Drug and Medical Supply Shortages Impacting Patient Safety at ‘Alarming Rate’

By Pat Anson, PNN Editor

Over half of U.S. hospitals are reporting shortages of drugs and supplies used in anesthesia, pain management and emergency care, according to a new survey by a nonprofit healthcare organization. Nearly nine of out of ten (86%) respondents said they were rationing or restricting the use of medications in short supply.

The survey of nearly 200 hospital administrators, pharmacists and supply chain managers was conducted by the Emergency Care Research Institute (ECRI) in July.

“Their responses suggested that providing safe and appropriate drugs, supplies, and equipment has become extremely challenging and led to numerous instances of unsafe practices, compromised care, and potentially harmful errors. Many of the respondents clearly communicated their struggles to address shortages which are occurring at an alarming rate,” the ECRI report said.

Respondents reported shortages of over 20 drugs, single-use supplies, or medical equipment. The shortages primarily affect surgery and anesthetics (74%), emergency care (64%), pain management (52%), cardiology (45%), hematology and oncology (44%), infectious diseases (39%), and obstetrics and gynecology (37%).

“While medication and supply shortages have been widely reported across healthcare, we now know with certainty that these shortages are causing preventable harm and have the potential to cause even more if they are not addressed soon,” Marcus Schabacker, MD, president and CEO of ECRI, said in a statement.

“There are strategies hospitals can use to reduce the impact of shortages, but they are a deviation from standard practice and resource-intensive -- two characteristics that themselves can increase the likelihood of preventable harm.”

Many hospitals (42%) are stretching supplies by using medications after their expiration date, reusing single-use devices, or using drugs for purposes outside of their specific labeling. Nearly a quarter of respondents (24%) said they knew of at least one medical error related to a drug, supply or device shortage.

Specific examples of how shortages have impacted patient care include:

• Interruption or delays in chemotherapy

• Use of more opioid analgesia due to lidocaine shortages

• Incorrect medication instructions given to patients

• Postponement or cancellation of surgeries 

To address shortages of masks, gowns and other personal protective equipment, many hospitals have turned to non-traditional sources that supplied products with “alarmingly poor performance,” according to ECRI.

For example, tests on KN95 masks obtained from nontraditional suppliers found that up to 70% did not filter particulates the way manufacturers claimed. And tests on disposable gowns revealed that over half failed to meet even minimum standards for protection.

“The extent to which medication, supply, and equipment shortages are negatively impacting patient care is inexcusable,” said Rita Jew, PharmD, president of the Institute for Safe Medication Practices, an ECRI affiliate. “While pharmacies and hospitals can triage shortages short-term, we need long-term, nationally coordinated solutions to solve the persistent shortages we’ve witnessed repeatedly over the last several years.”

Supply Interruptions

Many respondents also expressed concern about drug shortages worsening after a Pfizer plant in North Carolina was heavily damaged in July by a tornado. The Rocky Mount plant was a leading supplier of sterile injectable drugs used in surgery, pain management and emergency care. Pfizer recently resumed production at the plant, but doesn’t expect full operations to be restored until later in the year.     

“While manufacturing has resumed, it is important to note that some medicines may not be back in full supply until next year,” the company said in a statement.

The American Society of Health-System Pharmacists (ASHP) recently expanded its shortage list for injectable morphine to include morphine vials made by Pfizer. The company said the vials are on back order and could not estimate a release date. The lack of supply is having a snowball effect on other drug manufacturers, who say they’re running out of injectable morphine and hydromorphone due to increased demand.

The ASHP recommends that providers use “extreme caution” when switching morphine concentrations or interchanging them with other injectable opioids because patients could react to them differently.

Limited supplies of morphine, hydromorphone and other injectable opioids were being reported long before the tornado damaged Pfizer’s plant or the pandemic disrupted the global supply chain. Despite that, the Drug Enforcement Administration has aggressively cut the supply of many opioids, reducing production quotas for hydromorphone by 71% and morphine by 65% from their peaks in 2016.       

GRAPHIC COURTESY OF MONTY GODDARD

The Food and Drug Administration put injectable morphine and hydromorphone on its drug shortage list in 2017, the year after DEA started cutting the opioid supply.  In recent months, the ASHP added oxycodone and hydrocodone tablets to its drug shortage list, but their limited supply has not yet been acknowledged by the FDA.

A recent federal lawsuit accused the DEA of “incompetence” in its handling of the nation’s drug supply, specifically the production quotas the agency sets for amphetamines used in ADHD medication.

Drug makers are required to report shortages and supply interruptions to the FDA. Doctors, pharmacies and consumers can also report them by email to the FDA at drugshortages@fda.hhs.gov. To report a drug shortage to the ASHP, click here.

Woman Files Civil Rights Lawsuit Over Denial of Pain Treatment

By Madora Pennington, PNN Columnist

In September of 2022, millions watched Tara Rule’s emotional video on TikTok, about a doctor who refused to give her a non-narcotic pain medication because it might cause birth defects. The doctor would not even name the drug, even though Rule told him she has no intention of having children because she has Ehler's Danlos syndrome (EDS), a genetic disorder that causes severe health issues.

The 32-year old Rule recently filed a civil rights lawsuit to better establish the illegality of refusing medical treatment to women simply because they are of childbearing age.

Rule’s fight began when neurologist Jonathan Braiman, MD, steered her away from an effective treatment for her agonizing cluster migraines, a common symptom of EDS. According to Yale Medical School, cluster headaches can hurt more than childbirth.

When Rule realized she was being discriminated against by her doctor, she surreptitiously switched on her cell phone to record their discussion, which is legal in New York state. 

Brainman can be heard in the recording asking Rule intrusive questions about her sex life, while ignoring her answers. Rule explained that she was already on a medication that can cause birth defects -- known as teratogenic drug -- and wasn't well enough to have children anyway.

Brainman patronizingly told her she might change her mind if she were to become pregnant. He recommended that she bring in her boyfriend to consent to any treatment that might cause birth defects. Rule left without getting the pain relief she needed for her migraines.

In the parking lot of Albany Medical Center, where the appointment took place, a distraught and tearful Rule made the video and posted it online. Her raw emotion and disturbing story quickly went viral, not only on social media, but in news stories.

In her lawsuit against Braiman and Albany Medical, Rule alleges she was retaliated against by the hospital system. Rule says she was ejected from an unaffiliated urgent care center because Albany Medical had told other hospitals not to treat her. She believes this was a violation of her medical privacy.  

