Patents that pertain to health have always posed an ethical dilemma; the EPO apparently tackled this dilemma by altogether ignoring the rights and needs of patients (in favour of large corporations that benefit financially from poor people's mortality)
Replacement of the aortic valve with a minimally invasive procedure called TAVR proved effective in younger, healthier patients.
Gina Kolata Image With TAVR, the only incision is a small hole in the groin where a catheter is inserted. Traditional surgery involves cracking open the ribs and stopping the heart to insert the new valve.CreditJean-Paul Chassenet/Science Source
The operation is a daring one: To replace a failing heart valve, cardiologists insert a replacement through a patient’s groin and thread it all the way to the heart, maneuvering it into the site of the old valve.
The procedure, called transcatheter aortic valve replacement (TAVR), has been reserved mostly for patients so old and sick they might not survive open-heart surgery. Now, two large clinical trials show that TAVR is just as useful in younger, healthier patients.
It might even be better, offering lower risks of disabling strokes and death, compared to open-heart surgery. Cardiologists say it will likely change the standard of care for most patients with failing aortic valves.
“Is it important? Heck, yes,” said Dr. Robert Lederman, who directs the interventional cardiology research program at the National Heart, Lung and Blood Institute. The findings “were remarkable,” he added.
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Dr. Lederman was not involved with the studies and does not consult for the two device companies that sponsored them.
In open-heart surgery, a patient’s ribs are cracked apart and the heart is stopped to insert the new aortic valve.
With TAVR, the only incision is a small hole in the groin where the catheter is inserted. Most patients are sedated, but awake through the procedure, and recovery takes just days, not months, as is often the case following the usual surgery.
The results “shift our thinking from asking who should get TAVR to why should anyone get surgery,” said Dr. Howard Herrmann, director of interventional cardiology at the University of Pennsylvania.
“If I were a patient, I would choose TAVR,” said Dr. Gilbert Tang, a heart surgeon at the Icahn School of Medicine at Mount Sinai in New York, who was not involved in the new research.
The studies are to be published in the New England Journal of Medicine and presented on Sunday at the American College of Cardiology’s annual meeting.
The Food and Drug Administration is expected to approve the procedure for lower-risk patients. As many as 20,000 patients a year would be eligible for TAVR, in addition to the nearly 60,000 intermediate- and high-risk patients who get the operation now.
“This is a clear win for TAVR,” said Dr. Michael J. Mack, a heart surgeon at Baylor Scott and White The Heart Hospital-Plano, in Texas. From now on, “we will be very selective” about who gets open-heart surgery, said Dr. Mack, a principal investigator in one of the trials.
Some healthier patients will still need the traditional surgery — for example, those born with two flaps to the aortic valve instead of the usual three. Having two flaps can lead to early aortic valve failure.
TAVR was not tested in these patients, and the condition occurs more often in younger patients who are low surgical risks.
Aortic valve failure stems from a stiffening of the valve controlling flow from the large vessel in the heart that supplies blood to the rest of the body. Patients often are tired and short of breath.
There is no way to prevent the condition, and no treatment other than replacing the valve. The main risk factor is advancing age.
Although both studies enrolled over 1,000 patients, the trials differed slightly in design, making direct comparisons difficult.
The study led by Dr. Mack and Dr. Martin Leon, an interventional cardiologist at Columbia University in New York, tracked deaths, disabling strokes and hospitalizations at one year following the procedures. The rates were 15 percent with surgery versus 8.5 percent with TAVR.
The rates of deaths and disabling strokes — the factors most important to patients — were 2.9 percent with surgery versus 1 percent with TAVR.
The second study estimated deaths or disabling strokes at two years, finding rates of 6.7 percent with surgery versus 5.3 percent with TAVR.
The trials were sponsored by makers of TAVR valves, Edwards Lifesciences of Irvine, Calif., and Medtronic, headquartered in Dublin. The two companies make slightly different valves.
The Edwards valve is compressed onto a balloon catheter that is pushed through a blood vessel from the groin to the aorta. Once it reaches the aorta, a cardiologist inflates the balloon and expands the valve, which pushes aside the failing valve.
The Medtronic valve is made of nitinol, a metal that shrinks when it is cold and expands when warm. The valve is chilled and put onto a catheter. When it reaches the aorta, the cardiologist pulls back a sheath, freeing the new valve. Warmed by the body, it expands to fill the narrowed opening and remains there.
With traditional surgery, by contrast, a doctor cuts out the old valve and sews in a new one, removing the old valve instead of leaving it in the heart.
Robert Pettinato at Long Cove Club in Hilton Head, S.C., after receiving a nonsurgical treatment called TAVR to replace a valve in his heart.CreditJoy Bonala for The New York Times
Dr. Jeffrey J. Popma, an interventional cardiologist at Beth Israel Deaconess in Boston, led the second trial and is a consultant for both manufacturers. He uses both devices in surgery, and said the important finding is that both were preferable to surgery.
The studies involved leading surgeons and cardiologists at academic medical centers, many enlisted as consultants. Independent data and safety monitoring committees oversaw the trials, and independent statisticians confirmed the results.
Aortic valve replacements have been performed for decades, and surgeons know the valves placed during surgery last at least 10 to 15 years. It remains to be seen if TAVR valves will fare as well.
The question is especially important for younger patients. The average age of subjects in the current studies was the low to mid 70s, younger by a decade or more than most patients getting TAVR now.
Hospitals offering TAVR will take a financial hit when lower-risk patients start opting for it, Dr. Herrmann said. The TAVR valves cost far more than valves placed surgically, but insurers usually pay equally for either procedure.
“Open-heart surgery, particularly in low-risk patients, is very profitable,” Dr. Herrmann said.
