Articles Posted in Medications

lotsapills-300x200Consumers have gotten eyebrow-raising views of Big Pharma’s ugly business practices and the tough and sometimes sketchy efforts to rein in the industry’s ravenous pursuit of profits — in settling claims over distributors inundating the country with lethal painkillers, or with a maker’s behind-the-scenes campaign to win U.S. approval of an Alzheimer’s medication based on dubious data.

Patients are unlikely to come out ahead, or even satisfied with the outcomes of the cases involving how Johnson & Johnson (J&J), Cardinal Health, AmerisourceBergen, and McKesson handled opioids, and how Biogen and the Food and Drug Administration have dealt with Aduhelm.

A major opioids settlement

candidacdcauris-300x135Alarms are sounding yet again that the nation’s nursing homes and other long-term care facilities may need to increase important infection control measures and reexamine what’s going on with the staff they need to safeguard patients.

Details are still emerging. But federal officials say they have sufficient evidence to report a new outbreak of  Candida auris, aka C. Auris, highly drug-resistant fungus, in a nursing home in Washington, D.C., and at two Dallas-based hospitals.

This “superbug” is considered a menace because infected patients do not respond to treatment with three major drug groups. This outbreak also has experts’ attention because it shows signs of a different way of spreading — patient-to-patient transmission.

cdcnytopioidcrisisjuly2021-183x300“It’s huge, it’s historic, it’s unheard of, unprecedented, and a real shame. It’s a complete shame”

That quote, reported by the New York Times and made by Daniel Ciccarone, a professor of medicine at the University of California, San Francisco, tragically summarizes the latest  federal data on the opioid abuse and drug overdose crisis. As the newspaper and others reported:

“Drug overdose deaths rose nearly 30% in 2020 to a record 93,000, according to preliminary statistics released … by the Centers for Disease Control and Prevention. It’s the largest single-year increase recorded.”

fentanylillustration-300x99Just as attorneys generals for more than a dozen states inch toward a multibillion-dollar settlement with a drug maker faulted for its big role in the start of the opioid abuse and drug overdose crisis, that health menace is taking a new, deadly turn in the region around the nation’s capital.

In Washington, D.C., Maryland, and Virginia, officials report they are grappling with spiking overdose deaths, numbering in the hundreds, and blamed on the rise of fentanyl. It is a synthetic, prescription painkiller developed to assist late-stage cancer patients. It packs a wallop. And Big Pharma companies pushed for its wider use with aggressive marketing and sales campaign that landed some drug executives in jail.

The excessive promotion of fentanyl also led to its illegal manufacture, notably in chemical factories in China. Its increasing abuse, along with other opioids, also opened the door to big problems with illicit drugs.

aduhelm-300x250The  Food and Drug Administration has back-tracked on a major part of its  accelerated approval of Aduhelm, a prescription medication targeted at Alzheimer’s patients.

The  FDA green light for the drug also has created such consternation among medical specialists, insurers, policy experts, and politicians — including with news reports of hidden, cozy dealings between a top regulator and the medication’s maker —  that the acting agency chief has asked the independent inspector general to investigate what happened.

The fury over Aduhelm is occurring even as another drug maker is pushing legal action that authorities argue also could saddle taxpayers with other soaring costs for other expensive drugs.

aduhelm-150x150The federal Food and Drug Administration has created an instant medical and regulatory morass by giving an accelerated approval to Biogen’s costly prescription medication targeted at patients with Alzheimer’s disease.

This is the first drug to win the precious official nod from the FDA in almost two decades.

But the agency’s OK to market aducanumab (pronounced “add-yoo-CAN-yoo-mab”), which will go by the brand name Aduhelm, may go in the books as one of the sketchiest and most ferociously contested in recent times. The drug somehow overcame Everest-sized reasons why, at best, it needed further study — which it is supposed to get. And it faces Himalayan-sized criticisms that it will raise false hopes for those afflicted with a condition that is spiking in a fast-graying nation, and for which no effective medical remedy has been found.

cnnhoustonvaxprotest-300x169In the crunch to quell the coronavirus pandemic and to do so by getting as many people as possible their protective shots, public health officials consistently have stressed a big V in the national vaccination campaign: Voluntary.

But as hundreds of millions of people around the globe have willingly gotten them and the vaccines have shown to be overwhelmingly safe and effective, the unvaccinated may get leaned on with more than pleas, nudges, and incentives.

They may notice this quiet push in the workplace, especially if they hold health-related jobs, and at schools. The result may be to resurface the fiery and counter-factual anti-vaccination extremism in the country.

debbiedingell-150x150Just because myriad drugs and supplements are sold over the counter does not mean these pills are safe. They can pose serious health risks and cause major damage, a prominent Midwestern congressman has reminded by sharing her own near-disaster with a well-known OTC drug.

Debbie Dingell, a Michigan Democrat, told the Washington Post that she recently awoke with great pain and a feeling of bloating. Her symptoms were so severe and unrelenting that she called her doctor and was rushed into emergency surgery for a perforated ulcer. She was hospitalized for a week to recuperate.

The likely cause for her serious problems, her doctors told her: Her extended taking of high doses of an over-the-counter pain reliever found in many people’s medicine cabinets — Motrin, or ibuprofen. As she told the newspaper, she took it to ease her pain after dental implants and jaw surgery:

brooks-lasureandbecerra-300x240Chiquita Brooks-LaSure has won U.S. Senate confirmation and will become the first black woman to lead the federal Centers for Medicare and Medicaid Services or CMS.

The longtime government official, who was an adviser to President Obama and has served in multiple other top federal roles (shown right, with her boss, Health and Human Services head Xavier Becerra), jumps into a role with gigantic challenges. These include:

  • The administration by her agency of federal health insurance programs, including for children and those covered under the Affordable Care Act. The Biden Administration and Democrats, as part of coronavirus pandemic rescue efforts, bolstered Obamacare and opened enrollment in it, with subsidies, to millions of Americans slammed by the coronavirus pandemic. But those efforts, which have boosted ACA enrollment, also will need renewed legislative support — which may occur right as the midterm elections are under way. CMS also may be a key part of some Democrats’ plans to improve health care coverage in this country by lowering the qualifying age for Medicare for 60-something Americans who often must pay staggering premiums and who lose jobs and employer-related coverage at scary rates. This is an idea that Republicans reject.
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