Category: Drugs

Biden prioritises health care in State of the Union speech

Volume 403, Issue 10431
16 March 2024 

WORLD REPORT  Plans to protect reproductive rights, further reduce drug prices, and improve women’s health research have been welcomed by some experts. Susan Jaffe reports from Washington, DC.  

The State of the Union address is typically a report to Congress on the nation’s progress and goals entwined with occasional lofty rhetoric, but this one was different…. “This speech signals that health care will be a big part of President Biden’s campaign this year”, said Larry Levitt, Executive Vice President for Health Policy at KFF, formerly the Kaiser Family Foundation. [Continued here]…

Imported drugs unlikely to lower US prices any time soon

Volume 403, Issue 10423
20 January 2024 

WORLD REPORT  Americans pay some of the highest prices in the world for prescription drugs, but the decision by the US Food and Drug Administration to allow Florida to import cheaper medications from Canada won’t cut prices any time soon. Although the ruling represents a shift in the decades-long fight for drug importation, opposition from the US pharmaceutical industry, Canadian health officials, and others is expected to block implementation at every stage. [Susan Jaffe reports, here]…

US pharmaceutical companies sue to halt cuts in drug prices

Volume 402, Issue 10399
29 July 2023 

 

WORLD REPORT  Medicare will soon be able to negotiate some drug prices to reduce costs for patients and taxpayers. Susan Jaffe reports from Washington, DC.

The first set of ten drugs subject to price negotiations by the US Medicare programme will be unveiled on Sept 1, 2023, but some pharmaceutical companies and their allies are not waiting to find out which products will be on the list. So far, four manufacturers and two trade associations are suing to stop the process before it begins. [Continued here.] 

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Medicare Plan Finder Likely Won’t Note New $35 Cap on Out-of-Pocket Insulin Costs

By Susan Jaffe, KHN  | November 15, 2022 | This story also ran on

A big cut in prescription drug prices for some Medicare beneficiaries kicks in next year, but finding those savings isn’t easy.

Congress approved in August a $35 cap on what seniors will pay for insulin as part of the Inflation Reduction Act, along with free vaccines and other Medicare improvements. But the change came too late to add to the Medicare plan finder, the online tool that helps beneficiaries sort through dozens of drug and medical plans for the best bargain.

To fix anticipated enrollment mistakes, Medicare officials will give beneficiaries who use insulin a chance to switch plans next year. Typically, people are locked in for an entire year. [Continued on Kaiser Health News and US News & World Report]

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FDA panel says preterm birth drug should be withdrawn

Volume 400, Issue 10362
29 October 2022 

 

WORLD REPORT  Makena has been given to hundreds of thousands of patients over the past 11 years. Susan Jaffe reports from Washington, DC.  

The only treatment in the USA to prevent premature births is ineffective and should be withdrawn from the market, according to the Food and Drug Administration’s (FDA) Obstetrics, Reproductive and Urologic Drug Advisory Committee. The recommendation has renewed scrutiny of a special drug approval process that raises patients’ hopes by allowing them to take medications that have not been fully tested for efficacy and safety [Continued here.] 

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US Congress lets Medicare negotiate lower drug prices

Volume 400, Issue 10352
20 August 2022 

 

WORLD REPORT  A new law also targets climate change in a major victory for Democrats and President Joe Biden. Susan Jaffe reports from Washington, DC.

Shattering decades of opposition from the pharmaceutical industry and its allies, slim Democratic majorities in the US House of Representatives and Senate have passed landmark legislation to begin to control runaway drug prices for almost 50 million older Americans with Medicare’s pharmaceutical benefit. The bill also provides the largest federal investment in US history—US$370 billion—to slash greenhouse gases by 40% below 2005 emissions and respond to the devastating effects of climate change…. The legislation also ensures that no Medicare beneficiary pays more than $2000 a year for drugs. “That means you will have more money in your pocket”, said Tatiana Fassieux, education and training specialist at California Health Advocates. [Continued here.]
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Medicare Surprise: Drug Plan Prices Touted During Open Enrollment Can Rise Within a Month

By Susan Jaffe  | Kaiser Health News | May 3, 2022 | This KHN story also ran on

Something strange happened between the time Linda Griffith signed up for a new Medicare prescription drug plan during last fall’s enrollment period and when she tried to fill her first prescription in January.

She picked a Humana drug plan for its low prices, with help from her longtime insurance agent and Medicare’s Plan Finder, an online pricing tool for comparing a dizzying array of options. But instead of the $70.09 she expected to pay for her dextroamphetamine, used to treat attention-deficit/hyperactivity disorder, her pharmacist told her she owed $275.90.

