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Health Policy, NIH, Research, Science Policy, Stanford News

NIH tries to reduce the gray in the grant pool

NIH tries to reduce the gray in the grant pool

This 45-second animation vividly illustrates the funding crisis that young scientists face as they work to launch their research careers: For the last three decades, large NIH grants have increasingly been awarded to older investigators.

“The average age of first-time, R01-funded investigators who have PhDs remains 42, even after seven years of policies at NIH to increase the numbers of new and early-stage investigators,” said Robin Barr, director of the NIH’s Division of Extramural Activities, in a recent editorial on the NIH website.

But there is hope on the horizon, as the NIH rolls out a series of funding mechanisms that aim to give new investigators a leg up. I recently wrote about one such program, the KL2 mentored career development award, and an inspirational Stanford physician-researcher, Rita Hamad, MD, MPH, who is taking full advantage of it.

Hamad is interested in studying the cause-and-effect relationships between poverty and health. The KL2 program helps Hamad’s research through salary support, mentoring, pilot grants and tuition subsidies. In just two years, she has produced actionable data that can be used by policymakers and by health-care providers to improve the overall health of populations, including a study exploring the impact of the earned-income tax credit on child health in the United States. It will be published this fall in the American Journal of Epidemiology.

Previously:NIH funding mechanism “totally broken,” says Stanford researcher, NIH director on scaring young scientists with budget cuts: “If they go away, they won’t come back” and Sequestration hits the NIH – fewer new grants, smaller budgets
Animation by the NIH

Big data, Events, Health Costs, Health Policy, Medicine X

Peter Bach on drug pricing: “A system so broken even a child could manipulate it”

Peter Bach on drug pricing: “A system so broken even a child could manipulate it”

Peter Bach at MedX

The U.S. medical system is like a New England toll road: It’s designed to extract tolls from patients all along their health-care journeys, with a callous disregard for whether or not these travelers arrive at their desired destination, a place of better health.

This was the angry message delivered by Peter Bach, MD, director of Memorial Sloan Kettering’s Center for Health Policy and Outcomes, who was the keynote speaker at today’s Medicine X conference.

Dr. Bach is a physician, an epidemiologist, a researcher and a respected health-care policy expert whose work focuses on the cost and value of anti-cancer drugs. He was also a caregiver who has traveled down the patient side of the system as his wife died of cancer.

In his talk, Bach discussed three of the major toll takers in the system — pharmaceutical companies, hospitals and researchers — and how the public’s wielding of a growing body of health-care data could be used to reign in a process that is driven more by profit than health outcomes.

This week no discussion on escalating health-care costs could pass without mentioning Martin Shkreli, the 32-year-old hedge fund manager whose drug company raised the price of a decades-old anti-parasite drug by more than 5,400 percent. “He made it clear that the system is so broken even a child could manipulate it,” said Bach.

But Bach went on to show some promising quality improvement projects that are helping to bring accountability into the health-care system.

Continue Reading »

Infectious Disease, Public Health, Research, Stanford News

Hikers beware: New tick-borne disease discovered in Northern California parks

Hikers beware: New tick-borne disease discovered in Northern California parks

dan with wood rat 3Meet Dan Salkeld, PhD, a disease ecologist and friend, shown here looking for ticks on a wood rat from the San Francisco Bay Area. According to Popular Science, he has one of the worst jobs in science: tick collecting.

But thanks to the nitpicky diligence of Salkeld and co-author Eric Lambin, PhD, a senior fellow at the Stanford Woods Institute for the Environment, Bay Area residents now know that getting sick from a tick bite is a real and present danger — in a recent study published in PLoS One, the researchers found that 10.6 percent of young nymph ticks and 8.1 percent of adult ticks harbored the disease-causing bacteria Borrelia miyamotoi and/or Borrelia burgdorferi, the causative agent of Lyme disease. (See map below for tick collection areas.)

“We continue to be surprised by the number of ticks carrying Borrelia burgdorferi and Borrelia miyamotoi throughout the Bay Area, and we believe more research into the connections between human disease and strains and species of bacteria is critical,” said Salkeld. “It was astonishing that we could see such variety in tick ecology, ranging from low tick infection risk on one trail to high tick infection risk on another trail in the same park.”

