Thursday, April 28, 2016

There’s a new sheriff in town in Silicon Valley — the FDA - The Washington Post

SAN FRANCISCO — Helmy Eltoukhy's company is on a roll. The start-up is a leading contender in the crowded field of firms working on "liquid biopsy" tests that aim to be able to tell in a single blood draw whether a person has cancer.  

Venture investors are backing Guardant Health to the tune of nearly $200 million. Leading medical centers are testing its technology. And earlier this month, it presented promising data on how well its screening tool, which works by scanning for tiny DNA fragments shed by dying tumor cells, worked on an initial group of 10,000 patients with late-stage cancers.

Just one thing is holding the company back: Guardant Health has yet to get approval from government regulators.

As a tidal wave of new health-related gadgets, apps and tests hits the market, the Food and Drug Administration, the Federal Trade Commission and other enforcement agencies are showing up in Silicon Valley like they've never done before. They have slapped companies such as Theranos, 23andMe, Lumosity and Pathway Genomics with warning letters and fines and opened investigations into products that regulators believe promise more than they can deliver.

More regulatory scrutiny is probably coming. Venture capital investments in life sciences hit a record high in 2015, with $10.1 billion invested in 783 deals, and total start-up funding is approaching levels of the last dot-com bubble — a development that has some industry observers worried that pseudoscience is being confused with innovation.

But even as some companies push back against federal agencies' reach — contesting which rules, if any, apply to their work — there's now recognition that the government can be a powerful ally rather than a brake on progress. And its stamp of approval can take firms from being worth multimillions to multibillions.

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Why So Many Doctors Are Advising Startups | Fast Company | Business + Innovation

Ethan Weiss, a cardiologist at UC San Francisco, spends long hours at the hospital treating patients. But between shifts, he takes calls with health-technology entrepreneurs to offer them advice and feedback.

As Weiss explains, it's not about the money. He does the majority of this advisory work for free or in exchange for a tiny chunk of equity. It's also not about prestige: He doesn't speak publicly about the startups he's consulting with. So why does he bother?

For one thing, it makes for a stimulating break in the day. "I have an intense curiosity and I like novel things," says Weiss.

It's a challenge to quantify the exact number of doctors moving into health tech; even if a large physicians' group like the American Medical Association (AMA) tried to keep track, it would need to determine whether to include doctors that advise startups but still practice one or two days a week, or just those who have left medicine altogether. I suspect that the former category is much larger. Suffice it to say, though, that Weiss is far from alone—the migration of doctors into the health tech space is noticeable.

It is now fairly common for well-funded health-tech startups to have medical directors, physician founders, or chief medical/health officers on their team. Some high-profile examples include Collective Health, Sherpaa, Startup Health, Doximity, Aledade, and AthenaHealth. And the AMA tells me it is proactively forging partnerships in Silicon Valley and beyond to help doctors "work in tandem on the innovative tech solutions that promise to change health care."

To understand why doctors are dabbling in startups or even changing careers, I recently polled MDs involved with startups (very informally) on Twitter to gauge whether they were motivated by money, prestige, fun, or altruism. Of 45 respondents, 44% were motivated by "fun." But it runs deeper than that. Weiss, for instance, has other motivations. He is concerned that much of the $4.5 billion in venture capital raised by digital health companies in 2015 will be spent on the next "Uber for health care," or the 10th next-generation stethoscope, rather than on solving patients' most pressing needs. "A lot of startups are peddling really cool technology in search of a problem," he told Fast Company.

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Medical Costs Vary Wildly Around The Country : Shots - Health News : NPR

Need knee replacement surgery? It may be worthwhile to head for Tucson.

That's because the average price for a knee replacement in the Arizona city is $21,976, about $38,000 less than it would in Sacramento, Calif. That's according to a report issued Wednesday by the Health Care Cost Institute.

The report, called the National Chartbook on Health Care Prices, uses claims and payment data from three of the largest insurance companies in the U.S. to analyze how prices for procedures vary from state to state, and city to city.

The takeaway? 

Health care prices are crazy.

"There doesn't seem to be a systematic pattern with respect to what's high and what's low," says David Newman, HCCI's executive director. Newman is lead author of an article published Wednesday online in the journal Health Affairs that accompanied the release of the Chartbook.

