Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Twitter: @JjrkCh

Thursday, October 29, 2015

Marijn Dekkers, Bayer CEO: A US Welcome Wagon?

Marijn Dekkers, Bayer CEO: From GE to Germany

Andrew Ward  October 18, 2015

As consolation prizes go, the career of Marijn Dekkers has been a good one. His teenage ambition was to make a living from tennis and he came close, reaching number two in the youth rankings of his native Netherlands and spending several years on the fringes of the professional circuit. But when glory failed to arrive he turned instead to chemical engineering.
Four decades later, as chief executive of Bayer, he presides over Germany’s biggest company by market capitalisation (€90bn), as well as sitting on the board of General Electric, the company where he started out as a research scientist.

The 58-year-old is credited with transforming Bayer from a stodgy chemicals conglomerate into a more focused life sciences group. The latest step came this month with the initial public offering of its Covestro plastics division in the biggest German flotation for years. The IPO turned out to be the financial equivalent of a weak second serve as turbulent market conditions forced Bayer to cut the issue price. But there have been plenty of aces since Mr Dekkers took over in 2010; the share price has more than doubled in res­ponse to steady growth and a series of successful drug launches.
So why, in an era when many chief executives work long into their sixties, is he preparing to quit? An initial five-year contract has been extended by Bayer’s board only until the end of 2016 at the request of Mr Dekkers. He says this was because his children — he has three daughters — will be moving from school in Germany to college in the US. “I need flexibility to spend more time in the US and not have to be at a meeting here on Monday morning that I cannot miss.”
Willowy in stature with a shock of sandy hair, he does not look ready for retirement. But he insists there are no plans for another CEO job; instead he will put family first after a succession of taxing C-suite roles. Likening the pressures of executive life to that of an elite athlete, he says the fainting of his BMW counterpart, Harald Krüger, during a press call at the Frankfurt motor show last month, demonstrated the need for business leaders to protect their health.
“I’m very aware of the strain and stresses on my body, both physically and mentally, and put a lot of measures in place to manage that,” he says. “I know from my tennis days what it is to manage your energy. On the day of a match you need to peak at, say, 2pm not 5pm.”

Born 1957, Tilburg, Netherlands
Education Masters and PhD in chemical engineering from Eindhoven University of Technology
Career 1985-1995: Joined General Electric as a scientist at its research laboratory in Schenectady, New York, and rose to senior positions in GE’s polymers business
1995-2000: Various roles running units of AlliedSignal, the US engineering group later renamed Honeywell
2000-2009: Chief operating officer and later chief executive of Thermo Electron, which becomes Thermo Fisher Scientific after a merger to create the world’s biggest maker of laboratory equipment
2010: Appointed chief executive of Bayer
2012: Joined board of GE
Family Married with three daughters
Interests Played tennis semi-professionally before turning to business
Mr Dekkers witnessed the genesis of the modern, super-CEO at close quarters in the 1980s when he made the trans­ition from laboratory science to management with GE, during the early days of then CEO Jack Welch’s hard-charging leadership. Relatively junior at the time, he had little direct contact with the man who became famous for firing the worst-performing 10 per cent of managers each year. But he recalls: “The company had 350,000 employees and everybody felt they were close to Jack because we would all be very aware of his presence.”
Having survived the annual purges for a decade, Mr Dekkers eventually moved to Honeywell and later built Thermo Fisher Scientific into the world’s largest manufacturer of laboratory equipment during eight years as chief executive.
Despite this pedigree, his move across the Atlantic in 2010 was a surprise. Bayer had always been run by Germans promoted from within the company. “When I arrived, people thought I was American so when I started talking German with a Dutch accent people were a bit relieved,” he says, hinting at local mistrust of shareholder-driven US business culture.
The recent scandal over Volkswagen’s rigging of emissions data has called into doubt the virtues of German corporate governance. Bayer, too, has faced environmental questions over the impact of its insecticides on declining honey bee populations, as well as the myriad ethical controversies that swirl around big pharma.
Yet Mr Dekkers insists the German model of consensual labour relations and strong industrial policy remains a force for good. “I prefer this culture, particularly if you are running a company with a very long time frame,” he says. “In the [US] culture, pressure comes too quickly if something doesn’t go well. People start knocking on your door saying, ‘Why don’t you sell this’ or ‘I want to be on your board as an ac­tivist’.”
But he admits to missing the greater dynamism of US business life and complains of European sniffiness about entrepreneurship. “I lived in Boston and every professor was involved in three start-ups,” he says. “If a professor gets rich through a start-up in Boston everybody admires him or her; here, people are suspicious.”
At Bayer, he found a 150-year-old company with promising new drugs such as Xarelto blood thinner — known generically as rivaroxaban — but weighed down by slower-growing legacy assets. The Covestro IPO marked the completion of an overhaul that has left four remaining businesses: pharmaceuticals, consumer healthcare, animal health and crop science.
There is still wide diversity in products ranging from pesticides and flea collars to cancer medicines and the company’s oldest brand: aspirin. But they do all involve an intervention of one kind or another in the biochemical processes of living species, whether they be plants, animals or humans. This, says Mr Dekkers, positions the group to focus on high-value scientific innovation to meet rising global demand for healthcare and food.
“This is an unprecedented time,” he says, referring to the wave of medical breakthroughs created by advances in genomic science. “It’s like opening your eyes in the morning and seeing things you never saw before.”
He recalls working for Thermo Electron, the predecessor to Thermo Fisher, 15 years ago when it developed a machine that took a full year to sequence the structure of a protein. Today, the same process can be carried out in 20 seconds.
This is greatly accelerating the pace of research, but the data deluge also poses challenges for business leaders in all sectors, he says. “The faster the world moves [the more important is] your ability to absorb things. You get all this information and somehow you have to synthesise it and set the direction.”
Shifting the strategy of a company steeped in German industrial heritage has not always been easy. Bayer remains deeply rooted in its home town of Leverkusen in the manufacturing belt of North Rhine-Westphalia. Its ownership of the local Bundesliga football team, Bayer Leverkusen, symbolises these ties.
Mr Dekkers says he has tried to preserve the best of German culture while encouraging a more entrepreneurial spirit. He likens the process of bringing change to big companies to stretching a rubber band. “You can stretch it, but when does it snap? [If] you force people along at a faster pace than they are capable of . . . you end up out there on your own and no one knows what you are talking about.”

