1. Health care reform
How could the health care reform legislation that President Barack Obama signed into law on March 23, 2010, not be the #1 story of the year? Whether you are for or against it, the Patient Protection and Affordable Care Act is nothing if not ambitious, and if implemented, it will fundamentally alter how American health care is financed and perhaps delivered. The law is designed to patch holes in the health insurance system and extend coverage to 32 million Americans by 2019 while also reining in health care spending, which now accounts for more than 17% of the country’s gross domestic product. The biggest changes aren’t scheduled to occur until 2014, when most people will be required to have health insurance or pay a penalty (the so-called individual mandate) and when state-level health insurance exchanges should be in place. The Medicaid program is also scheduled to be expanded that year so that it covers more people, and subsidized insurance will be available through the exchanges for people in lower- and middle-income brackets. But plenty is happening before 2014. The 1,000-page law contains hundreds of provisions, and they’re being rolled out in phases. This year, for example, the law created high-risk pools for people with pre-existing conditions, required health plans to extend coverage to adult children up to age 26, and imposed a 10% tax on indoor tanning salons. Next year, about 20 different provisions are scheduled to take effect, including the elimination of copayments for many preventive services for Medicare enrollees, the imposition of limits on non-medical spending by health plans, and the creation of a voluntary insurance that will help pay for home health care and other long-term care services received outside a nursing home. Getting a handle on the complicated law is difficult. If you’re looking for a short course, the Kaiser Family Foundation has created an excellent timeline of the law’s implementation (we depended on it for this post) and a short (nine minutes) animated video that’s one of the best (and most amusing) overviews available. The big question now is whether the sweeping health care law can survive various legal and political challenges. In December, a federal judge in Virginia ruled that the individual mandate was unconstitutional. Meanwhile, congressional Republicans have vowed to thwart the legislation, and if the party were to win the White House and control of the Senate in the 2012 election, Republicans would be in a position to follow through on their threats to repeal it.
2. Smartphones, medical apps, and remote monitoring
Smartphones and tablet computers are making it easier to get health care information, advice, and reminders on an anywhere-and-anytime basis. Hundreds of health and medical apps for smartphones like the iPhone became available this year. Some are just for fun. Others provide useful information (calorie counters, first aid and CPR instructions) or perform calculations. Even the federal government is getting into the act: the app store it opened this summer has several free health-related apps, including one called My Dietary Supplements for keeping track of vitamins and supplements and another one from the Environmental Protection Agency that allows you to check the UV index and air quality wherever you are. Smartphones are also being used with at-home monitoring devices; for example, glucose meters have been developed that send blood sugar readings wirelessly to an app on a smartphone. The number of doctors using apps and mobile devices is increasing, a trend that is likely to accelerate as electronic health records become more common. Check out iMedicalapps if you want to see the apps your doctor might be using or talking about. It has become a popular Web site for commentary and critiques of medical apps for doctors and medical students. Meanwhile, the FDA is wrestling with the issue of how tightly it should regulate medical apps. Some adverse events resulting from programming errors have been reported to the agency. Medical apps are part of a larger “e-health” trend toward delivering health care reminders and advice remotely with the help of computers and phones of all types. These phone services are being used in combination with increasingly sophisticated at-home monitoring devices. Research results have been mixed. Simple, low-cost text messages have been shown to be effective in getting people wear sunscreen. But one study published this year found that regular telephone contact and at-home monitoring of heart failure patients had no effect on hospitalizations of death from any cause over a six-month period. Another study found that remote monitoring did lower hospital readmission rates among heart failure patients, although the difference between remote monitoring and regular care didn’t reach statistical significance.
3. New CPR guidelines
The American Heart Association issued new guidelines for cardiopulmonary resuscitation (CPR) this year that continue the trend toward simplifying CPR and emphasizing chest compressions. For trained rescuers, the guidelines change the CPR sequence from airway, breathing, and chest compressions and the A-B-C mnemonic to putting chest compressions first, followed by checks of the airway and breathing, or C-A-B. People who haven’t had CPR training are encouraged to do only chest compressions because they are easier and “more readily guided by dispatchers over the telephone.” The compressions should be fast (about 100 times a minute) and hard (so that the chest goes down by two inches or more). The American Heart Association produced a very good video about the guidelines that’s well worth watching. Fewer than half of those who suffer cardiac arrest receive CPR, so the hope is that more people will give CPR—and do so quickly— if it’s simpler and doesn’t involve mouth-to-mouth breathing. The guidelines note that the results for chest compression–only CPR are similar to those for traditional CPR for adults in cardiac arrest outside of the hospital. But conventional CPR is still better for children because cardiac arrest in children is usually preceded by a lack of breathing, so the mouth-to-mouth breaths are needed to restore oxygen levels in the blood. Research results reported this year in The Lancet, Journal of the American Medical Association, and The New England Journal of Medicine all suggested that in most cardiac arrest cases, chest compression–only CPR is as effective, if not more so, than conventional CPR.
