The Danger of Moderation

This week, the journal JAMA Internal Medicine published a study that should alarm social smokers, young and old—that cohort among us who “don’t smoke,” but bum a cigarette now and again…or who only smoke at parties, or in bars, or take just a puff now and again when friends go out to smoke, y’know, just to be social.

The authors, from the National Cancer Institute and the FDA, reviewed all-cause mortality data for 290,215 people between the ages of 59 and 82 in the NIH-AARP Diet and Health Study. People who smoked between one and 10 cigarettes a day, the researchers found, had a “substantially higher risk of premature death” than those who never smoked. “Okay,” you say, “half a pack—or even a handful of cigarettes—a day is still smoking. Understood.”

But notably, the researchers discovered that even those who consistently smoked fewer than one cigarette a day on average had a 64% higher risk of early death. When it came to lung cancer specifically, those who consistently smoked less than one cig a day throughout their adult life had nine times the risk of dying from the disease than never-smokers.

And in case you think vaping an e-cig can give you a risk-free fix, enter report No. 2: Just this morning the Surgeon General warned that the aerosolized nicotine products can lead not just to addiction but also to problems, in young vapers, of brain development and respiratory health.

Yet another medical review this week—this one in the prestigious Journal of the American College of Cardiology—found that people who drink very modest amounts of alcohol on a regular basis are at higher risk of experiencing an irregular heart beat (atrial fibrillation). Scores of studies in the past have shown that light to moderate intake of alcohol—“up to seven standard drinks per week for women and 14 standard drinks per week for men”—can have cardiovascular benefits for some people. This review—which, though not exactly a new finding, scoured the data from three large meta-analyses—offers a sobering counterpoint.

The poet Ralph Waldo Emerson advised that we weak mortals ought to practice “moderation in all things, especially moderation.” My personal take from this? Not even moderation is wise when it comes to smoking. And when it comes to the occasional drink, be moderate in the number of medical studies you read.

More news below.

Clifton Leaf

@CliftonLeaf

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DIGITAL HEALTH

Docs need to get a strategy for how they prescribe mobile health apps. A new study published in the journal Health Affairs finds that patients are often adrift when it comes to finding mobile health apps that can actually help improve their personal wellness. And a large part of the reason is that professional medical care providers still haven't settled on exactly how to evaluate and prescribe the most effective apps. "While the number of available mHealth apps has grown substantially, no clear strategy has emerged on how providers should evaluate and recommend such apps to patients," wrote the study authors. "Key stakeholders, including medical professional societies, insurers, and policy makers, have largely avoided formally recommending apps, which forces patients to obtain recommendations from other sources." The global mHealth market hit nearly $14 billion in 2015 and is expected to grow substantially in the coming years. (Health Affairs)

Abbott wants to kill its $5.8 billion deal for diagnostics and device maker Alere. Things are getting testy between Abbott Laboratories and Alere, a diagnostics firm that's hit a number of road bumps in recent months. Abbott on Wednesday officially moved to kill the merger, saying that the company has faced substantial loss in value since the deal was originally struck in January and noting that Alere was forced to recall a medical device that monitors blood thinner levels. (Another potentially relevant point: Abbott also struck a more recent deal to snap up St. Jude Medical, the heart device giant). But Alere won't let the transaction die without a fight. The firm believes Abbott's moves are meant to foster a decline in share price that could force Alere back to the negotiating table for a lower price tag, and plans to "take all actions necessary … to compel Abbott to complete the transaction in accordance with its terms." (Coins2Day)

Fat helps fuel spread of cancer in mice. Scientists at the Institute for Research in Biomedicine at the Barcelona Institute of Science and Technology in Spain have published a new study in the journal Nature finding that may help begin answering one of the oldest questions in cancer research: How do cancerous cells purposely depart from their home tissue and invade entirely different parts of the body? Their findings suggest that tumorous cells in mice rely on fats as an energy source in order to make the journey. And, armed with this new knowledge, it's possible to conduct further research on how to stop cancerous cells from metastasizing. For instance, the researchers found that inhibiting a molecule called CD36 which helps the cells absorb fats from their surroundings successfully stopped cancers from spreading and multiplying throughout the mice's bodies. (Nature)