As Mr Dekkers looks forward to spending more time with his family and his tennis racket from the end of next year, he is perhaps also showing that healthy limits can be placed on how long chief executives should expose themselves to the torrid pace of running a multinational company.

Marijn Dekkers
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Marijn Emmanuel Dekkers (born September 22, 1957 in Tilburg, The Netherlands) is a Dutch-American manager and chemist. He's CEO of Bayer AG since October 1, 2010.[1]

Dekkers grew up as the youngest of three children of a merchant in the Dutch city of Tilburg. After attending the local schools, St. Aloysius (primary school) and St. Odulphus (Lyceum), in 1976 he began studying chemistry at the Radboud University in Nijmegen. Three years later he switched to chemical technology at Eindhoven University of Technology, where he received his Master and PhD in chemical engineering.[2] From 1985 he worked in various research departments of General Electric (GE) in the USA and the Netherlands. In 1988 he was Research Director of the GE range of polymers and subsequently held management positions in various polymer units at GE.
In 1995, Dekkers joined Allied Signal (subsequently Honeywell International Inc.) and took over the management of various business units. In 2000, he became Chief Operating Officer at Boston-based Thermo Electron Corporation, one of the world's leading specialists in the manufacture of laboratory instruments. Within a short time, Dekkers implemented a complete corporate reorganization and became President and CEO in 2002. In this role he initiated further extensive restructuring measures, divesting various organizational units and strengthening the company's core business by means of targeted acquisitions, including the purchase in 2006 of the significantly larger laboratory consumables supplier Fisher Scientific. Dekkers thereby created a company (Thermo Fisher Scientific) with 35,000 employees in six business groups.
On January 1, 2010 Dekkers was appointed to the board of Bayer AG, on October 1, 2010 he took over as CEO from Werner Wenning.[3]
On June 3, 2014 Bayer AG announced that the Supervisory Board extended the contract of Marijn Dekkers in line with his own wishes by just two years on expiration of the initial five-year period. Dekkers cited family reasons for extending his contract only until the end of 2016.[4]
Dekkers is a member of the Board of Directors of General Electric in the USA. He is President of the German Chemical Industry Association (VCI), Frankfurt, and Vice President of the Federation of German Industry (BDI), Berlin. Dekkers is also a member of the Business Council and the Business Roundtable, two U.S.-based associations of business leaders and CEOs.
Awards and recognition[edit]
"Manager of the Year 2014" by German business magazine "Manager Magazin" [5]
"Business person of the Year 2015" by the "Finanzen Verlag" publishing group and the readers of its publications "€uro am Sonntag", "€uro" and "Börse online" [6]
"Most Innovative CEO International 2015" by the German industry's "Innovation Award" [7]
In 2013 some controversy was sparked during a Financial Times panel discussion with relation to Bayer's kidney and liver cancer drug Nexavar.[8]
He spoke at a conference in 2014, saying[9][10]
So now, is this going to have a big effect on our business model? No, because we did not develop this product for the Indian market, let's be honest. I mean, you know, we developed this product for Western patients who can afford this product, quite honestly.[11][12][13]
Médecins Sans Frontières responded to Dekkers comment saying that it
sums up everything that is wrong with the multinational pharmaceutical industry. Bayer is effectively admitting that the drugs they develop are deliberately going to be rationed to the wealthiest patients.[14]
Dekkers replied to this, referring to the decision made by the Indian government, not to protect a patent on Nexavar and the intellectual property of Bayer. He also said:
I regret that what was a quick response from me within the framework of a panel discussion at the recent FT Pharma conference has come across in a different way as it was meant by myself. It could not be more opposite to what I want and we do at Bayer.[15]
Marijn Dekkers holds both Dutch and U.S. citizenship. He is married and lives with his wife Andra Moffett Dekkers and his three daughters in Düsseldorf. He is passionate tennis player.
References and Notes[edit]
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    Gisela Maria Freisinger und Martin Noe, Überfliegender Holländer, in: Manager Magazin, January 2010 (1/2010), Vol. 40, pp. 36.
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    Title of Thesis: The Deformation Behaviour of Glass Beaded-Filled Glassy Polymers
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    The original quote causing the debate was "Is this going to have a big effect on our business model? No, because we did not develop this product for the Indian market, let’s be honest. We developed this product for Western patients who can afford this product, quite honestly. It is an expensive product, being an oncology product." – Columbia Journalism Review, January 29, 2014, Videorecording of the panel (19:00 – 19:30)
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External links[edit]

