[ad_1]
by
ICIJ
From Amsterdam to Seoul via Lima and Mumbai, to the small American town of Hiawassee in Georgia, medical implants make sick, mutilate and sometimes kill the people for whom they were designed.
Health authorities around the world have failed to protect millions of patients from poorly tested implants that can perforate organs, cause shocks to the heart, cause bone rot, and cause blood intoxication. spread an overdose of opioids and cause other unnecessary damage. the International Consortium of Investigative Journalists found.
Governments even require complex implants to have a lower safety test standard than most new drugs. Defective devices persist on the market as injuries multiply. As part of a free global system, device manufacturers remove implants in some countries while continuing to sell them in others.
For most people, medical devices have obvious advantages, and complex implants can dramatically improve health and even save lives. However, ICIJ reports raise the question of whether the appliance industry – which affects the lives of billions of people – unnecessarily exposes millions of patients to a risk of serious harm in their quest for profit .
Publicity
In hundreds of interviews with ICIJ as part of the implant case investigation, patients said they were not aware of the critical risks associated with their implants and described a set of horrifying complications.
In South Africa, 51-year-old Renate Scheepers is scheduled for surgery this month to get an implant to treat incontinence around her bladder after years of recurrent abdominal pain. atrocious. More than 100,000 women worldwide have filed lawsuits against manufacturers accused of being damaged by defective lattice products.
In India, Vijay Vojhala, a former hospital equipment salesman based in Mumbai, suffers from vision problems, walking difficulties and irregular heart rhythms that he attributes to Johnson & Johnson's replacement hip, accused of poisoned thousands of patients. More than half a million people have been implanted with such "metal-on-metal" hips before being recalled or removed from the market.
In the United States, Charlissa Dawn Boyce, age 27, died after an implantable defibrillator recalled by St. Jude Medical for battery problems failed to electrocute her heart, said her family in a lawsuit brought in Tennessee. Nearly 350,000 devices were implanted worldwide before being subjected to a massive recall for defective batteries in 2016.
"It is unacceptable to continue to maintain this system," said Carl Heneghan, clinical epidemiologist at the University of Oxford in England, who has written extensively on the regulation of medical devices. "At some point, patients raise their hands and say that we are suffering catastrophic harm, but when that happens, it often happens [years] on the road when a significant number of people have already been injured. "
The implant records is the world's first review of the medical device industry and its supervisors. ICIJ journalists and a team of more than 250 reporters and data specialists from 58 media outlets in 36 countries have reviewed hundreds of similar cases around the world. The investigation is based on reports in the Netherlands of Jet Schouten, an investigative journalist for Dutch Public Broadcasting, who was part of the international team.
The Implant Files report reveals a highly competitive industry that has repeatedly violated global law enforcement, financial and health authorities and used its considerable weight to lobby for pressure from regulators to accelerate approvals and lower standards of security. Manufacturers have paid at least $ 1.6 billion since 2008 to settle charges of corruption, fraud and other violations with regulators in the United States and other countries, according to a report by ICIJ on data from the US Department of Justice and the Securities and Exchange Commission.
They also paid billions of dollars to patients. Since 2015, a company, Johnson & Johnson, has agreed to pay – or was ordered to pay – $ 4.3 billion to people in the United States who claim to have been injured by hips, trellises and surgical staplers defective.
The governments of dozens of countries in Africa, Asia, and South America do not regulate medical devices at all, but rather trust the European authorities or the US Food and Drug Administration. States, which is generally considered to provide more rigorous surveillance than any other health system. agency in the world.
Yet even this surveillance is lacking, with complex devices approved too quickly by US authorities and annoying devices that have not been removed from hospital shelves quite quickly, according to patient advocates and health experts . The FDA is now considering loosening its rules further to bring new devices to market with far fewer tests than previously, a measure seen as part of a larger effort to strengthen the US as a competitor to Europe, thus offering manufacturers an even more efficient solution. faster way to approval of new products.
During the The Implant Files survey, ICIJ and its partners filed more than 1,500 requests for public records and collected more than 8 million device-related health records. These include reminder notices; Security warnings; legal documents and corporate financial documents.
More than 5.4 million reports of "adverse events" sent to the FDA over the last decade make up the bulk of this heritage. These reports come from doctors, manufacturers, patients and even lawyers. They describe cases in which a device is suspected of causing or causing a serious injury or death, or has malfunctioned that could cause harm if it were to occur again.
Medical devices that have broken, burned badly, corroded, fractured, or functioned differently after being implanted or used – despite assurances from regulatory authorities, the private sector and physicians – have been associated with more than 1.7 million injuries and nearly 83,000 deaths over the last decade. ICIJ analysis found. Nearly 500,000 reports mentioned an explant, an operation to remove a device, in connection with an adverse event.
In some cases, the link between the harm described in an adverse event report and the device is unclear, and the FDA asserts that the consequences regarding the safety of a device or its role in an injury or death can not be drawn from an adverse event alone.