More than half a dozen companies make surgical valves, but only two market TAVR valves. Perhaps with more competition, Dr. Herrmann said, prices for TAVR valves will come down.
At the moment, it will be up to most patients which procedure they choose, Dr. Popma said — TAVR or surgery.
For Robert Pettinato, 79-year-old retiree in Scranton, Pa., there was no question. He had been feeling mild chest pain, and he was finding it difficult to finish a round of golf.
But last year, when his cardiologist told Mr. Pettinato that he needed a new valve, the only way he could get TAVR was to enter a clinical trial. He enrolled in the Edwards trial at the University of Pennsylvania.
He had TAVR in November, stayed in the hospital for 24 hours and went home. A few days later, he went to the football game at Lehigh University against its archrival, Lafayette. (He’s a Lehigh alumnus and never misses that game.)
Shortly afterward, his younger brother Jim, who lives in Florida, had to have aortic valve replacement. He wanted TAVR, but the clinical trials were closed. He had surgery instead.
It took his brother four months to recover enough to play a round of golf, Mr. Pettinato said.
Mr. Pettinato is back to playing golf himself. “I am the luckiest guy in the world,” he said.
Gina Kolata writes about science and medicine. She has twice been a Pulitzer Prize finalist and is the author of six books, including “Mercies in Disguise: A Story of Hope, a Familyʼs Genetic Destiny, and The Science That Saved Them.” @ginakolata • Facebook
A version of this article appears in print on , on Page A29 of the New York edition with the headline: Trials Show Heart Valve Helps Younger Patients. Order Reprints | Today’s Paper | Subscribe
Dr. Zimmerman goes on to say that once the #DOJ lawyers learned of his position, they quickly #fired him as an #expert #witness and kept his opinion #secret from other parents and the rest of the public.
What’s worse, he says the #DOJ went on to misrepresent his opinion in federal vaccine court to continue to…
An Australian hacker has spent thousands of hours hacking the DRM that medical device manufacturers put on CPAP machines to create a free tool that lets patients modify their treatment. Article word count: 2934
An Australian hacker has spent thousands of hours hacking the DRM that medical device manufacturers put on CPAP machines to create a free tool that lets patients modify their treatment. Article word count: 2934
The Weakest Link is Motherboardʼs third annual theme week dedicated to the future of hacking and cybersecurity. Follow along.
Listen to Motherboard’s new hacking podcast, CYBER, here.
Christy Lynn was tired all the time, and, after months of trying to diagnose the problem, one of her doctors thought they’d figured out why.
“I didn’t fit any of the descriptions for sleep apnea,” she told me on a phone call. “I’m a woman, I wasn’t overweight. No one would have thought to test me, except I was seeing a doctor who had a similar medical history.”
Lynn, who lives in rural Arizona, did an at-home oximetry test, which tests blood oxygen levels, and then a sleep study. She was diagnosed with a difficult-to-treat form of sleep apnea, a disorder in which patients suddenly stop breathing for periods of time while they sleep that most often affects overweight men. She was given a continuous positive airway pressure (CPAP) machine and face mask—which blows air down a patient’s windpipe to keep the airways open—and sent home.
But a year-and-a-half and three sleep doctors later, her symptoms hadn’t improved. Her Apnoea-Hypopnea Index (AHI), which refers to the number of times she stopped breathing per night, was “horrible.”
“None of the doctors could get my AHI down and none of them seemed particularly concerned about it, to be honest,” she said. She started Googling for help, and came across a forum called CPAPtalk.com.
On the forum, users were talking about a piece of software called “SleepyHead.”
The free, open-source, and definitely not FDA-approved piece of software is the product of thousands of hours of hacking and development by a lone Australian developer named Mark Watkins, who has helped thousands of sleep apnea patients take back control of their treatment from overburdened and underinvested doctors. The software gives patients access to the sleep data that is already being generated by their CPAP machines but generally remains inaccessible, hidden by proprietary data formats that can only be read by authorized users (doctors) on proprietary pieces of software that patients often can’t buy or download. SleepyHead and community-run forums like CPAPtalk.com and ApneaBoard.com have allowed patients to circumvent medical device manufacturers, who would prefer that the software not exist at all.
“I cannot tell you enough how different my CPAP experience is with this software. It’s the difference between night and day,” Lynn said. “I’m possibly alive because it exists.”
Most modern CPAP machines create reams of data while they’re being used. They track things like average air pressure, AHI, average use per night, mask leak rates, “flow limitation index,” and other statistics about what the machine is doing and the patient’s sleep quality. Generally, the data is stored on an SD card, which a patient takes to their doctor once every six months (some new devices also transmit data wirelessly to an app; the data available on apps, patients told me, is rarely as thorough as what the machine is actually collecting.) This data can be used to alter a patient’s treatment; increasing or lowering pressure thresholds and other settings on the machine can lead to better outcomes.
But many doctors, several SleepyHead users told me, take a passing glance at the numbers and send patients on their way. Several academic reviews of the industry have found that there is a shortage of sleep specialists, which means that few doctors can give patients the personalized care that many of them want; a 2015 paper by the American Academy of Sleep Medicine found a “substantial shortage of board-certified sleep medicine providers,” and noted that “parts of the United States are grossly underserved or not served at all.”
Thomas Penzel, a sleep physiologist who is the scientific lead of the European Sleep Research Society, told me in an email that he “believes any bright patient can do what they want”
“A patient might modify the pressure if they know what they’re doing. Some of our patients have modified pressure themselves,” he added. “If things go wrong, they may end up dead in their bed. This is their own risk. CPAP is not a toy but a medical treatment.”
He agreed that most sleep apnea patients around the world are underserved: “Doctors don’t listen and don’t have time anywhere in the world.”