Good Chemistry at Bayer

Aggressive and outspoken, Bayer CEO Marijn Dekkers talks about the problems with the U.S. patent system and government demands for lower drug prices—and how he hopes to drive results at this 148-year-old German firm.

October 8, 2011
"As a tennis player, you win or you lose, and you can't blame anybody," says Marijn Dekkers, CEO of module article chiclet Bayer AG and a former No. 2-ranked junior tennis player in the Netherlands. "So you learn relatively early on when you are winning not to become arrogant. And, as a young child, when you do lose, having to deal with defeat on your own is a pretty good lesson."
Dekkers, 54 years old, has had more wins than losses in his 25-year business career, which has included stints at module article chiclet General Electric, AlliedSignal and module article chiclet Honeywell, and 10 years at what is now module article chiclet Thermo Fisher Scientific, eight of them as CEO. During his tenure at Thermo, the stock price more than doubled, while the market fell 26%.
Nearly 40 years later, tennis continues to inform his decision making: "When you go on the court you have to perform, and that means you have to think about your food, you have to think about your sleep, vitamins, not getting cramps. And you never know if it is going to be raining. So you learn how to manage when you peak in performance. And in business that is actually a very important part of how you manage your day. When you have the critical meeting or presentation, how do you peak for that? Managing your energy is a key thing that you learn as a tennis player."

In October 2010, Dekkers was named chairman of the board of management—the U.S. equivalent of CEO—at Bayer, the $46 billion German pharmaceuticals and chemicals maker best known for aspirin. Bayer (ticker: BAYRY) is expected to have $49 billion in revenue this year. Aspirin, which the company invented in 1897, still brings in $1 billion a year, blockbuster status for a 114-year-old drug.
But other issues, like patent expirations and government pressure on drug pricing, are not so easy, and Dekkers is not shy about speaking out about them.
BUSINESS WASN'T DEKKERS' first career choice, or even his second. Raised in Tilburg, a small city in the Netherlands, he received a classical education, including Latin and Greek. At 16, he was admitted to a prestigious tennis academy in The Hague, where he could train full-time while finishing his studies.
Circumstances intervened. His mother died, and with his two sisters away at college, his father asked him to defer his admission for a year. Without that high-level training and competition, he lost his edge. "That year I sort of lost my connection to tennis," he says.
Dekkers, who remains fit and trim, quickly found another outlet for energy and ambition. "I got more and more focused on my studies and decided to study chemistry and get a Ph.D.," he recalls. "I was not that good a student when I was playing tennis a lot, because I just didn't have the time. But then when I became less of a tennis player I wanted to be a very good student."
And so he did, earning an undergraduate degree in chemistry from Radboud University and a masters and a Ph.D. in chemical engineering from Technical University Eindhoven. His new goal was to become a university professor. "The typical career track for a professor at the university in the Netherlands was to work a number of years in industry and then come back, say, after 10 years, when you are around 40, and take a full professorship," he explains.
At 28, he left to take a position as a staff scientist developing polymer blends at GE's Global Research facility in Schenectady, N.Y. And he didn't look back.
DEKKERS TOOK THE HELM of Leverkusen, Germany-based Bayer at a critical time for the 148-year-old company. Of the company's three segments, pharmaceuticals,is the highest-profile, garnering about $14.5 billion in revenue last year, or 30% of the total and 43% of operating profits. Only one of the company's big drugs, Yaz birth-control pills, has lost patent protection, and the company has a strong pipeline of new drugs. Its cyclical chemicals business, which comprised 30% of revenue and less of profits, has recovered from the last economic turndown. Crop protection, including fungicides, pesticides and disease-resistant seeds, makes up the balance and is a steady single-digit grower.
Some observers argue that the businesses have little in common, and that the company should be broken up, Dekkers says that option is not on the table. The chemist in him explains that they all derive from the innovative use of molecules. And the key to Bayer's success, he says, is and has always been to keep inventing new molecules for which it can charge a lot of money.
Last year, Bayer spent $4 billion on research and development, up 11% over 2009, and it will spend a like amount this year.
Known for charging the net on the tennis court, Dekkers is equally aggressive when he talks about the challenges facing the pharmaceuticals industry.
"It gets harder and harder to spend a lot of money on innovation and to be financially rewarded for it," he says, arguing that the U.S. courts have watered down patent protection. And the big drug makers, he says, are easy targets for governments. "What's easier than just saying to the 15 largest pharma companies, 'We want a rebate'? It is a lot easier than closing 200 hospitals in rural areas in the country, even though that is actually more needed."
HAVING SPENT NEARLY TWO DOZEN years in the U.S., working under some of the best minds in industrial management—Jack Welch and Jeffrey Immelt at GE, and Larry Bossidy at AlliedSignal and Honeywell—Dekkers has strong opinions on the subject.
"It is easy, as a CEO, to get isolated. Usually, if you don't fight it, it will happen, and that's quite dangerous, because then you get very filtered information, and it doesn't allow you to make the right decisions."
At GE Plastics, Dekkers worked closely with Immelt, who he says "was a wonderful communicator and very good at market segmentation." But while he was named technologist of the year in the late 80s for his work with polymers, what he really wanted to do was run a business. Lacking an MBA, he felt his chances of moving up at GE were slim.
So in 1995, he hired on at AlliedSignal, run by former GE hand Larry Bossidy. Over the next five years, he ran three businesses of increasing size. "Bossidy was an extremely results-oriented person," he recalls, "but he gave you the tools to get to the results."
Bossidy returns the compliment, calling Dekkers "a very productive and efficient and smart guy," with a good analytical mind.
AlliedSignal was acquired by Honeywell in 1999. The following year, Dekkers moved to Thermo Electron, a maker of laboratory instruments with 24 separate publicly traded divisions. "I saw there was very good technology there, but pretty much everything else was a mess," says Dekkers, who came in as chief operating officer and moved up to CEO in 2002. "We had 75 different brands."

