Saturday, October 11, 2014

Can Big Data Tell Us What Clinical Trials Don’t? -

When a helicopter rushed a 13-year-old girl showing symptoms suggestive of kidney failure to Stanford's Packard Children's Hospital, Jennifer Frankovich was the rheumatologist on call. She and a team of other doctors quickly diagnosed lupus, an autoimmune disease. But as they hurried to treat the girl, Frankovich thought that something about the patient's particular combination of lupus symptoms — kidney problems, inflamed pancreas and blood vessels — rang a bell. In the past, she'd seen lupus patients with these symptoms develop life-threatening blood clots. Her colleagues in other specialties didn't think there was cause to give the girl anti-clotting drugs, so Frankovich deferred to them. But she retained her suspicions. "I could not forget these cases," she says.

Back in her office, she found that the scientific literature had no studies on patients like this to guide her. So she did something unusual: She searched a database of all the lupus patients the hospital had seen over the previous five years, singling out those whose symptoms matched her patient's, and ran an analysis to see whether they had developed blood clots. "I did some very simple statistics and brought the data to everybody that I had met with that morning," she says. The change in attitude was striking. "It was very clear, based on the database, that she could be at an increased risk for a clot."

The girl was given the drug, and she did not develop a clot. "At the end of the day, we don't know whether it was the right decision," says Chris Longhurst, a pediatrician and the chief medical information officer at Stanford Children's Health, who is a colleague of Frankovich's. But they felt that it was the best they could do with the limited information they had.

A large, costly and time-consuming clinical trial with proper controls might someday prove Frankovich's hypothesis correct. But large, costly and time-consuming clinical trials are rarely carried out for uncommon complications of this sort. In the absence of such focused research, doctors and scientists are increasingly dipping into enormous troves of data that already exist — namely the aggregated medical records of thousands or even millions of patients to uncover patterns that might help steer care.

More ...

Thursday, October 9, 2014

How to Prevent Ebola Panic in the Facebook Age -- Science of Us

To the casual observer, it seems that a new case of Ebola is diagnosed in the U.S. every day, that the disease will soon explode in a terrifying outbreak. Both of these observations happen to be false — most initial reports of Ebola have turned out to be false positives and, because of the United States' modern health infrastructure, it's exceedingly unlikely the disease will spread. But that hasn't prevented a fair amount of hysteria and misinformation from taking hold, and the very social-media tools that could help bring people accurate, panic-suppressing information about the virus are in many cases doing just the opposite.

"Ebola's the kind of disease that zombie movies are made out of," said Abdulrahman El-Sayed, a researcher at Columbia's Mailman School of Public Health. "It's the kind of thing where if you're not close to the science and don't understand the epidemiology of it, it's a very scary-sounding disease — you bleed all over the place, it kills more than 50 percent of the individuals who contract it, it's spreading like wildfire in West Africa." And given that we live in an age in which everyone is just a few keystrokes away from gruesome images of Ebola's symptoms and victims — not to mention from less-than-rigorous news sources stoking hysteria over the disease — experts face unique challenges in communicating key information about the virus to the public.

It is an inherently tricky task from a communications perspective. Ebola is, after all, a deadly and vicious disease. But the conditions that facilitated its spread in West Africa simply aren't present in the U.S., meaning its arrival here, while potentially tragic for those afflicted and their families, does not augur a larger outbreak.

Experts have actually known for a while that Ebola was going to show up in the U.S. Ever since the scope of the West African epidemic became clear, said El Sayed, American public-health officials have been hammering home the same message: "'There is gonna be an Ebola case here, but there's probably not going to be a transmission.'"

But before experts can effectively explain this, they first have to face down the biggest, scariest images of the disease lodged in the public's imagination thanks to both fictionalized accounts and sensationalistic news coverage. "You have to address everybody's worst fears before you can have a logical conversation about it," said El-Sayed.

Sandro Galea, also at Mailman, stressed that "Clear, consistent, honest communication is essential," especially now, during the early days of this outbreak's presence in the U.S., when rumors are running rampant, fueled by a lack of concrete information. "There's no question that uncertainty allows the space for misinformation to spread," said Galea, "which is why those in positions of authority need to be honest when there are things we don't know."

If officials don't get the message out effectively and misinformation and panic do spread, the results are unlikely to be rioting in the streets or toppling of the government (as opposed to the hardest-hit parts of West Africa, where Ebola really has caused varying degrees of societal upheaval), but they can still be damaging.

Galea said a primary symptom of panic over a disease is what he called "Flooding of the health-care system with the 'worried well'" — that is, folks who don't have the disease in question, but who think they do. "Something we learned from the SARS epidemic was that there were many more people who presented to emergency departments and their physicians because they were worried about having SARS than there were who actually did," he said. When these fears escalate, they can be dangerous in their own right, straining the health-care system with hypochondriacs "at a time when you want the system to be robust and able to respond to actual burdens."

There are reasons such straining is more likely to take place in 2014 than it might have been in, say, 1974. As Dietram Scheufele, a science-communications researcher at the University of Wisconsin pointed out, Americans get their health news and information in a vastly different way now than they did in the recent past.