“Your doctor says bring in your chip or card, and they read it, but they don’t read it for diagnostics. They read it for insurance compliance to make sure you’re actually using it,” Steve Levine, a SleepyHead user from California, told me on the phone. “Everybody is trying to get you in and out the door, and take some profit from your pocket.”
"I became increasingly disgusted at how the CPAP industry is using and abusing people"
Some CPAP machines allow patients to see rudimentary data on the screens of the machines themselves, but very few machines actually give patients access to all the data that’s being collected. One popular CPAP manufacturer, ResMed, makes data analysis software called ResScan, which, because of federal law, is only available to medical professionals or “on the order of a physician.”
This walled-garden approach to sleep apnea treatment and CPAP user data has resulted in the creation of the DIY world of CPAP hacking and settings modification.
Much of the discussion at CPAPtalk.com and ApneaBoard.com, the latter of which has roughly 71,000 members, centers around SleepyHead, which decodes the data created by CPAP machines and allows ordinary patients to access it. The software decodes the data quite literally: Watkins has painstakingly hacked and cracked the proprietary data formats for each individual CPAP machine that the software supports. These data formats are intended to only be read by the manufacturers’ own software.
“All machines have antitamper signing/checksumming built into the data formats, some more elaborate than others,” Watkins told me in a Facebook message. “Hacking the file formats is a complicated process that requires known data to compare against, this often means flipping settings in the machine menus or working of PDF reports generated from commercial software with known data sets, which have to first be begged for and collected from people with access to the machine and software.”
Watkins started the SleepyHead project seven years ago because he was interested in the “forbidden secrets” of his CPAP machine’s SD card. Since he first got started, SleepyHead has become a lifeline for the sleep apnea community.
“As time progressed, I became increasingly disgusted at how the CPAP industry is using and abusing people, and it became apparent there was a serious need for a freely available, data focused, all-in-one CPAP analysis tool,” he said.
Digital rights management and technical protection measures implemented to keep the owners of devices from accessing them have grown common across a wide swath of industries; the problem that CPAP users face is similar to one faced by farmers who want to repair their John Deere tractors, by people who own Keurig coffee machines that will only brew authorized coffee pods, and by independent electronics repair professionals who are increasingly locked out of iPhones, MacBooks, servers, air conditioning systems, vacuum cleaners, and internet of things devices.
CPAP users like Watkins are part of a new push by patients to take control of their own data; activist Hugo Campos gave a TEDx talk in 2011 about his fight to gain access to the data generated by his pacemaker, while a DIY group called Nightscout has launched an unsanctioned app that breaks DRM in order to allow parents to remotely monitor their diabetic child’s glucose monitors.
Medical device companies have generally not been very happy about this new DIY movement, but what Watkins is doing with SleepyHead is legal.
In 2015, Campos’s Coalition for Medical Device Researchers petitioned the Librarian of Congress and the US Copyright Office to create an exemption to the Digital Millennium Copyright Act—the most important law governing software copyright—that would allow patients to legally hack medical devices for security research and to gain access to the data that it generates.
The medical industry argued that "patients directly accessing the data on their devices may not understand the format of the data or may misinterpret the data. Such data access rights can be exercised (and already are provided) through health care providers"
Campos “was tracking his Pacemaker data on a Google Spreadsheet—not an ideal patient care situation,” Andrew Sellars, a lawyer at Harvard’s Berkman Center for Internet and Society who represented Campos, told me on the phone. “The pacemaker transmits data to a base station. His idea was to intercept that signal as it’s taken off the pacemaker in order to find out what his heart was doing.”
Medical device companies vehemently fought Campos and Sellars’s petition: “The medical device manufacturers took the position that the data is formatted in such a way that it’s protected, copyrighted information that’s protected by the DMCA,” Sellars added.
AdvaMed, a trade organization that lobbies on behalf of the medical device industry, told the copyright office in a petition to block Campos’s request that “patients directly accessing the data on their devices may not understand the format of the data or may misinterpret the data. Such data access rights can be exercised (and already are provided) through health care providers having the appropriate tools and training to collect and protect patient data without compromising the safety and longevity of his or her device.”
The organization also argued that an exemption that legalized patient data access would put patients’ health and privacy at risk and could “accelerate battery drain.” The Medical Alley Association—another medical device manufacturer trade group—argued that “allowing this exemption will directly interfere with the doctor-patient relationship—in effect inducing patients to make decisions without the support of their doctor.”
"Apnea Board freely distributes CPAP Clinician Manuals and publicizes the ‘secrets’ of these CPAP machines to our members so they can educate themselves and take control of their own sleep apnea therapy if they so choose"
The FDA, meanwhile, told the Copyright Office at the time that any device that was user-modified could not be marketed or resold without FDA approval, and that if any modified machine hurt a patient, the agency could have trouble determining whether it was the device manufacturer’s fault or the software modifier’s fault. But ultimately, the FDA did not try to stop the exemption from going through: “FDA recommends that the final rule explain that nothing in the rule will affect the regulation of products that fall within the jurisdiction of other federal agencies.”
In a major win for consumers, the Librarian of Congress granted the exemption, which legalized not only Campos’s attempts to gain access to his pacemaker data, but also the type of hacking that Watkins is doing with SleepyHead. Earlier this year, the exemption was renewed, and no medical device manufacturers (nor anyone else) attempted to stop it. AdvaMed declined to comment for this article. Medical Alley did not respond to a request for comment in time for publication; none of the CPAP manufacturers I contacted responded to a request for comment.
But just because hacking CPAP machines to gain access to the data is now legal doesn’t mean that medical device manufacturers have to make it easy. Watkins says that, without leaked documentation, hacking a new data format (and most manufacturers have their own formats) can take hundreds of hours. He uses a hexadecimal editor called Synalize It! to analyze the data formats and reverse engineer data against verified data that is shared with Watkins from friendly insiders.