Some of Thermo's divisions were spun off completely, and the rest were consolidated into a single brand. In 2006, he spearheaded a transformative acquisition, buying the much larger rival Fisher Scientific for $10.6 billion in stock. And Thermo, he takes care to note, paid no premium in the deal. "Every deal is a good idea, but when you pay too much, it quickly becomes a bad idea."
The deal ultimately paid off for shareholders of both companies. Now the world's largest producer of lab instruments, Thermo's shares rose 10% in a sharply down market from the time the acquisition was announced to when Dekkers exited in late 2009.
Dekker's skill at managing a portfolio of businesses and his experience in the capital markets no doubt made him an attractive catch for Bayer.
NONE OF BAYER'S CURRENT big drugs, including Kogenate, a $1.4 billion treatment for hemophilia, and Nexavar, a nearly $1 billion drug for liver and kidney cancer, face imminent patent expirations, and Dekkers says he inherited a strong pipeline with "five or six dream products."
One promising compound is Xarelto, a blood thinner developed with module article chiclet Johnson & Johnson that is now in Phase III clinical trials in the U.S. Dekkers thinks Xarelto could bring Bayer $2.5 billion to $3 billion in annual revenues. But that's not exactly easy money. "Between Johnson & Johnson and us, we will have spent two billion euros [$2.68 billion] on this thing by the time it's commercialized. And we haven't sold anything yet."
Another, Alpharadin, which is designed to treat prostate cancer after it metastasizes in the bones, is also in Phase III. Bone tumors need calcium to grow, Dekkers explains. Alpharadin is a radioactive calcium compound, and when the tumors go after it, the radiation destroys them.

Bayer also produces over-the-counter drugs, such as Aleve and Alka-Seltzer, and it has roughly a third of the global market for aspirin, according to Nicholas Hall & Co., a U.K.-based firm that tracks consumer health-care trends.
Bayer also does a strong business in animal health, and Dekkers points out that ingredients in insecticides that are sprayed on plants, corn, soybeans are also used for tick control and flea control in dogs.
Materials, like plastics for autos and construction, is the straggler in Bayer's portfolio, with sales down 3% from their peak. But Dekkers argues that polycarbonates, which are used in auto manufacturing to reduce weight, can grow faster than GDP.
Bayer's Frankfurt-traded shares, which closed Thursday at €41.14, are down 20% since Dekkers came in, compared with a 10% decline for the MSCI EAFE index.
But Dekkers doesn't fret about the stock price, at least for now. For American CEOs, he says, "the stock price is such a presence all day long. What is the stock doing, and how are investors reacting? What can I do to get the stock price up?
"That characteristic is much less present in a German company, where there is a balance between shareholders, employees, society and of course customers."
Which approach is better?
"It is easy to make quicker decisions here," says Dekkers, who met with Barron's in our New York offices last month, and management has more flexibility.
"There, it is harder to do things quickly. You need to bring more people along," including worker representatives and government officials, "and it is a longer process. But maybe in the end, also more sustainable because you are not just trying to please shareholders in the short term."
And having experienced both approaches?
"I don't think of it just this way or that," he replies. "I look at the conditions that are provided to me and then try to [excel] under those conditions."
So while there may not be big changes at Bayer in the next quarter or even next year, Dekkers, the competitor, is unlikely to play from the baseline forever. Ultimately, he will find relief for shareholders' pain. 

