Articles Posted in Medications

pretomanid-300x122Rare good news on destructive infections is emerging from Africa: Medical scientists, Good Samaritans, and public health officials are hailing the successes of powerful new therapies in treating a deadly and extremely drug-resistant strain of tuberculosis and Ebola, a killer viral hemorrhagic fever that spreads like wildfire.

Americans may skip over dispatches about these “foreign” news developments. They would be wise not to do so, because they have heightened importance these days, domestically, including in providing key lessons to be learned about how to safeguard the public health.

The TB care that is winning great attention overseas requires patients to take three drugs in a regimen in which they take five pills a day for six months. That already is a boon compared with other, now common therapies in which they might need 40 pills a day for as long as two years, or daily antibiotics shots with bad side effects like deafness, kidney failure, and psychosis.

zolegensma-300x225Big Pharma is testing crucial boundaries in the way that the nation determines the safety and effectiveness of prescription medications. And regulators, for patients’ sake, need to shove back — hard.

The concerning incidents involve “pay to play” clinical trials and “manipulated” data submitted to the federal Food and Drug Administration by maker Novartis as part of the approval process for a gene therapy drug with a sky-high price.

Neither instance, officials insist, had immediate effects in endangering patients. But both show extreme practices and conduct that regulators should slam to a halt.

axiosinsurancecost-300x170With the 2020 presidential campaign obsessing early about health insurance rather than costly health care overall, voters may wish to reframe their thinking about coverage and candidates’ views on making it affordable. Their chief query may need to be this: Just how much of the vig should the bagman take?

That may be a blunt a way to put it, but is the vernacular of the criminal “protection” racket all that out of place here? Michael Hiltzik, a financial columnist for the Los Angeles Times, makes pretty much the same argument, that the bagman’s share ought to be zero.  Why not get rid of health insurers, he asks in a bit of evidence-based hyperbole? He finds the companies don’t fulfill much of a public mission, save, as a former insurance executive describes it, to make themselves money and to persuade all of us that they are essential. Indeed, as Hiltzik sees it, insurers are not just a rip-off but a failure in their own terms:

“Let’s start by examining what the insurers say are their positive contributions to healthcare. They claim to promote ‘consumer choice,’ simplify ‘the health care experience for individuals and families,’ address ‘the burden of chronic disease,’ and harness ‘data and technology to drive quality, efficiency, and consumer satisfaction.’ (These claims all come from the website of the industry’s lobbying organization, America’s Health Insurance Plans (AHIP). They’ve achieved none of these goals. The increasingly prevalent mode of health coverage in the group and individual markets is the narrow network, which shrinks the roster of doctors and hospitals available to enrollees without heavy surcharges. The hoops that customers and providers often must jump through to get claims paid impose costly complexity on the system, not simplicity. Programs to manage chronic diseases remain rare, and the real threat to patients with those conditions was lack of access to insurance (until the Affordable Care Act made such exclusion illegal). Private insurers don’t do nearly as well as Medicare in holding down costs, in part because the more they pay hospitals and doctors, the more they can charge in premiums and the more money flows to their bottom lines. They haven’t shown notable skill in managing chronic diseases or bringing pro-consumer innovations to the table.”

nprsuicide-300x224The nation’s rising suicide crisis torments seniors, too, with just under one out of five such deaths in 2017 occurring with individuals 65 and older. Men 65-plus, experts say, face the highest suicide risk, while seniors 85 and older, men and women, rank No. 2 in groups most likely to die by taking their own lives.

As the nation grays — 10,000 baby boomers a day turn 65, in a trend that will persist until 2029 — the already high concern about suicide, especially among seniors, is rising,  National Public Radio reported.

NPR, noting that suicide already is the 10th leading cause of death among all Americans, said that experts see loneliness, bereavement, grief, and depression as key factors in cases in which older individuals kill themselves. They find themselves isolated, overwhelmed, and with unending sadness when spouses and friends die. Their children, grandchildren, and other family members often live far away. They also struggle with their lives due to age’s increasing debilitation. As NPR reported:

drugs-300x179The nation may be hitting an inflection point in the opioid crisis. But Big Pharma, regulators, and politicians have much to answer for prescription painkillers’ terrible toll and their sluggish efforts to reduce the tens of thousands of casualties.

