Health Policy

As I wrote about yesterday, new research in PLOS ONE suggests that sugar may play a stronger role in the origins of diabetes than anyone realized. Countries with more sugar in their food supplies have higher rates of diabetes, independent of sugar’s ties to obesity, other parts of the diet, and several economic and demographic factors, the researchers found.

Although the study focused on diabetes rates among adults aged 20 to 79, it got me thinking about children’s health. Type 2 diabetes, which accounts for 90 percent of adult cases and is tied to obesity, used to be unheard-of in kids. But over the last few decades, it has been showing up in many more children and teens at younger and younger ages. Meanwhile, reducing kids’ sugar intake is already the focus of several preventive-health efforts, such as campaigns to remove sugary drinks from schools and children’s hospitals.

To get some perspective on how the new findings apply to children, I turned to Thomas Robinson, MD, a Stanford pediatric obesity researcher who directs the Center for Healthy Weight at Lucile Packard Children’s Hospital. Though Robinson, also a professor of pediatrics at the School of Medicine, cautioned that the epidemiological, “10,000-foot view” given by this study doesn’t prove a cause-and-effect link between sugar and diabetes in individuals – “it does not prove that the amount of sugar an individual eats is related to his or her diabetes risk,” he said – he had lots to say about the new results.

What do you think the findings mean for children’s health?

Children’s behaviors and environmental exposures have an impact on adult health and disease. This study used sugar data for entire countries, not individuals. That means that both the children and the adults were living in countries where higher levels of sugars in the food supply were associated with higher rates of diabetes. The potential implications are even stronger for children than adults. Children are being exposed to that environment for a much longer time. This is particularly a problem in developing countries where their food supplies, diets and weights are changing so rapidly.

A number of us here at Stanford focus on what we can do in early life, and throughout the lifespan, to prevent diseases that have origins in childhood but only first become apparent in adulthood. One can consider our work on obesity, physical activity, sedentary behavior and nutrition in children as really the prevention of diabetes, heart disease, many cancers and other chronic diseases in adults.

What factors has prior research identified as the biggest contributors to the increase in diagnoses of type 2 diabetes in pediatric patients?

The biggest contributor identified has been increased weight, but the increasing rate of type 2 diabetes at younger and younger ages probably reflects obesity plus lots of different changes, including changes in our diets, such as more sugars and processed foods, and less physical activity. The CDC now projects that 1 in 3 U.S. children will have diabetes in their lifetimes, and it will be 1 in 2 among African-American and Latina girls. That is a pretty scary thought. That is why we focus so strongly on helping families improve their diets, increase activity levels, and reduce sedentary time. We want to prevent and control excessive weight gain and all the problems that go with it, of which diabetes is just one.

In light of the new findings, do you think that parents whose children are not obese should be concerned about how sugar consumption could raise their children’s diabetes risk?

This study doesn’t really address the question of what happens at the level of an individual child. However, it is still consistent with the advice we would give now, for both normal weight and overweight children. I definitely recommend that parents try to reduce sugars in their children’s diets. Most parents are not even aware how much sugar their children are eating. Sure, sodas and sweets are the obvious sources but sugars are also added to seemingly all processed foods, including even bread, pizza and French fries. The added sugars are just empty calories — providing extra calories and no additional nutritional benefit. So I recommend that all parents try at least to reduce the obvious sources of sugary drinks, sweets and desserts.

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Across-the-board cuts to discretionary spending required under the Budget Control Act of 2011 (.pdf) are set to take effect a week from today. Yesterday, National Institutes of Health Director Francis Collins, MD, PhD, and others warned that the budget sequester would “slow scientific progress, delay clinical trials, and put a generation of young researchers at risk if NIH’s $31 billion budget for this year is trimmed by $1.5 billion.”

A group of researchers from universities around the country have created a series of videos highlighting the far-reaching impact that the funding cuts imposed by the sequester will have on the nation’s ability to discover, innovate, educate and maintain its scientific and technological leadership.

