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Wednesday, August 22, 2018

Amazon’s latest health care hire is master of bringing technology into clinic

Dr. Maulik Majmudar has spent years toiling on a task Amazon must master to disrupt the nation’s health care industry: getting physicians to incorporate novel technologies into their practices.
This week, he announced he is taking a new job with the ecommerce giant following several years incubating new technologies at Massachusetts General Hospital.
In an interview with STAT Monday, Majmudar, the former associate director of the health care transformation lab at Mass. General, said the job at Amazon offers a chance to drive the uptake of technology solutions that could impact patients worldwide.

“The thing that truly attracted me was the opportunity to work with really meaningful products and services at the scale and scope Amazon has” around the world, Majmudar said in the interview. “There is an incredible amount of opportunity to bring into practice existing technology and digital tools that actually improve the experience and health and wellness of patients.”
Majmudar, who practiced cardiology until taking this job, declined to discuss his precise role at Amazon, but said he is working directly for the company, not the joint venture company being led by Dr. Atul Gawande. Amazon is working on an array of initiatives to build its health care business, including the use of artificial intelligence tools such as Alexa to make care more efficient and cheaper. It also recently acquired the online pharmacy PillPack as part of an attempt to upend the nation’s prescription drug business and is growing a unit focused on selling supplies to hospitals.
Majmudar has spurred the development of an array of technology products at Mass. General. He helped create a contest to drive innovation called the Ether Dome Challenge, which takes its name from the invention of surgical anesthesia at the hospital in the 1840s. The contest has generated a wide array of inventions, including a text messaging app to notify patients when they’re running behind, videos on atrial fibrillation that can be watched from mobile devices, and virtual tours to help patients understand the process and purpose of MRIs before undergoing their procedures, among many other products.

 
“At the innovation lab, we were all about the last mile — dealing with the implementation barriers,” Majmudar said. “You can have all the invention you want. But if you can’t actually implement and deploy it at scale and sustain it, it really is not going to have the impact that you anticipate.”
That describes the primary challenge facing Amazon and other technology companies as they seek to use data and digitally enabled products to upend medicine’s traditional practices and business models.
One colleague said Majmudar’s understanding of the cultural and business factors that often impede medical innovation makes him ideally suited for his new job. “He’s trained clinically and can think like an MBA and an entrepreneur as well,” said Zen Chu, a health care professor at the Massachusetts Institute of Technology’s Sloan School of Management. “He’s going to have a million ideas whipping past him from inside Amazon and outside, and he’s got the pattern recognition to figure out what is both clinically right and a good business as well.”
Chu and Majmudar co-authored an article for Fortune discussing the power of Apple’s research kit to change clinical practice by making it easier for physicians to gather and analyze sensor data and other information.
“This is the most exciting time in history for health technology to improve lives around the world, and the smartphone is a core enabler for health communication, education, monitoring, and telemedicine,” they wrote. “New technologies and services are extending this impact into diagnosis and simple therapeutic interventions.”
While he has successfully incubated tech inventions at Mass. General, Majmudar has also encountered barriers in his effort to implement mobile technologies. He served as a founder and chief clinical officer of Quanttus, which struggled with delays and technical challenges developing a wrist-worn device to monitor blood pressure.

After spending years and millions of dollars on that effort, it released an iPhone app for tracking blood pressure measurements that fell short of initial expectations, according to an article in MIT Technology Review, which reported the company struggled to solve accuracy problems related to the wrist-worn product.
But the challenges faced at Quanttus — gaining enough capital to bring a product to scale in a defined time frame — will be different from the ones he faces at Amazon, which has plenty of time and money to invest in changing health care.
“Putting innovations into practice is the part that gets me really excited,” Majmudar said, adding: “Even existing tools are rarely being utilized at their maximum potential, so how can we even just start with that, get adoption, get distributions … and drive behavior change not necessarily from the patient side, but from the provider side to actually deploy and adopt these tools? For me, it’s the right time to be part of that.”
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Aetna CEO Bertolini: Why we need CVS


