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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

Ethics, Genetics, History, In the News, Medicine and Society, Microbiology, Stanford News

Stanford faculty lend voices to call for “genome editing” guidelines

Stanford faculty lend voices to call for "genome editing" guidelines

baby feetStanford law professor Hank Greely, JD, and biochemist Paul Berg, PhD, are two of 20 scientists who have signed a letter in today’s issue of Science Express discussing the need to develop guidelines to regulate genome editing tools like the recently discovered Crispr/Cas9. Researchers are particularly concerned that the technology could be used to alter human embryos. From the commentary:

The simplicity of the CRISPR-Cas9 system enables any researcher with knowledge of molecular biology to modify genomes, making feasible many experiments that were previously difficult or impossible to conduct. […]

We recommend taking immediate steps toward ensuring that the application of genome engineering technology is performed safely and ethically.

We’ve written a bit here before about the Crispr system, which essentially lets researchers swap one section of DNA for another with high specificity. The potential uses, for both research or therapy, are touted as nearly endless. But, as Greely pointed out in an email to me: “Making babies using genomic engineering right now would be reckless – it would be unknowably risky to the lives of those babies, none of whom consented to the procedure. For me, those safety issues are paramount in human germ line modification, but there are also other issues that have sparked social concern. It would be prudent for science to slow down while society as a whole discusses all the issues – safety and beyond.”

The list of others who signed the commentary reads like a veritable who’s who of biology and bioethics. It includes Caltech’s David Baltimore, PhD; U.C. Berkeley’s Michael Botchan, PhD; Harvard’s George Church, PhD; and George Q. Daley, MD, PhD; University of Wisconsin bioethicist R. Alta Charo, JD; and Crispr/Cas9 developer Jennifer Doudna, PhD. (Another group of scientists published a similar letter in Nature last Friday.)

The call to action echos one in the 1970s in response to the discovery of the DNA snipping ability of restriction endonucleases, which launched the era of DNA cloning. Berg, who shared the 1980 Nobel Prize in Chemistry for this discovery, organized a historic meeting at Asilomar in 1975 known as the International Congress on Recombinant DNA Molecules to discuss concerns and establish guidelines for the use of the powerful enzymes.

Berg was prescient in an article in Nature in 2008 discussing the Asilomar meeting:

That said, there is a lesson in Asilomar for all of science: the best way to respond to concerns created by emerging knowledge or early-stage technologies is for scientists from publicly-funded institutions to find common cause with the wider public about the best way to regulate — as early as possible. Once scientists from corporations begin to dominate the research enterprise, it will simply be too late.

Previously: Policing the editor: Stanford scientists devise way to monitor CRISPR effectiveness and The challenge – and opportunity – of regulating new ideas in science and technology
Photo by gabi manashe

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

stanford-myheart-counts-iphone6-hero

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

Addiction, Behavioral Science, Ethics, Events, In the News, Media

At Stanford visit, Glenn Beck addresses compassion, change and humility

At Stanford visit, Glenn Beck addresses compassion, change and humility

glennUntil this week, I wouldn’t have associated radio personality Glenn Beck with compassion. And when Jim Doty, MD, director of Stanford Medicine’s  Center for Compassion and Altruism Research and Education invited Beck to the Stanford campus, he realized the right-of-center author and provocateur might be a tough sell to his audience accustomed to guests such as the Dalai Lama and Sri Sri Ravi Shankar.

“Please trust me,” Doty tweeted last week.

Yet fireworks were absent from the nearly two-hour conversation, which ranged from Beck’s struggle with addiction to his Mormon faith and his passion for radio.

Beck came across as human, a man who had endured struggles, made mistakes and is striving to learn from them. He is a father and husband, who organizes charity efforts and volunteers in his church. He said he’s gone from a person for whom the audience size was just a measure of his success to a man who cares deeply about people and his audience members. He prays for humility and said he is not trying to be divisive.

“I spend a lot of time, at the end of my day, saying, ‘Okay, am I that guy? What could I have done better,'” Beck said. “You self-examine all the time and with that self-examination you grow. It’s good. I know who I am because I’m pushed up against the wall all the time.”

Americans share a certain set of principles in common, Beck said. The rift begins when people replace their principles with specific interests and policies.

“For example, if I said to you, ‘Do we torture?’,” Beck said. Nearly everyone would say no. But once threats from terrorists are introduced, the conversation becomes more divided.

“The left and the right have principles in common. We may disagree on interests, but we have to start anchoring ourselves in the principles.”