Nevertheless, the analysis of ICIJ, which included identifying devices sometimes listed under hundreds of different brand names or spellings, gives an unprecedented view of the harms of a medical product.
But the data only tells part of the story. Doctors and manufacturers often fail to report side effects and, when they do, the information may be unverified and incomplete. And over vast areas of the world, health authorities refuse to disclose information about damage to the public – or simply do not collect it.
In the European Union, regulators are collecting more and more reports of injuries and malfunctions each year, but refuse to publish the data, claiming that they would give away confidential business information and unnecessarily frighten the public. In Chile, health authorities informed ICIJ partners that adverse reaction reporting was voluntary for implanted devices and that in ten years they had received four "relevant" statements, one for one year only. implanted device. In Mexico, the authorities do not share data on adverse events with the public.
When device manufacturers and regulators discover problems, information often fails to reach doctors, let alone patients. Manufacturers have issued reminders or security alerts, which can range from simple label changes to the immediate removal of a device from the market, in some countries but not in others. And while the auto industry can usually contact car owners to tell them about safety issues that require corrections, the device industry and its hospital customers often fail to find people with implants.
As there is no global resource for reminders and security advisories, ICIJ decided to build one. The International Medical Device Database (IMDD) brings together for the first time reminders, security alerts and security warnings in the field – more than 70,000 from 11 countries – to create a searchable portal accessible to all and enabling to discover if a device was reported for security reasons. Since there is no agreed method for identifying devices, ICIJ has created tools that allow users to search for the security history of their devices, even if they are described differently in different ways. 39, other countries.
ICIJ's analysis of IMDD data has shown that over the decade, manufacturers have published more than 2,100 "Class 1" recalls in the United States for defects deemed to constitute a "reasonable chance" of "safety problems". serious health or death ". Some can be easily solved, with a quick update of the software or a change of wording in the instructions, while others involve devices implanted in millions of patients that have resulted in thousands of surgical withdrawals.
An aging population and a growing business
The activity of the devices is important and is developing rapidly. Annual sales in the sector have more than doubled, from about $ 118 billion in 2000 to about $ 400 billion in 2018. A fund comprised of major medical device inventories recorded a record 125% return over the past five years. last years to 14 November, compared to 52% for all companies. Economy reflected in the Standard & Poor's 500.
The largest market for devices – people aged 65 and over – will increase by more than 60% to nearly one billion people by 2030, said an investment analyst. UBS.
The industry has countless successes to celebrate. Pacemakers have revitalized or saved the lives of millions of patients with heart disease. Orthopedic implants, among the most popular type of medical device, have helped put millions of people back on their feet, even people with bone cancer. According to AdvaMed, the leading US group of medical device manufacturers, intraocular lens implants have restored the sight of 36 million people in the United States alone.
In February, Omar Ishrak, CEO of Medtronic, the world's largest manufacturer of devices, said his company's products improve the quality of life of more than 70 million new patients a year, improving two lives. per second.
In his written submissions to ICIJ, AdvaMed pointed out that implants are much more difficult to randomize than drugs in clinical trials and that medical devices should therefore be evaluated differently from pharmaceuticals. "To suggest that human trials warrants an end to future harms encourages both the patient and the public to falsely think that all these adverse events can be erased by such tests," said Janet Trunzo, head of technology and regulatory affairs at AdvaMed.
AdvaMed also challenged the fact that the industry is having problems reaching patients after the recalls. "High-risk medical devices, especially life-sustaining implants, have specific monitoring procedures in place to ensure that companies can quickly inform patients and providers of any significant problems," said Trunzo. .
In many written responses to ICIJ questions, the FDA has stated that patient safety "is and will remain the cornerstone" of its regulatory commitment. He acknowledged long-standing "limitations" in his ability to identify "rapidly and consistently" post-device safety risks and announced that he was directing the efforts to create a program that analyzes clinical information and other data to detect problems. faster.
On Tuesday, the agency announced that it was setting a "new important and ambitious goal": to be "still the world's first regulator to identify and act on safety signals related to medical devices" .
Even the harshest critics of the device industry recognize that it is impossible to create products, especially those that provide life-sustaining features that do not put patients at risk.
But over and over again, patients have been exposed to products that have caused serious and preventable damage. These accidents often occur in the shadows, in slow motion, over the years, in bedrooms and in hospitals around the world.
Essure, a serpentine-shaped metallic contraceptive, has been placed in the fallopian tubes of more than one million women. Thousands of people subsequently reported serious injuries, including uterine perforation, pain, and bleeding. US adverse event data analyzed by ICIJ includes a description of nearly 8,500 events during the past decade that required the removal of Essure.
In 2017, Bayer wrote to European doctors asking them to stop using the product and to "temporarily quarantine the remaining stocks until further notice". The company quickly suspended sales in all countries except the United States.
In May 2018, Misty Holliman, a mother of four and a 26-year-old living outside Irving, Texas, was implanted with Essure. She is one of more than 200 patients who have reported to ICIJ or a partner that they have not been informed of the health risks prior to implantation.
