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Addiction, FDA, Health Policy, In the News, Podcasts

E-cigarettes and the FDA: A conversation with a tobacco-marketing researcher

E-cigarettes and the FDA: A conversation with a tobacco-marketing researcher

The FDA announced today its plans to regulate e-cigarettes. The news comes as little surprise to many, including Robert Jackler, MD, chair of otolaryngology at Stanford Medicine, who studies the effects of tobacco advertising, marketing, and promotion through his center, the Stanford Research Into the Impact of Tobacco Advertising. I asked Jackler this morning what he thought of the FDA’s plan, and he had this to say:

While I welcome the FDA proposal to deem electronic cigarettes as tobacco products under their regulatory authority, I’m disappointed with the narrow scope of their proposal and the snail’s pace of the process. Given its importance, I’m particularly troubled by the FDA’s failure to address the the widespread mixing of nicotine with youth-oriented flavorings (e.g. gummy bears, cotton candy, chocolate, honey, peach schnapps) in electronic cigarettes products.  Overwhelming evidence implicates such flavors as a gateway to teen nicotine addiction [which] led the FDA to ban flavors (except for menthol – which is presently under review) for cigarettes in 2009.  Give the lethargic pace of adopting new regulations, a generation of American teens is being placed at risk of suffering the ravages of nicotine addiction.

In a podcast last month, Jackler spoke in-depth about the rise of, and problems with, e-cigarettes. If you haven’t yet listened, now is a great time to.

Previously: E-Cigarettes: The explosion of vaping is about to be regulated, Stanford chair of otolaryngology discusses federal court’s ruling on graphic cigarette labels and What’s being done about the way tobacco companies market and manufacture products

Clinical Trials, Health Policy, Research, Science Policy, Stanford News, Videos

New Stanford center aims to promote research excellence

New Stanford center aims to promote research excellence

Updated 4-24-14: The center founders discuss METRICS in this just-posted 1:2:1 podcast.

***

4-23-14: Stanford has a new center, called the Meta-Research Innovation Center at Stanford, or METRICS for short, that will focus on ways to transform research practices to improve the reproducibility, efficiency and quality of scientific investigations.
When Stanford professor John Ioannidis, MD, DSc, discusses ideas on how METRICS might improve research quality, he points to the wealth of statistics within any newspaper’s sports section.

“Science needs as many ways to measure performance as sports do,” says Ioannidis. “More important, we need to find efficient approaches for enhancing this performance. There are many ideas on how to improve the efficiency of setting a research agenda, prioritizing research questions, optimizing study design, maximizing accuracy of information, minimizing biases, enhancing reporting of research, and aligning incentives and rewards so that research efforts become more successful. Possibly we can do better on all of these fronts.”

The center’s other co-director is Steven Goodman, MD, MHS, PhD, professor of medicine and of health research and policy.

METRICS’s core group of interdisciplinary scholars will be working on various aspects of meta-research, from methodologies to processes to policy. The center will also provide educational funding for students and scholars; organize collaborative working groups that include academics, policymakers, research funders and the public; and help establish similar initiatives worldwide.

You can learn more about “meta-research” and METRICS’s mission in the short interview above and in this release. Ioannidis discusses the center’s short- and long-term goals in the video clip below.

Previously: The Lancet documents waste in research, proposes solutions, “US effect” leads to publication of biased research, says Stanford’s John Ioannidis and Shaky evidence moves animal studies to humans, according to Stanford-led study
Photo in featured-entry box by Norbert Von Der Groeben

Chronic Disease, Health Disparities, Health Policy, Patient Care, Research, Stanford News

Study shows higher Medicaid coverage leads to lower kidney failure rates

Study shows higher Medicaid coverage leads to lower kidney failure rates

Years ago, nephrologist Manjula Tamara, MD, treated a 23-year-old uninsured patient whose kidneys were failing. The patient’s medical options, at that point, were life-long dialysis or a hoped-for kidney transplant – bleak options for such a young person, and ones that adequate preventive care could have been avoided.