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Bioengineering, Ethics, Fertility, Genetics, In the News, Parenting, Pregnancy

And baby makes four? KQED Forum guests discuss approval of three-parent IVF in UK

And baby makes four? KQED Forum guests discuss approval of three-parent IVF in UK

newborn feet Scope BlogLast week, the U.K. House of Commons voted to legalize a controversial in vitro fertilization technique called mitochondrial donation, popularly known as the “three-parent baby” technique. The technique is intended for mothers who have an inherited genetic defect in their mitochondria – the fuel compartments that power our cells – and can help them from passing on the incurable disease that often entails years of suffering and ends in premature death.

Doctors replace the DNA from a donor egg with the mother’s DNA, use sperm from the father to fertilize it, then implant it into the mother’s uterus via IVF technology. The donor egg’s cytoplasm contains defect-free mitochondria and DNA from both parents. Proponents say the technique gives parents with mitochondrial disease the chance to have disease-free children, but critics say it brings us one step closer to the reality of genetically modified “designer babies.”

On Friday, Stanford law professor and biotechnology ethicist Hank Greely, JD, was among the guests on KQED’s Forum broadcast to discuss the issue. He’s in favor of the procedure, noting that when looking at genetic modifications, “the purpose, the nature, [and] the safety” should be considered. “There are some things that I think shouldn’t be done,” he said, adding that “things like this, which gives women who have defective mitochondrial DNA their only chance to have genetic children of their own… if the safety proves up… seems to be a good use.”

Previously:  Daddy, mommy and ? Stanford legal expert weighs in about “three parent” embryos and Extraordinary Measures: a film about metabolic disease
Photo by Sean Drelinger

Aging, Ethics, Medicine and Society, Research, Science, Stanford News

Golden years? Researcher explores longevity research and the companies banking on its success

Golden years? Researcher explores longevity research and the companies banking on its success

Elderly Japanese woman for Scott blog postAlthough I haven’t had a birthday yet this year, the transition to writing 2015 on all my checks (whoops, did I just date myself there? ahem) has made me feel older. Coincidentally, I’ve also been working on an article for an upcoming issue of Stanford Medicine magazine about aging and longevity. So, yeah. I’ve been thinking a lot about the passage of time.

That’s why I was really interested to learn that Stanford bioethicist Christopher Scott, PhD, teamed up with Nature Biotechnology senior editor Laura DeFrancesco to c0-author a feature article examining the commercialization of longevity research. The article layers research advances with the rise and fall (and rise again) of companies and organizations that have tossed their hats into the anti-aging ring since the 1990s. With it, Scott and DeFrancesco paint a picture of a dynamic field on the brink of something big. As Scott explained in an email to me:

Aging research, as we knew it in the 1990s and 2000’s, is being abandoned in favor of something much more ambitious. The central features of longevity research include an embrace of big data, a pivot away from studies hoping to find aging genes, a recognition that aging is best thought of a collection of diseases, not just one disease.

I’m fascinated by how quickly this new direction has taken off, especially since classic aging research yielded so little, and became saddled with hype. Longevity research has that same feel to it, and from an ethics and policy perspective one question is whether the promise of healthy lifespans will outrun the reality of the science.

And there’s the rub. As Scott points out, it’s not enough to just live long. No one wants a prolonged, but unhealthy, old age. We need to live long and well. The concept that gained ground is “healthspan” rather than “lifespan.” And from Google’s Calico to Craig Venter’s Human Longevity, Inc , there are a lot of bright minds (and plenty of $) focused on this problem. But there’s a lot at stake.

As Scott explained:

These are highly consequential decisions (funding research, creating new companies, establishing new scientific disciplines), technological inventions, and social changes that are being pursued on the tacit assumption that such decisions, inventions, and changes do lead to a healthier, longer life and the promise of a better future. In ethics, I think these assumptions are largely unexplored and unacknowledged.

The article is a fascinating cross-section of a rapidly growing field, but, as Scott points out, there are still many questions that scientists haven’t addressed. It’s well worth the time to read, whether you’re a writer on a deadline or just a person trying to figure out how to gracefully change that “4” into a “5” on …all your paperwork.

