gives them false hope.”
Technique found ineffective
The supposed underlying condition — CCSVI — was identified in 2009 by Italian doctor Paolo Zamboni. But several studies conducted in the years since have found no proof that it causes multiple sclerosis or that the treatment works.
Even Zamboni has changed his view.
In a follow-up trial, he 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.
From the beginning, doctors did angioplasty to treat the condition, propping open veins with devices designed for arteries. In some cases, they implanted stents. Over time, variations developed, going by names such as “liberation therapy” and “transvascular autonomic modulation (TVAM).”
Leipzig, who lived in South Carolina at the time, had gone to McGuckin to have the procedure done at his clinic in Durham, N.C. She now lives in Burlington.
She has been battling MS since she was diagnosed in 2008, three years before the first procedure performed on her by McGuckin. A former salon manager, she has been unable to work since 2010 and now walks with a cane.
She said she felt more clear-headed after the procedures, though that only lasted a couple 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 on a confidential basis in 2017. The lawsuit noted another stent — one placed in her right jugular vein in an earlier procedure — also had moved.
That stent is at risk of moving to another location, such as her heart, but surgeons say it would pose a greater risk if they tried to remove it.
In 2012, the same year Leipzig had the procedure done a third time, Karen Crowson, 62, who has had MS since about age 20, underwent the procedure twice at McGuckin’s clinic in Washington state, paying him a total of $17,000.
Crowson, who lives in Hawaii, said the procedure did not help her.
“It’s MS, I never expect miracles,” she said in an interview. “You try things and take your gambles.”
In 2016, she got a refund after an investigation of McGuckin by the state of Washington medical commission. The commission ordered him to repay patients who had to put up their own money for procedures performed after May 10, 2012. Those whose procedures paid by private insurance companies or Medicare were not included in the order.
Washington fined him and ordered him to stop performing the procedure.
The commision said he had performed the procedures as part of a study without ensuring that the research had received FDA approval. In its order, the commission cited McGuckin’s “substandard practices,” but noted in the cases it reviewed there was no evidence the procedures had caused serious injuries.
McGuckin is listed as the 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 and had encouraged more scientific study. 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 he acted with a sincere 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.”
First performed in 2009
Patients began having problems with the procedure from the beginning.
Michael Dake, a doctor at Stanford University, was among the first in the country to perform it. Dake did the procedure roughly 40 times, according to an article in the Stanford Daily, a campus newspaper.
One of Dake’s patients died from a brain hemorrhage, though Dake has questioned if the stents were the cause. Two others claimed life-altering conditions, from sleeping problems to chronic pain to a blocked stent one patient feared could migrate to his heart.
After the complications, and after meeting with the Stanford medical dean and Stanford lawyers, Dake wrote in an email to his colleagues that “after deep soul searching” he had decided to stop performing the procedure.
He did not respond to multiple efforts to reach him.
In the years that followed, the procedure grew in popularity. Between 2009 and 2011, some 1,800 videos about it were posted on YouTube, according to one study examining the phenomenon.
In one video, a patient said: “I was resigned to the fact that I would spend the rest of my life fighting this awful disease. These last few days have been a liberation.” In other videos, patients claimed dramatic results: increased strength, regaining the use of limbs, decreased swelling and more.
A follow-up study found the number of new videos dropped dramatically after 2011 and the testimonials became more tepid — a result, researchers believed, of declining interest due to increasing evidence the procedure had no effect.
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 great 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.
“I was overwhelmed,” he said. “I actually started crying myself. … It was just amazing to see this young woman whose life literally was taken away by this disease be a normal woman again.”
‘A dog and pony show’
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 was eager 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 recalled. “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 drugs. 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 decided to take his wife off life support.
“We’ll look after you, we’ll take care of you,” Lamb remembers Arata saying. “Yeah, bullshit. 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 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 it had not approved their research. However, 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 stent devices were approved for use in arteries, not veins.
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 to doctors, 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.
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.
“As this is an ongoing enforcement matter, we are not able to provide any updates at this time,” said spokeswoman Stephanie Caccomo.
Despite the FDA warnings, California has not taken any public action against Arata. In fact, Arata’s California license indicates that no actions have been taken against him by anyone — including the federal government. His license in Michigan also does not list the FDA action. Nor does his license in New York.
