On the latest “Scheer Intelligence” episode, the activist speaks to Robert Scheer from India about wealthy countries’ reluctance to end global vaccine apartheid.
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The United States spends far more of its GDP on healthcare than other rich countries yet still has the highest infant and maternal mortality rates, the lowest life expectancy at age 60, and the most glaring inequities, according to a new report released Wednesday by the Commonwealth Fund.
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Hundreds of protesters gathered at Westlake Park in Seattle on the afternoon of July 24 for the Healthcare Equity March. This was the most recent of a series of protests centered around Kaloni Bolton, a 12-year-old Black girl who died tragically at the beginning of this year as a result of medical negligence.
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The press release says Monday’s talks ended with Tenet presenting a “disappointing” proposal that “failed to provide what the nurses need to end the strike.” It notes that it was “a proposal that the membership voiced strong opposition to at a meeting held last night.” No details of the new proposal have been published but the MNA previously pushed for nurses to concede their demands of 1:4 nurse-to-patient ratios on medical/surgical floors and telemetry units, as well as increased staffing in the emergency department and ancillary support in each unit.
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John Winkler II was dying of heart failure when doctors came to his hospital bedside, offering a chance to prolong his life. The HeartWare Ventricular Assist Device, or HVAD, could be implanted in Winkler’s chest until a transplant was possible. The heart pump came with disclaimers of risk, but Winkler wanted to fight for time. He was only 46 and had a loving wife and four children, and his second grandchild was on the way.
So, in August 2014, Winkler had surgery to implant the device. A golf-ball-sized rotor was attached to his left ventricle to pump blood through a tube and into his aorta. A cable threading out of a small incision in his waist connected to a battery-powered controller strapped to his body. If something went wrong, an alarm as loud as a fire drill would sound.
Winkler returned home weeks later and, as he regained his strength, became hopeful about the future. He started making plans to visit colleges with his daughter, and was able to host his parents and new grandchild for Christmas. “He was doing so much better,” his wife, Tina Winkler, said. “We thought he was coasting until he got his transplant.”
What John Winkler didn’t know: Months before his implant, the Food and Drug Administration put HeartWare on notice for not properly monitoring or repairing HVAD defects, such as faulty batteries and short circuits caused by static electricity, that had killed patients. The agency issued a warning letter, one of its most serious citations. It demanded fixes within 15 days, but took no decisive action as problems persisted.
Ten days after Christmas 2014, Winkler’s two teenage children heard the HVAD’s piercing alarm and ran upstairs. They found their father collapsed on his bedroom floor, completely unresponsive. Kelly, 17, dropped to his side and tried to copy how people on television did CPR. She told her brother to call 911, and over the device’s siren did her best to hear instructions from the operator.
When paramedics arrived and assessed her father, one made a passing comment that has haunted Kelly ever since: “Well, his toes are already cold.” He died two days later. Medtronic, the company that acquired HeartWare in 2016, settled a lawsuit by the family last year, admitting no fault. Tina Winkler believes her children blamed themselves for their father’s death. “Those two kids have never been the same,” she said. “I think they feel like they didn’t do things they needed to do.”
But it was the FDA that failed to protect Winkler and thousands of other patients whose survival depended on the HVAD, a ProPublica investigation found.
As HeartWare and Medtronic failed inspection after inspection and reports of device-related deaths piled up, the FDA relied on the device makers to fix the problems voluntarily rather than compelling them to do so.
The HVAD was implanted into more than 19,000 patients, the majority of whom got it after the FDA found in 2014 that the device didn’t meet federal standards. By the end of last year, the agency had received more than 3,000 reports of patient deaths that may have been caused or contributed to by the device.
Among them were reports of deaths the company linked to serious device problems: a patient who vomited blood as a family member struggled to restart a defective HVAD; a patient who bled out internally and died after implant surgery because a tube attached to the pump tore open; a patient whose heart tissue was left charred after an HVAD short-circuited and voltage surged through the pump.
The ineffective regulatory oversight of the HVAD is emblematic of larger, more systemic weaknesses.
For decades, the FDA and its Center for Devices and Radiological Health have been responsible for ensuring that high-risk medical devices are safe and effective. Yet they mostly rely on manufacturers to identify and correct problems. The agency says it can seize products, order injunctions against companies or issue fines, but it rarely does so, preferring instead for companies to make fixes voluntarily.
When federal investigators found repeated manufacturing issues with the HVAD for years, the FDA didn’t penalize the company, even as the company issued 15 serious recalls of the device starting in 2014, the most of any single high-risk device in the FDA’s database. Thousands of patients with recalled models needed to have external HVAD parts replaced or take extra caution while handling their devices and monitor them for signs of malfunctions that could cause injury or death.
Meanwhile, the processes to inform the public through formal FDA notices and messages to healthcare providers repeatedly failed and left patients in the dark about known problems with the HVAD.
“Patients have no idea, and they rely on the FDA to ensure the safety and effectiveness of high-risk devices,” said Dr. Rita Redberg, a cardiologist at the University of California, San Francisco who studies medical device regulation. “How can you not take action on a warning letter with these serious issues with very sick patients?”
In response to ProPublica’s findings, the FDA said it had been closely monitoring issues with the HVAD. It said that after Medtronic acquired HeartWare in 2016, it met with the company more than 100 times to ensure problems were being fixed and to review safety concerns related to the heart pump. The agency also said it initiated formal reviews of new device modifications and continually tracked whether the HVAD had a “reasonable assurance of safety and effectiveness.”
“Our decisions that we made along the way have always been patient-focused,” said Dr. William Maisel, the director of product evaluation and quality at the FDA’s device division. He added that more than 80% of companies fix their problems by the time the FDA reinspects.
That did not happen with the HVAD. In 2016 and 2018, inspectors found that issues detailed in the 2014 warning letter remained unresolved. Medtronic told the FDA last year that it had fixed the problems, but, before the agency could verify the claim, inspections were paused because of the coronavirus pandemic.
In June, Medtronic stopped HVAD sales and implants. The company conceded that a competing device was safer after a new study showed the HVAD had higher rates of death and neurological injury. Medtronic also cited a 12-year-old problem with its devices not restarting if they disconnect from power, leaving patients’ hearts without support.
Medtronic declined to make CEO Geoffrey Martha or president of mechanical heart support Nnamdi Njoku available for interviews. In an email, a spokesperson said, “There is nothing more important to Medtronic than the safety and well-being of patients.”
The email continued, “Medtronic takes this matter very seriously and, over the past five years, we have worked closely with FDA and engaged external experts to resolve the issues noted in the warning letter. FDA is aware of the steps Medtronic has taken to address the underlying concerns.”
The company said it will have a support system in place for the 4,000 patients worldwide and 2,000 in the United States who still rely on the HVAD. Medtronic will station 20 specialists across the globe to help with device maintenance and patient education. A centralized engineering team will also provide technical support and troubleshooting for patients and medical staff. Medtronic said it will also offer financial assistance if insurance doesn’t fully cover the surgery to replace a device with a competing product, but only if a doctor decides it’s medically necessary.
Patients with HVADs have little choice but to hope the devices keep working: The surgery to remove HVADs is so risky that both Medtronic and the FDA advise against it. The device is meant to be left in place until its wearer gets a heart transplant. Or dies.
In late 2012, HeartWare, then an independent company headquartered in Massachusetts, won FDA approval to sell a new device that could keep heart failure patients alive and mobile while awaiting a transplant.
A competing device, the HeartMate, was already gaining attention, with high-profile patients like former Vice President Dick Cheney, a heart attack survivor who eventually got a transplant after using the device for 20 months.
The HVAD offered a smaller option that could even be used in children, and it led to a string of publicized successes. A fitness model was able to return to the gym. A 13-year-old with heart defects could attend school again. Medtronic’s YouTube page features 16 interviews with grateful patients and families.
The patients who received HVADs had already been in grave peril. They had advanced heart failure, serious enough to need blood pumped out of their hearts artificially. Most patients were older than 50, but there were also younger patients with heart defects or other cardiac conditions. The device provided help but brought its own risks. Implanting it required invasive open-heart surgery, and clots could develop inside the pump, which, in the worst cases, led to deadly strokes.
The device also came with a steep price tag. Each HVAD cost about $80,000, and, even though HeartWare never made a profit as an independent company, in 2015 device sales brought in $276 million in revenue.
For many severe heart failure patients, the opportunity to survive longer and return to normal life made the device worth the risks and cost.
But patients were unaware the FDA started finding manufacturing issues at HeartWare’s Miami Lakes, Florida, plant as early as 2011, when the device was still seeking approval.
Among the findings, a federal inspector expressed concerns that engineering staff “were not completely reviewing documents before approving them” and found one employee assigned to monitoring device quality had missed several required monthly trainings. HeartWare leadership promised quick corrective action, according to FDA documents.
Then, in 2014, the FDA found more serious lapses, detailed in federal inspection reports.
For example, HeartWare knew of 119 instances in which batteries failed unexpectedly, which could leave the pump powerless, stopping support for the patient’s heart. But the company didn’t test the batteries in inventory for defects, or the batteries of current patients, even though one person’s death had already been linked to battery failure.
The company also received complaints that static electricity could short-circuit its devices. It learned of at least 27 such cases between 2010 and 2013, including four that resulted in serious injuries and two that led to death. HVAD patients would need to avoid contact with certain household objects like televisions or vacuum cleaners — anything that could create strong static electricity. HeartWare added warnings to the patient manual and redesigned its shield to protect the device controller, but the FDA found that the company didn’t replace shields for devices already being used by current patients or produced and sitting in inventory.
Continuing quality control concerns led to the FDA warning letter in June 2014. The document labeled the HVAD as “adulterated,” meaning the device did not meet federal manufacturing standards. The agency gave HeartWare 15 days to correct the problems or face regulatory action.
Still, investment analysts who followed HeartWare believed the warning posed little risk to the company’s business prospects. One described it as being “as benign as possible.”
The 15-day deadline passed, and the FDA never penalized the company.
The agency told ProPublica it had provided additional time because HeartWare was a relatively new manufacturer and the HVAD was a complicated device. It also said it avoided punitive action to make sure patients with severe heart failure had access to this treatment option. “We’re talking about the sickest of the sick patients who really have very few alternatives,” Maisel, the head of device quality, said.
But the HeartMate, the competing device, was available and already being used by the majority of patients. When Medtronic stopped HVAD sales, both companies said the HeartMate could fill the gap.
Inspectors continued to find problems at HeartWare facilities in 2015, 2016, 2017 and 2018. In the most recent report in 2018, inspectors identified seven separate violations at the HVAD plant, including three previously cited in the 2014 warning letter. The company was still mishandling newly discovered defects like pins connecting the controller to a power source that could bend and become unusable, and controllers built with incompatible parts that could chemically react and “attack” the plastic exterior.
Again, the inspection report said the company “promised to correct” the issues.
“What penalty is there for noncompliance? There isn’t one,” said Madris Kinard, a former public health analyst with the FDA and the CEO of Device Events, a software company that analyzes FDA device data. “There’s nothing the FDA is doing that penalizes, in any true sense of the matter, the manufacturer.”
By the time sales were halted last month, the HVAD had become the subject of 15 company-initiated “Class I” recalls for dangerous device problems that could cause injury or death.