Previously: Exploring the value of longevity with bioethicist Ezekiel Emanuel , Tick tock goes the clock – is aging the biggest illness of all? and Researchers aim to extend how long – and how well – we live
Photo by Maya Stone

Aging, Chronic Disease, Ethics, Health Policy

Exploring the value of longevity with bioethicist Ezekiel Emanuel

baby hand in old hand - big

In a popular article in the Atlantic published this past fall, Ezekiel Emanuel, MD, bioethicist and prominent federal policy adviser, made a controversial case against longevity. Just before the recent holidays, the USC Annenberg School for Communication & Journalism sponsored a webinar during which Emanuel explained and elaborated on his message. It’s not that he “hopes to die at 75,” as the title chosen by the Atlantic suggested, but he wants a life at 75 focused on living, not on living longer.

Emanuel essentially argues for quality of life over quantity of years, and he claims that American society is becoming obsessed by the latter. I listened in on his December talk, which began with an ad from the AARP that glorifies “going on forever” – a value he says is reflected in both the medical system and our contemporary culture.

He directed his scientific criticism against the idea of the “compression of morbidity” – the belief that with enough medical advances, disabilities will go away and people will live in good health until, more or less suddenly, they die. He calls this the “rectangularization” of life: falling off a cliff instead of rolling down a gradual decline. The idea is immensely popular and money-making, but while some research claims to prove it, far more proves the opposite. There is, in fact, an expansion of morbidity as people live longer, an elongated and more gradual decline with more disabilities and less and less creativity.

Given this, Emanuel’s hope and recommendation is two-fold: that people will consider what makes their life meaningful and spend their energy cultivating that, and that medical resources will be redirected from prolonging life to improving its quality at the outset – by reducing the country’s exceptionally high rate of premature births, for example.

American life expectancy is at an all-time high at nearly 80 years, but are octogenarians living meaningfully? Last month in the New York Times, David Brooks argued against Emanuel’s earlier piece by saying that the “happiest people” are ages 82-85; in the webinar, Emanuel says this misses the point. It’s much easier to measure happiness than meaningfulness, yet the latter is the real aim of life (and, furthermore, Brooks didn’t account for the perspectives of those in nursing homes, assisted living, or suffering from dementia). Emanuel talked of patients who say cancer was “the best thing that happened to me” because it made them focus on what was meaningful in their life. The end of life is important to think about, as it helps us see what we want from life now.

“Contorting life around living as long as possible seems to me to be counter-productive,” he said. “What we should be focusing our life on is what’s meaningful, how we enrich other people and contribute to our families and society.”

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Ethics, Health Policy, In the News, Medicine and Society, Research

Watching your spouse die on a TV reality show: De-identification as a myth, in death and life

Watching your spouse die on a TV reality show: De-identification as a myth, in death and life

Much biomedical research relies on the idea of “de-identification.” The Common Rule, the federal regulation on human subjects research, applies, as a general matter, if the researchers make some kind of intervention with the research subject or if they use “identifiable private information” about the research subject. But the “Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.”

De-identification doesn’t mean that no one will recognize the research subjects’ identity. Federal regulation says the researchers must not be able to ascertain it readily.

If the private information was not collected by the researcher (it comes from someone’s medical record or was collected as part of someone else’s research) and the research subject’s identity is not known to and cannot “readily be ascertained” by the researcher, it doesn’t count. No consent is required, no IRB review is required – it isn’t “human subjects research.”

And why should it be? If no one knows it is you, you cannot be hurt, or so the argument goes.

[Last Friday], the New York Times published an extraordinary article entitled “Dying in the E.R., and on TV Without His Family’s Consent” by Charles Ornstein, a reporter for ProPublica. It recounted how Anita Chanko, a 75-year-old widow, watching an ABC reality television show, NYMed, suddenly realized that she was watching her husband’s death in the emergency room. More than a year earlier, the 83-year-old man had been hit by a garbage truck while crossing the street and had died in the NewYork-Presbyterian hospital. The televised version blurred his face, but not the face of the surgeon, the description of the accident, or the sound of her late husband’s voice, asking “Does my wife know I’m here?”

At no time were any of the family told  that Mr. Chanko’s treatment was being filmed or asked their consent to its use on television.

The dead man’s widow and children were traumatized. One of their sons wrote in a complaint “I had to unnecessarily relive my father’s death at your hospital a second time, while knowing that the public at large was able to — and continues to be able to — watch my father’s passing, for the purposes of what can only be described as drive-by voyeuristic ‘entertainment.’ ”

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Ethics, Health Policy, In the News, Medicine and Society, Transplants

Moving the needle on organ donation

Moving the needle on organ donation

For the thousands of people on organ donation lists, news of an available heart, or lungs, or liver can’t come soon enough. But many don’t get that call in time. According to a new feature on The Atlantic’s website, 21 people die waiting for a transplant every day. That works out to more than 7,600 patients every year.

