Dubious Alternative Lyme Treatments Are Killing Patients

(Bloomberg Businessweek) -- Dejay Cartwright had visited more than 400 lighthouses, and she was setting out to see another. She was an aficionado, so drawn to the charm of these quaint relics that she’d joined the Lighthouse Preservation Society. The home she shared with her adult daughter, Tiffany Cartwright, in Townsend, Del., was teeming with miniature replicas.

She’d invited Tiffany to join her that summer evening in 2015. The trail was longer than anticipated, though, and Cartwright’s walker kept catching in the path. After about a half-hour, she was too tired to continue, and they headed home.

Even so, Tiffany was delighted. It was the first time in years her 62-year-old mother had felt well enough for a substantial walk. Cartwright had been diagnosed with Lyme disease in 2003, and she’d suffered persistent symptoms ever since: coughing, runny nose, joint aches, poor sleep, low energy. She’d been forced to retire from running the family’s child-care business and now spent much of her time playing games online. Over the years she’d tried all sorts of treatments. Nothing helped. But she’d recently started seeing a new specialist, Henry Childers IV, in Georgetown, a 90-minute drive to the south, and felt encouraged. Childers had strawberry-blond hair, a strong jaw, and an authoritative manner, and he came recommended by Cartwright’s primary-care doctor.

Childers was licensed to practice medicine in Delaware, but he largely eschewed traditional treatments. During an initial consultation in July, he proposed starting Cartwright on a nine-week program. Four times a week she would drive to his private clinic, Delaware Integrative Medicine LLC, for infusion procedures, typically involving the mixture of ozone gas or vitamins with her blood. Cartwright called her mother, Dee, from Childers’s office, sounding optimistic. The cost would be around $9,700, all out-of-pocket. Dee volunteered her credit card number so Cartwright could start that same day.

Not long into the treatments, to prevent the frequent venous draws from becoming uncomfortable, Childers sent Cartwright to Christiana Hospital in Newark, Del., to have a port surgically inserted in her chest. This would allow the infusions to be done via a central line, as is done for chemotherapy. After a couple of weeks, Cartwright was feeling hale enough to scout for lighthouses.

On Thursday, Sept. 24, Childers sent her back to the hospital to have the port replaced because it had become clogged. Over the next several days, the skin surrounding the new port became inflamed and hot to the touch. When Cartwright returned to Childers’s practice on Monday, according to assertions contained in court filings, she reported flulike symptoms. Clinic staff carried on with her treatment, and again the following day. (Childers says there was no inflammation at the clinic, calling the site “unremarkable.”)

The next morning, Cartwright collapsed in her bathroom. She recovered and continued going in for her next infusions, during which clinic records indicate she had an elevated, irregular heartbeat. On Oct. 1, Cartwright said she was in pain, so the clinic sent a blood sample to a lab.

The following morning, Tiffany found Cartwright lying on her kitchen floor. As Tiffany went to help, Cartwright lost consciousness. Tiffany called an ambulance to bring Cartwright to the emergency room at Christiana Hospital. Physicians there removed the port, which was infected, and began treating Cartwright with antibiotics, transferring her to intensive care.

When the bloodwork came back, it showed that Cartwright had MRSA, an aggressive staph infection resistant to many antibiotics. It had spread throughout her bloodstream and was too advanced for effective treatment. (The sample taken by Childers’s clinic later confirmed the diagnosis.) She spent the weekend on life support, drifting in and out of consciousness, surrounded by family. On Monday, Oct. 5, Tiffany and Dee instructed doctors to discontinue life support, in keeping with Cartwright’s wishes. She died within minutes.

That Cartwright’s original symptoms were commonplace had made their cause difficult to pinpoint. The affliction she thought they traced to, Lyme disease, is most often caused in North America by bacteria from the species Borrelia burgdorferi, typically transmitted via bites from infected ticks. Roughly 30,000 cases are reported each year to the U.S. Centers for Disease Control and Prevention, though the agency estimates that the true prevalence is closer to 300,000 cases. Symptoms include fever, headache, fatigue, and a bull’s-eye-shaped rash; left untreated, the infection can spread to joints, the heart, and the nervous system. The recommended remedy is a course of antibiotics lasting two to four weeks. If treated right away, most patients make a quick and full recovery.