In July, Bayer announced it would stop selling it in the US by the end of the year. In his comments to ICIJ, Bayer said its decision to withdraw devices globally was due to business reasons rather than security concerns, and referred to an overall decline in the number of devices worldwide. use of permanent contraceptives as well as "inaccurate and misleading advertising about the device". Bayer also noted that women suing the company had generated many of the reports of adverse events submitted to the FDA.
Holliman is now suffering from severe pelvic pain. She may need a complete hysterectomy and can not afford the procedure. "I can not see what's going on inside my body," she says, "and I can not take it off."
A regulatory look
The modern testing requirements for new drugs have been forged as a result of a medical scandal that shook the world. In the late '50s and early' 60s, thalidomide, a medicine sold to women for morning sickness, produced tens of thousands of children with malformed limbs and a wide variety of ailments. other congenital anomalies. Nearly 40% of high-risk babies died in infancy and many women had stillbirths and miscarriages.
A flood of new regulations on pharmaceuticals appeared in response. Despite the enormous costs involved, drug manufacturers were required to submit clinical evidence that their products were safe and effective before they could be marketed.
The electronics industry was chosen only after regulations and was out of control until 1976 in the United States and 1990 in Europe. From the beginning, the industry has argued that its devices should be treated differently than drugs.
The internationally accepted criterion for approval of almost all new drugs is that at least one randomized controlled trial, on patients undergoing human testing, must demonstrate safety and efficacy. Around the world, the approval standard for new devices is less stringent.
In the United States, drug manufacturers must demonstrate "substantial evidence" of the safety and efficacy of a new product and generally require three trials. For devices, the benchmark is "reasonable assurance", which usually means a single study and no randomized controlled trial, in which groups of patients receive different treatments and whose results are compared.
But even this norm is often only theoretical. Less than 5% of devices reviewed by the FDA are subject to so-called pre-market approval. Regulators allow major – and sometimes fatal – changes to devices in paths for incremental updates.
Most devices are trusted through procedures that erase devices based on the fact that they are "substantially equivalent" to devices already on the market or an earlier version of the same product.
Sometimes, after a chain of these equivalence-based approvals, a new device hardly resembles the original version. A research published by the BMJ, a partner of ICIJ, traced the family tree of 61 surgical mesh products up to two original devices approved in 1985 and 1996. None had completed the clinical trials at the time of approval.
Patients taking poor quality medicine can throw the pill bottle in the trash, said Adriane Fugh-Berman, a professor at Georgetown University, who studies marketing practices in the health sector. People wearing a useless or malfunctioning implant can find it in their bodies for the rest of their lives. "You can be crippled forever," she says.
Defibrillator failure: "struck by lightning"
In 2004, Medtronic obtained approval for the updated version of a lead or wire used to connect its implantable defibrillator to the heart. Called the Sprint Fidelis, the lead was much thinner than previous versions, an innovation considered an advantage because thin wires are more agile and easier to bend.
Over the next three years, Sprint Fidelis has been implanted in approximately 268,000 patients worldwide.
In January 2007, 32-year-old Sherry Robinson was preparing to sleep at her home in Sechelt, a coastal community outside Vancouver, Canada, when a staggering jolt in her chest pushed her towards the front. "I saw this white light through my eyes." It hurt me a lot, and I thought, "I've been struck by lightning."
The Robinson device is designed to put hearts back into rhythm, but tests done at the hospital have shown that it was failing. Before it was deactivated, a faulty Sprint Fidelis driver had electrocuted Robinson 18 times.
"[A]No one can tolerate multiple shocks, "said a cardiologist quoted in a Congressional Research Service report published nearly ten years later.[A]After a second or third shock, the anxiety about the possibility of new shocks progresses rapidly and becomes close to terror. "
Later this month, the doctors removed the defective device – another surgical procedure – but simply installed another Sprint Fidelis.
In July 2007, a Minnesota cardiologist published a study showing that Sprint Fidelis had failed at a higher than expected rate and was inappropriately shocking patients, or failing to work.
The company recalled the device and removed it from the market in October 2007.
Citing five deaths of patients who may have been linked to a fracture of Sprint Fidelis drivers, the company recalled the device and removed it from the market in October 2007.
Two years later, Medtronic acknowledged that the malfunction of the Sprint Fidelis probes could have caused 13 deaths, although it is not clear if these were added to the five mentioned in the ad reminder of the company.
His performance has deteriorated over time. A study conducted in 2015 on nearly 1,000 patients in France revealed that in fact more than one in five lead was fractured after five years. Younger, more active patients were particularly vulnerable.
An ICIJ analysis of the FDA's adverse event reports shows that, over the last ten years, Medtronic and other adverse event rapporteurs have linked Sprint Fidelis models to more than 8,000 injuries and 2,000 deaths.
Even though the FDA considered Sprint Fidelis a high-risk device, it was not tested on patients: the agency approved it with a "supplement" to an approved version more than ten years ago.
Medtronic did not answer a specific question about Sprint Fidelis, but stated that he was not marketing any device or therapy "unless and until we confirmed that the product is safe and effective for the treatment of the medical condition in question ". The company also stated that it continues to monitor the safety and performance of its devices after they are placed on the market.
