Articles Posted in Product Safety

prescription-bottles-1-300x170Some diligent, grown-up sons and daughters may want to check in on mom, dad, and grandma, grandpa, all the aunties and uncles, too. That’s because there’s yet another warning that too many doctors are whipping out their prescription pads all too readily and writing scripts for retirement-age Americans, who now take on average three psychiatric drugs without any mental health history.

Research published in the JAMA Internal Medicine shows that over-prescribing of powerful psychotropic drugs, including sleeping pills, painkillers, and anti-depressants may be more common than believed. The study was based on an analysis of data from a big number of doctors’ office visits, with researchers finding the number of “polypharmacy” incidents (cases in which seniors received scripts for multiple drugs) increased between 2004 and 2013 from 1.5 million to 3.68 million.

This doubling resulted from seniors’ greater openness in talking with their doctors about mental health issues, and, in instances where visits were related to “anxiety, insomnia, or depression,” the researchers write. But, in disturbing fashion, a high number of women and rural patients were involved in cases where multiple psychotropics were prescribed, and many of the prescriptions were for painkillers.

http://www.protectpatientsblog.com/wp-content/uploads/sites/69/2016/09/Food_and_Drug_Administration_logo.svg_-300x129.pngTo hear some powerful proponents tell it, Uncle Sam needs to really hurry up the government’s approval of drugs and medical devices. He’s got to make oversight over them easier, lighter, and less complex.

But consider just some of the health news in recent days:

marijuana-smoking-131013-300x200Although marijuana is marching toward legalization across the United States, expectant moms may wish to think long and hard still about smoking or ingesting a substance that has become as ubiquitous in some households as aspirin or a bottle of chardonnay. The New York Times has delved into this discussion, even as other news outlets recently have provided parental warnings about hype over apps for baby care and tossing some toxic homeopathic teething remedies.

Pot? Not for expectant moms

Let’s turn first, and not be blue noses about it, to why moms would consider pot while pregnant. Data show that few do (an estimated 4 percent of more than 200,000 women in one 12-year sample — though the number had doubled in recent time). For younger women, the answer may be, just because. They don’t equate it with risk but with recreation. They say they try to be cautious with it, just as they might curtail their alcohol consumption but still have a rare drink. Older and expectant moms may use pot, as many women do, because they find it helps with depression, anxiety, stress, pain, nausea and vomiting.

skepticism-image-197x300At one point, medical experts recommended that physicians aggressively treat patients 60 and older so the top number of their blood pressure readings ran as close as possible to 140. Maybe not so, anymore. For a while, physicians were told to treat patients so their “good cholesterol” increased significantly. But maybe this approach doesn’t protect against heart disease after all. Pediatricians once warned parents to protect newborns by not exposing them to certain allergens, especially peanuts. If you haven’t had your head buried in the sand, that counsel, of course, has just changed 180 degrees.

Thanks are due to Aaron E. Carroll, a pediatrician, health research and policy expert, and columnist with the New York Times “Upshot” feature, for reminding — yet again, as repetition is the Mother of Learning — that medical news must be taken in by patient-consumers with a “dose of healthy skepticism.” This he says is especially true about reports on nutrition.

I’ve written about the harms that result from hype and the many, sometimes dramatic reverses in health and medical news. I’ve pointed out that there are accessible resources, such as the excellent healthnewsreview.org, to watchdog coverage of medical science and so-called advances. I’ve suggested that patient-consumers look closely at key elements in research stories, including how the work was done, how long the study ran, whether its data is visible and if it was published in a reputable medical journal. This will help savvy readers look askance, even at pieces in quality news sites — such as recent articles touting turmeric or eating lots of hot peppers.

top-selling_edited-300x163Big Pharma has ruthlessly exploited a well-intentioned measure that sought to provide medications to treat patients with rare diseases that might otherwise have been ignored. Drug companies, instead, have manipulated the 1983 Orphan Drug Act to create legally protected monopolies so they can gouge desperate patients with astronomically priced products that already were taken by as many as millions.

These findings, part of an investigation by Kaiser Health News, a nonpartisan service focused on health policy issues, were just some of the outrages that surfaced in recent days involving Big Pharma: Two big drug makers have just agreed to pay hundreds of millions in fines for anti-competitive practices or failing to report suspicious transactions, while two pharmacy operations also will fork over millions to settle suits with federal authorities over anti-kickback violations or lax controls.

Kaiser said its scrutiny of orphan drugs, those targeted at diseases affecting fewer than 200,000 Americans nationwide, found that a third of the approvals by the federal Food and Drug Administration involved medications that already were approved for mass markets and were simply re-purposed.

pthiel-200x300Although attention has focused on the GOP-promised repeal and replacement of the Affordable Care Act, other big changes also are afoot in the federal government that will have significant effects on health care in this country.

There are appointments pending from President Trump at the federal Food and Drug Administration and the Centers for Disease Control and Prevention. Sonny Perdue, the administration’s pick for Agriculture secretary, also will play a big public health role, as will the personnel decisions that may be made at the troubled National Institutes of Health, where, for now, Francis Collins will continue to lead.