First discovered in the United States in 2013, the most extensive analysis of Borrelia miyamotoi infections in U.S. residents was published in the July issue of Annals of Internal Medicine. In this study, 51 patients from the Northeast were found to be “frequently very ill” with fever, headache (often severe), muscle pain, fatigue and joint pain. Almost one quarter of the patients required hospitalization. The researchers also found that the miyamotoi infections were not reliably detected by the standard two-tiered Lyme blood test and these patients didn’t develop the hallmark sign of Lyme disease, the bullseye rash.

“This research offers some insights into the complexity of diagnosing patients with tick-borne diseases, and the need for medical professionals to be alert to the different symptoms of this newly discovered infection,” said Linda Giampa, executive director, of the Bay Area Lyme Foundation, which funded this study.

The Bay Area Lyme Foundation also funds a number of projects at Stanford’s Lyme Disease Working Group, which is exploring ways to improve diagnostic tests, evaluate the effectiveness of innovative therapies, expand clinical services and build greater public awareness of tick-borne diseases.


Previously: Stanford study finds Lyme disease among ticks in California parksAdd a tick check to your vacation checklistPiecing together the clues: Diagnosing and treating autonomic disorders
Photo courtesy of Bay Area Lyme Foundation; map from PLoS One

Big data, Clinical Trials, Ethics, Public Health, Research, Stanford News

The public wants easier ways to participate in medical research, study shows

The public wants easier ways to participate in medical research, study shows

Informed consent, the time-consuming process for obtaining permission to conduct health-care research on a person, was developed long before computers, the Internet and smartphones. Last year, when government regulators proposed to add an even greater burden of paper, red tape and so-called patient protections to this process, a team of bioethicists cried foul. And they took the issue to the public via a cross-sectional survey study that was published today in the Annals of Internal Medicine.

What the survey respondents said surprised them: Keep the permissions simple, but always ask permission, even when the research only involves anonymized medical records.

“The good news was that most people said that they would accept simpler approaches to granting permission, even verbal permissions, if requiring written agreements would hinder this type of comparative-effectiveness research,” study author Mildred Cho, PhD, associate director of the Stanford Center for Biomedical Ethics, said in our press release.

Bioethicists from Stanford and the University of Washington are on the leading edge of addressing the ethical challenges of evolving research methods, where researchers will increasingly use data from wearable devices, electronic medical records, genomic databases and other sources to help improve our population’s health.

In an editorial accompanying Cho’s article, John Lantos, MD, from Children’s Mercy Hospitals and Clinics, summarized the importance of the study:

Cho and colleagues challenge us to think of a better way. Autonomy should mean participatory engagement. Respect for persons should mean empowering them to develop the rules. It is time to ask whether a system in which the fundamental principle is ‘respect for persons,’ can continue to ignore the preferences of many of the persons it claims to respect.

As a next step, the bioethicists will be developing media-rich tools to explain the risks and benefits of research that uses electronic medical records and stored biological samples. For example, the video above was developed to explain the concept of informed consent to survey respondents unfamiliar with research terminology.

Previously: Build it (an easy way to join research studies) and the volunteers will comeHarnessing mobile health technologies to transform human health and Video explains why doctors don’t always know best
Video by Booster Shot Media

Big data, Clinical Trials, Ethics, Public Health, Research, Stanford News, Technology

Build it (an easy way to join research studies) and the volunteers will come

Build it (an easy way to join research studies) and the volunteers will come


Just nine days after the launch of Stanford Medicine’s MyHeart Counts iPhone app, 27,836 people have consented to participate in this research study on cardiovascular health.

“To recruit that many patients into a traditional clinical trial would take years and hundreds of thousands of dollars,” said Michael McConnell, MD, professor of cardiovascular medicine and principal investigator for the MyHeart Counts study.

MyHeart Counts was built with Apple’s new ResearchKit, a software development framework that can be used to create apps that turn an iPhone into a research and data collection tool. Leveraging a smartphone’s built-in accelerometers, gyroscopes, camera and GPS sensors, medical researchers can easily and inexpensively collect streams of data on exercise, diet and biometrics. Unlike most traditional clinical trials, which capture only a snapshot of patient data, ResearchKit studies are able to collect data from thousands of participants simultaneously, over long periods of time.

While the potential for this technology to accelerate medical research is tantalizing, the ethical issues of this shift in researcher-volunteer interactions took Stanford researchers and collaborator Sage Bionetworks nine months to work out.