Fast lane approval
New versions of high-risk devices have also been marketed via a substantial equivalent fastlane called 510 (k). In 2009, a review of the Government Accountability Office blamed the FDA for continuing to approve high-risk devices up to 510 (k), despite a decades-long congressional order.
Two years later, the Institute of Medicine, now part of the national academies of science, engineering and medicine, urged the FDA to abandon the 510 (k) program. The FDA rejected the recommendation as unachievable.
Janice Hogan, a device industry lawyer trained in biomechanical engineering, warned that while some 510 (k) applications are relatively straightforward, many of them include extensive human testing and thousands of pages of documentation. "The FDA has significant discretion as to the data required."
In written responses to questions asked by ICIJ, the FDA stated that it had not removed high-risk devices up to 510 (k) by 2017.
"In recent years, the FDA has made concerted efforts to ensure that we need the appropriate level of testing," the agency said in written responses to ICIJ questions. In some cases, the FDA may require "exhaustive testing" for devices subject to 510 (k), which requires more evidence, the agency said.
Clinical tests and patient trials are neither appropriate nor necessary for most devices, the FDA said. The elimination of "quick approvals" would not necessarily provide better protection for patients, but would result in unnecessary costs and delays while diverting FDA staff resources from the study and to the project. evaluation of new high-risk devices, "said the FDA.
Trunzo, AdvaMed's spokesman, disputed the idea that extensive clinical trials are needed for device approval, saying other forms of non-clinical testing, such as laboratory testing, may produce more precise conclusions.
The European edge
The implant approval system of the European Union is even more business friendly. In fact, it is a business.
Device manufacturers pay private companies, known as notified bodies, to certify that high and medium risk devices comply with European safety standards.
The major players, including BUV Group in the United Kingdom and the German companies TUV Rheinland and TUV South, are applying the same CE marking to medical devices as the one used for many consumer goods in Europe – toasters, fires, and the like. artifice, toys for children, certifying that they meet the "essential requirements" for safety and environmental protection.
Among the benefits to the industry, most notified bodies are exempted from the laws obliging government agencies to make the records of device approval public. In the case of implants, this is particularly a concern. According to a March 2016 email to top health officials in Germany and Denmark, European regulators have no clinical data on about 90% of high-risk devices because they were deemed sufficiently similar to existing products.
Patient advocates have long struggled to suppress the notified body system, calling it a secret, deeply conflicting and potentially disastrous device.
Despite everything, CE marking is accepted worldwide, making Europe an important entry point into the device industry. In Saudi Arabia, India, the Philippines, Singapore and much of Latin America, aircraft are agitated or under surveillance if they have already been certified as safe in Europe .
Lowering the barriers, precipitation on the market
Device manufacturers are competing to launch new devices on the market and introduce new models with new features to improve quality and increase sales. Wall Street analysts are closely monitoring the time needed to remove regulatory hurdles. Experts believe that the standard life cycle of a device before it is replaced by the next model is only 18 to 24 months.
Et avec la croissance de l'industrie, la complexité de ses appareils a également évolué.
Boston Scientific Corp., Medtronic, Abbott Laboratories et d’autres fabricants d’appareils vendent des implants appelés stimulateurs du nerf vague qui envoient des impulsions électriques au cerveau, au cou ou à l’abdomen afin de lutter contre les maux allant du mal de dos au hoquet chronique et à la dépression. Les valves cardiaques démontables, fabriquées par Edwards Lifesciences et d’autres sociétés, peuvent être introduites dans une petite incision et pénétrer dans le cœur à l’aide de cathéters orientables, leur taille maximale leur permettant d’atteindre leur destination comme un bateau dans une bouteille. Medtronic fabrique une "pompe à douleur" entièrement implantable qui envoie des microdoses de médicaments antidouleur dans la colonne vertébrale et génère des rapports de performance que les patients peuvent lire sur une tablette. Ces appareils offrent des avantages, mais créent également des risques.
Parfois, les calculs de risque-récompense peuvent être extrêmement bien. Par exemple, la valvule cardiaque pliable, appelée remplacement de la valvule aortique par transcathéter, ou TAVR aux États-Unis, a un sens pour les personnes très âgées ou malades, car elle élimine le besoin d’une chirurgie traumatique à cœur ouvert. Mais personne ne sait combien de temps ils durent, il est donc d'autant moins logique que plus le patient est jeune et en santé. Mais quelle jeunesse et quelle santé?
Être le premier sur le marché avec un produit révolutionnaire peut constituer une année d'entreprise.
En 2014, Dan Starks, alors chef de la direction de St. Jude Medical Inc., est apparu dans l'émission télévisée de sélection des actions de CNBC "Mad Money". Il a sorti de sa poche un implant plus petit qu'une pile AAA, et l'a tenu debout comme l'appareil photo Il s'agissait de Nanostim, le premier stimulateur cardiaque sans conducteur, le câble de connexion à fils mince qui avait longtemps causé des problèmes aux fabricants. "Nous pensons que cela va révolutionner le terrain", a déclaré Starks.
