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Ethicon Media Monitoring 12/17/2018
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Uncovering the implants scandal: 'the lack of transparency is shocking'
Dec 15, 2018 | The Guardian
By Hilary Osborne and Hannah Devlin
It began with an orange bag and ended in health authorities around the world pledging to look at the way medical devices are regulated. -
J&J shares plunge 10% after report that the company knew for decades about asbestos in baby powder
Dec 14, 2018 | CNBC
By Angelica LaVito
Johnson & Johnson knew for decades that its baby powder contained asbestos, Reuters said in a new report that drove the company's shares down more than 10 percent Friday. -
The Bleeding Edge: a terrifying, enraging look at the corrupt, deadly world of medical implants
Dec 15, 2018 | Boing Boing
By Cory Doctorow
Prior to 1976, the FDA did not regulate medical implants, and so shoddy and even deadly devices proliferated, inserted into Americans' body.
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Uncovering the implants scandal: 'the lack of transparency is shocking'
Dec 15, 2018 | The Guardian
By Hilary Osborne and Hannah Devlin
It began with an orange bag and ended in health authorities around the world pledging to look at the way medical devices are regulated. The Implant Files investigation we were involved with has taken months of work but has already had an impact which will, we hope, last long into the future.
Since spring we have been exploring the world of medical devices, working as part of an international team coordinated by the International Consortium of Investigative Journalists (ICIJ). We have ploughed through pages and pages of court documents and data released through freedom of information requests, spoken to surgeons and specialists around the world, and heard – often heartbreaking - stories from those who have suffered when things have gone wrong.
The project was the latest in a long line of collaborations that the Guardian has worked on with ICIJ, a group that brings together media organisations around the world. This time more than 250 journalists from 58 news organisations were involved, including the BBC and the British Medical Journal (BMJ) in this country, and Le Monde, Canada’s Toronto Star and the Associated Press in America.
Unlike the most recent ICIJ investigations, the Implant Files did not involve a leak of information – instead it started with a pitch from a Dutch journalist, Jet Schouten, who four years ago made a documentary revealing how easy it was to get a medical device approved. Armed with an empty mandarin net from a supermarket and a file of made-up data, she was able to impress the organisations that approve devices almost to the point of gaining approval to sell the net as vaginal mesh.
Following the Guardian’s award-winning stories about the problems caused by mesh, joining in with the collaboration was an easy decision. Those stories had exposed some of the problems with the system, and this gave the chance to look at the wider industry.
Working as part of an international team allowed us to follow stories across borders. Thousands of documents released to our French partners at Le Monde revealed how the industry had lobbied against forthcoming changes designed to toughen up the rules across Europe. Analysis of data from the US regulator, which included manufacturers’ reports, allowed us to see what devices were causing the most problems around the world.
Reporters across the world were interested in problems with breast implants and we had regular conference calls to exchange information. We heard of the scale of the problem, of research papers and investigations by clinicians in other countries, and of the way regulators were responding to concerns. And we shared what we had learned from experts and patients in this country.
Some aspects of the investigation were less straightforward – although the medical devices industry is global, with many of the makers huge companies sending products into many different countries, there are quirks. In the UK we were unable to uncover figures that were available to colleagues in other countries. Different products are popular in different places, so some of things of great interest to other partners were not things we chose to cover from the UK.
As UK reporters we have been shocked by the lack of transparency. FOIs have been turned down on the basis of commercial confidentiality, requests to press offices for details of how devices were approved or why approval had been withdrawn have met with similar responses. The NHS’s labyrinthine structure has made it impossible to get facts and figures about the cost of clearing up once a device has gone wrong.
Luckily, what we were able to get out of regulators was turned into something meaningful by the Guardian’s data editor, Caelainn Barr, who worked with us on the project. We were able to publish new figures showing the large number of reports being sent to the UK’s health watchdog, and what the most common issues were.
Reporting patients’ experience was key, and we are indebted to everyone who told us their stories. Since we wrote, more than 240 people have responded to a call-out, telling us of their experiences with faulty devices. Some of the stories are heartbreaking; many involve years of pain and struggles to get problems put right.
Throughout the investigation we dug into the evidence behind claims made by device companies, doctors and patients. We did not want to cause unjustified alarm among our readers, and so carefully chose the devices we focused on and did everything we could to make sure our reporting was measured and responsible.
As we counted down to the day when the first stories were going to go live, there was a big announcement from the US regulator. On the Friday before we published, and following weeks of questions from the ICIJ and partners, the FDA said it would be overhauling its approval process. It said it had planned the change for some time.
After we went live in Canada, our partners at the Toronto Star were able to proclaim an “implants crackdown” on their front page, after the country’s health minister asked its regulator to speed up improvements. In Germany, our partners at Süddeutsche Zeitung won a promise from the country’s health minister that the government would set up a new register of all implanted devices.
Researching the problems with medical devices is not for the squeamish. Some of the photos we’ve seen and descriptions we have read and heard have made us shudder. But more shocking was how hard it is to get information about the industry – not just as a patient, but as a journalist too. The investigation has led to the creation of the International Medical Devices Database, hosted by the ICIJ, which we hope will prove a small step towards patients being able to make informed, evidence-based decisions about treatment. We also hope that by continuing to tell these stories we will help keep up the pressure for more transparency and better access to data for everyone.
https://www.theguardian.com/membership/2018/dec/15/medical-implants-scandal-project-lack-transparency-shocking
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J&J shares plunge 10% after report that the company knew for decades about asbestos in baby powder
Dec 14, 2018 | CNBC
By Angelica LaVito
Johnson & Johnson knew for decades that its baby powder contained asbestos, Reuters said in a new report that drove the company's shares down more than 10 percent Friday.
Reuters based its report on a review of documents and deposition and trial testimony. It said the review showed that from 1971 to the early 2000s, J&J executives, mine managers, doctors and lawyers were aware the company's raw talc and finished powders sometimes tested positive for small amounts of asbestos. Those involved discussed the problem but they did not disclose it to regulators or the public, Reuters' examination found.
The company released a statement Friday calling the Reuters article "one-sided, false and inflammatory."
"Simply put, the Reuters story is an absurd conspiracy theory, in that it apparently has spanned over 40 years, orchestrated among generations of global regulators, the world's foremost scientists and universities, leading independent labs, and J&J employees themselves," the company said in a statement.
Reuters stands by its reporting, a spokeswoman told CNBC.
The company has faced thousands of lawsuits alleging its talc baby powder products contain asbestos and caused ovarian and other cancers. Some juries have sided with J&J and others have been unable to reach verdicts. A Missouri jury in July ordered J&J to pay $4.69 billion in a case involving 22 women and their families. A judge affirmed the verdict in August, and J&J vowed to appeal it.
J&J has filed thousands of documents in court proceedings, though most have been designated as confidential.
By Friday's close, J&J stock had fallen 10.04 percent, its worst day in more than a decade, when its shares closed down 15.85 on July 19, 2002. The stock dropped as much as 11.9 percent Friday.
On top of likely being the stock's biggest drop since 2002, the plunge was likely a shock for shareholders used to a boring consumer staple that moves in much steadier increments than the overall market and more volatile stocks. J&J's stock beta over the last five years is 0.72, meaning that it swings much less than the market on a daily basis. A beta of 1 would mean it moves equal to the market and greater than 1 means it is more volatile than the S&P 500.
J.P. Morgan analyst Chris Schott in a note to clients said the price drop Friday was an "over-reaction, especially from a longer-term perspective" because J&J's exposure to the talc legal risk probably won't come close to the roughly $40 billion in market cap J&J lost Friday.
"At the same time, talc does not seem to be an issue that is going to resolve quickly for JNJ and we would expect shares to trade at a lower multiple pending further clarity on the company's exposure to this issue (which could be an extended period of time)," Schott wrote.
J&J has also faced nearly 54,000 lawsuits against its pelvic mesh for allegedly causing injuries and complications. Citi analysts in a note to clients said that despite the large amount of cases, it estimates the total liability has cost J&J roughly $5 billion.
Read J&J's full statement below:
"The Reuters article is one-sided, false and inflammatory. Simply put, the Reuters story is an absurd conspiracy theory, in that it apparently has spanned over 40 years, orchestrated among generations of global regulators, the world's foremost scientists and universities, leading independent labs, and J&J employees themselves.
Johnson & Johnson's baby powder is safe and asbestos-free. Studies of more than 100,000 men and women show that talc does not cause cancer or asbestos-related disease. Thousands of independent tests by regulators and the world's leading labs prove our baby powder has never contained asbestos.
J&J attorneys provided Reuters with hundreds of documents and directly responded to dozens of questions in order to correct misinformation and falsehoods. Notwithstanding this, Reuters repeatedly refused to meet with our representatives to review the facts and refused to incorporate much of the material we provided them.
The Reuters article is wrong in three key areas: The article ignores that thousands of tests by J&J, regulators, leading independent labs, and academic institutions have repeatedly shown that our talc does not contain asbestos. The article ignores that J&J has cooperated fully and openly with the U.S. FDA and other global regulators, providing them with all the information they requested over decades. We have also made our cosmetic talc mines and processed talc available to regulators for testing. Regulators have tested both, and they have always found our talc to be asbestos-free. The article ignores that J&J has always used the most advanced testing methods available to confirm that our cosmetic talc does not contain asbestos. Every method available to test J&J's talc for asbestos has been used by J&J, regulators, or independent experts, and all of these methods have all found that our cosmetic talc is asbestos-free.
https://www.cnbc.com/2018/12/14/johnson--johnson-shares-drop-on-reuters-report-that-the-company-knew-for-decades-of-asbestos-in-its-baby-powder.html
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The Bleeding Edge: a terrifying, enraging look at the corrupt, deadly world of medical implants
Dec 15, 2018 | Boing Boing
By Cory Doctorow
Prior to 1976, the FDA did not regulate medical implants, and so shoddy and even deadly devices proliferated, inserted into Americans' body.
When the FDA finally decided to regulate implants, they were reluctant to subject the devices already in the field to regulation -- after all, these were already in peoples' bodies. So they enacted rule 510(k), which grandfathered in any devices in the market, and any devices that were "substantially similar" to those devices.
This is a loophole that eventually grew to consume the rule. Since 1976, medical implant makers like Johnson and Johnson have worked in a stepwise fashion: in 1977, make a device and argue that it's "similar" to a 1976 device. Then in 78, you make another device and argue that it's similar to the device you got approved in 1977. Flash forward to 2018, and practically all medical implants are approved through this process.
Releasing the companies from regulatory oversight did not go well. From "metal on metal" joints that released deadly cobalt into patients' bloodstreams and dissolved their surrounding tissues into metal-studded slurry to vaginal mesh implants that caused incredible, life-threatening harm and could never be removed; to "Essure," a permanent female sterilization tool that also causes life-threatening harm, tens of thousands of Americans have been permanently disabled or killed by their medical implants, their lives turned upside-down, subjected to medical bankruptcy, collapsing marriages, even homelessness and loss of their children.
But the FDA has not stepped up, and the companies routinely refuse to withdraw their products even when confronted with stories from injured and dying implantees. The FDA even approves devices if they're "similar" to devices that had to be withdrawn because they were killing people -- the criteria for approval is similarity to an approved device, even if that approval led to disaster.
In a The Bleeding Edge, a 2018 documentary from Kirby Dick (previously) and Amy Ziering, we follow the regulators, the patients and the manufacturers as they enact this awful drama. We see how former FDA officials go into industry, and how industry executives end up running the FDA -- Trump's pick for FDA chief is predictably awful -- and how the manufacturers game the system, getting away with literal murder.
It's a wrenching, amazing movie. Like Dick's other movies, it's making a difference: less than a week after the film was released, Bayer withdrew its Essure product from the market, despite its staunch assertions that the product was safe for use. It was an important victory, if a small one: Bayer had already withdrawn Essure in every other country in the world, fearing regulatory scrutiny: only in the USA was it possible for this deadly product to be inserted into women's bodies for all these years.
The movie is on Netflix. It's amazing.
From The Guardian's review:
Stephen Tower, an orthopedic doctor profiled in the film, had developed a tremor and was having a hard time thinking when he decided to scrawl all over the walls and ceiling of a hotel room during a medical conference, eventually using soap as ink.
Tower, his friends and family knew he was in the throes of mental health crisis, but no one was sure why. So, Tower studied himself until he found the answer in a blood and urine sample: his levels of cobalt, a metal used in rechargeable batteries, were more than a hundred times higher than normal.
Tower thought it might be related to his metal-on-metal hip replacement and had it redone. On the operating table, his surgeon found metal sludge seeping from the device before it was removed. “Within a month I had an incredible recovery in terms of my psychologic symptoms and ability to think,” Tower said.
Tower said he would never have believed neurological problems could come from orthopedic devices, if it wasn’t for that experience, and now tests the cobalt levels of his patients if they complain of having Parkinson’s or dementia-like symptoms.
Hundreds of thousands of people in the world may have been exposed to toxic metals from “metal on metal” hip implants, according to a 2012 joint investigation by the British Medical Journal and BBC Newsnight.
“If we can’t change the laws and we can’t convince companies to put moral issues above profits, then all of us really have to be vigilant,” said The Bleeding Edge’s producer, Amy Ziering. “My great hope is you watch this film and then you are really, really, really careful and ask a lot of questions and do a lot of research.”
https://boingboing.net/2018/12/15/johnson-and-johnson-bayer.html
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