California disciplined McGuckin, citing his unapproved research involving the same procedure. State regulators wouldn’t confirm or deny whether they were investigating Arata. A spokeswoman said the medical board reviews any information it receives from any source.
Meanwhile, a spokesman for the Michigan Department of Licensing and Regulatory Affairs noted that Arata’s license in California is clear, but said the state could take action if California does.
Under federal law, doctors can be excluded from the Medicare program if they provide unnecessary or substandard services to Medicare or Medicaid patients.
Yet, Arata collected more than $1.2 million in Medicare money in the first three years after the first FDA warning against him, according to a Journal Sentinel/MedPage Today analysis of federal data. It was not known how much, if any, of that involved using vein-opening procedures to treat multiple sclerosis or CCSVI.
A staff person at Arata’s medical office in California — Arata Medical — said the doctor would not comment for the story.
Doctor ordered to repay patients
In 2015, the state of Washington found McGuckin had performed the procedure on 233 patients in the state between 2010 and 2013. He was ordered to stop and repay patients who had used their own money.
The Journal Sentinel and MedPage Today obtained hundreds of pages of records from the state of Washington investigation, which took the unusual step of having outside doctors review the medical records of seven McGuckin patients.
In an email to state investigators, neurologist James Bowen, medical director of the Multiple Sclerosis Center at the Swedish Neuroscience Institute in Seattle, wrote:
“In the MS neurology world, I do not know of a single MS specialist that believes that CCSVI exists. We get these unusual treatments springing up in MS every few years, but this is the 1st one being driven by social media.”
Bowen also raised concerns to investigators about possible insurance fraud, writing that many places around the country were charging $10,000 to treat MS. He said they may have billed the procedure as one for vascular disease, not as a treatment for MS.
“In other words, lying about the diagnosis in order to get a $10,000 procedure paid for,” he wrote.
Washington found McGuckin engaged in unprofessional conduct. It said and that by performing an experimental procedure — one that created an unreasonable risk of harm — he failed to meet the basic standard of patient care.
McGuckin agreed to the order, which included a fine of $17,500.
Florida, Illinois, North Carolina, Pennsylvania and California were among states that used Washington’s action to bar McGuckin from performing the procedure. But two other states did not act until after the Journal Sentinel and MedPage Today began asking questions about the case.
Georgia ordered McGuckin to stop in December — two years after the action by Washington state. New Jersey issued a similar order in September.
In 2013, four years earlier, the FDA had sent a letter to McGuckin’s office in Trenton, N.J., accusing him of conducting an unapproved clinical study involving the procedure and citing other violations.
Among the violations was his failure to report serious complications experienced by three people who had been in the unauthorized study.
But there is little communication between the FDA and state medical boards.
The medical board in New Jersey has no record of ever receiving the FDA order, said spokeswoman Lisa Coryell. Washington state officials uncovered the letter only after asking McGuckin to supply all communications with the FDA.
Ethics course required
As part of his Washington punishment, McGuckin was required to take an ethics course and write an essay reflecting on his behavior.
In his first attempt, in March 2016, he suggested Washington’s Medical Quality Assurance Commission needed better oversight.
The essay was rejected. An evaluator said it “does not demonstrate a capacity to think ethically about why he is being held to account.”
McGuckin failed the course.
In July 2016, he took it again. In that essay, McGuckin wrote that the investigation had a profound impact on him, including having to temporarily resign as medical director at more than 15 clinics, incurring legal costs to defend himself in 20 states where he had licenses, losing admitting privileges at three hospitals and the loss of insurance affiliation that cost him millions in uncollected revenues.
“More than anything it cost me my innocence and trust,” he wrote.
That essay, too, was deemed to suffer from “persistent justification and defense” of his conduct.
Rather than take the class again, the company handling his ethics courses set up one-on-one tutoring sessions for McGuckin.
In December 2016, more than a year after his punishment was handed down, he turned in a third essay. While they still had reservations, evaluators were more understanding.
“Dr. McGuckin demonstrated in his tutorial sessions that he has developed a capacity to consider his actions from an ethical perspective and an ability to think more deeply about why the Commission should care about one of its licensees who behaved as he did,” an evaluator wrote in her final report to the Washington health department.
“However, the carelessness — both in the manner in which the essay was written and as a prevalent feature in the conduct for which he is being held to account — may be an area for additional investigation.”
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.