La conception sans plomb de Nanostim était un argument de vente majeur. Des sondes fracturantes ou présentant d'autres dysfonctionnements, comme le Sprint Fidelis, avaient gêné les précédents implants cardiaques.
"Je peux vous dire que nous avons eu le premier implant avec cette technologie en Grande-Bretagne dans la semaine dernière et que le temps de l’implant entre les mains de ce médecin particulier [was] huit minutes ", a déclaré Stark sur Mad Money.
La patiente était Maureen McCleave, une grand-mère de 77 ans, originaire de Londres. "J'ai l'impression d'être une nouvelle femme", a-t-elle déclaré au quotidien Daily Mail dans le cadre de plusieurs interviews organisées par St. Jude peu après son départ de l'hôpital. "Si j'avais installé un stimulateur cardiaque traditionnel, je serais probablement toujours à l'hôpital maintenant, et je ne me sentirais certainement pas aussi bien que maintenant."
Trois mois après l'opération, St. Jude a révélé les premières préoccupations concernant Nanostim. Les médecins ont découvert que six des 147 patients participant à un essai européen avaient subi une perforation du muscle cardiaque. Deux étaient morts. Plus tard, la batterie de Nanostim a échoué chez plusieurs autres patients, rendant leurs stimulateurs cardiaques inutiles.
Les problèmes de batterie sont devenus tellement courants qu'en 2016, St. Jude a demandé aux médecins qui utilisent Nanostim de "faire une pause" et d'arrêter d'en implanter de nouveaux. Cette pause a duré depuis.
À la fin de 2016, McCleave a commencé à avoir des palpitations cardiaques et à se sentir fatigué. "Je savais que quelque chose n'allait pas quelque part", a-t-elle déclaré à des partenaires médiatiques de l'ICIJ.
Dans un hôpital, une infirmière a expliqué que son stimulateur cardiaque s'était arrêté. McCleave, alors âgé de 80 ans, avait besoin d'une autre intervention chirurgicale rapide. Bien que Nanostim ait été commercialisé avec une autonomie allant jusqu'à 19 ans, soit six ans de plus qu'un stimulateur cardiaque standard, celui de McCleave a échoué sur trois.
Les stimulateurs traditionnels sont relativement faciles à remplacer une fois que la pile est morte. Ils reposent juste sous la peau, sous la clavicule, et envoient des impulsions électriques au cœur par l'intermédiaire de sondes qui peuvent rester en place si un appareil de stimulation de remplacement est requis. Extraire une nanostim de l'intérieur du cœur est beaucoup plus une épreuve.
La deuxième opération de McCleave fut difficile. Les chirurgiens ont implanté un autre stimulateur cardiaque et ont laissé le Nanostim défaillant en place, le jugeant trop dangereux à retirer. "Cela m'a causé beaucoup de problèmes parce que j'ai tellement saigné", a déclaré McCleave.
L'implant cardiaque futuriste de St. Jude avait été certifié comme étant sûr avec seulement des tests minimaux. L'Union européenne exige que la plupart des médicaments fassent l'objet d'au moins un essai clinique sur des centaines, voire des milliers de patients, afin de déterminer leur sécurité et leur efficacité. Nanostim avait été testé sur 33 patients humains et pendant une période relativement courte – 90 jours. Les seuls autres sujets testés étaient 30 moutons.
McCleave a déclaré que personne de St Jude, qui fait maintenant partie des Laboratoires Abbott, ne lui a expliqué pourquoi son Nanostim avait échoué. "Je me sentais comme un peu d'ordures qui avaient été jetées sur le côté", a-t-elle déclaré.
Le lobbying change la mélodie américaine
Dans le passé, les régulateurs américains ont vivement critiqué la réglementation des dispositifs dans le reste du monde en général et en Europe en particulier.
"Nous n'utilisons pas notre peuple comme cobaye aux États-Unis", a déclaré le Dr Jeffrey Shuren, responsable de l'appareil de la FDA, dans un appel lancé en 2011 aux journalistes lors d'un débat au Congrès sur l'opportunité d'adopter davantage de règles de style européen aux États-Unis. déclenché un volet diplomatique.
En 2012, la FDA a publié un rapport nommant "dispositifs dangereux et inefficaces", approuvés et testés de manière limitée dans l'UE. La liste comprend les greffes d'endoprothèse utilisées pour réparer des anévrismes, ou ballonnements, dans les parois de l'aorte. La FDA a constaté que beaucoup présentaient "des risques graves pour les patients", selon le rapport, "notamment des caillots sanguins, une défaillance de la greffe et une rupture d'anévrisme".
