Published by
Stanford Medicine

Category

Health Policy

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.

Continue Reading »

Health Costs, Health Policy, Patient Care, Stanford News

A call for medical malpractice reform

Golden Lady Justice, Bruges, BelgiumA new report in the Journal of the American Medical Association offers a look at the current decline in medical malpractice suits and makes some predictions about their future. The authors include two Stanford faculty, Michelle Mello, JD, PhD, and David Studdert, LLB, ScD, who both have joint appointments at the School of Medicine and the School of Law.

Using national databases, the researchers found that the paid claims against doctors decreased between 2002 and 2013. Rates decreased by an average of 6.3 percent for medical doctors (MDs) and 5.3 percent for doctors of osteopathy (DOs). The amount of an average paid claim peaked in 2007 at $218,400, but had gone down a bit as of 2013. A post on the Stanford Law School’s blog explains why this may be a good time for policy-makers to consider reforms in the medical liability system:

“After years of turbulence, the medical liability environment has calmed,” said Mello. “Although many aspects of the malpractice system are dysfunctional, causing angst for physicians, the cost of malpractice claims and insurance have been stable for the last few years and the number of claims has been declining.”

She added, “Usually, attention is only focused on reform during ‘malpractice crises,’ but highly charged political environments are not conducive to cool-headed policy decisions. This current period of calm is a good time to be thinking about reforms that could improve our medical liability system.”

In their piece, the authors describe seven different novel approaches to medical malpractice reform, including one that encourages medical institutions and providers to communicate with complaining patients and find resolutions that might include payouts to patients before they file suit.

The paper also includes some predictions about the trends that will be important for medical liability policy in the coming decade. The authors assert that traditional tort reforms “will never deliver,” but the previously mentioned communication-and-resolution programs are likely to expand, as will “safe harbor” laws that protect clinicians and their institutions if they can show they are following a prescribed course of clinical treatment. Other trends include the increasing consolidation of health care within hospitals and large health systems. These large entities are likely to use their growing size to influence the liability system.

More ominously, authors note that liability insurance crises have happened in regular cycles since the system was expanded in the 1960s, and warn that another is imminent. They conclude their report by saying:

Action now to reduce the amplitude of the next medical liability cycle is both prudent and feasible. Further testing of nontraditional reforms, followed by wider implementation of those that work, holds the most promise. Prospects for permanent improvement in the medical liability climate depend on it.

Photo by Emmanuel Hybrechts

Events, Health Costs, Health Policy, In the News, Medicine and Society, Stanford News

Experts discuss high costs of health-care – and what it will take to change the system

Experts discuss high costs of health-care - and what it will take to change the system

4386861133_5e79734a6f_zNew York Times reporter Elisabeth Rosenthal, MD, visited Stanford this week for a Health Policy Forum, “Can we put a price on good health? Controlling the cost of health care,” with Stanford health-policy researcher Doug Owens, MD.

Those who attended looking for answers, easy fixes, or a master villain were out of luck. Instead, attendees gained insight into a convoluted system that all agree is broken, yet no one has the total power, or know-how, to fix. Here’s Rosenthal:

The issues and the problems are so diffuse… There’s the tendency to be very reductionist – ‘Oh, it’s the hospital, it’s the insurance companies, it’s pharma’… We’re all so codependent and it’s all so intertwined.

Finances dictate what we do and the incentives are so powerful. The message to patients is that we’re responsible too.

So that complimentary coffee you might get in a hospital lobby? Not actually free, Rosenthal said. She knows: While reporting for the well-known series “Paying Till It Hurts” she has talked to scores of patients and doctors and insurance representatives and policy-makers.

The main problems with the American health-care system are cost, quality and access, Owens said. The Affordable Care Act improved access, yet did little to lower costs or improve quality, he said.

And costs will continue to escalate if all the players remain most responsive to economic pressures, Rosenthal said. “Physicians feel like their income is being squeezed. Hospitals are better prepared to push back, and hospitals and physicians are looking to recoup some of that lost income in other ways. What’s lost in that very real tug of war is that patients are held hostage in the middle. That’s what’s distressing,” she said.