That memory, along with the federal government’s recent expansion of Medicaid spurred Tamura as a scientific researcher to pose the question: Does expanded Medicaid coverage translate into better care for low-income patients with chronic diseases, such as kidney disease?

According to the Stanford study published today in the Journal of the American Society of Nephrology, the answer is yes. Using data from national registries, Tamura, who is lead author of the research, and colleagues collected data on the more than 400,000 American adults who developed end-stage renal disease (or ESRD) between 2001 and 2008. As I explained in a release:

Medicaid coverage during those years among low-income, nonelderly adults ranged from 12.2 to 66 percent, depending on the state, with California averaging between 30 and 35 percent. For each additional 10 percent of the low-income, nonelderly population covered by Medicaid, the study found there was a 1.8 percent decrease in ESRD incidence.

The study is particularly timely because states are in the process of deciding whether to adopt the recent changes to Medicaid, which came with the passage of the Affordable Care Act. So far, only about half of the states have. The study discusses these recent changes and what the expansion in Medicaid coverage could mean to low-income Americans with kidney disease, along with patients with other chronic diseases:

Before the Affordable Care Act, only low-income Americans who were pregnant, had a disability or were parents of minors could receive Medicaid coverage if they met their state’s income eligibility levels. States now have the option to increase Medicaid coverage to all adults under the age of 65 with incomes below 133 percent of the poverty level regardless of whether they are pregnant, disabled or parents of minors.

“The care of patients approaching kidney failure or end-stage renal disease is a useful model to study the potential effects of Medicaid expansion on chronic disease care because ESRD care is costly and the quality of pre-ESRD care is tracked nationally,” Tamura said.

What the study did not look at was whether this expansion could ultimately result in financial savings. In the United States, 75 percent of health care dollars goes into the treatment of chronic diseases and these conditions – which include heart disease, diabetes, hypertension, and kidney disease – are all on the rise. In an interview, Tamura suggested that future research on this topic is needed.

Previously: Study shows higher rates of untreated kidney failure among older adults and Geography may determine kidney failure treatment level

Addiction, FDA, Health Policy, Podcasts, Public Health

E-Cigarettes: The explosion of vaping is about to be regulated

E-Cigarettes: The explosion of vaping is about to be regulated

E-cigarettes are about to get zapped. To date, across the globe, they’ve been largely unregulated – and their growth since they first came on the scene in 2007 has been exponential. Now, in the first big regulatory action that is sure to spur similar responses across the pond, the European Parliament approved rules last week to ban e-cigarette advertising in the 28 EU member nations beginning in mid-2016.  The strong action also requires the products to carry graphic health warnings, be childproof and contain no more than 20 milligrams of nicotine per milliliter. It’s expected that the U.S. Food and Drug Administration will soon follow suit and the days of great independence for e-cigarettes will come to a crashing halt. A few U.S. cities, Los Angeles most recently, have banned e-cigarettes in public spaces.

e-cigUntil recently, I was completely ignorant about the whole phenomenon of e-cigarettes. What is the delivery system? Where are they manufactured? Are they a safe alternative to smoking? And how are they being marketed and to whom? Well here’s an eye opener: According to the Centers for Disease Control and Prevention, e-cigarette usage more than doubled among middle and high school students users from 2011 to 2012. Altogether, nearly 1.8 million middle and high school students nationwide use e-cigarettes.

Robert Jackler, MD, chair of otolaryngology at Stanford Medicine, has long studied the effects of tobacco advertising, marketing, and promotion through his center, SRITA (Stanford Research Into the Impact of Tobacco Advertising). After years of detailing how tobacco use became ubiquitous in the U.S. he’s now tracking the marketing of e-cigarettes, and what he’s found probably won’t surprise you. The same sales techniques that brought about the explosive growth of tobacco use are being deployed again to make e-cigarettes look sexy, cool and defiant.