“I didn’t pick it up because I thought something as wrong,” said Griffith, 73, a retired construction company accountant who lives in the Northern California town of Weaverville.  “To me, when you purchase a plan, you have an implied contract,” she said. “I say I will pay the premium on time for this plan. And they’re going to make sure I get the drug for a certain amount.”

But it often doesn’t work that way.  [Full story in Kaiser Health News, NPR  and Tampa Bay Times]  

 

 

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Medicare covers new Alzheimer’s drug, but there is a catch

Volume 399, Issue 10335
23 April 2022 

 

WORLD REPORT  The federal health plan for older Americans will pay for the controversial new drug aducanumab only for patients participating in clinical trials.  Susan Jaffe reports.  

The Biden administration’s long-awaited decision to pay for a controversial new Alzheimer’s disease treatment, aducanumab, will not make it easier for many older Americans with Medicare health insurance to get it. [Continued here.] 

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Califf takes the helm at the US FDA, again

Volume 399, Issue 10330
19 March 2022 

WORLD REPORT   Robert Califf will have to face several controversial health issues in his second tenure as commissioner. Susan Jaffe reports from Washington, DC.  

Califf takes over amid a lull in the COVID-19 pandemic and an array of hotly debated issues 9 months before a congressional election. The
election results could shrink, if not eliminate, the Democratic majority President Joe Biden needs to propel his health agenda, including the relaunched cancer moonshot and the Advanced Research Projects Agency for Health that would accelerate the development of medical treatments. [Plus new COVID-19 tests and treatments, opioid misuse, accelerated approval process, abortion pill conflict, continued here.] 
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Biden’s science adviser resigns over bullying

Volume 399, Issue 10326
19 February 2022

 

WORLD REPORT   Experts say that Eric Lander’s resignation should not affect the President’s plans to reboot the cancer moonshot project. Susan Jaffe reports.…

US FDA defends approval of Alzheimer’s disease drug

Volume 398, Issue 10294
3 July 2021

 

WORLD REPORT An avalanche of criticism has forced the US Food and Drug Administration to defend its decision to grant accelerated approval for aducanumab, the first new Alzheimer’s disease treatment in two decades. “It will be a very long time before we ever figure out whether or not this drug really works”, said Aaron Kesselheim, professor of medicine at Brigham and Women’s Hospital and Harvard Medical School who resigned in protest from an FDA advisory panel that recommended against approval.[Continued here.]

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US drug importation plan hits snag

Volume 397, Issue 10291
12 June 2021

WORLD REPORT The Biden administration says it has “no timeline” for deciding if states can import cheap drugs from Canada. 

President Joe Biden’s administration said last week that it won’t decide whether to allow states to import drugs from Canada anytime soon, if ever. Biden supported drug importation during the presidential campaign, as did his opponent, Donald Trump, to mitigate sky-rocketing drug costs in the USA. Americans pay more per capita for prescription drugs than any other country…. [Continued here.]

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US election 2020: the future of the Affordable Care Act

Volume 396, Number 10260     31 October 2020 

WORLD REPORT   President Donald Trump pledges to replace the Affordable Care Act while his Democratic opponent Joe Biden offers detailed proposals to improve it. Susan Jaffe reports from Washington, DC.

Since winning the presidency in 2016 in large part by promising to eliminate Obamacare, otherwise known as the Affordable Care Act (ACA), Donald Trump has promised more than a dozen times that his replacement plan would be ready soon. The plan would be released in 2 weeks, a White House spokeswoman said 2 months ago.

“We’re going to have a health-care plan that will be second to none”, Trump said in 2017. “It’s going to be great and the people will see that.” And at last week’s final presidential debate, he vowed “to terminate Obamacare, [and] come up with a brand new beautiful health care”.

A decade after the ACA—President Barack Obama’s signature achievement—became law, repealing and replacing Obamacare is again central to Trump’s re-election. And improving and expanding the law is a crucial part of the campaign of his challenger, former Vice President Joe Biden. [Continued here.]     

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US election 2020: public health

Volume 396, Number 10256

3 October 2020

 

WORLD REPORT   In the race for the White House, where do US President Donald Trump and his Democratic challenger, former Vice President Joe Biden, stand on public health? Susan Jaffe reports from Washington, DC. 

Analyzing the candidates’ plans to address the opioid epidemic, gun violence, women’s health, global health and COVID-19.