INDICATIONS

Big pharma gets its early Christmas present: 21st Century Cures. After three years of lobbying, finessing, and legislative purgatory, it finally happened on Wednesday afternoon: Congress passed the 21st Century Cures Act, a monster of a health care reform bill that's been one of biopharma's biggest priorities in the waning years of the Obama administration. The final version sailed through the Senate on a 94-5 vote, spurred by late additions such as $1 billion to combat the opioid crisis and a mental health reform bill that had been stagnating in Congress (not to mention funding for high profile Obama administration initiatives including Vice President Joe Biden's Cancer Moonshot and the Precision Medicine Initiative). But the law's passage will present plenty of questions for regulators, who will be responsible for implementing provisions aimed at speeding drug and device approvals that some have criticized as potentially weakening standards. And while patient advocacy groups are cheering Cures' potential to bring treatments to those with unmet medical needs, some proponents for orphan drug availability expressed disappointment that the final bill nixed measures that could incentivize running clinical trials on existing drugs for rare disease indications. You can catch up with my explainer. (Coins2Day)

Mylan slated for thousands of layoffs, Lilly for hundreds. Two pharma giants are reportedly preparing for massive layoffs: Mylan, which is still reeling from the blowback to its massive price hike for the EpiPen, and Eli Lilly, which is still reeling from the clinical trial body blow to its investigational Alzheimer's treatment. Mylan's motivations aren't related to the EpiPen, though—the company is looking to cut out redundancies after a series of M&As and could potentially cut as many 3,500 jobs, or just under 10% of its global workforce. Lilly's layoffs, on the other hand, will be a bit more concentrated and reportedly number in the hundreds. The department on the chopping block? Sales. (FiercePharma)

Gilead chief apologizes for hep C drug price sticker shock. In a surprising move, biotech giant Gilead's CEO John Milligan expressed a mea culpa of sorts about payers' outrage over the high cost of the company's hepatitis C cures Sovaldi and Harvoni. The two products have been putting massive financial strains on insurers and payers like Medicare and Medicaid, and Gilead has been accused of restricting access due to its high prices (and eventually pressured into offering far steeper discounts). "Perhaps we were a little conservative about what we could have or should have said to them to allow them to prepare for the number of patients that came forward," Milligan said during the Forbes Healthcare summit. "Honestly, it was far more than we thought. We did not think the system could or would try to handle as many patients as it did. We essentially quadrupled the number of patients treated in a year. That surge really created a lot of pain." Milligan stopped shy of saying that the topline price was unjustified. (Endpoints)

THE BIG PICTURE

Could Donald Trump appoint an FDA commish who doesn't think drugs should have proven efficacy? President-elect Donald Trump's cabinet picks have come with no small share of controversy. But this one's a true head turner: Trump is reportedly considering Jim O'Neill, an associate of Silicon Valley billionaire and noted libertarian Peter Thiel, to run the Food and Drug Administration (FDA). Such a pick wouldn't come completely out of the blue—O'Neill does have some government experience as a former principal associate deputy secretary of the Department of Health and Human Services under George W. Bush. But he's expressed some... Interesting thoughts on drug regulation, as Bloomberg reports. "We should reform FDA so there is approving drugs after their sponsors have demonstrated safety—and let people start using them, at their own risk, but not much risk of safety," he said at a biotech conference in 2014. "Let’s prove efficacy after they’ve been legalized." The specter of an FDA commissioner who doesn't think the agency should take a drug's efficacy into account would, indeed, be a major break from precedent in a year that's already upending all sorts of norms. (Bloomberg)

Insurance lobbying giant delivers the GOP a post-Obamacare wish list. America's Health Insurance Plans (AHIP), the insurance industry's lobbying titan, is warning Congressional Republicans that they must take care to ensure a post-Obamacare world doesn't become more chaotic than a pre-repeal one. The organization has unveiled a five-page series of talking points urging that subsidies to help people buy insurance, "risk corridor" payments to help insurers cover medical care for those who require more than expected, and subsidies that help lower patients' out-of-pocket costs are important provisions for stabilizing insurance markets (these are also all parts of Obamacare). Those latter two measures may prove controversial for a GOP Congress which has actually sued the Obama administration over cost-sharing subsidies, which Republicans argue aren't appropriated under the health law. (CNN)

U.S. Life expectancy drops for first time since 1993. The Centers for Disease Control's (CDC) latest life expectancy report carries some sobering news: Americans' life expectancy dropped by 0.1 years in 2015 compared to 2014. That may not seem like a whole lot; but it's the first decline in life expectancy since 1993, raising concerns that medical care and lifestyle management may be starting to hit diminishing returns. "Life expectancy at birth decreased 0.1 year from 78.9 years in 2014 to 78.8 in 2015, largely because of increases in mortality from heart disease, chronic lower respiratory diseases, unintentional injuries, stroke, Alzheimer’s disease, diabetes, kidney disease, and suicide," wrote the study authors. The sole disease area where the death rate actually declined? Cancer. (CDC)