One recall came with a warning sent to health care providers in December that said pumps were failing to start up properly. The pattern of malfunctions was almost as old as the device itself, the company later admitted when it halted device sales in June. But even recent patients were completely unaware of the problem.
When children asked Latoya Johnson Keelen about the cable that came out of her side and connected to a controller on her hip, she told them she was Iron Woman.
For a while, she felt invulnerable with the HVAD on her heart.
Johnson Keelen, who lives in the Atlanta suburbs, learned she needed the device after delivering her fourth child, Isaiah, in early 2018. Doctors diagnosed her with postpartum cardiomyopathy, a rare and mysterious form of heart failure that afflicts mothers during pregnancy or after birth. Black mothers in the South have among the highest rates of the illness. Some mothers quickly regain heart function, some only partially recuperate and others never recover.
Tests showed that Johnson Keelen, then 42, was suddenly in end-stage heart failure.
Her body’s immune response at the time was too strong for her to receive a heart transplant. Doctors gave her two choices: an HVAD or end-of-life hospice care.
“It became a no-brainer,” she said. “I just had a baby. I just gave birth. I’m not ready to plan for a funeral.”
Johnson Keelen, a woman of faith, believed God would heal her, either through a medical advancement or a miracle. She thought the HVAD was the answer.
Living with a life-sustaining medical device was difficult at first for the fiercely independent mother. She had to leave her job as a public health communications specialist, ask her older sons to change her bandages and lean heavily on her new husband, only a year into their marriage.
But, for about three years, she found comfort in the soft humming of the HVAD’s spinning rotor at night. It served as a lullaby for her new baby when he lay on her chest.
She said she was never told about the manufacturing problems the FDA repeatedly found at HeartWare’s facilities or about device recalls, including one sent to patients in December 2020. The notice said the device sometimes wouldn’t restart properly, which had led to two patient deaths at that point. It warned that current patients should always keep at least one power source, a battery or an AC or DC adapter, connected at all times to avoid the need for a restart.
Two months after that notice, Johnson Keelen was getting her kids ready for school when the HVAD’s low-battery alarm blared. She had unplugged the battery to replace it without realizing her wall adapter was disconnected.
Once before, Johnson Keelen had simply plugged the charger back into the outlet and her device restarted. But this time it wouldn’t.
As an emergency alarm sounded, she called the ventricular-assist team assigned to her case, and a specialist directed her to switch out the device controller.
Nothing changed, and panic crept into the voice on the phone.
An ambulance took Johnson Keelen to a hospital where medical staff used several backup controllers to try to start the pump.
Still nothing.
Doctors and nurses tried to keep calm, but Johnson Keelen could see fear and shock on their faces. Without the HVAD, her only options were a transplant or a completely new pump.
Doctors scurried to locate a donor heart and airlifted her for an emergency transplant. But while running tests, the medical team was stunned to find that Johnson Keelen’s miracle had occurred: Her heart was once again pumping blood on its own.
She had a new choice. She could avoid the risks of transplant rejection and open heart surgery during the pandemic by leaving the device on her functioning heart, while cutting the wires, removing the external components and sealing the pump.
She chose to trust her newly functioning heart, and leave the decommissioned HVAD inside her.
Three months later, when Medtronic said it was stopping HeartWare sales and implants, its announcement cited the problem with pumps not restarting among the reasons.
If evidence suggests a medical device may be linked to a serious patient injury or death, hospitals and other health care facilities must submit a report to the manufacturer and the FDA. Device companies must also submit reports if they learn independently of any incidents.
By the end of 2020, roughly 3,000 death reports and 20,000 injury reports related to the HVAD had been filed with the FDA.
Any details that could identify patients, like their age or gender, are removed from the publicly available reports. Most only have limited details about circumstances surrounding deaths or injuries. But it’s clear from the reports on the HVAD that some of these outcomes could be linked to problems previously identified by FDA inspectors.
Doctors attempted CPR for two hours after an electrostatic shock short-circuited one patient’s device in 2014, a few months after the FDA inspection that year. An autopsy revealed voltage had caused “deep charring” of the tissue inside the patient’s chest.
Friends found another patient dead in the kitchen, with groceries still on the counter, in 2018 after their device, which did not have the recommended static shield, short-circuited.
Last year, paramedics found a patient with the device disconnected from power. They struggled to restart the device, but it wouldn’t plug back into the power source because the connector pins were bent. The patient would die at the hospital.
In most cases, the FDA turned to the company to investigate whether a malfunction caused or contributed to the incidents.
But the FDA has long known HeartWare and Medtronic could not be relied on to properly submit HVAD incident reports.
In 2014, the FDA cited HeartWare because in at least 10 cases, there were no documents showing the company attempted to investigate.
In 2016, the agency wrote another citation when the company was late in reporting more than 200 cases, some more than a year past their 30-day reporting deadlines, and failed to report malfunctions that occurred during clinical trials.
The FDA told ProPublica the agency increased its monitoring of HVAD reports, and Medtronic hired new employees to submit timely reports. But by 2018, its backlog had only grown, with 677 late case filings. Again, the FDA did nothing beyond telling the company to fix the problem and further increasing its monitoring.
In an email, Medtronic said it “has robust systems in place to monitor the safety of all of our products, including the HVAD device.”
The email said, “When any potential safety issues are identified, those issues are thoroughly investigated and relevant information is shared with regulators and healthcare providers.” The company didn’t respond to the pattern of late reports and incomplete investigations identified in FDA inspections.
Maisel, the director of FDA device evaluation and quality, once criticized asking companies to investigate their own devices. In 2008, as a practicing cardiologist, he testified to the U.S. House oversight committee about his concerns.
“In the majority of cases, FDA relies on industry to identify, correct and report the problems,” he said. “But there is obviously an inherent financial conflict of interest for the manufacturers, sometimes measured in billions of dollars.”
Maisel has since had a change of heart. When asked about his 2008 testimony, he told ProPublica that he now believes the regulatory system “generally serves patients well” and “most companies are well intentioned.”
HeartWare’s track record of questionable investigations was glaring in John Winkler II’s case.
A report submitted by HeartWare that matches the dates and details of Winkler’s case shows the company decided there was “no indication of any device malfunctions.” It told the FDA that the device couldn’t be removed from the body because the hospital said his family declined an autopsy. HeartWare added that the evidence of the device’s role in Winkler’s death was inconclusive.
Yet little of this appears to be true. Documents reviewed by ProPublica show an autopsy of the heart and lungs was performed a day after the death. Tina Winkler said she was told the pump was removed from her husband’s body and was available for inspection.
A year after John Winkler’s death, HeartWare recalled 18,000 potentially faulty batteries produced between 2013 and 2015. Tina Winkler came across the notice online and found her husband’s battery serial numbers on the list. The company never contacted her about it or any further investigation, she said.
As deaths and recalls mounted, HeartWare and Medtronic touted additional FDA approval to treat more patients and their attempts to develop new cutting-edge devices.
With the company on notice under the 2014 warning letter, HeartWare geared up to begin human trials on a smaller heart pump, called the MVAD or Miniaturized Ventricular Assist Device. It would be powered by a new algorithm to more efficiently pump blood. Industry analysts predicted robust sales.
In July 2015, implantations were set to begin on a select group of 60 patients in Europe and Australia. But they were abruptly stopped less than two months later after only 11 implants. Patients experienced numerous adverse events, including major bleeding, infection and device malfunction, according to published data.
HeartWare’s stock price plummeted from about $85 to $35 by October 2015. The next year, Medtronic bought HeartWare for $1.1 billion, replacing much of the company’s leadership shortly after.
Some former HeartWare investors filed a class action lawsuit in January 2016 alleging deception in the development of the MVAD.
According to the accounts of six anonymous former employees in the lawsuit, the details mirror the scandal surrounding Theranos, the former blood test company charged with fraud for raising more than $700 million by allegedly lying about its technology.
Where Theranos made empty promises of a test that only needed a few drops of blood, the suit alleges HeartWare promoted a life-sustaining medical device that former employees said had many problems and actually worsened blood flow, increasing clotting risks.
“Nothing really worked right,” one former HeartWare manager said in the lawsuit, citing “improper alarms, improper touch screen performance, gibberish on display screens — just so many alerts and problems.”
Leadership proceeded with human testing anyway, the suit alleges.
Months later, at an investor conference, HeartWare leadership acknowledged the pump and algorithm led to multiple adverse events. For two patients in particular, the algorithm would direct the pump to speed up so fast that it would try to suck up more blood than was available inside the heart for prolonged periods of time.
HeartWare and Medtronic settled the investor suit for $54.5 million in 2018, admitting no fault.
None of the allegations slowed the FDA as it gave Medtronic additional approval and support for its heart pump technologies.
In September 2017, the agency approved the HVAD as “destination therapy” for patients who were not heart transplant candidates and would rely on the device for the rest of their lives.
“We’re really excited about our HVAD destination therapy approval,” a Medtronic executive said on an investor earnings call. “That’s a real game changer for us in that market.”
Two years later, Medtronic announced it was developing a fully implantable version of the HVAD that would no longer need a cable coming through the waist to connect to power.
Even though issues with the HeartWare device had been unresolved for five years at that point, the FDA accepted the pitch into its new fast-track approval process for high-risk devices.
After Johnson Keelen’s pump failed in February, she found a news story about the recall notice sent to medical providers two months prior.
It said the company had identified a problem with pump restarts that could cause heart attacks or serious patient harm. Nineteen patients had been seriously injured so far, and two people had died. The recall warned that patients should be careful to avoid disconnecting the device’s power sources.
“I kept seeing Medtronic on record saying they notified patients,” Johnson Keelen said. “Who did they contact? No one told me.”
Her doctor later told her she must have “slipped through the cracks,” she said.
The current system for informing patients of new safety concerns with high-risk devices relies on a communication chain that can easily break. The device company contacts the FDA and health care providers that work with device patients. The FDA typically issues a public notice, while health professionals contact their patients.
But the agency admits most patients don’t know to look for formal FDA postings. And, experts say, the medical system can lose track of who needs to be notified, especially if a patient moves or switches primary care physicians.
Tina Winkler still wonders why she was never told about FDA-known safety issues with the HVAD. She said her husband’s medical team “had to teach me how to clean his wound, how to change his batteries and what to do if alarms go off. And they never mentioned any of this.”
She said, “If we had all the facts, there’s no way he would have gotten that device implanted in his heart.”
When FDA inspectors find serious safety issues with a medical device, inspection reports are not posted online or sent to patients. The public can obtain reports through a Freedom of Information Act request, but the agency’s records department has said new requests can be stuck behind a year-long backlog.
Patients can find warning letters online in a searchable database of thousands of letters from different FDA divisions, including the center for devices. But HeartWare’s 2014 letter is no longer available for public review because the website purges letters older than five years.
There are also few documents available in state courts about faulty products, because of restrictions on lawsuits related to medical devices. The restrictions date back to a 2008 Supreme Court decision in a case against Medtronic. The court found that U.S. law bars patients and their survivors from suing device makers in state court, essentially because their products go through such a rigorous FDA approval process.
Two recent patient lawsuits against HeartWare and Medtronic, including one filed by Tina Winkler, were moved from state court to federal court. In both cases, Medtronic filed to dismiss the cases because of the U.S. law that protects device companies. Medtronic and the families reached private settlements soon after.
Winkler and an attorney for the other family said they could not comment on their settlements.