Unfortunately unless you’re personally touched by the issue… you don’t really think about it

Although many people say they support organ donation, in many countries, only a minority actually register as organ donors. (“Unfortunately unless you’re personally touched by the issue, unless you have a child that gets a virus and suddenly needs a new heart, you don’t really think about it,” one expert says in the piece.) It’s a paradox many people in the field are trying to unravel. The reasons they’ve uncovered so far include mistrust of medical professionals: Some people believe that if a medical team finds out that you’re an organ donor, they won’t work as hard to save your life, in order to harvest your organs. And how much TV a person watches can influence how much he or she trusts doctors. One study found that people who watched more of the TV series Grey’s Anatomy were more likely to mistrust doctors and nurses.

Religion also influences the picture, probably because of concepts of bodily integrity in the afterlife. Catholics are less likely to donate their organs, even though the Vatican officially supports organ donation.

So what can be done about the organ shortage? Some groups are working on solutions, as highlighted in the piece:

“What we’re trying to do in New York is move the cultural needle on the issue,” says Aisha Tator, executive director of the New York Alliance for Donation. “Organized tissue donation should be a cultural norm like we did with bike helmet and seatbelt interventions.” Her organization isn’t the only one. Throughout the United States there have been a smattering of recent educational campaigns and studies on their efficacy. Campaigns have targeted the young, the oldnursesDMV employees, and ethnic minorities who tend to donate less than white Americans or white Brits.

Another, more drastic change is to shift the U.S.’s current opt-in system to one that requires people to opt-out. Many experts point to Spain, which has an opt-out system – and one of the highest rates of organ donation. But the logistics of such a system would probably be difficult, best, to implement.

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Ethics, FDA, Health Policy, In the News, Stanford News

Stanford experts weigh in on spate of "right to try" laws for the terminally ill

Stanford experts weigh in on spate of "right to try" laws for the terminally ill

4286759185_f958aedc10_zTerminally ill patients should be able to access medication that could help them, regardless of how far along that drug might be in the FDA‘s in-depth approval process, right? Yes, some states such as Colorado, Missouri and Lousiana have said. They’ve adopted so-called “right-to-try” laws that gives dying patients access to drugs that have passed only the first stage of the FDA approval process.

Yet these laws — which are modeled on a policy from the libertarian Goldwater Institute — are ultimately useless given that federal law trumps state law, according to Stanford scholars Patricia Zettler, JD, and Henry Greely, JD, in an opinion piece published recently in JAMA Internal Medicine. In addition, the laws are redundant, they write:

Since the late 1980s, patients with serious and terminal conditions have been treated with unapproved medical products. Following sharp criticism from AIDS access about blocking access to potentially effective, but unproved, treatments, as well as congressional intent, the FDA issued regulations that are intended to provide patients with faster access to novel drugs for life-threatening conditions… Although satisfying the agency’s requirements may, at first glance, seem onerous, in practice the FDA very rarely rejects requests for expanded access.

Zettler, who formerly worked for the FDA, pointed out a link that is telling: During fiscal year 2012-2013, the FDA received 977 requests for “expanded access” (these requests may include more than one patient, Zettler said). It approved 974 of them.

None of the state or federal laws require a drug company to provide experimental drugs, and Zettler said she knows of only one – NeuralStem, Inc., a Maryland-based company that is developing therapies for central nervous system disorders –  that intends to provide drugs under these laws. By skipping the FDA’s process, the companies risk angering the FDA, whose favor they need for their drug approval, Zettler told me.

Why then these laws, which are currently also being considered in Michigan, Nevada and Arizona?

Well, Zettler told me, they’re political no-brainers. Imagine the political rants: “So-and-so made my mom die faster,” or “Joe Baloozabum opposes dying patients” – nope, that doesn’t fly inside any Beltway. Many state politicians are also motivated by a “good faith desire to help people,” Zettler said.

But she doubts that states have the expert staff needed to evaluate drug applications. And they don’t have the legal green-light either, she said, pointing out a recent ruling blocking Massachusetts’ attempt to ban a long-acting opiod.

Zettler said the state-based debates simply add a new wrinkle to a discussion that’s been percolating for decades.

Previously: No one wants to talk about dying, but we all need to and Asking the hardest questions: Talking with doctors while terminally ill
Photo by Melanie Tata

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