L’année prochaine, la FDA a diffusé un message différent: les États-Unis s’efforceront d’être le premier au monde en tant que point d’entrée pour les appareils importants pour la santé publique. Sous la direction de Trump, qui s'est engagé à abolir la réglementation, la FDA a proposé d'accélérer les tests de pré-commercialisation de certains dispositifs à haut risque. Cette initiative pourrait réduire les années d’essais avant le lancement d’un produit et faire économiser des millions de dollars aux entreprises. Dans un discours prononcé devant un groupe industriel en mai, M. Shuren a reconnu que la politique proposée impliquait "d'accepter un peu plus d'incertitude" dans certains cas.
En 2017, la FDA a approuvé plus de trois fois plus de périphériques qu'en 2010, alors que ses avertissements aux fabricants concernant la sécurité des produits ont chuté de près de 80%.
La FDA a déclaré à l'ICIJ que son objectif de "premier au monde" reflétait les inquiétudes concernant les retards empêchant les "nouvelles technologies pionnières" d'atteindre les patients américains plus rapidement que ceux d'autres pays développés, et qu'elle restait déterminée à garantir la sécurité et l'efficacité de ces dispositifs. .
Bien que l'agence émette moins de lettres d'avertissement, elle effectue plus d'inspections dans les usines, a annoncé la FDA.
Les critiques disent que le ton de la FDA marque un changement préoccupant vers un programme promu par l'industrie. "La teneur de la déréglementation de ces dernières années soulève de réelles questions quant à savoir si l'agence est suffisamment capable de protéger le public américain contre les dispositifs dangereux ou inefficaces", a déclaré le Dr Peter Lurie, ancien commissaire associé de la FDA.
Le lobby des dispositifs médicaux est une force à Washington. Selon le Center for Responsive Politics, le secteur a dépensé plus de 335 millions de dollars sur une période de 10 ans jusqu'en 2017. L'industrie des appareils finance également 35% du budget du programme d'appareils de la FDA au moyen de "frais d'utilisation" renégociés tous les cinq ans.
Selon le Dr Michael Carome, directeur du groupe de recherche sur la santé du public citoyen, ces frais permettent à l’industrie de restructurer son organisme de réglementation. Le résultat des négociations sur les frais "correspond souvent à une liste de souhaits de l'industrie", a déclaré Carome.
The industry's formidable presence at the agency is also evidenced in the decades-long controversy over the safety of breast implants. After a virtual ban, and a fierce internal fight, the FDA allowed the silicone version back on the market in 2006 — even though data showing the long-term safety of the product remained limited.
"They were tenacious," said Susan Wood, director of the FDA's Office of Women's Health from 2000 to 2005. "Unlike other companies, after being told no, they came back. And back and back and back. They just wore down any resistance."
A breach of trust
After regulators, a final line of defense stands between a patient and a bad device: her doctor.
But that line, too, has been breached.
Cardiologists, orthopedists and other doctors who implant medical devices are influenced by a wide range of sources, including medical conferences, training seminars and sales representatives. It is common practice for those representatives to join surgeons in the operating room, offering advice on complicated devices they sell.
In 2016, Georgetown University researchers found that company-sponsored events and company employees in operating rooms undermine doctors' independence and ability to choose the best treatment. One hospital administrator cited in the study described the relationship between surgeons and sales reps as an "incestuous bucket of worms."
Physicians and manufacturers are, in some cases, in business together. The companies pay royalties for technologies developed with doctors, and give them research grants and stock options, creating a conflict of interest that has frequently drawn the attention of government authorities.
In the U.S., where drug and device manufacturers are required to disclose payments to physicians, the 10 largest medical device companies paid nearly $600 million to doctors or their hospitals last year,according to an ICIJ analysis of data from the Centers for Medicare & Medicaid Services. This figure doesn't include device-related payments from heavyweights that sell other products, including Johnson & Johnson and Allergan.
One Los Angeles orthopedic surgeon, Thomas Schmalzried, earned nearly $30 million in royalties and other payments from Johnson & Johnson for his role in designing two metal-on-metal hip replacement systems, one the subject of a global recall. Those devices were later pulled from the market amid concerns they shed dangerous levels of metal ions.
Schmalzried didn't respond to ICIJ requests seeking comment. Johnson & Johnson said that while Schmalzried did receive royalties, he received none for products he used in his practice or that were implanted in hospitals where he had privileges. The company said its policies bar such payments.
Device companies have funneled money, sometimes via offshore accounts, to third-party distributors who then paid surgeons or sham nonprofits that doctors set up to receive the payments, according to U.S. and Italian prosecution documents.
After a series of scandals that led to the Physician Payments Sunshine Act of 2010, a U.S. law that forced disclosure of these payments, the device industry's trade association revised its ethics code. The group called for "modest" and "reasonable" compensation for doctors participating in company-sponsored events and restrictions on royalties and consultancy agreements.
Over the last decade, the European trade association has strengthened its ethics code from 15 to 61 pages, even warning companies of "potential adverse public perceptions" of the location chosen for sponsored events. "Cruise ships, golf clubs or health spas and venues renowned for their entertainment facilities are not appropriate venues," the code reads.
Yet law enforcement officials have continued to accuse device companies of misconduct. Doctors, company insiders and government authorities have alleged in court cases that sales representatives are influencing surgeons' clinical decisions and encouraging them to use products in unapproved ways.