Johnson Keelen, with a decommissioned HVAD still attached to her heart, wonders what that means for her and other patients’ chances of recourse.
“Why isn’t anyone now stepping up for the patient?” she asked. “They are now liable for taking care of us because we relied on them.”
Deserae Cain, 33, is one of the 4,000 patients still relying on a HeartWare device.
She was implanted with the heart pump in late 2017, after suddenly being diagnosed with heart failure. Scans showed her heart was three times normal size. It took time for her to come to terms with needing a life-sustaining device — not long before her diagnosis, she had been going on five-mile runs. In the four years since, though, Cain has built a life around the HVAD with her fiance in their Dayton, Ohio, home.
They know the device can malfunction. In 2019, the pump failed for almost an hour as doctors at a nearby hospital struggled to restart it. Cain just tried to stay calm, knowing anxiety could threaten her unsupported weak heart. Months later, she needed an emergency experimental procedure to clear out blood clots developed within her HVAD.
Then, in 2020, Cain developed a widespread infection. Doctors told her she needed surgery to clean out and replace the pump.
Cain asked her medical team if she could switch to the alternative HeartMate device, which other patients told her presented fewer problems, she said. Doctors said the HVAD was better suited for her smaller frame.
But her new pump had problems soon after the surgery.
The device’s suction alarms, which alert when the pump is trying to pull in more blood than is available within the heart, sounded multiple times a day, for hours at a time, she said. Baffled by the issue for months, her medical team eventually turned off that specific alarm.
Soon after, her ventricular-assist specialist called her about a patient’s death linked to the belt that holds the device controller, she said. The belt had ripped and the equipment had fallen, yanking on the cable that connected the controller to the pump. Cain replaced her belt but it quickly frayed and had to be replaced again within six weeks.
Then, in June, she found out about Medtronic’s decision to stop sales and implants. Cain received a letter from her hospital mentioning a Medtronic support program, but it provided few specifics.
Cain wondered if things would be any different than before. Anxious about her future, she asked: “Are they just going to let it run its course until there is none of us left?”
This post was originally published on Latest – Truthout.
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John Winkler II was dying of heart failure when doctors came to his hospital bedside, offering a chance to prolong his life. The HeartWare Ventricular Assist Device, or HVAD, could be implanted in Winkler’s chest until a transplant was possible. The heart pump came with disclaimers of risk, but Winkler wanted to fight for time. He was only 46 and had a loving wife and four children, and his second grandchild was on the way.
So, in August 2014, Winkler had surgery to implant the device. A golf-ball-sized rotor was attached to his left ventricle to pump blood through a tube and into his aorta. A cable threading out of a small incision in his waist connected to a battery-powered controller strapped to his body. If something went wrong, an alarm as loud as a fire drill would sound.
Winkler returned home weeks later and, as he regained his strength, became hopeful about the future. He started making plans to visit colleges with his daughter, and was able to host his parents and new grandchild for Christmas. “He was doing so much better,” his wife, Tina Winkler, said. “We thought he was coasting until he got his transplant.”
What John Winkler didn’t know: Months before his implant, the Food and Drug Administration put HeartWare on notice for not properly monitoring or repairing HVAD defects, such as faulty batteries and short circuits caused by static electricity, that had killed patients. The agency issued a warning letter, one of its most serious citations. It demanded fixes within 15 days, but took no decisive action as problems persisted.
Ten days after Christmas 2014, Winkler’s two teenage children heard the HVAD’s piercing alarm and ran upstairs. They found their father collapsed on his bedroom floor, completely unresponsive. Kelly, 17, dropped to his side and tried to copy how people on television did CPR. She told her brother to call 911, and over the device’s siren did her best to hear instructions from the operator.
When paramedics arrived and assessed her father, one made a passing comment that has haunted Kelly ever since: “Well, his toes are already cold.” He died two days later. Medtronic, the company that acquired HeartWare in 2016, settled a lawsuit by the family last year, admitting no fault. Tina Winkler believes her children blamed themselves for their father’s death. “Those two kids have never been the same,” she said. “I think they feel like they didn’t do things they needed to do.”
John Winkler II with his wife, Tina Winkler (Courtesy of Tina Winkler)But it was the FDA that failed to protect Winkler and thousands of other patients whose survival depended on the HVAD, a ProPublica investigation found.
As HeartWare and Medtronic failed inspection after inspection and reports of device-related deaths piled up, the FDA relied on the device makers to fix its problems voluntarily rather than compelling them to do so.
The HVAD was implanted into more than 19,000 patients, the majority of whom got it after the FDA found in 2014 that the device didn’t meet federal standards. By the end of last year, the agency had received more than 3,000 reports of patient deaths that may have been caused or contributed to by the device.
Among them were reports of deaths the company linked to serious device problems: a patient who vomited blood as a family member struggled to restart a defective HVAD; a patient who bled out internally and died after implant surgery because a tube attached to the pump tore open; a patient whose heart tissue was left charred after an HVAD short-circuited and voltage surged through the pump.
The ineffective regulatory oversight of the HVAD is emblematic of larger, more systemic weaknesses.
For decades, the FDA and its Center for Devices and Radiological Health have been responsible for ensuring that high-risk medical devices are safe and effective. Yet they mostly rely on manufacturers to identify and correct problems. The agency says it can seize products, order injunctions against companies or issue fines, but it rarely does so, preferring instead for companies to make fixes voluntarily.
When federal investigators found repeated manufacturing issues with the HVAD for years, the FDA didn’t penalize the company, even as the company issued 15 serious recalls of the device starting in 2014, the most of any single high-risk device in the FDA’s database. Thousands of patients with recalled models needed to have external HVAD parts replaced or take extra caution while handling their devices and monitor them for signs of malfunctions that could cause injury or death.
Meanwhile, the processes to inform the public through formal FDA notices and messages to healthcare providers repeatedly failed and left patients in the dark about known problems with the HVAD.
“Patients have no idea, and they rely on the FDA to ensure the safety and effectiveness of high-risk devices,” said Dr. Rita Redberg, a cardiologist at the University of California, San Francisco who studies medical device regulation. “How can you not take action on a warning letter with these serious issues with very sick patients?”
In response to ProPublica’s findings, the FDA said it had been closely monitoring issues with the HVAD. It said that after Medtronic acquired HeartWare in 2016, it met with the company more than 100 times to ensure problems were being fixed and to review safety concerns related to the heart pump. The agency also said it initiated formal reviews of new device modifications and continually tracked whether the HVAD had a “reasonable assurance of safety and effectiveness.”
“Our decisions that we made along the way have always been patient-focused,” said Dr. William Maisel, the director of product evaluation and quality at the FDA’s device division. He added that more than 80% of companies fix their problems by the time the FDA reinspects.
That did not happen with the HVAD. In 2016 and 2018, inspectors found that issues detailed in the 2014 warning letter remained unresolved. Medtronic told the FDA last year that it had fixed the problems, but, before the agency could verify the claim, inspections were paused because of the coronavirus pandemic.
In June, Medtronic stopped HVAD sales and implants. The company conceded that a competing device was safer after a new study showed the HVAD had higher rates of death and neurological injury. Medtronic also cited a 12-year-old problem with its devices not restarting if they disconnect from power, leaving patients’ hearts without support.
Medtronic declined to make CEO Geoffrey Martha or president of mechanical heart support Nnamdi Njoku available for interviews. In an email, a spokesperson said, “There is nothing more important to Medtronic than the safety and well-being of patients.”
The email continued, “Medtronic takes this matter very seriously and, over the past five years, we have worked closely with FDA and engaged external experts to resolve the issues noted in the warning letter. FDA is aware of the steps Medtronic has taken to address the underlying concerns.”
The company said it will have a support system in place for the 4,000 patients worldwide and 2,000 in the United States who still rely on the HVAD. Medtronic will station 20 specialists across the globe to help with device maintenance and patient education. A centralized engineering team will also provide technical support and troubleshooting for patients and medical staff. Medtronic said it will also offer financial assistance if insurance doesn’t fully cover the surgery to replace a device with a competing product, but only if a doctor decides it’s medically necessary.
Patients with HVADs have little choice but to hope the devices keep working: The surgery to remove HVADs is so risky that both Medtronic and the FDA advise against it. The device is meant to be left in place until its wearer gets a heart transplant. Or dies.
The HeartWare Ventricular Assist DeviceA pump with a rotor attached to the left ventricle circulates blood through a tube and into the aorta. A cable, or driveline, connects the pump to a battery-powered external controller through a small incision in the waist.
(Laila Milevski/ProPublica) Warning SignsIn late 2012, HeartWare, then an independent company headquartered in Massachusetts, won FDA approval to sell a new device that could keep heart failure patients alive and mobile while awaiting a transplant.
A competing device, the HeartMate, was already gaining attention, with high-profile patients like former Vice President Dick Cheney, a heart attack survivor who eventually got a transplant after using the device for 20 months.
The HVAD offered a smaller option that could even be used in children, and it led to a string of publicized successes. A fitness model was able to return to the gym. A 13-year-old with heart defects could attend school again. Medtronic’s YouTube page features 16 interviews with grateful patients and families.
The patients who received HVADs had already been in grave peril. They had advanced heart failure, serious enough to need blood pumped out of their hearts artificially. Most patients were older than 50, but there were also younger patients with heart defects or other cardiac conditions. The device provided help but brought its own risks. Implanting it required invasive open-heart surgery, and clots could develop inside the pump, which, in the worst cases, led to deadly strokes.
The device also came with a steep price tag. Each HVAD cost about $80,000, and, even though HeartWare never made a profit as an independent company, in 2015 device sales brought in $276 million in revenue.
For many severe heart failure patients, the opportunity to survive longer and return to normal life made the device worth the risks and cost.
But patients were unaware the FDA started finding manufacturing issues at HeartWare’s Miami Lakes, Florida, plant as early as 2011, when the device was still seeking approval.
Among the findings, a federal inspector expressed concerns that engineering staff “were not completely reviewing documents before approving them” and found one employee assigned to monitoring device quality had missed several required monthly trainings. HeartWare leadership promised quick corrective action, according to FDA documents.
Then, in 2014, the FDA found more serious lapses, detailed in federal inspection reports.
For example, HeartWare knew of 119 instances in which batteries failed unexpectedly, which could leave the pump powerless, stopping support for the patient’s heart. But the company didn’t test the batteries in inventory for defects, or the batteries of current patients, even though one person’s death had already been linked to battery failure.
The company also received complaints that static electricity could short-circuit its devices. It learned of at least 27 such cases between 2010 and 2013, including four that resulted in serious injuries and two that led to death. HVAD patients would need to avoid contact with certain household objects like televisions or vacuum cleaners — anything that could create strong static electricity. HeartWare added warnings to the patient manual and redesigned its shield to protect the device controller, but the FDA found that the company didn’t replace shields for devices already being used by current patients or produced and sitting in inventory.
Continuing quality control concerns led to the FDA warning letter in June 2014. The document labeled the HVAD as “adulterated,” meaning the device did not meet federal manufacturing standards. The agency gave HeartWare 15 days to correct the problems or face regulatory action.
Still, investment analysts who followed HeartWare believed the warning posed little risk to the company’s business prospects. One described it as being “as benign as possible.”
The 15-day deadline passed, and the FDA never penalized the company.