In some cases, though, Lyme patients continue reporting symptoms for months or even years after treatment. The CDC recognizes these cases, describing them collectively as post-treatment Lyme disease syndrome, but says there are no proven treatments for them and they’re not likely the result of an active infection. Some patient communities have adopted the term “chronic Lyme disease” to describe their symptoms. Many say their concerns often aren’t taken seriously by traditional doctors, which has created an opportunity for hundreds of alternative practitioners—some licensed medical doctors such as Childers, some not—who call themselves “Lyme-literate medical doctors,” or LLMDs.

These practitioners have proliferated in recent years, with officials and industry watchers estimating their ranks at more than 500. Many of them join the International Lyme and Associated Diseases Society (ILADS), an advocacy organization that offers conferences and training programs. They tend to rely on nonstandard diagnostic criteria and scientifically unproven treatments, including ozone therapy, long-term antibiotics, and vitamin supplements. Insurers rarely cover these treatments, and doctors typically require payment upfront. Nevertheless, the treatments are compelling to many patients, in part because the practitioners offering them tap into a strain of American culture that will be familiar to anyone paying attention during the coronavirus pandemic: surging skepticism of scientific expertise and regulation. They also trade on the notion that wellness can be purchased.

The results include a pattern of harm. Patients, family members, physicians, and government officials describe LLMDs routinely misdiagnosing Lyme disease instead of other, treatable conditions and injuring patients. Many of these stories have effectively been buried—quashed by confidentiality agreements struck during litigation, papered over by bureaucratic procedure, stuck in limbo between agencies, or redacted as they pass through layers of compliance. But internal government documents obtained by Bloomberg Businessweek through a Freedom of Information Act request show that physicians at the CDC are aware of malpractice allegations at a constellation of private clinics. Since around 2013 they’ve tracked dozens of reports of significant harm, including several deaths, that were the direct consequence of procedures ordered or administered by LLMDs. And yet, even those who’ve been reprimanded have tended to face few professional repercussions. Often, they’ve continued to practice.

In 2017 the CDC published a collection of anonymized reports about practitioners whose Lyme treatments had led to a patient’s hospitalization. The cases followed a pattern: A patient received a Lyme diagnosis, sometimes without evidence, from an alternative doctor who recommended unproven IV treatments via a central-line catheter. The catheter then became a site of life-threatening infection. Long-term use of these devices, which include chest ports and peripherally inserted central catheters (PICCs), requires ongoing care by trained professionals. Even then, problems can occur.

Dr. Christina Nelson, a medical epidemiologist at the CDC Division of Vector-Borne Diseases and an author of the publication, says it was intended to raise awareness in the absence of a robust surveillance system for alternative Lyme treatments. “A lot of these patients have had symptoms for years, and they’re desperate for answers,” she says. But with alternative therapies delivered through indwelling lines or ports, “the risk-benefit balance is completely skewed to the risk side. And there’s no proof that there’s benefit.” After receiving multiple reports of complications related to such treatments and to misdiagnoses, Nelson says, she became concerned. Her alarm grew as she researched the practitioners and turned up scathing reviews on public sites such as Yelp.

Among the reviews she found was one from a patient in San Diego who described being diagnosed with Lyme and high levels of toxic heavy metals. Following treatments with chemicals the doctor said would remove heavy metals, the patient began to experience severe pain, for which the doctor prescribed fentanyl patches and at-home blood-thinning injections. The pain persisted, landing her in an emergency room, where she learned that the real issue was leaking silicone implants. The alternative doctor, she wrote, “acted in a way that was both dangerous, and reckless in his treatment. I feel very fortunate that I survived.”

Most prospective patients researching alternative treatments or doctors online will swiftly land on a clinic homepage. Childers’s website features video clips of people who say they improved under his care. In one, a patient wearing an olive-green T-shirt and seated in front of a ship replica introduces herself as a 26-year-old with Lyme disease undergoing ozone therapy and other infusions through a chest port. She describes symptoms such as brain fog, joint pain, and inflammation. Since beginning treatment with Childers, she says, she’s had more energy. “I’m definitely able to not have those days of feeling bedridden.”