While there are claims by the e-cigarette industry that e-cigarettes are important tools to help people kick the tobacco habit, there’s little evidence to date to back up that claim. And Jackler isn’t completely sold on the notion that e-cigarettes will bring about a great cessation of tobacco smoking; he sees them more as a continuity product. He told me:

What the industry would like to see you do is when you go to a place that you can’t smoke, that you pick up your e‑cigarette and you vape, and you get your nicotine dose in the airport when waiting, or when you’re in your workplace, or when you’re even in school, and that way, when you leave school or the workplace, you go back to the combustible tobacco products.

Sorry if I’m a bit cynical, but as an ex-smoker I find it hard to believe that Big Tobacco – which is increasingly getting into the e-cigarette business – doesn’t also see vaping as a way to continue to keep smokers smoking. Bubble gum flavors and packaging designed to resemble lipstick containers! Who’s really being targeted here?

After my 1:2:1 podcast (above) with Jackler, I’m convinced we’ve been down this road before and it wasn’t pretty health-wise. More than 16 million Americans suffer from a disease caused by smoking. Listen to the podcast and you be the  judge about the true intentions of those promoting e-cigarettes.

Previously: Stanford chair of otolaryngology discusses federal court’s ruling on graphic cigarette labelsWhat’s being done about the way tobacco companies market and manufacture products and Image of the Week: Vintage Christmas cigarette advertisement
Photo by lindsay-fox

Addiction, Health Policy, In the News, Mental Health, Stanford News

A reminder that addiction is a chronic disease

A reminder that addiction is a chronic disease

holding pills - smallerThis morning on KQED’s Forum, guests discussed addiction in the wake of the apparent heroin overdose of actor Philip Seymour Hoffman.

During the show, Stanford’s Keith Humphreys, PhD, a professor of psychiatry and behavioral sciences, noted that addiction is a disease:

Addiction is like other chronic disorders that are not curable – I mean, they can be managed, but we can’t eliminate them. Just like diabetes or low back pain or high blood pressure, you can go through treatment periods and recover your function, but that doesn’t mean that it can’t come back. And people are particularly prone to relapse in times of stress, in times of deprivation. Sometimes in also very good times people haven’t learned to celebrate and be happy without reaching for their drug or alcohol.

Humphreys, who recently served as a senior advisor in the Office of National Drug Control Policy in Washington, outlined two common barriers to receiving treatment: “Not having enough money, and being stigmatized.” But he also shared good news on how addiction is being viewed by the American public – and treated as a medical condition worthy of health insurance coverage.

“Several hundred million Americans, although they might not know it, just got better coverage for addiction treatment in their insurance,” Humphreys said. “The Affordable Care Act defines substance abuse for the first time as an essential health-care benefit. So all new plans must offer benefits, and they must offer them at parity.”

Previously: We just had the best two months in the history of U.S. mental-health policy, Is it damaging to refer to addicts as drug “abusers?”, “Brains are unmentionable:” A father reflects on reactions to daughter’s mental illness, Breaking Good: How to wipe out meth labs, How police officers are tackling drug overdose and Addiction: All in the mind?
Photo (modified from original) by vmiramontes

Addiction, Health Policy, In the News, Mental Health, Stanford News

We just had the best two months in the history of U.S. mental-health policy

We just had the best two months in the history of U.S. mental-health policy

For decades, descriptions of the status of U.S. mental health services have included references to service cuts, funding constraints and poor access to care. That makes it only more astonishing and important that the past two months have witnessed the most expansive support for mental-health services in U.S. history. Three critical pieces of federal legislation are responsible for this remarkable turn of events.

Bipartisan support for mental-health services has probably never been this strong before at the U.S. federal level

In early November, the Obama Administration released the final regulations for implementing the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act (MHPEA) of 2008. One of the very last laws passed during the George W. Bush Administration, MHPEA affects the more than 100 million Americans who receive their health insurance through large group employers. It mandates that any insurance plan that offers benefits for the treatment of mental-health disorders must make those benefits comparable to those for other medical disorders. In other words, the higher co-pays, more intensive utilization review requirements and lower benefit caps historically applied to mental health care are now illegal.