In December 2017, CVS Health and Aetna announced a $69 billion merger that left an awful lot of people—shoppers, doctors, and executives—scratching their heads.
A drugstore combined with a health insurer? Is nothing sacred?
The deal, which was met with resistance by the American Medical Association but not U.S. regulators, is expected to close this year. (Aetna will become a standalone unit of CVS Health.) It will also almost certainly radically change the landscape of the healthcare industry.
So why CVS and Aetna? In March, at Fortune’s Brainstorm Health conference in Laguna Niguel, Calif., I sat down with Aetna CEO Mark Bertolini to ask that very question.
His answer? It’s about getting closer to the community. CVS has 10,000 stores within five miles of 80% of the American public; that’s a huge footprint to leverage, he says. But there’s a lot of work to do to accomplish that. “The insurance company isn’t going to be about making money anymore,” Bertolini says. “It’s [going to be] about facilitating the financing of affordable and convenient care.”
Yes, but you have to make money, too. In 2017, Aetna made $60 billion and CVS made $185 billion. Surely shareholders won’t stand for losses. “But you don’t have to make it there,” he says of the insurance component. “When you bring together owner economics in a vertical integration, where you make your money should be where the customer value sits.”
That changes the context of how you think about customers, too. Technology has allowed for more personalization in health—but “that means reaching each person, not populations,” Bertolini says. “Right now, we manage populations of risk.” The health industry is moving toward managing risk on an individual level, he says. “The price arbitrage is so significant between what goes on in the current medical-industrial complex of health care and providing other services in the community that can help a person live a healthy life,” he says. So it makes sense to do things that “are not covered by benefits” and “not part of the traditional health care system.”
And that means you just might need to get closer to 80% of the American population. “You’ve gotta get local, you’ve gotta get personalized, you’ve gotta get in the home,” Bertolini says. “None of which can be done from Hartford.”
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17 health systems form Medicaid transformation project


Former CMS Acting Administrator Andy Slavitt will co-lead collaborative that focuses on behavioral health, women and infant care, substance abuse and avoidable ER visits.

KEY TAKEAWAYS

Collaborative will focus on digitial solutions to improve care for vulnerable populations.
It’s not clear if the collaborative is working with CMS to achieve its goals.
Slavitt is an outspoken critic of the Trump administration’s efforts to reform Medicaid and Medicare.
Seventeen health systems in 21 states are collaborating to identify, develop, and scale financially sustainable digital solutions to improve healthcare for the 75 million Americans on Medicaid.
The Medicaid Transformation Project will focus on critical challenges facing vulnerable populations across the country, including behavioral health, women and infant care, substance use disorder, and avoidable emergency department visits.
“Geisinger has joined the Medicaid Transformation Project because of AVIA’s emphasis on action. … The gap between the needs of vulnerable populations and the healthcare they receive is too great,” said David Feinberg, CEO of Geisinger, in Danville, Pennsylvania, one of five “anchor” health systems in the collaborative.
“We are no longer interested in discussing the problems our patients are facing or just piloting solutions – we’re interested in solving them as quickly as possible,” Feinberg said.
The other four anchor health systems are Advocate Aurora Health in Chicago and Wisconsin; Baylor Scott & White Health in Dallas; Dignity Health  in San Francisco; and Providence St. Joseph Health in Renton, Washington.
The collaborative will be led by AVIA, the health system digital transformation network, and Andy Slavitt, former acting administrator at the Centers for Medicare & Medicaid Services, and founder of the venture capital firm Town Hall Ventures.
“The current healthcare system fails the people who need it most,” Slavitt said. “The Medicaid Transformation Project will be part of a decade-long journey leading some of the best health systems in the country. Our work will be to deepen and refine the best innovations and then implement them at an accelerated pace at providers across the country.”
Slavitt is an outspoken critic of the Trump administration and its ongoing efforts to hobble the Affordable Care Act and reform Medicare and Medicaid. It is not clear if the collaborative intends to work with Medicaid, or in spite of it, to achieve its transformational goals. No mention of collaboration with the current leadership at CMS made in a media release issued by the collaborative.
AVIA will work with a team at each health system to implement solutions that share best practices across the network, and create a roadmap for partner organizations to act quickly to create change. The work will feature a Leadership Council, chaired by Slavitt and composed of health system CEOs.
The collaborative said that Medicaid in its existing form is not sustainable, and the fallout from a destabilized program could be catastrophic. Medicaid insures one-in-five Americans, pays for 50% of births in the United States, is the biggest payer for behavioral health services, and with Medicare accounts for 33 cents of every dollar for physician services.
Combined, the 17 hospitals in the collaborative span 21 states, 280 hospitals with more than 53,000 hospitals beds, and more than $100 billion in combined annual revenues.
The collaborative said the allied health systems will be able to better meet their communities’ needs by adopting shared digital solutions and innovative care models.
In addition to the five anchor health systems, the 12 other health systems in the Medicaid Transformation Project are:
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Pfizer, Astellas revise two cancer drug trial protocols to speed up results