Continue Reading »

Clinical Trials, Health Policy, NIH, Women's Health

A look at NIH’s new rules for gender balance in biomedical studies

A look at NIH’s new rules for gender balance in biomedical studies

In May, Francis Collins, MD, PhD, director of the National Institutes of Health, co-authored a Comment piece in Nature, outlining new requirements for biomedical researchers that made balancing the sex of animals and cell lines in studies much more important than they have been in the past. The first changes were set to be implemented this month. But, as Scientific American reported earlier this week,  the NIH isn’t likely to implement the changes as quickly as previously thought:

Funding rules, however, have yet to change, with only one week left in the month. Instead, the agency is gathering comments from researchers about which research areas need sex balance the most and the challenges scientists face in including male and female subjects in their studies. Officials have set aside $10.1 million in grants for scientists who want to add animals of the opposite sex to their existing experiments. The NIH is also making videos and online tutorials to teach scientists who are new to studying both sexes how to design such studies. Meanwhile, [Janine A. Clayton, director of the NIH’s Office of Research on Women’s Health] “can’t say” when new funding rules will take effect. “Details about the policy and implementation plans will roll out during the next year,” she says.

Scientists rely heavily on male animals, rarely using females, and the changes would require some drastic changes for researchers seeking funds from NIH. More from Scientific American:

Once in place and codified, the requirement would be a major shift for the nation’s biomedical labs, many of which study mostly or exclusively male animals. One estimate found that pharmacology studies include five times as many male animals as female ones, while neuroscience studies are skewed 5.5:1 male-to-female.

Scientists assumed biology findings that held in males would apply just as well to females, but a growing body of research has discovered this is not always true. Female and male mice’s bodies make different amounts of many proteins, for example. Men and women have differing risks for many health conditions that are not obviously sex-based, including anxiety, depression, hypertension and strokes. Yet those diseases are still predominantly studied in male animals. Scientists who study sex differences think the mismatch might be the reason women suffer more side effects than men do from drugs approved by the U.S. Food and Drug Administration. Pharmaceuticals that researchers test mainly on male animals may work better for men than for women.

When the NIH does begin to implement these changes, the first steps will be training staff and grantees on what these changes mean for experimental design. And it should be noted that this isn’t the first time that NIH has encouraged sex balance. In 2013, its Office of Research on Women’s Health started a program of supplemental grants for currently funded researchers to add enough animals for gender-balanced study results.

Previously: Why it’s critical to study the impact of gender differences on diseases and treatments, Large federal analysis: Hormone therapy shouldn’t be used for chronic-disease prevention and A call to advance research on women’s health issues
Photo by Mycroyance

Addiction, Emergency Medicine, Health Policy, Research, Stanford News

Assessing the opioid overdose epidemic

Assessing the opioid overdose epidemic

Vicodin bottle Flickr Sharyn MorrowIn recent years, doctors and policy-makers have become aware of the dangers of prescription opioid medications like methadone, oxycodone and hydrocodone (which is sold as OxyContin or Vicodin). In a study published in this month’s JAMA Internal Medicine, Stanford medical student Michael Yokell and Stanford surgeon Nancy Wang, MD, took a new approach to quantifying those dangers.

Many previous studies of the toll of opioids looked at death certificate data and examined trends among deaths due to opioid overdoses, including street drugs like heroin and prescription painkillers. The new study looked at emergency department admissions and found that more than two thirds of ER visits due to overdoses were related to prescription opioids, while heroin overdoses accounted for 16 percent. Moreover, only about 2 percent of cases that made it to the ER died, but more than half the patients needed further hospitalization.

The study also found that those admitted to the emergency room because of opioid overdoses are more likely to have conditions such as chronic breathing problems, heart problems or mental health issues. Yokell explained that it’s important for doctors to be aware of the possibility of overdose and consider prescribing alternatives or discuss the risk of overdose with patients.