Early Defects Flagged, But Patients Go UnprotectedThe agency told ProPublica it had provided additional time because HeartWare was a relatively new manufacturer and the HVAD was a complicated device. It also said it avoided punitive action to make sure patients with severe heart failure had access to this treatment option. “We’re talking about the sickest of the sick patients who really have very few alternatives,” Maisel, the head of device quality, said.
But the HeartMate, the competing device, was available and already being used by the majority of patients. When Medtronic stopped HVAD sales, both companies said the HeartMate could fill the gap.
Inspectors continued to find problems at HeartWare facilities in 2015, 2016, 2017 and 2018. In the most recent report in 2018, inspectors identified seven separate violations at the HVAD plant, including three previously cited in the 2014 warning letter. The company was still mishandling newly discovered defects like pins connecting the controller to a power source that could bend and become unusable, and controllers built with incompatible parts that could chemically react and “attack” the plastic exterior.
Again, the inspection report said the company “promised to correct” the issues.
“What penalty is there for noncompliance? There isn’t one,” said Madris Kinard, a former public health analyst with the FDA and the CEO of Device Events, a software company that analyzes FDA device data. “There’s nothing the FDA is doing that penalizes, in any true sense of the matter, the manufacturer.”
By the time sales were halted last month, the HVAD had become the subject of 15 company-initiated “Class I” recalls for dangerous device problems that could cause injury or death.
One recall came with a warning sent to health care providers in December that said pumps were failing to start up properly. The pattern of malfunctions was almost as old as the device itself, the company later admitted when it halted device sales in June. But even recent patients were completely unaware of the problem.
“A No-Brainer”When children asked Latoya Johnson Keelen about the cable that came out of her side and connected to a controller on her hip, she told them she was Iron Woman.
For a while, she felt invulnerable with the HVAD on her heart.
Johnson Keelen, who lives in the Atlanta suburbs, learned she needed the device after delivering her fourth child, Isaiah, in early 2018. Doctors diagnosed her with postpartum cardiomyopathy, a rare and mysterious form of heart failure that afflicts mothers during pregnancy or after birth. Black mothers in the South have among the highest rates of the illness. Some mothers quickly regain heart function, some only partially recuperate and others never recover.
Tests showed that Johnson Keelen, then 42, was suddenly in end-stage heart failure.
Her body’s immune response at the time was too strong for her to receive a heart transplant. Doctors gave her two choices: an HVAD or end-of-life hospice care.
“It became a no-brainer,” she said. “I just had a baby. I just gave birth. I’m not ready to plan for a funeral.”
Johnson Keelen, a woman of faith, believed God would heal her, either through a medical advancement or a miracle. She thought the HVAD was the answer.
Latoya Johnson Keelen (Lynsey Weatherspoon for ProPublica)Living with a life-sustaining medical device was difficult at first for the fiercely independent mother. She had to leave her job as a public health communications specialist, ask her older sons to change her bandages and lean heavily on her new husband, only a year into their marriage.
But, for about three years, she found comfort in the soft humming of the HVAD’s spinning rotor at night. It served as a lullaby for her new baby when he lay on her chest.
She said she was never told about the manufacturing problems the FDA repeatedly found at HeartWare’s facilities or about device recalls, including one sent to patients in December 2020. The notice said the device sometimes wouldn’t restart properly, which had led to two patient deaths at that point. It warned that current patients should always keep at least one power source, a battery or an AC or DC adapter, connected at all times to avoid the need for a restart.
Two months after that notice, Johnson Keelen was getting her kids ready for school when the HVAD’s low-battery alarm blared. She had unplugged the battery to replace it without realizing her wall adapter was disconnected.
Once before, Johnson Keelen had simply plugged the charger back into the outlet and her device restarted. But this time it wouldn’t.
As an emergency alarm sounded, she called the ventricular-assist team assigned to her case, and a specialist directed her to switch out the device controller.
Nothing changed, and panic crept into the voice on the phone.
An ambulance took Johnson Keelen to a hospital where medical staff used several backup controllers to try to start the pump.
Still nothing.
Doctors and nurses tried to keep calm, but Johnson Keelen could see fear and shock on their faces. Without the HVAD, her only options were a transplant or a completely new pump.
Doctors scurried to locate a donor heart and airlifted her for an emergency transplant. But while running tests, the medical team was stunned to find that Johnson Keelen’s miracle had occurred: Her heart was once again pumping blood on its own.
She had a new choice. She could avoid the risks of transplant rejection and open heart surgery during the pandemic by leaving the device on her functioning heart, while cutting the wires, removing the external components and sealing the pump.
She chose to trust her newly functioning heart, and leave the decommissioned HVAD inside her.
Three months later, when Medtronic said it was stopping HeartWare sales and implants, its announcement cited the problem with pumps not restarting among the reasons.
Company-Led OversightIf evidence suggests a medical device may be linked to a serious patient injury or death, hospitals and other health care facilities must submit a report to the manufacturer and the FDA. Device companies must also submit reports if they learn independently of any incidents.
By the end of 2020, roughly 3,000 death reports and 20,000 injury reports related to the HVAD had been filed with the FDA.
Any details that could identify patients, like their age or gender, are removed from the publicly available reports. Most only have limited details about circumstances surrounding deaths or injuries. But it’s clear from the reports on the HVAD that some of these outcomes could be linked to problems previously identified by FDA inspectors.
Doctors attempted CPR for two hours after an electrostatic shock short-circuited one patient’s device in 2014, a few months after the FDA inspection that year. An autopsy revealed voltage had caused “deep charring” of the tissue inside the patient’s chest.
Friends found another patient dead in the kitchen, with groceries still on the counter, in 2018 after their device, which did not have the recommended static shield, short-circuited.
Last year, paramedics found a patient with the device disconnected from power. They struggled to restart the device, but it wouldn’t plug back into the power source because the connector pins were bent. The patient would die at the hospital.
In most cases, the FDA turned to the company to investigate whether a malfunction caused or contributed to the incidents.
But the FDA has long known HeartWare and Medtronic could not be relied on to properly submit HVAD incident reports.
In 2014, the FDA cited HeartWare because in at least 10 cases, there were no documents showing the company attempted to investigate.
In 2016, the agency wrote another citation when the company was late in reporting more than 200 cases, some more than a year past their 30-day reporting deadlines, and failed to report malfunctions that occurred during clinical trials.
The FDA told ProPublica the agency increased its monitoring of HVAD reports, and Medtronic hired new employees to submit timely reports. But by 2018, its backlog had only grown, with 677 late case filings. Again, the FDA did nothing beyond telling the company to fix the problem and further increasing its monitoring.
In an email, Medtronic said it “has robust systems in place to monitor the safety of all of our products, including the HVAD device.”
The email said, “When any potential safety issues are identified, those issues are thoroughly investigated and relevant information is shared with regulators and healthcare providers.” The company didn’t respond to the pattern of late reports and incomplete investigations identified in FDA inspections.
Maisel, the director of FDA device evaluation and quality, once criticized asking companies to investigate their own devices. In 2008, as a practicing cardiologist, he testified to the U.S. House oversight committee about his concerns.
“In the majority of cases, FDA relies on industry to identify, correct and report the problems,” he said. “But there is obviously an inherent financial conflict of interest for the manufacturers, sometimes measured in billions of dollars.”
Current Top FDA Official Said in 2008: Regulatory Failures Enable “Potentially Defective Devices To Reach Unwary Consumers” (C-SPAN)Maisel has since had a change of heart. When asked about his 2008 testimony, he told ProPublica that he now believes the regulatory system “generally serves patients well” and “most companies are well intentioned.”
HeartWare’s track record of questionable investigations was glaring in John Winkler II’s case.
A report submitted by HeartWare that matches the dates and details of Winkler’s case shows the company decided there was “no indication of any device malfunctions.” It told the FDA that the device couldn’t be removed from the body because the hospital said his family declined an autopsy. HeartWare added that the evidence of the device’s role in Winkler’s death was inconclusive.
Yet little of this appears to be true. Documents reviewed by ProPublica show an autopsy of the heart and lungs was performed a day after the death. Tina Winkler said she was told the pump was removed from her husband’s body and was available for inspection.
A year after John Winkler’s death, HeartWare recalled 18,000 potentially faulty batteries produced between 2013 and 2015. Tina Winkler came across the notice online and found her husband’s battery serial numbers on the list. The company never contacted her about it or any further investigation, she said.
Rewards, Not PenaltiesAs deaths and recalls mounted, HeartWare and Medtronic touted additional FDA approval to treat more patients and their attempts to develop new cutting-edge devices.
With the company on notice under the 2014 warning letter, HeartWare geared up to begin human trials on a smaller heart pump, called the MVAD or Miniaturized Ventricular Assist Device. It would be powered by a new algorithm to more efficiently pump blood. Industry analysts predicted robust sales.
In July 2015, implantations were set to begin on a select group of 60 patients in Europe and Australia. But they were abruptly stopped less than two months later after only 11 implants. Patients experienced numerous adverse events, including major bleeding, infection and device malfunction, according to published data.
Problems Worsen, But the FDA Expands HeartWare’s ReachHeartWare’s stock price plummeted from about $85 to $35 by October 2015. The next year, Medtronic bought HeartWare for $1.1 billion, replacing much of the company’s leadership shortly after.
Some former HeartWare investors filed a class action lawsuit in January 2016 alleging deception in the development of the MVAD.
According to the accounts of six anonymous former employees in the lawsuit, the details mirror the scandal surrounding Theranos, the former blood test company charged with fraud for raising more than $700 million by allegedly lying about its technology.
Where Theranos made empty promises of a test that only needed a few drops of blood, the suit alleges HeartWare promoted a life-sustaining medical device that former employees said had many problems and actually worsened blood flow, increasing clotting risks.
“Nothing really worked right,” one former HeartWare manager said in the lawsuit, citing “improper alarms, improper touch screen performance, gibberish on display screens — just so many alerts and problems.”
Leadership proceeded with human testing anyway, the suit alleges.
Months later, at an investor conference, HeartWare leadership acknowledged the pump and algorithm led to multiple adverse events. For two patients in particular, the algorithm would direct the pump to speed up so fast that it would try to suck up more blood than was available inside the heart for prolonged periods of time.
HeartWare and Medtronic settled the investor suit for $54.5 million in 2018, admitting no fault.
None of the allegations slowed the FDA as it gave Medtronic additional approval and support for its heart pump technologies.
In September 2017, the agency approved the HVAD as “destination therapy” for patients who were not heart transplant candidates and would rely on the device for the rest of their lives.
“We’re really excited about our HVAD destination therapy approval,” a Medtronic executive said on an investor earnings call. “That’s a real game changer for us in that market.”
Two years later, Medtronic announced it was developing a fully implantable version of the HVAD that would no longer need a cable coming through the waist to connect to power.
Even though issues with the HeartWare device had been unresolved for five years at that point, the FDA accepted the pitch into its new fast-track approval process for high-risk devices.
“Slipped Through The Cracks”After Johnson Keelen’s pump failed in February, she found a news story about the recall notice sent to medical providers two months prior.
It said the company had identified a problem with pump restarts that could cause heart attacks or serious patient harm. Nineteen patients had been seriously injured so far, and two people had died. The recall warned that patients should be careful to avoid disconnecting the device’s power sources.
“I kept seeing Medtronic on record saying they notified patients,” Johnson Keelen said. “Who did they contact? No one told me.”