Drugmakers Pfizer Inc and Astellas Pharma Inc said on Wednesday they would change protocols for two late-stage trials testing prostate cancer drug Xtandi to speed up completion.
The companies now expect the ARCHES trial to end late this year, ahead of the previously anticipated completion date of April 2020, and the EMBARK trial to complete by mid-2020, earlier than the prior goal of March 2021.
Both trials are testing Xtandi in men with hormone-sensitive prostate cancer.
Xtandi is already approved in the United States to treat castration-resistant prostate cancer and brought Pfizer revenue of $171 million in the latest reported quarter.
Prostate cancer is the second most common cancer in men worldwide and over 164,000 men in the United States are estimated to be newly diagnosed with the disease this year, according to the American Cancer Society.
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Pharma sector warns Saudis on German drug curbs


European and U.S. pharmaceutical associations have waded into a diplomatic row between Germany and Saudi Arabia, warning that ongoing restrictions on German-made drugs could hurt Saudi patients and dampen future investment in the kingdom.
In a strongly worded letter to Crown Prince Mohammed bin Salman, a copy of which has been seen by Reuters, the associations highlighted the level of concern in Germany and elsewhere about restrictive procurement measures implemented by Riyadh in response to criticism of its policies.
While a human rights row between Canada and Saudi Arabia has dominated headlines in recent weeks, Germany has been embroiled in its own spat with the oil-rich kingdom since November.
Germany’s foreign minister at the time, Sigmar Gabriel, condemned “adventurism” in the Middle East in comments perceived by some as an attack on increasingly assertive Saudi policies. Riyadh dismissed the comments as “shameful” and withdrew its ambassador to Germany.
Since then, Chancellor Angela Merkel has tried to ease the tensions, speaking to Prince Mohammed by telephone. But the row has rumbled on and German officials say companies such as Siemens Healthineers (SHLG.DE), Bayer (BAYGn.DE) and Boehringer Ingelheim are being excluded from public healthcare tenders in Saudi Arabia.
“For the past six months German healthcare companies have been having trouble doing business in Saudi Arabia,” said Oliver Oehms of the German chamber of commerce and industry in Riyadh. “It is not a general boycott, but the healthcare sector is clearly suffering.”
The dilemma for Berlin has been deepened by the Canada-Saudi dispute, which was triggered by a tweet from the Canadian foreign minister calling for the release of human rights activists in Saudi Arabia.
The kingdom responded by expelling the Canadian ambassador, recalling its own envoy, freezing new trade and investment, suspending flights and ordering Saudi students to leave Canada.
Some German politicians have denounced the Saudi reaction, but the government has remained conspicuously quiet for fear of sabotaging its own conciliation efforts.

‘MAJOR NEGATIVE EFFECTS’

News that Saudi Arabia was punishing German companies broke in May. But the existence of the letter, dated June 12 and addressed to Prince Mohammed, has not been reported previously..
“This action could have major negative effects on the sustainable supply of innovative, critically necessary medicines for the treatment of patients in the Kingdom of Saudi Arabia,” the letter from the German (VFA), European (EFPIA) and American (PhRMA) pharmaceutical associations reads.
It says a decision to exclude German-made products from the centralized Saudi procurement process for medical supplies “is likely to significantly dampen industry’s perception of Saudi Arabia as a site for future investment in innovative medicines”.
The associations declined to comment further, but German officials said there had been no response from the Saudis or an improvement in their situation since the letter was sent.

Siemens Healthineers AG38.005
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Saudi Arabia is the largest pharmaceuticals market in the Middle East and Africa, with sales of $7.6 billion last year, according to healthcare information company IQVIA.
With a growing burden of chronic diseases tied to a more Western lifestyle, Saudi Arabia’s overall drugs market is growing at 10 percent a year and the tender sector is expanding by about 30 percent.
Neither Bayer nor Boehringer rank among the top 10 drug suppliers in Saudi Arabia. That list is led by Novartis (NOVN.S), Pfizer (PFE.N) and local manufacturer Tabuk, according to IQVIA.
German exports to Saudi Arabia fell 5 percent in the first half of 2018. They totaled 6.6 billion euros in 2017, with an estimated 15 percent coming from the healthcare sector.