Will the FDA be run by a venture capitalist?

fireextinguisher-211x300They’re likely jammed into many of the toys and electronic gadgets that overflowed the house during the holidays. But they’ve also been linked to sufficient fires that products have been recalled because of them, and some devices with them have even been banned in the nation’s skies. Now federal regulators are warning hospitals and doctors’ offices to beware, too: Their many battery-laden medical carts may burst into flames or explode.

The federal Food and Drug Administration has written to caregivers nationwide with a new caution that, within the last three years, it has received a dozen reports of “smoke, fire, melting batteries, burning, and other hazards” with medical carts. No injuries have been recorded but facilities have been evacuated due to smoke and fire hazards from cart blazes or smoldering, the FDA says. The rolling stations have grown increasingly common so staffers can conveniently dispense medication, or carry equipment related to colonoscopes, ultrasound, and anesthesia machines.

They’re also prized because their electrical sources—lead acid or increasingly lithium batteries—pack the power needed, they’re portable, convenient, and they’re long lasting. But those batteries also can generate a lot of heat, and they have proven problematic in other uses.

Because the holidays should be filled with abundant joy, here are a few ways to safeguard the health and well-being of you and yours in the days ahead:

house fireDon’t ignore deadly fire dangers

The tragic Oakland, Calif., warehouse-concert hall blaze that claimed at least 36 lives has provided a timely reminder: Fires remain a huge concern, and, especially as cold weather sets in and families add seasonal lighting displays, caution needs to be a watchword. Yes, building codes have improved admirably over time, and fire fighters and many inspectors do a public service that deserves a salute. But affordable housing, especially in big cities like Washington, D.C., remains in crisis shortage. This has forced many, including young people, into overcrowded, substandard housing—some as little more than squatters in dangerous, vacant, or dubious buildings. Meantime, many homeowners resort to space heaters or other devices (including turning on kitchen stoves and ovens) as temperatures fall. Or they’re putting up flashy holiday light displays or even Christmas trees with risky electricals. These excesses can overwhelm safety systems, and not every property owner does due diligence to maintain now common household alarms.  The National Fire Protection Association reports that firefighters across the country in 2015 responded to more than 1.3 million blazes, which killed more than 3,200 Americans and injured almost 16,000, and caused more than $14 billion in damages.  U.S. fire departments, between 2010 and 2014, responded to an estimated average of 210 home fires per year that began with Christmas trees. These blazes caused an annual average of six civilian deaths, 16 civilian injuries, and $16.2 million in direct property damage. Common sense doesn’t change: Be careful while cooking holiday feasts. Think super safety when setting up holiday displays. Reconsider if portable heaters make sense in your home. Ensure your smoke and carbon monoxide alarms are working. Click here for some seasonal fire safety ideas.

cancer immunoThe news media enthusiasm for novel treatments, especially for cancer, has been on full display: Stat, the online health news site, has just written about one patient, a noted ophthalmologist, and how he had a favorable outcome with a lingering hospital acquired infection—not due to antibiotics but after  treatment with viruses a researcher found in a nearby pond. Multiple news organizations, meantime, have reported extensively on one woman with advanced colon cancer and how she benefited from her unique genetics and cultivation of her tumor-fighting cells to experience, for now, a recovery of rare extent. The New York Times devoted thousands of words in a multi-part series about the rise of immunotherapy, medical care in which the body’s own disease-fighting capacities (see illustration of T-cell attacking a cancer cell, right) are mobilized and which Washington Post has called the “hottest field in cancer treatments.

This isn’t a knock at any one reporter or news organization. It’s vital for the media to keep audiences advised about work on the frontiers of science and medicine. Gee-whiz stories can play a key function in capturing fickle public attention and keeping it focused on a critical concern like health care, a sector that comprises 17.5 percent of the U.S. GDP. But caution and skepticism may be in real order about therapeutic innovations, especially in cancer. As the health news watchdog organization Healthnewsreview.org points out, “too many [news] stories ignore or under-report the harms of cancer immunotherapies.” The New York Times deserves some credit for balancing its hefty reporting on this issue with a detailed report on unexpected outcomes, particularly harms, from this approach:

These so-called immunotherapy drugs have been hailed as a breakthrough in cancer treatment, attracting billions of research dollars and offering new hope to patients out of options. But as their use grows, doctors are finding that they pose serious risks that stem from the very thing that makes them effective. An unleashed immune system can attack healthy, vital organs: notably the bowel, the liver and the lungs, but also the kidneys, the adrenal and pituitary glands, the pancreas and, in rare cases, the heart.

VPJoeBiden_PresidentObamaPresident Obama is expected to sign the $6.3 billion 21st Century Cures Act, capping a rare, multi-year, bipartisan push to significantly improve the nation’s health care. The Senate, with Vice President Biden presiding and winning salutes from political colleagues and patient advocacy groupsapproved the act 94-5.

Proponents say it has many benefits to go around, as I’ve written, providing:

  • a $4.8 billion boost to the National Institutes of Health to support an array of innovative research in its facilities, as well as at universities, medical schools, academic medical centers, and major hospitals;

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