“It’s been my experience that getting documentation out of manufacturers without a NDA is like getting blood out of stone,” Watkins said. “Most [manufacturers]have completely ignored my emails, some have even expressed displeasure at my efforts.”
CPAP patients regularly ask Watkins to hack new machines for them, and it’s gotten to the point where Watkins has had to basically stop development of the core software in order to spend time supporting new machines. Though he has done most of the software development and hacking, others in the community have helped with specific projects, and there are occasionally group hacking efforts to figure out the data format for a particularly difficult machine.
“Contec oximeters were fun, the ‘Protocol 7’ hack was an all-nighter team effort by myself, and a couple of other hackers supplying me with serial port captures, helping break protocols with python code, and testing the importer I wrote and tweaked it in SleepyHead,” he said.
The thousands of hours of development work has been tough on Watkins—he said he regularly suffers from spells of burnout, and development on SleepyHead has gone in fits and starts depending on his own health and job situation (he is currently looking for paid development work.)
“Iʼve been on the sidelines away from the workforce as a stay at home dad, which while it has been beneficial to the SleepyHead project and my daughter, it hasnʼt exactly been so beneficial for my familyʼs long term wellbeing,” he said. “Over the past seven years Iʼve been mostly supported by my wife whoʼs been patient with me and supportive of my project activity, but now my health has improved a lot and my daughter is old enough, Iʼve really got no choice but to put family responsibilities ahead and return to work. Until I get into a rhythm with that and find some suitable paid work that fits my circumstances, Iʼll have to pause SleepyHead development for a while.”
He said his dream would be to create an open-source, easily repairable, DRM-free CPAP machine.
“Iʼm pleased others have found it genuinely helpful, their words of encouragement, donations, data samples, and willingness for patience despite slow development have helped keep me motivated,” he said. “Iʼm proud of my accomplishments so far, despite it being difficult doing this without any kind of commercial backing.”
When a new machine is hacked and added to SleepyHead’s list of supported machines, it’s documented in a Facebook group and on CPAPtalk and Apnea Board, which also play a crucial role for patients: The userbase on those forums helps new patients make sense of the data that SleepyHead is spitting out. It also helps patients decide what tweaks to make to their treatment and has information about how to actually make those changes on the machines (treatment modification menus are often hidden and are supposed to be accessed only by doctors.)
“Apnea Board’s primary goal is to promote ‘patient empowerment’ (where the patient takes a more active role in their own sleep apnea treatment),” SuperSleeper, who founded the forum in 2004, told me in a private forum message. “Quite simply, the sleep apnea industry as a whole is overwhelmed and cannot provide the one-on-one follow-up service that many CPAP users need. Theyʼre very good at creating ‘billable events’ (for a sleep study, a doctorʼs visit, or the sale of a CPAP machine and supplies), but they have little time and not enough of a financial incentive to help with ongoing detailed questions and problems that many CPAP users have.”
"I would be devastated if I lost the software. If it quit working, I don’t know what I would do.”
Apnea Board has become a bastion of information and self-taught sleep apnea experts; the forum features a private section in which users can download user manuals and, in some cases, leaked manuals that are intended for doctors. These manuals teach users how to get into the “clinician menu” where they’re able to modify their CPAP’s settings to tailor their treatment in coordination with what SleepyHead is telling them about their treatment.
“Apnea Board freely distributes CPAP Clinician Manuals and publicizes the ‘secrets’ of these CPAP machines to our members so they can educate themselves and take control of their own sleep apnea therapy if they so choose,” SuperSleeper told me. “Once one knows these ‘secrets,’ itʼs relatively easy to get into and program the ‘Clinician Menu’ of most CPAP machines, although increasingly, manufacturers are making it more difficult for patients to do that, and a bit of ‘hacking’ might become necessary with some machines.”
Both Levine and Lynn say that the combination of SleepyHead and the forums has completely changed their lives and their treatments.
“When you’re first diagnosed, you feel alone,” Levine said. “On the forum, people say ‘hey, this is what happened to me last night, and this is what I did. What do you recommend?’”
Lynn said that, when her doctors analyzed her numbers, they were looking at an average of her last six months, and not individual nights that may have been harder than others: “They’re not drilling down to where your problems are happening.”
“I can see the numbers every day on SleepyHead and I can tweak my settings,” she said. “I’ve been upping my exhale pressure to get my numbers down. I feel a lot better than I did when I was first diagnosed. I have more energy, I sleep better.”
Several people with sleep apnea I spoke to said that any concern that altering their treatment is dangerous is misplaced; many said they believe it’s fear-mongering by doctors and device manufacturers, and all of them stressed that they would never make modifications without fully understanding how the machines work and what the data is telling them.
Lynn said that treating herself is the only option that’s ever worked, and it’s the only option she has.
“I’m 62 years old and I don’t have health insurance because I can’t afford it and I’m self employed,” she said. “I would be devastated if I lost the software. If it quit working, I don’t know what I would do.”
Image Jennifer Lamptey, a radiologic technologist, adjusting a CT scan at the Saint Raphael campus of Yale New Haven Hospital, part of a bigger system set to control a quarter of Connecticut’s hospital beds.CreditCreditChristopher Capozziello for The New York Times
The nation’s hospitals have been merging at a rapid pace for a decade, forming powerful organizations that influence nearly every health care decision consumers make.
The hospitals have argued that consolidation benefits consumers with cheaper prices from coordinated services and other savings.
But an analysis conducted for The New York Times shows the opposite to be true in many cases. The mergers have essentially banished competition and raised prices for hospital admissions in most cases, according to an examination of 25 metropolitan areas with the highest rate of consolidation from 2010 through 2013, a peak period for mergers.