Rule suspects she was blacklisted by other providers in her area. She tried to make an appointment with another neurologist, but was told she was “not an appropriate patient.” Her primary care provider sent a back-dated letter to Rule and her mother saying he was dismissing them as patients. That doctor gave no valid reason for the patient abandonment.

TARA RULE (TIKTOK)

Rule is on disability and lives on less than $1,000 per month. Being banned as a patient is a real hardship.

“Now I have to go to Connecticut to see physicians in a different hospital system. Or travel three and a half hours to New York City. With hotels and gas, it’s very hard. Some of these specialists outside the state are not fully covered by my insurance,” Rule said.

Traveling is made more complicated because Rule can’t stay just anywhere — she needs accessible hotel rooms. And she is accumulating thousands of dollars in debt.

After posting her video, Rule heard from many other patients who have also been discriminated against by their doctors. She felt motivated to find out what legal remedies existed.

With legal guidance, Rule wrote the civil rights complaint herself in what is known as a “federal question” lawsuit, an action that seeks to clarify a constitutional issue in US federal court. Rule has been advised that the medical care she sought does not fall under “conscience protections,” which allow doctors to refuse treatment on religious or moral grounds.  

In preparation for her lawsuit, Rule obtained her medical and insurance records, to help prove that privacy violations occurred. She discovered she had been billed for services not received, and believes her medical records were forged.

Albany Medical did not respond to a request for comment.

Rule’s lawsuit is potentially precedent-setting. It marks the first federal question case against a medical provider for refusing to provide teratogenic drugs because a woman is of “childbearing age.” Refusing to give routine medical care because a patient might get pregnant is discrimination. Patients cannot be forced into unnecessary restraints on their care.

"I am prepared for whatever happens,” says Rule, who is hopeful her lawsuit will help prevent other patients from being discriminated against by their doctors. 

Madora Pennington is the author of the blog LessFlexible.com about her life with Ehlers-Danlos Syndrome. She graduated from UC Berkeley with minors in Journalism and Disability Studies. 

‘I’m Still in Pain’: A Patient’s Long Wait to See a Specialist

By Molly Castle Work, KFF Health News

Teresa Johnson can’t escape the pain. It’s as if she’s getting pierced by needles all over her body, all at once. At night, she sometimes jolts out of sleep thinking bedbugs are attacking her. But it’s just the unfailing pain — day in and day out.

Johnson, 58, said her ordeal started in September 2022, when she went for a CT scan of her abdomen after a bout of covid-19. Though Johnson warned the lab she was allergic to iodine, she believes the lab tech used it in an injection, triggering an allergic reaction. She spent the next three weeks in the hospital, feeling as if her body was on fire.

When she was discharged to her home at the base of the San Jacinto Mountains in Riverside County, Johnson said, her quality of life deteriorated and her frustration mounted as she waited for her Medi-Cal plan to get her assessed by a specialist. She could barely walk or stand, she could no longer cook for herself, and sometimes she couldn’t even lift her leg high enough to step into the tub.

“I would never wish this on anybody,” Johnson said while rocking back and forth on the couch to still the pain. “You don’t know if you should cry, or just say OK, I can make it through this. It messes with you mentally.”

Johnson said her primary care doctor told her he wasn’t sure what triggered the pain but suspects it was compounded by the lingering effects of covid.

Johnson, who is diabetic, developed neuropathy, a type of nerve damage, possibly after the allergic reaction caused her blood sugar levels to skyrocket, her doctor told her.

He referred Johnson, who receives care through California’s Medicaid program for low-income people, to an endocrinologist in March.

But Johnson said she was not offered timely appointments, and it took more than six months, four referrals, multiple complaints to her health plan, and a legal aid group’s help to finally snag a phone call with an endocrinologist in mid-September.

TERESA JOHNSON

Access to specialists — from gastroenterologists to cardiologists — has been a long-standing challenge for many Medi-Cal patients, especially those in rural areas or regions facing staff shortages. The Inland Empire, where Johnson lives, has the second-lowest supply of specialists in the state, according to the California Health Care Foundation.

The state Department of Managed Health Care, which regulates most Medi-Cal health plans, requires plans to get patients in to see specialists within 15 business days, unless a longer waiting time would not harm the patient’s health. But the timeline often looks very different in reality.

“It’s hard to get a specialist to contract for Medi-Cal patients. Period,” said Amanda Simmons, executive vice president of Integrated Health Partners of Southern California, a nonprofit organization that represents community health clinics. “Specialists don’t want to do it because reimbursement rates are so low.”

Johnson said she made her first call in March to the endocrinologist assigned by her Medi-Cal insurer, Inland Empire Health Plan, and that the office offered her an appointment several months out. Over the next four months, she received three more referrals, but she said she got a similar response each time she called. When Johnson objected to the lengthy wait times, requesting earlier appointments, she was told there was no availability and that her condition wasn’t urgent.

“They told me it wasn’t important,” Johnson said. “And I asked, ‘How would you know? You’ve never seen me.’”

Esther Iverson, director of provider communications for the plan, declined to speak about Johnson’s case but said the plan makes every effort to meet the 15-day requirement. It can be challenging to meet the standard, she said, due to a lack of available physicians — especially for certain specialties, such as endocrinology and pain management.

She pointed to the nationwide physician shortage, which is more pronounced in rural areas, including parts of San Bernardino and Riverside counties, where the plan operates. She also noted that many physicians decided to leave the field or retire early due to burnout from the covid pandemic.

At the same time, she said, the plan’s enrollment ballooned to 1.6 million as eligibility expanded in recent years. Statewide, more than 15 million Californians are enrolled in Medi-Cal.

“The highest priority for us is timely access to quality care,” Iverson said.

‘I’m So Burned Out’

During her quest, Johnson enlisted the help of Inland Counties Legal Services, which provides free legal representation to low-income residents. They called the plan multiple times to request earlier appointments but got mired in bureaucratic delays and waiting periods.

In one instance in August, after the insurer told Johnson it couldn’t meet the 15-day time frame, her legal representative, Mariane Gantino, filed an appeal, arguing that Johnson’s request was urgent. The insurer’s medical director responded within a few hours denying the claim, saying the plan concluded that her case was not urgent and that a delay would not cause a serious threat to her health.

“I’m so burned out after dealing with this for so long,” Johnson said in mid-September. “Why do they have the 15-day law if there aren’t going to be any consequences?”

A few days later, Johnson finally received the call she had been waiting for: an offer of a phone appointment with an endocrinologist, on Sept. 18. During the appointment, the doctor adjusted her diabetes and other medications but didn’t directly address her pain, she said.