Nelson had heard that beyond the testimonials were negative experiences with various doctors that might have been obscured by patient privacy concerns or legal settlements. She started compiling records of misdiagnoses and adverse events, first drawing from reports to the CDC and online reviews, then by writing to infectious-disease physicians in search of case reports. Dozens rolled in: patients who’d experienced complications from treatment with intravenous garlic or with intravenous silver compounds. One who’d been diagnosed in Connecticut with Lyme but in fact had leukemia. A 37-year-old woman in Maryland who developed sepsis and died after being fitted with a PICC line to receive antibiotics.

Time and again, Nelson found that practitioners had previously been reprimanded for malpractice. Time and again, they’d been allowed to go on treating patients, resulting in casualties that might have been prevented. “We continue to hear of concerning situations that patients are put in and concerning treatments that they’re undergoing,” she says.

In the early 2010s, Marvin “Rick” Sponaugle was running an opiate-detox practice in Florida when his teenage daughter was diagnosed with Lyme disease. In an online account published around 2016 and since removed from his website, Sponaugle, an anesthesiologist by training, detailed how—counter to the guidance of the American Medical Association, which discourages physicians from treating immediate family members—he’d taken over his daughter’s care from a Florida LLMD whose antibiotic regimen was making her “sickly.” Because he lacked experience treating tick-borne diseases, he read up on naturopathic medicine.

Eventually, he and his wife “designed an Integrative Treatment for Lyme Disease,” he wrote. “The initial version saved Alexa’s life.” He began to market himself as a Lyme disease expert and to advertise his private clinic as the Sponaugle Wellness Institute, a destination for pricey, unconventional treatments for Lyme and chronic illnesses.

Previously, Sponaugle had trained at West Virginia University School of Medicine, completed residencies at the University of Florida, and served as chief of anesthesiology at Helen Ellis Memorial Hospital outside Tampa from 1986 to 2005, practicing there until 2010. He’d also worked as an addiction-recovery specialist starting around 1998 and in 2001 opened Florida Detox Inc., a clinic offering an unproven treatment called anesthesia-assisted rapid opiate detoxification.

Outcomes were uneven. Insurance records show that in 2004, a detox patient in Sponaugle’s care allegedly experienced inflamed blood vessels after being given Adderall unnecessarily, leading his insurer’s risk-management division to say it had counseled Sponaugle on safety. The same year, according to court filings, a patient suffered a permanent brain injury following detox treatment with Sponaugle; the doctor won the resulting malpractice lawsuit. In 2006 a patient sustained nerve damage during a detox infusion with Sponaugle at Helen Ellis, leading to a malpractice lawsuit and a subsequent $95,000 settlement payment. (Sponaugle didn’t respond to an emailed request for comment on these cases.) In 2013, Sponaugle sued a dissatisfied detox patient for defamation and won.

The same year, the CDC published guidance warning that anesthesia-assisted detox treatments could have adverse effects. Sponaugle had by then left Helen Ellis, pivoting to focus on alternative treatments for Lyme and for ailments posited, without scientific proof, to be related to mold and chemical toxicity. His star rose: Reality-TV personality Yolanda Hadid shelled out $30,000 to be treated by him, and he spoke at an ILADS conference in 2016.

Sponaugle offered hope to families such as the Burgesses. Growing up in Jena, La., Anna Burgess listened to classic rock, wrote poetry, and fashioned dream catchers by hand. Over time, though, fatigue, aches, and other symptoms damped her bubbly nature. Her struggles made attending high school difficult and her ambition of becoming a physician seem unattainable. After a Mayo Clinic doctor diagnosed Burgess with POTS, an autonomic nervous system disorder, she and her parents, Gawan and Sherrie, a former school administrator and a nurse, respectively, found Sponaugle online.

When they visited his clinic in Oldsmar, Fla., in the fall of 2016, he told Burgess she suffered from a variety of conditions, including Lyme (for which she’d previously tested negative) and toxicity caused by mold and chemicals. He recommended she enroll in his 12-week treatment program. Clinic staff fitted her for a catheter so they could administer antibiotics and other compounds through her arm. In the following weeks, she developed severe new symptoms, including stomach pain, a burning sensation in her head, and tremors. She started coughing up dark fluid. “The tremors and head pressure are returning,” she wrote on Facebook on Nov. 25. “Unsure what the next course of action is.”