Wednesday, October 28, 2015

Bayer Essure Failure Rate 10%: E-Free Act

Fitzpatrick’s E-Free Act Would Take Essure Off the Market

By Jay W. Belle Isle - Oct 27, 2015
U.S. Representative Mike Fitzpatrick (R-PA) is set to introduce a bipartisan bill to Congress regarding the dangerous Bayer HealthCare product Essure. This purportedly “permanent” birth control device not only doesn’t work, but has caused countless women incredible suffering. Fitzpatrick’s E-Free Act would take Essure off the market.
Essure is a flexible, nickel-titanium coil that is surgically implanted into the fallopian tubes. The resulting scar tissue is supposed to render the user sterile. However, studies have shown that the failure rate (i.e., number of women who’ve become pregnant) is almost 10%. Furthermore, the coil often migrates causing perforation damage and the nickel is causing multiple serious allergic reactions.
Fitzpatrick chose the November 4 introduction for the E-Free Act as that is the 13th anniversary of Essure getting premarket approval from the FDA, despite the review panel’s misgivings. The FDA held a committee hearing on September 24 to review Essure’s safety and efficacy, but no recommendations have yet been made to the agency.
Fitzpatrick issued a statement saying, “Bayer is a trusted name in the industry. However, right now, one of their products, the Essure device, is harming women and needs to be removed from the market. I believe it is imperative to the continued success of their brand and the other work they do to immediately end production of a product that poses such a danger to patient safety.”
One of the Congressman’s spokespeople said that his office has heard from hundreds of women complaining about Essure. Bayer’s spokeswoman, Tara DiFlumeri, countered that by stating that more than 10 years of research support Essure’s safety.
“Bayer stands by the positive benefit-risk profile of Essure and we look forward to working closely with the FDA as it considers the advice of its Obstetrics and Gynecology Panel of the Medical Devices Advisory Committee,” she said. Bayer’s highest priority is patient safety and we sympathize greatly with any woman who may have experienced problems following an Essure procedure.”
Sure, there’s more than 10 years of Essure research out there. Internal documents have shown that Bayer “adjusted” some of that research, skewing it such that the FDA would grant premarket approval.
Bayer is no more sympathetic to the women victimized by its irresponsibility than is the FDA, which, despite its claims, turns a blind eye toward the suffering. Victims of Essure were not allowed to speak at the September 24 hearing; only medical professionals and industry representatives were heard.
The FDA may try to get away with silencing Essure victims, but Congress will hear these brave women this week. Below is a press release from Essure Problems, an advocacy group comprised of women injured by Essure:
“Four administrators of the Essure Problems Facebook page, Angie Firmalino, Amanda Dykeman, Lisa Saenz, and Melanie Goshgarian, their congressional liaison and E-Sister Amanda Rusmisell, E-Sister and scientist Tess Shulman, attorneys Marcus Susen and Holly Ennis, and local DC E-Sister Lisa Fouser, will be attending multiple congressional meetings tomorrow and Wednesday. The goal of their meetings is to gain support for Congressman Fitzpatrick’s E-Free Act. Congresswoman Rosa DeLauro has co signed the E-Free Act, and they will be presenting it to congress on November 4th, 2015, on the 13 year anniversary of the approval of Essure. The act asks that the FDA revoke PMA status for Essure and also remove it from the market. The meetings are listed below.
They will also be handing out packets to every single congressman and woman’s office. The packet can be viewed by clicking here.”

The medical device industry has insinuated itself into our local, state and national government by lobbying for legislation that would protect it from accountability for unsafe and ineffective products. In addition, the FDA that is charged with protecting patients by regulating the industry is deeply financially conflicted with both Director Shuren (his wife Allison is a partner in a DC lawfirm specializing in medical devices and FDA clearance) and the members of advisory panels that are salaried by the medical industrial complex. There is no process for harmed patients to be heard.

Tuesday, October 27, 2015

Media Has Role in Exposing Unsafe Medical Devices!

Why the media must play a bigger role in policing unsafe medical devices

Trudy Lieberman  October 27, 2015

Contributor Trudy Lieberman has been tracking the progress of industry-friendly regulatory legislation — the 21st Century Cures Act — through Congress. Here she examines how current medical device regulations are already allowing many faulty devices on the market — and how the media will need to be more vigilant if and when current regulations are further weakened under 21st Century Cures.  