“I’m in the same position,” Johnson said. “I’m still in pain. What’s next?”

Over the years, Johnson has worked a variety of jobs — from driving eighteen-wheelers cross-country to weaving hair — but her most consistent work was as a caregiver, including to her six children, 21 grandchildren, and three great-grandkids, with another great-grandchild on the way. Now, because of her extreme pain, the roles have been reversed. A daughter and granddaughter who live with her have become her full-time caregivers.

“I can’t do nothing. I can’t take care of my grandkids like I used to,” said Johnson, who sleeps most of the day and wakes up only when her pain medication wears off. “I was planning to take care of the new baby that’s coming. I probably can’t even hold her now.”

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. 

Genetic Variations Involved in a Third of CRPS Cases

By Pat Anson, PNN Editor

Chronic Regional Pain Syndrome (CRPS) is one of the worst and most baffling of pain conditions. It usually starts after an injury to an arm or leg, with the skin in the affected area becoming warm, red and painful to touch. Most cases are mild and people recover after a few months, but in rare cases the condition grows worse, resulting in intense nerve pain that can spread and last for years.

Why do some people develop CRPS, while others get better? A small new study in the UK suggests that a genetic variant may be responsible for about a third of CRPS cases.

Researchers at the University of Cambridge took blood samples from 84 patients enrolled in the CRPS-UK Registry to look for variations in certain genes known as single nucleotide polymorphisms, or SNPs for short. Their DNA was compared to a control group of patients with chronic pain from fibromyalgia and low back pain.

Their findings, recently published in the Journal of Medical Genetics, show that an SNP in 4 genes (ANO10, P2RX7, PRKAG1 and SLC12A9) was “more common than expected” in patients with CRPS for at least a year (CRPS-1) than it was in the fibromyalgia/back pain group.

In all, 25 of the 84 patients (30%) with CRPS-1 had the variations in at least 1 of the 4 genes. None of the variations was found in the control group.

Interestingly, men with CRPS were more likely to have the variations (57%) than women (24%), although the sample sizes are so small the discrepancy will need to be confirmed in a larger study. In real life, women are more likely to have CRPS than men.

“This raises the possibility of different mechanisms of disease in males and females in CRPS-1 and that therapeutic responses may also be influenced by sex,” wrote lead author C. Geoffrey Woods, a clinical geneticist at the Cambridge Institute for Medical Research.  “Our data support an underlying genetic predisposition to CRPS-1 in up to a third of cases, with this effect being most prominent in males.”

There may be a biological explanation for the findings, because the ANO10, P2RX7and SLC12A9 genes are found in immune cells of the peripheral nervous system, which becomes inflamed by CRPS.

All 4 genes are also expressed in macrophages — a type of white blood cell involved in the immune response of healthy people. This suggests that variations in those 4 genes may be what triggers CRPS, which is also known as Reflex Sympathetic Dystrophy (RSD).

CRPS/RSD is difficult to treat and there is no known cure. Some patients have found relief through Scrambler therapy and ketamine infusions.

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.

Lawsuits Accuse DEA of ‘Incompetence’ in Regulating Drug Supply

By Pat Anson, PNN Editor

Two federal lawsuits accuse the Drug Enforcement Administration of incompetence and heavy-handed regulation of the nation’s drug supply, which could worsen shortages of ADHD medication and drive a drug manufacturer and specialty pharmacy out of business.

At issue is the DEA’s enforcement of the Controlled Substances Act (CSA), a federal law that gives the agency broad authority to limit the production and sale of opioids, ADHD drugs and other controlled medications that have the potential for abuse. Under the CSA, the DEA decides who can write and dispense prescriptions for hundreds of controlled substances and the amount that drug makers can produce.   

“They shouldn't be playing God with people's medications. And really, that's what's happening here,” says attorney Jim Walden, who recently filed a lawsuit in the Second Circuit Court of Appeals on behalf of Ascent Pharmaceuticals, a leading producer of generic drugs used to treat attention deficit hyperactive disorder (ADHD), a condition that primarily affects children.

By its own estimate, Ascent produces about 20% of the nation’s supply of generic ADHD medication. In its 12-year history, Ascent had never been accused of a regulatory violation or faced any sanctions, so it was surprised to learn on September 29 that DEA would not renew its production quota for ADHD drugs because it has doubts about the company’s record keeping.

“After reviewing these records, DEA lacks confidence in the data provided by Ascent in its quota requests,” the agency said in its denial.

Ascent’s lawsuit disputes that claim, saying DEA investigators spent 18 months “bumbling about” its business records, without ever making clear what they were concerned about or why the quota was denied.

“The Quota Denial nowhere explains the basis for DEA’s alleged confidence gap. If that detail resides in the administrative complaint served alongside the Quota Denial, DEA should be embarrassed: the errors in it reveal a fundamental inaptitude with DEA’s own recordkeeping requirements,” the lawsuit alleges.

“This case highlights the perils of a hapless administrative agency, which (ironically) acknowledged the scarcity of ADHD medications on the very day it effectively sought to shutter Ascent, a company with a time-proven capability of quickly getting medicine to children in need. Ascent and patients have been victimized by DEA’s incompetence, having rendered an arbitrary, capricious, and unsubstantiated quota denial based on erroneous conclusions.”

Before going into private practice, Walden spent 10 years as a federal prosecutor, often handling DEA cases. He’s asking the federal appeals court to issue an emergency injunction that forces DEA to approve Ascent’s quota application.

“We're in the middle of a national scarcity crisis that is really putting children at risk. So it's very, very hard to understand what could possibly be motivating DEA, because they're obviously not alleging that there are quality control problems with the drugs or that there's a threat of diversion,” Walden told PNN. “So, by definition, their decision is arbitrary and it should be reversed.”

The DEA’s actions do seem puzzling. Shortages of ADHD drugs began in the early stages of the pandemic and have steadily worsened, as more children and adults sought mental health treatment. Yet in December of last year, when the DEA issued its quotas for 2023, the agency said there was no need to increase production because the supply of Adderall and other stimulants was sufficient to meet demand.

“The majority of the manufacturers contacted by DEA and/or FDA have responded that they currently have sufficient quota to meet their contracted production quantities for legitimate patient medical needs,” the DEA said in the Federal Register. “Based on this trend, DEA has not implemented an increase.”

A few months later, DEA and FDA officials changed their tune. In an unusual joint letter,  FDA commissioner Dr. Robert Califf and DEA Administrator Anne Milgram admitted there was an ADHD shortage, blamed drug makers for not making enough medication, and washed their hands of the problem.