Sponaugle continued to increase Burgess’s antibiotics dosage and prescribed sedatives, explaining that she was experiencing a “biofilm burst” as toxins left her body. Each visit to her bedside cost her family $1,000, on top of a sum in the low six figures for the treatments and affiliated accommodations. To defray the costs, Sherrie started a crowdfunding campaign.

In court filings, Burgess’s parents say her condition continued to worsen until, in the early morning hours of Nov. 29, emergency medical services transported her to a local hospital, where diagnostic tests indicated she was suffering from pancreatitis. Sponaugle arrived with a nurse. Lacking privileges to practice at the hospital, he instructed the nurse to rotate the security cameras so they wouldn’t capture him administering eight vials of the antioxidant compound glutathione to Burgess’s IV drip, according to allegations made by Burgess’s parents in court filings. She died in the hospital the following day, her 19th birthday, with her fiancé, Ben Ketchens, still en route to her bedside. “I just felt like my whole body was tearing up,” he says. “It was gut-wrenching.” Gawan and Sherrie sued over Burgess’s death in 2017.

After court proceedings began, the Florida Department of Health issued a public complaint against Sponaugle for malpractice in a different Lyme-related case involving a 27-year-old man treated in 2014. The complaint, signed by the state’s surgeon general in February 2018, requested that the state licensure board revoke, suspend, or restrict Sponaugle’s license or take other corrective action such as a fine. No action has been taken, though Sponaugle has requested a hearing on the matter, according to the health department. His license remains active, as does his practice. Sponaugle denies wrongdoing in this case and the Burgesses’ but declined to comment further for this story, citing ongoing litigation.

When regulators have tried to publicly intervene in cases involving alternative Lyme treatments, they’ve struggled to make their judgments stick. State boards can investigate complaints, issue warnings, and suspend or revoke professional licenses, but their decisions tend to be enforced only upon referral to state prosecutors. Some LLMDs continue to helm lucrative practices despite a record of sanctions.

In 2017, for example, Daniel Cameron, of Mount Kisco, was charged by the New York State Department of Health Office of Professional Medical Conduct with violations including gross incompetence, gross negligence, and failure to keep appropriate patient records. Cameron disputed the allegations but ultimately signed a consent order subjecting him to three years of probation. That year the board also charged Bernard Raxlen, who ran the clinic Lyme Resource Medical of New York, with a similar set of violations; he, too, signed a consent order submitting to three years of probation. Cameron continues to practice in New York, while last summer New Jersey granted Raxlen a license, and he now sees patients in Guttenberg.

One of the best-known Lyme-focused practitioners, Joseph Jemsek, who began his career in AIDS research, was able to set up shop in Washington, D.C., despite having had his license restricted by North Carolina in 2006 and having been subsequently denied one in Maryland. (He fought the North Carolina judgment and later had the conditions lifted.)

Henry Childers didn’t set out to be an alternative Lyme specialist, either. He trained at elite institutions, graduating from Tufts University School of Medicine and serving as a resident and then a fellow in cardiothoracic surgery at the University of Pennsylvania. In 2008 he became chief of cardiothoracic surgery at Southern Ohio Medical Center, a hospital in Portsmouth, and in 2011 he joined Beebe Medical Center in Lewes, Del., in the same role.

The following year, Childers left Beebe and veered away from cardiothoracic surgery—and conventional medical practice altogether—ultimately founding Delaware Integrative Medicine. In a recorded talk, he attributed the decision to having benefited himself from ozone therapy for shoulder injuries. “That changed the rest of my life and how I practice medicine,” he said. He began to market himself as a Lyme-literate doctor specializing in ozone treatments. He spoke at an ILADS conference in October 2015, just days after Dejay Cartwright’s death.

In 2017, Tiffany Cartwright sued Childers and his clinic for negligence. In a pretrial order, the court stated that in his deposition, Childers testified he’d left Beebe because of a finger injury and “had never been subject to any attempts to suspend or revoke his medical license.” But, according to that order, Tiffany’s lawyers later learned that, in 2012, the Delaware Board of Medical Licensure and Discipline and the state attorney general’s office had jointly filed a complaint and moved for an emergency suspension of his license “due to the clear and immediate danger he poses to the public health.” The complaint said Beebe had suspended Childers’s privileges in 2012. (Childers says personal animosity on the part of hospital co-workers drove them to build an inflated case for his ouster.) The complaint didn’t trigger disciplinary action from the Delaware board, and Childers says it was subsequently dismissed. That left scant public record of the accusations.