"The big problem that agencies [like the CDC] have is that they, in most cases, can't communicate with audiences directly," he said. According to Scheufele, this was less of a problem back in the days when there were more reporters immersed in public-health and epidemiology beats, he said — and back when Americans had fewer sources of information. Today, though, he thinks there are fewer competent "middlemen" positioned between experts and mainstream audiences, and there's also a lot more social media — which is, by its nature, agnostic on the question of which information is accurate.

So yes, one can argue — as El-Sayed and Galea did — that the CDC's recent Twitter Q&A, in which it addressed some pretty scary questions, was an effective, modern way of cutting out the middleman altogether and communicating with the public directly. But Scheufele pointed out that there might be limits to this approach: "What's the Twitter following of the CDC? I'm sure it's much less than what Jenny McCarthy has, who routinely writes against vaccinations and everything else." (He's right: TheCDC has 378,000 followers, a number dwarfed by McCarthy's 1.23 million.)

It cuts both ways: People have as much access to information — including from trusted sources — as ever before, but they are also are enmeshed in networks, on Facebook and elsewhere, that might serve them heaping doses of panic rather than some much-needed perspective.

"On the one hand, the internet has democratized everything, which is excellent," said El-Sayed. "On the other hand, science is one of those places where there is a right answer. We don't always know it, but it's not a matter for public debate and conversation and opinion."

Security Theater Morphs Into Ebola Theater -- Science of Us

Is the government doing enough to protect us from Ebola? At a time of widespread panic and misunderstanding, it's a hot question — one that has generated a lot of conversation and at least one memorably nonsensical rant from Nancy Grace. And this week, the Centers for Disease Control announced plans to institute Ebola screening for passengers arriving in the country (as of this writing, we don't yet have details as to what this will look like).

As it turns out, this is a pretty pointless move from a public-health standpoint, but it can still tell us something interesting about how governments respond to a fearful populace.

During a segment on the screening program on yesterday's Morning Edition, reporter Anders Kelto interviewed Larry Gostin, a global health professor at Georgetown. "Let's not have the false impression that this is a tried-and-true method and it's gonna keep Ebola out of the United States — it's just not the case," said Gostin. There's little evidence such screening would actually detect Ebola patients, he explained.

It raises an obvious question: Why, then, is the government instituting this policy? Gostin's response:

[People who are scared] insist to their government, "Do something. It doesn't matter what it is — show us that you're doing something. Tell us that we have no risk." And governments, even if they know better, will sometimes respond to that political outcry. They're under a lot of pressure to do something, [to] make the public feel reassured even if it really doesn't make them safer.

Remember that Ebola just doesn't appear to be a major threat to the U.S. — none of the factors that turned it into a West African pandemic are present here. That doesn't mean people aren't freaking out, though — and understandably so given how horrific a disease this is. So how does the government respond? Um, we'll screen people at airports! Yeah! Which leads to an odd situation in which the government wins political points for taking ineffectual action against an imaginary threat.

Odd, yes, but not particularly uncommon. Think of all the 9/11 TSA reforms that people love to gripe about. Was taking off our shoes going to provide any sort of meaningful defense against the next Al Qaeda plot? Probably not (just ask the administrators at the many, many top-tier airports around the world that did not enact these measures). But even as we complained and struggled to bend over and get our footwear off, it made us feel like the authorities were responsive to our fears. At a time of great uncertainty, that was important.

The same logic applies here. As human beings, we derive a real psychological benefit from tangible evidence that the people charged with protecting us are doing a vigilant job — even when the substance of the action in question is questionable. So thank you, government, for soothing our misplaced Ebola fears in a highly visible but ultimately ineffectual way. Or something?

These Medical Apps Have Doctors and the FDA Worried | WIRED

Iltifat Husain has seen an awful lot of sickness and injury during his time as an emergency room doctor, but lately, he's worried about something new. He's worried about the ill effects of mobile healthcare apps. 

There are hundreds of medically themed apps in Apple's App Store and Google Play, and by most accounts, they've been wonderful tools for tracking, evaluating, and taking control of our personal health. Husain loves apps such as Draw MD, which lets physicians draw out surgical procedures for patients, and MicroMedex, a prescription drug reference encyclopedia. But he's concerned about the emergence of untested apps that are marketed as replacements for legitimate medical equipment—apps such as Instant Blood Pressure, which purports to take your blood pressure by way of the iPhone.

According to Husain, a faculty member in the Emergency Medicine department at the Wake Forest University School of Medicine, these apps could very well land someone in his E.R.—and maybe even get them killed. 

He's not alone in his concern. With an editorial in The New England Journal of Medicine last week, Nathan Cortez, an associate professor of law at Southern Methodist University Dedman School of Law in Dallas, Texas, called attention to this problem, and you'll hear much same complaint from Eric Topol, a medical doctor and director of the Scripps Translational Science Institute. "These apps have no validated data compared with accepted reference standards and therefore are quite concerning," he says. 