The analysis showed that the price of an average hospital stay soared, with prices in most areas going up between 11 percent and 54 percent in the years afterward, according to researchers from the Nicholas C. Petris Center at the University of California, Berkeley.
The new research confirms growing skepticism among consumer health groups and lawmakers about the enormous clout of the hospital groups. While most political attention has focused on increased drug prices and the Affordable Care Act, state and federal officials are beginning to look more closely at how hospital mergers are affecting spiraling health care costs.
During the Obama years, the mergers received nearly universal approval from antitrust agencies, with the Federal Trade Commission moving to block only a small fraction of deals. State officials generally looked the other way.
President Trump issued an executive order last year calling for more competition, saying his administration would focus on “limiting excessive consolidation throughout the health care system.” In September, Congress asked the Medicare advisory board to study the trend.
But not only have big consolidations continued, the behemoths have further cemented their reach in some regions of the country by gobbling up major doctors’ and surgeons’ practices.
“You have to watch for these systems throwing their weight around,” said Xavier Becerra, the California attorney general whose office has sued Sutter Health, a sprawling system in the northern part of the state. “We are looking for cases where consolidation does nothing for efficiency and leads to distortions of the market.”
Ted Doolittle, who heads Connecticut’s Office of the Healthcare Advocate, has fielded angry complaints from residents, but he sees few options available to officials. “A lot of this is too little and too late,” he said.
The latest giant hospital consolidations continue to stir concerns. Dignity Health and Catholic Health Initiatives, two large chains, are expected to become one of the nation’s largest groups — with 139 hospitals in 28 states — by the end of the year. And two of Texas’ biggest systems, Baylor Scott & White Health and Memorial Hermann Health System, recently announced plans to combine.
The New Haven area has witnessed the most significant decline in competition. Yale New Haven Health, one of the largest hospital groups in Connecticut, took over the only competing hospital in the city and has also aggressively expanded along the state’s coast. The group recently added another hospital to its collection, merging Milford with its Bridgeport location.
Although the price of a hospital admission in the New Haven-Milford area was already three times higher than in other parts of the state, prices surged by 25 percent from 2012 to 2014, compared with 7 percent elsewhere in the state, according to the Petris Center.
In the national analysis, a third of the metropolitan areas experienced increases in the cost of hospital stays of at least 25 percent from 2012 to 2014, from roughly $12,000 to at least $15,000.
Prices rise even more steeply when these large hospital systems buy doctors’ groups, according to Richard Scheffler, director of the Petris Center.
“It’s much more powerful when they already have a very large market share,” said Mr. Scheffler, who recently published a study on the issue in Health Affairs. “The impact is just enormous.”
Thousands of Connecticut residents were stranded without a local hospital last year when another big hospital group, Hartford HealthCare, battled the state’s biggest health insurer over how much it would charge for patient care.
Image The merger of Yale New Haven and Saint Raphael in 2012 led to a 1,519-bed hospital with two main campuses.CreditChristopher Capozziello for The New York Times
Its six hospitals are clustered around the state capital and are the only resort for residents in broad swaths of the eastern part of the state. This month, it announced plans to add a seventh hospital to its network.
“These systems are empire-building, there’s no question,” said Jill Zorn, a senior policy officer for the Universal Health Care Foundation of Connecticut, which seeks to improve access for residents. “But to whose benefit?”
Numerous studies by economists and others have underscored how hospital consolidation is driving up the cost of medical care. “Within the academic community, there is near unanimity,” said Zack Cooper, a health economist at Yale University who is among a group of researchers that has looked at how dominant hospitals affect prices.
The emergence of a one-hospital town is inevitable in many places, and the Parkersburg, W.Va., area is no exception. St. Joseph’s merged with neighboring Camden-Clark Memorial in 2011, and then they were consumed by what is now the state’s largest health system.
“We’ve got it down to a single campus,” said Albert L. Wright Jr., the chief executive of West Virginia University Health System. “Parkersburg is not big enough to support two hospitals.”
Residents can get most care locally but they go to Morgantown, where the academic medical center is situated, for complex conditions. “We’ve elevated the level of care,” Mr. Wright said.
But private insurers are paying more. In the Parkersburg-Vienna area, the overall price of a hospital stay increased 54 percent from 2012 to 2014, after the mergers. That is compared with 10 percent elsewhere in the state, according to the Petris Center.
Large systems “get paid better by some of the insurers,” Mr. Wright said.
Flailing hospitals often have little choice but to be acquired or go out of business, and a larger system can offer badly needed capital and management skills. “They can fix a hospital and benefit the community,” said Torrey McClary, a lawyer who specializes in mergers at King & Spalding.
When Yale New Haven Health took over the Hospital of Saint Raphael, a Catholic hospital six blocks away from its New Haven location, Saint Raphael was in danger of going under. Over the last six years, the system has invested more than $200 million in capital improvements at Saint Raphael, said its president Richard D’Aquila, including modernizing “everything behind the walls.”
Because it converted Saint Raphael into what is essentially a second 555-bed campus for its academic medical center, Yale New Haven Health defends the higher rates it charges private insurers as appropriate for a top-tier medical institution. Its community hospitals negotiate prices individually with insurers.
“Our focus is not on getting bigger,” Mr. D’Aquila said. He said Saint Raphael, which was half empty when it was taken over, is now seeing record numbers of patients.
Systems also say they are trying to improve the care for smaller communities. “We’re actively trying to move care toward places that are accessible,” Hartford’s chief executive, Elliot Joseph, said.
But patients rarely reap the rewards of lower insurance premiums or out-of-pocket expenses when mergers occur.
Hartford executives talk about reducing the total cost of care in the same breath that they discuss the need to charge insurers more. “The math for us is how we move the care out of the hospitals while maintaining our financial stability,” Mr. Joseph said.
