New Physical Therapy Helps Older Adults with Chronic Low Back Pain

By Pat Anson, PNN Editor

Older adults suffering from chronic low back pain experienced faster pain relief after getting a new type of physical therapy focused on strengthening their hip muscles, according to a new study.

The study findings, recently reported in The Lancet Rheumatology, are notable given the limited research on back pain therapies for older adults.

“Unfortunately, the societal attitude is that older people don’t warrant the same level of care that younger people do when it comes to musculoskeletal problems,” lead author Gregory Hicks, PhD, Distinguished Professor of Health Sciences at the University of Delaware, said in a press release.

“When I started this work, there were a lot of naysayers. I’d tell them, ‘Read the literature — why are we excluding older adults from low back pain research?’ We all hope to get older. Why ignore a place in time where we all hope to end up?”

Hicks and his colleagues enrolled 184 people aged 60 or older who reported moderate low back pain, hip pain, and muscle weakness for at least 6 months. Patients were randomly assigned to a hip-focused physical therapy known as Manual Therapy and Strengthening the Hip (MASH) or a more traditional physical therapy for back pain that focused on the spine. Both groups received therapy for eight weeks at the University of Delaware, Duke University or the University of Pittsburgh.

Researchers found that participants who received the MASH therapy had more pain relief after eight weeks than those who had spine-focused therapy. They also showed more improvement in walking endurance and in their ability to rise from a seated position. However, after six months, both groups showed similar levels of improvement.

Previous research by Hicks, funded by the National Institutes of Health, has studied the impact of hip impairment, vitamin D deficiency, and trunk muscle composition in older patients with low back pain. He learned that there were distinct sub-groups of patients with back pain who had unique characteristics and treatment needs.

“It’s becoming quite clear, if you make the assumption that all low back pain is the same, you’re wrong,” said Hicks. “If you can identify sub-groups of low back pain patients with similar traits, you can develop matched treatments, which hopefully lead to better outcomes.”

Low back pain is the leading cause of disability worldwide. According to a recent Harris Poll, nearly 3 out of 10 U.S. adults currently suffer from chronic low back pain, surpassing the number of Americans who have arthritis, diabetes or heart disease. On average, the typical back pain sufferer has sought relief from at least three healthcare providers, with many treatments such as epidural steroid injections proving ineffective.   

Lax FDA Oversight of Medical Devices Exposed in Lawsuits

By Fred Schulte and Holly K. Hacker, KFF Health News  

Living with diabetes, Carlton “PeeWee” Gautney Jr. relied on a digital device about the size of a deck of playing cards to pump insulin into his bloodstream.

The pump, manufactured by device maker Medtronic, connected plastic tubing to an insulin reservoir, which Gautney set to release doses of the vital hormone over the course of the day. Gautney, a motorcycle enthusiast, worked as a dispatcher with the police department in Opp, Alabama.

The 59-year-old died suddenly on May 17, 2020, because — his family believes — the pump malfunctioned and delivered a fatal overdose of insulin.

“There’s a big hole left where he was,” said Gautney’s daughter, Carla Wiggins, who is suing the manufacturer. “A big part of me is missing.”

The wrongful-death lawsuit alleges the pump was “defective and unreasonably dangerous.” Medtronic has denied the pump caused Gautney’s death and filed a court motion for summary judgment, which is pending.

The pump Gautney depended on was among more than 400,000 Medtronic devices recalled, starting in November 2019, after the company said in a recall notice that damage to a retainer ring on the pump could “lead to an over or under delivery of insulin,” which could “be life threatening or may result in death.”

CARLA WIGGINS AND CARLTON GAUTNEY

As the recall played out, federal regulators discovered that Medtronic had delayed acting — and warning patients of possible hazards with the pumps — despite amassing tens of thousands of complaints about the rings, government records show.

Over the past year, KFF Health News has investigated medical device malfunctions including:

• Artificial knees manufactured by a Gainesville, Florida, company that remained on the market for more than 15 years despite packaging issues that the company said could have caused more than 140,000 of the implants to wear out prematurely.

• Metal hip implants that snapped in two inside patients who said in lawsuits that they required urgent surgery.

• Last-resort heart pumps that FDA records state may have caused or contributed to thousands of patient deaths.

• And even a dental device, used on patients without FDA review, that lawsuits alleged has caused catastrophic harm to teeth and jawbones. CBS News co-reported and aired TV stories about the hip and dental devices.

The investigation has found that most medical devices, including many implants, are now cleared for sale by the FDA without tests for safety or effectiveness. Instead, manufacturers must simply show they have “substantial equivalence” to a product already in the marketplace — an approval process some experts view as vastly overused and fraught with risks.

“Patients believe they are getting an implant that’s been proven safe,” said Joshua Sharlin, a former FDA official who now is a consultant and expert witness in drug and medical device regulation. “No, it hasn’t,” Sharlin said.

And once those devices reach the marketplace, the FDA struggles to track malfunctions, including deaths and injuries — while injured patients face legal barriers trying to hold manufacturers accountable for product defects.

In a statement to KFF Health News, the FDA said it “has a scientifically rigorous process to evaluate the safety and effectiveness of medical devices.”

‘Too Little, Too Late’

The FDA approved the MiniMed 670G insulin pump on Sept. 28, 2016, after its most stringent safety review, a little-used process known as premarket approval.

In a news release that day, Jeffrey Shuren, who directs the FDA’s Center for Devices and Radiological Health, lauded the device as a “first-of-its-kind technology” that would give patients “greater freedom to live their lives” and to monitor and dispense insulin as needed. The pump was tested on 123 patients in a clinical trial over several months with “no serious adverse events,” the release said. Shuren declined to be interviewed for this article.

The FDA’s enthusiasm didn’t last. In November 2019, Medtronic, citing the ring problem, launched an “urgent medical device recall” of the pumps, which it expanded in late 2021.

During an inspection at Medtronic’s plant in Northridge, California, FDA officials learned the company had logged more than 74,000 ring complaints between 2016 and the November 2019 recall.

More than 800 complaints weren’t investigated at all, according to the FDA, which sharply criticized the company in a December 2021 warning letter.

MiniMed 670G insulin pump (MEDTRONIC IMAGE)

Medtronic is facing more than 60 lawsuits filed by injured patients and their families and the company believes it may be hit with claims for damages from thousands more patients, the company disclosed in an August Securities and Exchange Commission filing.

Medtronic pumps that allegedly dispensed too much, or too little, insulin have been blamed for contributing to at least a dozen patient deaths, according to lawsuits filed since 2019. Some cases have been settled under confidential terms, while others are pending or have been dismissed. Medtronic has denied any responsibility in response to the lawsuits.

In one pending case, a Las Vegas man using the pump allegedly fell into an “insulin-induced coma” that led to his death in 2020. In another 2020 case, a 67-year-old New Jersey resident collapsed at her home, dying later the same day at a local hospital.

The recall notice Medtronic sent to a 43-year-old Missouri man’s home arrived a few days after police found him dead on his bedroom floor, his family alleged in a lawsuit filed in August. “Simply too little, too late,” the suit reads. The case is pending, and Medtronic has yet to file an answer in court.

Medtronic declined to answer written questions from KFF Health News about the pumps and court cases. In an emailed statement, the company said it replaced pump rings with new ones “redesigned to reduce the risk of damage” and “fulfilled all pump replacement requests at no cost to customers.”

In April, Medtronic announced that the FDA had lifted the warning letter a few days after it approved a new version of the MiniMed pump system.

Shortcut to Market

The 1976 federal law that mandated safety testing for high-risk medical devices also created a far easier — and less costly — pathway to the marketplace. This process, known as a 510(k) clearance, requires manufacturers to show a new device they plan to sell has “substantial equivalence” to one already on the market, even if the prior product has been recalled.

Critics have worried for years that the 510(k)-approval scenario is too industry-friendly to protect patients from harm.

In July 2011, an Institute of Medicine report concluded that 510(k) was “not intended to evaluate the safety and effectiveness of medical devices” and said “a move away from the 510(k) clearance process should occur as soon as reasonably possible.”

More than a decade later, that hasn’t happened, even amid mounting controversy over the clearance of hundreds of devices that employ artificial intelligence.

The FDA now clears about 3,000 low- to moderate-risk devices every year through 510(k) review, which costs the device maker a standard FDA fee of about $22,000. That compares with about 30 approvals a year through the stricter premarketing requirements, which cost nearly $500,000 per device, according to FDA data.

Diana Zuckerman, president of the National Center for Health Research, said even many doctors don’t realize devices cleared for sale typically have not undergone clinical trials to establish their safety.

“Doctors are shocked to learn this,” she said. “Patients aren’t going to know it when their doctors don’t.”

In response to written questions from KFF Health News, the FDA said it “continues to believe in the merits of the 510(k) program and will continue to work to identify program improvements that strengthen the safety and effectiveness of 510(k) cleared devices.”

The FDA keeps a tight lid on data showing which devices manufacturers choose to demonstrate substantial equivalence — what the agency refers to as “predicate” devices.

“We can’t get detailed data,” said Sandra Rothenberg, a researcher at the Rochester Institute of Technology. “It’s very hard for researchers to determine the basis on which substantial equivalence is being made and to analyze if there are problems.”

Rothenberg cited the history of “metal-on-metal” artificial hip implants, which under 510(k) spawned many new brands — along with a disastrous toll of patient injuries. The implants could release metal particles that damaged bone and led to premature removal and replacement, a painful operation. Just four of these hip devices have been the target of more than 25,000 lawsuits seeking damages, court records show.

In early 2016, the FDA issued an order requiring safety testing before approving new metal-on-metal hip devices.

Alarm Bells

Two former Medtronic sales executives in California argue in a whistleblower lawsuit that the 510(k) process can be abused. According to the whistleblowers, the FDA approved the Puritan Bennett 980, or PB 980, ventilator in 2014 based on the assertion it was substantially equivalent to the PB 840, an earlier mechanical ventilator long viewed as the workhorse of the industry.

Medtronic’s subsidiary company Covidien made its claim even though the device has completely different “guts” and operates using software and other “substantially different” mechanisms, according to the whistleblowers’ suit. In response, Medtronic said it “believes the allegations are without merit and has moved to dismiss the case.” The case is pending.

The whistleblowers argue the PB 980 ventilator was plagued by dangerous malfunctions for years before its recall in late 2021. One ventilator billowed smoke in an intensive care unit while the whistleblowers were told by one hospital that “the wheels for the ventilator cart may actually fall off the ventilator during transport,” according to the suit.