4. Making stem cells
Heart attacks, strokes, and many other conditions destroy cells, and for years, scientists believed that it was impossible to make replacements. Then, four years ago, a Japanese researcher, Shinya Yamanaka, discovered a technique for reprogramming cells back into stem cells, so that they would function like a biological blank slate and be capable of turning into any other type of cell. Dr. Yamanka called his creations induced pluripotent stem cells, and a whole new frontier of stem cell research opened up. Scientists have since figured out ways to turn one cell type directly into another type: blood vessel cells have been turned into bone and fat cells, and skin cells have been turned into blood cells. And this year, stem cell research took another leap forward when a Harvard researcher, Derrick Rossi, reported results demonstrating a technique that may make the creation of induced pluripotent stem cells a lot easier and safer. Rossi and his colleagues at the Harvard Stem Cell Institute reprogrammed adult skin cells with synthetic messenger RNA that leaves DNA intact, instead of inserting genes into DNA. Research with embryonic stem cells remains important, and in October 2010, Geron, a California biotech company, began enrolling people in a trial to test the safety of using cells derived from embryonic stem cells to treat spinal cord injuries. But researchers are also making some remarkable progress toward turning readily available cells, such as skin or blood cells, into other types of cells. These new cells would be genetically identical to other cells in the body and therefore shouldn’t be rejected by the immune system when they’re transplanted to replace cells lost to disease.
5. Heightened awareness of concussions
Concern about sports-related concussions, especially in football, has been growing as evidence has increased that repeated concussions can cause permanent brain damage over the long term, even if the short-term effects are fairly mild (most concussions do not result in a loss of consciousness, for example) and CT and MRI scans are normal. Some researchers are calling concussion-related brain damage chronic traumatic encephalopathy (encephalopathy is a catchall term for any degenerative disease of the brain). There were several efforts in 2010 to reduce the number and severity of concussions. The National Football League started to fine players for illegal hits this season. The American Academy of Neurology came out with a position paper that says any athlete who might have suffered a concussion shouldn’t be allowed to partcipate again until he or she has been evaluated by a doctor with training in the evalulation and management of sports concussions. The American Academy of Pediatrics released a report about sports-related concussions in children and adolescents that says younger people often need more time (7 to 10 days or even longer) to recover from a concussion than college or professional athletes. Several states have passed laws requiring high schools to have concussion management programs. The concussion risk is greatest for football players, but girl basketball and soccer players also have relatively high rates. Meanwhile, research into concussions continues. Boston University researchers who have been prominent in the field caused a stir with a finding that linked concussions and chronic traumatic encephalopathy to amyotrophic lateral sclerosis (Lou Gherig’s disease).
6. An anti-aging possibility
Researchers at the Harvard-affliliated Dana-Farber Cancer Institute reported results this year that kindled hopes for altering the fundamental biology of aging. Their experiment involved mice that had been genetically engineered so that an enzyme called telomerase that is known to be important in the aging of cells could be turned on and off. When the enzyme was turned off, the mice aged prematurely. When they reached the chronological equivalent of adolescence, they appeared to be biologically very old: their brains and other organs had shrunk and were starting to fail. Then the scientists turned on the enzyme. Promptly, the brain and other shrunken organs started to grow with new cells, and organ failure ceased. The animals recovered their sense of smell. You might say the mice became adolescents again. Of course, what works in mice doesn’t always work in humans. There are concerns that the activation of telomerase could cause cancer, although that didn’t occur in this particular experiment. And this is very much an experimental finding; at this point, all those products making anti-aging claims are way ahead of the game and not to be trusted. Still, along with other research, this study hints at a future when it might be possible to slow down biological aging and possibly prevent some of the diseases associated with it.
