A year-long investigation of the $400 billion medical device industry by the International Consortium of Investigative Journalists reveals how lax regulation has allowed under-tested devices to flow into the market, and to remain there, even after grisly problems emerge. Time and again, our Implant Files reporting led us to devices made for women, and to women who were injured when an implant fractured, ruptured, triggered an autoimmune reaction or otherwise didn’t work as intended.
Yet a seemingly basic question — whether there is a pain and suffering gender gap — remains vexingly tough to answer.
After reviewing the histories of dozens of problematic devices, and talking to hundreds of patients, this much is clear: women were disproportionately harmed in many of the scandals that have plagued the industry in recent years.
Women have higher complication rate, and need to be treated differently – Rita Redberg
Regulators, under heavy pressure from women-led patient groups – angered that their concerns have often been dismissed by doctors and by health authorities – are scrambling to make reforms. And while there is no way to determine whether more women are injured or killed than men in terms of absolute numbers, studies show that many medical implants pose a higher risk to women than men.
“Women have higher complication rate, and need to be treated differently,” says Rita Redberg, a cardiologist and medical device researcher at the University of California, San Francisco.
The best source for gender-specific data on injuries and deaths linked to medical devices should be the U.S. Food and Drug Administration. The FDA collects that information in “adverse event” reports filed by manufacturers, doctors and others when a device has harmed a patient – or has experienced a malfunction that would lead to harm if it were to recur. An ICIJ analysis of this data identified more than 83,000 deaths and 1.7 million injuries linked to medical devices.
Yet the FDA won’t make gender information public. An agency spokeswoman told ICIJ that revealing gender or age would violate patient confidentiality rules and that more broadly, “conclusions can not be drawn” about sex-specific differences in adverse event rates, because the reports themselves often contain unverified and incomplete information.
There are large gender differences in device usage – heart devices, for example, skew male – so it’s not clear whether or not the data would show a gender divide. But the FDA has issued statements that seem to acknowledge a problem, at least of perception.
On Nov. 20, the FDA announced that the agency will be “focusing on addressing clinical questions on device therapies that are unique to women.”
Asked by ICIJ what prompted the declaration, a spokeswoman pointed to previous agency communications, including a pledge to “improve the quality and efficiency of real-world evidence generation, specifically for technologies used to address women’s health” in light of “several significant medical device safety issues [that] have involved devices intended for women’s health uses.”
Those “significant” issues concern medical disasters that have wrecked the lives of tens of thousands of women.
Vaginal mesh, used to treat incontinence and hold prolapsing organs in place, has pierced sensitive tissue and caused infections in thousands of women. Josephine Kilroy, a former taxi driver, told The Irish Times, an ICIJ partner, that the mesh implant she received to treat a bladder problem a decade ago caused her so much pain that she was essentially homebound. “It has taken my whole life from me,” she said.
Dawn Criss, a breast implant patient and bookkeeper who lives near Edmonton, Alberta, is one of more than 2,400 people to have responded so far to an ICIJ survey. Four years ago, she began to experience pain, itching and other discomforts in her breasts, she said in an interview this week.
Doctors found associated anaplastic large cell lymphoma (BIA-ALCL) in her left breast, her medical records show. Symptoms from colitis, an autoimmune disorder she suffers from that causes inflammation in the colon, disappeared almost completely after the implants were removed, she said.
Essure coils are a sterilization device that have damaged reproductive organs and triggered allergic reactions in thousands of women worldwide. El Confidencial, another ICIJ partner, told the story of María Ángeles, a Spanish women who died in May from complications stemming from a hysterectomy after she was implanted with Essure.
These devices are associated with huge numbers of patients: More than 10 million people have received breast implants over the last decade, and more than 1 million have gotten Essure, which as of the end of this year will have been pulled from the market in every country. Hundreds of thousands have had a mesh implant. There is no comparable group of male-focused products with these kinds of widespread problems.
Even many devices used by all genders appear to harm women more often than men.
Women who received a Thoratec HeartMate II, an implant that pumps blood out of the left side of the heart in patients that have suffered heart failure, were three times as likely as men to have a stroke in the pre-approval studies. Women who underwent hip replacement surgery were found to have a 29 percent higher rate of hip implant failure than men — and also experience a “remarkable and significant” increase in hypersensitivity to metals used in hip implants.
Women’s voices are not granted the same authority in doctors’ offices –Maya Dusenbery
Higher complication rates don’t necessarily mean devices shouldn’t be used in women. Heart pumps and other cardiac devices save and extend lives, and artificial hips help people walk again. But patients should be apprised of the risks, and doctors must factor in elevated risks when recommending a course of care, health experts say.
Redberg said there are procedures that she would recommend for men that she would not advise for women. A continuing problem, she said, is that women are often underrepresented in many clinical trials.
In dozens of interviews with ICIJ reporters and our partners, women said that when they complained of illnesses and maladies they believed were tied to an implant, they weren’t believed.
One of those women was Laura DiCarlantonio, who by December of 2017 was exhausted, suffered persistent aches and pains and had flu-like symptoms that seemed to never go away, she told ICIJ. Four years earlier she had breast implants after a mastectomy. A scan revealed a rupture in one of the silicone implants — yet her plastic surgeon refused to acknowledge her symptoms or the evidence of a rupture.
Months passed while she researched her options. She had the implants finally removed in May.
In her book Doing Harm, released earlier this year, journalist Maya Dusenbery describes an “unconscious and systemic” bias that affects the care women receive.
“Women’s voices are not granted the same authority in doctors’ offices,” she told ICIJ. The majority of people suffering autoimmune disorders are women, yet the records abound of doctors turning women away when they complain of pains and other hard-to-pin-down ailments that are the hallmark of many autoimmune illnesses, Dusenbery said.
Dusenbery, whose book emerged from research after she was diagnosed with rheumatoid arthritis in her 20s, realized how fortunate she was to have gotten an early diagnosis.
“The medical profession needs to recognize that needless delays in diagnosing women is a really big blind spot,” she said.
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Implant Files in Asia: Regulation and transparency on medical devices remains patchy while patients suffer
On a stormy Seoul morning in early October, local reporters met with visiting journalists from Tokyo, New Delhi, Islamabad, Beijing, Stockholm, New York and Washington D.C. at a quiet cafe.
With just two months to go ‘till publication, ICIJ partners shared newly-uncovered incident data from Korea, leads on overtreatment allegations in Pakistan and the harrowing accounts of Japanese patients suffering the side effects of gel fillers.
The reporters interrogated the international relevance of their findings on faulty stents, breast implants and other medical devices.Related articles
Their stories, which began appearing on November 26 (Asia time), helped to paint a complex international picture of the $400 billion industry and regulatory oversight of it.Japanese Olympus fined $85 million
Japanese news agency Kyodo News reported that some endoscopes manufactured by Olympus caused bacterial infections in about 190 patients in Europe and the U.S. between 2012 and 2015.
Executives of the Tokyo-based company allegedly knew about infection risks but failed to warn U.S. authorities, according to court records cited in the report. (The product was never sold in Japan.)
On Monday, a U.S. Federal judge ordered Olympus pay an $85 million fine for failing to report infections connected to its endoscopes. As part of a plea deal with the Justice Department, the company and a former executive also pled guilty to continuing to sell the products in the U.S.
The Japanese reporters also found that patients who got gel filler injections in breast-augmentation surgeries had been reporting complications including lumps and suspicious tumors.
Unlike in Japan, gel fillers are banned in the U.S. and France, and experts have criticized the procedure in neighboring South Korea, the Asahi Shimbun reported.Chart 1: Adverse events reported to US regulator. Data analysis by ICIJ, analyzed by ICIJ. Chart 2: Adverse events reported to the Japanese regulator from 2008 to 2017.
In the past decade, about 90,000 incidents were reported to Japan’s health ministry as potentially linked to medical devices, an ICIJ analysis of ministry data shows. Coronary stents were responsible for most of the adverse events.Device incidents found in Korea
In South Korea, where the government doesn’t disclose detailed adverse event data, Newstapa reporters found that nearly 4,900 incidents were reported as caused by devices over the past four years. Most reports were related to silicone breast implants.
Newstapa also reported that often patients were not informed about the potential risks associated with an implant before undergoing surgery, nor were they notified when their product was recalled.
Medical device companies were also found to finance South Korean doctors’ trips and attendance at medical conferences. Every year they pay an estimated $2.4 million to doctors through dozens of overseas academic conferences. Manufacturers don’t pay physicians directly, according to Newstapa. Instead, they cover the operating expenses of the company that organizes the conference so the link between the manufacturer and the physician remains secret, the report said.A public hospital in New Delhi, India. i Scilla Alecci Payment to doctors and weak rules in India
In India, authorities are currently examining the tax-exempt status of such payments, as well as gifts, training fees and trips to conferences for doctors provided by pharmaceutical and device makers.
An Indian Express investigation found that, over the last decade, multinationals such as Abbott Laboratories, Medtronic and Johnson & Johnson were flagged by the Indian government for allegedly claiming such expenses as tax-deductible “invention”, “advertisement”, “publicity”, “propaganda” and “customer relationship” items. Courts are still debating whether restrictions on such tax benefits apply only to physicians or to companies too.
India has yet to enact a Medical Device Regulation Bill that was drafted in 2006. In 2016, the government issued a set of rules on design and manufacturing requirements, saying stronger legislation would “curtail competition.” Experts and industry insiders interviewed by the Indian Express described the new rules “as an easy way out for politicians of the day.”
Indian patients are seldom informed about device safety issues or potential risks. The Indian government has published recalls for just 23 devices, despite data from U.S. regulators showing three times that a number of devices sold into India were recalled overseas between 2016 and 2017 over serious safety concerns.