Batteries could die without warning, kicking off a scramble to keep patients alive; monitor screens froze up repeatedly or otherwise went on the blink; and, in several cases, alarm bells warning of a patient emergency rang continuously and could be quieted only by unplugging the unit from the wall socket and pulling out its batteries, according to the suit.

The December 2021 recall of the PB 980 cited a “manufacturing assembly error” that the company said may cause the ventilator to become “inoperable.”

Medtronic said in an email that the ventilator “has helped thousands of patients around the world,” including playing a “critical role in the global response to the COVID-19 pandemic.”

Late Warnings

The FDA operates a massive database, called MAUDE, to alert regulators and the public to emerging device dangers. The FDA requires manufacturers to advise the agency when they learn their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that might recur and cause harm. These reports must be submitted within 30 days unless a special exemption is granted.

But FDA officials acknowledge that many serious adverse events go unreported — just how many is anybody’s guess.

Since 2010, the FDA has cited companies more than 5,000 times for not handling, reviewing, or investigating complaints properly, or for not reporting adverse events on time. For instance, the FDA cited an Ohio company that made electric beds and other devices more than 15 times for failing to properly scrutinize complaints or report adverse events, including the death of a patient who allegedly became trapped between a bedrail and mattress, agency records show.

In about 10% of reports, more than a year or two elapsed from when a death or serious injury occurred and when the FDA received the reports, a KFF Health News analysis found. That works out to nearly 60,000 delayed reports a year.

Experts and lawmakers say the FDA needs to find a way to detect safety problems quicker.

Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) have tried for years to persuade the agency to add unique device identifiers to Medicare payment claim forms to help track products that fail. In an email statement to KFF Health News, Grassley called that a “commonsense step we can take up front to mitigate risk, improve certainty and save money later.”

The FDA said it is working to “strike the right balance between assuring safety and fostering device innovation and patient access.” Yet it noted: “Additional resources are required to establish a fully functioning active surveillance system for medical devices.”

For now, injured patients suing device companies often cite the volume of adverse event reports to MAUDE, or FDA citations for failing to report them, to bolster claims that the company knew about product malfunctions but failed to correct them.

In one case, a New York man is suing manufacturer Boston Scientific, claiming injuries from a device called the AMS 800 that is used to treat stress urinary incontinence.

Though Boston Scientific says on its website that 200,000 men have been treated successfully, the lawsuit argues complaints piled up in MAUDE year after year and no action was taken — by the company or by regulators.

The number of complaints filed soared from six in 2016 to 2,753 in 2019, according to the suit. By far, the largest category involved incontinence, the condition the device was supposed to fix, according to the suit. Boston Scientific did not respond to a request for comment. The company has filed a motion to dismiss the case, which is pending.

By the FDA’s own count, more than 57,000 of some 74,000 complaints Medtronic received about the MiniMed insulin pump’s retainer rings were reported to the agency. The FDA said the complaints “were part of the information that led to the compliance actions.” The agency said it “approved design and manufacturing changes to the retainer ring to correct this issue” and “has reviewed information confirming the effectiveness of the modification.”

“What is the threshold for the FDA to step in and do something?” said Mara Schwartz, who is a nurse, diabetes educator, and pump user. “How many deaths or adverse events does there have to be?”

In 2020, she sued Medtronic, alleging she suffered seizures when the pump mistakenly delivered an overdose of insulin. Medtronic denied her claims, and the case has since been settled under confidential terms.

Private Eyes

Some countries don’t trust the device industry to play such a key role in oversight.

Australia and about a dozen other nations maintain registries that measure the performance of medical devices against competitors, with an eye toward not paying for care for a substandard device.

That’s not likely to happen in the United States, where no device or drug manufacturer must demonstrate its new product is better than what’s already for sale.

Product liability lawsuits in the U.S. often cite troubling findings from overseas. For instance, registries in Australia and other countries pinpointed durability problems with the Optetrak knee implants manufactured by Florida device company Exactech years before a major recall. Exactech has declined comment.

The Australian surveillance network also detected deficiencies with the Medtronic PB 980 ventilator, prompting the country’s health authority to suspend its use for six months until Medtronic completed training for health care workers and took other steps to improve it, court records show. Medtronic told KFF Health News that it had “worked closely” with the Australian group to resolve the problems. “We take patient safety very seriously and have processes to identify quality issues and determine appropriate actions,” Medtronic said.

Registries have gained some traction in America. But so far, they typically have been controlled, and sometimes funded, by industry and medical specialty groups that share their findings only with doctors.

One private registry managed by the Society of Thoracic Surgeons, called Intermacs, tracks death and injury rates at 180 hospitals in the United States certified to implant a mechanical heart pump known as an LVAD. Some patients might find that information helpful, but it’s not available to them.

‘New and Exciting Features’

While the FDA clears thousands of devices for use based on the “substantial equivalence” premise, manufacturers often tout “new and exciting features” in their advertising and other marketing, said Alexander Everhart, a researcher at the Washington University School of Medicine in St. Louis.

These marketing campaigns have long been controversial, especially when they rely partly on wining and dining surgeons and other medical professionals to gain new business, or when surgeons have financial ties to manufacturers whose products they use. Orthopedic device makers have funneled billions of dollars to surgeons, including fees for consulting, doing medical research, or royalties for their role in fine-tuning surgical tools and techniques, even promoting the products to their peers.

Marketing campaigns directed at prospective patients may receive little scrutiny. The FDA has “limited resources to actively monitor the volume of direct-to-consumer advertising,” according to a Government Accountability Office report issued in September. From 2018 to 2022, the FDA took 255 enforcement actions involving advertising claims made for devices, according to the GAO report.

While manufacturers can advertise devices directly to patients, courts may not hold them accountable for communicating possible risks to patients.

Consider the case of Richard Greisberg, a retired electronics business owner in New Jersey. He sued Boston Scientific in 2019, years after having a Greenfield vena cava filter implanted. The device is intended to prevent blood clots that develop in the lower body from traveling into the lungs, which can be deadly.

Greisberg argued that the device had migrated in his body, causing pain and other symptoms and damage that took years to identify. Representing himself in court, he tried to argue that nobody had told him that could happen and that if they had done so he wouldn’t have agreed to the procedure.

He lost when the judge cited a legal doctrine called “learned intermediary.” The doctrine, which is recognized in many states, holds that manufacturers must warn only physicians, who are presumed to have the knowledge to understand a medical device’s risks and relay them to patients.

The court ruled that a 27-page manual the manufacturer sent to the physician who implanted it, which included details about possible risks, was adequate and tossed the case.

Greisberg, 81, felt sucker-punched. “They never gave me any warning about what could happen down the road,” he said in an interview. “I never had a chance to have my day in court.”

The family of PeeWee Gautney also faces challenges pursuing the insulin pump lawsuit.

Gautney died in a motel room in Destin, Florida, a day after riding his Harley-Davidson to the Panhandle beach town on a weekend jaunt. The MiniMed pump was still strapped to his body, according to a police report.

Medtronic had sent Gautney a form letter in late March 2020, less than two months before he died, advising him to make sure the ring was locking in place correctly. A week later, he wrote back, telling the company: “It’s fine right now,” court records show.

Wiggins, 33, his daughter, who is also a neonatal respiratory therapist, said she believes a crack in the retainer ring caused it to release too much insulin, which her dad may not have recognized.

“It should never be put on the patient to determine if there is a problem,” Wiggins said.

Medtronic has denied the pump failed and caused Gautney’s death. The FDA approved the device knowing patients faced the risk of it administering wrong doses, but believed the benefits outweighed these risks, Medtronic argued in a motion for summary judgment in September. The motion is pending.

Medtronic also cited a legal doctrine holding that Congress granted the FDA sole oversight authority over devices receiving premarket approval, which preempts any product defect claims brought under state laws. Manufacturers have drawn on the preemption defense to sidestep liability for patient injuries, and often win dismissal, though federal courts are split in applying the doctrine.

Wiggins hopes to beat those odds, arguing that the December 2021 FDA warning letter reveals that Medtronic violated safety and manufacturing standards.

Her lawyer, Scott Murphy, said that insulin pumps are “really wonderful” devices for people with diabetes when they work right. He argues that the FDA records confirm that Medtronic significantly downplayed its pump’s hazards.

“The risks get minimized and the benefits exaggerated,” he said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

Can Herbal Supplements Effectively Relieve Pain?

Drs. Nial Wheate and Joanna Harnett, University of Sydney

In an era where chronic pain affects millions worldwide, the search for effective and safe pain relief has never been greater.

PanaNatra is a line of herbal products from Haleon, the makers of Panadol. Haleon claims the three PanaNatra’s products, made from plant extracts, help manage and provide relief from mild joint aches, mild muscle pain, and mild pain affecting sleep.

They contain different combinations of four plants:

• Boswellia serrata (contained in the joint and muscle products)

• Curcuma longa (in the joint and muscle products)

• Piper nigrum (just in the joint product)

• Withania somnifera (just in the sleep product).

These products are “listed medicines” in Australia. This means the ingredients are considered broadly low risk, have been used in traditional medicine, and are manufactured to a high standard. But the manufacturer has not provided evidence to the government regulator that they work.

So can herbal ingredients effectively and safely relieve different types of pain? Let’s consider the evidence for the four main ingredients.

Boswellia serrata

Indian Frankincense (Boswellia serrata) has been described in traditional Indian Ayurveda texts since the 1st century AD. Key active compounds derived from the gum resin of the tree called boswellic acids are thought to have anti-inflammatory effects.

The Boswellia serrata dry concentrate extract (Rhuleave K) used in the Muscle Pain product contains 50 mg of the herb per tablet, whereas the Joint Pain product includes 33.3 mg as a different formulation (Apresflex).

Boswellia serrata

A review of various human clinical trials using a range of formulations of this herb supports its ability to reduce some types of pain and improve function in osteoarthritis. But a key finding of the study was that improvement only begins when Boswellia serrata is used continuously for four weeks and at a dose of at least 100–250 mg per day.

In a clinical trial, 100 mg daily of a Boswellia serrata gum-based product was found to reduce pain and improve physical functions for people with osteoarthritis.

Curcuma longa

Turmeric (Curcuma longa) has been used in Chinese and Indian medicine for at least 2,000 years. It contains a well-known chemical called curcumin, a natural compound used for its anti-inflammatory properties, especially for osteoarthritis.