AMERICAN HELP

Bayer and Boehringer declined to comment. But Siemens Healthineers, which makes X-ray and MRI machines as well as diagnostic equipment, acknowledged that its business in Saudi Arabia had been affected and said it had turned to U.S. authorities for help in ending the impasse.
“The decision of the Saudi Arabian government indeed has an impact on our local business,” said a spokesman for the Siemens unit, which does not provide a breakdown of its Saudi business.
“We are working on a solution together with U.S. authorities to utilize our global value chain to overcome the restrictions of the Saudi Health Ministry,” he added, declining to provide further details.
The company employs about 13,000 people in the United States, more than a quarter of its global workforce, and could make the case to American authorities that its U.S. operations and jobs will be hit if Saudi restrictions are not lifted.
It could also rejig supply routes to send more products from the United States instead of Germany.
Johann Wadephul, a senior member of parliament from Merkel’s conservative Christian Democrats (CDU), described the row with Saudi Arabia “very damaging”.
“Should there be solidarity with Canada? Yes. But I don’t think this should be the focus of German foreign policy in the region,” he told Reuters.
“The focus should be on improving relations with Saudi Arabia. Unfortunately, we haven’t achieved this so far.”
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U.S. appeals court says Glaxo cannot be sued over generic drug suicide


A U.S. appeals court on Wednesday tossed a $3 million verdict against GlaxoSmithKline over the suicide of an attorney who took a generic version of the company’s antidepressant Paxil, finding the company could not be held liable for injuries allegedly caused by a generic copy.
A unanimous three-judge panel at the 7th U.S. Circuit Court of Appeals said claims against GSK were preempted by federal law and U.S. Supreme Court rulings.
The case weighing whether brand-name manufacturers can be sued for injuries blamed on generic drug versions was closely watched within the pharmaceutical and legal industries, and GSK drew support from industry groups including the U.S. Chamber of Commerce.
A lawyer for GSK during a May hearing in front of the appeals court said allowing the verdict to stand would be catastrophic and “totally upend the pharmaceutical industry.”
A jury in Chicago federal court in 2017 awarded $3 million to the widow of Stewart Dolin, a partner at Reed Smith LLP who jumped in front of an oncoming commuter train in 2010 after taking a generic equivalent of GSK’s Paxil.
Wendy Dolin filed the lawsuit in 2012 against London-based GSK, which controlled Paxil’s design and label at the time her 57-year-old husband committed suicide.
Under a 2011 ruling by the U.S. Supreme Court, generic drug companies cannot be sued for failing to provide adequate label warnings about potential side effects because federal law requires them to use the brand-name versions’ labels.
As a result, Dolin instead sued GSK, saying its Paxil label failed to warn of suicide risks among adults, alleging that the company had underreported adult suicide rates during its trial studies to the FDA.
GSK said the FDA had repeatedly refused to update Paxil’s warnings on the risk of adult suicide, despite the company asking the agency to do so. The label includes warnings on suicide risks among patients below the age of 24.
The 7th Circuit on Wednesday said there was clear evidence the FDA would have rejected adult suicide warnings on Paxil’s label.
GSK did not immediately respond to a request for comment on the decision.
Brent Wisner, a lawyer for Wendy Dolin, did not immediately respond to a request for comment.
Wednesday’s decision follows a series of state court rulings in similar cases. The top courts of Massachusetts and California ruled brand-name manufacturers could be sued by generic drug users.
However, West Virginia’s Supreme Court in May rejected liability claims against brand-name manufacturers for alleged failures to warn over a generic company’s drug.
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‘NEW’ Prehab Prior to Cardiac Surgery May Improve Outcomes


Researchers are investigating the effects of “prehabilitation,” using wait times prior to cardiac surgery as an opportunity to improve postoperative outcomes for frail older adults.
A three-pronged approach called NEW, a component of the enhanced recovery protocols (ERPs), targets nutritional status (N), exercise capacity (E), and worry reduction (W) to support the growing number of older patients undergoing complex cardiac procedures.
A new review examines the evidence supporting the NEW approach to prehabilitation in these patients as well as barriers to implementation, including the need for further research.
“The fundamental premise behind prehab ERP is that improving patients’ functional reserve before their procedure will improve postoperative outcomes that are important to older adults, including preserving mental and functional independence and enhancing postoperative recovery,” lead author Rakesh C. Arora, MD, PhD, University of Manitoba, St. Boniface Hospital, Winnipeg, told theheart.org | Medscape Cardiology.
The article was published in the July issue of the Canadian Journal of Cardiology.