To defend higher rates, many hospitals cite low reimbursements from government sources, particularly Medicaid, and highlight their role as a safety net. “We’re left with no choice,” Mr. D’Aquila said.
Others, like Hartford, negotiate prices as a single entity, forcing health insurers to include all of their hospitals in a network or risk losing access in areas where there are no alternatives.
Hartford “has taken over so many hospitals and practices that, with the Anthem dispute, we felt we had no choices at all,” Sharry Goldman, a Storrs, Conn., resident, told state lawmakers. Although Hartford and Anthem Blue Cross, the insurer, eventually reached an agreement, Connecticut passed a law this year requiring hospitals and insurers to extend previous contracts for two months to protect consumers when the parties are at an impasse.
While patients may pay more for a well-known brand, like Yale, it is not clear that the higher price tags lead to better care, said Francois de Brantes, a health care executive who once worked at General Electric, which is headquartered in the state.
Since the merger, Yale New Haven has defended the higher rates it charges private insurers as appropriate for a top-tier medical institution.CreditChristopher Capozziello for The New York Times
“We have more lower-rated hospitals in Connecticut than in other New England states,” he said, pointing to an analysis he did at the time of the Anthem-Hartford dispute.
In the Albany, Ga., area, where the Berkeley researchers found a rare decline in hospital prices, the Federal Trade Commission had unsuccessfully attempted to block HCA, the for-profit hospital chain, from selling its hospital to its only local competitor in 2011. But the merger took place, and the F.T.C. reached a settlement with the parties involved.
While Berkeley researchers foundarea prices dropped, another study by two former F.T.C. employees, Christopher Garmon and Laura Kmitch, found that certain hospital quality measures declined. The merger “highlights the problems that can occur when competition is reduced,” the authors said.
The hospital group, Phoebe Putney Health System, dismissed the findings. “Phoebe has made great strides in enhancing the quality of health care available to the people of southwest Georgia,” Dawn Benson, Phoebe’s general counsel, said in a statement.
To foster competition, Lee County is planning a new 60-bed hospital within the Albany area.
In some cases, state regulators have opposed actions they consider illegal and anti-competitive. In Washington, state officials accused CHI Franciscan Health, based in Tacoma, of using its ties to two doctors’ practices to raise prices and decrease competition on the Kitsap Peninsula, according to a lawsuit filed last year.
The regulators argue that CHI wanted to wield its newfound clout by shifting some operations and imaging from less expensive outpatient settings to hospitals where they could charge more.
“I am all for taking advantage of hospital-based pricing, if we think it is doable in the market and the market can support it,” a CHI executive is quoted as saying in the lawsuit. “It would be great to drop a couple of million more to our bottom line.”
CHI Franciscan said the attorney general’s allegations were “misguided and unfounded.”
In California, Mr. Becerra, the state attorney general, brought a lawsuit against Sutter in March, claiming that its actions led to significantly higher prices in Northern California.
Sutter says it adopted methods encouraged by the federal health care law, by combining hospital services with care delivered outside the hospital to better meet patients’ needs.
But Mr. de Brantes, the health care executive in Connecticut, and others wonder why many mergers were allowed in the first place. “The puzzling part for many of us in the state is why anyone would allow these oligopolies to form,” he said.
Some researchers are starting to believe MDMA, the party drug commonly known as “ecstasy” or “molly,” could become a recognized treatment for post-traumatic stress disorder (PTSD) in the coming years. https://futurism.com/mdma-therapy-help-treat-ptsd
By Sean Coughlan BBC News education and family correspondent
surgery Image copyright Getty Images
A professor of surgery says students have spent so much time in front of screens and so little time using their hands that they have lost the dexterity for stitching or sewing up patients.
Roger Kneebone, professor of surgical education at Imperial College, London, says young people have so little experience of craft skills that they struggle with anything practical.
"It is important and an increasingly urgent issue," says Prof Kneebone, who warns medical students might have high academic grades but cannot cut or sew.
"It is a concern of mine and my scientific colleagues that whereas in the past you could make the assumption that students would leave school able to do certain practical things - cutting things out, making things - that is no longer the case," says Prof Kneebone.
The professor, who teaches surgery to medical students, says young people need to have a more rounded education, including creative and artistic subjects, where they learn to use their hands.
Do smartphones really affect surgeonsʼ skills?
Prof Kneebone says he has seen a decline in the manual dexterity of students over the past decade - which he says is a problem for surgeons, who need craftsmanship as well as academic knowledge.
"An obvious example is of a surgeon needing some dexterity and skill in sewing or stitching," he says.
Image copyright Getty Images
"A lot of things are reduced to swiping on a two-dimensional flat screen," he says, which he argues takes away the experience of handling materials and developing physical skills.
Such skills might once have been gained at school or at home, whether in cutting textiles, measuring ingredients, repairing something thatʼs broken, learning woodwork or holding an instrument.
Students have become "less competent and less confident" in using their hands, he says.
"We have students who have very high exam grades but lack tactile general knowledge," says the professor.
Stay ahead of the robots
Prof Kneebone will be speaking on Tuesday at the V&A Museum of Childhood in east London, at the launch of a report, published by the Edge Foundation, calling for more creativity in the curriculum.
Alice Barnard, chief executive of the Edge education charity, says: "The government pays lip service by saying creative subjects are important, but its policies demonstrate otherwise."
She says the way school performance is measured tends to push schools to focus on core academic subjects, to the detriment of arts and creative subjects.
The report warns that entries to creative subjects have fallen by 20% since 2010, including a 57% fall in design and technology GCSE.
Tristram Hunt, director of the Victoria and Albert Museum, will be speaking alongside Prof Kneebone.