Turmeric compounds such as curcumin are often combined with Boswellia serrata compounds to improve their anti-inflammatory effects to reduce pain.

Curcuma longa

A review of 16 different clinical trials found turmeric extracts were effective for knee osteoarthritis.

A similar conclusion was drawn from a review of 11 clinical trials which examined the use of curcuminoids (of which curcumin is one) for one to four months. It found curcuminoids had similar pain-relieving qualities as non-steroidal anti-inflammatory based drugs.

Piper nigrum

Black pepper (Piper nigrum) contains the chemical piperine, which has anti-inflammatory properties.

Piper nigrum is often added to curcumin products to improve the absorption of curcumin, as is the case with the PanaNatra Joint Pain product.

Piper nigrum

For musculoskeletal pain, a preliminary human trial that examined the effects of a 1,000 mg daily dose of Rhuleave K (the extract used in PanaNatra) found it was as effective as paracetamol.

But the study was not placebo-controlled and the dose of paracetamol given (1,000 mg per day) was below the recommended daily intake for pain relief. 

Withania somnifera

Withania somnifera (also called Ashwagandha) has been used in traditional Indian Ayurvedic medicine for thousands of years to reduce stress and ease inflammation.

One of the key chemicals appears to be withaferin A, which interferes with the inflammatory signalling pathway.

Withania somnifera

PanaNatra’s Pain and Sleep product contains 300 mg per tablet of a Withania somnifera extract called KSM66.

A human trial found a daily 600 mg dose of Withania somnifera extract improved sleep quality and helped in managing insomnia.

In a separate trial, Withania somnifera was found to improve sleep quality, again when administered at a dose of 600 mg per day.

Does Herbal Medicine Work?

Whether, and how well, a herbal medicine works is largely dependent on the formulation (how it’s made and the extract used) and the dose provided. The same herb used in one formulation may result in a different outcome than a different formulation containing the same herb.

It’s also important to note that effectiveness for one type of pain does not mean a product will work for other types of pain.

Overall, similar herb extracts to those that have been included in the PanaNatra products do have some evidence that they work for pain and sleep. Whether they work for you will depend on a number of factors including the effectiveness of the PanaNatra formulation, how much you take, and the extent of your pain.

Is It Safe?

PanaNatra needs to be used carefully by some patients.

Overall, there is insufficient human data to recommend any of these herbal ingredients in pregnancy or lactation. In fact there is some evidence that Withania somnifera may be unsafe to use in pregnancy, and other than the amounts commonly found in food, turmeric and its compounds are not considered safe to use in pregnancy either.

The herbs may also impact the effectiveness and safety of other medicines. For example, the blood levels of the cancer drug tamoxifen may be reduced when taken concurrently with turmeric supplements.

Withania somnifera has been associated with drowsiness and cases of liver toxicity.

Curcuma longa products, including formulations containing curcumin and piperine, have also been associated with liver toxicity. As such, Australia’s Therapeutic Goods Administration has proposed adding warning labels to any products that contain those ingredients. But this discussion is ongoing and a decision won’t be made until next year.

While there is a long history of traditional use of the herbs in the PanaNatra products, there is limited high-quality scientific evidence for the effectiveness and safety for these specific products.

Pregnant and breastfeeding women should not take these products, and you should not exceed the daily dose recommended by the manufacturer.

If you have an underlying health condition, or are taking other medication, before you try them, consult your doctor or pharmacist to check if these products are suitable for you.

Nial Wheate, PhD, is an Associate Professor at the University of Sydney’s School of Pharmacy. He is a Fellow of the Royal Australian Chemical Institute and a member of the Australasian Pharmaceutical Science Association.

Joanna Harnett, PhD, is a Senior Lecturer at University of Sydney’s Faculty of Medicine and Health Pharmacy School, where she teaches and conducts research in the field of traditional, complementary, and integrative medicine.

This article originally appeared in The Conversation and is republished with permission.

Herbal Pain Relief Tea Recalled for Having Undeclared Drugs

By Pat Anson, PNN Editor

“Alleviates Pain & Inflammation Within 10 Minutes”

“Drug-Free All Natural Herbal Pain Relief”

As the saying goes, if the ads sound too good to be true, they probably are. Especially the part about being “drug-free.”

An herbal tea being marketed as a pain reliever for arthritis, gout, fibromyalgia and migraine is being voluntarily recalled after the Food and Drug Administration found that it contained “undeclared drugs.”

WS Global, a New York-based distribution company, is recalling all packages of Himalayan Pain Relief Tea after being informed by the FDA that the tea contains diclofenac, a non-steroidal anti-inflammatory drug (NSAID) and dexamethasone, a corticosteroid.

The company said it had not received any reports of adverse events involving the tea, but urged consumers to “immediately consult their health care professional” if they consumed it.

In a news release, the FDA said diclofenac may raise the risk of cardiovascular events, such as a heart attack or stroke, and could interact with other medications.

Dexamethasone can suppress the adrenal gland, impair a person’s ability to fight infections, and cause high blood sugar, muscle injuries and psychiatric problems. It may also have serious side effects when combined with other medications.

Neither diclofenac or dexamethasone are mentioned on the tea’s product label or advertising. The company claims the tea was “formulated by a traditional comprehensive recipe from the Himalayan monks.”

Himalayan Pain Relief Tea was being sold online, primarily through Amazon.

This is not the first time that an herbal or dietary supplement sold by Amazon was recalled due to undeclared drugs, contamination or other health concerns. In recent months, recalls were also ordered for a male sexual enhancement product, a glucose supplement, apple sauce, and an anti-cavity mouthwash for kids. All were being sold on Amazon.  

In a recent warning letter to Amazon’s CEO about selling several brands of unapproved eye drops, the FDA said the company should take more responsibility for the products it sells.

“The violations cited in this letter are not intended to be an all-inclusive statement of past or present violations that may exist in connection with the products you distribute. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations,” said Jill Furman, Director of the FDA Office of Compliance, Center for Drug Evaluation and Research.

Amazon complied with that request by removing the eye drops from its online marketplace.

“Safety is a top priority at Amazon. We require all products offered in our store to comply with applicable laws and regulations,” the company said in a statement.

Amazon received a similar warning letter in 2022, for selling a “misbranded” dietary supplement for arthritis that was linked to liver toxicity and at least one death. That product also contained diclofenac and dexamethasone.

You can still find Himalayan Pain Relief Tea on Amazon, with a notation that it is “currently unavailable.”

“We don't know when or if this item will be back in stock,” Amazon cautions potential buyers.

Back Pain? Bum Knee? Be Prepared to Wait for Physical Therapy

By Mark Kreidler, KFF Health News

At no point along his three-year path to earning a degree in physical therapy has Matthew Lee worried about getting a job.

Being able to make a living off that degree? That’s a different question — and the answer is affecting the supply of physical therapists across the nation: The cost of getting trained is out of proportion to the pay.

“There’s definitely a shortage of PTs. The jobs are there,” said Lee, a student at California State University-Sacramento who is on track to receive his degree in May. “But you may be starting out at $80,000 while carrying up to $200,000 in student debt. It’s a lot to consider.”

As many patients seeking an appointment can attest, the nationwide shortage of PTs is real. According to survey data collected by the American Physical Therapy Association, the job vacancy rate for therapists in outpatient settings last year was 17%.

Wait times are generally long across the nation, as patients tell of waiting weeks or even months for appointments while dealing with ongoing pain or post-surgical rehab. But the crunch is particularly acute in rural areas and places with a high cost of living, like California, which has a lower ratio of therapists to residents — just 57 per 100,000, compared with the national ratio of 72 per 100,000, according to the association.

The reasons are multifold. The industry hasn’t recovered from the mass defection of physical therapists who fled as practices closed during the pandemic. In 2021 alone, more than 22,000 PTs — almost a tenth of the workforce — left their jobs, according to a report by the health data analytics firm Definitive Healthcare.

Growing Demand for PT

And just as baby boomers age into a period of heavy use of physical therapy, and covid-delayed procedures like knee and hip replacements are finally scheduled, the economics of physical therapy are shifting. Medicare, whose members make up a significant percentage of many PT practices’ clients, has cut reimbursement rates for four years straight, and the encroachment of private equity firms — with their bottom-line orientation — means many practices aren’t staffing adequately.

According to APTA, 10 companies, including publicly held and private equity-backed firms, now control 20% of the physical therapy market.

“What used to be small practices are often being bought up by larger corporate entities, and those corporate entities push productivity and become less satisfying places to work,” said James Gordon, chair of the Division of Biokinesiology and Physical Therapy at the University of Southern California.

There’s a shortage of physical therapists in all settings, including hospitals, clinics, and nursing homes, and it’s likely to continue for the foreseeable future, said Justin Moore, chief executive of the physical therapy association. “Not only do we have to catch up on those shortages, but there are great indicators of increasing demand for physical therapy,” he said.

The association is trying to reduce turnover among therapists, and is lobbying Congress to stop cutting Medicare reimbursement rates. The Centers for Medicare & Medicaid Services plans a 3.4% reduction for 2024 to a key metric that governs pay for physical therapy and other health care services. According to the association, that would bring the cuts to a total of 9% over four years.

Several universities, meanwhile, have ramped up their programs — some by offering virtual classes, a new approach for such a hands-on field — to boost the number of graduates in the coming years.

“But programs can’t just grow overnight,” said Sharon Gorman, interim chair of the physical therapy program at Oakland-based Samuel Merritt University, which focuses on training health care professionals. “Our doctoral accreditation process is very thorough. I have to prove I have the space, the equipment, the clinical sites, the faculty to show that I’m not just trying to take in more tuition dollars.”

Rising Cost of PT Education

All of this also comes at a time when the cost of obtaining a physical therapy doctorate, which typically takes three years of graduate work and is required to practice, is skyrocketing. Student debt has become a major issue, and salaries often aren’t enough to keep therapists in the field.

According to the APTA’s most recent published data, median annual wages range from $88,000 to $101,500. The association said wages either met or fell behind the rate of inflation between 2016 and 2021 in most regions.

A project underway at the University of Iowa aims to give PT students more transparency about tuition and other costs across programs. According to an association report from 2020, at least 80% of recent physical therapy graduates carried educational debt averaging roughly $142,000.