In this video, Melinda Crommie, PhD, a postdoctoral research fellow at Stanford, discusses her research on the tissue engineering of muscle at the Palo Alto VA Hospital and speaks out in defense of funding for scientific and medical research. As she explains, her work has helped veterans home from deployment with battlefield injuries and led to the creation of a company.

Previously: Why basic research is the venture capital of the biomedical world, Future of medical research is at risk, says Stanford medical school dean and The economic benefits of publicly funded medical research

Last week, I wrote about efforts to boost IUD use in developing countries. This form of birth control, despite its benefits, isn’t widely embraced here in the United States, either – with surveys showing that less than 10 percent of women of reproductive age use it. But, as reported earlier this week by Kaiser Health News, the recently enacted Affordable Care Act might change that:

IUDs and the hormonal implant — a matchstick-sized rod that is inserted under the skin of the arm that releases pregnancy-preventing hormones for up to three years — generally cost between $400 and $1,000. The steep upfront cost has deterred many women from trying them, women’s health advocates say, even though they are cost-effective in the long run compared with other methods, because they last far longer.

Under the Affordable Care Act, new plans or those that lose their grandfathered status are required to provide a range of preventive benefits, including birth control, without patient cost-sharing. Yet even when insurance is covering the cost of the device and insertion, some plans may require women to pick up related expenses, such as lab charges.

Long-acting reversible contraceptives (LARCs) require no effort once they’re put into place, so they can be an appealing birth-control option for teens and young women, whose rates of unintended pregnancy are highest, experts say.

Via Our Bodies, Our Blog
Previously: Promoting the use of IUDs in the developing world, For many women, no more co-pay for birth control and A look at the federal mandate to cover contraceptives

Because I spend so much time writing about children with serious medical problems, I’m acutely aware of one of the most challenging problems facing really sick kids: the rarity of severe pediatric illness.

Most children are extremely healthy, and while that’s great for them, it can leave the ones who do get really sick in a bind. Often, their conditions are so uncommon that treatment is a sort of Jerry-rigged version of adult medicine. As a result, pediatricians are forced to give children medications that have not been thoroughly tested in their age group, use oversized surgical tools designed for adults or adapt medical equipment, such as MRI scanners, to suit smaller patients.

The irony of this is that what’s better for kids often proves help in treating adults. This concept was first explained to me by Sanjeev Dutta, MD, a pediatric surgeon at Lucile Packard Children’s Hospital who does a lot of minimally-invasive laparoscopic surgery. Surgical-tool manufacturers are reluctant to adapt their instruments for pediatric care, since so few children need surgery relative to adults. But once someone does make a smaller tool for kids, surgeons quickly discover that it helps perform certain tasks better in adult patients, and suddenly they’re clamoring for it.

In a new version on this trickle-up theme, the American Society for Clinical Oncology recently released new guidelines (.pdf) for the care of cancer survivors, which draw heavily on principles established in pediatric cancer patients. As a story I wrote for Stanford Medicine explained, cancer survivorship has been studied in kids for more than two decades. This makes sense because when a child survives cancer, as most kids with cancer now do, he or she has decades of life ahead. It’s logical that doctors would put a lot of energy into figuring out how to make those years as healthy as possible.

But now, more and more adults are surviving cancer; there are a total of more than 13 million cancer survivors alive in the U.S. today. Physicians are increasingly realizing that just getting them through the disease isn’t enough. Cancer survivors grapple with a host of challenges that can necessitate specific medical attention. I’m really glad to see that the principles pediatricians have gleaned from studying the youngest cancer patients are now being applied to benefit all cancer survivors.

Previously: Report forecasts U.S. cancer survivors to increase to 18 million in a decade, How pediatrics could help adult medicine improve quality of care for patients and Cancer’s next stage: A report from Stanford Medicine magazine

Next year, the federal government will launch a publicly accessible database of industry payments to doctors. Surprised to hear that? So were a group of physicians surveyed last month, the majority of whom “were unaware of the so-called ‘Sunshine Act,’ written by Sen. Chuck Grassley (R-Iowa) and former Sen. Herb Kohl (D-Wis.), to expose financial relationships between medical practitioners and industry players.” Healthwatch has the story.