“This is not a problem that the FDA and DEA can solve on our own,” Califf and Milgram wrote. “The FDA and DEA do not manufacture drugs and cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug.” 

DEA production quotas may also be partially responsible for shortages of opioid pain medication. In recent years, the agency has aggressively cut the supply of many opioids, leading to current shortages of hydrocodone and oxycodone.     

Judge, Jury and Executioner

The second lawsuit against DEA involves Simfa Rose Pharmacy, a Pembroke Pines, Florida pharmacy that specializes in making drugs for seniors, palliative care, and cancer patients.

Simfa Rose came under scrutiny nearly three years ago when investigators saw it was filling an unusual number of high-dose, immediate release opioid prescriptions, often in combination with stimulants and muscle relaxants. Some of the prescriptions were paid for in cash.

As far the DEA is concerned, these were signs of “multiple red flags of abuse or diversion” that posed “an imminent danger” to public health. On May 2 of this year, DEA suspended the pharmacy’s license to dispense controlled substances, a move that severely impacts its ability to continue operating.

“It’s affected them greatly. It’s a miracle they are still open at this point,” says Vittorio Penza, a lawyer for Simfa Rose.

Under DEA rules, there is only one recourse for a pharmacy or doctor to challenge a license suspension – an appeal to a DEA Administrative Law Judge. Such appeals are not only time consuming; they are rarely granted. The few that are granted are referred back the DEA Administrator, who then has the final say on whether the license is restored or permanently revoked.

The Simfa Rose lawsuit alleges this is an “unconstitutional administrative process” that denies the pharmacy due process.

“It’s totally nuts what they are doing. You have a judge, jury and executioner system. It’s all in secret. They don’t publish anything until it’s a decision that’s favorable to them. You’re kept in the dark by it,” Penza told PNN. “All you have to do is take someone's license, whether they need it or not. You're still screwed and you're going to go down. Because once your reputation is tainted, you lose your customers and you lose the patients.”

Penza says the expert witness hired by DEA to review the pharmacy’s practices made outrageous claims.

“Their expert says you can't fill immediate release opioids more than two times. If you are a cancer patient or someone on their deathbed, it doesn't matter. It's an unresolvable red flag if you give someone an immediate release opioid,” he said. “And the kicker is he doesn't even look at what the patient's diagnosis is. One of the patients was shot was shot in the back, the bullet is still lodged in there. The other one was wounded overseas in the Gulf War.”

Perhaps the biggest challenge faced by someone seeking to reverse a DEA decision is that federal agencies have sovereign immunity – they can’t be sued for monetary damages. All they can do is challenge the DEA’s statutory authority under the Controlled Substances Act and its use of an in-house “kangaroo court” to keep pharmacies, doctors and drug makers in line.        

“I've come to realize that this is a nationwide issue. I've been getting calls ever since we filed from around the country. It pains me to hear some of these stories of doctors and nurses and pharmacists that have just been stripped of their livelihoods because of what the DEA is doing,” Penza said.  

Lack of Education Is Fueling Overdose Crisis

By Pat Anson, PNN Editor

Anti-opioid activists have long claimed that excessive prescribing of opioids over a decade ago created an “epidemic of addiction” that lingers to this day. Once hooked on prescription opioids, patients turned to stronger and more lethal drugs — like heroin and illicit fentanyl — sending the overdose rate to record levels.

A large new study debunks that theory, showing that socioeconomic factors – particularly lack of education -- play a hidden but central role in the overdose crisis.

"The analysis shows that the opioid crisis increasingly has become a crisis involving Americans without any college education," said lead author David Powell, PhD, a senior economist at RAND, a nonprofit research organization. "The study suggests large and growing education disparities within all racial and ethnic groups --- disparities that have accelerated since the beginning of the COVID-19 pandemic."

Powell looked at data from the National Vital Statistics System from 2000 to 2021, and identified over 912,000 fatal overdoses for which there was education information on the people who died.

His findings, published in JAMA Health Forum, show that overdose deaths increased sharply among Americans without a college education and nearly doubled in recent years for those who don’t have a high school diploma. The findings are notable because they came during a period when per capita consumption of prescription opioids plummeted, sinking to levels last seen in 2000.

For people with no college education, the overdose death rate increased from 12 deaths per 100,000 individuals in 2000 to 82 deaths per 100,000 in 2021. That rate is sharply higher than Americans who have some college education. In 2000, their overdose rate was 4.6 deaths per 100,000 people, which rose to 18.6 deaths per 100,000 in 2021.

Trends in Overdose Deaths by Educational Attainment

JAMA HEALTH FORUM

Powell is not the first researcher to link socioeconomic factors to overdose deaths. The so-called “deaths of despair” were first reported in 2015 by Princeton researchers Angus Deaton and Anne Case, who found that economic, social and emotional stress were major factors in the reduced life expectancy of middle-aged white Americans, who increasingly turned to substance abuse to dull their physical and emotional pain.

Education plays a significant role in socioeconomic status. People without college degrees are more likely to have blue-collar jobs requiring manual labor, which raise the risk of work-related injuries and conditions such as arthritis. One recent study found that people who did not finish high school in West Virginia, Arkansas and Alabama were three times more likely to have joint pain compared to those with bachelor degrees in California, Nevada and Utah.

“Overall, the analysis suggests that the opioid crisis has increasingly become a crisis disproportionately impacting those without any college education. Research is needed to understand the driving forces behind this gradient, such as isolating the independent roles of differences in income, employment, family composition, health care access, and other factors,” said Powell.

“Overdose death rates grew during the COVID-19 pandemic, and the education gradient increased further, although it is unclear what role the pandemic had relative to changes in fentanyl penetration in illicit drug markets and other factors.”

Powell says education merits further attention in understanding how and why the opioid crisis continues to intensify and lower U.S. life-expectancy.

How to Advocate With the News Media

By Barby Ingle, PNN Columnist 

So many in the chronic pain community wonder how to share their stories with the news media and connect with reporters. I have been doing that for years as a patient advocate, creating newsworthy content that helps educate the public about the issues we face.

The media are a powerful tool for advocacy because they can help you reach a larger audience and get your message out there. Networking with different media outlets has allowed me to spread my advocacy message further and make a real impact. I have built relationships with the media and gained access to publications I never had before. 

For example, I researched all of the major news outlets in Arizona, where I live, and learned who the producers, publishers and health writers are. I then connected and introduced myself to each of them.

Whenever I have a significant news item in the chronic pain or rare disease community that affects Arizonans, I reach out. Even when I do not have a specific story to pitch, I stay in touch. That helps to keep me in their minds. When they have a new story or need to verify something, they contact me for comment and to confirm the information. 