Gordon said USC, in Los Angeles’ urban core, has three PT clinics and 66 therapists on campus, several of whom graduated from the school’s program. “But even with that, it’s a challenge,” he said. “It’s not just hard to find people, but people don’t stay, and the most obvious reason is that they don’t get paid enough relative to the cost of living in this area.”

Fewer therapists plus growing demand equals long waits. When Susan Jones, a Davis, California, resident, experienced pain in her back and neck after slipping on a wet floor in early 2020, she went to her doctor and was referred for physical therapy. About two months later, she said, she finally got an appointment at an outpatient clinic.

“It was almost like the referral got lost. I was going back and forth, asking, ‘What’s going on?’” said Jones, 57. Once scheduled, her first appointment felt rushed, she said, with the therapist saying he could not identify an issue despite her ongoing pain. After one more session, Jones paid out-of-pocket to see a chiropractor. She said she’d be hesitant to try for a physical therapy referral in the future, in part because of the wait.

Universities and PT programs graduate about 12,000 therapists a year, Moore said, and representatives of several schools told KFF Health News they’re studying whether and how to expand. In 2018, USC added a hybrid model in which students learn mostly online, then travel to campus twice a semester for about a week at a time for hands-on instruction and practice.

That bumped USC’s capacity from 100 students a year to 150, and Gordon said many of the hybrid students’ professional skills are indistinguishable from those of students on campus full time.

Natalia Barajas received her PT doctorate from USC last year and was recently hired at a clinic in nearby Norwalk, with a salary of $95,000, a signing bonus, and the opportunity to earn more in incentives.

She’s also managing a lot of debt. Three years of tuition for the USC physical therapy program comes to more than $211,000, and Barajas said she owes $170,000 in student loans.

“If it were about money alone, I probably would have shifted to something else a while ago,” Barajas said. “I’m OK with my salary. I chose to do this. But it might not be the perfect situation for everybody.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

The Trauma-Pain Connection Explored at For Grace’s Women In Pain Conference

By Cynthia Toussaint, PNN Columnist

Four years ago, I was wheeled into my pain management doctor’s office, not to talk about Complex Regional Pain Syndrome, but rather my newest and most dire diagnosis: Triple Negative Breast Cancer (TNBC). I knew I didn’t have a good chance at survival, but didn’t know why I had the most rare and aggressive form of the disease.

I asked Dr. Richeimer why this cancer would appear now, as my oncologist and genetic counselor were baffled. Without pause, he answered, “Cynthia, you’ve been trying to fix your dysfunctional family your entire life. The toll that’s taken on your body is why you have TNBC.”     

Thus began my trauma-informed journey.

I was already aware and intrigued that many researchers were identifying trauma as the main driver for chronic pain. Despite this, I passed on having trauma release treatment because I’d heard it could be triggering. But now that I was fighting for my very existence, I was all in.

In the midst of full-dose chemotherapy, no less, I took to reading and researching everything I could get my hands on about childhood trauma and how it leads to adult on-set chronic illness. On the trauma release front, I jumped into talk therapy and EMDR (Eye Movement Desensitization and Reprocessing), complimenting those treatments with big doses of music, writing, meditation, inner child work and ancestral healing.

I also started focusing my “For Grace” work on the trauma-pain connection. This included interviewing a boatload of experts and survivors as well as collecting and spotlighting lived experiences, all culminating in Friday’s 11th Annual Women In Pain Conference – “The Trauma-Pain Connection: A Path to Recovery and Growth.”

Radene Marie Cook

You see, I now understand that my 40+ years of pain and chronic illness are the result of serious and sustained trauma, suffered primarily during my early development. In short, trauma is not a piece of my chronic pain puzzle. It’s the whole puzzle.

I want to share all that I’ve learned with women in pain, during a day that I hope will launch your own trauma-informed journey, one that I promise will bring you healing and growth.

To start you on your way, our five-hour online seminar, beginning at 10am PT on November 17, will be broken into three sessions led by world-class speakers, panelists and breakout leaders, all who have survived trauma and volunteered their time.

• Session One will examine what trauma is, how it can be passed down generationally, and how it’s a driver for chronic pain.

• Session Two will highlight trauma release and the myriad of effective techniques, methods and strategies used to achieve that end, both practitioner-led and solo.

• Session Three will celebrate what I call the silver-lining of trauma, Post-Traumatic Growth, a process that paves the way for recovery, deeper meaning, new-found strength, and helping others.            

Themed throughout the conference will be the beauty, struggle and resilience of the Native American people. Because I’ve read time and again that this community suffers greatly from generational trauma, the day will be infused with stunning music and photography, compliments of one of our main speakers, Dr. Noshene Ranjbar, a leader of indigenous studies at the University of Arizona. It touched my heart that two of her students put in hours to gift us these sacred elements.

Perhaps the most poignant part of our event will be the extraordinary gift of intensely personal video vignettes sprinkled in from people who’ve traveled the dimly-lit trauma-pain tunnel, found healing through release, and moved on to the light of growth. The courage of these generous souls is a triumph of the spirit.      

This conference was For Grace’s heaviest lift to date. Coming from a chronic pain background, I didn’t know anyone in trauma and it took several years to build a critical mass of relationships. Also, because this conference is the first of its kind, our planning committee had to build it from whole cloth. Perhaps most difficult and most satisfying, was getting people to talk publicly about their deepest, darkest experiences. I know the challenge well because when I recorded my story, I was brought to tears more than once.

It was worth the sweat and tears because we struck gold.

This is the most important topic For Grace has covered. I’m certain that if you do the work, it will be a catalyst for healing and renewed wholeness. Remembering, facing and addressing our past traumas is our best hope to overcome the scourge of chronic pain.

Don’t wait to get a deadly disease to learn, to explore, to discover trauma’s place in your life. You’re braver than you think - and when you use that courage, you’ll be on the path to finding the last piece to your pain puzzle.

You can watch the conference for free at this link.

Cynthia Toussaint is the founder and spokesperson at For Grace, a non-profit dedicated to bettering the lives of women in pain. She has lived with Complex Regional Pain Syndrome (CRPS) and 19 co-morbidities for four decades, and has been battling cancer since 2020. Cynthia is the author of “Battle for Grace: A Memoir of Pain, Redemption and Impossible Love.”

Study Finds Why Some Patients Do Poorly with Spinal Cord Stimulators

By Pat Anson, PNN Editor

Spinal cord stimulators (SCSs) are often considered the treatment of last resort for people with severe back or leg pain, who don’t respond well to more conventional ways of treating pain.

The neuromodulation devices are surgically placed near the spine and send out mild electrical impulses to mask pain signals. Because stimulators are invasive and have poor success rates, it’s customary for patients to go through a short trial period before having the devices surgically implanted.

A new study has documented why some patients do well with stimulators and others don’t.

In a retrospective analysis, researchers at the University of Kansas Medical Center looked at 237 patients who received SCSs, about a third of them considered “nonresponders.” They found that people with severe pain and disability who fear physical activity because of the pain it might cause – a condition known as kinesiophobia – are significantly less likely to respond to the devices.

The study is being presented this month at the annual meeting of the American Society of Regional Anesthesia and Pain Medicine (ASRA).

Researchers analyzed several patient characteristics, such as their age, gender, body mass index, history of spinal surgery, diabetes, alcohol and tobacco use, psychiatric illness, and use of opioids. None appeared to have an association with how a patient responds to SCS.

But researchers found that three out of four (76%) nonresponders had clinically high levels of kinesiophobia, compared to about half (56%) of those who did respond to SCS treatment. Nonresponders were also more likely to have severe pain, disability, and to complain or worry about their pain – a condition known as “catastrophizing.”

“Collectively, our findings indicate a clinically relevant association of high levels of kinesiophobia, greater disability, severe pain intensity and pain catastrophizing, as subtle indicators, and possible predictive factors to nonresponders,” researchers said.

“As such, it may be appropriate to utilize preoperative screening tools for these factors to help optimize patient selection and predict a patient’s response to neuromodulation. Furthermore, if risk factors are present, it might be prudent to consider a pre-rehabilitation program with pain neuroscience patient education prior to SCS therapy to address these modifiable risk factors and potentially enhance outcomes in neuromodulation.”

About 50,000 spinal cord stimulators are implanted annually in the U.S. The devices are often touted as a safer alternative to opioid pain medication, although a growing number of studies have questioned their safety and efficacy.

A recent Cochrane review of SCSs concluded the devices work no better than a placebo for treating chronic low back pain, and provide little to no benefit in improving quality of life. That negative review led some doctors who perform the surgeries to demand a retraction from Cochrane because of “striking errors in the methodology, execution and conclusions” of the study.

Meanwhile, a 2018 investigation found that SCSs have some of the worst safety records of medical devices and called for better FDA oversight of their growing use in pain management. A subsequent FDA review of complaints involving stimulators found that nearly a third were reports of unsatisfactory pain relief.

Yet another recent study found that many patients given stimulators did not reduce their use of opioids, and continued getting procedures such as epidurals, corticosteroid injections and radiofrequency ablation to relieve their pain.

Let’s End the Silence About Endometriosis

By Dr. Kristina Brown, Adler University

Endometriosis causes physical, sexual and emotional pain. About 190 million people around the globe have endometriosis, including one in 10 American women, but there has historically been a deafening silence about the disease and the pervasive impact it can have on a person’s life.

While endometriosis is a chronic gynecological illness that can affect anyone with a uterus – women, transgender men and nonbinary individuals – it often goes undiagnosed because its symptoms can be attributed to other physical or psychological concerns. Patients presenting with this pain are often told it is “all in your head.”

However, endometriosis is becoming a more visible illness, thanks in part to celebrities such as Lena Dunham, Chrissy Teigen, Amy Schumer, Whoopi Goldberg and others who have begun sharing their stories publicly.

After going undiagnosed for 23 years, Padma Lakshmi, a popular cookbook author, actress and host of the TV show “Top Chef,” founded EndoFund, previously Endometriosis Foundation of America, in 2009 so that others do not have to go through what she did.

I am a couple and family therapy professor, clinician and researcher. My own endometriosis diagnosis at the age of 19 has inspired my work exploring how this illness affects others beyond the physical symptoms.

To better understand the impact of endometriosis on relationships, I interviewed 10 couples about their experiences of diagnosis, treatment and living with this disease. Through their stories of how endometriosis-related pain can affect every aspect of daily life, including their intimate relationships, I provide some specific recommendations. The quotes I have included in this article are from my doctoral dissertation research.