Beyond providing better access to emergency medical care and treatments for patients, an important next step to resolving the problem of opioid misuse is to establish or improve statewide prescription monitoring programs. For example, California has a prescription drug-monitoring database called CURES, but not all doctors actively use the program. “We can do a better job of making that database more widely used by physicians in the state.  We need more doctors to sign up and use it. It’s a valuable resource,” said Yokell.

Additionally, many people get access to prescription opioids via fraudulent prescriptions or from dealers that have illegally obtained the drugs – sometimes from breaking into and raiding pharmacies. “It’s important to keep in mind that good prescribing practices are one component of an effective strategy. There are many other ways for people to get their hands on [prescription opioids] and use them inappropriately.”

Although fixing things on the prescription side is important for managing the opioid overdose epidemic, Yokell notes that it’s not enough. Cases that make it to the ER are likely to survive, but Yokell noted that the fear of criminal charges often results in people avoiding medical care for overdoses caused by opioids and that getting this group better access to emergency services and treatment could improve outcomes. Paramedics and doctors have access to the drug naxolone, marketed as Narcan, which is safe and effective treatment for opioid overdose. But “people don’t call 911, so they are dying,” Yokell told me.

Previously: Stanford addiction expert: It’s often a “subtle journey” from prescription-drug use to abuse, Increasing access to an anti-overdose drug and A focus on addiction, the country’s leading cause of accidental death
Photo by Sharyn Morrow

Health Costs, Health Policy, Medicine and Society, Public Health, Research, Stanford News

Competition keeps health-care costs low, Stanford study finds

Competition keeps health-care costs low, Stanford study finds

The term market competition usually sparks a mental image of business suits and ties, not white coats and stethoscopes. Yet even the health-care system plays by the rules of the economic market place.

A new study, conducted by Stanford researchers Laurence Baker, PhD; M. Kate Bundorf, PhD; and colleagues, provides important evidence that less competitive health-care markets are more likely to charge higher prices for office visits. The article was published today in The Journal of the American Medical Association.

There’s a push through the private sector and through Medicare to encourage the formation of larger practices, which could improve the efficiency of the health-care system, said Bundorf.  The researchers sought to understand what effect these larger practices have on health-care spending.

To make the comparisons, the researchers used a database to establish the prices paid by PPOs for the most commonly billed office visits within 10 physician specialties. Next, they adapted a standard economic competition measure to calculate physician practice competition for different U.S. regions.

As I wrote in a release today:

Studying a measure that averaged prices across multiple types of office visits, in their most conservative model, being in the top 10 percent of areas with the least competition was associated with 3.5 to 5.4 percent higher mean price. The researchers point out that in 2011, privately insured individuals in the United States spent nearly $250 billion on physician services. In that context, these small percentage increases could translate to tens of billions of dollars in extra spending.

The study’s findings show the importance of developing policies that will encourage a balance between the quality of care and health-care spending. As Baker explained, “Sometimes it can be tempting to say our goals for the health care system should be only about taking care of patients and doing it as well as possible – we don’t want to worry about the economics. But the truth is we do have to worry about the prices because the bill does come even if you wish it wouldn’t.”

Previously: What’s the going rate? Examining variations in private payments to physicians

Aging, Health Policy, In the News, Neuroscience, Patient Care

The toll of Alzheimer’s on caretakers

The toll of Alzheimer’s on caretakers

Loving Hands Vannesa Pike-Russell FlickrMy last grandparent, my paternal grandmother, passed away earlier this year. She lived into her 90s and, like both my maternal grandmother and grandfather, she suffered mild to moderate dementia in the final years of her life. My mother cared for each of them as one by one their health declined. She had ample support from our extended family, but she was the one who had to bathe them and help them go to the bathroom or remind repeatedly them that so-and-so relative had died many years ago. My parents’ experience taking care of elderly family members who no longer had their full mental faculties lasted two to three years in each case, unlike people who care for family members with Alzheimer’s disease – a task that can last a decade or more.