“One of the big challenges in designing this study was to develop an ethical mechanism for informed consent on mobile devices,” David Magnus, PhD, director of the Stanford Center for Biomedical Ethics, told me. “It was essential that volunteers understand the nature of the research and what it means for them.”

The concept of informed consent is an important tenet of any research institution’s commitment to respect individuals and to “do no harm.” Without face-to-face meeting between a researcher and volunteer, there could be misunderstandings about risks, benefits and time commitments.

Stanford bioethicists are on the leading edge of addressing the communications challenges of these new frontiers in medical research. Rethinking long, text-based consent forms, they are exploring alternatives, such as audio, video, animation and interactivity.

For example, a team of bioethicists from Stanford and the University of Washington recently released animated videos that explain comparative-effectiveness research within medical practices to potential volunteers. Next, they’ll be developing media-rich tools to explain the risks and benefits of research that uses electronic medical records and stored biological samples.

To solicit ideas on how to best regulate this brave new world of informed consent, the U.S. Food and Drug Administration just posted draft guidance on “Use of Electronic Informed Consent in Clinical Investigations.” Public comments will be accepted through May 7, 2015.

To sign up for the MyHeart Counts study, visit the iTunes store.

Previously: Harnessing mobile health technologies to transform human healthMyHeart Counts app debuts with a splashStanford launches iPhone app to study heart health and Video explains why doctors don’t always know best
Photo by iMore

Applied Biotechnology, Bioengineering, Medical Education, Stanford News, Videos

An online film festival for medtech inventors

An online film festival for medtech inventors


The Stanford Biodesign program recently posted 296 short education videos on medical technology innovation. From needs finding through business planning, it offers entrepreneurs hours of useful advice on developing medical products.

This video library, which was launched with the second edition of the Biodesign textbook, is free to all. Its well-designed online interface makes it easy to access the advice that medtech innovators need, when they need it.

To create the video library, Biodesign hired filmmakers from both inside and outside of Stanford to capture the essence of the 2013-14 Biodesign fellowship program. During this ten-month program, multidisciplinary teams undergo a process of sourcing clinical needs, inventing solutions and planning for implementation of a business strategy. The program’s track record for bringing new medical devices and technologies to patients is impressive: Biodesign fellows have founded more than 30 companies in the last 14 years.

Each three- to four-minute video features interviews with faculty, fellows, CEOs, investors and alumni who have gone on to launch companies. A few of my favorites are:

The Biodesign video library, which was supported by the Walter H. Coulter Foundation, is an extension of the program’s mission — to help train the next generation of leaders in biomedical technology innovation. While the Stanford-based Biodesign program admits only 12 full-time postgraduate fellows a year, now these lessons-learned can be shared with medtech entrepreneurs around the globe. Just B.Y.O.P. (Bring your own popcorn.)

Previously: A medical invention that brings tears to your eyesBiodesign fellows take on night terrors in children, Stanford Biodesign Program releases video series on the FDA systemHeart devices get at mobile makeover
Illustration from Cambridge University Press

Autoimmune Disease, Chronic Disease, Immunology, Stanford News, Videos

Chronic fatigue syndrome gets more respect (and a new name)

Chronic fatigue syndrome gets more respect (and a new name)

As has been widely reported, an Institute of Medicine (IOM) report released yesterday acknowledged that chronic fatigue syndrome is a real and serious disease and renamed the disorder “systemic exertion intolerance disease” to better reflect its key symptoms.

Stanford professor José Montoya, MD, who served as a reviewer on the IOM report, is featured in the video above, which accompanied Washington Post coverage of the development. The Post article goes on to say:

“We just needed to put to rest, once and for all, the idea that this is just psychosomatic or that people were making this up, or that they were just lazy,” said Ellen Wright Clayton, a professor of pediatrics and law at Vanderbilt University, who chaired the committee of the Institute of Medicine, the health arm of the National Academy of Sciences.

Although the cause of the disorder is still unknown, the panel established three critical symptoms for the condition (also known as myalgic encephalomyelitis):

  • A sharp reduction in the ability to engage in pre-illness activity levels that lasts for more than six months and is accompanied by deep fatigue that only recently developed.
  • Worsening of symptoms after any type of exertion, including “physical, cognitive or emotional stress.”
  • Sleep that doesn’t refresh the sufferer.