Jeffrey Ford, investigative supervisor at the Delaware Division of Professional Regulation, which vets complaints for the medical board, says Childers has received three complaints related to malpractice in the state. Two were found to be unsubstantiated and were closed. The division referred the third, which it received in March 2019, to the office of the state’s attorney general last October, even as its own investigation into Childers’s conduct continues. A spokesman for the attorney general’s office confirmed the case is still pending; because of privacy rules, it’s unclear whether it’s related to Cartwright’s death. Says Childers: “We’ve never, ever had a problem like this with any patient. One’s too many.”

In addition to disputing that Cartwright’s port was noticeably infected, Childers recalls urging her to seek emergency care since she felt unwell. “She was a great lady, and she was really doing well,” he says. “It was so unfortunate.” As Tiffany’s lawsuit headed toward a jury trial early last year, the parties agreed to settle. She received a payment in the low six figures.

The controversy around how to characterize and treat apparent Lyme symptoms has lately become a front in the larger war on science, reminiscent of the fights over vaccines or using hydroxychloroquine on Covid-19 patients. Infectious-disease specialists who’ve raised concerns about unproven Lyme protocols have sometimes faced coordinated harassment and threats. In some cases, even clinicians who’ve harmed patients end up being defended by vocal, organized, and well-funded networks. Groups such as the Global Lyme Alliance and the Bay Area Lyme Foundation are flush with cash; the hedge fund manager Steven Cohen, whose wife, Alexandra, has persistent Lyme symptoms, has given more than $50 million toward related groups since 2015. They also boast celebrity allies such as Justin Bieber and Avril Lavigne, both of whom received Lyme diagnoses and have shared details of their alternative treatment protocols.

Advocates have pushed for legislation that would shield doctors from medical board discipline and liability for unorthodox practices. In 2012, Mitt Romney, during his campaign as the Republican candidate for president, distributed materials promising to protect alternative Lyme practitioners from lawsuits related to aggressive antibiotic regimes. Elected officials, including Senators Richard Blumenthal (D-Conn.) and Kirsten Gillibrand (D-N.Y.), have been involved in fundraising and advocacy that undermine established CDC guidelines for Lyme. Blumenthal, Gillibrand, and others pushed for a provision in a 2016 package of drug-development laws, the 21st Century Cures Act, that established a Tick-Borne Disease Working Group under the U.S. Department of Health and Human Services. The group is populated by activists who oppose the primacy of evidence-based treatments, according to current and former members, and its reports to Congress include their rebuttals alongside scientific findings.

“We have this notion that if you’re desperate, you’re your own judge of what risks you want to take,” says Arthur Caplan, head of the Division of Medical Ethics at NYU Grossman School of Medicine. “But you can be so easily exploited. And desperation doesn’t make for a rational choice.”

The uncertainty surrounding the causes of people’s suffering has left tens of thousands of them—some with past Lyme diagnoses, some not—to gather in private Lyme-focused Facebook groups, sharing a steady stream of anti-science propaganda, self-diagnoses, and questionable home remedies that they inject, ingest, or feed to children and pets. Some group rules stipulate that practitioners’ names may be shared only in private messages so they don’t become targets for regulators or media. On Instagram, patients promote products such as an unproven treatment with bee venom and clothing designed to accommodate port or PICC devices. And a search for “Lyme disease” on GoFundMe turns up more than 4,300 crowdfunding campaigns, some with five- or six-figure fundraising goals. Absent a strong regulatory system, officials express fears that desperate patients will continue to be exploited.

At his clinic, Henry Childers has lately expanded his offerings to include a menu of stem-cell treatments, some of which are derived from a patient’s own cells and which aren’t FDA-approved. The clinic’s website markets these as remedies for a swath of conditions, including rheumatoid arthritis and chronic obstructive pulmonary disease. The typical stem-cell protocol runs about $8,000 and isn’t covered by insurance, but in a video posted online in April, Childers offers a discount. “Anyone who’s watching,” he says, “if you come in for a consultation, we’re gonna reduce the price by another $1,000.”

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