Last September, the Food and Drug Administration convened a panel of experts to publicly examine the safety of Essure, a birth control device sold to more than half a million women over the past 13 years. The device, a coil implanted in a woman’s fallopian tubes, was sold as a way to permanently prevent pregnancies without the need for abdominal surgery and general anesthesia. Despite the touted advantages, more than 5,000 women have reported complications to the FDA, including tubal perforations, allergic reactions, severe pain and bleeding resulting in hysterectomies and hundreds of unintended pregnancies. In the last few years those complaints have multiplied, and more than 20,000 women have turned to Facebook to share their experiences.
Through the years Essure has gotten its share of press, but media coverage has swelled in the past month thanks to the power of Facebook, the FDA’s expert panel meeting, and a study released this month in The BMJ, which concluded that Essure was not associated with a higher risk of unintended pregnancies but was associated with a substantially increased risk of additional operations to fix the complications arising from use of the device. Outlets such as Reuters, the Wall Street Journal, NBC, and the Philadelphia Inquirer ran stories.  A New York Times editorial called for the FDA to consider suspending sales of Essure until better data is available.
In early September, a few weeks before the FDA hearing, came more troubling news about a different medical device–the C.R. Bard Recovery filter.  The Bard Recovery filter is inserted into the body’s largest vein and is intended to prevent blood clots that form in the legs from traveling to the heart and lungs. In a two-part series, which moved beyond the usual safe topics of network news, NBC reported that the filter could migrate through the body, puncture the heart, and had caused 27 deaths and 300 non-fatal medical events. Neither the FDA nor the manufacturer C.R. Bard would talk about the device or NBC’s revelation that Bard may have forged the signature of its employee who refused to sign off on the FDA approval application because of unresolved safety issues. (They did issue statements — see here and here.) Although NBC pointed out that some 20,000 people were estimated to be walking around with the device implanted in their bodies as far back as 2006, it was disappointing that the story of the migrating heart filter received so little media traction except from trade pubs like Fierce Medical Devices and websites sponsored by law firms no doubt trolling for clients.
As good as the NBC story was, it may have gotten more attention had NBC noted that the FDA had sent Bard a warning letter in July which flagged violations of the Food, Drug, and Cosmetics Act. The FDA said Bard had manufactured and marketed its Recovery Cone Removal System, intended to remove Bard filters from the body, without the required clearance or approval from the agency. The warning letter also advised the company that its “complaint investigation procedures do not ensure product complaints are adequately evaluated.” One case was reported by the company as a malfunction of a medical device when it “should have been filed as a death;” others were filed as malfunctions when they should have been filed as “serious injuries,” the FDA said. Scary stuff the public might want to know! When I asked NBC about this omission, a PR official said the letter “was not germane to the heart of our report,” but noted the warning and other legal and regulatory issues facing Bard were discussed in an online piece. The brief online mention, however, hardly communicated the seriousness of the warning.
Media interest in medical devices is a hit or miss affair, and when there is coverage, it usually doesn’t mean that the device, no matter what harm it may have caused, will be pulled from the market. Such devices continue to be sold, potentially causing more harm. The FDA’s response is often to call for stronger warnings or restricted use rather than ask the manufacturer to recall the device. The rationale: It may still help some people. It also helps the seller’s bottom line. In Washington’s current regulatory climate regulated industries rule the roost.
Most devices are approved with very little evidence they work and are safe.
Bard’s Recovery filter, for example, was approved in 2003, but two years later the company took it off the market and swapped it for a different model. Modifications in the new device were intended to prevent complications that had occurred. Both devices were approved under what’s called the 510(k) approval process that allows manufacturers to avoid conducting safety studies if a device is substantially equivalent to another already on the market. Essure was approved in 2002 on the basis of two nonrandomized, nonblinded prospective studies that lacked a comparison group. Since then some post-marketing studies have found problems.
FDA’s panel of experts concluded “that additional research needs to be done” to prove the device is safe, and they called for its use to be limited.  It’s not clear what action the FDA will eventually take.
“Once the device has been implanted and used, it’s hard to pull back because it has become the expected way of practicing medicine,” says Sanket Dhruva, a cardiologist and clinical scholar at Yale. “In the U.S. there’s no systematic reassessment of device safety and effectiveness years later.” And there’s no systematic, comprehensive, and uniform way of collecting complaints through product registries that other countries have which track problems with medical devices. Medical specialty organizations, the government, and even manufacturers sponsor registries in the U.S. Jeff Lerner, who heads ECRI, the independent organization that tests medical devices, drugs, and other healthcare technologies, told me, “A lot of information comes from registries outside the U.S.”
These shortcomings in policing unsafe medical devices argue for increased media scrutiny, including from social media. (Facebook acted as kind of a registry in the Essure controversy, but consumer complaints–as important as they may be–are no substitute for official registries with controls and rigorous data collection practices.) “The press is absolutely critical,” says Dr. Hooman Noorchashm, a cardiologist, who has spent the last few years trying to get a device called the power morcellator off the market. The device treats uterine fibroid tumors but can also spread hidden cancers throughout the body. Noorschashm and his wife, Amy Reed, also a physician who has cancer thought to have been spread by the morcellator, have been on something of a crusade to warn others and challenge the FDA. “Any success we’ve had is because a few Wall Street Journal reporters listened to us,” Noorchashm told me. So far one manufacturer has pulled the product, and the FDA has called for a black box warning, the strictest cautionary label a product can have. “They put out a black box warning and an advisory. That doesn’t protect patients,” he says. “Doctors still think it’s okay.” One Dallas gynecologist  told the Wall Street Journal that he asks patients to sign an informed consent document describing the risks of the procedure, but he added: “We tell them verbally that we don’t think those numbers are correct.”
As the 21st Century Cures Act moves closer to becoming law, media vigilance over medical devices will be even more crucial. The Senate is now considering the bill, which passed the House in July, and the PR campaign to speed up passage is gaining momentum. Earlier this month the Manhattan Institute, a conservative think tank that has provided the intellectual ammunition for the legislation, bought a full-page ad in the New York Times arguing “a new era in science and medicine calls for a new approach at the federal Food and Drug Administration…every American has a stake in this change because everyone will be a patient someday.” The Act would make it easier for devices to pour into the market in this “new golden age of medicine” the ad proclaimed. As I wrote in a previous post, should 21st Century Cures become law, devices will get even less regulatory scrutiny than they get now. Of course, there can be studies after a device has been around for awhile, but research published this summer in JAMA found that post-market studies varied in quality and only about 13 percent were completed between three and five years after approval. That’s a lot of time during which a bad device can be causing harm to unsuspecting patients.
I asked one of the study’s authors, Dr. Joseph Ross, an associate professor of medicine at Yale, how media coverage of devices could be better. Too often, he said, reporters who do cover devices don’t go far enough. “When you stop at the bad event, it doesn’t illustrate the path that got us there.” The larger story is really about the FDA, America’s laissez-faire philosophy of regulation, its insatiable appetite for cures, and the clash of these elements with costs and safety. That story is much harder to tell.