Basics of Endometriosis

When a person has endometriosis, the endometrial cells that line their uterus “implant” in places outside the uterus, such as the ovaries, fallopian tubes and the lining of the abdomen — called the peritoneum. At the end of each menstrual cycle, the uterus sheds its lining, which exits the body via the cervix and vagina. The “misplanted” endometrial cells also shed, but they have no place to go – resulting in internal bleeding, inflammation and pain.

An endometriosis diagnosis is described in stages related to the visual presence of the disease, from minimal, or Stage 1, to severe, or Stage 4. However, there is no connection between the stage and the experience of pain.

One symptom of endometriosis is intense pain during the menstrual cycle. Another is pain with sex. Because pain with menses or sex can be attributed to “normal” pain, a history of sexual abuse or psychiatric reasons such as a dislike of sex, some people with endometriosis wait an average of seven years for diagnosis, which can be visually confirmed only through a procedure called laparoscopy.

In addition to these and other types of severe pain, endometriosis can also cause infertility, and patients who want to have children must often undergo medical or surgical interventions to conceive.

Impact on School, Work and Sex

Physical pain from endometriosis can be debilitating. Adolescents with endometriosis may struggle to keep up with their classes, friends, homework or extracurricular activities when the pain becomes too severe. They may shift to home-schooling or virtual learning to complete their studies.

The pain can also deeply affect a career trajectory. “I almost lost my job because of time off,” one interviewee told me. “In fact, when I had to get my hysterectomy, I walked in to tell my manager and he goes, ‘Well, I hope you’re not going to tell me that you have to have a hysterectomy and have to be out for six weeks!’ And I just broke down in tears.”

All of my participants shared experiences where doctors dismissed complaints of sexual pain – called dyspareunia – from endometriosis. This can delay diagnosis and treatment.

Sex and intimacy often become nonexistent, while some couples shared that they have come to accept that pain is part of sex. One woman shared with me: “I don’t want to be touched or have my naked body seen because I feel bloated and ugly and I’m in horrible pain!”

Partners can also be affected emotionally. “I just feel horrible,” one told me. “There are times when we are having sex that I actually feel guilty that I know that I am hurting her and I know she is going to be in pain and it makes me unhappy.”

These experiences of pain, of not being believed by doctors and professionals, of negative effects on education and career and of intimacy destroyed create a heavy emotional burden on individuals and relationships.

Breaking the Silence

When I was diagnosed with endometriosis, it changed the course of my life. My partner and I learned to expand our definition of intimacy and to redistribute household responsibilities when I was incapacitated. As the risk of infertility only increases without intervention, we started conversations about having children earlier than anticipated. My diagnosis also led me to focus my professional identity as a medical family therapist to help others deal with endometriosis and chronic illnesses.

Based on this experience, here are some ways to break this silence:

• Learn about endometriosis. It directly helps when one’s support systems are educated.

• Separate the person from the disease. When the pain you are experiencing from endometriosis is debilitating, help those around you who are also affected to understand that it is because of your endometriosis and it is not personal.

• Speak from your own experience, saying, “I …” rather than “You …” When we do this, it decreases the other person’s defenses and opens up the communication, making space for connection.

My research participants shared their own recommendations with me, especially the importance of believing that their pain is real; accept that what they are sharing is their very real experience, and let them know that they are believed.

Bestselling author and social work researcher Brené Brown has said, “Empathy fuels connection, sympathy drives disconnection.” Approaching someone with endometriosis from a position of empathy sends a message that you want to work with them collaboratively.

By practicing these important relationship skills, we can break the silence around endometriosis.

Kristina S. Brown, PhD, is a Marriage and Family Therapist, and Professor and Chair of Couple and Family Therapy at Adler University in Chicago. Dr. Brown is the Editor-in-Chief of the Journal of Feminist Family Therapy and also serves as the Director of Mental Health for Floating Doctors.

This article originally appeared in The Conversation and is republished with permission.

Experimental Fiber Implants Block Nerve Pain with Light

By Pat Anson, PNN Editor

Researchers at the Massachusetts Institute of Technology have developed experimental fiber implants that could potentially be used to deliver pulses of light from inside the body to inhibit nerve pain. Unlike other implants, the hydrogel fibers are flexible and stretch with the body during movement.     

“Current devices used to study nerve disorders are made of stiff materials that constrain movement, so that we can’t really study spinal cord injury and recovery if pain is involved,” said co-author Siyuan Rao, PhD, now an assistant professor of biomedical engineering at the University of Massachusetts at Amherst. “Our fibers can adapt to natural motion and do their work while not limiting the motion of the subject. That can give us more precise information.”

In tests on laboratory mice with genetically modified nerves, researchers used the fiber implants to deliver blue light to the sciatic nerve, which activated the animals’ hind limb muscles.

When pulses of yellow light were used, the light inhibited neuropathic pain in the mice.

For now, MIT engineers see the fibers primarily as a research tool that can help them study the causes and potential treatments of peripheral nerve disorders in animals.

Credit: Sabrina Urbina Villafranca

Neuropathic pain occurs when peripheral nerves are damaged, resulting in tingling, numbness and stinging sensations in the hands and feet. About 20 million Americans suffer from peripheral neuropathy, which can be caused by diabetes, chemotherapy, lupus, HIV, Lyme disease, celiac disease and many other disorders.

“Now, people have a tool to study the diseases related to the peripheral nervous system, in very dynamic, natural, and unconstrained conditions,” said co-author Xinyue Liu, PhD, who is now an assistant professor at Michigan State University. 

The MIT team’s study, recently published in the journal Nature Methods, grew out of a desire to expand the use of optogenetics -- a technique in which nerves are genetically engineered to respond to light. Exposure to specific light waves can either activate or inhibit a nerve, giving scientists a new way to study how nerves work. 

Scientists have used optogenetics in animals to trace nerves involved in a range of brain disorders, including addiction, Parkinson’s disease, and mood and sleep disorders.

Until now, optogenetics has primarily been used in the brain, an organ that lacks pain receptors, which allows for the relatively painless implantation of rigid devices. The MIT team wondered if optogenetics could be expanded to nerves outside the brain to study peripheral nerve pain.  

Because peripheral nerves undergo constant pushing and pulling from adjoining muscles and tissues, they needed more flexible devices that would not constrain movement or cause tissue damage.  

The new optical fibers are made with hydrogel — a rubbery mix of polymers and water – that is soft and flexible. The fiber has two layers; a core and an outer shell that funnel light through the fiber without escaping or scattering. 

When implanted in mice, researchers say the animals were still able to run freely on an exercise wheel. After two months, the fiber was still resistant to fatigue and could transmit light efficiently to trigger muscle contractions. 

“We are focusing on the fiber as a new neuroscience technology,” Liu says. “We hope to help dissect mechanisms underlying pain in the peripheral nervous system. With time, our technology may help identify novel mechanistic therapies for chronic pain and other debilitating conditions such as nerve degeneration or injury.”

Thousands of Artificial Knees and Hips Wear Out Prematurely

By Fred Schulte, KFF Health News

Ron Irby expected the artificial knee implanted in his right leg in September 2018 would last two decades — perhaps longer.

Yet in just three years, the Optetrak implant manufactured by Exactech in Gainesville, Florida, had worn out and had to be replaced — a painful and debilitating operation.

“The surgery was a huge debt of pain paid over months,” said Irby, 71, a Gainesville resident and retired medical technologist with the Department of Veterans Affairs.

Irby is one of more than 1,100 patients suing Exactech after it began recalling artificial knees, hips, and ankles, starting in August 2021. A letter Exactech sent to surgeons blamed a packaging defect dating back as far as 2004 for possibly causing the plastic in a knee component to wear out prematurely in about 140,000 implants.

Many patients argue in hundreds of lawsuits that they have suffered through, or could soon face, challenging and risky operations to replace defective implants that failed.

Although Exactech does not offer an express warranty on its products, the company stresses the durability of its implants in advertising, even suggesting they likely will outlive their human recipients.

RON IRBY

Exactech, which grew over three decades from a mom-and-pop device manufacturer into a global entity that sold for $737 million in 2018, declined comment, citing the “ongoing litigation,” said company spokesperson Tom Johnson. In court filings, Exactech has argued that its products are not defective and have “an excellent history.”

A KFF Health News review of thousands of pages of court filings in patient lawsuits, a pending whistleblower lawsuit, and other government records shows that the company is being accused of downplaying or concealing evidence of product failures from patients and federal regulators for years. In hundreds of instances, according to government records, the company took years to report adverse events to a federal database that tracks device failures.

In his suit, Irby alleges that Exactech “knew or should have known” that the Optetrak “had an unacceptable failure and complication rate.” He said Exactech used packaging materials of “an inferior grade or quality.”

“I think they were cutting corners to improve their bottom line,” Irby told KFF Health News.

Exactech denied the allegations in a legal filing in Irby’s suit, in which it described the Optetrak device as “safe and effective.”

‘Trailblazing’ Implant

Surgeon William “Bill” Petty chaired the orthopedics department at the University of Florida in Gainesville, when he, his wife, Betty, and Gary Miller, a biomedical engineer and fellow faculty member, formed Exactech in November 1985. The Pettys served in corporate roles until retiring in early 2020. Their first hire was their son David in 1988, who remains on Exactech’s board of directors.

Exactech’s fortunes started to take off in 1994, when it inked a major deal to license and market the Optetrak knee implant based on designs by surgeons and engineers at the prestigious Hospital for Special Surgery in New York City. That alliance won Exactech instant credibility in the fiercely competitive device industry.

So did its pedigree as a “surgeon-focused” business with a family-run vibe, small enough that surgeons considering its wares could meet the owners and tour its Florida plant.

Building on that goodwill, Exactech’s sales shot past $124 million in 2007, about half generated by the Optetrak knee system.

“It’s not just a road we’re on, it’s a trail we’re blazing,” the company boasted in sales literature aimed at surgeons.

Exactech’s corporate confidence belies years of warnings and doubts about the durability of the Optetrak, according to whistleblowers — one whistleblower called it an “open secret” inside the company.

Notably, there were concerns about the fragility of a finned tibial tray, one of the four pieces of the knee replacement that fits into the shin bone, according to the whistleblower lawsuit.

For starters, several surgeons complained that the knee implants loosened prematurely, causing patients pain and limiting their ability to move around, court records allege.