Media outlets can help you reach your target audience and spread the word about patient issues, products, services and disease-specific information. The more information we share effectively, the better access we’ll have to treatment. Media can be a friend or foe. We must learn to use them to get others involved.

We must also be mindful of our message and portrayal in the media, ensuring the information we provide is accurate and that the story is told to benefit our cause. We should also be prepared for any potential negative backlash from media campaigns. Choosing bipartisan, non-political topics, such as promoting individualized care and understanding how our medical system works can avoid this. 

We must also remain vigilant and aware of misinformation and bias in the media. It is essential to consider the impact of our message and how different communities may perceive it. 

Sharing Your Message

How can you share your message through the media to make a difference? Focus on issues that resonate with their audience and yours. Be bold in your advocacy approach. Feel free to challenge the status quo and use the media to highlight critical issues.

You can use a variety of mediums to reach your target audience. Be open to sharing on television, radio, newspapers, magazines, online, and in support groups. 

Communicate your message creatively to build interest in topics. You will need to offer something “new” to the media and be prepared to discuss your subject from multiple points of view, so that it connects with more people. Monitor the response to your message and adjust accordingly. Follow up and ensure the right message is heard.

Different people have different interests and perspectives. It's essential to tailor your message to specific groups of people so that they can understand and appreciate what you have to say. 

A 60-second message I could leave for a local news reporter might go something like this:

“Hello. I am Barby Ingle, a health advocate and chronic disease patient with multiple rare diseases. I live in Gold Canyon, AZ, and am excited to be working with my state senator on health bill SB1234.

I live with a rare pain condition called Reflex Sympathetic Dystrophy. It has affected every aspect of my life: financial, social, family and access to care. 2.9 million Arizonans live with a condition that involves pain; here in our district, approximately 150,000 are affected.

SB1234 is designed to help patients like me get better access to proper and timely care. I would love to set up a time to speak with you in detail or I can come in for an interview or live segment. I will email you a copy of the bill and supporting details. Please be on the watch for it in the next few minutes.

Feel free to call me back or email me to schedule a meeting. I look forward to hearing from you or one of your staff members soon. Thanks!” 

You should know the audience or readership of the media outlet you work with. That will help you understand what approach to take with your messaging and takeaways for that audience. It will make your pitch stronger, and give readers and viewers an opportunity to act on it. Be creative in your approach and use various media platforms. 

Additionally, by monitoring the response, you can identify which messages are resonating and which may need further adjustments. Following up with your audience shows that you care and are invested in the conversation.

Making or sharing a video, podcast or online post to explain your topic further is also possible. Don't just do the media as a one-and-done -- share it on social media to reach a wider audience.

To conclude, we must be willing to engage with the news media and the public to ensure our message is heard. The media can give the pain community the attention needed to spread a message of need.

Be it a lack of individualized care, a decision that negatively affects the pain community, or a desire for an amended state/federal law, our voices can be used to make change and make a difference in the lives of the patients. Ultimately, we are responsible for accurately communicating our message to the press and the public. 

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. 

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.

There Is Help Out There, But You Have Look For It

By Ann Marie Gaudon, PNN Columnist

As a patient, you strive to be heard. Nowhere is this truer than when your medical issues are chronic and complex. However, when your physicians dismiss, minimize, invalidate, and/or ignore what you say, this can lead to a misdiagnosis or lack of diagnosis – which can lead to your condition getting worse.

Physicians rely on test results, but what if the test is an epic failure? What if there is no test at all to diagnose you?

Medical providers can erroneously blame your suffering on your age, race, sexuality, gender, weight or other factors that have nothing to do with your complaint. It’s also not uncommon for a physician to tell a patient that there is nothing at all wrong with them and that it’s essentially “all in their head.”

Even if your symptoms do not resolve, further testing may not be offered. You may not be listened to or you may have your symptoms downplayed.

I learned that the hard way after experiencing a significant back injury in 2017. I thought I was going to be disabled forever. My own medical system could not help me. I was told I had to wait six weeks for an appointment and if I was still in pain then, an MRI would be ordered.

The MRI was ordered and the imaging showed a significant injury. But my general practitioner could offer no help aside from a mild muscle relaxant. I was referred to an orthopedic surgeon who could also offer no help. I never considered surgery – truth be told it terrified me – but I was looking for any treatment to help myself heal.

Fate brought me to a CBC radio interview with Stuart McGill, PhD, Professor Emeritus at the University of Waterloo. I immediately bought McGill’s book “Back Mechanic” and started my healing journey with one of his master clinicians.

I learned the medical system knows virtually nothing about the injury I had and had no way to help me heal from it.

Fast forward six years. Here I am “back” to back pain; limping and having significant pain in my upper right leg. I found out that I had been engaging in activity that I should not have been (weight lifting) and not doing enough to strengthen my core.

Now a loss of height and stiffness in my spinal joints are giving me much grief. My L4 and L5 have lost their strength due to injury, and the lower joint L3 is feeling the lack of support.

The entire point of this column is to show you the difference between seeing a physician who has no knowledge and relies on unreliable tests, and finding and seeing someone who has the essential knowledge to help you heal.

Take a look for yourself. Remember, my symptoms were lower back pain, upper right leg pain and a limp. Here is a copy of my recent MRI report, which is the only test my GP has ordered. Also, here is a copy of my personalized treatment recommendations from Professor McGill, which I use along with his book. Notice anything different between these two assessments?

This difference means everything! Why? Because one is antiseptic, hopeless and sounds like my pain was of my own doing. The other offers the reason for the pain, plus exercise and treatment options I can do to make it better.

My lapse in keeping up with the exercises necessary to protect my spine was slow and happened over time. I’m not sure that I even noticed. By the time I did, I had already irritated my compromised spine.

If I want to be free of back pain, I will always have to do protective exercises. I will always have to take care. This is of little consequence, considering that pain and disability are the alternative.

Thank you, Professor McGill for being the compassionate and skilled researcher that you are. There are so many of us in need of real help with our back injuries. I am so grateful for you and your life’s work.

Here is what I have learned. Often there is a practitioner who is knowledgeable and skilled in helping you with a complex and chronic condition. But the only way I have found these people is by accident or by word of mouth. I don’t see this changing anytime soon.

Don’t give up hope and be prepared to investigate your options!

Ann Marie Gaudon is a registered social worker and psychotherapist in the Waterloo region of Ontario, Canada with a specialty in chronic pain management.  She has been a chronic pain patient for over 30 years and works part-time as her health allows. For more information about Ann Marie's counseling services, visit her website. 