The reports compare average state prices for 242 medical services — from primary doctor visits to coronary angioplasty to a foot x-ray — to the national average price for those services. It shows that states such as Minnesota and Wisconsin have higher than average prices while others, such as Florida and Maryland, were cheaper overall.

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Monday, April 25, 2016

Book Review: ‘Hoping to Help’ Questions Value of Volunteers - The New York Times

Some do it to get into heaven, and some do it to get into medical school. Some do it because everyone else is doing it. Whatever the motivation, the number of health care volunteers heading from developed to developing countries has soared in recent years, with commentators straggling behind debating the merits of the stampede.

The reasons to applaud are self-evident: All the old epidemics are compounded by all the new ones, and the health-related fallout of wars and natural disasters never ends. If both skilled and unskilled labor can help, then surely those who provide such labor should do good, feel good and learn much.

Not necessarily, critics say. Some would concur instead with an opinion published by a Somali blogger in The Guardian in 2013 and quoted by the sociologist Judith Lasker in "Hoping to Help: The Promises and Pitfalls of Global Health Volunteering" — "The developing world has become a playground for the redemption of privileged souls looking to atone for global injustices by escaping the vacuity of modernity and globalization." (Read an excerpt.)

And indeed, as Dr. Lasker watched groups of American and Canadian volunteers in matching T-shirts surging through the Port-au-Prince airport two years after Haiti's disastrous 2010 earthquake, she was reminded of nothing so much as "the weekly Saturday turnover at American time-share vacation resorts."

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Sunday, April 24, 2016

NYTimes: The Dangers of ‘Polypharmacy,’ the Ever-Mounting Pile of Pills

Dr. Caleb Alexander knows how easily older people can fall into so-called polypharmacy. Perhaps a patient, like most seniors, sees several specialists who write or renew prescriptions.

"A cardiologist puts someone on good, evidence-based medications for his heart," said Dr. Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness. "An endocrinologist does the same for his bones."

And let's say the patient, like many older adults, also uses an over-the-counter reflux drug and takes a daily aspirin or a zinc supplement and fish oil capsules.

"Pretty soon, you have an 82-year-old man who's on 14 medications," Dr. Alexander said, barely exaggerating.

Geriatricians and researchers have warned for years about the potential hazards of polypharmacy, usually defined as taking five or more drugs concurrently. Yet it continues to rise in all age groups, reaching disturbingly high levels among older adults.

"It's as perennial as the grass," Dr. Alexander said. "The average senior is taking more medicines than ever before

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Saturday, April 23, 2016

Vancouver Prescriptions for Addicts Gain Attention as Heroin and Opioid Use Rises - The New York Times

VANCOUVER, British Columbia — Dave Napio started doing heroin over four decades ago, at 11 years old. Like many addicts these days, he heads to Vancouver's gritty Downtown Eastside neighborhood when he needs a fix.

But instead of seeking out a dealer in a dark alley, Mr. Napio, 55, gets his three daily doses from a nurse at the Crosstown Clinic, the only medical facility in North America permitted to prescribe the narcotic at the center of an epidemic raging across the continent.

And instead of robbing banks and jewelry stores to support his habit, Mr. Napio is spending time making gold and silver jewelry, hoping to soon turn his hobby into a profession.

"My whole life is straightening out," Mr. Napio, who spent 22 of his 55 years in prison, said during a recent interview in the clinic's mirror-lined injection room. "I'm becoming the guy next door."

Mr. Napio is one of 110 chronic addicts with prescriptions for diacetylmorphine hydrochloride, the active ingredient in heroin, which he injects three times a day at Crosstown as part of a treatment known as heroin maintenance. The program has been so successful at keeping addicts out of jail and away from emergency rooms that its supporters are seeking to expand it across Canada. But they have been hindered by a tangle of red tape and a yearslong court battle reflecting a conflict between medicine and politics on how to address drug addiction.

The clinic's prescription program began as a clinical trial more than a decade ago. But it has garnered more interest recently as a plague of illicit heroin use and fatal overdoses of legal painkillers has swept across the United States, fueling frustration over ideological and legal obstacles to forms of treatment that studies show halt the spread of disease through needles and prevent deaths.