While 95% of artificial knees should last at least a decade, surgeons had to pull out and replace many Optetrak components — a complex operation known as revision surgery — much sooner, according to allegations in patient lawsuits.

Optetrak knee implant

Christopher Hutchins, a Connecticut orthopedic surgeon who relied on the Optetrak finned devices for more than 350 knee surgeries, said in a court deposition that some loosened in as little as two to three years. He called that “awfully premature” and “extraordinary.”

Hutchins vented his frustrations in a brief meeting with Exactech co-founder Bill Petty at a Rhode Island hospital in either 2006 or 2007, according to his deposition. Petty told him at the meeting he “realized that it was a problem” with the device, according to Hutchins.

“I was somewhat struck that if they knew there was a problem why it wasn’t being addressed and why the product wasn’t being pulled from the market,” Hutchins testified in the November 2021 deposition.

“There was no disclosure or transparency.”

Older patients not only suffered physical pain, but also felt an “emotional burden” from facing revision surgery in which results often are “not as good as the first go around,” Hutchins explained during his deposition testimony.“I’m in the business to try to make people better, and when things fail, I take it to heart.”

Hutchins was not the only surgeon alarmed by what he says were early failures of the Optetrak devices and the company’s tepid response.

‘Popping Out Right and Left’

In August 2005, Maine orthopedic surgeon Wayne Moody told company officials that Optetrak had loosened and needed to be revised in 25 out of 385 operations he had performed over the previous four years, according to meeting minutes filed in court.

One knee implant gave out in just nine months, Moody told the group, according to the minutes.

In a deposition, Robert Farley, a former Exactech sales agent who filed a whistleblower lawsuit in 2018 alleging fraud by the company, alleged that he heard two colleagues joke about Moody’s tribulations at a national sales conference.

Moody “probably had 50-something revisions. … They’re just popping out right and left,” the sales agent said, according to Farley’s suit.

Fellow whistleblower Manuel Fuentes, a former Exactech senior product manager, testified in a deposition that pulling the product off the market around 2008 “would have been the ethical and moral thing to do.”

At a meeting in early 2008 attended by the company’s top brass, including Bill Petty, the company’s marketing director at the time, Charley Rye, floated the idea of a recall, Fuentes said. Company executives shot that down as “financially detrimental,” Fuentes testified in a sworn declaration filed with the court.

Asked about the meeting during a December 2021 deposition, Petty replied, “I don’t recall that anyone suggested a recall.”

Exactech discussed the loosening problem in an internal memo that said between 2006 and 2009 the company “began to get some negative feedback” about the Optetrak “that was at times confounding and difficult to process,” court records show.

The discouraging reports ranged from complaints of early revisions from at least 10 U.S. surgeons and surgery practices in several of the more than 30 countries where Exactech sold the implant, court records show.

The results did little to dim Exactech’s prospects. From 1994 through April 2022, Exactech sold 58,763 Optetrak devices with finned trays for use by 514 surgeons nationwide, according to an affidavit by a company official.

Many lawsuits argue that instead of warning patients and surgeons about the loosening problem, Exactech replaced the finned tray component in its newest products, a strategy device industry critics refer to as a “silent recall.” Exactech denies that and said in a court filing that design changes it made were part of a “natural evolution” of the Optetrak.

Even as Exactech rolled out newer generations of the Optetrak, the company faced lawsuits and other criticism alleging it had failed to come clean about unusually high surgical revision rates.

Late Reporting to FDA

The Food and Drug Administration runs a massive, public, searchable databank called MAUDE to warn the public of dangers linked to medical devices and drugs.

Manufacturers must advise the FDA when they learn their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that might recur and cause harm.Those reports must be submitted within 30 days unless a special exemption is granted.

But court and government records show that reports of adverse reactions tied to Exactech’s implant sometimes took years to show up in the government database — if they were reported at all.

Exactech failed to advise the FDA of dozens of Optetrak early revision complaints lodged by orthopedic surgeons Moody and Hutchins, a company representative acknowledged in a court filing.

KFF Health News downloaded the FDA data and found about 400 examples in which Exactech reported adverse events to the MAUDE database two years or more after learning of them.

FDA inspectors who combed through Exactech’s internal files in 2017 cited the company for failing to undertake an “adequate investigation” of complaints, according to FDA records cited in court filings.

In court filings, Exactech steadfastly denied Optetrak has any defects. Instead, it blamed the loosening problem on surgeons, saying they had failed to cement the knee implants into place correctly or misaligned them.

The company said it had no obligation to report poor outcomes tied to mistakes by surgeons — even though the FDA requires companies to report injuries involving “user error.” In 2022, a federal judge in the whistleblower case, in denying a motion to dismiss, found that Exactech was “hard-pressed” to claim it was not obligated to report the adverse events.

The three whistleblowers are accusing Exactech of fraud for allegedly selling defective products to Medicare and other federal health care programs. The case is pending in federal court in Alabama and Exactech has denied any wrongdoing. Exactech in mid-August filed a motion to dismiss the case.

Lawyers for more than 300 injured patients suing in Alachua County Circuit Court in Florida are pressing for full disclosure of 2,435 complaints to the company alleging deficiencies with Exactech knee products, which the company admits receiving as of the end of April.

Cutting Corners

In other pending lawsuits, patients argue the company pointedly ignored evidence of chronic safety issues to fuel profits.

Keith Nuzzo, of Litchfield, Maine, is one. He alleged that Exactech “cut corners, utilized inferior manufacturing practices … [and] only disclosed information or took corrective action if contacted by regulatory authorities.”

Nuzzo had a right knee replacement done by orthopedic surgeon Moody in February 2012 and a left knee implanted a week afterward.

His right knee became painful and wobbly about four years later and a second surgeon replaced it in August 2016. The left knee gave out in November 2020, also requiring replacement, according to the suit.

Despite the revisions, Nuzzo lives with “daily knee pain and discomfort,” which limits his “activities of daily living and recreation,” according to the suit. The case is pending. As of mid-September, Exactech had not filed an answer.

In advertising directed at surgeons, Exactech boasts about the long life of its implants.

One sales brochure states that the Optetrak “demonstrated 91-99 percent implant survival rates” over just under a decade. That is consistent with, if not superior to, industry standards, though as a rule of thumb many surgeons expect implants to last 15 to 20 years, sometimes longer.

The mounting legal claims allege many Exactech knee and hip implants have worn out well before their time.

The KFF Health News analysis of more than 300 pending cases in Alachua County found that surgeons removed about 200 implants after less than seven years. Some people in the sample, whose surgeries spanned more than two dozen states, were awaiting revision procedures. In the federal court sample, patients alleged that half of the 400 implants that were removed lasted less than six years.

Advertising materials aside, Exactech is circumspect in describing the reliability of its implants when it speaks to courts. In a 2021 filing, the company noted that the Optetrak comes with no express warranty.

How long it lasts “depends on a multitude of factors, including those pertaining to surgical technique and the particular patient,” the company said.

Consulting Fees

Exactech’s focus on its surgeon customers includes paying handsome consulting fees to some orthopedists who have used the company’s implants in the operating room or promoted them in advertising.

Exactech paid surgeon consultants $23.2 million combined from the start of 2013 through the end of 2022, the most recent year available, according to a government database called Open Payments.

In promoting the Optetrak in sales materials, Exactech touted “excellent results” achieved by orthopedic surgeon Raymond Robinson. Left unsaid: Exactech paid Robinson more than $900,000 in consulting fees and other payments from 2013 through 2022. In a court filing, Exactech denied any consultants “were compensated in exchange for product promotion.” Robinson could not be reached for comment.

Exactech’s sales brochures also boast that surgeons “around the world have documented excellent results with the Optetrak knee system.”

Yet Exactech bottled up a succession of sharply negative reports from other countries, while working to discredit others, according to internal company records filed in court by the whistleblowers.

One surgery group in France concluded in 2012 that nine of 110 Optetrak procedures required revision due to loosening in under three years, for instance. Exactech disputed the findings in a published response, and in a court filing said the conclusions were “based on incorrect information and a flawed understanding of the true causes.”

A hospital in Buenos Aires, Argentina, reported that 25% to 30% of Optetrak knees required revisions in under two years, according to whistleblower Fuentes.

The Australian implant registry criticized Optetrak’s reliability as early as 2007 and in several later years. In response, Exactech executives said in depositions and court filings that they traced many of the poor results to a single hospital and three surgeons who failed to align the implants correctly.

The Australian registry pegged Exactech’s revision rate at 19.4% at seven years and 22% at 10 years, the worst of any knee implant on the market, which led the government health system to stop purchasing it, court records allege. Exactech denied the allegations in a court filing.

James Brooks, a retired Texas orthopedic surgeon, said in a court affidavit that he believed Exactech had an obligation to tell surgeons about the poor outcomes overseas rather than touting rosy results tied to doctors on its payroll.

In the 2021 affidavit, Brooks recalled implanting the Optetrak knee in a Dallas man in 2011, only to confirm from X-rays that it was failing in 2017 and needed to be replaced two years later. Brooks said he would have steered clear of Optetrak had he known of its “much higher failure rate than comparable products.”

‘Dear Patient’

Laura Grandis is suing Ohio orthopedic surgeon and Exactech consultant Ian Gradisar, who received $132,720 from the company, including research payments, from 2013 through 2022, according to government records.

Gradisar’s father, Ivan, also an orthopedic surgeon, served on the original Optetrak design team. In 2008, Ian Gradisar helped his father with an audit of “patient outcomes” commissioned by Exactech. The audit showed that 12 of 47 Optetrak patients operated on over the course of 15 months required revisions, giving the son “first-hand knowledge of the failing and defective Optetrak,” Grandis alleges in her suit.

Ian Gradisar put an Exactech implant in Grandis’ left knee in Akron, Ohio, in November 2020.

In early 2021, she had “severe” pain in her knee and needed a cane or a walker to get around, according to the suit.

Gradisar told her the knee had failed, which he said was “very rare and only happened 5% of the time,” according to the suit.

Grandis had revision surgery in July 2021 with an Optetrak implant. Some seven months later, she felt pain that worsened throughout the day. She tried ice and rest, but that did not work. Her knee hurt when she put weight on it and started making a clicking sound when she moved, according to the suit.

In June 2022, Grandis received a “Dear Patient” form letter from the hospital where her surgery was performed notifying her of the Exactech recall.

Gradisar’s office told her the surgeon could not see her until October 2022 “as he was inundated with phone calls from patients about the Exactech recall,” according to the suit.

