Articles Posted in Product Safety

fdanulogo-300x126As snarky youngsters might say, “Well, OK, Boomer:” Federal watchdogs keep looking more than a little pitiful as they find they not only have fallen behind the times but keep racing to chase trends and technologies that have zoomed beyond their control.

In the meantime, consumers suffer the consequences.

Recent news reports show, for example, how vaping youths already may have found a big work-around with federal crackdowns on e-cigarettes and how social media has become a viper’s nest of not only quackery but a dubious diamond mine for Big Pharma exploitation.

alexahhs-150x150Federal regulators may be on the brink of not only protecting but also advancing patients access and use of a key component of their care: their electronic health records. Or will bureaucrats fold up in the face of a muscle campaign by corporate interests and hospitals?

To its credit, the giant Health and Human Services agency has emphasized that it is moving forward in its announced plans to prepare new regulations on so-called EHRs, pressing patients’ rights and newer, and potentially more nimble tech firms’ abilities to make the information in the records more accessible and helpful.

But Epic, the giant software company that has installed electronic systems in hospitals and health systems nationwide — often for billions of dollars — is leading resistance to the new rules. It has convinced dozens of institutions and groups, some sizable, to lobby officials to oppose this federal intervention.

coronavirusdoc-265x300The toll of the coronavirus outbreak in China keeps worsening, with the infections exceeding tens of thousands and the deaths spiking toward 1,000, also claiming the first American and Japanese lives of people in the disease epicenter of Wuhan.

The illness’ most significant harms continue to afflict China, particularly its central province of Hubei and regional capital Wuhan.

But the infection has raised global alarms, in part because its death toll, for example, has far exceeded in China the fatalities recorded with the 2003 disease incident involving Severe Acute Respiratory Syndrome, or SARS. That infection killed hundreds in China.

practicefusion-300x169Federal prosecutors have provided 145 million reasons why enthusiasts may want to curb their exuberance about how high tech will work miracles in the U.S. health care system.

That’s because investigators have ferreted out “abhorrent” conduct by Practice Fusion, a San Francisco firm that specialized in electronic health care records software, according to the U.S. Attorney’s Office in Vermont.

“During the height of the opioid crisis, the company took a million-dollar kickback to allow an opioid company to inject itself in the sacred doctor-patient relationship so that it could peddle even more of its highly addictive and dangerous opioids,”  Christina E. Nolan, U.S. Attorney for the District of Vermont, said in a statement. Practice Fusion, she added,  “illegally conspired to allow [a] drug company to have its thumb on the scale at precisely the moment a doctor was making incredibly intimate, personal, and important decisions about a patient’s medical care, including the need for pain medication and prescription amounts.”

The public’s health and safety sometimes find protections in the civil justice system and sometimes under regulators’ threat. Here’s hoping that whatever means are required, just and proper outcomes result.

For women, two separate suits have sought a modicum of justice for sexual abuse of talented young gymnasts by a predatory caregiver and damages tied to the maker of what has become a notorious material for supposed surgical repairs in the pelvic area.

For parents, the positive but potentially inconvenient recent news is that regulators finally have cracked down on risky baby sleepers, ordering the recall of tens of thousands more of them.

adamsmug-150x150Cigarette smokers got yet more chiding from public health officials about why and how they should quit an addictive and destructive habit. To do so isn’t easy, and a “shocking” number of doctors aren’t helping enough, the Surgeon General of the United States conceded. But there are big reasons to give up the nasty vice, especially before elective surgery, the World Health Organization warned.

The health experts found much to agree on when it comes to the carnage smoking causes. As the New York Times reported on the surgeon general’s work:

“More than 55 years after the first surgeon general’s report warned that smoking causes cancer, it remains the leading cause of preventable death and disease in the United States. According to the Centers for Disease Control and Prevention, the rate of smoking in the United States has declined to an all-time low of 14%. More than 3 of every 5 adult Americans who have smoked have quit, the report said. Still, 34 million Americans currently smoke, and an estimated 480,000 die from smoking-related illnesses each year, the agency said. About 16 million people in the United States now suffer from cancer, heart disease and smoking-related disorders, according to the CDC. The financial toll is enormous too, with annual health care spending attributed to smoking exceeding $170 billion, the agency said.”

califgovnewsomBig Pharma, with its relentless price gouging, may finally have poked in the eye the wrong people. But even as patients wait to see if hospitals, and now states and insurers, can beat down skyrocketing drug prices, isn’t it past time for more public shaming for doctors who persist in writing excessive, dubious, and downright risky prescriptions?

Although the Trump Administration and Republicans in Congress have failed to deliver on repeated promises to attack excessive costs for prescription drugs, the state of California and now leading insurers are following some hospitals in tackling the problem.

Calif. Gov. Gavin Newsom (shown, above right), in unveiling his state budget, told lawmakers that he wants the Golden State to consider contracting with generic drug makers to produce products that would cost less and be sold under a California label. As the Los Angeles Times described the still-to-be fleshed out gubernatorial plan:

darrow-300x168For anyone concerned with the quality and safety of prescription medications, this may be an especially displeasing commentary from a pharmaceutical expert about drugs raced to approval now:  “Some of them are really great,” the professor observed. “And some of them [are] not so great. And a lot of them are very expensive.”

That quote, by the way, comes from a news report by NPR on so-called reforms of the federal Food Drug and Administration prescription drug oversight process. Big Pharma has howled for some time now at politicians, regulators, and the public for fixes to the system — and the industry has gotten its way.

Now, as NPR reported, based on a new study posted online on the JAMA Network:

dresserfallikea-300x169Doctors, hospitals, insurers, politicians, and businesses may assail the civil justice system over sums it awards to people who have proven they have been harmed. But as significant as some judgments may be, they may be exactly what judges and juries decide may be required to get institutions and enterprises to stop stubborn wrongs.

Is $215 million enough in a federal case, for example, to get the University of Southern California to learn the hard lesson that it needs to listen and to act swiftly if  coeds and nurses complain about  inappropriate sexual behavior of  its student health service staff?

Is $46 million sufficient to get Ikea to fix, recall, and inform the public yet more about the dangers to children of pieces of its furniture that can tip over and kill kids — the latest victim being Jozef Dudek, 2?

boozengals-300x180Tipple much, much less in 2020. That might be a life-saving bit of advice for too many Americans to follow, especially because of new data on a worrisome spike in alcohol-related deaths.

As NBC News reported, based on published research by federal researchers:

“The yearly total of alcohol-related deaths for people ages 16 and over more than doubled, from 35,914 in 1999 to 72,558 in 2017. There were almost 1 million such deaths overall in that time. While middle-age men accounted for the majority of those deaths, women — especially white women — are catching up, the study found. That’s concerning in part because women’s bodies tend to be more susceptible to the effects of alcohol.”

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