The panel also requires that a patient have one of two other disease manifestations, either cognitive impairment or orthostatic intolerance. Orthostatic intolerance is an autonomic nervous system disorder that is caused by an abnormal increase in heart rate and low blood pressure, believed to be triggered by the disease.

Susan Kruetzer, an SEID patient interviewed by Erin Allday in this San Francisico Chronicle article, expressed guarded optimism about the report’s ability to generate more research funding and patient support, saying “What I want to see is someone in Congress get pretty riled up by this report — have them see how many people are affected, how these people are really ill, how they’ve been mistreated,” Kreutzer said. “I’d just like to light a fire. I don’t know if this report will do that, but I suppose it gives us some ammunition.”

Previously: Some headway on chronic fatigue syndrome: Brain abnormalities pinpointed, Unbroken: A chronic fatigue syndrome patient’s long road to recovery and Deciphering the puzzle of chronic fatigue syndrome

Applied Biotechnology, Bioengineering, Ophthalmology, Stanford News, Videos

A medical invention that brings tears to your eyes

A medical invention that brings tears to your eyes

dry-eye-implantMore than 20 million Americans suffer from dry eye, a painful condition where a personal’s lacrimal glands don’t create enough tears to lubricate the surface of the eye.

But relief is around the corner for these sufferers – a tiny implantable device that stimulates natural tear production on a long-term basis is currently in clinical trials. The device increases tear volume by delivering micro-electrical pulses to the lacrimal gland. It’s inserted into the mucus lining of the sinus cavity or under the skin beneath the eyebrow. Tear delivery rates can be adjusted manually with a wireless controller. (You can watch a video of this device producing tears, below.)

This clever invention is the brainchild of bioengineer and former Stanford Biodesign fellow Michael Ackermann, PhD, who says he spent a good part of his boyhood in Louisville, Kentucky, taking apart things like VCRs, radios and weed-whackers.

“My parents wanted me to be a doctor, but it was very clear from a young age that I was going to be an engineer,” said Ackermann.

He’s now at the helm of Oculeve, a 20-person startup dedicated to helping people with dry-eye. Ackermann’s tale of how he took one crazy idea and turned it into a product that has the potential to help millions of people is featured in the latest issue of Inside Stanford Medicine.

More than one person’s story, it’s another example of the efficacy of the Stanford Biodesign training program, whose fellows have started 36 medtech companies and filed more than 200 patents, all of which have reached 250,000-plus patients.

Previously: Crying without tears unlocks the mystery of a new genetic disease, Instagram for eyes: Stanford ophthalmologists develop low-cost device to ease image sharing and Stanford-developed eye implant could work with smartphone to improve glaucoma treatments
Photo and video by Michael Ackermann

Applied Biotechnology, Bioengineering, Global Health, Microbiology, Stanford News

Foldscope beta testers share the wonders of the microcosmos

Foldscope beta testers share the wonders of the microcosmos

Foldscopes-TanzaniaChristmas came early for citizen-scientists who received the first batch of Foldscope build-your-own paper microscope kits from Stanford’s Prakash Lab over the last several months. These beta testers have begun sharing a variety of fascinating images, videos, tips and ideas on the Foldscope Explore website.

From this site, you can watch Foldscope videos of fluid pulsing through the brain of a live ant or the suction mechanism of a fly foot. One citizen scientist analyzes the structural differences between his brown and gray hair follicles. Another provides a tutorial on FBI bird-feather forensics. (Germophobes might want to skip the close-ups of a face mite or the fungus that grows in half-eaten yogurt cartons.)

Half the fun of receiving a Foldscope kit is the unboxing and building process, which has been captured in YouTube videos by Foldscope fans Christopher and Eric.

lens-mounterEach kit includes parts for building two microscopes, multiple lenses, magnets that attach a Foldscope to a smartphone camera lens, slide mounts, and a battery-powered light module. This allows users to view magnified images with the naked eye or projected on a wall. Photos or videos of Foldscope images can easily be captured and shared via smartphones.

For those of you who haven’t received your Foldscopes yet, rest assured that those who signed up on the beta test site will receive them soon. It’s taking longer than anticipated to build and ship 50,000 microscopes. (The gadget on the right was custom-designed to insert the tiny spherical ball lenses into the magnetic smartphone-mounting platform.)