7. CT scans for lung cancer screening
More Americans die from lung cancer than from any other type of cancer, yet there’s no accepted screening test for the disease. Study results reported this year may change that situation. The National Cancer Institute (NCI) stopped the National Lung Screening Trial comparing CT scans to chest x-rays earlier than expected because the CT scans appeared to be so effective at reducing lung cancer deaths. The trial included 53,000 current and former heavy (30 pack years or more) smokers. Results released in October showed that over a five-year period, 354 of those screened with CT scans died from lung cancer (or about 1.4%) compared with 442 of those screened with chest x-rays (about 1.7%). Catching any cancer at an earlier, more treatable stage is an appealing idea, and especially lung cancer, because of its high mortality rate. But screening tests have become more controversial lately because of concerns that they lead to overdiagnosis and overtreatment. Almost one in every four people who were screened with CT scans in the National Lung Cancer Screening Trial had a false positive, the finding of an abnormality that turns out not to be cancer. There are also concerns about radiation exposure from CT scans and whether scans for lung cancer will add to that problem.
8. New vitamin D guidelines
After years of debate, discussion, and research, the Institute of Medicine (IOM) issued new vitamin D guidelines this year. The Recommended Dietary Allowance (RDA) is now 600 international units (IU) a day for people ages 1 to 70 and 800 IU a day for those 71 and older. The previous guidelines, set in 1997, recommended a daily intake of 200 IU through age 50, 400 IU between the ages of 51 and 70, and 600 IU for those 71 and older. The IOM panel also established a new safe upper limit of 4,000 IU a day, double the old limit of 2,000 IU. The new guidelines were criticized as being too conservative by many experts, who would have preferred an RDA closer to 1,000 IU a day and a blood level target of 30 ng/ml (75 nmol/l) for the vitamin, not the 20 ng/ml (50 nmol/l) set by the IOM panel. The difference of opinion stems, in part, from the fact that the IOM panel gave results from randomized clincial trials (RCTs) far more weight than results from other types of studies. As a result, the panel found evidence that vitamin D benefits bone and little else. If other kinds of studies are taken into account, a case can be made that blood levels of 30 ng/ml or even higher would result in optimal bone health and that the vitamin has a wide range of health benefits beyond bone, including protective effects against some cancers (especially colon cancer) and some autoimmune disorders. The debate about vitamin D is bound to continue. Soon after the IOM panel released its report, a different set of experts, the U.S. Preventive Services Task Force, came out with fall-prevention recommendations that include an endorsement of vitamin D.
9. Alternatives to warfarin
The FDA approved one alternative to warfarin this year, a drug called dabigatran (sold as Pradaxa). Another alternative, rivaroxaban, seems to be waiting in the wings after largely favorable results were reported this year (here and here) from trials testing the drug in patients with deep-vein thrombosis and atrial fibrillation. A third drug, apixaban, which is related to rivaroxaban, is also looking promising. Warfarin (the brand-name version is called Coumadin) has been the mainstay for preventing blood clots for decades, but it’s a tricky, high-maintenance drug that requires frequent blood tests to make sure the dose is producing the desired results: enough anti-coagulation to prevent blood clots but not so much as to cause bleeding . Warfarin also interacts with many foods and drugs. In contrast, these warfarin alternatives seem simple as pie: they can be given in fixed doses, don’t require blood monitoring, and don’t seem to pose interteaction problems. Cost, however, will be a barrier. Drug companies set high prices for new brand-name drugs. Warfarin, widely available as a generic, is relatively cheap. And there’s always the possibility of unforeseen side effects once the new drugs are more widely used. Still, millions of people stand to benefit if good alternatives to difficult-to-use warfarin pan out.
10. Concerns about bisphosphonates
Bisphosphonates are prescribed to prevent and treat osteoporosis, a decrease in bone density that makes fractures more likely. Well-known brands include Fosamax (alendronate) and Actonel (risedronate). Millions of people, most of them postmenopausal women, take bisphosphonates; for the most part, they are safe and effective medications that have been shown to cut the risk of fractures by 50%. But concerns about ill effects from long-term use have been growing. In October, the FDA issued a new warning about bisphosphonates increasing the risk of a rare kind of thighbone (femur) fracture. Two years ago, the agency issued a different warning about the bone drugs causing bone, joint, and muscle pain. There have also been reports about a small percentage of bisphosphonate users developing osteonecrosis in their jawbones, although most of those cases have occurred in cancer patients who have received high intravenous doses (bisphosphonates can relieve pain and strengthen bone if cancer has spread to the bone). Some doctors are now recommending “drug holidays” for people who take bisphosphontes for osteoporosis for extended periods. Other bone-building drugs, such as denosumab (sold as Prolia), which was approved by the FDA this year, may get a closer look because of concerns about the side effects of bisphosphonates. And perhaps the nonpharmacological ways to strengthen bones will gain some adherents. Pill-free bone builders include a regimen of regular weight-bearing exercise and adequte intake of calicum and vitamin D (see item #8).