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Friday, April 22, 2016

NIH hospital needs sweeping reform to better protect patient safety, panel says - The Washington Post

Practices at the National Institutes of Health Clinical Center, the hospital where cutting-edge medical research is conducted, require sweeping reform to better protect patient safety, a task force appointed by the agency reported Thursday.

The panel of experts, appointed by NIH Director Francis S. Collins, found that the hospital's research focus sometimes took priority over the safety of the critically ill patients treated there. It also said that the center has many "outdated or inadequate facilities" and that personnel lack expertise on regulations that apply to the hospital and its research and drug-manufacturing units.

The task force concluded that while clinical research at the hospital is integral to its mission, "it suffers from shortcomings that potentially impact patient safety and research outcomes." Regulatory deficiences in its drug production components "are examples of sustained weaknesses in structure, facilities, practices and compliance."

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Should Therapists Write About Patients? - The New York Times

When it came time for the pre-publication legal review for my most recent book, I had an idea of what to expect, or so I thought. The book was highly critical of the American Psychiatric Association, a deep-pocketed, fiercely self-protective organization. I took particular aim at its most lucrative product, the Diagnostic and Statistical Manual of Mental Disorders. So I figured the review would rigorously investigate whether my account was fair and accurate enough to withstand any legal challenge.

I was right about one thing: The review was a veritable inquisition. But I was wrong about the subject of the lawyer's concern. It wasn't the A.P.A. Instead, she was worried, nearly obsessively, about my accounts of interactions with my therapy patients. 

I'd told such stories before. My previous book was full of descriptions of therapeutic encounters, and I'd taken the industry-standard precautions. For detailed case studies, I obtained written consent. In cases where that was not possible (for instance, if the therapy had taken place long ago and I'd lost touch with the patient), I changed all the identifying information; a woman became a man, a doctor became a truck driver and so on. And sometimes I would assemble composite characters, golem-like, out of many people I had seen — a physical characteristic here, a verbal tic there — in order to illustrate a clinical point with a brief anecdote.

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Tuesday, April 19, 2016

Developing a Framework for Evaluating the Patient Engagement, Quality, and Safety of Mobile Health Applications - The Commonwealth Fund


Rising ownership of smartphones and tablets across social and demographic groups has made mobile applications, or apps, a potentially promising tool for engaging patients in their health care, particularly those with high health care needs. Through a systematic search of iOS (Apple) and Android app stores and an analysis of apps targeting individuals with chronic illnesses, we assessed the degree to which apps are likely to be useful in patient engagement efforts. Usefulness was determined based on the following criteria: description of engagement, relevance to the targeted patient population, consumer ratings and reviews, and most recent app update. Among the 1,046 health care–related, patient-facing applications identified by our search, 43 percent of iOS apps and 27 percent of Android apps appeared likely to be useful. We also developed criteria for evaluating the patient engagement, quality, and safety of mobile apps.

Health apps: Unlimited promise or 'like having a really bad doctor' - LA Times

For Julie Hadduck, a smartphone app that could diagnose cancer seemed like a miracle.

Her husband died of skin cancer in 2010. She worried that her three children could also be at risk, so she took them to a dermatologist twice a year.

When Hadduck photographed one of her daughter's moles, the app offered a diagnosis within seconds. "It came back red, and I was freaked out," said Hadduck, who lives in Pittsburgh.

She took her 9-year-old to a dermatologist, who reassured them the mole was benign. Hadduck, 47, deleted the app.

The app that Hadduck tried is one of more than 165,000 involving health and wellness currently available for download — a blending of technology and healthcare that has grown dramatically in the last few years. Experts see almost unlimited promise in the rise of mobile medical apps, but they also point out that regulation is sometimes lagging the pace of innovation, which could harm consumers.

"It's clearly a net positive, but I think there are risks to it," said Dr. Karandeep Singh, a professor at the University of Michigan who recently evaluated the quality and safety of hundreds of mobile health apps.

Major changes in the healthcare system set in motion by the Affordable Care Act, passed in 2010, coincided with the proliferation of smartphones. From 2013 to 2015, the number of health and fitness apps available on Apple's mobile operating system increased by 106%, according to one report.

Some of the most popular apps include Plant Nanny, a reminder to drink water; Sworkit, a personalized exercise video player; and HeartWatch, a heart rate tracker that's hooked up to the Apple Watch.

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