For Foldscope updates, sharing and inspirations, bookmark Foldscope Explore.

Previously: Stanford bioengineer develops a 50-cent paper microscopeStanford microscope inventor invited to first White House Maker Faire, The pied piper of cool science tools and Free DIY microscope kits to citizen scientists with inspiring project ideas
Photo of Foldscope co-inventor Jim Cybulski and Tanzanian children building foldscopes by Manu Prakash; photo of lens mounting gadget by Kris Newby

Chronic Disease, Imaging, Immunology, Neuroscience, Research, Stanford News

Patients' reaction to ME/CFS coverage in Stanford Medicine magazine

Patients' reaction to ME/CFS coverage in Stanford Medicine magazine


In the last few weeks, Stanford published two articles on chronic fatigue syndrome, a.k.a. myalgic encephalomyelitis, and the outpouring of positive feedback from ME/CFS patients has been tremendous. In my long-form Stanford Medicine story and video, I describe a young woman’s seven-year battle with the disease and the groundbreaking research being done by her physician, José Montoya, MD, and immunologist Mark Davis, PhD, to identify the biomarkers and root causes of ME/CFS. My colleague Bruce Goldman followed up with an elegantly written article describing the distinct differences between the brains of ME/CFS patients with those of healthy people, in a newly released study from this same research team.

While our primary job as medical science writers is to explain new research accurately, it’s a bonus to know that we captured the patient experience in a compassionate way, and that we have in some way eased their suffering with hope.

Here is a sampling of a few of these letters from around the world:

From British Columbia, Canada:
Thank you for an article that is very well done. I will be printing it for my MD and forwarding it to family and a few close friends because it captures this devastating illness so well. I will keep a copy for myself to remind me (on those dark days) that Dr. Montoya is in my corner.

From Sweden:
I would like to thank you for your very informative and interesting article! This kind of information of what research is going on at Stanford, etc., is very important for us patients with ME all over the world! There is a lot of disinformation coming out about this disease and I therefore very much appreciate your article and especially Dr. Montoya’s passionate engagement with this disease.

From Cali, Colombia:
Here in Cali, Colombia, the city of birth of Dr. Montoya, I feel very happy reading your excellent article, and learning the marvelous and difficult investigation performed by these brilliant scientists. I was moved to tears. Thank you.

From the San Francisco Bay Area:
I want to thank you very much for the powerful piece you wrote about ME/CFS. You tell the story in a very engaging way, which is so compelling. It’s not the usual doom/gloom/dark room story which my daughter and I have encountered frequently in what people write about ME/CFS. Family and friends with whom I have shared the article are appreciative of your writing so descriptively and articulately about all aspects of ME/CFS: the science, the inequity of research funding, the personal experience of a patient, the work of Drs. Montoya/Mark Davis/Holden Maecker.

From India:
Today I have gone through your article about Erin’s story. How she recovered from CFS had given me a ray of hope as I am also suffering from such an ailment for the last 6-8 years.

From Atlanta, Georgia:
I just read your beautifully written article on Immune System Disruption. First soccer caught my eye, then “swimming in the primordial soup of creative disruption” locked me in. I read every word … and I am going to spend the rest of the night in Atlanta copying [my internal medicine doctor] on the article.

From Australia:
Just wanted to thank you for your excellent article. It could really make a difference in raising awareness and I appreciate the quality of your writing. I have suffered from CFS/ME for many years in Australia and find the research project and your understanding very encouraging.

From the blogosphere:
I just wanted to thank you for taking the time to write such an in-depth, accurate article on our oft-ignored illness. Dr. Montoya is a hero within the ME/CFS community, but I didn’t know about the others at Stanford also working on ME/CFS — that gives me some hope for a better future! I plan to share your article on my ME/CFS blog and in several Facebook groups for ME/CFS that I belong to.

Previously: Some headway on chronic fatigue syndrome: Brain abnormalities pinpointedUnbroken: A chronic-fatigue patient’s long road to recovery, Deciphering the puzzle of chronic-fatigue syndrome and Stanford Medicine magazine traverses the immune system
Image, showing white matter differences between a ME/CFS patient sample an a healthy control, by Michael Zeineh/Stanford

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