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Trump Rules: F.D.A. Chief Goes Against the Administration Stereotype

“He doesn’t want to blow up the agency,” said Mark I. Schwartz, a Washington lawyer who worked at the F.D.A. in Republican and Democratic administrations.Dr. Gottlieb has briefed Mr […]

Opinion: Can Your Hip Replacement Kill You?

These devices have helped countless people, and some have saved lives. But many others are harmed — and doctors and patients are at the mercy of manufacturers’ claims about the safety and efficacy of the devices. Medical interventions are now the third-leading cause of death in the United States, and devices play an increasing role in that statistic.Many people assume that the Food and Drug Administration requires rigorous testing of medical devices before they are approved, the same as the lengthy approval process it requires for new drugs. In fact, most high-risk devices on the market, including implants, have undergone no clinical testing at all.Although the standard for approval of a new drug usually calls for two randomized, controlled clinical trials, the standard for many medical devices is no standard at all. Since medical devices didn’t come under regulatory control by the F.D.A. until 1976, the agency simply grandfathered in all devices that were already on the market under a provision known as 510(k), which allows manufacturers to sell most new devices without requiring any clinical testing as long as the manufacturer says its product is “substantially equivalent” to an existing device.Newsletter Sign UpContinue reading the main storySign Up for the Opinion Today NewsletterEvery weekday, get thought-provoking commentary from Op-Ed columnists, the Times editorial board and contributing writers from around the world.Thank you for subscribing.An error has occurred. Please try again later.You are already subscribed to this email.View all New York Times newsletters.In addition to the 510(k) pathway, medical device companies can avoid clinical testing for the highest risk devices through the supplement pathway by telling the F.D.A. […]

9 lifestyle choices to help prevent dementia

With one in 3 cases of dementia preventable, a sweeping new report identifies modifiable factors in early, mid- and late life that make a difference […]

Gunman Kills Doctor and Himself in Bronx Hospital Shooting; 6 Others Hurt

A disgruntled doctor armed with an AR-15 rifle and wearing a lab coat went on a rampage on Friday in the Bronx hospital where he had worked, killing a female doctor and wounding six other people — five of them seriously — before setting himself on fire and shooting himself in the head, the authorities said.The furious attack by the doctor — identified by the police as Henry Bello, 45 — sent workers at the hospital, Bronx-Lebanon Hospital Center, diving behind desks and doors as gunshots and smoke filled the hallways of a place devoted to healing. Witnesses described medical workers’ ripping a fire hose from the wall to use as a tourniquet on one victim’s leg, while others recalled the horrific sight of the gunman, his torso aflame, running down a hallway.Dr. Bello had a troubled past, having worked at the hospital for about six months before quitting after being accused of sexual harassment, officials said. And years earlier, he was arrested and charged with sexual abuse after assaulting a woman in Manhattan.The attack appeared to be the type of mass shooting by a lone gunman that has struck communities around the United States.PhotoHenry Bello“He’s shooting! He’s shooting!” one woman yelled in the frantic initial moments of the afternoon assault, as recounted by a mother in the pediatric emergency room who had cowered with her five children, ages 1 to 10.Some believed that the death toll would have been far higher had the shooting occurred anywhere but where it did — a hospital filled with state-of-the-art medical equipment, and with doctors and nurses who rushed to victims and performed triage where they fell, in staircases and hallways, even as the gunman was still at large.“The situation unfolded in the middle of a place that people associate with care and comfort,” Mayor Bill de Blasio told reporters outside the hospital, on the Grand Concourse in the Claremont Village neighborhood. The gunman acted alone, Mr. de Blasio said, adding that it appeared to be a workplace dispute that ended when the gunman committed suicide — “but not before having done horrible damage,” the mayor said.The police did not identify the victim, other than as a woman and a doctor. The five seriously injured patients were “fighting for their lives,” said the police commissioner, James P. […]

Economic Scene: When Cutting Access to Health Care, There’s a Price to Pay

And the American deficit has been getting worse. “Each year, other high-income countries are improving their health at a much faster rate than the United States, and the United States currently ranks lowest on a variety of health measures,” the report by the Institute of Medicine and the National Research Council noted.Continue reading the main storyI bring this up, senators, because you are considering whether to drive a stake through the Affordable Care Act, cutting access to care for millions of mostly poorer, sicker and older Americans.Of course, the dismal health situation is not all the fault of the health care system — which, until the passage of the Affordable Care Act, was the only one in the developed world that routinely barred access or limited care for millions of people of modest means.That is because violence accounts for a large share of Americans’ excessive mortality, and accidents take a disproportionate toll. Nor is the health care system entirely to blame for the nation’s elevated obesity rate — a leading cause of problems like diabetes.What’s more, the United States’ higher tolerance of poverty undoubtedly contributes to higher rates of sickness and death. Americans at all socioeconomic levels are less healthy than people in some other rich countries. But the disparity is greatest among low-income groups.Still, senators, you are not off the hook. Limited access to health care may not entirely account for the poor health and the early deaths of so many of your fellow Americans. But it accounts for a good chunk.A study about equity in access to health care for 21 countries in 2000 revealed that the United States had the highest degree of inequity in doctor use, even higher than Mexico — which is both poorer and generally more inequitable.Photoreported that health insurance improves the diagnosis and treatment of high blood pressure, and reduces death rates from breast cancer and trauma.” data-mediaviewer-credit=”Whitten Sabbatini for The New York Times” itemprop=”url” itemid=”https://static01.nyt.com/images/2017/06/28/business/28PORTER2/28PORTER2-master675.jpg”/>Annals of Internal Medicine reported that health insurance improves the diagnosis and treatment of high blood pressure, and reduces death rates from breast cancer and trauma.Credit Whitten Sabbatini for The New York TimesAnd as noted in a 2003 study by the Institute of Medicine, insurance status, more than any other demographic or economic factor, determines the timeliness and quality of health care, if it is received at all.It doesn’t require an advanced degree to figure out what limited access to a doctor can do to people’s health. A review of studies published this week in Annals of Internal Medicine reported that health insurance substantially raises people’s chances of survival. It improves the diagnosis and treatment of high blood pressure, significantly cutting mortality rates. […]

Newly discovered fossils fill gaps in amphibian evolution

The newfound fossils shed light on the early evolution of one of the planet’s most mysterious amphibians. […]

Indulgent food labels get people eating more vegetables

Which would you rather have — rich buttery roasted sweet corn or reduced-sodium corn? […]