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By Mitch Weiss and Holbrook Mohr
WEST COLUMBIA, South Carolina ̵
1; Desperate for relief after years of anxiety, Jim Taft cautiously listened when his pain relief doctor described a medical device which can change their lives.
It would not fix the nerve damage in his weak right arm, Taft and his wife recalled the doctor to say, but a spinal cord stimulator would hug his pain and make him “good as new.”
The tablet’s stimulator failed shortly after it was implanted surgically. After an operation to repair it, he said that the device shocked him so many times that he could not sleep and even fell down the stairs. Today, the 45-year-old Taft is almost paralyzed, barely able to take care of the bathroom.
“I thought I would have a wonderful life,” said Taft. “But look at me.”
For years, medical device companies and doctors have spun spinal cord stimulators as a panacea for millions of patients suffering from a wide range of pain reliefs, making them one of the fastest growing products in the medical device industry of $ 400 billion. Companies and doctors drive them as a safe antidote to the opioid crisis in the United States and as a treatment for an aging population who needs pain relief.
But the stimulators – devices that use electrical currents to block pain signals before reaching the brain – are more dangerous than many patients know, found an AP study. They account for the third highest number of injured reports on medical devices for food and drug administration, with more than 80,000 incidents flown since 2008.
Patients report that they have been shocked or burned or have suffered nerve damage in the spinal cord from muscle weakness to paraplegia, FDA data shows. Among the 4000 types of devices traced by the FDA, only metal lift changes and insulin pumps have logged more harmful cases.
Manufacturers of medical devices insist on spinal cord stimulators are safe – about 60,000 are implanted annually – and doctors specializing in these operations say they have helped reduce pain to many patients.
However, most of these devices have been approved by the FDA with small clinical testing and the body’s data show that stimulators have a disproportionately higher number of injuries compared to hip implants, which are more abundant.
AP reported on spinal stimulators as part of an almost annual joint investigation of the global medical technology industry that included NBC News, the International Consortium of Investigative Journalists and more than 50 other media partners around the world. Reporters analyzed millions of medical records, recalls and other security warnings, in addition to interviewing doctors, patients, researchers and whistleblowers.
The media partners found that over all types of medical devices over 1.7 million injuries and nearly 83,000 deaths were reported to the FDA over the past decade.
The investigation also showed that the FDA – considered by other countries to be the gold standard in medical equipment monitoring – puts people at risk by pushing devices through a shortened approval process, then responding slowly when it comes to forcing companies to correct sometimes life-threatening products.
Devices rarely pulled out of the market, even when major problems arise. And the FDA does not describe how many devices are implanted in the US every year – critical information that can be used to calculate success and failure.
The FDA confirms that its data has limitations, including mistakes, omissions and underreports that may make it difficult to determine if a device directly caused an injury or death. However, it rejects some suggestions for failed monitoring.
“There are over 190,000 different devices in the US market. We approve or clean up a dozen new or modified units every business day,” says Dr. Jeffrey Shuren, FDA’s medical device device director said at an industry conference in May. “The few devices that get attention at any time in the press are fewer than the devices we can put on the market in a single business day. It does not say the system fails. It is remarkable that the system works as it does.”
In response to journalists’ questions, the FDA said last week that there were new measures to create “a more robust medical device safety network for patients through better data”.
“Unfortunately, the FDA can not always know the full extent of the benefits and risks of a device before it reaches the market,” said the agency. Over the past 50 years, the medical technology industry has revolutionized the treatment of some of the deadliest swings in modern medicine, introducing devices for treating or diagnosing heart disease, cancer and diabetes.
Medical technology companies have invested innumerable resources – both capital and human – to develop advanced compliance programs, “says Janet Trunzo, Technical Manager and Regulatory Business for AdvaMed, the industry’s main industry organization.
At the same time, medical device manufacturers have also spent billions to try to influence regulators, hospitals and doctors.
In the US, where drug and apparatus manufacturers are obliged to disclose medical payments, the 10 largest medical devices companies paid nearly $ 600 million to physicians or their hospitals last year to cover consulting fees, research and travel and maintenance costs, according to an AP – and ICIJ analysis of data from Centers for Medicare & Medicaid services. This figure does not include payments from device manufacturers such as Johnson & Johnson and Allergan, who also sell other products.
In addition to this, lobby entries show that the four leading spinal cord stimulators manufacturers have spent more than $ 22 million in combination since 2017 to try to influence legislation that benefits their overall business, including other devices.
Medtronic Inc. agreed in a case that year that involved stimulators to pay $ 2.8 million to determine the Justice Department claims that the company had injured patients and deferred the federal health care program by giving physicians ‘powerful’ financial incentives that made them to “sellers” for costly procedures. Medtronic denied error. “As a matter of politics, Medtronic does not comment specifically on specific litigation,” the company said in a statement. “We stand behind the safety and efficacy of our spinal cord stimulators and the strong benefits that this technology gives to patients, many of whom have tried no other therapies.”
Some doctors promote enthusiastic spinal cord stimulators without revealing to patients they have received money from medical device manufacturers. Some experts say doctors are not legally required to disclose such payments, but they have an ethical obligation to do so. Sometimes the money goes to the medical hospital and not directly to them.
When it comes to Taft he said he just wanted to get better, but he lost his hope.
“This is my death sentence,” Taft said, stretching under the head of his bed, where he spoke the word “death row”.
“I’ll die here,” he said.
Dr. Steven Falowski shows an exhibition of spinal stimulation equipment in Bethlehem, Pennsylvania, October 4, 2018. Peter Banda / AP File
A generation ago, tens of thousands of women were injured by Dalkon Shield, an intrauterine device that caused life-threatening infections. Consumer advocates demanded testing and prior approval of medical devices to prevent deaths and injuries associated with defective products.
In 1976, the Congress passed medical device modifications, a law designed to assure Americans that devices recommended by their doctors would do well and not harm.
The FDA created three classes of medical equipment. High-risk products such as spinal cord stimulators are equipped with the most rigorous clinical testing standards. However, the vast majority of devices go through a less rigorous review process that provides an easy way to market the devices that are considered “substantially equivalent” to products already approved for use.
The process became the standard pathway to thousands of units, including hip replacements implanted in tens of thousands of patients who would later be revoked because metal chips from the devices made some people sick.
AP found that some spinal cord stimulators could reach the market without new clinical studies, which largely approve them based on results from previous stimulator studies.
Spinal stimulators are complex devices that send electrical currents through wires placed along the spine, with a battery implanted under the skin.
The four largest manufacturers of stimulators are Boston Scientific Corp, based in Massachusetts; Medtronic, headquartered in Ireland and USA Nevro, in Redwood California; and Illinois-based Abbott, who entered the market after their $ 23.6 billion purchase of St Jude Medical Inc.
St. Juda’s application to market with its first stimulator contained no original patient data and was based on clinical results from other studies while Boston Scientific’s Precision Stimulator application was based largely on older data, although it included a small, original study of 26 patients traced in as little as two weeks.
Once approved, medical device companies can use countless additional requests to change their products, even when the changes are high.
For example, only six new spinal cord devices have been approved since 1984, with 835 complementary changes in units forwarded in the middle of this year, AP found.
“It’s kind of the story of FDA’s regulation of devices where they” just put things on the market, “said Diana Zuckerman, president of the National Center for Health Research, who has studied medical equipment for almost 30 years.
Medical equipment manufac tourists have cited several industry-funded studies that show the efficacy of spinal cord stimulation in the treatment of chronic pain.
A 2016 study that looked at different stimulation systems found “significant evidence” that they were “a safe, clinical and cost-effective treatment Too many chronic pain conditions. “
However, Zuckerman noted that the more extensive studies came after the devices were commonly used in humans.
” These patients are guinea pigs, “she said.
The FDA said in a statement that its decision is” based on valid scientific evidence “that the devices are safe and effective.”
