Archives for May 2021

The Biden administration’s call to lift patent protections on COVID-19 vaccines to help poor parts of the world get more doses has drawn praise from some countries and health advocates.

But it has run into resistance from the pharmaceutical industry and others, who say it won’t help curb the outbreak any time soon and will hurt innovation.

Here’s a look at what patents do and why they matter:

HOW DO DRUG PATENTS WORK?

Patents reward innovation by preventing competitors from simply copying a company’s discovery and launching a rival product. In the U.S., patents on medicines typically last 20 years from when they are filed, which usually happens once a drugmaker thinks it has an important or lucrative drug. Because it often takes a decade to get a drug approved, companies typically enjoy about a dozen years of competition-free sales. But drugmakers usually find ways to improve their product or widen its use, and they secure additional patents that can extend their monopoly for many more years.

WHY IS PATENT PROTECTION SO IMPORTANT TO DRUGMAKERS?

Medicines are incredibly expensive to develop. Most experimental drugs fail at some point during the years of laboratory, animal and finally human testing. Averaging in the cost of those flops, it typically costs over $1 billion to bring a drug from discovery to regulatory approval. Without the prospect of years of sales without competition, there’s far less incentive to take that risk.

WHY IS THE U.S. BACKING EFFORTS TO LIFT PROTECTIONS ON COVID-19 VACCINES?

The Biden administration has been under intense pressure, including from many Democrats in Congress, to get more COVID-19 vaccines to the rest of the world. Support for the waiver idea floated by India and South Africa in October has been growing in other countries while the outbreak worsens in some places, especially India.

WHY HAVE THE U.S. AND OTHERS OPPOSED LIFTING PROTECTIONS IN THE PAST?

The U.S. and some other wealthy countries lead the world in many areas of research and innovation, particularly medicines. Aside from the prestige that confers, pharmaceutical companies provide millions of well-paying jobs, generate tax revenue and provide new medicines that can save or improve lives. Drugmakers and their trade groups spend millions every year lobbying governments to maintain the status quo on patents.

WHY IS THE INDUSTRY SO OPPOSED TO THE EFFORT?

In a word, money. In the U.S., pharmaceutical companies can charge whatever they want for their medicines. They typically raise prices twice a year, often doubling or tripling them during a drug’s patent-protected years. That makes the big, long-established drugmakers among the world’s most profitable companies. But a huge amount of innovation also comes from startup companies, which relay heavily on investors to fund early research. Without the prospect of a big payday, it would be much harder to attract investment.

Les Funtleyder, health care portfolio manager at E Squared Asset Management, thinks the industry is less worried about protecting its patents for the COVID-19 vaccines than about the “slippery slope” such a precedent could create.

WHAT IS THE PROCEDURE FOR LIFTING PATENT PROTECTIONS?

The decision is up to the 164-member World Trade Organization, which administers complex trade rules among nations. And all of them would have to agree for it to happen. If waivers are approved, vaccine developers would then have to share their know-how for the very complex manufacturing.

HAS THIS EVER HAPPENED BEFORE?

There’s no precedent for vaccines, but two decades ago WTO members passed a temporary waiver allowing poor countries to import cheap generic drugs for HIV, tuberculosis and malaria amid health crises. That temporary waiver eventually was made permanent.

WHAT WOULD LIFTING PROTECTIONS ON COVID-19 VACCINES ACCOMPLISH?

That’s not entirely clear, but drugmakers and analysts say waiving patent rights won’t do much to get COVID-19 vaccines to developing countries faster. That’s because making them is far more complex than following a recipe, requiring factories with specialized equipment, highly trained workers and stringent quality control. There is also little available factory capacity. In addition, many raw materials to make the vaccines, along with vials, stoppers and other components, are in very short supply, which won’t change soon.

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AP Business Writer Tom Krisher contributed to this report from Detroit.

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Follow Linda A. Johnson at https://twitter.com/LindaJ_onPharma

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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KABUL, Afghanistan (AP) — After nearly 20 years since the ouster of the Taliban and billions of dollars spent on infrastructure and aid, many Afghan women still have desperately poor access to health facilities and adequate health care, a leading rights group said Thursday.

Human Rights Watch offered a bleak assessment of women’s health care in Afghanistan in its latest report, saying that even basic information on health and family planning is not available to most Afghan women. And even when women can get the care they need, the quality is often poor, the New York-based group said.

New health facilities that have opened over the years are often insufficiently staffed and inadequately equipped, HRW said. The group’s researchers visited several health facilities in the capital of Kabul, where many of the country’s better clinics and hospitals are located.

The report says there are 4.6 medical professionals to 10,000 people in Afghanistan; the World Health Organization considers 23 medical professionals to 10,000 people a critical shortage.

“What emerged is a picture of a system that is increasingly unaffordable to the estimated 61% to 72% percent of Afghan women, who live in poverty, and one in which women often have more children than they want because of lack of access to modern contraception; face risky pregnancies because of lack of care; and undergo procedures that could be done more safely with access to and capacity to use more modern techniques,” the report said.

Most women cannot afford the increasingly costly medicines they need or even the cost of a taxi ride to a clinic, often at least a half hour away. Most Afghans live on less than $1.90 a day.

Patricia Gossman, associate director of HRW’s Asia division, said the money that came to Afghanistan after 2001 was squandered due to widespread corruption. Before that, the Taliban regime, which was also heavily sanctioned, had mostly ignored women’s health issues.