Is Your Doctor a Master or Servant?

By Carol Levy, PNN Columnist

Recently, I heard a doctor on TV say something that seems to be common sense: a doctor must be the servant of his patient and not the master. The Hippocratic Oath says as much, that a doctor should be “a servant of people.”

Though the wording is old-fashioned, the point is well taken. I have experienced doctors trying to act as masters, not servants.

I’ll tell a doctor all of my symptoms, only to have her concentrate on one or two. Then she makes her pronouncement: “This is my diagnosis. This is the treatment I am prescribing.”

If I ask, “What about my other symptoms?” I’ll be dismissed.

“Try the treatment and if it’s not better, come back in six weeks.”

There’s no room for discussion. That’s the way a master would talk to a servant.

Some patients think they are the masters. They’ll say, “No you're wrong. I need and will only accept this medication or treatment.”

It seems many chronic pain patients, more so than others, are of two beliefs: we want the doctor to help us, to diagnose our condition and to end our pain to the best of their ability. That makes them somewhat our master.

But many of us also think we should be the master of the doctor when it comes to what he will give us to end our pain: “I want this drug, this dosage, and this number of pills.”'

I almost never hear someone say, “The doctor refuses to give me the test I want” or “She won't refer me to the specialist I want to see.” Pain patients tend to want those decisions left to the doctor.

In recent years, a major loss for doctors is their ability to be their own masters when it comes to prescribing pain medication, specifically opioids.

The best example I have of this is my own experience from decades ago. My ophthalmologist understood that my trigeminal neuralgia pain was unmanageable. He had nothing to offer that would completely eliminate my facial pain, but he wanted to at least mitigate it. He gave me with a prescription for an 8-ounce bottle of Tincture of Opium.

The first pharmacy I went to couldn't fill it because they didn't carry opium. But the pharmacist didn't look askance at me or the prescription. The second pharmacist I saw also gave me no debate, no questions, and no dirty or suspicious looks. Within 10 minutes, I left the pharmacy with a bottle of opium in my purse.

Of course, we all know that could never happen now.  I don't even know if a doctor can write a prescription for opium anymore. It is hard to be a master of the patient when your hands are tied, and you fear losing your livelihood, freedom or both.

When it comes to opioids, we cannot be masters of our doctor, no matter how much we may want to be. We can't insist that we need an opioid, when by law or fear, a doctor won’t comply.

What we need to accept is that neither doctor or patient should be master or servant of the other. Some doctors may not accept this and some patients may not want it, but the best relationship we can have with our medical providers is a partnership.

Doctors need to do a better job explaining why they prescribe something. And, if it is an opioid, why the amount and dosage is less than what we may want.  And we, as patients, need to understand that we can’t insist on what a doctor is unwilling to provide.

For partnerships to work, both sides need to come to a mutual understanding of what can and can't be done. Sometimes that means being disappointed. But disappointment that is based on mutual acceptance and respect can help mitigate the negative, allowing for a much better relationship.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

Stem Cell Discovery Could Revolutionize Spine and Cancer Care

By Pat Anson, PNN Editor

The discovery of a new type of stem cell could revolutionize the treatment of spine disorders and slow the progression of some cancers, according to a groundbreaking study published in Nature.

Researchers from Hospital for Special Surgery (HSS) and Weill Cornell Medicine say the vertebral stem cells they found in human spines appear to play a key role in spinal health and in the metastasis of cancerous tumors as they spread through the body.

“There are two big takeaway discoveries that were made here. One is that we have discovered a stem cell that forms the spine and maintains the spine throughout life. This cell makes all the other cells that mineralize the spine,” said lead investigator Matthew Greenblatt, MD, associate professor of pathology and laboratory medicine at Weill Cornell Medicine.

“The second discovery here is that we found that this stem cell drives tumors. Breast cancer is what we focused on here, but likely also prostate cancer.”

Cancer experts have long believed that tumors metastasize to other parts of the body simply through blood flow. But Greenblat and his colleagues found that vertebral stem cells essentially attract cancer cells to the spine. That could explain why some cancers are first detected in the spine after they have metastasized from the breast, prostate and lung.

“Because we found that molecular ‘come here’ signal that's made by this spine stem cell, that gives us the ability to block that signal therapeutically. And that's something we're working on to try to prevent or treat established spine metastases,” Greenblatt told PNN.

Boosting Bone Health

Researchers say their discovery could also lead to breakthroughs in spinal health, by giving physicians a way to speed up recovery from spinal injuries and slow the progression of degenerative conditions such as osteoporosis, a disease that makes bones thinner, less dense and more likely to fracture.

For example, someone with degenerative disc disease could have their vertebral stem cells harvested, reproduced in a laboratory, and then reinjected to stimulate the growth of new bone. In animal tests, human vertebral stem cells helped laboratory mice form new bones in their spines.

“We can show that they formed basically little vertebral bones when those patient cells are put into mice, which really tells us that we found the right cell. And we can work with the cell transplant and retain stability to make new bone,” said co-author Sravisht Iyer, MD, a spine surgeon at HSS.

“I think kind of figuring out how to recruit the cells or how to how to encourage them to form more bone is going to be an important area or avenue of investigation for us, as a way to help people and protect people against what is a very morbid condition for them.”

Iyer says early treatment with vertebral stem cells could help someone with osteoporosis or a spine fracture, but wouldn’t necessarily benefit patients suffering from more advanced cases of bone loss.

“By the time people are presenting to us with spine pain, they usually have some element of compressive pathology or a degree of degeneration, which will likely require some intervention, whether that's surgery or epidural injection,” Iyer said.

“Where this work I think can really help push us forward is once you get those at-risk patients, they probably will need a surgery because a lot of degeneration is asymptomatic, and by the time they get to you they probably need something, but maybe you can prevent the second, third or fourth operation or intervention.”

More research and human studies are needed before the stem cells can be used in clinical settings to improve bone health and slow the metastasis of cancer cells. But researchers are excited by what they’ve learn so far.    

“We predict this discovery will lead to the targeting of these cells to disrupt the function and ultimately reduce the spread of cancer to the spine," said Greenblatt.

Lyme Disease: How a Bacteria Plays Havoc with Immune Systems

By Dr. Jenny Wachter, University of Saskatchewan

Lyme disease is the leading vector-borne disease — meaning diseases that are transmitted to humans from another organism like a tick or mosquito — in North America and Europe.