The spare good news about U.S. drug abuse — the first drop in overdose deaths since 1990 — came from the federal Centers for Disease Control and Prevention. The agency also warned its findings were freighted with many “yes, but …” elements, including:

  • The reported 5% decline occurred in deaths from prescription opioids;

uti-240x300For kids, women, and seniors, the three letters U, T, and I long described an uncomfortable, inconvenient, and embarrassing condition. The time, though, may have past for the swift and easy relief that diagnoses of  urinary tract infections once might have brought. Instead, doctors are expressing concern that the bugs that cause all-too-common UTIs are becoming different and antibiotic resistant.

As the New York Times reported, the shifts already are meaning “more hospitalizations, graver illnesses and prolonged discomfort from the excruciating burning sensation that the infection brings.” The newspaper added:

“The New York City Department of Health has become so concerned about drug-resistant UTIs … that it introduced a new mobile phone app this month that gives doctors and nurses access to a list of strains of urinary tract infections and which drugs they are resistant to. The department’s research found that a third of uncomplicated urinary tract infections caused by E. coli — the most common type now — were resistant to Bactrim, one of the most widely used drugs, and at least one fifth of them were resistant to five other common treatments.”

kidneysnatlinstitute-241x300More than 37 million Americans who suffer from chronic kidney disease soon may see big changes in the way their disabling condition gets treated, potentially also reducing the $100 billion that the federal Medicare program pays for care of the body’s crucial blood cleaning organs.

President Trump issued an executive order calling on the federal government to use all means possible to attack kidney disease in three key ways:

  • Reduce the number of patients who suffer from kidney failure;

drugcostsunreasonablekff2019-300x172It takes more than a lot of huffing and puffing to blow down the ever-rising high costs of prescription drugs, the Trump administration has found. Two defeats happened last week:  officials were forced to pull a plan to curb profit-making by drug industry middlemen, and a federal judge axed on First Amendment grounds a plan to muscle Big Pharma into including price information in its ubiquitous product ads.

These were key pillars of the president’s multi-part plan to address increasing drug costs, one of Americans’ most pressing concerns with their health care, and Trump had put considerable of his political capital behind them as he rolls toward the 2020 election campaign.

As the New York Times reported:

fdagottlieb-240x300Consumers may want to think long and hard about whether the federal Food and Drug Administration protects the interests of the vulnerable public or profit-raking Big Pharma and medical device makers.

As a scrutiny of data by Science magazine  shows:

“From monitoring clinical trials and approving medicines and vaccines, to ensuring the safety of blood transfusions, medical devices, groceries, and more, the U.S. Food and Drug Administration (FDA) is one of the nation’s most vital watchdogs. By several measures, however, FDA’s compliance and enforcement actions have plummeted since President Donald Trump took office … The agency’s ‘warning letters’—a key tool for keeping dangerous or ineffective drugs and devices and tainted foods off the market—have fallen by one-third, for example. Such letters typically demand swift corrections to protect public health and safety. FDA records from Trump’s inauguration through 22 May show the agency issued 1,033 warning letters, compared with 1,532 for the most recent equivalent period under former President Barack Obama. Compared with the start of the Obama presidency, Trump-era letters dropped by nearly half. Warnings from the FDA Center for Devices and Radiological Health, which helps ensure the safety and quality of medical devices, and from some of the agency’s district offices—including Philadelphia, Florida, and New York—have dropped even more steeply, by more than two-thirds. Two district offices have not issued a warning in more than 2 years. The numbers don’t just reflect a new administration’s slow start. FDA sent significantly fewer warning letters in the second year of Trump’s presidency than in his first.

covervf-300x210As the nation’s opioid and drug overdose crisis deepens, it can be hard to watch as the “Not My Fault” crowd clucks about its blamelessness in pushing potent painkillers that have played a part in killing more Americans in 2016 and 2017 alone than lost their lives in the Vietnam War.

The latest NMF protagonists include:

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
Washingtonian Top Lawyer 2011
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