"Creativity is not just for artists. Subjects like design and technology, music, art and drama are vitally important for children to develop imagination and resourcefulness, resilience, problem-solving, team-working and technical skills," says Mr Hunt.
"These are the skills which will enable young people to navigate the changing workplace of the future and stay ahead of the robots, not exam grades."
This difference between what other countries pay for costly, #patented #drugs and what #Americans pay has long irked #PresidentTrump. “For decades, other countries have #rigged the system so that American #patients are charged much more—and in some cases, much, much more—for the exact same #drug,” Trump said. “In other words, Americans pay more, so that other countries can pay less.”
But in the 2000s, a new #strategy emerged, pioneered in large part by #Swiss pharmaceutical giant #Roche and its U.S. #biotechnology subsidiary #Genentech. The new approach would be to focus on so-called “orphan” or #rare #diseases, which affected fewer than 250,000 Americans, but where companies had more ability to charge higher #prices with lower R&D expenditures.
If you want to develop a new drug to treat, say, #diabetes, you face several extreme hurdles. The #FDA will require that you do #clinical #trials in at least 20,000 patients that monitor the #safety and #efficacy of your drug over at least five years. Clinical trials of that scale cost more than $2 billion to do. If, at the end of that process, your drug manages to be better than the current standard of care, you have to #market it in a #competitive #environment in which there are plenty of well-established #inexpensive #alternatives.
The #Roche-Genentech #strategy addressed this problem by focusing on rare diseases, where phase III clinical trials could be much smaller—200 patients, say, instead of 20,000—reducing R&D costs tenfold, with drugs that treated diseases for which there was little to no #competition, and therefore could be priced more aggressively.
The Trump administration unveiled a new proposal to reduce the price of certain costly drugs administered under Medicare, by linking what Medicare pays for these drugs to what other countries pay. It’s a stunning move that could reshape the way the pharmaceutical and biotechnology industries think.
\* 62 percent of cancer patients report being in debt due to their treatment. \* 55 percent accrue at least $10,000 in debt, while 3 percent file for bankruptcy. \* Cancer costs exceed $80 billion in America each year. Rebecca Meyer was diagnosed with glioblastoma when she was 5 years old. She fought bravely for 10 months before dying on her 6th birthday. The total cost of of her treatments during that time? $1,691,627.45.
Cancer is costly, emotionally and socially. But itʼs especially pricey in terms of money. The stress of being unable to pay for treatment doesnʼt help your immune system while going through chemotherapy or radiation. Itʼs impossible to relieve yourself of tension when your medical costs are bankrupting you and your family.
This is more common than you might imagine. A new study, published this month in The American Journal of Medicine, discovered that 42 percent of patients deplete their life savings during the first two years of treatment. Thereʼs good reason the term "financial toxicity" is in the name of this report.
Of the 9.5 million cancer diagnoses studied between 2000–2012, researchers discovered that 42.4 percent of patients (median age 68.6±9.4 years) spent all of their money, averaging $92,098. This follows disturbing news from earlier this year that 40 percent of Americans canʼt afford to pay $400 in case of an emergency. The math is not adding up.
Financial toxicity led Fumiko Chino to co-write a research letter in JAMA Oncology last November. After her husband surpassed his insurance policyʼs $500,000 lifetime limit, Chino drained her savings to pay for his treatment. When he died, she was left hundreds of thousands of dollars in debt.
In her study of 300 cancer patients, Chino and team discovered that over one-third of them had to pay more than expected for their care, which put a strain on their decision-making process.
Facing unexpected treatment costs was associated with lower willingness to pay for care, even when adjusting for financial burden. This suggests that unpreparedness for treatment-related expenses may impact future cost-conscious decision making.
A 2016 systematic review of 45 studies, published in Journal of the National Cancer Institute, found that up to 62 percent of patients report being in debt due to treatment. Another study of over 4,700 patients from that year discovered that 55 percent accrued at least $10,000 in debt, while 3 percent filed for bankruptcy.
Cancer costs exceed $80 billion in America each year. Over half of all cancer patients "experienced house repossession, bankruptcy, loss of independence, and relationship breakdowns." Up to 85 percent of patients have to stop working for up to six months, putting further strain on their finances.
On October 16, cancer patients in New Zealand petitioned Parliament for treatment funding. Photo by Hagen Hopkins/Getty Images
The financial toxicity study above comes to possibly the only conclusion imaginable:
As large financial burdens have been found to adversely affect access to care and outcomes, the active development of approaches to mitigate these effects among already vulnerable groups remains of key importance.
Health care remains one of the most important issues in this election cycle — it always seems to be an issue, sadly. Seventy-two percent of all political ads that ran in Washington during September mentioned health care in some capacity, while 50 percent of national ads run by Democrats have used this talking point (compared to 28 percent of national Republican campaigns). We need to figure this out.
As a cancer survivor, I deeply empathize with this problem. There is no easy answer, as cancer treatment is expensive. Funding is needed to keep researchers searching for cures and better treatments. Hospitals need to stay in business, and cancer happens to be one of the more expensive widespread diseases to treat.
But weʼve also set up our society in such a way that these high costs are passed on to those who can afford it least. This study is just one example of a culture that continues to divide its wealth to such extremes. That might not be the country we wanted, but itʼs what weʼve got. Where we go from here is up to us, and a sizable piece of this puzzle will be put into place on November 6.
Stay in touch with Derek on Twitter and Facebook.
L'amendement au projet de loi de financement de la sécurité sociale adopté hier par l'assemblée générale. Adopté sous le joug de la rentabilité, l'amendement constitue dans la lignée du plan « Ma Santé 2022 », une véritable attaque contre l'hôpital public et le droit à la santé.