Just seven weeks after the final MHPEA regulations were issued, Medicare ended its decades-long practice of reimbursing outpatient mental-health care at a lower rate than care for all other disorders. Historically, Medicare had covered 80 percent of all outpatient care except for mental health care, which was reimbursed at only 50 percent. Due to the final implementation of the Medicare Improvements for Patients and Providers Act of 2008 (.pdf), this disparity was eliminated on January 1, 2014. That’s good news for the approximately 50 million Americans who are covered by Medicare.

Last but not least, as everyone knows the remaining provisions of the Affordable Care Act also came into force over the past month. The ACA had already helped families facing mental illness by allowing parents to keep their children on their insurance policies until the age of 26. That was critical because addictive and psychiatric disorders almost always have onset in adolescence or young adulthood. But an even more influential feature of the law is to define substance use disorder and mental-illness treatment as essential health care benefits, and, to specify that those benefits be at parity with benefits for other disorders, such as is specified in MHPEA. This standard will apply to all plans issued through state and federal health insurance exchanges and the Medicaid expansion, as well as to insurance plans to be issued in the future that are subject to ACA regulations. The HHS Office of the Assistant Secretary for Planning and Evaluation projects the impact of these changes as improving mental-health care coverage for more than 60 million Americans.

Of course, while the above changes all were implemented in the past two months, they each were the product of many years of advocacy by office holders, political activists, grassroots organizations, clinicians and researchers. These laws coming to fruition in such a compressed time window was fortuitous in some respects, but it also reflects a new political reality in Washington: Bipartisan support for mental-health services has probably never been this strong before at the U.S. federal level. That augurs well for American families who will face the challenge of mental illness in the coming years.

Addiction expert Keith Humphreys, PhD, is a professor of psychiatry and behavioral sciences at Stanford and a career research scientist at the Palo Alto VA. He recently completed a one-year stint as a senior advisor in the Office of National Drug Control Policy in Washington. He can be followed on Twitter at @KeithNHumphreys

Previously: Managing primary care patients’ risky drinking, Full-length video available for Stanford’s Health Policy Forum on serious mental illness and How states will benefit from Medicaid expansion

Health Policy, In the News, Stanford News

Stanford’s Sanjay Basu named a Top Global Thinker of 2013

Stanford's Sanjay Basu named a Top Global Thinker of 2013

In case you haven’t seen it, Foreign Policy magazine recently announced its Top 100 Global Thinkers of 2013. These movers, the piece accompanying the list notes, “have made a measurable difference in politics, business, technology, the arts, the sciences, and more” this year. Stanford Medicine’s Sanjay Basu, MD, PhD, was named one of the top thinkers – alongside luminaries such as Angela Merkel, the Intergovernmental Panel on Climate Change, and Pope Francis. Basu and University of Oxford’s David Stuckler, MPH, PhD, are being honored for research on the public health effects of different economic policy responses to the recession – or as the magazine puts it, “for warning that austerity can be deadly.”

Previously: Could a palm oil tax lower the death rate from cardiovascular disease in India?Can food stamps help lighten America’s obesity epidemic? and New evidence for a direct sugar-to-diabetes link

Cardiovascular Medicine, Ethics, Health Policy, Stanford News

Will new guidelines lead to massive statin use?

As recently written about on Scope, new guidelines on statin use, and an accompanying risk-assessment calculator, have generated much conversation in the medical community. In a new Viewpoint piece in the Journal of the American Medical Association, Stanford professor and health research and policy expert John Ioannidis, MD, DSc, discusses potential implications of the guidelines, which could lead to more widespread use of statins for primary prevention. “It is uncertain whether this would be one of the greatest achievements or one of the worst disasters of medical history,” he writes of potential worldwide “statinization.” Read on to get more of his thoughts.