Her doctor later told her she must have “slipped through the cracks,” she said.
Johnson Keelen’s family became caregivers after she was implanted. Her older sons changed her bandages. (Lynsey Weatherspoon for ProPublica)The current system for informing patients of new safety concerns with high-risk devices relies on a communication chain that can easily break. The device company contacts the FDA and health care providers that work with device patients. The FDA typically issues a public notice, while health professionals contact their patients.
But the agency admits most patients don’t know to look for formal FDA postings. And, experts say, the medical system can lose track of who needs to be notified, especially if a patient moves or switches primary care physicians.
Tina Winkler still wonders why she was never told about FDA-known safety issues with the HVAD. She said her husband’s medical team “had to teach me how to clean his wound, how to change his batteries and what to do if alarms go off. And they never mentioned any of this.”
She said, “If we had all the facts, there’s no way he would have gotten that device implanted in his heart.”
When FDA inspectors find serious safety issues with a medical device, inspection reports are not posted online or sent to patients. The public can obtain reports through a Freedom of Information Act request, but the agency’s records department has said new requests can be stuck behind a year-long backlog.
Patients can find warning letters online in a searchable database of thousands of letters from different FDA divisions, including the center for devices. But HeartWare’s 2014 letter is no longer available for public review because the website purges letters older than five years.
There are also few documents available in state courts about faulty products, because of restrictions on lawsuits related to medical devices. The restrictions date back to a 2008 Supreme Court decision in a case against Medtronic. The court found that U.S. law bars patients and their survivors from suing device makers in state court, essentially because their products go through such a rigorous FDA approval process.
Two recent patient lawsuits against HeartWare and Medtronic, including one filed by Tina Winkler, were moved from state court to federal court. In both cases, Medtronic filed to dismiss the cases because of the U.S. law that protects device companies. Medtronic and the families reached private settlements soon after.
Winkler and an attorney for the other family said they could not comment on their settlements.
Johnson Keelen, with a decommissioned HVAD still attached to her heart, wonders what that means for her and other patients’ chances of recourse.
“Why isn’t anyone now stepping up for the patient?” she asked. “They are now liable for taking care of us because we relied on them.”
“Run Its Course”Deserae Cain, 33, is one of the 4,000 patients still relying on a HeartWare device.
She was implanted with the heart pump in late 2017, after suddenly being diagnosed with heart failure. Scans showed her heart was three times normal size. It took time for her to come to terms with needing a life-sustaining device — not long before her diagnosis, she had been going on five-mile runs. In the four years since, though, Cain has built a life around the HVAD with her fiance in their Dayton, Ohio, home.
They know the device can malfunction. In 2019, the pump failed for almost an hour as doctors at a nearby hospital struggled to restart it. Cain just tried to stay calm, knowing anxiety could threaten her unsupported weak heart. Months later, she needed an emergency experimental procedure to clear out blood clots developed within her HVAD.
Then, in 2020, Cain developed a widespread infection. Doctors told her she needed surgery to clean out and replace the pump.
Cain asked her medical team if she could switch to the alternative HeartMate device, which other patients told her presented fewer problems, she said. Doctors said the HVAD was better suited for her smaller frame.
But her new pump had problems soon after the surgery.
The device’s suction alarms, which alert when the pump is trying to pull in more blood than is available within the heart, sounded multiple times a day, for hours at a time, she said. Baffled by the issue for months, her medical team eventually turned off that specific alarm.
Soon after, her ventricular-assist specialist called her about a patient’s death linked to the belt that holds the device controller, she said. The belt had ripped and the equipment had fallen, yanking on the cable that connected the controller to the pump. Cain replaced her belt but it quickly frayed and had to be replaced again within six weeks.
Then, in June, she found out about Medtronic’s decision to stop sales and implants. Cain received a letter from her hospital mentioning a Medtronic support program, but it provided few specifics.
Cain wondered if things would be any different than before. Anxious about her future, she asked: “Are they just going to let it run its course until there is none of us left?”
Tell Us About Your Experience With Life-Sustaining Medical Devices
This post was originally published on Articles and Investigations – ProPublica.
As much of the world struggles to cope with the pandemic and its impacts, we speak with Dr. Rupa Marya and Raj Patel, co-authors of the new book, Inflamed: Deep Medicine and the Anatomy of Injustice, which examines the social and environmental roots of poor health. “Inflammation is the body’s appropriate response to damage, or the threat of damage,” says Marya, a physician and co-founder of the Do No Harm Coalition. “We’re learning that the social structures around us, the environmental, political structures around us, are tuning the immune system to sound out the full range of inflammation.” Patel adds that “capitalism primes bodies … for sickness.”
This is a rush transcript. Copy may not be in its final form.
AMY GOODMAN: This is Democracy Now!, Democracynow.org, the War and Peace Report. I’m Amy Goodman.
The highly infectious coronavirus Delta variant is causing huge spikes in cases across the United States and around the world with China struggling to control surging infections and the Philippines preparing for a new, stricter lockdown. The United States is now averaging some 80,000 new COVID cases a day, about six times as many daily cases than a month ago. As much of the world struggles to cope with the pandemic and its impacts, we begin today’s show with the authors of a new book that examines the social and environmental roots of poor health. “Your body is part of a society inflamed,” write the authors. In a minute, we’ll speak with the co-authors of Inflamed: Deep Medicine and the Anatomy of Injustice, bestselling author Raj Patel and physician and activist Rupa Marya. But first, this is an animated introduction to their book by Aaron Kierbel.
NARRATOR 1: You wake up one morning with a dry, hacking cough and you have lost your sense of smell. You visit your doctor for a diagnosis. With an x-ray and nasal swab, she diagnosis COVID. The coronavirus infected your body, and your lungs and nerves are now inflamed.
NARRATOR 2: The inflammation sends you to hospital, and when you are in the ICU, you look around and notice a disproportionate number of people of color. In the United States, hospitalization and death rates for people of color are far higher than for white people. You make another kind of diagnosis yourself. This, you observe, is the outcome of structural racism. But how did those structures come to be?
NARRATOR 1: To understand that, we must go back 600 years to a time when a different pestilence spread across the globe, one that continues today and still makes us sick. And it makes us sick in a patterned way, through inflammatory disease which underlies all the leading causes of death in industrialized places.
NARRATOR 2: European colonization transformed the planet. Through slavery, genocide and disease, colonists brought with them a cosmology that changed how people relate to each other and to the living world around them. Those who resisted were set to the flame.
NARRATOR 1: This history lives inside you, whether you know it or not. Since you were conceived, your body has been exposed to the consequences of a world on fire.
NARRATOR 2: The COVID hospital ward and the specific patients who are in its beds look that way because of centuries of attempts to extinguish other kinds of knowledge and civilizations.
NARRATOR 1: If we understand disease with this new kind of diagnosis, the treatment options become radically different. The deep medicine we prescribe to address the inflammation of people and planet has been prescribed by others before us. Rudolf von Virchow and Sitting Bull and Frantz Fanon.
NARRATOR 2: Huda Sha’arawi and B.R. Ambedkar. And Harriet Tubman.
NARRATOR 1: They understood that our modern ills can’t simply be vaccinated away. We need a world rebuilt with care at its heart.
NARRATOR 2: But what does that look like? Many indigenous communities have resisted colonialism by continuing to care for the living world around them. Their care for life protects them inside and out.
NARRATOR 1: Indigenous communities defend the greatest range of biodiversity on the planet and as a result host the most diverse microbiota inside their bodies. These microbes confer protection against inflammatory disease.
NARRATOR 2: When culture isn’t capitalist and isn’t colonized, it can soothe the inflammatory diseases that afflict us and fuel the burning of our planet.
NARRATOR 1: Deep medicine offers new and old stories that connect humans to the teeming microbes in our guts and to the teeming stars in the skies. We offer a glimpse into cosmologies that bring a cooling balm.
NARRATOR 2: To a world, to societies and bodies that are—
BOTH NARRATORS: Inflamed.
AMY GOODMAN: That’s the animated introduction by Aaron Kierbel to the book Inflamed: Deep Medicine and the Anatomy of Injustice. For more we are joined by the book’s authors.
In Austin, Texas, Raj Patel is with us, Research Professor at the University of Texas’s Lyndon B. Johnson School of Public Affairs, a Professor in the University’s Department of Nutritional Sciences, and a Research Associate at Rhodes University, South Africa. He is also the author of Stuffed and Starved: The Hidden Battle for the World’s Food System and the bestselling book The Value of Nothing: How to Reshape Market Society and Redefine Democracy.
And in Berkeley, California, we are joined by Dr. Rupa Marya, Associate Professor of Medicine at the University of California, San Francisco, where she practices and teaches internal medicine. She is a co-founder of the Do No Harm Coalition, a collective of health workers committed to addressing disease through structural change. We welcome you both to Democracy Now! This is an epic work. Raj, let’s begin with you in Texas. If you can talk about this connection between capitalism and the COVID pandemic?
RAJ PATEL: Thank you, Amy, for having us. For listeners and viewers who are unaware, one of the ways that the modern food system operates is through a sort of legacy of separating humans from the rest of the web of life. Now what that means is that humans feel, under capitalism and particularly under capitalist colonialism, to be free to exploit the world around us. We feel free to be able to do that because the rest of the web of life is just worth less than our profit motive. That is why, for example, 60% of current human infectious diseases come from pathogens that jump from one species to another, and the industrial food system incubates those kinds of diseases.
Now, while the jury is out around COVID, it is certainly the case that we have seen a vast array of diseases coming from the industrial food system. H1N1, for example, in 2009, was one example of a disease that emerged from a food system which is quite happy with treating the rest of the web of life as a disposable resource. And also quite happy in treating the working class as an expendable kind of insulation between the burn of disease and the needs of the rich and the Global North.
Now, when you have a kind of set-up that’s based on this 600-year process of exploitation and colonial domination, then you are preparing the world for pandemics not just of a virus, but also for the consequences of a virus reverberating through societies that are deeply unequal. And so we opened today’s show talking about the climate disasters that are happening around the world. Guess who it is that’s on the front lines of the climate crisis? It’s the same communities that are at the forefront, who have been predominantly exposed to the kinds of narratives, the kinds of exposures that render their body more ready to become susceptible to COVID.
AMY GOODMAN: Which brings us to the title. Dr. Rupa Marya, the title of your book, Inflamed: Deep Medicine and the Anatomy of Injustice. Talk about why you called it Inflamed and the kind of work you have been doing that shows the disparities that result from the system that we have.
DR. RUPA MARYA: Thank you for having us, Amy. I’m happy to be speaking to you today from the occupied territory of Huichin. You can see the West Berkeley Shellmound, which our friends are trying to save, the oldest inhabited site here in the Bay Area. So, inflammation is the body’s appropriate response to damage, or the threat of damage. And the leading cause of death and illness in industrialized places are all inflammatory disease, whether we’re talking about cardiovascular disease or cancer, Alzheimer’s disease, depression, even suicide. All of these diseases have inflammation as a part of their process.
And we are learning now that the immune system is being primed for inflammatory disease through not just genetics, which is what we’ve been thinking about for many years. You know,, why do some people get autoimmune disease? Why do some people get inflammatory bowel disease? Why do some people get cancer? But now we are learning that the social structures around us, the environmental and political structures around us, are tuning the immune system to sound out the full range of inflammation.
And unfortunately, medical education is steeped in the same Enlightenment errors that Raj was just speaking of, separating humans from the web of life, separating civilization from nature. These kinds of false dichotomies and errors are a part of medical education today. And so while it is helpful that we are talking about structural determinants of health as we’re looking at the glaring disparities with the COVID crisis, we don’t learn in medicine where these structures came from or how to dismantle them. And that is really what deep medicine is. If we want to be making an impact on these structures, if we want to be making an impact on the health outcomes, we have to start working with communities who are already identifying the problems and leading the change. And so that is a brief summary of what we are doing in this book.
AMY GOODMAN: And if you can talk about the pandemic, Raj Patel, providing this kind of autopsy, of racial disparities in the country, the profound injustices in the system? In just a few moments, we will be linking up with Congressmember Cori Bush, who has been sleeping on the steps of the Capitol with a number of other people protesting the fact that the eviction moratorium was allowed to expire, threatening millions of people in this country. This, in the midst of a pandemic that is surging in this country.
RAJ PATEL: As we approach this expiration, one of the big ideas that we have in the book is particularly the way that capitalism primes bodies, as Rupa was saying, for sickness. And this expiration is going to drive more people into despair. But we already have the technologies of oppression that are geared towards sending the working class to despair.
Things like payday loans, for example. If you take out a payday loan for $300, you might end up paying upwards of $800, an APR of 400%. And we know that the stress of needing to repay these loans is causing ill health. To the extent that if we were to ban things like payday loans, then in the United States the suicide rate would fall by 2.1% and the fatal drug poisoning rate would drop by 8.9%. Now, that kind of ongoing stress is just a normal feature of the way that capitalism operates in the United States. And this moment of triggering the lapse of the eviction moratorium is going to drive yet more people to the abyss. But Rupa has been working, for example, in San Francisco, working with physicians and protesting with them around some of the eviction-related issues and the issues around the unhoused there.
AMY GOODMAN: Dr. Rupa Marya, if you can talk about that work for just about 30 seconds. Then we’re going to go to break. We’re going to go to Congressmember Cori Bush, who has been sleeping out on the Capitol steps for the last few days to protest this eviction moratorium expiring. And then we’re going to come back to the two of you.
DR. RUPA MARYA: The Do No Harm Coalition has been working very closely with the Coalition on Homelessness, with POOR Magazine, formerly unhoused folks, poor people who have solutions to the manufactured crisis of homelessness here. While London Breed has been celebrated for her response to COVID, over 8,000 people were left on the streets of San Francisco in the midst of wildfire and the pandemic. And so this is really a health crisis, and it’s an unnecessary health crisis. It’s going to jeopardize—it already is jeopardizing the health of so many people. So I applaud Cori Bush and her Bill of Rights for unhoused people. We need to look to formally unhoused and unhoused people for these solutions and follow their lead.
AMY GOODMAN: We’re going to go to her right now, but we hope you both will stay by. Dr. Rupa Marya and Raj Patel, co-authors of Inflamed: Deep Medicine and the Anatomy of Injustice. When we come back, we will go to the U.S. Capitol steps to speak with Congressmember Cori Bush, where she and others have been sleeping outside on the steps since Friday night to protest the house adjourning without passing another extension of the eviction moratorium for renters. This is the Democrat-controlled House. Stay with us.
[Music Break]
AMY GOODMAN: “I Don’t Want To Get Arrested” by Rupa & the April Fishes, whose music was described by the legendary Gil Scott-Heron as liberation music. Yes, that is our guest that we just spoke with, Dr. Rupa Marya.
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Bayer Monsanto stated Thursday that “the company and its partners will replace its glyphosate-based products in the U.S. residential Lawn & Garden market with new formulations that rely on alternative active ingredients beginning in 2023, subject to a timely review by the U.S. Environmental Protection Agency (EPA) and state counterparts…..”
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2021 is also a very special year in the history of single-payer health insurance and public health in the U.S. because Reps. Pramila Jayapal (D-Wash.) and Debbie Dingell (D-Mich.) introduced the modern Medicare for All Act of 2021 (H.R. 1976) in Congress. M4A 2021 is new legislation establishing a cutting edge single-payer national health program in the United States that addresses decades of health/mental health-related injustices that have been made even more painfully apparent by the Covid-19 pandemic.
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Between 2015 and 2019, the government of Iceland and the Reykjavik City Council undertook an employment experiment, allowing a sample of workers access to a shorter work week without any loss of pay. The results are now in, and over the past week or so the study’s findings have garnered significant media attention. Many are declaring the Icelandic pilot “an overwhelming success,” reporting that workers experienced greater work-life balance, reduced stress and more free time with family.
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Why is the U.S. an outlier with regard to health care? What keeps the country from adopting a universal health care system, which most Americans have supported for many years now? And what exactly is Medicare for All? On the eve of scheduled marches and rallies in support of Medicare for All, led by various organizations such as the Sunrise Movement, Physicians for a National Health Program, the Democratic Socialists of America and concerned citizens throughout the country, the interview below with Peter S. Arno, a leading health expert, sheds light on some key questions about the state of health care in the United States.
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Six independent UN human rights experts alerted that hundreds of Venezuelan cancer patients’ lives are under threat because of an “excessively strict application” of US sanctions.
In a press release published on Wednesday, the group of experts warned that Venezuelan cancer patients “have been stranded, destitute, in countries where they went for treatment” because “money cannot be transferred out of Venezuela,” laying blame on US unilateral measures and overcompliance policies.
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The Behavioral Health Emergency Assistance Response Division, or “B-HEARD” program, which started in a portion of Harlem a month ago, has already responded to about 110 calls where there was no weapon or imminent risk of violence, according to summary data provided by the city on Thursday. Instead of cops and paramedics responding to 911 mental health calls, three-person teams of social workers and paramedics respond instead. In 95 percent of those cases, the city said, the subject of the call accepted the team’s offer of assistance.
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“When it comes to misinformation, not sharing is caring,” Surgeon General Vivek Murthy said during a White House press briefing last week. His advisory offers a detailed account of the ways that the spread of health mis- and disinformation has flooded communities with lies.
Health misinformation was deadly prior to the rise of internet platforms, but the problem is proliferating in new ways because of the technology these companies use to extract and exploit our demographic and behavioral data.
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The United States is one of the richest countries in the world, yet its poverty rates are higher and its safety nets are far weaker than those of other industrialized nations. It is also the only large rich country without universal health care. In fact, as Noam Chomsky argued in Truthout, the U.S. health system is an “international scandal.”
Why is the U.S. an outlier with regard to health care? What keeps the country from adopting a universal health care system, which most Americans have supported for many years now? And what exactly is Medicare for All? On the eve of scheduled marches and rallies in support of Medicare for All, led by various organizations such as the Sunrise Movement, Physicians for a National Health Program, the Democratic Socialists of America and concerned citizens throughout the country, the interview below with Peter S. Arno, a leading health expert, sheds light on some key questions about the state of health care in the United States.
Peter S. Arno is senior fellow and director of health policy research at the Political Economy Research Institute at the University of Massachusetts-Amherst, and a senior fellow at the National Academy of Social Insurance. Among his many works is his Pulitzer Prize-nominated book, Against the Odds: The Story of AIDS Drug Development, Politics & Profits.
C.J. Polychroniou: U.S. health care is widely regarded as an outlier, with higher costs and worse outcomes than other countries. Why are health care expenditures in the U.S. significantly higher than those of other industrialized countries? And how do we explain poor health outcomes, including life expectancy, compared to most European nations?
Peter Arno: The short answer as to why the U.S. has the highest health care expenditures in the world is simply that, unlike other developed countries, we exercise very few price constraints on our health care products and services, ranging from drugs, medical devices, physician and hospital services to private insurance products. On a broader level, the corporatization and profits generated from medical care may be the most distinguishing characteristics of the modern American health care system. The theology of the market, along with the strongly held mistaken belief that the problems of U.S. health care can be solved if only the market could be perfected, has effectively obstructed the development of a rational, efficient and humane national health care policy.
Despite the U.S.’s outsized spending on health care, its relatively poor health outcomes are beyond dispute. For example, in 2019, the U.S. ranked 36th in the world in terms of life expectancy at birth — behind Slovenia and Costa Rica, not to mention Canada, Japan and all the wealthy countries in Europe. This is not solely, as one might at first think, a function of racial and ethnic health disparities, as dramatic as they are in the U.S. A recent study found that even white people living in the nation’s highest-income counties often have worse health outcomes on infant mortality, maternal mortality, and deaths after heart attack, colon cancer and childhood leukemia than the average citizens of Norway, Denmark, and other wealthier countries.
The relatively poor health outcomes in the U.S. require a more nuanced explanation based on income, wealth and power inequalities. These factors drive inadequate and inequitable access to health care. But they also undermine many of the social determinants of health, particularly for poor and vulnerable populations, which fall largely outside the health care sector. These include, for example, higher income, access to healthy food, clean water and air, adequate housing, safe neighborhoods, etc.
Given the above facts, it’s important to ask: Why doesn’t the U.S. have universal health coverage?
The simple answer is that the economic and political forces that profit greatly from the status quo are opposed to universal health coverage. It’s certainly not too complicated to implement such a system — nearly every wealthy country in the world has figured out how it can be done. Many academics and pundits point to surveys indicating that Americans are fearful of change and are satisfied with the status quo, in particular with their employer-based health insurance (which covers more than 150 million workers and their families). In part, these attitudes are understandable. Most people are healthy and thus are not faced with the inequities and indignities that befall those who become ill and must deal with the private insurance industry and a dysfunctional health care system. Additionally, the true costs of health care are often hidden from workers who receive their insurance through jobs in which insurance premiums are automatically deducted from their paychecks. Even less well understood is the fact that we all subsidize employers’ contributions to workers’ health insurance with more than $300 billion of our tax dollars (employer contributions are not taxed but are considered a line item in the federal budget). But public sentiment is changing as health care expenditures continue to outpace earnings. Over the past 10 years, insurance premiums have risen more than twice as fast as earnings, while deductibles rose more than six times as fast. And the even more rapidly rising price of prescription drugs has particularly captured the public’s attention. This is likely because prescription drug prices rose by 33 percent between 2014 and 2020, and the average price of new cancer drugs now exceeds $100,000 per year. There is also an increasing public recognition of the massive and growing medical debt burden. One recent study estimated that nearly 1 out of 5 individuals in the U.S. collectively had $140 billion worth of medical debt in collections in June 2020.
You have done outstanding research on the economics and politics of AIDS. How did your background in AIDS research shape your views on health care and social insurance?
My background in AIDS research, which began in the mid-1980s as the epidemic exploded around the country, highlighted a central weakness of American health care — if you become ill and lose your job, you frequently lose your health insurance. Thus, at the point when you need it most, you lose access to health care. This was driven by the private health insurance profit-maximizing model, the reliance on employment-based insurance and the lack of recognition of health care as a human right. The Affordable Care Act provided some mitigation but, with tens of millions uninsured today, these issues are still with us.
Another dimension of American health care that came into sharper focus for me was the sheer power of dominant stakeholders, such as the pharmaceutical companies, to extract profits with little restraint. The clearest example of this is perhaps the relentless increase in drug prices, which one could argue began when the first AIDS drug, AZT, was marketed at $10,000 per year in 1987; today we have cancer drugs sold at more than 10 times that price.
Medicare for All is now gaining traction in the U.S. What exactly is Medicare for All and how would it work?
The term “Medicare for All,” as it is commonly known and described in congressional bills such as the Medicare for All Act of 2021 (H.R. 1976, which currently has 117 co-sponsors in the House of Representatives), is a short-hand expression for a universal, single-payer health care system. Essentially, this means that health care will be provided to all U.S. residents and a single payer — the federal government — will pay all bills. The Act’s summary states in part:
Among other requirements, the program must (1) cover all U.S. residents; (2) provide for automatic enrollment of individuals upon birth or residency in the United States; and (3) cover items and services that are medically necessary or appropriate to maintain health or to diagnose, treat, or rehabilitate a health condition, including hospital services, prescription drugs, mental health and substance abuse treatment, dental and vision services, and long-term care.
The bill prohibits cost-sharing (e.g., deductibles, coinsurance, and copayments) and other charges for covered services. Additionally, private health insurers and employers may only offer coverage that is supplemental to, and not duplicative of, benefits provided under the program.
The “single payer” aspect of Medicare for All has several crucial virtues. First, it would do away with the thousands of private claim processes that currently exist to service the private insurance industry, thereby reducing an enormous amount of bureaucratic waste that is estimated to be in the hundreds of billions of dollars each year. At the same time, with the negotiating power given to the federal government, prices for pharmaceuticals, medical devices, and other medical expenditures could be brought under control. But most importantly, the single-payer approach is the most realistic approach to providing health care to all Americans.
Medicare for All marches and rallies are taking place in scores of cities across the country on Saturday, July 24. In fact, there is ample evidence that most Americans already support universal health care. But can we have health care reform without reforming the political system?
There is no doubt that the road to Medicare for All is an uphill struggle, given the array of political and economic forces that benefit from the status quo. However, the more than 50 marches and rallies around the country on July 24 reflect not only public support for transformative change in our health care system, but the type of movement building that is necessary to carry out this change. A complementary strategy, which could ignite a national consensus, would be a breakthrough success for a Medicare for All-type program at the state level, particularly in large states such as California or New York, where organizing efforts have been underway for several years. This could well have a cascading effect on other states and ultimately at the federal level. The common strategic thread for success at the state or federal level, is building a strong, popular social movement demanding universal health coverage for all.
This post was originally published on Latest – Truthout.
Parasites attach themselves to your body and suck your blood to feed themselves. Most, like ticks and mosquitos, while they may provide food for birds, bats and other animals, seem to provide no direct benefit at all to humans.
That “no benefit” equation goes double for the latest parasites who have attached themselves to the backs of Americans and are rapidly draining us of our economic blood: health insurance companies.
There is quite literally no reason for these corporations to exist, at least when it comes to providing for the health needs of 99 percent of Americans.
Virtually every other developed country in the world has a universal healthcare system to provide for the needs of all of their citizens. The one exception is Switzerland, where everyone is required to purchase health insurance, but all the primary health insurance companies must operate as nonprofits and the federal government pays the premiums for low income and poor people.
Other developed countries typically have a few health insurance companies around but mostly they serve the very wealthy, insuring that if they become sick or injured they get private suites in the hospital or have jet- and helicopter-based air ambulance service when out of country. In a few countries they fill in cracks, like for dental or eyeglasses. But, other than Switzerland, that’s it.
Severe parasite infections can inhibit a host’s ability to respond to disease, and that’s just what’s happening to America right now as we’ve faced and continue to face the Covid pandemic. More than half of all Americans who’ve become infected with Covid and survived are now “struggling with medical debt” as a result of their illness, according to a new study by The Commonwealth Fund.
Even people who didn’t get Covid are being wiped out by medical debt:
Think about the people who live around you, on your street or in your apartment building. Imagine one out of every five of them, from the very old to newborns, having already had their medical debt turned over to another parasitic American industry, debt collectors.
One in five Americans. Today. Are in collection for medical debt. Getting harassing phone calls day and night. Having their checking accounts garnished, their credit and ability to get a new job ruined for years or decades. One in every five people in America. And every one of their lives has been turned upside-down because they or their child got sick.
We are the only developed country in the world that does this to its citizens, and the only reason we do it is so people like Bill McGuire, the former CEO of UnitedHealth, can walk away with, literally, a billion dollars.
Meanwhile, the University of Chicago finds that 8 million Americans have started a crowdfunding page to raise money to cover their own medical bills, and an additional 12 million pages have been started by others trying to pay bills of friends, relatives, children or grandparents who aren’t computer literate.
One third of all GoFundMe and similar sites are people trying to raise money to pay for medical bills not covered by insurance companies. Families like George Fushi’s are desperately turning to the contributions of friends and even strangers to simply avoid homelessness.
A City University of New York/Harvard study found that the number one cause of bankruptcy in America is medical debt; it averages over a half-million families wiped out this way every year. The number of people in Canada, all of western Europe, Australia, New Zealand, Taiwan, South Korea and Japan who went bankrupt exclusively from medical debt last year: Zero.
As Michael Hiltzik writes for the Los Angeles Times: “It’s also virtually unique to the U.S. among developed countries; when experts from Japan and Europe were asked by the PBS program ‘Frontline’ about the prevalence of medical bankruptcy in their countries, some had trouble even comprehending the question.”
Poll after poll shows that a solid majority — 60 to 80 percent, depending on how the question is phrased — want America’s legislators to put a national healthcare system in place or give people an easy and inexpensive option to buy into our biggest single payer system, Medicare.
And, indeed, we still have two single-payer systems left over from LBJ’s Great Society programs in the 1960s that were able to get passed just a decade before the US Supreme Court legalized political bribery and corruption: Medicare and Medicaid.
Medicare, of course, pays for healthcare for people over 65, and Medicaid covers healthcare costs for low-income working people, the profoundly poor and elderly folks in nursing homes. The Affordable Care Act expanded Medicaid coverage to all low-income Americans…until five “conservative” justices on the Supreme Court changed the law to let individual states decide if their citizens deserved it.
Twelve states today deny Medicaid to many or most of their low-income working citizens even though the federal government pays for almost all of it. Every single one’s legislature is run entirely by Republicans: Alabama, Florida, Georgia, Kansas, Mississippi, North Carolina, South Carolina, South Dakota, Tennessee, Texas, Wisconsin, and Wyoming.
That’s no coincidence: the GOP has been the party of billionaires and predatory corporations ever since Warren Harding’s election in 1920, when it turned its back on Teddy Roosevelt and William Howard Taft and purged the Party of its progressives.
They then spent the past four decades stacking the federal court system and the Supreme Court with partisan hacks and prostitutes to big money and big business so they could continue their bloody business of extracting cash from working people and shoveling it into the money bins of the morbidly rich.
But it’s not just low-income people who are being sucked dry by our medical industry. The study by Commonwealth Fund found that fully a third of insured Americans under 65 had difficulties paying off medical debt last year. The same was true for half of uninsured Americans under 65 just in the past year.
In my new book The Hidden History of American Healthcare: Why Sickness Bankrupts You and Makes Others Insanely Rich, I lay out how the average American is paying around $3000 a year more for healthcare and health insurance than Canadians, Europeans, Japanese and South Koreans.
That money is lining of the pockets of the literally thousands of health industry executives who each “earn” over a million dollars a year (some “earning” tens or hundreds of millions a year). We pay 24 percent of our GDP for healthcare and healthcare insurance.
By comparison, Taiwan’s singly-payer healthcare system in its entirety, including doctors, hospitals, pharmacies, all care facilities, all billing and payment operations — everything — costs that country just a bit over 6 percent of GDP. In most developed countries it’s 6 to 14 percent.
Insurance premiums make up 24 percent of gross US payroll, while a Canadian-style nonprofit Medicare-For-All system would cost between 10 and 14 percent depending on how it was implemented.
And every effort Democrats make to deal with the problem — including their most recent “infrastructure” bill that would cut drug prices and expand Medicaid to those 12 states that have refused to do so themselves — faces 100% rigid opposition from bought-and-paid-for elected Republicans.
Meanwhile, the healthcare industry has funded literally hundreds of websites and “advocacy” organizations that have flooded the internet with lies and misinformation about how healthcare is done around the world or the “horrors of single-payer.” Just try googling the issue and you’ll find the majority of the top hits come from these sources: the industry is readying for war.
As Covid sweeps across America with a fourth wave, this time hitting the Red states and counties hardest because their unvaccinated citizens have been listening to Republican politicians and watching Fox “News,” medical bankruptcies are starting to explode.
The only way to deal with parasites is to remove them from their host. It’s time to expand Medicare to full coverage in all regards for all Americans so we can dislodge these healthcare parasites from our body politic.
This post was originally published on Latest – Truthout.
The drop spelled out by the Centers for Disease Control and Prevention is due mainly to the COVID-19 pandemic, which health officials said is responsible for close to 74% of the overall life expectancy decline. More than 3.3 million Americans died last year, far more than any other year in U.S. history, with COVID-19 accounting for about 11% of those deaths.
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In early March of this year, I was in a hospital bed in Delhi for a week following a Covid diagnosis. This was just about four weeks before the second wave hit the country, showcasing the dystopic deadliness of the virus. It was strangely calm at that time with fewer than ten Covid patients at the facility; the same hospital was recently treating close to 400.
I’d occasionally chat with the nurses who recalled the ‘Covid times’ earlier in the year when each nurse had to attend to up to a dozen patients at a time. But thankfully that, they said, was in the past; the virus had been controlled. Later, I thought of those nurses and how in a mere few weeks their lives had been upended, of the nightmare they were living through. How many patients were they attending to during the latest peak: 25, 30, 40? Were they themselves OK? Not all of them had been vaccinated.
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Larry King, president of Churchrock Chapter and a former uranium worker, doesn’t stand a snowball’s chance in the melting Arctic of receiving federal benefits afforded sick Navajos who worked in the uranium industry before 1971. King isn’t the only one.
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We are a coalition of groups that are coming together to march for Medicare for All. Who is in that coalition depends on which city you are talking about. There is no one single group behind this. The list seems to grow every day. Some people are even politically homeless and simply focused on doing what they can to move #M4A forward. We are nonpartisan, but some local parties have joined in the fight! We are proud to say that this type of coming together hasn’t happened in recent memory, if ever.
Our movement was founded from a place of compassion and love. We came together out of frustration with the lack of action from the powers that be. Many of us have our own personal stories as to why we are in this fight. All of us know that healthcare is a right, not a privilege.
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“Maybe now, half a century later, it’s finally time to end the war on drug users — repeal the heavy penalties for possession; pardon the millions of nonviolent offenders; replace mass incarceration with mandatory drug treatment; restore voting rights to convicts and ex-convicts alike; and, above all, purge those persistent stereotypes of the dangerous Black male from our public discourse and private thoughts.”
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Many blame the relatively lower vaccination rates in communities of color on “vaccine hesitancy.” But this label overlooks persistent barriers to access and lumps together the varied reasons people have for refraining from vaccination. It also places all the responsibility for getting vaccinated on individuals. Ultimately, homogenizing peoples’ reasons for not getting vaccinated diverts attention away from social factors that research shows play a critical role in health status and outcomes.
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From Ronald Reagan’s notorious 1961 rant against the horrors of socialized medicine to present-day propaganda of the insurance industry, right-wing and corporate efforts to halt the expansion of public health care seem to strike the exact same notes again and again — and draw on the same bogus arguments.
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Using kitchen table economics is critical for winning workers over to Medicare for All. Before this training, members may be wary of trading something they’re familiar with for something that’s unknown. But in the workshop, they see for themselves that what they have now is robbing them blind—and that Medicare for All would bring them real economic gains.
What threads its way through much of our conversation is that the insurance companies are a big part of why we pay so much for health care. For example, a Center for American Progress study shows that more than 8 percent of U.S. health care spending goes to administrative costs. However, the study put out by the Congressional Budget Office last year indicated that administrative costs under a single-payer system would be 1.8 percent or even less.
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Thousands of city frontline workers — including paramedics and emergency medical technicians — plan to boycott Mayor de Blasio’s Hometown Heroes ticker tape parade Wednesday.
Members of FDNY EMS will not be marching up the Canyon of Heroes unless they are on duty and working, union leaders said Tuesday.
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As physicians and trainees, we take an oath to do no harm. While this orientation may have practical applications within individual treatment plans, it begs some questions: Why stop at the passive “do no harm” rather than actively confronting harm? What is the physician’s duty to their patients and communities they serve? What role can we have in addressing the structural violence that causes harm to patients, such as homelessness and displacement, food insecurity, or trauma from the police and the prison system?
To adequately address these questions, we must make the ideological shift from neutrality to intentional, politicized community engagement to confront harm. Confronting harm can take many forms, including fighting back against corporations and pharmaceutical companies that prey on patients; working to end medical practices that serve as social control and exploit marginalized people; advocating for reparations and reinvestment in communities (including but not limited to health care infrastructure); resisting colonization and state-based repression, even in the face of institutional backlash; and fighting for the liberation of Indigenous communities, both in the United States and globally.
One role the physician can take on when confronting harm is that of witness. Physicians are uniquely positioned to be witnesses to the physical and psychological manifestations of structural violence. In these cases, we must move beyond reactionary practices and begin to see patients’ concerns, symptoms and trauma as not just problems to diagnose but the outcomes of a larger sociopolitical context. It is important for us to not lose sight of the whole picture when dealing with everyday issues like struggling to provide care to a patient who cannot afford medication; while this is an opportunity to advocate for an individual patient, it is also important to note this instance as a manifestation of the harms inflicted by insurance companies and pharmaceutical companies. For many patients, their diagnosed diseases may also be in large part due to structural oppression, with food insecurity, environmental racism, and lack of access to services due to segregation and disinvestment leading to physical harm.
On an interpersonal level, the physician can serve as a witness for patients and work to address these harms through treatment and care that centers the needs and lived reality of the patient. On a structural level, the physician must work to amplify the voices of the most marginalized rather than speaking on behalf of patients. This work must be community-aligned and in service of addressing the structural roots of oppression. The group Doctors 4 Camp Closure is a good example of physicians using their social capital to witness and confront inhumane detention of migrants and refugees who experience harm at the hands of the U.S. immigration prison system. Health Justice Commons is a group that centers the voices of those most impacted by the harms of the medical-industrial complex, and they call into question the lines and implicit hierarchies between providers, patients and community members. These are just some examples of the ways in which physicians can use their position as witness to drive structural change.
A second role that physicians can take on, beyond bearing witness, is that of a worker for wages. As health systems continue to grow, most physicians are workers in an industry increasingly operated by large hospitals, health systems, insurance companies, pharmaceuticals and medical technology companies. This nexus of health care capitalism allows for the exploitation not only of patients and communities, but also us as workers as well. There is a reason there is such severe physician burnout, and it comes to the lack of power we have to make the best decisions for care. These groups that hold power benefit from physicians not organizing as workers and demanding change collectively — health care workers lose power by not building together, and it takes away from the ability to advocate as effectively as we could for ourselves, our patients and communities we serve.
While our wage work may demand that most of us work within large institutions to care for patients, we must make an active choice to align ourselves with the communities we serve over the institutions we work in. Aligning ourselves as a labor force opens radical possibilities of change by giving us greater bargaining power. Take the issue of police in hospitals and emergency rooms during the uprisings of 2020. Many physicians and health care workers took issue with the fact that the police could make arrests in the ER — individually, any one physician may not have the power to escalate this issue. An organized labor force would be able to draw the attention of health care administration and demand the removal of police in the ER and in the health system at large. Organizing collectively also protects workers from institutional backlash, as seen against health care workers who speak out openly in support of the Palestinian struggle for liberation.
This kind of organizing in health care is not new — the National Nurses Union (NNU) works because nurses see themselves as workers who are organizing for themselves and the patients and communities they serve. Just most recently, the NNU published a statement against the Centers for Disease Control and Prevention guidelines for the relaxing of the mask mandate. As witnesses to the devastation of COVID-19, and as workers concerned for their own health and wellbeing, they collectively fight for change. And while less common, resident unions exist in pockets across the country; however, as physicians move up through the hierarchy, those unions tend to disappear. As physicians move through their careers, it is crucial to keep in mind who benefits from doctors not aligning with one another and with other health care workers: hospital systems and corporations. Ultimately, it is crucial for the care of patients and the movement toward health justice that physicians align as workers and witnesses; if not, we will be complicit in the structural harms we claim to stand against.
This post was originally published on Latest – Truthout.
At a Bernie Sanders healthcare town hall last year, Rep. Pramila Jayapal glibly stated that the problem to enacting Medicare for All was not more education of the public, but a question of “political will” necessary to actually push it forward. Yet, despite a pandemic, which has laid bare the inequalities and deficiencies of our healthcare system coupled with Democrat majorities in three branches of government, Medicare for All seems off the table. Where is the political will?
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To use the social wealth of a population, to teach science, and to establish a basic norm of scientific literacy are essential lessons of the pandemic. These are lessons well-learnt by the Cubans. This is why Cuba has, against all odds, developed five different vaccines. Abdala and Cuba’s four other vaccines stand as a shield against COVID-19. These vaccines emerge out of the social productivity of socialist Cuba, which has not surrendered to the ugliness of the five monopolies.
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Over the course of the COVID-19 pandemic, Southern states have been among those that have done the least to protect their residents from contracting the deadly virus.
They were some of the last to impose mask mandates and among the first to reopen after temporary shutdowns. And many sectors in the region, like poultry processing, never shut down at all. That makes it particularly striking that essential workers in Southern states disproportionately fall in the Medicaid coverage gap. Not provided health insurance through their jobs and unable to afford it in the private market, these workers risk their lives to keep the economy running — and disproportionately die in the process. Eight of the 12 states that have refused to accept federal funds to expand Medicaid under the Affordable Care Act are located in the South: Alabama, Florida, Georgia, North Carolina, Mississippi, Tennessee, Texas, and South Carolina. All have Republican-controlled legislatures.
A recent report by the Center on Budget and Policy Priorities (CBPP) looked at data from 2019, the year before the pandemic hit, and calculated that over 550,000 people working in essential or frontline industries fall in the Medicaid coverage gap. The states with the greatest number of essential workers in the coverage gap are Texas (209,000) and Florida (98,000) — GOP-led states that have had notoriously ineffective public health responses to the COVID-19 pandemic. In total, over 2 million people living in Southern states fall into the gap.
“A large body of research demonstrates that Medicaid expansion increases health insurance coverage, improves access to care, provides financial security, and improves health outcomes,” the report states.
CBPP also documented glaring racial disparities, finding that people of color make up 60% of those in the Medicaid coverage gap even though they account for only 41% of the non-elderly adult population in non-expansion states. In Texas, 74% of those in the coverage gap are people of color, while Black people account for a majority of people in the coverage gap in Mississippi and 40% in Georgia and South Carolina. At the same time, people of color face a higher risk of COVID-19 infection, hospitalization, and death.
The report notes that about three in 10 adults in the coverage gap have children at home. And a third are women of childbearing age, meaning that if they get pregnant they can apply for existing Medicaid coverage. However, the coverage would not begin until they are determined to be eligible, meaning they could miss out on critical prenatal care during the first months of pregnancy. CBPP points to an Oregon study that found Medicaid expansion was associated with an increase in early and adequate prenatal care.
In addition, CBPP calculates that about 15% of people in the Medicaid coverage gap have disabilities. That includes 7% with serious cognitive difficulties, and more than 6% who have difficulty with basic physical activities such as walking, climbing stairs, carrying, or reaching.
In the years leading up to the pandemic, states that expanded Medicaid cut their uninsured rates by half. That made them better prepared for both the ensuing public health crisis and consequent economic downturn, which resulted in an estimated 2 million to 3 million people nationwide losing employer-based coverage between March and September.
Efforts are now underway in the Democratic-controlled Congress to find a way to bring Medicaid to more essential workers — and Americans in general — despite Republican resistance at the state level.
U.S. Rep. Lloyd Doggett, a Texas Democrat, recently proposed the “Cover Outstanding Vulnerable Expansion-Eligible Residents (COVER) Now Act.” The bill, which already has over 40 cosponsors, would authorize the federal Centers for Medicare and Medicaid Services (CMS) to work directly with counties, cities, and other local governments to expand Medicaid coverage in states that have refused to do so. It’s based on previous successful demonstration projects in several counties in California, Illinois, and Ohio, and it’s won the endorsement of groups including the American Diabetes Association, National Alliance on Mental Illness, and the Texas Academy of Family Physicians.
“The COVER Now Act empowers local leaders to assure that the obstructionists at the top can no longer harm the most at-risk living at the bottom,” Doggett said in a statement.
And over in the Senate, Raphael Warnock of Georgia this week announced that he is drafting a proposal that would bypass his state’s Republican leadership while calling on the White House to include a “federal fix” in the next jobs package. Warnock told reporters that he’s hoping to introduce legislation soon. The Georgia Recorder has reported that Gov. Brian Kemp (R) is pushing a plan to expand Medicaid to about 50,000 additional Georgians, but the Biden administration has put the brakes on it over concerns that it requires participants to rack up 80 hours of work, school, or other qualifying activity every month to gain and keep their coverage.
In a letter sent last month to Senate Majority Leader Chuck Schumer of New York and Minority Leader Mitch McConnell of Kentucky, Warnock and U.S. Sen. Jon Ossoff of Georgia suggested that one possible solution could be a federal Medicaid look-alike program run through the CMS.
“We have a duty to our constituents and a duty to those suffering from a lack of access to health care to provide for them when they are in need,” Warnock and Ossoff said in the letter. “We can no longer wait for states to find a sense of morality and must step in to close the coverage gap and finally ensure that all low- and middle-income Americans have access to quality, affordable health care.”
This post was originally published on Latest – Truthout.
Trans youth are under attack around the country. Though we are only halfway through 2021, it has already become the worst year in recent history for legislative attacks on trans youth. 33 states have introduced anti-trans laws across the country, many of which ban trans students from playing sports. Arkansas recently became the first state to ban trans youth from accessing gender-affirming health care, and many other states have either passed or are debating similar bills. All of these laws must be repealed, and we need to build a militant trans rights movement to defend against these right-wing attacks.
The results of efforts to oppress and dehumanize trans people hit trans youth the hardest. The American Journal of Psychiatry reports that trans people are about six times more likely to suffer from mood and anxiety disorders, and over half of trans and nonbinary youth in the U.S. reported having seriously contemplated suicide in 2020.
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