Both Fortune 500 companies like Medtronic and smaller industry players have been the subjects of such allegations.
In 2014, Biotronik, a German medical device maker, paid $4.9 million to settle charges brought by the U.S. Justice Department that it paid kickbacks to doctors and illegally promoted its cardiac devices for treatments that were not authorized by regulators.
The company's sales representatives rewarded physicians who promoted unauthorized therapies and implanted large numbers of Biotronik devices with tickets to sports events, golf outings and lavish meals, according to Brian Sant, a Biotronik employee-turned-whistleblower whose lawsuit sparked the government investigation. "It's almost like an annuity," a sales manager wrote in an email cited in Sant's complaint, referring to payouts doctors could receive for enrolling patients in company-sponsored studies.
In a written response to ICIJ, Biotronik said that "its practices were lawful and ethical." It also said the government didn't pursue allegations into Biotronik's training practices or education programs.
Governments around the world have also found manufacturers guilty of paying hospital administrators and physicians with Armani watches and expensive vacation packages to increase sales and secure contracts. In Mexico, a company's employees in charge of bribing physicians had a code word for illicit payments: chocolates.
A Johnson & Johnson implant sales representative in Italy is on trial for bribing a prominent Milan surgeon with more than $20,000, along with expensive trips, dinners and more for him and his son, in exchange for the surgeon implanting J&J artificial joints and promoting its brand on TV shows. The company said it cannot comment on the specifics of this ongoing case but added that it "has fully cooperated with the investigation."
In response to ICIJ, Matt Wetzel, AdvaMed's associate general counsel, said the industry is "dedicated to doing business the right way, and medtech companies have invested countless resources – both capital and human – in developing leading edge compliance programs."
Hidden harm
With barriers lowered for new implants coming to market, more responsibility shifts to watching for problems and informing patients when they arise.
The U.S. has the most public data – by a long shot – about implants that maim and kill. The FDA keeps it in the "Manufacturer and User Facility Device Experience" database, known as MAUDE.
But, for the vast amount of its data, MAUDE relies on device companies themselves. By law, they are supposed to collect complaints from doctors, hospitals, patients, lawyers and others and pass them along to the FDA.
In practice, device companies frequently supply information that is wrong or misleading, or they don't report it at all.
Between 2008 and 2018, FDA inspectors cited manufacturers more than 4,400 times for violating its complaint-handling policy. Each violation can cover hundreds or even thousands of mishandled, lost or buried complaints.
The FDA cited a Cleveland, Ohio-based Philips Healthcare facility for mishandling thousands of complaints about medical imaging equipment that revealed high risk problems that could cause injuries or even deaths, including reports that body scanners had mixed up images among patients. In written answers to ICIJ, Philips noted that no patients were harmed in the incidents and that its records review team had evaluated all the complaints.
When companies do report adverse events, they sometimes cloak their severity. ICIJ found that manufacturers have classified an event as a "malfunction" or "injury" even if the patient died.
Using a machine learning algorithm to search millions of reports, ICIJ found 2,100 cases where people died, but their deaths were classified as malfunctions or injuries. Of these, 220 reports showed that devices may have caused or contributed to the deaths. The other reports did not include enough information to determine conclusively if the device played a role in the patients' deaths.
FDA guidelines call on manufacturers to report deaths that may be related to their devices, even if the connection is uncertain.
The FDA uses adverse event reports to help identify dangerous devices. "If a death is classified as a malfunction, it's possible it never gets read at all," said Madris Tomes, a former FDA data specialist who runs a company that analyzes adverse events.
Dr. Jacob Shani, chairman of cardiology at Maimonides Medical Center in Brooklyn, New York, said that adverse event information provided by manufacturers and physicians is essential for deciding which product to implant. "If you don't have transparency, and you don't have honesty, then forget it," Shani said.
Broken alarm system
The reports that do ultimately get to regulators can trigger actions including safety alerts or recalls. These can require hospitals to remove devices from their shelves or, depending on the severity, even unleash a wave of surgeries to remove devices from patients.
Whether a product is recalled or restricted may depend on where you live, ICIJ found. Over the past year, health authorities in New Zealand, Ireland, Scotland and England heavily restricted the use of the type of vaginal mesh used to treat incontinence or to hold reproductive and other organs in place while regulators studied the devices' safety. But the products have remained largely on the open market in other countries, including Canada and South Africa, where Renate Scheepers received hers.
Government-overseen safety alerts, often called "recalls" in the U.S. or "field safety notices" elsewhere, can range from simple label changes to immediate removal of a device from the market. Manufacturers also in some cases quietly pull products from the market without admitting fault.
Experts told ICIJ that governments must issue recall and safety alert notices so patients and doctors are aware of problems. An ICIJ analysis found that some governments post notices frequently and some almost never do. Health regulators in Mexico only shared information on two issued recalls, ever. In the U.S., the FDA has published more than 26,000 in the last decade.