Previously: The NIH gets tough on conflicts of interest, Stanford’s medical school expands its policy to limit industry access, Faculty consulting work: now on public view and Let the sun shine: Legislation would publicly disclose physician-industry relationships

Earlier this month, close to 200 heavy-hitters in academics, government and the private sector assembled at Stanford to discuss health-research policy. The ultimate goal of the event, which was co-hosted by Stanford’s Clinical Excellence Research Center and the White House Office of Science and Technology Policy, was to help guide the White House in developing policy changes to improve health care and its affordability.

As reported by my colleague yesterday, recommendations that emerged from the day-long summit included:

• Leveraging information within electronic medical records by creating incentives for health-care providers and insurers to make privacy-protected patient data widely and easily accessible to researchers.
• Creating more flexible research funding categories and regulatory “safe havens” that encourage the testing of unconventional health-care delivery innovations.
• Stimulating commercial investments in cost-saving medical devices by linking insurance reimbursement levels to the incremental value they deliver.
• Reinventing patient consent forms to be more relevant to new ways of safely conducting medical research, such as analyses of previously collected biological specimens or of health-care quality improvement programs.

I like the way participant Mark Hlatky, MD, a professor of health services research and of medicine at Stanford, put it: “While there is no single silver bullet for our inefficient health-care system, this event suggested a number of ideas that could synergize such that the whole will be greater than the sum of the parts.”

Previously: Making health care better and more affordable, Stanford expert urges physicians to take the high road in slowing health care spending, How can we slow growth of U.S. health-care spending? and New Stanford center to address inefficient health care delivery

Stanford’s Clinical Excellence Research Center, which we’ve previously written about on Scope, was the focus of a recent edition of Minnesota Public Radio’s The Daily Circuit. As reporter Kerri Miller describes it, the center is “taking on some of the toughest quandaries in health care,” and its work was prompted by director Arnold Milstein, MD, asking himself “why the care for cancer, and kidney disease, and morbid obesity is often so expensive, too often not as effective as it should be, and frequently so difficult for the patients who are going through it.” Take a listen to find out how he and colleagues are trying to change that.

Previously: Stanford expert urges physicians to take the high road in slowing health care spending, Uncommon hero: A young oncologist fights for more humane cancer care, Innovative Stanford clinic to support chronic care patients and New Stanford center to address inefficient health care delivery

Drug therapies with sales exceeding $1 billion should be subject to a mega-trial, a randomized clinical trial with at least 10,000 patients. That’s what  John Ioannidis, MD, DSc, chief of the Stanford Prevention Research Center, argues in a perspective published today in the Journal of the Americal Medical Association.

In the piece, Ioannidis points out that while so-called “blockbuster” drugs are used by hundreds of thousands of individuals, the supporting randomized trials typically include only a few hundred participants, “often with relatively short-term follow-up.” Describing how larger trials could benefit what we know about psychiatric drugs, he writes:

…5 of the top 24 blockbusters are mental health–related drugs: aripiprazole (Abilify), quetiapine (Seroquel), duloxetine (Cymbalta), olanzapine (Zyprexa), and escitalopram (Lexapro). None of them has ever been tested in a mega-trial, and most evidence comes from short-term trials of 3- to 4-months’ duration with only hundreds of participants. Nevertheless, several million doses of each of these drugs are dispensed annually. Mega-trials would help settle and even preemptively address concerns about deaths and suicides associated with some mental health interventions.

Besides mortality outcomes, mega-trials can focus on other specific major questions of interest. For example, for mental-health interventions, these trials would provide sufficient power to address the effects of drug interventions on important outcomes such as suicide attempts, hospitalizations, and job loss instead of relying solely on subjective scales and also would help define the spectrum of disease severity at which these treatments are effective, another issue debated endlessly based on small trials and meta-analyses thereof…

Ioannidis also outlines how challenges relating to cost and recruitment for such large trials could be overcome, and he proposes a framework for carrying out the studies. He calculates that streamlining the design, monitoring, data collection and outcomes of the traditional clinical trial process could greatly reduce the cost of mega-trials. With an intervention with $2 billion in annual sales, for example, the expense of a study consisting of 80,000 participants could be covered with one month of sales – about $167 million.