FiDA comment

Trudy Lieberman, thank you!  The media is welcome to review the chronicle of the medical device industry unearned entitlements and the FDA lax enforcement of regulation that I have collected since 9/2010 when I was invited and attended FDA/CDRH Patient Representative training.  OSHI (office of special health issues) never selected me for a panel because a) most (98%+) devices are grandfathered in by 510(k) process and b) they select the Patient Representative that has no opinion about the product.  So, in effect, the harmed patients are not in the room when decisions are made.  No wonder the profit flows along with the harm!  My blog:  FiDA  Failed implant Device Alliance

PREVENTABLE Patient Harm: Justice Illusive When Hospitals Play Hardball

Ruling opens hospitals to lawsuits

Jonathan Ellis,
Hospitals in South Dakota that grant doctors privileges to practice medicine can be sued if they acted in bad faith or were unreasonable in granting those privileges, a circuit court judge has ruled.
The ruling by Judge Bruce Anderson also opens the door to lawsuits against the individual members of committees that granted those privileges.
Anderson’s ruling sets the stage for South Dakota becoming a state that allows lawsuits against health providers under a concept known as “negligent credentialing.” At least 30 other states recognize the tort that hospitals have an obligation not to allow health providers to practice.
“Based upon this court’s review of the law and the briefs presented in these cases it appears South Dakota has all the necessary legal precedents as ingredients other courts have found prerequisite to adopting such a claim including a hospital’s duty of care for patient safety,” Anderson wrote.

The ruling, which could be appealed to the South Dakota Supreme Court, is a significant victory for three dozen plaintiffs who are suing Dr. Allen Sossan, a spine surgeon who practiced in Yankton. The plaintiffs in the cases are also suing Lewis & Clark Specialty Hospital, where Sossan was one of the doctor owners, and Avera Sacred Heart, where Sossan was also credentialed to perform surgeries. The doctors on the credentialing committees are also being sued.
In addition to ruling that health providers can be sued for failing to properly credential doctors, Anderson also ruled that a statute allowing medical peer review committees to keep their findings and materials private is not an absolute privilege.
Under South Dakota law, medical peer review committees operate in secrecy, and plaintiffs in medical malpractice cases don’t have access to their materials. Peer review is supposed to foster greater patient safety by allowing medical professionals to speak freely and critique each other without fear that the conversations and materials generated by the committee can be used in lawsuits. But critics say the system enables doctors and hospitals to hide their mistakes, thus depriving justice to victims of medical malpractice.
But Anderson noted that other privileges – attorney/client privilege and spousal privilege – are also not absolute, and that they are subject to a crime/fraud exception. Anderson ruled that the medical peer review privilege should also be subject to a crime/fraud exception.
“These committees owe a substantial and important fiduciary obligation to the entire community, and in order for the public to be satisfied that they are properly carrying out that important fiduciary obligation, when the appropriate case arises, the plaintiffs should have access to the information to make sure the legislative intent as expressed in the statute is upheld,” Anderson wrote.
It’s a big victory for the plaintiffs because they are attempting to prove that Sossan was credentialed by the hospitals because of the profits he would bring them by performing lucrative spine surgeries. Sossan got credentials even though the medical community in Yankton knew that he had lost credentials at a hospital in Norfolk, Neb., and that he had past problems.

John Hughes, a Sioux Falls lawyer who tries medical malpractice cases, said that trial courts have typically ruled that the medical peer review statute is absolute and an “insurmountable barrier to any independent review.”
“Judge Bruce Anderson’s opinion is one of the most well-researched and well-reasoned judicial decisions that I have read,” Hughes said in an email. “He addressed all of the interests in a fair and balanced manner. I cannot recall exactly who said this, but the saying goes like this, ‘those who do not control themselves will soon find themselves governed by others’ or words to that effect. Plainly, that is what we have going here.