Unlike more conventional presidential candidates, Trump does not intend to issue formal policy proposals or position papers. With less than 5 weeks remaining before the election, his campaign says he will share “details about his plans through policy-focused speeches on the campaign trail”. …Joe Biden’s campaign has released a total of 51 policy proposals outlining how he will accomplish his goals if he wins in November. [Continued here.]…

Media reports reveal political interference at the US CDC

Volume 396, Number 10255

26 September 2020

 

WORLD REPORT  News accounts say that Trump administration officials wanted to edit and approve COVID-19 studies and publish guidance without the usual scientific review. Susan Jaffe reports.

After news stories about attempts by members of the Trump administration to manipulate COVID-19 reports published by the US Centers for Disease Control and Prevention (CDC) and over-rule its scientists, one top official is taking a sudden leave of absence for health reasons. Another’s government contract has abruptly ended. The 2-month absence of Michael Caputo, chief spokesman for the US Department of Health and Human Services (HHS), comes after he claimed that a CDC “resistance unit” seeks to undermine Trump. He and an adviser reportedly demanded the right to revise and approve COVID-19 studies published in the CDC’s highly respected Morbidity and Mortality Weekly Report journal.  [Continued here.]…

Federal Regulators split on antimalarials for COVID-19

Volume 395    Number 10231     
11 April 2020                          
WORLD REPORT   US and French authorities have authorised the use of chloroquine and hydroxychloroquine, but the EU regulator and WHO say the science doesn’t support the decision. Susan Jaffe reports. 
With no “adequate, approved and available” alternative, the US Food and Drug Administration (FDA) is allowing the use of the antimalarial drugs hydroxychloroquine and chloroquine to treat coronavirus disease 2019 (COVID-19).

The FDA’s emergency use authorisation (EUA) issued last week gives physicians the option to prescribe the drugs, which President Donald Trump has recommended. However, both drugs are unproven and untested for COVID-19, and have rare but potentially deadly side-effects.  The decision bypassed the usual drug approval process including doubleblind, placebo-controlled clinical trials, stoking a worldwide debate about whether the drugs are appropriate for treating the disease.

“I think it was resorted to more out of a sense of desperation”, said Joseph Masci, an infectious disease specialist and director of global health at Elmhurst Hospital in Queens, a borough of New York City, which is at the centre of the epidemic in the USA. “It is just an indication of how sudden and massive this outbreak has been.” [Continued here.]  

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Medicare for All scrutinised in Democratic primaries

Volume 395       Number 10225     29 February 2020                          
WORLD REPORT  On March 3, 14 states will pick their nominees for the US presidential election. The feasability of a single payer insurance plan is a key issue. Susan Jaffe reports from Washington, DC.
Anxiety about rising health-care costs— the top issue for Democratic voters, according to recent polls—propelled Bernie Sanders to the head of the pack in last week’s Democratic primary contest in Nevada. Of the six leading candidates vying for the party’s presidential nomination, Sanders, a Vermont senator and self-described democratic socialist, has proposed the most radical solution for lowering medical bills and reaching universal coverage. His signature policy initiative, the Medicare for All single-payer programme, would eliminate private health insurance, including employment-based plans that cover about half of the US population. [Article compares Medicare for All and the public option proposal favoured by former Vice President Joe Biden; continued here]
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As Medicare Enrollment Nears, Popular Price Comparison Tool Is Missing

By Susan Jaffe  | Kaiser Health News | October 8, 2019 | This article also ran in the

Millions of older adults can start signing up next week for private policies offering Medicare drug and medical coverage for 2020. But many risk wasting money and even jeopardizing their health care due to changes in Medicare’s plan finder, its most popular website. 

 For more than a decade, beneficiaries used the plan finder to compare dozens of Medicare policies offered by competing insurance companies and get a list of their options. Yet after a website redesign six weeks ago, the search results are missing crucial details: How much will you pay out-of-pocket? And which plan offers the best value?  [Continued at Kaiser Health News, San Francisco

 Chronicle  Chicago Tribune and The Seattle Times]…

Congress and President Trump take on high drug prices

Volume 394       Number 10204     28 September 2019   
WORLD REPORT Proposals from the White House and Congress to lower prescription drug costs, which both rejected more than a decade ago, are making a comeback. Susan Jaffe reports.  
The Trump administration’s Department of Health and Human Services (HHS) is the first federal health agency to claim they are “open” to the idea of importing cheaper drugs from Canada and overseas. And both Republicans and Democrats in Congress now advocate familiar strategies to rein in drug price increases.  [Continued here]   
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Social Security Error Jeopardizes Medicare Coverage For 250,000 Seniors

By Susan Jaffe  | Kaiser Health News | June 6, 2019 | This KHN story also ran on 

At least a quarter of a million Medicare beneficiaries may receive bills for as many as five months of premiums they thought they already paid.