Doctors who got a letter notifying them of a patient's overdose death scaled back their prescribing of opioids and other medications implicated in an epidemic claiming 174 lives per day. Article word count: 1161
Doctors who got a letter notifying them of a patient's overdose death scaled back their prescribing of opioids and other medications implicated in an epidemic claiming 174 lives per day. Article word count: 1161
Addressed directly to the doctor, the letter arrived in a plain business envelope with a return address of the San Diego County medical examiner’s office.
Its contents were intended, ever so carefully, to focus the physician on a national epidemic of opioid abuse — and his or her possible role in it.
“This is a courtesy communication to inform you that your patient [name, date of birth inserted here] died on [date inserted here]. Prescription drug overdose was either the primary cause of death or contributed to the death,” the letter read.
In the blandest of clinical language, the “courtesy communication” went on to inform the doctor of how many medication-related deaths the San Diego County medical examiner sees each year (between 250 and 270). It offered five prescribing tips (or “evidence-based interventions”) proven to help lower overdose death rates. And it steered the doctor to an online program designed to help medical professionals who are “dedicated to avoiding prescribing controlled substances when they are likely to do more harm than good.”
The letters — signed by San Diego County’s chief deputy medical examiner, Dr. Jonathan Lucas, who has since become Los Angeles County’s chief medical examiner — were part of an experiment to gauge how to reduce the prescribing of drugs implicated in fatal overdoses.
At a time when legally prescribed opioids and other medications are claiming 174 lives a day in the United States, the research aimed to test a new way to get physicians to rethink their prescribing habits.
Medical societies, state boards and the federal government have sought for several years to educate doctors and dentists about the risks of prescribing opioids, with limited results. The new research is among the first to take a different tack: Get physicians, who are inclined to view the opioid crisis as stemming from other doctors’ poor management, to understand how their own decisions may contribute in small ways to a national epidemic. And then give them tools to guide a change in behavior.
The study, written by a group of researchers led by Jason Doctor of USCʼs Leonard D. Schaeffer Center for Health Policy and Economics, was published Thursday in the journal Science.
Dated Jan. 27, 2017, the letter went out to 388 doctors. All had prescribed at least one of several drugs with known risks to a patient within a year of that person’s overdose death. The letters were careful not to suggest that the death was directly attributable to the doctor’s actions: Of the 82 deceased patients named, most had received prescriptions from several sources.
An additional 447 physicians found to have prescribed the same range of drugs to 85 patients who died of overdose got no such letter. But like their colleagues who got the letter, this comparison group’s prescribing practices were tracked over the next three months in an effort to discern whether the communication had made a difference.
Compared with the doctors who did not get a letter, those who did reduced their prescribing of opioid medications by almost 10% over the three-month study period. Doctors who got the “courtesy communication” started 7% fewer patients on a regimen of prescription opioids. And they were between 3% and 4.5% less likely to write prescriptions for the highest doses of opioid medication — those implicated most often in fatal overdoses.
Lucas acknowledged that such a shift may seem marginal. But he called it “just a piece” of a broader raft of initiatives that can nudge physicians in the direction of safer prescribing practices. With time, consistent messaging and a bit more insight into the role that they may play in the epidemic, doctors increasingly will rethink their prescribing of opioid medications, he said.
“It’s sort of a process,” said Lucas, who reported that he got only five or six calls from physicians wanting to follow up on the letter with him. Given the growing awareness of the issue, he said, “if we had extended the study period out to a year or so, we probably would have seen a bigger difference.”
In a first-of-its-kind initiative, San Diego County soon will be routinely sending “courtesy letters” that notify doctors when an overdose of certain drugs has claimed the life of a patient.
Los Angeles County is exploring the feasibility of sending similar letters to physicians, Lucas said.
“We are definitely thinking about it,” he said Thursday. “It’s the right thing to do.”
Few experts doubted that the letter got doctors’ attention — at least in the short term.
“I have to imagine it’s gut-wrenching,” said Dr. Sean Michael, a University of Colorado emergency physician who has studied opioid prescribing habits but was not involved in the new research. “The job that everybody is trying to do on a daily basis is the exact opposite of this outcome. The intention when people wrote these prescriptions was to try to help someone, not to accidentally kill them. But that’s the problem: The edge is so narrow and the risk is so high with these medications.”
Knowing that those prescribing decisions may have contributed to a patient’s death appears to challenge a comforting delusion that Michael’s research shows is shared by most doctors — that they are less likely than their peers to prescribe opioids, or to do so in ways that have been found unsafe.
“It tells them, ‘I might be part of the problem here,’” Michael said. “It turns out that a decent proportion of them are probably prescribing more than their peers and don’t have the insight to recognize that.”
Whether getting such a letter will spark long-term change is a matter still to be studied.
Stanford University pain medicine specialist Dr. David Clark is hopeful. But, he said, it could take years for the letters’ effects to reverberate through a doctor’s practice.
“You don’t change doctors’ prescribing habits — or patients’ consumption habits — overnight,” said Clark, who teaches anesthesiology, perioperative and pain medicine at the VA Palo Alto Health Care System. “I imagine if a physician has to change their practice, they have to initiate a long and difficult conversation with a patient … and we all experience pushback,” he said.
Dr. Andrew J. Schoenfeld, an orthopedic surgeon at Brigham & Women’s Hospital in Boston who has studied the opioid prescribing habits of surgeons, said that notifications of a patient’s death might help doctors who are on the receiving end of that pushback.
“It gives a doctor something objective to present to a patient and say, ‘I’m not just deciding out of the blue that we should reconsider your opioid medication use,’” said Schoenfeld, who was not involved in the new research. “It helps answer that question from patients, ‘Why now?’”
Physicians also will have to put aside years of conventional wisdom — much of it fostered, funded and promulgated by the makers of opioid narcotics — that the medications are safe and effective for a wide range of pain conditions, Clark said.