Last week, Tiffany Stanley wrote a feature in the National Review about her experience caring for her ailing aunt, Jackie, who was diagnosed with early onset Alzheimer’s. Stanley’s father had been caring for his sister when his congestive heart failure made him too ill to continue, so his 29-year-old daughter stepped in. She was unprepared for the realities of caring for an Alzheimer’s patient, and she chronicles her experiences with touching anecdotes about her family’s experiences, as well as a detailed look at Alzheimer’s care in the U.S. She also details the impact the disease has on caregivers:

Alzheimer’s places a heavy toll on family caregivers. Their own health suffers. Dementia caregivers report higher rates of depression and stress than the general population. Some studies show they have an increased risk for heart disease and stroke as well as higher mortality rates. Their own use of medical services, including emergency-room visits and doctors’ appointments, goes up, and their yearly health care costs increase by nearly $5,000, according to research from the University of Pittsburgh and the National Alliance for Caregiving. “Caring for a person with dementia is particularly challenging, causing more severe negative health effects than other types of caregiving,” reads an article in the American Journal of Nursing.

Stanley also writes about the tension between funding a cure – to keep people from spiraling late stage dementia – and caring for those who are already sliding down that route:

Lost too often in the discussion about a cure has been a much more basic, more immediate, and in many ways more important question: How can we better care for those who suffer from the disease? Dementia comes with staggering economic consequences, but it’s not the drugs or medical interventions that have the biggest price tag; it’s the care that dementia patients need. Last year, a landmark Rand study identified dementia as the most expensive American ailment. The study estimated that dementia care purchased in the marketplace—including nursing-home stays and Medicare expenditures—cost $109 billion in 2010, more than was spent on heart disease or cancer. “It’s so costly because of the intensity of care that a demented person requires,” Michael Hurd, who led the study, told me. Society spends up to $56,000 for each dementia case annually, and the price of dementia care nationwide increases to $215 billion per year when the value of informal care from relatives and volunteers is included.

The story is equal parts frustrating and heart-wrenching, but I came away much better informed about what a diagnosis entails, not just for the patients, but the families connected to them.

Previously: No one wants to talk about dying, but we all need to, Mindfulness training may ease depression and improve sleep for both caregivers and patients, Can Alzheimer’s damage to the brain be repaired?The state of Alzheimer’s research: A conversation with Stanford neurologist Michael Greicius and Exploring the psychological trauma facing some caregivers
Photo by Henry Rabinowitz

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

Cancer, Global Health, Health Policy, Infectious Disease, Public Health

Treating an infection to prevent a cancer: H. pylori and stomach cancer

Treating an infection to prevent a cancer: H. pylori and stomach cancer

Hpylori-pic-thumb-460x385-2092

The number of newly diagnosed stomach cancer cases in the United States is less than a tenth of the number of prostate cancer cases or breast cancer cases, which may be part of the reason it doesn’t get the same attention as breast and prostate cancer. But the mortality rate is much higher for stomach (or gastric) cancer. Nearly 11,000 Americans will likely die from gastric cancer this year, with only 28 percent of cases surviving five years or more. For comparison, the five-year survival rate for prostate cancer is nearly 99 percent and for breast cancer, it’s more than 89 percent.

On a global scale, an estimated 700,000 people will die from gastric cancer this year, as Stanford infectious disease specialist Julie Parsonnet, MD, and her co-authors note in a Viewpoint piece in the most recent issue of the Journal of the American Medical Association. The authors also point out that worldwide, about 77 percent of gastric cancer cases are linked to chronic infections of Helicobacter pylori, a helix-shaped bacteria that was identified in the early 1980s and found to be linked to gastric ulcers a few years later, as well as to gastritis, an inflammation of the stomach lining that is a precursor to stomach cancer.