Clinic severing ties with patients suing former spine surgeon

Jonathan Ellis,  12:05 a.m. CDT September 6, 2015
A clinic that provides basic medical services for residents in southeastern South Dakota and northeastern Nebraska is withdrawing care to patients who are suing a former spine surgeon and the doctors who credentialed him.
The Yankton Medical Clinic is not a party to the lawsuits against Dr. Allen Sossan, but some of the doctors who work at the clinic were on the credentialing committee that allowed Sossan to practice medicine at Avera Sacred Heart. At least a half-dozen doctors who practice at the clinic are parties to the lawsuits for their role in granting surgical privileges to Sossan at Sacred Heart.
Patients who filed suit and who also go to the Yankton Medical Clinic were notified by letter late last month that the clinic and its more than four dozen health providers are severing their relationships. The patients were informed that the clinic will cease treating them after Sept. 23.
“This is due to the breakdown of the physician-provider/patient relationship, in particular, your filing a lawsuit against a YMC, PC physician-provider and/or YMC, PC,” the letter says. The notice also bars these patients from the Vermillion Medical Clinic and the Yankton Medical Clinic Pharmacy.
Dr. James Young, a dermatologist and president of the Yankton clinic, signed the letters, which were dated Aug. 24. Young said he didn’t know how many patients were affected, putting the number at a “few.” There are approximately three dozen lawsuits against Sossan, but not all of them include the doctors who credentialed Sossan at Sacred Heart.
Young said the decision to terminate relationships with the patients follows a longstanding policy at the clinic. He added that it’s not unusual for medical facilities to have such a policy.
“Sir, all I know is those people filed suit against our doctors,” he said.
But Steve Johnson, a Sioux Falls lawyer with decades of experience trying and defending medical malpractice suits, said he is not aware of a situation in which a medical facility cut off services to patients.
“I think it’s a little unusual and rare for sure,” Johnson said.
Typically, he added, patients are the ones who pull the plug on a physician-patient relationship.
“Generally speaking, doctors practice medicine and they let the lawyers handle the legal part of it,” Johnson said.
The decision means that the patients who are being cut off will have to find new medical providers. In rural South Dakota and Nebraska, that could require patients to have to travel long distances for basic medical care.

Tim Bockholt, and his sister Judith, were among the patients who are being banned by the Yankton Medical Clinic. The Bockholts’ mother died after undergoing more than a dozen surgeries by Sossan in a year.
Tim Bockholt sees a cardiologist and a family practice doctor at Yankton Medical Clinic. None of the doctors who are being sued for credentialing Sossan provide care to either he or his sister, he said.
Bockholt now faces the prospect of traveling 50 miles to Norfolk, Neb., or 70 miles to Dakota Dunes. The travel will be harder for his sister, who suffered a stroke three years ago.
“She’s not that good at driving into those big cities because she can’t distinguish lefts from rights very well,” he said.
In a motion filed in court last week, Mary Weibel, another patient who is being released by the Yankton Medical Clinic, accused the clinic of using intimidation tactics because she is also suing Sossan. The motion noted that Weibel filed her lawsuit in February, and it accuses the Yankton Medical Clinic of violating a state law that bars corporations from interfering with physician treatment of patients.
Weibel, through a brother, declined to comment.
Health providers have been known to end their relationships with disruptive patients and patients who have not paid bills. At other times, they will sever their relations with patients who don’t take medicines or follow treatment instructions.
The American Medical Association has an ethical code dictating that physicians have an obligation to support continuity of care for patients. “While physicians have the option of withdrawing from a case, they cannot do so without giving notice to the patient, the relatives, or responsible friends sufficiently long in advance of withdrawal to permit another medical attendant to be secured,” the code says.
Jonathan Van Patten, a law professor at the University of South Dakota School of Law, said that someone suing a doctor in a medical practice might be reason enough for the entire practice to part ways with the patient.
“That seems to be enough of a reason to say no,” Van Patten said.
“You don’t have a right to do business with a professional,” he added. “It’s a two-way street.”
Randy Bury, the chief administrative officer for Sanford Health’s health services division, said in a statement that Sanford tries to work with patients even if they have a legal action against the system. Sanford also follows state and federal regulations on terminating patient relationships.
“It is uncommon for physicians to terminate a relationship with a patient,” Bury said. “In those unfortunate situations where it happens, we have policies/procedures to ensure that every effort was made to maintain continuity of care for the patient. At Sanford, we do everything possible to work with the patients regardless of the situation, including those difficult circumstances where legal action is underway.”
Lindsey Meyers, a spokeswoman for Avera Health, said in an email that the issue of terminating patient relations depends on the situation, the facility and the provider.
For Tim Bockholt, the decision to terminate his care means he and his sister have a daunting task of finding new providers. Both of them have health problems, and for Bockholt, who was born in Yankton 64 years ago, he now has to go outside of the place where he has always received basic medical care.
“They’re discriminating against us and we’ve never had anything to do with them,” he said. “We’ve never hurt them in any way I know of.”
More about Sossan

Dr. Allen Sossan began performing surgeries in Yankton in about 2008 to 2012. He practiced at both the Lewis & Clark Specialty Hospital, where he was an owner, and Avera Sacred Heart. Dozens of former patients or their relatives have filed lawsuits alleging he botched their spine surgeries. Last month, a judge unsealed an arrest warrant and grand jury indictment for perjury and filing a false document. The indictment stems from Sossan failing to disclose felony convictions for burglary and bad checks on his application for a South Dakota medical license. Sossan, who went by the name Alan Sossan before the convictions, is currently residing in Iran.