The Implant Files, the Indian Express said, “exposed how almost every medical device is advertised, sold, and surgically implanted under regulatory systems that, effectively, don’t exist.”
India began requiring hospitals to report adverse events only in 2014, according to previously undisclosed information obtained by the Indian Express. Most of the incidents reported so far — about 900, more than half of them this year — were associated with stents, orthopedic implants, and intrauterine devices.Patient’s ‘eventual casualties’ in Pakistan
On the other side of the northern border, in Pakistan, no regulatory body checks the safety of medical devices that are imported from the U.S., Canada, Australia, and Europe, ICIJ’s media partner, The News, reported.
After a scandal over unregistered stents, in January this year, Pakistan’s Supreme Court began requiring the licensing of device importers and their registration with the regulatory agency. Yet, the government doesn’t require hospitals to report incidents caused by implants, a task that is left to device distributors and manufacturers, with poor results.
Despite recent inquiries by the National Investigation Agency that have shed light on the health risks of corruption, abuse of stents by unscrupulous doctors continues. One patient interviewed by the Pakistani outlet described how he became sick after an interventional cardiologist implanted a stent which was later deemed unnecessary. Another patient died after a stent caused a blood clot.
The News report concluded: “As records of adverse events are not kept, and the investigation of such occurrences is not carried out by the hospital in absence of a strong regulator, the patients are eventual casualties.”
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Bianca Malandrino, a businesswoman in Sao Paolo, Brazil, was 22 years old when she got silicone breast implants in 2008.
She recalls having a single, brief consultation with her plastic surgeon before her operation, in which he encouraged her to get larger implants than she originally intended. She did not receive any documents detailing health hazards or other information about the implant she was about to receive, she said.Related articles
“I was young and didn’t ask about any complications that could happen, but he did not warn me either,” Malandrino told reporters from Revista Piaui. The Brazilian magazine was a part of the Implant Files, a global investigation of the medical device industry and its regulation, led and reported by the International Consortium of Investigative Journalists.
“We were in the middle of a boom to put in silicone, and I was just one more patient for him.”
In the years after the implant, Malandrino suffered from a series of ailments including bursitis, which created inflammation in her shoulder, mental fog and hair loss. She remembers so much of her hair falling out that she sometimes cried in the shower when she washed it.
Malandrino is one of hundreds of breast implant patients who have shared their experience with ICIJ and its partners in surveys and interviews. The striking similarity? How many reported that they received either limited warnings or no warnings at all about possible safety risks.
While growing numbers of women around the world reported health problems linked to breast implants, that information often was kept hidden from public view by the way it was reported, the investigation found. Breast implants were one of many medical devices covered in the year-long investigation by ICIJ and more than 250 reporters around the world.
As part of the Implant Files, news organizations asked readers to share their experiences with breast implants and other medical devices. This survey built on months of interviews with women who suffered health problems after receiving breast implants and were members of online support groups.
In two weeks, more than 650 patients reported problems related to breast implants, making it the most common device cited by the more than 2,200 patients, health providers and device industry professionals who have completed ICIJ’s survey to date.
The responders – who are self-selected and do not represent a scientific sample – overwhelmingly reported that they didn’t receive thorough warnings about breast implant safety risks.
More than two-fifths said they received no safety warning at all before receiving their implants. More than half said that were warned of local complications, such as rupture and infection, but not about more serious potential risks such as associated anaplastic large cell lymphoma (BIA-ALCL) and autoimmune disease, both of which have been linked to breast implants.
Only 12 said that they received a thorough warning of breast implant safety risks.Gel injections
The results parallel reporting by ICIJ partners who found that often patients aren’t being properly warned about breast implant health hazards.
In Japan, ICIJ partners at Kyodo News found that women who got injections with a gel filler to enlarge their breasts experienced side effects possibly linked to the material. Plastic surgeons and their staff members were promoting the filler without mentioning the risks to their patients, even though gel fillers are banned in the U.S. to protect patient safety, Kyodo News found. The U.S. Food and Drug Administration declared in 1992 that gel injections were prohibited because their safety was unproven, and gel injections have been reported to cause serious complications in the past.
A survey by the Japan Society of Aesthetic Plastic Surgery found that more than one hundred plastic surgeons had patients who reported complications from gel fillers, including lumps, infections and skin deformities.
One woman, who was 20 years old when she was injected with gel fillers in 2016, told Kyodo News that she developed severe medical problems one year after the procedure, when she began breastfeeding her newborn child.
“It was so painful that I couldn’t lift my arms up, and I couldn’t change my clothes well,” said the woman, who remains anonymous in the story. “My mind wasn’t working properly and I thought I was going to die.”
Following the story, the Japan Society of Aesthetic Plastic Surgery called for gel filler injections for breast enlargement to be banned.Hidden camera investigation
In Canada, CBC Marketplace and the Toronto Star conducted a hidden camera investigation in which undercover reporters requested breast implants from three Toronto plastic surgeons. The reporters recorded the plastic surgeons and their staffs promising quick, seamless recovery from the procedure and sometimes understating the chances of ruptures, leaks and required revision surgeries.
“The promotional machine driving the $1-billion global breast implant industry runs on tastefully lit, aspirational images of perfect bodies, glowing testimonials and inspirations from celebrities — but in many cases provides little mention of the potential risks,” the two news organizations said of the investigation.
Nicole Carruthers, whose story was at the heart of the CBC/Toronto Star report, said that at the time of her surgery, it was made to seem so minor and routine that it was akin to getting a haircut.
“I was told they were 100 percent safe now,” Carruthers wrote to ICIJ in responses to its reader survey.
But several years after, she experienced an array of ailments so severe they came to take over her life. “Chest pain. Difficulty breathing. Shortness of breath. Chronic fatigue. Sensitivity to light/sound/people speaking. Migraine that never went away,” Carruthers wrote.
CBC’s undercover reporters recorded eye-opening safety promises by plastic surgeons.
One plastic surgeon told CBC’s reporter that she would be out to dinner the night after the implant surgery and on the beach the following day.
When asked to explain how that was possible, the doctor told her: “You don’t have to understand, just need to know that I can deliver, and I’ve done it on thousands of patients.”Unqualified doctors
In India, patients faced unexpected dangers of a different sort: unqualified doctors performing implants sometimes with substandard materials.No one is checking the implants for safety; regulators do not exist…shame and stigma prevent patients from reporting the gruesome aftermath. Ritu Sarin, The Indian Express
Two plastic surgeons told another ICIJ partner, The Indian Express, that roughly half the breast implant operations they performed were corrective surgeries to fix previous botched breast implants. One of them said some of the botched surgeries were performed by health providers who lacked the necessary qualifications, including dermatologists and ayurvedic doctors.
“No one is checking the implants for safety; regulators do not exist; technicians often double up as surgeons; shame and stigma prevent patients from reporting the gruesome aftermath of what has gone wrong, an investigation by The Indian Express has found,” reported ICIJ member Ritu Sarin.
Among the complications detailed in Sarin’s investigation were those of a patient whose implant was so badly misplaced that it almost touched her neck and another who found mites on the surface of her breast implant after it was removed.
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When I went to visit Jill Vahldieck, the first patient I met in person for our breast implant investigation, I was expecting a somber evening.
Vahldieck, a U.S. citizen by birth who has lived in Germany for almost three decades, had seen her health devastated by a series of ailments that she attributed to her saline-filled implants. She said she had suffered insomnia, migraines, chronic pain and had lost more than 40 pounds in a year.
“I was disintegrating before everyone’s eyes,” Vahldieck said.
But when I arrived in Clinton, Virginia, where Vahldieck was recuperating after surgery to remove her implant, what I encountered instead was a powerful display of solidarity.
Vahldieck was hosted in Virginia by Karen Dillinger, who years before had also suffered a debilitating illness after getting breast implants. The two had connected through a Facebook group for women who faced health problems after getting implants. Although they had never met in person, Dillinger agreed to host Vahldieck for two weeks to help her recover from surgery.Related articles
The bond between the two women was visible. They shared health tips, avocado brownies, and referred to each other as “breasties” – which I would learn was a frequent term of endearment in the community of breast implant patients. They spent much of the evening smiling, laughing and enjoying their unexpected friendship.
The evening was an introduction to a community of thousands of women around the world who experience health problems, including severe illness, after getting breast implants.
More than 50,000 women have joined a Facebook group, Breast Implant Illness and Healing, whose membership has skyrocketed in the last year. The reason for the surge, says the group’s founder, Nicole Daruda, is that no one else would take their ailments seriously.
“Women were having all these problems, and, when they go to their doctors, they get told there’s nothing wrong with their implants,” Daruda said.It hadn’t occurred to me before this project that being believed by my doctor when I said I had a problem wasn’t a universal experience
In speaking to these women, I was struck not only by the severity of their symptoms but also the parallels among their stories.
Over and over, they observed that a major traumatic part of their experiences was not knowing what was wrong with them and not being believed by their doctors, an attitude that many attributed to sexism.
Plastic surgeons in particular, they said, dismissed the idea that their breast implants could be making them sick.
Although breast implants are not always found to be the cause of patients’ symptoms, their stories opened my eyes to something I hadn’t personally experienced.
It hadn’t occurred to me before this project that being believed by my doctor when I said I had a problem wasn’t a universal experience — or what it would be like to be gravely sick and discounted by the people I needed in order to get well.
But then, I’m a man. Studies abound of doctors treating women’s symptoms less seriously than men’s.
In the final months of reporting, I reconnected with Daruda and other patient advocates. They were planning a September trip to Washington, D.C., where the International Consortium of Investigative Journalists’ offices are located, to meet with U.S. Food and Drug Administration officials and Rep. Rosa DeLauro, D-Conn. Many of the advocates were mothers who had struggled to balance their illness with family responsibilities, and they were methodical, deeply informed and strategic in their approach.