In response to the suit, Exactech denied the allegations, including that its knee implants had “increased failure rates.” The case is pending. Gradisar and his lawyer did not respond to requests for comment.

But in a court filing, Gradisar denied any defects in the implant and said he “provided quality care and treatment” to Grandis.

In December 2022, Grandis ended up having a second revision operation that kept her hobbling around on crutches for six weeks, according to her suit.

Total Recall

Two years after the initial recall, Exactech and its owners — past and present — face a rush of lawsuits demanding accountability for alleged patient injuries.

Most of the suits in the Alachua County group name Bill, Betty, and David Petty and Miller as defendants for their roles at Exactech. Their attorney did not respond to requests for comment, but in May, the defendants jointly filed a motion to dismiss, arguing that the suits fail “to allege sufficient facts to impose liability.”

Many suits in the federal court cluster also name as a defendant TPG Capital, a Texas-based private equity firm that paid $737 million to acquire Exactech in February 2018. TPG declined to comment but has filed a motion to dismiss the cases.

In one recall letter sent to surgeons, Exactech acknowledged that the data from the Australian registry confirmed that Optetrak had “statistically significant” higher rates of revisions than knee implants made by other companies — a conclusion it had previously disputed.

The letter adds that Exactech is “uncertain” if the packaging defect is the “root cause” of Optetrak’s poor performance. An FDA “safety communication” issued in March said the agency is working with Exactech to assess whether other implants packaged in the defective bags pose similar risks.

Exactech lawyers say the company may not be to blame for every implant that wears out unexpectedly.

In a November 2022 hearing, Exactech attorney Michael Kanute said wear of polyethylene implant components is a “known risk no matter who makes them.” He said the patient’s size and activity level as well as the technique of the surgeons could also be factors.

“So every case is different,” he said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

Will Thinking About Chronic Pain Differently Help Reduce It?

By Pat Anson, PNN Editor

Want to make your chronic back pain go away?

Then stop thinking about the physical cause of your pain with words like accident, bad posture or disc bulge.

Start attributing the cause of your pain to your own emotions. Use words like anxiety, stress and fear.

That’s the conclusion of a new analysis of an old study that found pain reprocessing therapy (PRT) beneficial in a small group of patients with chronic back pain. PRT is based on the theory that patients can reduce or even stop their pain simply by changing the way they think about it, without the use of drugs, injections or physical therapy.

“Millions of people are experiencing chronic pain and many haven’t found ways to help with the pain, making it clear that something is missing in the way we’re diagnosing and treating people,” says lead author Yoni Ashar, PhD, assistant professor of internal medicine at the University of Colorado Anschutz Medical Campus.

“Our study shows that discussing pain attributions with patients and helping them understand that pain is often ‘in the brain’ can help reduce it.”

Ashar and his colleagues were early proponents of PRT. In a 2021 clinical study, they recruited 151 people with moderate back pain, with an intensity of at least four on a pain scale of zero to 10. Participants assigned to PRT were encouraged to reappraise the severity of their pain and to think about it differently by engaging in movements they were afraid to do. About two-thirds found that helpful in reducing or even eliminating their pain.

In their new study, published in JAMA Network Open, researchers doubled down on their previous study by performing a “secondary analysis” of those same 151 people. Did they attribute their pain to a physical or emotional cause? What words did they use to describe it?

Before PRT treatment, only 10% of participants’ thought their back pain was mind or brain-related. After PRT, about half of them did. And the more they thought about their pain as a mind or brain process, the greater the reduction in pain they reported.

The graphic below demonstrates how participants thought about their pain differently before and after PRT. In a word cloud text analysis of their responses, PRT recipients were more likely to use words like stress and anxiety, and less likely to use words like muscles and injury.

Words Associated with Chronic Pain Before and After PRT

JAMA NETWORK OPEN

“These results show that shifting perspectives about the brain’s role in chronic pain can allow patients to experience better results and outcomes,” Ashar said.

“This study is critically important because patients’ pain attributions are often inaccurate. We found that very few people believed their brains had anything to do with their pain. This can be unhelpful and hurtful when it comes to planning for recovery since pain attributions guide major treatment decisions, such as whether to get surgery or psychological treatment.”

There are a number of caveats to this study. First is the small size. Second, participants had only low to moderate back pain, not the severe intractable pain caused by a spinal injury or disease. Thinking about your pain differently isn’t going to do much good for someone with arachnoiditis or Ehlers Danlos syndrome – and it is worrisome that studies like these are often used to deny patients with severe pain access to effective treatment such as opioid medication.

Third, pain reattribution was only modestly effective (about 9% on average) in relieving pain. Some participants who bought into the idea of thinking differently about their pain had no pain relief, leading the authors to admit that “reattribution alone is not sufficient for pain relief.”

Despite these weaknesses, researchers hope their study will encourage providers to talk to their patients more about the possible causes of their chronic pain.

“Often, discussions with patients focus on biomedical causes of pain. The role of the brain is rarely discussed,” said Ashar. “With this research, we want to provide patients as much relief as possible by exploring different treatments, including ones that address the brain drivers of chronic pain.”

You can learn more about PRT therapy by reading “The Way Out,” a book by psychotherapist Alan Gordon, who uses mindfulness and cognitive behavioral therapy to reduce the fear that many patients have about their pain and its triggers.

How Technology Could Improve Healthcare in Underserved Communities

By Barby Ingle, PNN Columnist 

This year I was fortunate to visit all 15 counties in Arizona, from large cities and rural areas to those considered “frontier” and tribal reservations. I talked to patients, providers and caregivers about the stress points in their access to healthcare. I was in towns with no EMS, no hospital, and no specialists.

Seeing these disparities in healthcare closeup was an eye-opener for me. Imagine being injured or needing surgery, and you must take a helicopter to get immediate care. It’s like living on another planet.  

We can ensure that underserved communities have equal access to healthcare services, regardless of location, by providing remote and rural areas with access to telemedicine. Although the ability to access the internet is still difficult in some areas, services like Elon Musk's Star Link are being utilized to improve healthcare no matter where you live. 

With the recent pandemic, we were able to utilize telemedicine more often and see advancements in digital health solutions. Healthcare professionals can now remotely diagnose, treat and monitor patients from a distance. But will relaxed telehealth rules continue in the same form now that the pandemic has ended? Many of the details are still being worked out.

Mobile applications and wearable devices enable patients to monitor their vital signs and share the data with providers, allowing for remote monitoring and proactive intervention. They can also empower patients to more closely monitor their own health, receive medical advice, and manage chronic conditions from their homes.

With the increased availability of internet connectivity and mobile networks, technology has the potential to revolutionize healthcare delivery and improve health outcomes in remote and underserved regions. Several steps can be taken to address the digital divide in healthcare between urban and rural areas.

First, it is crucial to educate individuals about the benefits of technology and digital health tools. Technology can reduce transportation barriers, provide on-demand health advice, and minimize the risk of exposure to infectious diseases by enabling patients to stay at home.

Second, partnerships between stakeholders, such as academia, the private sector and government can help narrow the digital divide by leveraging resources to place healthcare technology where it is most needed. By building awareness, partnerships and targeting resources, it will be possible to bridge the digital divide and ensure that all communities have access to healthcare technology.

Here are some specific steps that can be taken:

• Conduct a comprehensive needs assessment in underserved communities to understand their unique healthcare challenges, cultural context and technological requirements. A needs assessment can involve surveys, interviews and focus group discussions with community members, healthcare providers and other stakeholders.

• Engage community members, healthcare professionals, and technology experts in a co-design approach. This means collaborating with the community to design and develop healthcare technology solutions that align with its needs, preferences and capabilities.  

• Adopt a user-centered design approach to make sure healthcare technology is user friendly.  Involve people from underserved communities in testing and interface design to ensure the technology is accessible, culturally appropriate and easy to operate.

• Consider the affordability and sustainability of healthcare technology by addressing cost barriers. ensuring compatibility with low-resource settings, and developing tools that can operate with limited infrastructure or connectivity.

• Provide training and support for people to utilize healthcare technology effectively. The training should include digital literacy programs, capacity-building workshops, and ongoing technical assistance.  

By involving underserved communities in the design process, healthcare technology can be tailored to their specific needs, leading to increased adoption and improved healthcare outcomes. It is crucial to prioritize the needs of these communities to ensure that they are included in the design and development of healthcare technology. By doing so, we can create more effective and sustainable solutions that genuinely address the healthcare challenges faced by underserved communities.

I am grateful for the opportunity to talk to patients, providers and caregivers in Arizona, thanks to a grant from HealtheVoices, Respond & Rescue, KB Companies and the International Pain Foundation. I look forward to continuing to gather feedback from underserved communities nationwide. By listening to patients and understanding their unique healthcare challenges, we can work towards creating meaningful solutions that improve access to care and overall health outcomes. 

Barby Ingle is a reality TV personality living with multiple rare and chronic diseases. She is a chronic pain educator, patient advocate, motivational speaker, and best-selling author on pain topics. You can follow Barby at www.barbyingle.com. 

FDA Recalls Abbott Stimulators for Technical Malfunction

By Pat Anson, PNN Editor

After receiving reports of dozens of injuries, the Food and Drug Administration has issued a Class I recall for two models of implantable neurostimulators due to a technical malfunction. The recall affects over 155,000 of Abbott’s Proclaim and Infinity devices, which are primarily used in spinal cord and deep brain stimulation.

Although Class I recalls are the most serious type of recall because they may result in injuries or death, patients are not being advised at this time to have the devices surgically removed. The stimulators were implanted in some patients as far back as 2015.

The malfunction occurs when the devices are temporarily turned off when a patient is having magnetic resonance imaging (MRI). There have been 186 complaints of patients being unable to turn the devices back on once the MRI ends, resulting in a loss of therapy and 73 injuries. No deaths have been reported.

In July, Abbott sent an “urgent medical device correction” letter to healthcare providers who install the devices, to clarify instructions on how to exit MRI mode.

The letter also advises providers to tell patients not to delete their device controller’s connection to Bluetooth if a malfunction occurs, and to update their systems and consult with a physician before having an MRI scan.   

ABBOTT IMAGE

Abbott estimates that only about 0.06% of the recalled devices malfunctioned, with 0.03% of them resulting in loss of therapy and additional surgery.   