Under Ioannidis’ proposal, companies would be required to pay one month’s worth of previous year’s sales into a special fund, which would be used for funding mega-trials. In return, companies with drugs that performed well during the trials could receive incentives such as a patent extension. Ioannidis notes, “For instance, a 4-year extension of the patent would offset by 50 times the cost of the mega-trial.”

Previously: NIH funding mechanism “totally broken,” says Stanford researcher, Research shows small studies may overestimate the effects of many medical interventions, Animal studies: necessary, but often flawed, says Stanford’s Ioannidis and Outing bias in scientific research
Photo by Keith Ramsey

Phillip Pizzo, MD, former dean of the School of Medicine, and has been selected for an Institute of Medicine committee tasked with recommending ways to improve end-of-life care in America.

The San Jose Mercury News reports:

The Institute, part of the prestigious National Academy of Sciences, seeks changes in federal policy, financing and hospital practices that will bring care into line “with individual values and preferences to promote high-quality, cost-effective care at the end of life,” according to a statement.

…

The Institute stated in its announcement that “coordinated, expert, compassionate care for people dying from chronic diseases continues to challenge the American health care system.

“During the last century and more, death has evolved from a common family event centered in the home to a medical event occurring in a distant medical facility overseen by trained experts and administrators,” it said.

In addition to Pizzo, provisional members of the panel include UC San Francisco professor Bernard Lo, MD, and 17 other experts from Brown University, the University of Pennsylvania, Duke University and elsewhere.

Previously: A farewell to Dean Philip Pizzo, The legacy of Stanford’s Philip Pizzo, Phil Pizzo, the marathon man, moves on and Lloyd Minor named dean of Stanford School of Medicine

Fisher, Fleshman, Eshoo, Swayze and Rubin (L-R) at yesterday’s press conference.

In a press conference held at Stanford Hospital & Clinics yesterday, Rep. Anna G. Eshoo (D-Palo Alto) announced the passage of a new law aimed at developing better treatments and potential cures for the deadliest of cancers.

Signed into law by President Obama on January 3, the Recalcitrant Cancer Research Act, requires the National Cancer Institute to examine its current research efforts on cancers with very low survival rates, including pancreatic and lung cancer, and work to develop early detection methods and better treatment options to improve outcomes. The NCI will develop a long-term plan, or scientific framework, for pancreatic and other recalcitrant cancers to gauge its current efforts in the disease and make recommendations on ways to speed progress.

Eshoo was joined by Lisa Niemi Swayze, Patrick Swayze’s widow and chief ambassador of hope for the Pancreatic Cancer Action Network; Stanford oncologist George Fisher, MD, a leading cancer-research advocate who treated Patrick Swayze for pancreatic cancer; and Julie Fleshman, president and CEO of the Pancreatic Cancer Action Network. Eshoo was introduced by Amir Dan Rubin, president & CEO of Stanford Hospital & Clinics.

In her speech, Eshoo explained the signficance of the law:

This is larger than a piece of legislation. This is about hope for families and people across our country. We are here in a place that does the most superb research in the world and to speed up the research and to move these recalcitrant cancers to the top of the list at the NCI is absolutely essential for us to make progress.

Fisher also shared his views as a physician and researcher:

When patients come to me with pancreatic cancer, they come to me with both hope and fear. They fear what they’ve read. They fear the statistics we’ve already heard today. But they hope they can beat the odds and that some cutting edge treatment will give them a better outlook in life, more time, or maybe chance for a cure. We do cure some, but only some. My patients deserve better than that. They deserve better than what I can offer them.

I’m confident that the success that we will achieve in pancreas cancer through this effort will have a tremendous trickledown effect. If we can beat one of the toughest cancers, we’re going to have gains in many other cancers.

Previously: New clues arise in pancreatic cancer from Stanford researchers
Photo by Norbert von der Groeben/Stanford Hospital