A metal-on-metal hip manufactured by Indiana-based Biomet has been linked to flesh-rotting metallosis, and the company discontinued sales of the device several years ago. Biomet later sent safety alerts to surgeons and other health care providers in Australia, the U.K. and a slew of other Western European countries in 2015 and 2016, but not to those in Canada and the U.S. Had the FDA pushed for a recall of the Biomet hip device in the U.S., the company could have been forced to send such letters to American doctors.
"We adhere to strict regulatory standards and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network," the company, now called Zimmer Biomet, said in a statement.
In a statement to ICIJ, the FDA pointed to a generalized safety communication it had posted online in 2011 about metal-on-metal hips as a reason for not requiring a recall of the Biomet hip.
Officials often can't find patients with problem devices – or even the doctors who implanted them. Harold Paz, chief medical officer and executive vice president at Aetna, one of the largest health insurers in the U.S., noted the automobile industry's comparatively good track record for reaching owners of recalled cars.
"We currently have no way to identify which of our members has received the affected implant," Paz said.
Patients living with already recalled devices inside them said they were left in the dark about problems. In interviews with ICIJ's global partners, hundreds of implant recipients said doctors never warned them of risks and didn't tell them about recalls or safety alerts.
Connie Hill, a 72-year-old resident of Sun City, Arizona, is one of several patients who say they wished they would have known earlier of foreign safety alerts of the Biomet hip implant. "I never heard a damn thing about it," Hill told ICIJ.
Mending a 'broken system'
In the early 1990s, an Australian orthopedic surgeon named Stephen Graves was growing increasingly uneasy about the medical devices he was implanting. The hip and knee replacement products carried both huge benefits to patients and also huge risks — but he had little clue as to which device was safer than another. "We didn't know how many or what types of devices were going in," Graves said. "And we didn't know the comparative performance of the devices."
In 1996, Graves began working with a group of fellow surgeons to establish a central database to track Australians with hip and knee implants and monitor their health. Within a few years, Graves' national device registry was logging the vast majority hip and knee replacements in Australia — and revealing dozens of problem devices.
In 2009, Australian regulators would use Graves' data to raise early safety concerns about Johnson & Johnson's ASR XL, the metal-on-metal hip brand implanted in Vijay Vojhala of Mumbai. To date, the registry has identified more than 150 poorly performing joint replacement products, Graves said.
A better system for tracking devices after they go on the market enjoys broad support among industry, physician and patient advocates. Dr. Henrik Malchau, a Swedish orthopedic surgeon who has helped establish several national registries, said they allow authorities to alert doctors and patients of problems. Pointing to the Australian case, he said: "The beauty of it was that they could go back and find all the patients."
After recent high-profile device recalls, India is considering a proposal to create its own joint replacement registry, while others are advancing in Finland, Norway and the U.K., Malchau said.
The U.S. remains a laggard. In an effort to improve post-implant surveillance of devices, the FDA is attempting to unify various private registries with insurance claims data into a single centralized system.
But this program relies largely on the success of a related FDA initiative calling for each device to be assigned a unique identification number in order to make them more traceable — a step taken long ago by auto regulators. While a "Unique Device Identifier" (UDI) program could usher an age of more advanced postmarket surveillance, its full implementation is years away. One potential hurdle: the federal government has yet to issue final rules mandating device identifiers to be included in electronic health records and in insurance claims data — crucial ways that the initiative can be used to help track patients and the performance of their devices.[5]
And the prospect of a globally harmonized UDI system — now under discussion by medical device regulators — remains even more distant.
Hanifa Koya, a gynecologist in Wellington, New Zealand, who has performed many gruesome surgeries to remove defective meshes, said keeping track of devices sold and implanted is basic. "If surgeons are looking to constantly adopt innovative devices but not asking for a registry, then this is a broken system," she said.
Koya said hospital ethics panels should have the power to bar doctors from using implants that haven't been tested or are subject to safety concerns.
But she recognizes that her hoped-for fixes won't come easily. And even those are a small piece of larger systemic problems.
"When it comes to protecting the people who will suffer," Koya said, "the system is absolutely in shambles."
* Contributors to this story: Ben Hallman, Jet Schouten, Dean Starkman, Simon Bowers, Emilia Díaz-Struck, Gerard Ryle, Sasha Chavkin, Spencer Woodman, Cat Ferguson, Petra Blum, Scilla Alecci, Sydney P. Freedberg, Fergus Shiel, Richard H. P. Sia, Tom Stites, Martha M. Hamilton, Joe Hillhouse, Rigoberto Carvajal, Cécile Schilis-Gallego, Hilary Fung, Marina Walker Guevara, Miguel Fiandor, Pierre Romera, Hamish Boland-Rudder, Will Fitzgibbon, Delphine Reuter, Amy Wilson-Chapman, Margot Williams, Pauliina Siniauer, Razzan Nakhlawi, Jesse McLean, Matthew Perrone, Holbrook Mohr, Mitch Weiss, Esther Oxford, Charles Babcock, Andrew Lehren and Emily Siegel.
[ad_2]
Source link