New human cases are estimated at over 400,000 in the United States each year. Canada has experienced a drastic increase in human cases, from 266 cases in 2011 to 3,147 in 2021, as the habitat of its vector, a tick, expands north.

The initial symptoms of human Lyme disease can be vague, such as fever, headache, fatigue and often rash. It is a potentially serious condition that can affect multiple systems in the body — including the heart, nervous system and joints — and can become a chronic illness.

Lyme disease is caused by a unique, spiral-shaped (spirochete) bacterium called Borrelia burgdorferi. B. burgdorferi cannot survive in the environment on its own. For survival and transmission, it requires susceptible hosts (usually small mammals or birds) and a specific vector: the black-legged tick, also called the deer tick.

Evading the Immune System

B. burgdorferi must survive extremely diverse conditions over the course of its transmission and infection cycle: from host to tick vector, and then into new hosts.

This bacterium senses and responds to its surroundings, most notably by modifying its appearance by changing the proteins on its outer surface to help it survive in either the tick or the host.

When a tick infected by B. burgdorferi bites and feeds on a vertebrate host, it provides a signal for the bacteria to switch its proteins to those required to infect the host, and to begin migrating through the tick and into the bite site. This process takes between 36 and 72 hours.

However, many of these proteins are recognized by the host as foreign, and the host’s immune system works to try to clear the infection. This includes a strong, antibody response targeted against B. burgdorferi.

Despite these immune responses, B. burgdorferi is able to cause long-term infections. In natural host reservoirs — the animals that the bacterium usually finds itself in via tick bites, such as small rodents — these infections do not cause diseases like those seen in humans and other non-natural reservoirs.

In fact, the bacteria itself does not produce any products that would be toxic to its hosts, either natural or non-natural. Yet chronic infection in humans can lead to Lyme neuroborreliosis, carditis and Lyme arthritis.

How then, are these bacteria able to cause such a devastating disease in humans and other animals, but not in their natural host reservoirs?

While there is still much to learn about B. burgdorferi, we know of several factors that play a role in the range of disease it causes. These include:

• its genetic make-up,

• its ability to access various tissues (such as the joints, heart and nervous system) due to its ability to move around (motility), and

• the immune response of the host.

Apart from motility, B. burgdorferi also protects itself from the strong B. burgdorferi-specific targeted antibody response of its host’s immune system by changing the appearance of the main outer surface protein expressed during persistent infection in a process called antigenic variation.

In addition to antigenic variation, B. burgdorferi bacteria can also change their DNA by exchanging genetic information, a process also known as gene transfer. This process allows these bacteria to further alter their appearance during infection to avoid the host immune system.

This process works so well that these B. burgdorferi bacteria appear different enough to allow re-infection or even co-infection (where multiple strains of B. burgdorferi infect a single host at the same time) of a vertebrate host, like a mouse or a human, despite the presence of specific antibodies to fight the bacterium.

In fact, in nature, the majority of host reservoirs and the ticks that carry the bacterium are infected with multiple strains of B. burgdorferi. The ability of B. burgdorferi to reinfect and co-infect both ticks and hosts increases the spread of the bacteria in the environment as well as the chances that humans will encounter Lyme disease.

Human Cases of Lyme Disease Are Increasing

As a vector-borne pathogen, B. burgdorferi only infects individuals that are bitten by an infected tick. It is not transmitted from person to person.

Environments that support black-legged/deer ticks are at risk of harbouring B. burgdorferi. In North America, these species of ticks are widely distributed throughout the eastern and midwestern United States. Recent geographic expansion to the north is increasing the prevalence of Lyme disease in Canada.

The increase of human Lyme disease cases highlights the failure of existing preventive strategies — such as minimizing exposure to tick habitats, performing diligent tick checks, and wearing suitable clothing when performing activities in known tick habitats — and emphasizes the need for an effective human vaccine.

At Vaccine and Infectious Disease Organization at the University of Saskatchewan, we are taking a One Health approach by recognizing that human health is closely related to the health of animals and the shared environment. We are investigating the role of B. burgdorferi, ticks, and susceptible animals on the spread and survival of the Lyme disease bacterium.

It is important to mimic the natural infectious cycle as much as possible when identifying potential vaccine and drug targets. This is because the way host animals are infected (for example, artificial needle infection or natural tick bite) can produce drastic differences in the resulting infection.

Additionally, despite the prevalence of this disease, there are still many aspects of the infectious cycle that remain unknown due to the uniqueness of B. burgdorferi and a lack of knowledge about the tick vector.

For example, we recently learned that a B. burgdorferi protein is responsible for regulating the components necessary for the bacterium to infect vertebrates, including humans. The absence of this protein, among other things, leads to the death of B. burgdorferi in ticks, making it an exciting target for research investigation.

By learning more about the molecular mechanisms that change or reduce the severity of the disease caused by this bacterium, we can identify new targets for the prevention of human Lyme disease. 

Jenny Wachter, PhD, is a research scientist and adjunct professor at University of Saskatchewan.

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

Millions Disabled by Chronic Pain, Anxiety and Depression

By Pat Anson, PNN Editor

About 12 million people in the United States – nearly 5% of the adult population – have chronic pain that is accompanied by anxiety or depression so severe that it limits their ability to work, socialize and complete daily tasks, according to a new study.

The co-occurrence of chronic pain with anxiety and/or depression (A/D) is well known, but little research has been conducted on its prevalence or impact. To see how often the symptoms occur, researchers at the University of Arizona Health Sciences analyzed responses from nearly 32,000 people who participated in the 2019 National Health Interview Survey.

Their findings, published in in the journal PAIN, show that adults with chronic pain are about five times more likely to report anxiety or depression than those without chronic pain. The risk is even higher in adults with “high impact pain” – pain severe enough to limit daily life and work activities -- who are eight times more likely to have A/D.

"The study's findings highlight an underappreciated population and health care need -- the interdependency between mental health and chronic pain," said lead author Jennifer De La Rosa, PhD, director of strategy for the UArizona Health Sciences Comprehensive Pain and Addiction Center.

De La Rosa and her colleagues found that adults with co-occurring symptoms of pain, anxiety and depression had a significantly more disability compared to those with either chronic pain alone or A/D symptoms alone. Nearly 70% reported that their work was limited, about 44% had difficulty doing errands alone, and over half (56%) had problems participating in social activities.

"I was surprised by the magnitude of the effect with functional limitations," said De La Rosa. "Across all domains of functional activity in life, we saw an enormous jump among people who are living with both conditions. These are people who are at a high risk for functional limitation, which will disturb their quality of life."