In the meeting with the patients, Rep. DeLauro compared their experience and those of patients implanted with the birth control device Essure and vaginal mesh used to treat organ prolapse. The parallels were striking: all three were women’s devices with health consequences that are sometimes hard to discuss in public. In each case, women’s complaints had often been dismissed by manufacturers and physicians as scientifically misguided and psychological in their origins.
And in all three cases, patients’ advocacy was turning the tide. Essure patient advocates, who call themselves “E-sisters,” helped bring about an FDA black box warning for Essure and its withdrawal from the U.S. market. Days before ICIJ published its Implant Files investigation, the FDA put out a statement pledging its commitment to patient safety, announcing a focus on women’s health and specifically mentioning breast implants and mesh.
It was the final and most important way in which the community of women with breast implant health issues had upended my expectations: from finding a determined rather than a disheartened patient who was recuperating with the support of a new-found friend, to thousands of isolated victims who became united in bringing their problems forcefully to regulators’ attention.
In everything we discovered in our nearly yearlong investigation of medical devices and the broken system that regulates them, the emergence of women-led patient groups as a powerful voice shaping the rules for device safety felt like the most hopeful sign of all.
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“The patient XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX …
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXThe lead was discarded after explant, so was unable to be analyzed by the manufacturer.”
A glitch in this article? No. An example of what the International Consortium of Investigative Journalists and its partners in the Implant Files investigation received when they asked for public information on faulty medical devices.A section of a Dutch response.
This one from the Netherlands was typical in its redaction (or blacking out) of information that might have been more specific and revealing.
More than 250 reporters from 36 countries participated in the global investigation led and reported on by ICIJ. Over the course of the nearly year-long probe, they filed more than 1,500 requests for public records in their countries. But not even half were successful. In one that was strikingly not, Mexican reporters submitted 964 requests to federal agencies that produced only 44 responses.
Across the world, public bodies in charge of monitoring and regulating the medical device industry, as well as of keeping track of incidents caused by the devices, have fully or partly denied journalists’ requests for public records for a variety of reasons.
Among the rationales for rejecting requests or redacting documents: classified information or absence of data in Mexico and France; a year-long backlog of requests in the U.S.; lack of staff who can redact sensitive details in Belgium; trade secrets in Japan, Europe, the U.K. and many other countries.Disclosure and public scrutiny are very important in finding what is wrong in our community Yasuomi Sawa
When reporters did get data on incident reports, it wasn’t always in a format that could be used to do trend analysis or advance any reporting leads.
In France, the list of incidents associated with medical devices that was provided by health authorities looked like “a spreadsheet filled by an intern,” said Le Monde’s Stéphane Horel. The file didn’t include any information on incident outcomes, such as deaths or injuries, and had many empty rows, she said. “That’s how we realized the system is broken.”
If authorities can’t keep track of possibly harmful incidents, who can?Related articles
In Canada, it took two years for David McKie, a data journalist with Canadian Broadcasting Corporation, to obtain adverse event data from the national regulatory agency.
The breakthrough came last summer when a frustrated McKie decided to apply a strategy basketball players use when a victory is uncertain. “I exercised a ‘full-court press’ where you pull out all the stops in order to achieve success,” McKie said. “I complained and inundated [the agency] with requests. I became one of their bigger problems.”
Just a few months before publication, his efforts were successful. CBC obtained a copy of Canada’s medical device adverse event data since 1977, which went on to become the “heart” of the reporting team’s investigation.
“The database gave us an unprecedented window into the medical device regulatory process,” McKie said. It also “highlights that lack of transparency is at the heart of the system.”
CBC created Canada’s first medical device incident database and made it available for the public on its website. ICIJ created another database, also from public records. The International Medical Devices Database permits users to explore more than 70,000 recalls, safety alerts and field safety notices in 11 countries. Users can search by device name, by manufacturer, or by country, and the database will grow as ICIJ acquires and records more information.
More than one hundred countries around the world have legislation on freedom of information, but its application “leaves a lot to be desired,” said Toby Mendel, director of Halifax-based Centre for Law and Democracy and specialized in freedom of expression law.
Some reporters also fear that corporations’ concerns tend to prevail even when public health is at stake.
Jet Schouten, a reporter with Dutch TV show Radar, who has been covering safety issues tied to medical devices for years, said she was “flabbergasted” when her country’s authorities explained the reason they weren’t publishing all the adverse event reports they receive.
Their response to Schouten and the daily Trouw put it simply: “The relationship between the inspectorate and manufacturers of medical devices, which is indispensable for the effective monitoring of the profession, will be disproportionately damaged by the disclosure of medical data.”The response from authorities in The Netherlands.
“It’s a system based on fear,” Schouten said. Regulators “listen to the industry and not to patient safety.”
A week after publication, in countries such as France, Spain and Japan, ICIJ’s media partners’ fight — and long wait — for open records continues.
“Disclosure and public scrutiny are very important in finding what is wrong in our community,” said Yasuomi Sawa, a reporter with Japanese news agency Kyodo, who is still waiting for a response to his team’s 76 requests. Just because the government has information on medical device safety it doesn’t mean the public is safe, he said.Read (some of) the FOIA responses ICIJ and partners received The Netherlands
- Manufacturers Incident Report
- FOIA Response, The Netherlands – Ministerie van Volksgezondheid Wlzijn en Sport
- Team NB- EC on Notified Bodies – 2012
- EC document on Notified Bodies – 2012
- EC “revision of MD legislation” – 2012
- Draft report of EP on MD regulation – 2013
- EC Medtech Europe – 2013
- Eucomed – 24 Ares(2013)3050282
- EC Mimica’s Hearing in the EP – 2018
- France NCARs 2012 2018
- European Commission’s rejection letter
- Medtronic FDA Inspection Document – 2013
- Baxter Auto Syringe AS50A 501(k) Review – 1994
- Response – Infusion Systems LLC Request for Summary of Safety and Effectiveness – 2010
- Infusion Systems LLC Request for Summary of Safety and Effectiveness – 2008
- FDA Response – University of Washington request for Medtronic SynchroMed research and studies – 2008
- University of Washington FDA request for Medtronic SynchroMed research and studies – 2005
- Medtronic SynchroMed Recall Action Memo
- Covidien pension complaint
- Codman Infusion Pump FDA Summary of Safety and Effectiveness – 1991
- Medtronic SynchroMed Summary of Safety and Effectiveness – 1988
- Medtronic SynchroMed Intraspinal Morphine Supplement – 1991
- Medtronic FDA Inspection Document – 2013
- Medtronic Parmadigm Complaint – 2016
- Dexcom Consumer Fraud Complaint – 2008
- Recall recommendation review SynchroMed – 2018
- CDRH’s Health Hazard Evaluation SynchroMed II – 2011SynchroMed II – 2011
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As part of ICIJ’s Implant Files investigation, we looked at a new type of heart valve, called TAVR (or TAVI, depending on where you’re from), and how manufacturers like Edwards and Medtronic are manufacturers are finding creative ways to market directly to patients.
Here are five takeaways from our investigation.TAVR is a heart valve replacement that can be implanted without open heart surgery
Aortic stenosis is a common disease where one of the heart valves narrows, restricting the flow of blood into the body. When it gets bad enough, the diseased valve often needs to be replaced. For decades, the only option was open-heart surgery to cut out the damaged valve and sew in a new one.Related articles
The newer alternative is far less invasive. Cardiologists compress an artificial valve into a tiny package on the end of a thin, flexible tube called a catheter. They feed the tube through a small incision, usually in the leg, then thread it through blood vessels until it enters the leaky valve. The replacement pops open and takes over the job of letting blood out of the heart.
The procedure is called either transcatheter aortic valve replacement (TAVR) or transcatheter aortic valve implantation (TAVI).Doctors don’t know how long TAVR valves last
TAVR is saving lives, and extending them. But the valve’s durability, and longevity remain in doubt.
It was originally developed for people with health conditions that made open-heart surgery risky. Many participants in the original clinical trials were elderly and in poor health, and died within a few years. There isn’t much long-term data on how long the valves last.
Many experts think TAVR valves might stop working sooner than surgically-implanted ones. Compressing the valve may cause microscopic damage, and being squeezed into the heart is hard on the device.
“We have no idea what the durability of those valves is, at all, period,” said Joseph Bavaria, a doctor who co-directs the TAVR program at the University of Pennsylvania, where he is also a professor of surgery.
The companies that make TAVR, including Edwards and Medtronic, say they have good data that the valves last five years. They also say newer valves are more durable than earlier generations.Younger patients are getting TAVR, even though potential risks are unclear
Even though questions about durability remain, some doctors are putting TAVR valves into younger and healthier patients who may live with the prosthetic for decades.
This practice is already common in Germany and other European countries, ICIJ found. In the U.S., Medicare will only pay for a TAVR procedure if the patient is at medium or high risk of surgical complications, but doctors are free to recommend it to anyone. Manufacturers are currently running clinical trials in patients at low risk of surgical complications.
Cardiologists haven’t dealt with enough broken-down TAVR valves to know how risky it is to fix them. Several prominent TAVR doctors told ICIJ that surgery is still the best bet for most people at low risk of surgical complications, unless they are part of clinical trials.
Doctors have also told ICIJ that degradation of the TAVR valve may cause serious problems, including a need for open-heart surgery when patients are older, more frail and at greater risk of death or serious injury. Several studies have suggested that patients who are good candidates for surgical valve replacement have higher mortality rates if they receive a TAVR valve, instead.TAVR manufacturers are finding creative ways to market directly to patients
Visit our new website https://t.co/uPZ6qvzqTv to learn how #TAVI can help more #AorticStenosis patients than ever. Get the latest info, download valuable materials, and see the latest innovations at https://t.co/7nVbeiiQfU. #ESCCongress #HCP pic.twitter.com/Z4KCPNemPf
— Edwards Lifesciences (@EdwardsLifesci) August 25, 2018
Manufacturers are donating to advocacy organizations like Mended Hearts and the Alliance for Aging Research, which promote TAVR to patients and government officials. They also buy lots of ads at conferences hosted by the Cardiovascular Research Foundation (CRF), a non-profit that hosts major events for TAVR doctors.
The co-founder of CRF, Martin Leon, also co-founded the first TAVR company. He made at least $6 million when Edwards bought it and then helped run the U.S. clinical trials for Edwards. He says he doesn’t get any money from Edwards now, but acknowledges financial ties to other TAVR-related companies.Balancing TAVR’s risks and rewards
TAVR has extended the lives of many people, but its long-term durability remains unknown. Patients who may need an aortic valve replacement should talk with their doctors about the risks and benefits of each option.
The post What is TAVR? Five takeaways from our investigation into a new heart valve device appeared first on ICIJ.
Health authorities in Canada announced an action plan to improve oversight of medical devices, days after the Implant Files investigation revealed broad failures to protect Canadian patients from flawed and dangerous medical implants.
The Implant Files, the first ever global examination of the medical devices industry, featured extensive reporting from the Toronto Star, CBC and Radio Canada, and was led and reported on by International Consortium of Investigative Journalists.
“The government of Canada agrees that more can be done to further strengthen the oversight of medical devices and to be more open and transparent with Canadians,” said Health Minister Ginette Petitpas Taylor in a statement on Thursday.Related articles
“I am deeply concerned by recent reports of serious issues Canadians have been facing with implanted medical devices,” she said.
The action plan released by Health Canada is focused on three areas: strengthening processes for premarket approval of devices, enhancing post-market surveillance, and making both systems more transparent to members of the public.
To improve premarket approvals, Health Canada said it would review the scientific requirements needed get high-risk devices greenlighted for the market, including requirements for clinical evidence. Petitpas Taylor also pledged increase consultation with outside experts on medical device safety issues.
In the area of surveillance once a device is on the market, Health Canada said it would require companies to inform it when key foreign health agencies issue safety warnings and to increase its capacity for conducting inspections of medical device facilities.
The agency said it would enhance transparency by providing public summaries explaining decisions on whether to approve higher-risk devices. In addition, Health Canada said it would provide greater access to clinical data used to support its approval of devices.
The agency said that it would publish the full details of its action plan, which was only briefly summarized in the Nov. 29 announcement, within coming weeks.
The move by Canada’s health agency follows closely on calls by government regulators and consumer advocates in Europe are calling for stepped up measures to protect patient safety after the publication of the Implant Files.
The U.S. Food and Drug Administration also said on Monday that it would enact the “most significant modernization” in a generation of how the agency clears most medical devices for sale.
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Senior doctors, consumer groups and transparency campaigners are urging the European Commission to force the manufacturers of high-risk medical devices to make public all the evidence they hold on the safety of their products.
The calls come just days after the International Consortium of Investigative Journalists and its media partners published the results of their year-long investigation into the medical device industry, known as the Implant Files.
A new law for medical device regulation in the European Union was passed last year, and comes into effect from 2020. It sets data transparency as one of its main goals, but the Commission – which has been the subject of intense lobbying from the device industry – has told ICIJ it plans to withhold detailed information in order to protect manufacturers’ commercial secrets and to avoid scaring the public.
Commission officials are shortly expected to announce what information manufacturers must share with doctors, patients and the public concerning the tests that were carried out on their product before they were certified as safe for use in hospitals across Europe. Officials will also make clear whether manufacturers’ files on device malfunctions and patient injuries – know as “incident reports” – will be made public.
“Transparency… should only be restricted when it affects the privacy of patients and individuals,” said the Spanish General Council of Medical Colleges in a statement in response to the Implant Files. “Existing data should be made public by default, and be accessible and usable on the Internet.”
Professor Terence Stephenson, chair of the United Kingdom’s General Medical Council, who carried out a critical review of medical device regulation in the U.K. four years ago, said: “These data sets should be publicly available in a way that is unbiased and comprehensible.”
In his 2014 review, Stephenson highlighted the link between public data and public health, arguing that publishing injury and malfunction reports would “significantly improve the safety of devices by empowering patients and healthcare professionals and increasing scrutiny on industry and regulators.”It simply isn’t right or fair to have anything less than full transparency when it comes to the devices that are being used in healthcare. Professor Carrie MacEwen
In Sweden, Dr. Pia Caduff-Janosa, deputy director and chief medical officer of the Uppsala Monitoring Centre, said: “The same stringent regulatory principles for medicines should also apply for medical devices. But no regulatory process can be good enough without full transparency and open communication.”
It was a view echoed in France by Anne Chailleu, president of Formindep, an organisation that campaigns for independent medical information for patients. “Access to all existing data, along with the possibility to audit and analyze them independently from the manufacturer or the payer is key to protect the patients and citizens interests.”
Dr. Till Bruckner, founder of TranspariMED, a global initiative working to end evidence distortion in medicine, said: “Why do companies have to make public the evidence they hold on heart drugs, but not on pacemakers? This is absurd. Doctors and patients need access to the full evidence on all drugs, devices and treatments. The new EU regulation for medical devices will fail to deliver on this basic transparency principle.”Related articles
In the U.K., Professors Michael Griffin, President of the Royal College of Surgeons of Edinburgh, and Carrie MacEwen, Chair of the Academy of Medical Royal Colleges, argued that withholding detailed data on the safety of devices jeopardised patients’ ability to give informed consent to their doctors.
“It is impossible for a patient to give informed consent to experimental treatment technologies, when the full short- and long-term consequences are not fully known,” Griffin said.
MacEwen added: “It simply isn’t right or fair to have anything less than full transparency when it comes to the devices that are being used in healthcare. It’s also vital that patients are monitored after any device is fitted to ensure it is both effective and safe in the same way as patients are monitored for any adverse drug reactions.”
Monique Goyens, director general of European consumer group BEUC and a long-standing campaigner for better medical device safety, said: “Information such as when patients have been harmed … should be available to allow public scrutiny of a particular device. Patients must have transparent and timely information, and be able to rely on the fact there is real and strong market surveillance, to avoid future health scandals.”Reporters fight for medical device knowledge
Calls for data transparency come as ICIJ media partners across Europe continue to battle for more knowledge about medical devices using freedom of information (FOI) laws.
On Friday, documentary-makers from ICIJ’s Dutch TV partner Avotros are taking an FOI claim to court as part of their long-running efforts to obtain information about controversial medical devices from their national regulator.
Journalists are using freedom of information laws to try and discover what, if anything, Dutch regulators were told before a small trial of Nanostim – an untested, next-generation pacemaker – was started in patients in the Netherlands, Germany and the Czech Republic.
In European law, Manufacturers must give details of any medical device trial to the national regulator before a study can start. Journalists from Avotros want to discover what the Dutch regulator was told about the Nanostim trial, and arguments will be heard in court today.
The regulator has already said it would be happy to release information to the journalists, but U.S. manufacturer of the device, Abbott, has joined the case and claims any disclosure would be a breach of its confidence.
A recent study by another Dutch regulator found that 38 percent of trials were carried out in the Netherlands without proper notification to the local regulator.
Meanwhile, in France the national regulator this week refused to give journalists from Le Monde newspaper, an ICIJ media partner, information concerning medical devices. The regulator cited new European trade secret laws as the justification for its refusal to release copies of the documents requested. It is the first time these trade secret laws have been used in France to block a request made by a journalist. Le Monde is contesting the decision.
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Deutsche Bank’s Frankfurt headquarters have been raided by 170 German police officers and officials as part of a Panama Papers-related money laundering investigation.
The investigation is focused on whether Germany’s biggest bank helped clients set up offshore accounts to transfer money from criminal activities. Police and officials searched six of the bank’s offices, and have seized a number of documents, according to the prosecutor’s office.
The public prosecutor suspects two employees, aged 50 and 46 but not yet publicly identified, and other, as yet unidentified staff members may have been part of the illegal activities that involved 900 clients and transactions worth about $350 million.Related articles
Prosecutors said in a statement that Panama Papers and Offshore Leaks documents showed Deutsche Bank helped clients found offshore companies in tax havens, which were used to transfer money from criminal activity. Employees of the bank allegedly failed to report these transactions to authorities.
ICIJ’s German partners Süddeutsche Zeitung first reported on German banks’ alleged roles in money laundering in 2016.
The story was part of the Panama Papers investigation, a global collaboration of more than 370 reporters and 100 media outlets probing 11.5 million leaked files from offshore law firm, Mossack Fonseca.
Deutsche Bank issued a statement that said it had already provided authorities with “all the relevant information regarding the Panama Papers,” but that it would work with the prosecutor to “clarify the facts.”
“We will be issuing further details in due course. We are cooperating fully with the authorities,” the statement said.
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Government regulators and consumer advocates from Europe are calling for stepped up measures to protect patient safety, following the latest investigation by the International Consortium of Investigative Journalists into how lax medical device regulation allowed flawed devices to come to market.
German health minister Jens Spahn announced an overhaul of that country’s registry of medical devices in an interview with ICIJ partner newspaper Süddeutsche Zeitung.Related articles
“We will build an institution which is independent from industry, where all implanted devices need to be registered,” Spahn said, adding that the register will help inform patients about problems with implants and provide advice on the lifespan of devices.
“We are going to tighten the control in Denmark,” health minister Ellen Trane Nørby told ICIJ media partner, Danish Broadcasting Corporation, adding that her ruling party will increase funds for the Danish Medicine Agency.
She noted Europe-wide safety rules that will come into effect in 2020 but that have been criticized for keeping patients and doctors in the dark about implant safety but added that she couldn’t “rule out that we have to tighten the rules even further.”
Italy’s health minister, Giulia Grillo, thanked the Italian TV show and ICIJ media partner Report for its part in the investigation and announced an expansion of the existing medical devices registry. According to the new proposed rule, regional health bodies will be mandated to register all medical devices.
“Citizens must know that there will be no more tolerance on the opacity of the system,” Grillo said.
Spain’s College of Medicine called for a review of European regulations, according to ICIJ media partner La Sexta.
Spain’s nonprofit consumer advocacy group, Facua, criticized “the lack of notification” when a medical device is withdrawn. Implant patients “receive virtually no information” when a recall alert is issued, Facua said in a statement.
The parliamentary leader of France’s communist party, André Chassaigne, requested the creation of a committee to probe “the shortcomings in the control of medical implants,” according to a letter obtained by ICIJ media partner Le Monde.We will certainly take advantage of this moment to see how we can still do better with all players in the sector. Xavier De Cuyper, Belgium
In the United Kingdom, the Royal College of Surgeons said the investigation shows “urgent” and “drastic” changes are needed to protect patient safety, and called for a new register to be set up to track every device in every patient.
In Slovenia, ICIJ media partner, Oštro, reported that the national regulator announced for the first time its intention to publish safety notices online about medical devices.
Elsewhere, government agencies took advantage of the Implant Files to defend their safety records and to highlight the work they have already done.
“We will certainly take advantage of this moment to see how we can still do better with all players in the sector,” said Xavier De Cuyper, the general administrator of Belgium’s medical agency.
Continent-wide, the Greens Group at the European Parliament called for an “in-depth debate” in response to revelations of flaws in the way implants are approved.
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At ICIJ, we’re taking this day to celebrate our nonprofit newsroom and those who keep us running – individuals like you.
With our newly-released Implant Files investigation already having an impact, we’re reminded that the dedication and continued support of our readers are crucial to the success of our mission. Together, we can expose the truth, hold the powerful to account and change the world for the better.
That’s why we’re looking to expand grow our ICIJ Insiders community. Can you help us reach our goal of welcoming 100 new Insiders today? Add your name to this growing list and join a global community of people who, like you, believe in the power of investigative journalism.
Remember – it only takes a one-time gift of $35 or a monthly gift of $3 to become an Insider.
If you make this gift today, we will send you a brand-new ICIJ logo sticker and an Implant Files sticker. We hope you’ll use ICIJ’s latest swag to publicly stand up for independent journalism and proclaim your support of our work.
As we’ve shared, ICIJ is participating in NewsMatch this year, which means all individual donations are matched up to $1,000 through December 31. So by joining us today and helping us reach our goal, you’ll also have the opportunity to double your donation. Give now, at the same $35/one time or $3/month level, and you’ll help us in our sprint to add 100 new ICIJ Insiders and $25,000 in additional funds from NewsMatch.
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The U.S. Food and Drug Administration said Monday that it will enact the “most significant modernization” in a generation of how the agency clears most medical devices for sale.
The agency is focusing on a heavily used pathway for approval based not on human testing but on similarity to older approved devices. The news that the FDA is considering revamping the process comes a day after ICIJ and 58 media partners published findings from the Implant Files, a global investigation of the medical device industry and its governmental regulators that included detailed descriptions of problems that had arisen from that approval process.
FDA Commissioner Scott Gottlieb, announcing the changes along with the agency’s device chief Jeffrey Shuren, highlighted their historical significance. He also acknowledged that the substantial equivalence test, known as 510(k), has allowed new devices to be approved for sale based on their similarity to devices approved decades ago.Related articles
“We believe firmly in the merits of the 510(k) process,” said Gottlieb. “But we also believe that framework needs to be modernized to reflect advances in technology, safety and the capabilities of a new generation of medical devices. In short, we believe that it’s time to fundamentally modernize an approach first adopted in 1976.”
This substantial equivalence path to approval is just one of many areas of weak device oversight highlighted in a 12-month investigation by ICIJ and its global reporting partners. The investigation found that governments around the world hold even highly complex implants to a lower safety testing standard than most new drugs.
It also found that flawed devices can linger on the market for years as injuries mount. Apart from weak approvals, the investigation also found significant problems in the way safety problems are communicated by national regulators, device companies and doctors around the world. Device companies sometimes pull implants in some countries while continuing to sell them in others, the Implant Files investigation found. More than 200 patients with implanted medical devices told ICIJ and its partners that they were not warned of crucial risks of their devices or notified of recalls or safety alerts.
The FDA is generally considered to have the world’s most robust — if still imperfect — oversight of medical devices, resulting in device regulators in countries across the globe often following its lead on which devices to sell domestically. “Products that are harmful can spread across the world very quickly,” according to Carl Heneghan, a U.K.-based epidemiologist and director of Oxford University’s Centre for Evidence-Based Medicine. The 510(k) route has been widely identified as the weakest aspect of the FDA’s device approval standards and is alleged to have contributed to hundreds of thousands of defective devices being implanted in patients around the world.
Some of the largest global device controversies in recent years were rooted in that process. A variety of metal-on-metal hip implants, associated with a range of severe complications, were cleared through FDA’s substantial equivalence route, only to be removed from the global market years later amid grave safety concerns.
Sometimes after a chain of equivalence-based approvals, a new iteration of a device scarcely resembles the original version. Research published by ICIJ partner BMJ, traced the family tree of 61 surgical mesh products to two original devices approved in 1985 and 1996. None had completed clinical trials to win approval.
The FDA’s announcement addressed the distance in years between some devices from their predicates. Focusing on companies that clear new devices based on products more than a decade old, the proposal calls for encouraging companies to use comparisons to more recently approved devices when seeking approval through the 510(k) process. The agency also noted separate changes the agency has made to the 510(k) pathway in recent years.
Among the most concrete steps outlined in the announcement is FDA’s plan to create a website listing all devices approved based on a previous version more than a decade old. “It looks like what they’re trying to do is shame companies into using newer devices when they seek clearance in this pathway,” Dr. Michael Carome, the director of Public Citizen’s Health Research Group, told ICIJ.
Industry groups argue that the 510(k) route is necessary because devices are constantly being improved incrementally. From a practical standpoint, human testing doesn’t make sense in such cases, according to the industry.
AdvaMed, the main American trade association for medical device makers said that, in some cases, it is proper and safe to use older versions of a device to approve new ones. The group said that the FDA’s concerns regarding using older devices as predicates only applies to a minority of devices that have no demonstrated safety concerns. “The proposed 10-year cut off criteria could prove arbitrary as older predicates can offer extensive data about their performance, which helps sponsors introduce newer, safer devices,” the group said in a statement.
Despite the strong wording of the agency’s statement, Carome of Public Citizen said he doubts it will herald historic change to the FDA’s troubled approval process. As worded, the proposal does not call for any increase in clinical testing to win approval through this pathway, Carome noted. “The 510(k) process remains a fundamentally flawed approach to medical device oversight.”
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Government regulators, industry lobbyists and medical experts scrambled to get ahead of the International Consortium of Investigative Journalists’ latest investigation, the Implant Files, before the first word was even published.
Shortly before the first findings were due to be published, public safety organizations in both the United States and Europe announced new advice and renewed efforts to better protect patients.
ICIJ had sent questions to regulators around the world as part of the global investigation that found that failures to adequately test medical implants led to human harm — including injury and death.
Late last week, U.S. Food and Drug Administration Commissioner Scott Gottlieb issued a statement that committed his agency to a “more robust medical device safety net for patients through better data.”Related articles
The agency announced that its goal of “ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.”
Earlier today, Gottlieb’s “Sunday Tweetorial” thread was about the agency’s future reform goals on medical devices.
ICIJ and its media partners first contacted the FDA with questions about medical devices in September.
After receiving the ICIJ inquiries and 11 days before publication, the FDA issued an alert to doctors and patients about the risks of one of those devices, pain pumps.
Faulty pain pumps were just one of many devices analyzed during the 12-month long investigation by 250 journalists from 36 countries. The investigation looked at suffering that resulted from the marketing and implantation of a variety of devices, including breast implants, replacement hips, heart valves and others developed by the fast-growing $400 billion global industry.
The pain pump alert warned that the devices, which deliver medication into the spinal fluid, may have serious complications, including dosing errors and pump failure. The complications can cause opioid withdrawal and infection, as well as pain, fever, vomiting, muscle spasms, cognitive changes, weakness, and cardiac or respiratory distress. The alert noted that complications are “more frequent with the use of medicines not approved for use with the pump.”
The alert, which the FDA said was in response to reports from patients and doctors, also came one day after ICIJ informed the agency that its website had been modified to delete a sentence ICIJ had questioned about the safety and effectiveness of a popular pain pump.
On 20 Nov., the FDA also announced “new steps” for medical devices used by women, including mesh inserted to stabilize internal organs when pelvic muscles weaken, often after childbirth. Some forms of mesh have caused infection, pain, bleeding and other conditions requiring surgical intervention. It will convene an advisory committee meeting on the issue in February, the agency said.The FDA wasn’t alone
In Europe, France’s Society of Plastic, Reconstructive and Aesthetic Survey (SoFCPRE) announced last week that it “now recommends” against using textured “Biocell” breast implants manufactured by the French multinational, Allergan, because of “over-representation” in cases of a rare form of breast implant-related cancer, anaplastic large cell lymphoma. The announcement by the French organization followed months of reporting by ICIJ media partners.
Allergan told ICIJ that scientific evidence shows that its products are safe.
Hours after the announcement by the French surgeons’ group, France’s National Agency for the Safety of Medicines and Health Products (ANSM) announced that it too advised against textured breast implants, pending a review in 2019. On Nov. 23, two days after ICIJ’s media partners in France interviewed government officials for the Implant Files, ANSM also issued a call for patients and doctors to report “undesirable” consequences of vaginal mesh.
Dutch regulators acknowledged in response to questions from ICIJ and its partners that some manufacturers were not accurately reporting certain breast implant complications. A European taskforce has been convened to address the issue, regulators told reporters. ICIJ will publish the findings of its investigation into breast implants tomorrow.
In Spain, the Ministry of Health announced within hours of publication on Sunday that it would convene a meeting of health, science and patient organizations to discuss and respond to the findings of the Implant Files investigation.And from the private sector
The most explicit reaction to the impending publication of the Implant Files was a podcast interview with two top executives for the U.S. medical device trade group Advanced Medical Technology Association (AdvaMed).
AdvaMed’s CEO Scott Whitaker and head of public affairs Greg Crist discussed the upcoming ICIJ investigation, saying the organization had heard both from companies it represents and directly from ICIJ.
“When we heard of the questions, we realized it was something we should take seriously,” Whitaker told the podcast Pharma Intelligence.
AdvaMed said that it would “fight back with facts” against what the lobby group described as journalists with “a complete misunderstanding of the way the system works,” including using paid advertisements.
“We are bracing for a series of stories around the globe that casts the industry in a negative light,” Whitaker said. “It’s not just in the U.S….It’s in Europe, and it’s probably going to spread through Asia as well.”
“We’re going to push back,” Whitaker said. “And we’re going to push back really hard.”
Immediately following publication of the Implant Files, AdvaMed published a statement that claimed the project had overlooked the “overwhelmingly positive experiences of millions” of patients.
“Instead of a comprehensive look at both the challenges and the achievements of an industry that touches almost every human life, these stories counterfeit the life-changing and life-saving solutions delivered to billions of people worldwide,” AdvaMed wrote.
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Health authorities across the globe have failed to protect millions of patients from poorly tested implants that can sicken, maim — and sometimes kill — the people they were designed to help, new global investigation the Implant Files has found.
The International Consortium of Investigative Journalists, which previously produced the Panama and Paradise Papers investigations, partnered with more than 250 journalists in 36 countries to examine how devices are tested, approved, marketed and monitored.Related articles
Medical devices provide clear, even life-changing benefits in most cases, radically improving health and sometimes saving lives. But ICIJ’s reporting raises questions about whether the device industry is needlessly putting patients at risk of serious harm in its quest for profits.
The investigation has found that even complex, high-risk implants are held to a lower safety testing standard than most new drugs. Flawed devices linger on the global market unrecalled as injuries mount. Under a free-for-all system, device companies pull implants in some countries while continuing to sell them in others.
Anchoring the probe is an analysis of more than 8 million device-related records, including death and injury reports and recalls. To increase transparency and to provide information around the world where such information is scarce, we have built the world’s only publicly searchable global database of recalls and safety warnings. The International Medical Devices Database includes 70,000 records from 11 countries, and will be updated with data from more jurisdictions in the coming weeks.
Among the findings of this year-long investigation into the regulation of devices that touch billions of lives:
- More than 1.7 million injuries and nearly 83,000 deaths suspected of being linked to medical devices over 10 years, and reported to the U.S. alone
- Governments in dozens of countries in Africa, Asia and South America don’t regulate medical devices at all, instead placing their trust in approvals by European authorities or the U.S. Food and Drug Administration.
- Manufacturers have paid at least $1.6 billion since 2008 to settle charges of corruption, fraud and other violations with regulators in the U.S. and other countries, according to an ICIJ review of data from the U.S. Justice Department and the Securities and Exchange Commission.
- The global team made more than 1,500 Freedom of Information requests for access to government-held records, and spoke to hundreds of patients around the world.
- Doctors and manufacturers often fail to report adverse events, and when they do, the information can be unverified and incomplete. Over large swaths of the planet, health authorities refuse to disclose information about harm to the public — or just never collect it in the first place.
- Using a machine learning algorithm to search millions of reports, ICIJ found 2,100 cases where people died, but their deaths were classified as device malfunctions or injuries only. Of these, 220 reports indicated that devices may have caused or contributed to the deaths.
- Whether a product is recalled or restricted may depend on where you live. Experts told ICIJ that governments should publicly 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 have only shared information on two issued recalls ever. In the U.S., the FDA has published more than 26,000 recalls in the last decade.
- The EU has borne the brunt of many of the world’s worst implant scandals, unnecessarily resulting in patients scarred, injured or in permanent pain, or even dead. Leading surgeons, regulators, lawyers and patient advocates have said Europe’s approach treats its citizens “like guinea pigs.”
- Responses from regulators in 19 European countries — responsible for the safety of more than 85 percent of EU citizens — to an ICIJ request for the raw numbers of reported malfunctions, injuries and deaths show a steep rise in incident reports over recent years.
The Implant Files investigation builds on reporting in the Netherlands by Jet Schouten, an investigative journalist for Dutch Public Broadcasting, which was part of the international team that included 58 media partners.ICIJ’s new investigation i Christina Chung / ICIJ
Even before our first stories were published, after receiving questions from ICIJ, regulators in the U.S. and Europe announced policy changes and renewed efforts to protect patient safety
ICIJ and its partners will release more findings in the coming days, including reporting on the hidden dangers of breast implants, a new heart valve device that may be risky for younger patients, and the often excruciating experiences of people living with broken medical implants that can’t be removed from their bodies.
ICIJ and its partners welcome more information from whistleblowers, insiders and patients to help us continue our reporting and expand our data. Please contact us via this form or any of these secure platforms.
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Supporters of one of Russia’s last independent media outlets have raised enough money to pay a court-imposed penalty widely seen as politically motivated.
On Tuesday, International Consortium of Investigative Journalists member Yevgenia Albats said she had received more than $373,000 in donations — well beyond the fine imposed by a Moscow court in October.
“We’ve done it!!!!!! Thanks to everyone!!!!!” Albats tweeted earlier in the day.
The court fined Albats and the online magazine The New Times more than $340,000 for allegedly failing to report donations received from readers submitted via the nonprofit Fund in Support of Freedom of the Press. The fine represents one year’s operating costs.
Albats, The New Times’ editor-in-chief, told ICIJ she believed most donations came from Russian citizens and were exempt from Russia’s so-called “foreign agents” law that would have required the news organization to disclose foreign donations.Russian businesses are afraid to give us ads, because any association with an opposition magazine implies that they are not exactly loyal to Putin Yevgenia Albats
“I wasn’t surprised by the fine, because I know the punitive nature of the regime, which is run by a KGB operator,” Albats told ICIJ. “I’ve been writing about the KGB my entire life, so I know the guys.”
Russia introduced laws in 2012 that required organizations to register as foreign agents if they receive foreign money and are engaged in loosely-defined “political activity.” Human rights, LGBTQI and environmental associations were among those hit with fines and other penalties for failing to do so, according to Human Rights Watch. Russian authorities extended the law to media outlets in 2015.
Since then, Russia has further restricted the freedom of independent media. Last year, Russia’s parliament approved measures to force news organizations that receive non-Russian funding or are based outside Russia to file regular reports and identify themselves as foreign agents.
The foreign agent laws make it difficult to find local financial support, Albats said.
The New Times is now available online only after it suspended its print edition and closed its office last year due to financial difficulties.
“Russian businesses are afraid to give us ads, because any association with an opposition magazine implies that they are not exactly loyal to [president Vladimir] Putin,” Albats said.
“All of them are afraid there will be all kinds of punitive action.”
The New Times is one of the only remaining independent political publications operating from inside Russia.
“I don’t believe in long-distance political journalism,” Albats said. “ I believe you have to share the risks with your readers, especially when it comes to such a harsh regime as the one we have in Russia.”
Russia’s recent measures are part of a “foreign agent” tit-for-tat between Russia and the U.S.
The U.S. intelligence community’s January 2017 assessment of election interference described the news channel RT, which broadcasts within the U.S., as “the Kremlin’s principal international propaganda outlet.” The Department of Justice, which monitors foreign lobbying within the U.S., later ordered RT to register as a foreign agent.Related articles
“Over the last five years, the Kremlin has adopted a bunch of laws against independent media and, of course, the foreign agents law was one of them,” said reporter and ICIJ member, Roman Anin. “With this law, they can close any media in Russia.”
Anin said he believes Russian authorities want to implement further laws that would allow individual journalists to be classified as foreign agents.
“That’s what happening in Russia. And The New Times’ case proves that it’s going to worsen.”
Albats told Human Rights Watch that it appears that authorities fined The News Times in retaliation for an interview with opposition politician and Kremlin critic, Alexei Navalny. Albats, who also hosts a popular radio program, aired the interview four days before the court’s decision.
By Tuesday, donations from Russian readers smashed through the amount required to meet the fine.
Albats said she will appeal the decision but knows that this may not be the end.
“We have a saying here in Russia: Do what you must and come what may.”
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Now for something a bit different… in celebration of it being one year since we released the Paradise Papers.
It’s not every day a poem is written about a global investigation. So when we learned that University of British Columbia professor Philip Resnick had penned one about the Paradise Papers, we had to get a copy.
Professor Resnick told ICIJ he writes a number of political poems.
“This one spoke to the shared concern I have with your journalists regarding the rampant inequality and tax evasion that characterizes the global system.”Related articles
However, the professor said he feared his “bleak evaluation” had been borne out with the top 1 to 5 percent continuing to “rule the roost.”
“Countries like the United States have gone even further down the road of inequality,” he said, noting the “hefty tax cuts voted this past year.”
“Still, it is important to keep sounding the alarm about fiscal paradises and tax evasion and publicize some of the more egregious examples that can be uncovered.”The Paradise Papers
“Not Ceaser now, but money, is all.”
— Alain de Lille, 12th-century monk
So the Fourth Estate has come to our rescue,
telling truths about power
That the powerful only whisper to themselves.
Will it change an iota
now that we know the feints and subterfuges
by which fortunes can escape
the gatekeepers meant to keep
the ship of state afloat —
where rock stars rub shoulders with royals,
political fundraisers with CEOs,
in the game of tax evasion and high finance?
Age-old suspicions will be confirmed,
a few indignant voices will be stirred,
as the masters of the universe carry on undeterred
in worshipping the deity that reigns on earth.
ICIJ has hundreds of members across the world. Typically, these journalists are outstanding in their countries and have won many national and global awards. Our monthly series, Meet the Investigators, highlights the work of these tireless journalists.
This month, we speak to Miranda Patrucic, from Bosnia, who has worked with the Organized Crime and Corruption Reporting Project since it began in 2007. Currently, she works in central Asia and Azerbaijan, where she develops investigative reporting by training and working with young reporters. She has been recognized by numerous awards, and in 2016 won the Knight International Award for Life Achievement. Follow her on Twitter here.You have worked on so many projects exposing corruption in some of the most repressive countries in the world. What was your favorite investigation?
It’s hard to pick an all-time favorite. Every story in each investigation has been a growing and learning experience for me and brought me forward personally. A turning point in my career was certainly the collaboration with ICIJ on the tobacco smuggling project. I did the reporting on the prime minister of Montenegro, and this brought me into the world of cross border investigations.
When I worked on Panama Papers and covered the gold mining empire of the Aliyeva family, this story turned out to have a major impact. It was fascinating to bring the complex network of offshore companies to life for the audience. Every story I worked on was a turning point and changed the way I see journalism. All of them were challenging and difficult but at the same time rewarding.Related articles What are the challenges you face in your daily job?
With the kind of investigations we do, projects about corruption and money laundering, for example, we often expose wrongdoing by the most powerful people in the world. We need care to develop sources, handle dangerous situations, deal with threats and parry attacks by the government.
I see every story I do as a way to challenge myself to do something I have never done before. I can never say: I know how to do the next story, it’s easy, because it’s not. With the last investigation, the Paradise Papers, the storytelling, for example, was challenging. How do you make these stories interesting to read for people — not only the difficult-to-understand offshore companies — but how do you show the ways in which it affects the lives of people? There are new challenges with each new project.What is the situation for media organizations in the countries you work in?
I do a lot of work in Central Asia, large parts of which are ruled by dictators. There are no investigative reporters in those countries, or they are jailed. Our role is not to be critics of the governments — our job is to report about what they try to hide.
If you lose journalists, you lose freedom. People then have no way to find out what’s true. We see more and more countries in which media are bought up by people close to the government. When the majority of people in a country only have access to media controlled by the government, the public doesn’t have anybody to hear the truth from. They only get propaganda.
If powerful people with government ties buy the media, they can make them [the media] say whatever they want, and cover whatever the owners want. That’s not the only problem journalists face. In many other countries, newsrooms are hemorrhaging. We need to change the laws in order to prevent people from destroying journalists financially by suing them. We need to get people to understand that journalism is public good. We are a watchdog.With all the recent attacks and murders of journalists – do you feel more threatened?
I think we are just waking up! Of course I have dealt with threats during my career, I received the first death threats seven years ago. It’s something that can happen to anybody, and I think many of us are dealing with it in silence. We journalists are an endangered species. We are more and more vulnerable. It’s a terrifying thing. We need to speak more about it. Often the public is not aware of the difficulties we face. We need to educate people to care about us. As journalists, we actually do have power. We are not only casual viewers, we can make a difference and send a clear message about what we stand for.If you could give young, aspiring journalists one tip, what would it be?
Never think you can’t do what it takes! We have all these threats we have do deal with, if you don’t believe you can get a document, or you can get a person to speak, you’ll never do it. Believing in yourself is the strongest message you have! When I was first starting my editor used to tell me: “Go get the miracle.” I live by those words. Every story you do has a miracle in it!What was the biggest lesson you learned?
The lessons I’ve learned are the mistakes I have made, and that’s what teaches you you’re human. We are all humans. We are not those incredible people who are seemingly perfect to young people who want to become journalists. Our job is about constant learning. My first project with ICIJ was on tobacco smuggling, then we did work on tax evasion and money laundering, among other things, and after that we looked into illegal medicine. We have to become expert in each single domain, so don’t be afraid to become experts. Be open and ready to learn about things, including safety: Learn about physical threats, but also learn to keep your data safe with encryption, for example. You never know when to get a sensitive source, it just might happen. If you are reckless, you can endanger that person and yourself. This is a risky job. We need to be aware of the risks, not only for ourselves, but also for our sources.What do you like about investigative reporting?
Very often back in Sarajevo, when a member of our team or I found a crucial piece of evidence that shaped a story, it would make me scream in excitement. This is the moment I live for. I have given my heart to this work. All investigative journalists should experience that moment and have fun. It is the most fun reporting job!
From the ongoing fight for press freedom and unjust imprisonment of colleagues to the latest investigations and podcasts, the Uncovering Asia 2018 conference covered vital ground.
The conference, attended by more than 400 journalists and hosted by the Global Investigative Journalism Network, the Korea Center for Investigative Journalism (Newstapa) and the Konrad-Adenauer-Stiftung, aims to help reporters develop skills, create networks and support watchdog journalism.
All of ICIJ’s favorite journalism topics (and quite a few of our members) were prominently featured, from accountability journalism to data analysis, source protection and cross-border collaboration.
These highlights are but a snippet of GIJN’s comprehensive coverage of the three-day event in Seoul earlier this month.
— Tanya Pampalone (@tanyapampalone) October 5, 2018Tell the story that needs to be told
That’s one idea from a group of reporters who face threats in their day-to-day work. ICIJ’s Pakistani member Umar Cheema was kidnapped and tortured in 2010 after writing articles critical of the country’s military, but instead of allowing the attack to silence him, he spoke out about his ordeal and stood by his reporting:
“I did a good job! It was worth it!” he told the crowd. “They didn’t want me to talk about what they did. But that was the first thing I did afterwards. Otherwise, they would have threatened me over a lifetime.”
They have six tips basic protection measures against threats and harassment.Related articles More investigations to check out
This list wouldn’t be complete without a callout to the other great investigative projects going on right now. Our top pick is from ICIJ’s Korean partners, Newstapa, who recently exposed the world of fake scientific conferences.
You can also read our wrap of the #FakeScience investigation here.Tips from the pros… for everybody!
I would recommend this one, about how to start an investigative podcast. Maybe ICIJ can follow it soon!Radiation levels (data) in Tokyo
It all started with the tuna fish, said Yoichiro Tateiwa, the executive editor of Japan Center for Money and Politics.
Tateiwa used United States government data to expose the ionizing radiation levels for Tokyo on the day of the 2012 Fukushima disaster. The Japanese government still disputes his findings, despite being presented with the data. “It is amazing what data can tell you,” he told the conference audience.
You can also read his full report here.Music for your ears, and information too
Here are three podcasts you “need in your life” according to the experts from Uncovering Asia. We’ve added all three to our playlist!Security for you, me, and our sources
Digital security expert Chris Walker has four handy (and relatively easy) tips for anyone wanting to protect themselves online.Tracking China
Clearly, this one piqued the interest of many reporters…
— Khairil Yusof (@kaerumy) October 5, 2018
And why wouldn’t it? Chinese investments reach all corners of the globe, so these tips and resources on how to track them and ‘follow the money’ are invaluable.‘Responsibility is bigger than fear’
With this message Malaysian cartoonist Zulkiflee Anwar Ulhaque, aka Zunar, encouraged a room full of reporters to “keep fighting” for freedom of expression.
He also seemed popular with the crowd…
— Devjyot Ghoshal (@DevjyotGhoshal) October 6, 2018Journalism is not a crime
As we’ve reported, the world is an increasingly dangerous place for journalists. Two Reuters reporters Wa Lone and Kyaw Soe Oo were jailed in Myanmar earlier this year. Prosecutors have used a rarely invoked the Official Secrets Act to charge them with obtaining documents relating to the Rohingya persecution crisis.
Conference attendees called on governments across the world to fight for their freedom.
Nearly 440 journalists from 45 countries called on the Myanmar gov’t to immediately free Wa Lone and Kyaw Soe Oo, two brave Reuters reporters unjustly sentenced to 7 years in prison for “simply for doing their crime of exemplary reporting” on Rohingya mass killings #IJAsia18 pic.twitter.com/PjLg1MNuoA
— Feona Imperial (@FeonaImperial) October 6, 2018
The post Data analysis, accountability and a little humor: The best of Uncovering Asia 2018 appeared first on ICIJ.
As a nonprofit organization, the International Consortium of Investigative Journalists relies on donations to support our investigative journalism. This series provides a regular update on who our major donors are and why they choose to support us. If you have questions or would like to learn more about donating to ICIJ, please contact us.
Now is the time to support independent, investigative journalism like ours. Join ICIJ Insiders, our global community of supporters, and you can make your impact go twice as far.
During NewsMatch, the largest grassroots campaign for nonprofit news that runs from November 1 to December 31, if you start a monthly donation (that also helps us be sustainable), it will be matched at its annual value.Related articles
So, your new $15/month donation will be automatically matched with a $180 donation.