A Growing Need for Prehabilitation

Medical advancements have expanded overall life expectancy and the demand for cardiac surgery among the aging population has increased. The authors note that 8.5% of the world’s population is older than 65 years of age, with that number projected to increase to 17% by 2050.
An increase in older adults with heart disease as well as related surgeries can lead to “comorbid-associated higher vulnerability with associated deconditioning” resulting in a problematic recovery process and less than ideal postoperative outcomes, they write.
“This places some patients, particularly those who are more frail, at a higher vulnerability to poorer postoperative outcomes and a complicated recovery process after cardiac surgery,” says Arora. “In addition, such patients experience a reduced quality of life as a result of loss of the ability to independently perform activities of daily living.”
In Canada, patients who require elective cardiac surgery are placed on a waiting list for up to 2 months. This waiting period can often result in further inactivity because of cardiac symptoms and anxiety, which results in further deconditioning, the authors say.
The goal of prehab is to “reduce postoperative complications and hospital length of stay as well as ideally improving the transition from the hospital back home.”
Prehab has been effective in supporting the patients’ physical and psychological readiness for surgery, the authors note. “We’re taking patients before their operation and putting them through the same program they would have after their operation,” says Arora.
Prehab has been used with bone and bowel surgery but has not been widely used for patients with cardiac conditions.

The Components of NEW

Current evidence shows that improving a patient’s physical functioning, providing adequate nutrition, and focusing on psychological and mental health needs are important factors in achieving postoperative outcomes, the authors write.
“The ideal prehab intervention would, therefore, target the biological, psychological, and social domains of frailty that can all limit recovery after the stress of cardiac surgery,” they note.
The NEW approach, says Arora, “may improve the patient journey through their operation and alleviate the surgical stress-related health deconditioning.”
The approach integrates dietary modification to counter protein-energy malnutrition, individually tailored exercise intervention to improve baseline functional capacity, and alleviate preoperative anxiety and stress.
Arora concludes that although there is some evidence to support the effectiveness of prehab, the programs are not widespread. There are several reasons for this, including potential patient-related issues. “As opposed to a pill or a lab test, prehab requires a substantial commitment from the patient (and potentially their caregivers) as well as resources from the healthcare team,” the authors write.
However, Arora says, “fundamentally, we need more research to answer some important questions,” not least of which is the safety of exercise-based interventions in these high-risk cardiac surgery patients which, the authors note, “has not yet been clearly shown.”
Other questions include better defining the target populations who may benefit most from prehab and examining specific characteristics of a prehab program including whether it is necessary to include all three exercise, nutritional, and anxiety-reduction components.
“Trying to protect people’s functional independence so they don’t just survive but thrive after the surgery is what we’re trying to do with the paradigm shift of care of older adults undergoing these procedures,” says Arora.
At present there are two Canadian trials studying prehab in older adult cardiac patients.
The multicenter Pre-Operative Rehabilitation for Reduction of Hospitalization After Coronary Bypass and Valvular Surgery (PREHAB) trial provides safety information for using prehab in older patients to “evaluate the feasibility of exercise intervention before elective cardiac surgeries and its efficacy in improving postoperative outcomes including length of hospitalization, health-related outcomes, and health-related quality of life outcomes.”
The Protein and Exercise to Reverse Frailty in Older Men and Women Undergoing Transcatheter Aortic Valve Replacement (PERFORM-TAVR) trial, led by Jonathan Afilalo, MD, McGill University, Montreal, Quebec, set to begin soon, will study “patient outcomes and transitions for frail older adults undergoing TAVR,” the authors note.
The study will use a “home-based physical activity program that combines walking and strength-building exercises under the supervision of a trained physiotherapist and nutritional supplementation that seeks to empower patients to adopt self-care behaviors before the procedures that will improve their recovery and diminish their likelihood of progressive deconditioning after a TAVR procedure.”
Arora has received an unrestricted educational grant from Pfizer Canada and honoraria from Mallinckrodt Pharmaceuticals for work unrelated to the article. The other authors have reported no relevant financial relationships.
Can J Cardiol. 2018;34:839-849. Abstract
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