Washington alone committed $1.5 billion to rebuild Afghanistan’s health care sector, according to a 2017 report by the U.S. watchdog overseeing the billions of dollars America invested in Afghanistan’s reconstruction.

“The question everyone should be asking is why after 20 years and hundreds of millions of dollars the state of women’s health care is so grim,” said Gossman in an email. “Where did the money go … a horrendous amount has been lost to corruption, and nothing — nothing — has really ever been done about it.”

Gossman said some organizations have done better than others delivering aid, particularly in rural areas and even in Taliban-controlled parts of the country.

International aid to Afghanistan has also been dwindling in recent years, in part because of the deteriorating security amid relentless violence, but also because of increasing demands on funds exacerbated by the coronavirus pandemic.

As U.S. and NATO troops continue their final withdrawal from Afghanistan, expected to be completed by Sept. 11 at the latest, assistance is likely to further decrease.

“This is a critical moment in Afghanistan,” said Humans Rights Watch, citing fears of a growing Taliban influence and escalating violence as U.S. and other NATO troops pull out.

“The need for international assistance is greater than ever,” it said.

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President Joe Biden has met his goal of having most elementary and middle schools open for full, in-person learning in his first 100 days in office, according to new survey data, but the share of students choosing to return has continued to lag far behind.

The survey, conducted in March by the Education Department and released Thursday, found that 54% of public schools below high school were offering full-time classroom learning to any student who wanted it. It marks steady progress since January, when the figure was 46%.

But most students were still learning at least partly away from school. Almost 4 in 10 students continued to take all their classes remotely, the survey found, and an additional 2 in 10 were split between classroom and remote learning.

The disparity reflects a trend that has alarmed education officials at all levels: Even when schools reopen, many families have opted to keep students at home for remote learning. It has been most pronounced among Black, Hispanic and Asian American students, most of whom spent no time in a classroom in March, the survey found.

“While we’ve made important progress, I will not be satisfied until 100% of schools are safely open for full time in-person learning for all students,” Education Secretary Miguel Cardona said in a statement. “The department will continue to work with students, families, educators, states and districts, to ensure our education system serves all students, not just some.”

Among students of all races, there was a modest shift toward classroom learning in March, but gains were largest among whites. Just more than one-half of white students were learning entirely in-person, compared with about one-third of Black and Hispanic students. Only 15% of Asian Americans were learning entirely in the classroom.

Progress has been equally uneven based on geography. One-half of all students in the South and Midwest were learning entirely in-person in March, compared with less than one-fifth in the West and Northeast. Still, the Northeast saw the largest gains, with Connecticut doubling its share of fourth grade students learning fully in-person, from 17% to 35%.

Wyoming had the largest share (94%) of fourth grade students attending full time in the classroom; California (5%) had the lowest. Schools in rural areas were the most likely to be opened. Schools in cities have been the slowest to reopen.

Younger children, who are less likely than adults to get seriously ill from COVID-19, have returned to the classroom at higher rates. As of March, more than 4 in 10 fourth grade students were back in the classroom full time, compared with one-third of eighth graders.

Among Republicans, the survey’s findings were seen as a failure by the White House. North Carolina Rep. Virginia Foxx, the top Republican on the House Education and Labor Committee, said Biden’s “weak stance” on school reopening has contributed to students’ learning loss.

“Fifty-four percent is a failing grade in any classroom and we need to treat it as such,” Foxx said in a statement. “There is no excuse for this administration’s level of incompetence.”

The latest survey reflects a period of growing momentum in the push to open schools.

In March, the Centers for Disease Control and Prevention said students could sit 3 feet apart in classrooms as long as they are wearing masks; earlier guidance suggested 6 feet. Several states adopted the revised recommendation, allowing more students to return to schools.

At the same time, Biden was pushing states to make teachers and other school workers a priority in vaccine rollouts. Some governors went on to order some or all of their schools to reopen in March, including in Arizona and Oregon.

Since then, schools have continued to reopen. States including Massachusetts and New Hampshire have ordered districts to invite students back to the classroom, and major districts elsewhere have started to reopen, including in San Francisco.

The administration started the survey this year to track the pandemic’s effect on schools and students. It’s based on responses from 3,500 public schools that serve fourth graders and 3,500 schools that serve eighth graders. Several states have declined to participate, including Montana, West Virginia and Utah.

The survey does not include high schools, which pose additional challenges and have been the slowest schools to reopen. Biden has acknowledged that high schools will take longer to reopen because of the higher risk of contagion among older students.

Schools have been a priority for Biden as he works to jump-start the economy and address learning setbacks among students. In March he signed a $1.9 trillion relief bill that included $123 billion to help schools reopen and recover from the pandemic. Last month he proposed a budget that would significantly expand education funding, with a proposal to double Title I money for low-income schools.

Biden in December pledged to reopen “the majority of our schools” in his first 100 days in office. In February he reframed the goal, promising to have most schools from kindergarten through eighth grade opened five days a week in that period.

Cardona has rallied behind Biden’s efforts, saying schools will need help addressing disparities worsened by the pandemic. On Thursday, he urged schools and education officials to “maintain a high level of urgency” even as more schools reopen.

“This success is the result of hard work and intentional collaboration between the administration, states, school districts, educators and families across the country,” he said. “Nothing can replace in-person learning, and thousands of schools have made that a reality for millions of students.”

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