But they shouldn’t toss the letter in the garbage. It’s not a scam or a mistake.

Because of what the Social Security Administration calls “a processing error” that occurred in January, it did not deduct premiums from some seniors’ Social Security checks and it didn’t pay the insurance plans.

 [Continued at Kaiser Health News or NPR ]

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Home Health Care Providers Struggle With State Laws And Medicare Rules As Demand Rises

“We can send prescriptions to the pharmacy, including [for] narcotics,” says Marie Grosh, a geriatric advanced practice nurse practitioner and the owner of a medical house calls practice in a Cleveland suburb. “We can order lab work, x-rays, ultrasounds, EKGs [electrocardiagrams]; interpret them; and treat patients based on that. But we’re just not allowed to order home care—which is absurd.”

By SUSAN JAFFE  | Health Affairs | June 2019 | Volume 38, Number 8

When Christine Williams began working as a nurse practitioner some forty years ago in Detroit, Michigan, older adults who couldn’t manage on their own and had no family nearby and no doctor willing to make house calls had few options besides  winding up in a nursing home.

Not anymore.

Home check: Nurse practitioner Marie Grosh visits Leroy Zacharias at his home in a Cleveland suburb, He has Parkinson disease, and Grosh says he would be living in a nursing home if he couldn’t get medical care at home. (Photo by Lynn Ischay.)

“The move towards keeping seniors in their homes is a fast-galloping horse here,” says Williams, who settled in Cleveland, Ohio, more than a decade ago. “We don’t have space for them in long-term care [facilities], they don’t want to be in long-term care, and states don’t want to pay for long-term care. And everybody wants to live at home.”

But despite the growing desire for in-home medical care for older adults from nearly all quarters, seniors’ advocates and home health professionals claim that rules set by the Centers for Medicare and Medicaid Services (CMS)  along with  state regulations have created an obstacle course for the very providers best positioned—and sometimes the only option—to offer that care.  [Continued here] …

Doctors arrested in US crackdown on illegal opioids

Volume 393, Number 10182      

27 April 2019       

 

WORLD REPORT   The multiagency operation hit five states and led to the arrest of 60 people. Perpetrators face up to
50 years’ prison sentence if found guilty. Susan Jaffe reports.

Arrests of 31 doctors, pharmacists, and other health care professionals for allegedly prescribing and distributing illegal opioids affected some 28,000 of their patients. That’s why Department of Justice officials are working with state health departments, the Centers for Disease Control and Prevention and the Department of Health and Human Services to help patients by “… bringing enforcement and [opioid addiction] treatment closer together…than ever before,” says Benjamin Glassman, the US attorney for the southern district of Ohio. [Continued here.]
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Scott Gottlieb steps down from US FDA leadership

 Volume 393, Number 10176      

 16 March 2019       

 

WORLD REPORT   The announcement came as a surprise, prompting many to ask: Can the US FDA commissioner’s policies continue without him? Susan Jaffe reports.

Unlike some government agencies that can toil peaceably in relative obscurity, the FDA is frequently in the headlines. It is responsible for ensuring the safety of products that account for about 20 cents of every dollar US consumers spend—or US$2·5 trillion annually.  …When Gottlieb became commissioner in 2017, the agency had an estimated 1000 vacancies which has now risen to 1400.[Continued here.]
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US lawmakers seek cuts in prescription drug prices

 Volume 393, Number 10175      

 9 March 2019       

 

WORLD REPORT   A committee brought together Senators and drug company representatives to discuss why drug pricing in the USA is so high, but little progress was made, Susan Jaffe reports.

A much-publicized Trump Administration proposal allows — not requires —  pharmaceutical companies to pass large rebates on to Medicare patients. Savings as much as 30 percent for seniors depend on companies’ voluntarily cutting prices but several top drug makers tell Senate committee they can’t promise to do so. [Continued here.]
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USA sets goal to end the HIV epidemic in a decade

Volume 393, Number 10172   

16 February 2019       

 

WORLD REPORT   The unexpected announcement in the State of the Union address could set the start of a realistic agenda to end HIV/AIDS in the USA, provided funds are secured. Susan Jaffe reports.

Nearly an hour into his 90 min State of the Union address, President Donald Trump called for a government-run health-care programme “to eliminate the HIV epidemic in the United States within 10 years”.

Although the president has promised to get rid of the Affordable Care Act (ACA) along with its health insurance marketplaces and Medicaid expansion, these and other policies did not appear to dampen his enthusiasm. [Continued here.]…