Previously: Stanford expert weighs in on new guidelines for statin useThe exercise pill: A better prescription than drugs for patients with heart problems?“U.S. effect” leads to publication of biased research, says Stanford’s John Ioannidis and A call for mega-trials for blockbuster drugs

Health Policy, Medical Education, Medical Schools

Future doctors have a lot at stake, even if they don’t know it: A student’s take on the Affordable Care Act

“You’re going into medicine? Let me give you a piece of advice: Don’t.”

A community physician said those words to me more than three years ago, right before I started medical school, and I’ve heard variations on the theme ever since: Medicine is a thankless profession. Contrary to popular opinion, it’s hardly the path to riches. You can’t spend enough time with patients. It’s depressing.

In recent days, I asked several peers at different medical schools what they thought of the ACA. The overwhelming answer: “I don’t know enough to have an opinion.”

Now I stand poised to enter the world of MDs. And with the passage of the Affordable Care Act, my classmates and I, the newest generation of doctors, look out at the horizon without knowing the shape our careers will have. We are reasonably sure about one thing — along with providing unprecedented access to insurance for Americans, the new health care law will change how we practice medicine, including how many patients we see and possibly how we get reimbursed.

Yet when the endless wave of media coverage crashes over us, it’s rare to find an examination of how the law will affect us, your future health-care providers. Instead, we get a big dose of political posturing from all sides.

Why does this matter? Because the first and probably saddest truth I can tell you is that most medical students know very little about the Affordable Care Act, or about insurance and health economics in general. We get the occasional lecture about health systems, but the information shows up on none of our exams or evaluations. In recent days, I asked several peers at different medical schools what they thought of the ACA. The overwhelming answer: “I don’t know enough to have an opinion.”

I find myself in a unique position. Thanks to Stanford and NBC News, I’m spending the year learning more about health journalism. So I’ve pulled my head out of the textbooks and hospitals and gotten a chance to really see how health-care issues affect communities. If not for this opportunity, I probably would have been one of those students who knew next to nothing about a law that will alter my career.

As medical students, we’re exposed to certain physicians who don’t consider costs and money; they tell us that such thoughts are not only unbecoming of a physician but also a distraction from caring about your patient.

I don’t see it the same way. Physicians are meant to be advocates for patients, and that means pursuing appropriate medical treatment in the context of a patient’s real life. Being uninsured is a health problem, pure and simple. A 2009 study revealed a direct correlation between lack of insurance and increased mortality, suggesting that nearly 45,000 American adults die each year because they have no medical coverage.

Whether or not you support the Affordable Care Act, that figure alone makes it our business to care about this issue.

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Events, Health Policy, Mental Health, Patient Care, Stanford News

Full-length video available for Stanford’s Health Policy Forum on serious mental illness

Full-length video available for Stanford's Health Policy Forum on serious mental illness

Previously on Scope, we discussed a Health Policy Forum on mental illness. As Stanford addiction expert Keith Humphreys, PhD, explained in his post, the goal of the forum – entitled “Serious Mental Illness: How can we balance public health and public safety?” – was to explore issues related to health policies for the mentally ill in a transparent and productive way.

Paul Costello, chief communications officer for the School of Medicine, led the forum’s diverse panel of experts which included:

The forum addressed several issues related to serious mental illness including violence, life as a mentally ill patient in prison, the stigma of mental illness, and cluster suicides. Costello and the panel bring fresh insights to a topic of longstanding debate; the video is worth a watch.

Holly MacCormick is a writing intern in the medical school’s Office of Communication & Public Affairs. She is a graduate student in ecology and evolutionary biology at University of California-Santa Cruz.

Previously: “Brains are unmentionable:” A father reflects on reactions to daughter’s mental illness, Upcoming Stanford Health Policy Forum to focus on mental illnessExamining mental health policies in the wake of school shooting tragedy and Probing the underlying physiological causes of mental illness

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