Dr. Walter J. Koroshetz, Head of Neurological Diseases and Stroke Department at the National Institutes of Health, says that attempts for medical devices like spinal cord stimulators are generally small and industry sponsored with a “significant” placebo effect.
I do not know anyone who is pleased with the spinal cord technology as it stands, “said Koroshetz. “I think everyone thinks it can get better.”
Dr. Steven Falowski holds an electrode for a spinal cord stimulator in Bethlehem, Pennsylvania on October 4, 2018. Peter Banda / AP File
Every time Jim Taft entered his pain relief doctor, he would look at the leaflets rolling out spinal cord stimulators – they with pictures of people swimming, cycling and fishing.
In the test room, Taft said his doctor told him that the device had succeeded in his other patients and would improve his quality of life.
Taft had broken the lifetime worker’s compensation after his right arm when he took material to an architectural company, Taft had studied the doctor for five years before deciding to stimulate in 2014. What finally wiped him, he said, was the doctor’s plan to pamper him from analgesics.
“I felt backbone in a corner,” said Taft.
Taft said his doctor praised the technology and said that stimulators had improved the quality of life for their patients. But four years later, Taft can not go more than a few steps.
Taft is one of 40 patients interviewed by AP who said they had problems with spinal cord stimulators. The AP found them through the online forum for people with medical equipment. Twenty-five of them said that their stimulators not only failed to relieve pain but left them worse than before surgery.
Zuckerman, who worked at the Department of Health and Human Services and as senior policy adviser to then-first lady Hillary Clinton said no doctor wants to believe that they hurt patients.
“But there’s a huge financial incentive to kill, ignore or forget bad patient experiences and just focus on how happy patients are,” she said.
More than half of the patients interviewed by the AP said they felt pressured to get stimulators because they feared that their doctor would cut off their analgesics – the only one that helps them.
Stimulators are considered to be a “last resort” treatment by insurance companies, as well as Medicare and Medicaid. This means that doctors must follow a protocol before the insurance pays for the device and the implant.
Doctors must show that conservative treatments failed. Patients also undergo psychological assessments to evaluate the likelihood of success. They typically pass a trial period lasting three days to a week of thin electrodes inserted under the skin. If patients say they were relieved from the external transmitter that sends electrical pulses to the contacts near their spine, they have surgery to implant a permanent stimulator.
Taft said that his three-day trial helped reduce his pain a few days before his surgery, he began to prepare for a new life. He ordered timber to renovate a patio and deck for his wife, Renee, thanks for her years of support.
In April 2014, Boston Scientific’s Precision Stimulator was implanted in Taft by Jason Highsmith, a Charleston, South Carolina, neurosurgeon who has received 181,000 dollars from the company over the last five years in the form of consulting fees and travel and entertainment payments. A Boston Scientific sales representative was in the operating room – a common practice found by the AP.
Highsmith would not comment on the payments. Other doctors have defended the exercise and say they do an important job that helps companies – and finally patients – and deserves to be compensated for their time.
From then on, Taf’s unit was placed in his body, but he had nothing but trouble, according to hundreds of pages of records reviewed by the AP. The device randomly began to shock him and the battery burned his skin.
Taft and his wife complained repeatedly, but said his doctor and a Boston Scientific representative told them that stimulators did not cause the problems he had.
It contradicts Boston Scientific’s own literature, recognizing that stimulants and procedures for implanting them carry risks such as movement’s movement, over stimulation, paralysis and infections.
It is also not reflected in the AP’s analysis of FDA injury reports, which found shocking and burning had been reported for all major models of spinal cord stimulators. For Boston Scientific units, infection was the most common complaint in the past decade, mentioned in more than 4000 injuries.
In response to questions, the company called “unfortunately a risk of surgical intervention” that the company is working hard to avoid. It added that the FDA data “would not be interpreted as a causal link to a challenge with our device. In fact, many examples of reportable infections include those caused by surgical treatment or post-operative care.”
“In our internal quality assessments, over 95 percent of the injury reports were temporary or reversible,” said the company.
Tafts stimulator was surgically removed in August 2015. In June, Taft received a second opinion from a clinic specializing in spinal cord injuries, which said that he had “significant axial and low back pain due to implantation and explantation” of the stimulator.
Highsmith said that other doctors have documented severe arthritis in Taft and that while he has not been investigating Taft for more than three years, it is likely that his current condition is the result of disease progression and other factors.
He did not answer questions as to whether he informed Taft about the risks of stimulators
. The doctor said that the overwhelming majority of his stimulator patients showed significant pain relief.
“Unfortunately, despite the major medical breakthroughs with such devices, some patients still suffer from unpleasant pain,” he said. 19659007] Renee Taft, a paralegal, arrived at Boston Scientific in 2017 but said the company refused to help because her husband’s stimulator had been removed and blamed Taft for his problems and also said he had engaged in “rigorous physical activity” after operation.
In the letter from the company’s Legal Department, Boston Scientific also noted that federal law-protected manufacturers from personal claims claims for medical devices approved by the FDA.
In response to questions from AP, Boston Scientific again revealed Taf’s “activity level” but did not work out. The company also said that other factors could contribute to his problems like “hyperalgesia, a phenomenon associated with prolonged opioan use, which leads to patients becoming more sensitive to some stimuli”.
Boston Scientific said that it never got the stimulator implanted in Taft and could not “conclusively identify” the cause of his problem. “Many factors can contribute to the patient’s ongoing symptoms, from increased physical activity to pain in other areas,” said the company.
Dr. Steven Falowski stands for a portrait in Bethlehem, Pennsylvania, October 4, 2018. Peter Banda / AP File
While manufacturers and top FDA officials radiate stimulators as a weapon in the fight against opioids, neurosurgeons like Steven Falowski are ” 19659007] “Chronic pain is one of the biggest health concerns we have in the United States. It’s more than heart disease, cancer and diabetes combined, “Falowski said in an interview.
He referred AP to Pete Corby as one of his surgical patients who helped a spinal cord stimulator.
Corby, who injured his back working as a movie stuntman, got the device more than two years ago saying that after some initial adjustments, no further problems have occurred. He says he would not trade an opioid stimulator.
“I actually bought them on the street … a bit like a drug drink because I could not get them anymore” from their painter, Corby said. 19659007] Falowski said opioids are good for acute pain, but were never meant to treat long-term chronic pain. For him, that’s where stimulators come in.
If used early enough for pain, they can prevent people from going on opiate-based analgesics, says Falowski, speaking at neuromodulation conferences, and teaching other doctors how to implant stimulants.
Since 2013, device manufacturers have paid Falowski or St Luke’s Health Network in Fountain Hill, Pennsylvania, where he works – nearly $ 863,000, including $ 611,000 from St. Jude or the new parent company Abbott, according to the Centers for Medicare and Medicaid Services database. Payments range from consulting fees for travel and maintenance costs.
Falowski said he had researched and done other work for manufacturers and added: “The contract with industry is at my hospital and not with me.”
St. Luke told AP that it holds the majority of payments from machine makers, but Falowski “receives some of these payments through its annual compensation.”
Falowski said that physicians do an important work for medical technology companies, and he has been involved in unit development, education, clinical trials and research.
“You try to help patients and you as a doctor realize that you will not generate 200 million dollars to make the next best implant for a patient and it will take a business to do it,” he says. “So I believe that the important part of that relationship is transparency and information. “
Experts interviewed by the AP said that doctors are not legally required to tell patients about financial relationships with medical device manufacturers, but that it would be right to
The patient should be fully informed before agreeing to a procedure, “said Genevieve P. Kanther, Assistant Professor at the University of Pennsylvania, specializing in Internal Medicine, Medical Ethics and Health Policy.
] Washington DC-based Associated Press- reporters Meghan Hoyer and Matthew Perrone contributed to this report, as well as Denver-based video editor P. Solomon Banda.
This story is part of a global project organized by the International Consortium of Investigative Journalists investigating the medical technology industry. More than 250 reporters in 36 countries, including reporters for NBC News and AP, worked on stories that began publishing Sunday.