Although Husain believes these apps could be seriously harmful, the good news is that the FDA says it is now working to crack down on questionable healthcare apps, and some app makers may be willing to provide additional disclosures about their software when pushed to do so.

More ...

Mobile Medical Applications - FDA

The widespread adoption and use of mobile technologies is opening new and innovative ways to improve health and health care delivery.

Mobile applications (apps) can help people manage their own health and wellness, promote healthy living, and gain access to useful information when and where they need it. These tools are being adopted almost as quickly as they can be developed. According to industry estimates, 500 million smartphone users worldwide will be using a health care application by 2015, and by 2018, 50 percent of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health applications ( -be-using-healthcare-mobile-applications-in-2015/). These users include health care professionals, consumers, and patients.

The FDA encourages the development of mobile medical apps that improve health care and provide consumers and health care professionals with valuable health information. The FDA also has a public health responsibility to oversee the safety and effectiveness of medical devices – including mobile medical apps.

The FDA issued the Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff(PDF - 269KB) on September 25, 2013, which explains the agency's oversight of mobile medical apps as devices and our focus only on the apps that present a greater risk to patients if they don't work as intended and on apps that cause smartphones or other mobile platforms to impact the functionality or performance of traditional medical devices. 


Tuesday, October 7, 2014

Wrapped in Plastic: Preparing for Ebola - Photos - The Atlantic

As several African nations struggle to contain outbreaks of the deadly Ebola virus, and other countries ready themselves for any possible spread, images of healthcare workers wrapped in colorful personal protective equipment have become symbolic of the fight against the disease. In Liberia, Sierra Leone, and Guinea, local health providers and international volunteers protect themselves as best as they can, while caring for the sick and dying and disposing of infected belongings. In other countries, health professionals are making plans, preparing to handle any possible Ebola cases, and demonstrating their methods and protective gear for the press and government officials.

Is Your Dentist Ripping You Off? | Mother Jones

My household's level of confidence in dentistry is at an all-time low. About six months ago, my dentist informed me that my "bunny teeth" were likely getting in the way of my professional success, a problem he could correct with a (pricey) cosmetic procedure. If I let him fix my teeth, he told me, he was sure I would start "dressing better." A few months later, my husband scheduled a basic cleaning with a new dentist. Once they had him in the chair and looked at his teeth, they informed him that the regular cleaning wouldn't do at all: He would need to reschedule for an $800 deepcleaning. No thanks.

We were convinced we must look like suckers—until I came across an op-ed in ADA News, the official publication of the American Dental Association. The article, by longtime pediatric dentist Jeffrey Camm, described a disturbing trend he called "creative diagnosis"—the peddling of unnecessary treatments. William van Dyk, a Northern California dentist of 41 years, saw Camm's op-ed and wrote in: "I especially love the patients that come in for second opinions after the previous dentist found multiple thousands of dollars in necessary treatment where nothing had been found six months earlier. And, when we look, there is nothing to diagnose."

Some toddlers treated at one chain underwent as many as 14 procedures—often under restraint and without anesthesia.
"In recent years, I have been seeing more and more creative diagnosis," Camm told me when I called him at his practice in Washington state. A dentist, he said, might think, "'Well, the insurance covers this crown, so I'm not hurting this patient, so why don't I just do it?' That's the absolutely wrong approach."

Poking around, I found plenty of services catering to dentists hoping to increase their incomes. One lecturer at a privately operated seminar called The Profitable Dentist ($389) aimed to help "dentists to reignite their passion for dentistry while increasing their profit and time away from the office." Even the ADA's 2014annual conference offered tips for maximizing revenue: "Taking time to help our patients want what we know they need," notes one session description, "can drive the economic and reward engine of our practice."

More ...

Monday, October 6, 2014

After New Federal Rules, Popular Painkillers Will Be Harder to Get | Valley News

It's going to be more difficult to refill prescriptions for the most popular painkillers starting today, when new federal rules move products with hydrocodone into a stricter drug class reserved for the most dangerous and addictive substances.

In approving the change, the Drug Enforcement Administration cited the 7 million Americans who abuse prescription drugs and the 100,000 overdose deaths from painkillers in the last decade. Hydrocodone combinations, including Vicodin, Lortab and Norco, now account for more prescriptions than any other drug, with more than 130 million filled each year.

Proponents of the new rules believe many prescriptions go to younger people for recreational use because they are less likely to suffer from arthritis or other chronic pain conditions.

But many doctors, pharmacists and patients say the rule change effectively punishes people suffering from pain conditions because a small minority of the population abuses the drugs. The changes will be most burdensome for patients with cancer, disabilities and those who live in rural areas or in nursing homes, advocates say.

"For some patients who are legitimately using hydrocodone products for pain, this will be more challenging for them," said Amy Tiemeier, associate professor at St. Louis College of Pharmacy. "For physicians, the hassle will make them think twice about whether it's really necessary to prescribe this drug or maybe they should prescribe something else that has less addiction potential."

More ..,