Like pain, anxiety and depression are difficult to measure and clinicians have to rely on patients self-reporting their symptoms. Making a diagnosis is also difficult because chronic pain and A/D are interconnected neurologically, affecting the same parts of the brain that control cognition and emotional function. Anxiety and depression can heighten the perception of pain and may increase the likelihood of acute, short-term pain becoming chronic.

"When someone is experiencing both chronic pain and anxiety or depression symptoms, achieving positive health outcomes can become more challenging," said senior author Todd Vanderah, PhD, director of the Comprehensive Pain and Addiction Center. "This study gives us another avenue to explore in our continuing effort to find new ways to treat chronic pain."

Researchers say further studies are needed to see if people receiving pain treatment are also getting mental health care, and whether that care is helping with their symptoms.

A recent study found that anxiety, depression and other mood disorders often precede the development of fibromyalgia, irritable bowel syndrome (IBS), and chronic fatigue syndrome (CFS).

Unions Threaten Strike Against Kaiser Permanente

By Bernard J. Wolfson, KFF Health News

Kaiser Permanente and union representatives pledged to continue negotiating a new contract up until the last minute as the threat of the nation’s latest large-scale strike looms next month.

Unless a deal is struck, more than 75,000 health workers will walk out for three days from Oct. 4-7, disrupting care for KP patients in California, Colorado, Oregon, Virginia, Washington, and Washington, D.C. The unions represent a wide range of KP health workers, including lab technicians, phlebotomists, pharmacists, optometrists, social workers, orderlies, and support staff.

A strike, if it occurs, would affect most of Kaiser Permanente’s 39 hospitals and 622 medical offices across the U.S., and would disrupt care for many of its nearly 13 million patients. If workers walk off their jobs, “it will start to impact patient care right away,” said John August, director of health care and partner programs at Cornell University’s Scheinman Institute on Conflict Resolution, who is a former head of the union coalition currently negotiating with KP.

“You are immediately subject to problems with not being able to get patients in and out of the hospital. You risk problems with infection control. You’re not going to get meals,” August said.

Arlene Peasnall, Kaiser Permanente’s senior vice president for human resources, said the Oakland, California-based health care giant’s goal is “to reach a mutually beneficial agreement before any work stoppage occurs.” But she also said the nonprofit has plans in place to blunt the impact of a walkout.

“We will be bargaining with Kaiser up until the day we go on strike,” said Caroline Lucas, executive director of the Coalition of Kaiser Permanente Unions, which represents about 40% of KP’s workforce. “Our front-line health care workers are fed up, and we really need Kaiser executives to seize the initiative and move forward on resolving the contract.”

The current contract expires Sept. 30 and, after months of talks, the two sides still disagree over pay and staffing. The coalition wants a $25-an-hour minimum wage across the company. KP executives agree there should be an organization-wide floor, but they’ve proposed $21.

KP prefers varying wage increases across regions, since the cost of living can vary sharply. The coalition, which is pushing for uniform wage increases across all regions, contends that management’s proposal is part of a “divide-and-conquer strategy.” Peasnall said the union’s stance “would prevent us from addressing fair market wages where we need to pay more to attract and retain the best people.”

The unions say their lowest-paid workers can barely make ends meet in the face of soaring prices for food, gasoline, and other essentials. And, they say, KP hospitals and clinics are severely understaffed, forcing workers to put in long hours and fill multiple roles. They argue that management is not moving quickly enough to fill positions and that the quality of care has suffered as patients, some with serious illnesses, often wait months for appointments, face extremely long waits in the emergency room, and experience delays in hospital admissions.

Healthcare Labor Shortage

An industrywide labor shortage hangs heavily over the contract talks. The pandemic was particularly brutal for health care workers who often worked long hours in grueling conditions, as colleagues fell ill, died, or quit. Workers say many of the positions that became vacant during the pandemic still have not been filled.

Miriam De La Paz, a secretary in the labor and delivery department of KP’s Downey Medical Center in Southern California and a union steward, said when she is alone on a shift, she is responsible for two labor and delivery stations as well as triage, where patients are prioritized based on the acuity of their cases.

“Imagine if I’m putting this baby in the system and your wife shows up in pain, crying, but I’m not there to register her,” De La Paz said. “I can’t break myself in two.”

Unions want KP to invest more in education, training, and recruitment to fill current openings and create a pipeline of future workers. KP says it is doing so.

Peasnall said KP has already filled more than 9,700 out of 10,000 new coalition-represented jobs the two sides had agreed to create this year. And she said KP’s turnover rate is one-third the industry rate, in part because of “excellent pay and benefits.”

Earlier this month, California lawmakers passed legislation to gradually raise the minimum wage for health care workers in the state to $25 an hour. If Democratic Gov. Gavin Newsom signs the bill into law, KP will have to comply. And nearly 80% of workers represented by the coalition in the current contract talks are in California.

On Sept. 22, as bargaining continued in San Francisco, the unions announced that more than 75,000 of the 85,000 workers they represent would stage the three-day walkout if there’s no deal. Federal law requires 10 days’ notice of strikes at health care facilities. The coalition said it is “prepared to engage in another longer, stronger strike in November,” if no agreement is reached by then.

A coalition spokesperson, Betsy Twitchell, said workers would welcome the Biden administration’s involvement in the talks “because of the importance of these negotiations to millions of patients and 75,000 frontline healthcare workers.”

The unions say KP can afford to be more generous, citing its robust financial health.

Although KP reported a net loss of almost $4.5 billion in 2022, it generated a cumulative net income of nearly $22 billion over the three preceding years — both results driven largely by investment performance. In the first half of this year, KP posted profits of over $3 billion. And it is in a strong position to manage its debt, according to a report earlier this year by Fitch Ratings.

The unions note that Kaiser Permanente’s CEO, Greg Adams, received almost $16 million in compensation in 2021 and that dozens of others in KP management made more than $1 million, according to a KP filing with the IRS.

Peasnall said the compensation of KP’s senior management is less than that of their peers at other health care companies.

A KP walkout would be the latest in a string of worker movements. Strikes have hit Hollywood, hotels, auto manufacturers, and other industries. Public approval of unions is at a nearly 60-year high, according to a Gallup Poll released in August 2022.

Health workers are increasingly engaged, too. Several hospital groups have been hit by strikes, including Cedars-Sinai Medical Center in Los Angeles and numerous facilities belonging to Sutter Health in Northern California, as well as health care organizations in other states.

“There is an atmosphere in the country: It’s labor summer, it’s strike summer, it’s all that,” August said. “That definitely has an influence on union leadership that says, ‘We need to be a part of that.’”

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