The following devices are included in the recall:

• Proclaim XR 5 IPG Model 3660 (previously known as the ‘Proclaim 5 Elite IPG Model 3660’)

• Proclaim XR 7 IPG Model 3662 (Previously known as the ‘Proclaim 7 Elite IPG Model 3662’)

• Proclaim Plus 5 IPG Model 3670

• Proclaim Plus 7 IPG Model 3672

• Proclaim DRG IPG Model 3664

• Infinity 5 IPG Model 6660

• Infinity 7 IPG Model 6662

Implantable neurostimulators are an invasive treatment of last resort for people with chronic back, leg or head pain. The devices are surgically implanted near the spine or brain, and emit low-level electrical impulses to block pain signals.

About 50,000 spinal cord stimulators (SCSs) are implanted annually in the U.S. and their use is growing – in part because of the belief they’ll reduce the need for opioids and other pain therapies. A recent study found that many patients with stimulators did not reduce their use of opioids, epidurals, corticosteroid injections or radiofrequency ablation; and about one in five had complications so severe the devices had to be removed or revised.

A 2018 study found that SCSs have some of the worst safety records of medical devices tracked by the FDA. An FDA review of adverse events involving stimulators found that nearly a third were reports of poor pain relief. The review also identified nearly 500 deaths linked to the devices, along with nearly 78,000 injuries and 30,000 malfunctions.

Virtual Reality Has Long-Term Benefits for Patients with Back Pain

By Pat Anson, PNN Editor

A novel treatment that combines virtual reality with cognitive behavioral therapy significantly reduced pain levels and other symptoms in patients with chronic back or neck pain, according to results of a new study presented at the annual meeting of the Congress of Neurological Surgeons.

Unlike other therapies using virtual reality (VR) – which temporarily distract people from their pain – patients in this study had long term reductions in their pain, anxiety and depression. This suggests that combining VR with cognitive behavioral therapy (CBT) induces neuroplasticity, a “rewiring” of the brain and nervous system that reduces the impact of physical and emotional trauma.    

“What we found is it actually creates new neural pathways to form, what's called neuroplastic reprogramming or neuroplastic change, and that actually creates a more resilient patient,” said co-author Gerry Stanley, MD, Chief Medical Officer of Harvard MedTech, a medical device company that offers VR therapy.

“The patient who may be thinking about their pain 22 hours a day, and their pain (level) has always been eight or nine, now thinks about their pain one or two hours a day and their pain (level) is a three or four, because the brain is no longer fixating on it. So it allows for, I don't want to say permanent distraction, it’s really neuroplastic reprogramming.”

Stanley and his colleagues enrolled 145 patients with non-operative degenerative neck or back pain in Harvard MedTech’s Vx Therapy program, which included daily virtual reality sessions for 14 weeks and weekly telephone calls with a therapist trained in CBT.  

Unlike other VR therapies, which encourage physical activity, participants sat stationary in a chair while watching and listening to prerecorded programs with a headset and earphones. The VR programs come in four categories that emphasize education, meditation, distraction or entertainment, depending on the patient’s needs and goals.

HARVARD MEDTECH IMAGE

After 14 weeks, results showed that Vx Therapy reduced pain and anxiety during sessions by an average of 33% and 46%, respectively. The duration of pain relief also increased over time, from 2.5 hours in the first weeks of treatment to 4.5 hours in the final weeks.

The study has not been peer-reviewed or published yet, but Stanley says the findings mirror what his company has learned after treating about 4,000 patients. The benefits of Vx Therapy continue long after the treatment ends, with many patients still reporting improvement after two years.  

“They're often reporting the same level of resiliency. I think a lot of it is they start getting into better sleep patterns,” he told PNN.  “And they really get good at meditation. Most people fail in meditation because of distractions. But when they're doing it in the virtual reality, they get very good at it. So they really develop some nice, I'm going to say muscle memory, even though I know it's cognitive. But they do develop a little bit of muscle memory around the meditation.”

Because Vx Therapy is done remotely, it’s available to any patient regardless of location, as long as they have a prescription. Some worker compensation insurers cover the treatment.   

Previous studies have also suggested that virtual reality therapy has long-term benefits for people with chronic back pain. A 2022 study showed that people with moderate lower back pain reported improvements in pain, function, mood and sleep six months after treatment ended.  

ChatGPT Is Replacing Dr. Google

By Andrew Leonard, KFF Health News

As a fourth-year ophthalmology resident at Emory University School of Medicine, Riley Lyons’ biggest responsibilities include triage: When a patient comes in with an eye-related complaint, Lyons must make an immediate assessment of its urgency.

He often finds patients have already turned to “Dr. Google.” Online, Lyons said, they are likely to find that “any number of terrible things could be going on based on the symptoms that they’re experiencing.”

So, when two of Lyons’ fellow ophthalmologists at Emory came to him and suggested evaluating the accuracy of the AI chatbot ChatGPT in diagnosing eye-related complaints, he jumped at the chance.

In June, Lyons and his colleagues reported in medRxiv, an online publisher of health science preprints, that ChatGPT compared quite well to human doctors who reviewed the same symptoms — and performed vastly better than the symptom checker on the popular health website WebMD.

And despite the much-publicized “hallucination” problem known to afflict ChatGPT — its habit of occasionally making outright false statements — the Emory study reported that the most recent version of ChatGPT made zero “grossly inaccurate” statements when presented with a standard set of eye complaints.

The relative proficiency of ChatGPT, which debuted in November 2022, was a surprise to Lyons and his co-authors. The artificial intelligence engine “is definitely an improvement over just putting something into a Google search bar and seeing what you find,” said co-author Nieraj Jain, an assistant professor at the Emory Eye Center who specializes in vitreoretinal surgery and disease.

But the findings underscore a challenge facing the health care industry as it assesses the promise and pitfalls of generative AI, the type of artificial intelligence used by ChatGPT: The accuracy of chatbot-delivered medical information may represent an improvement over Dr. Google, but there are still many questions about how to integrate this new technology into health care systems with the same safeguards historically applied to the introduction of new drugs or medical devices.

The smooth syntax, authoritative tone, and dexterity of generative AI have drawn extraordinary attention from all sectors of society, with some comparing its future impact to that of the internet itself. In health care, companies are working feverishly to implement generative AI in areas such as radiology and medical records.

When it comes to consumer chatbots, though, there is still caution, even though the technology is already widely available — and better than many alternatives. Many doctors believe AI-based medical tools should undergo an approval process similar to the FDA’s regime for drugs, but that would be years away. It’s unclear how such a regime might apply to general-purpose AIs like ChatGPT.

“There’s no question we have issues with access to care, and whether or not it is a good idea to deploy ChatGPT to cover the holes or fill the gaps in access, it’s going to happen and it’s happening already,” said Jain. “People have already discovered its utility. So, we need to understand the potential advantages and the pitfalls.”

The Emory study is not alone in ratifying the relative accuracy of the new generation of AI chatbots. A report published in Nature in early July by a group led by Google computer scientists said answers generated by Med-PaLM, an AI chatbot the company built specifically for medical use, “compare favorably with answers given by clinicians.”

AI may also have better bedside manner. Another study, published in April by researchers from the University of California-San Diego and other institutions, even noted that health care professionals rated ChatGPT answers as more empathetic than responses from human doctors.

Indeed, a number of companies are exploring how chatbots could be used for mental health therapy, and some investors in the companies are betting that healthy people might also enjoy chatting and even bonding with an AI “friend.” The company behind Replika, one of the most advanced of that genre, markets its chatbot as, “The AI companion who cares. Always here to listen and talk. Always on your side.”

“We need physicians to start realizing that these new tools are here to stay and they’re offering new capabilities both to physicians and patients,” said James Benoit, an AI consultant. While a postdoctoral fellow in nursing at the University of Alberta in Canada, he published a study in February reporting that ChatGPT significantly outperformed online symptom checkers in evaluating a set of medical scenarios. “They are accurate enough at this point to start meriting some consideration,” he said.

A ’Band-Aid’ Solution

Still, even the researchers who have demonstrated ChatGPT’s relative reliability are cautious about recommending that patients put their full trust in the current state of AI. For many medical professionals, AI chatbots are an invitation to trouble: They cite a host of issues relating to privacy, safety, bias, liability, transparency, and the current absence of regulatory oversight.

The proposition that AI should be embraced because it represents a marginal improvement over Dr. Google is unconvincing, these critics say.

“That’s a little bit of a disappointing bar to set, isn’t it?” said Mason Marks, a professor and MD who specializes in health law at Florida State University. He recently wrote an opinion piece on AI chatbots and privacy in the Journal of the American Medical Association.

“I don’t know how helpful it is to say, ‘Well, let’s just throw this conversational AI on as a band-aid to make up for these deeper systemic issues,’” he said to KFF Health News.

The biggest danger, in his view, is the likelihood that market incentives will result in AI interfaces designed to steer patients to particular drugs or medical services. “Companies might want to push a particular product over another,” said Marks. “The potential for exploitation of people and the commercialization of data is unprecedented.”

OpenAI, the company that developed ChatGPT, also urged caution.

“OpenAI’s models are not fine-tuned to provide medical information,” a company spokesperson said. “You should never use our models to provide diagnostic or treatment services for serious medical conditions.”

John Ayers, a computational epidemiologist who was the lead author of the UCSD study, said that as with other medical interventions, the focus should be on patient outcomes.

“If regulators came out and said that if you want to provide patient services using a chatbot, you have to demonstrate that chatbots improve patient outcomes, then randomized controlled trials would be registered tomorrow for a host of outcomes,” Ayers said.

He would like to see a more urgent stance from regulators.

“One hundred million people have ChatGPT on their phone,” said Ayers, “and are asking questions right now. People are going to use chatbots with or without us.”

At present, though, there are few signs that rigorous testing of AIs for safety and effectiveness is imminent. In May, Robert Califf, the commissioner of the FDA, described “the regulation of large language models as critical to our future,” but aside from recommending that regulators be “nimble” in their approach, he offered few details.

In the meantime, the race is on. In July, The Wall Street Journal reported that the Mayo Clinic was partnering with Google to integrate the Med-PaLM 2 chatbot into its system. In June, WebMD announced it was partnering with a Pasadena, California-based startup, HIA Technologies Inc., to provide interactive “digital health assistants.” And the ongoing integration of AI into both Microsoft’s Bing and Google Search suggests that Dr. Google is already well on its way to being replaced by Dr. Chatbot.

KFF Health News is a national newsroom that produces in-depth journalism about health issues.