For these reasons, we ’re honored to participate in NewsMatch to raise important funds for nonprofit news outlets.
Like last year, NewsMatch will match, dollar-for-dollar, all individual donations up to $1,000 between November 1 and December 31. In total, we have an opportunity to raise $25,000 in matching funds to boost our year-end fundraising efforts.
And if you join as a monthly donor, even for as little as $3/month, you will be part of our ICIJ Insiders community. ICIJ Insiders receive benefits, like a quarterly newsletter and sneak peeks of our behind-the-scenes stories. (More information on the Insiders program can be found here).
Our monthly donors are critical to ICIJ’s long-term sustainability. Monthly gifts represent a revenue stream that is reliable and predictable. Those donations keep us going year round, so we can pursue the deep dives and in-depth reporting that can take months of even years, of work.
“I trust you and rely on your work, to understand how and why our democracy is in danger right now,” one ICIJ Insider told us when they joined.
They allow us to maintain the strong team of reporters, editors, researchers, data analysts and developers that are behind unprecedented global investigations, like the Paradise Papers, and regional investigations, like West Africa Leaks.
As a nonprofit, we rely on support from readers like you to pursue fearless, independent journalism. And this work is needed now more than ever. Won’t you join us and stand up for journalism that exposes the truth and holds the powerful to account? There is no better time than during NewsMatch to start a monthly gift or support us with a one-time donation.
NewsMatch is made possible through the support of the Democracy Fund, the John S. and James L. Knight Foundation, the John D. and Catherine T. MacArthur Foundation, the Jonathan Logan Family Foundation and others.
The post Meet the Funders: Double your impact with NewsMatch 2018 appeared first on ICIJ.
More than 10 years ago, the first non-profit investigative journalism in Africa was established. Following this development, more nonprofit investigative journalism organizations have been set up in more than 20 countries throughout the continent. And that number continues to grow.
The question now is, what are the motivating factors behind the proliferation of these organizations on the continent? Who is funding them and how? Are these organizations making an impact in Africa? Over a period of six months, during my fellowship at the Reuters Institute for the Study of Journalism at the University of Oxford, I studied these organizations and found that, at a time when traditional media organizations in Africa are increasingly failing to hold power to account, it is the nonprofit organizations that are coming to the party, setting an agenda and scrutinizing those in power more than ever before.
In South Africa, the amaBhungane Center for Investigative Journalism, an organization made up of about 10 reporters, helped take down a sitting president. In Nigeria, the not-so-well-funded Premium Times Center for Investigative Journalism has exposed graft in government which led to the arrests of senior figures both in government and the military. And in Botswana, the INK Center for Investigative Journalism, an organization formed by frustrated reporters — of which I’m one — has exposed incidents of corruption and human rights violations in a country often lauded as “Africa’s shining example of democracy.”
Although I studied a dozen other nonprofit investigative journalism organizations in Africa, my focus was mainly on those three.
After studying them, I put together 14 recommendations to help nonprofit investigative journalism in Africa thrive, defended and protected by both donor organizations and nonprofit organizations. This is essential to ensure that these vulnerable organizations continue to hold power to account and also to serve the public effectively.Invest in nonprofit start-ups A major problem for investigative journalism in Africa is the lack of financial backing and seed stage funding.
Where are homegrown good-hearted donor organizations when journalism needs them the most? Philanthropic and donor organizations, in Africa in particular, should be encouraged to come on board and invest in nonprofit investigative journalism. Nonprofits organizations should reach out to credible donor organizations in Africa to complement funding from organizations such as the Ford Foundation, the Open Society Foundations and the MacArthur Foundation.Readers should be made to either pay or subscribe to have access to at least certain investigative stories and certain times
With the exception of organizations such as amaBhungane in South Africa, almost all nonprofit journalism organizations rely on foreign donors for survival. Relying solely on international donor organizations may be problematic in the long run. Simply put, this is not sustainable.Increase funding and commitment
Are donors in it for the long haul? International grant-making organizations supporting investigative journalism in Africa should consider multi-year funding. According to amaBhungane’s Stefaans Brümmer, this will reduce the administrative burden on both sides and will also give greater insulation from what can be called “passive editorial interference” when funders don’t replicate funding if they don’t like the editorial line a grantee has taken. Secondly, it allows grantees to put in place long-term strategic goals for the organizations. Nonprofits need an unwavering commitment from the donors to commit to serving the public.Increase the number of nonprofit journalism organizations
Grant makers should offer financial support to nonprofit investigative start-ups on the continent. The nonprofit phenomenon is growing in Africa, but the major problem at the moment is lack of financial backing. Most African investigative journalists interviewed in the study have expressed their willingness shift from for-profit to nonprofit journalism to protect their independence and produce investigative journalism in the public interest. The major hurdle is the seed stage funding.Diversify donors Investigative journalism media should consider a grassroots funding model or putting up paywalls to encourage citizens to support their work.
It is unhealthy and dangerous to have one donor contributing more than 50 percent of an organization’s annual budget. Organizations should diversify donors and ensure that at least one donor contributes less than 10 percent to their annual budget. Of course, it is difficult, but it can be done. This is important to allow the organization’s program to continue in the event that one funder pulls out. Having more donors will also give organizations a fair level of independence from the donors themselves.Build up a grassroots funding model
What are you waiting for? Let the public fund your work. While this may not be attractive to some organizations (see the full study for reasons), it is important that nonprofits encourage citizens to support investigative journalism by making regular monetary contributions. AmaBhungane received around 19 percent of its annual funding from crowdfunding in 2017 alone. Other organizations can replicate this. This model may not provide enough funding to the organizations, but it remains important and at times more efficient than traditional fundraising activities.Related articles Put up that porous paywall
This is controversial. Most nonprofit investigative journalism organizations shun the idea of a paywall and would prefer to give away content for free. However, the reality is that nonprofits spend lots of money producing top-grade investigative stories, only to receive no monetary benefits from their work. Readers should be made to either pay or subscribe to have access to at least certain investigative stories and certain times. Also, nonprofit organizations should find innovative ways to generate revenue apart from donors.Engage professional fundraisers
Fundraising is important for the survival of nonprofits. But it is tough, and depressing at times. Nonprofits in Africa should engage professional fundraisers to handle their fundraising activities. Fundraising in most organizations in Africa is handled by journalists who are, in most cases, unqualified to enter into the fundraising terrain.Investigative journalists are not managers
Nonprofit organizations in Africa are started by journalists who immediately assume positions of leadership. In most cases, they juggle between editorial and administrative duties and this can affect the smooth running of the organizations. These organizations should engage managers to oversee the centers and allow journalists to concentrate on the editorial side of things. Alternatively, journalists managing these organizations should undergo rigorous management training.Create an endowment fund for the continent “With six journalists, amaBhungane was able to produce groundbreaking investigative work that helped to take down a sitting president.”
Grant makers or donor organizations and nonprofit organizations should consider creating a continental endowment fund managed by distinguished Africans, with donors having representation. The fund should be formed with a clear mandate of supporting the work of nonprofit investigative reporters and their organizations, including capacitating nonprofit organizations on issues of sustainability, personal and data protection, ethical and professional standards, as well as protecting nonprofits from external threats such as litigations, harassment and imprisonment.Country-to-country collaborations
African nonprofit investigative journalism organizations should collaborate more to hold those in power accountable. International journalism organizations like the International Consortium of Investigative Journalism (ICIJ) have done much to foster the spirit of collaboration among African journalists. In particular, ICIJ has worked well with African journalists on projects such as Fatal Extraction, Panama Papers and the Paradise Papers projects that looked at illicit financial flows. To augment this, there is a need for internal homegrown collaborative efforts on issues such as poaching, human trafficking, terrorism, the refugee crisis and many others.Break it down
Most high-quality investigative stories by organizations in Africa reviewed in this study were not appealing to the ordinary person on the street. The public find them too long, complicated, convoluted to comprehend and at times abstract. Organizations should consider ways of breaking down long stories into shorter stories that are easier to understand. They can do this through audiovisuals, graphics, cartoons and even comedy.Ditch newspapers, go online High-quality investigative stories by African media can be convoluted and unappealing to the public; stories need to be packaged better.
Nonprofits work closely with other organizations such as newspapers, TV and radio stations, in addition to regular social media. INK, amaBhungane and other nonprofit organizations have memorandums of agreement with news organizations to provide them with content. This is not sustainable because newspapers are no longer setting the agenda due to a decline in circulation.
Besides, these legacy media organizations are not willing to pay for content. Nigeria’s Premium Times has demonstrated that it is possible to publish content online, build a loyal base and create lasting impact. Nonprofits should take all their content online and not share it with newspapers in order to build their own bases.Keep it small, but efficient
Nonprofits are not meant to be big organizations because they operate on a shoestring budget. While this may appear to be a major disadvantage, smaller organizations are easy to manage. A fully fledged investigative center should not have more than 10 editorial staff. With six journalists amaBhungane has been able to produce groundbreaking investigative work that eventually helped to take down a sitting president.Stay on the story — we don’t trade in scoops
Scoops are the currency of mainstream journalism, not investigative journalism. Investigative reporters are journalists, and often times there is a temptation to follow the story of the day and compete with the mainstream media. This study recommends that it is important for nonprofits to leave breaking stories to those in the business of trading in scoops and focus on connecting the dots and holding those in power to account. This is important not only because it builds credibility but saves time and costs as well.
Ntibinyane Ntibinyane, from Botswana, is a member of International Consortium of Investigative Journalists. He wrote the following piece for the Global Investigative Journalism Network, it’s republished here under Creative Commons.
The post Want to change how investigative journalism is done in Africa? Here are 14 recommendations appeared first on ICIJ.