Researchers are still trying to understand exactly how H. pylori causes cancer or even how it colonizes the gastrointestinal track – they believe it’s picked up via food or water. Until recently, there was a dearth of randomized clinical trials that looked at the effectiveness of screening and treatment for H. pylori as a method for preventing stomach cancer.

Ignoring gastric cancer in the hope that it will soon disappear is not a tenable health policy

In the opinion piece, the authors describe the recommendations of a working group that met in December 2013 at the behest of the International Agency for Research on Cancer. Taking the burden of the disease and the availability of treatment options in consideration, the group considered gastric cancer “a logical target for intervention,” according to the authors of the JAMA piece. They go on to write:

Screening and treatment for H pylori is generally acceptable and affordable. An inexpensive serological test can determine who may be infected, with a sensitivity and specificity that could be sufficient for population-based prevention programs. Low-cost treatment regimens using 2 or 3 generic antibiotics plus a proton pump inhibitor for 7 to 14 days can eradicate the infection in more than 80% of cases, depending on the antibiotic resistance patterns of H pylori within the population. Economic modeling studies indicate that H pylori screening and treatment strategies are cost-effective under a large range of assumptions about effectiveness and costs. However, the models are limited by reliance on observational data rather than randomized trial results, by a lack of information on possible adverse effects of treatment, and by limited data from lower-income countries.

Researchers still have many gaps in their understanding of the best methods to prevent stomach cancer, but several trials may answer some of those questions in the coming decade.

Stomach cancer is not the only cancer known to be linked with an infection. Doctors routinely test whether women who come in for a PAP smear are infected with the human papilloma virus (HPV), which is linked to cervical cancer. Chronic hepatitis B and C infections are known to be linked to liver cancer. In time, screening for H. pylori to prevent stomach cancer may become routine. Until then, Parsonnet and her coauthors say in their conclusion, “Ignoring gastric cancer in the hope that it will soon disappear is not a tenable health policy.”

Previously: Researchers identify potential drug target in ulcer bug that infects half the world’s population, Good-bye cancer, good-bye stomach: A survivor shares her tale and Image of the Week: Helicobacter pylori colonizing the stomach
Photo by Shuman Tan and Lydia-Marie Joubert

Health Costs, Health Policy, In the News, Media, Medicine and Society, NIH

#ACT4NIH campaign seeks stories to spur research investment

#ACT4NIH campaign seeks stories to spur research investment

ACT4NIH_Samples_FINAL

No ice buckets are involved in the latest push for investment in medical research. Instead Act for NIH: Advancing Cures Today, a Washington D.C.-based non-profit led by a former National Institutes of Health staffer, is a good ‘ol fashioned media campaign using data, stories and images, including a haunting photo of a presumably sick child captaining its home page.

The need is real. NIH funding has failed to keep pace with inflation or with investments by other nations including China. Now, only one in six research proposals, the lowest ever, are accepted, according to Act for NIH.

The campaign’s goal is simple: “We advocate an immediate, significant funding increase for the NIH, followed by steady, predictable budget growth in the future.”

Not so simple, of course, is the actual funding hike. That’s why the campaign is hunting for stories, as well as money. It urges supporters to photograph themselves besides a ACT for fill-in-the-blank poster. ACT for cancer, for hope, my grandfather, for AIDS – you name the reason to support research, action (and money) is needed.

Science released an interview with leader Patrick White today. White admitted the group lacks a formal plan, but it does have momentum, thanks to the backing by real estate developers Jed Manocherian.

It’s launch comes just in time for the 2015-16 federal budget cycle, which usually begins with the president’s budget proposal in February.

Becky Bach is a former park ranger who now spends her time writing about science and practicing yoga. She’s an intern with the Office of Communications and Public Affairs. 

Previously: How can health-care providers better leverage social media to improve patient care?, NIH network designed to diagnose, develop possible treatments for rare, unidentified diseases and Federal investments in research and higher education key to U.S. maintaining innovation edge
Photo by Act for NIH

Stanford Medicine Resources: