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It’s time to stop the suffering: New York must pass aid-in-dying

By admin | November 28, 2021

Amy Paulin

Special to the USA TODAY Network

The horrific suffering I witnessed my sister endure at the end of her life is something that will remain with me every day for the rest of my life. It was one of the reasons I decided to introduce the New York Medical Aid in Dying Act, which allows terminally ill adults with a confirmed prognosis of six months or less to live to take medication prescribed by a doctor to end their lives peacefully and with dignity. Just as I strongly support legislation that gives compassion and fairness in life, I support this bill which would give terminally ill people that same compassion and fairness when it comes to their death.

Medical aid in dying is currently legal in 10 states, including New Jersey. Even in these states, it’s only available in a narrow set of circumstances: you must be 18 or older, have an incurable and irreversible illness or disease, have a prognosis of six months or less to live confirmed by two doctors, be mentally capable, make the request both verbally and in writing, and be able to self-ingest the medication.

There is a quarter-century of history and data on medical aid in dying since the first law took effect in Oregon in 1997. We know from that data that very few dying patients request a prescription and about one-third of patients who request the prescription never take it. But we also know that for many of them, having the prescription — or just knowing it was available — provided them with the peace of mind they were seeking as they faced the end of life.

Since introducing this bill I’ve heard gut-wrenching stories from countless New Yorkers about how their loved ones were forced to endure horrible deaths. No one should be forced to needlessly suffer, or have to watch their child, parent, spouse, or sibling suffer as they die, wishing they could just close their eyes and pass away peacefully. New Yorkers should have an option and across-the-board overwhelmingly support medical aid in dying. A recent Marist College poll showed New York voters support medical aid in dying, 59-37 percent, with support from Democrats, Republicans and Independents, upstaters and downstaters, white New Yorkers and New Yorkers of color.

New York doctors overwhelmingly support the medical aid in dying bill. The New York Academy of Family Physicians said, “Supporting the authorization of medical aid in dying is commensurate with the Family Physician’s desire to empower our patients not only in their pursuit of wellness, their management of chronic disease, but also the alleviation of suffering when faced with a terminal illness.” The Medical Aid in Dying Act is also supported by the League of Women Voters of New York State, New York Civil Liberties Union, New York State Public Health Association, StateWide Senior Action Council, Planned Parenthood Empire State Acts, NOW-NY, Gay Men’s Health Crisis, Harlem United, Latino Commission on AIDS, and the WESPAC Foundation, among many others.

The Medical Aid in Dying Act is supported by New York doctors and New Yorkers because it provides a compassionate and dignified option to those suffering horribly as they approach their inevitable death.

Now is the time. New Yorkers have endured enough suffering. I’m committed to working with my colleagues to pass this law in 2022 and give dying New Yorkers a compassionate end-of-life care option.

Amy Paulin, D-Scarsdale, is the prime sponsor of the Medical Aid in Dying Act in the New York State Assembly, along with over 50 co-sponsors.

https://www.lohud.com/story/opinion/2021/10/29/new-york-must-pass-aid-dying-legislation/6184799001/

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Covid vaccine resistance is nothing new. Anti-vaxxers are as old as vaxxing itself.

By admin | November 28, 2021

Nov. 27, 2021, 12:41 PM EST

By Daryl Austin, health and history journalist

More Americans are getting the Covid-19 vaccine, but a recent study in the Journal of the American Medical Association showed that 32 percent of people in the United States remain unlikely to get vaccinated against the virus. The newest group of vaccine doubters are parents of children who just received approval to get the shots. A poll in late October from the Kaiser Family Foundation shows that fewer than 1 in 3 American parents want to vaccinate their 5- to 11-year-olds.

More Americans are getting the Covid-19 vaccine, but a recent study in the Journal of the American Medical Association showed that 32 percent of people in the United States remain unlikely to get vaccinated against the virus. The newest group of vaccine doubters are parents of children who just received approval to get the shots. A poll in late October from the Kaiser Family Foundation shows that fewer than 1 in 3 American parents want to vaccinate their 5- to 11-year-olds.

While the issue of vaccine resistance has taken on new urgency and is receiving many more headlines because of the pandemic, hesitancy about inoculations is nothing new. In fact, the sentiment is not only as old as the republic itself, but older.

Vaccine hesitancy has always gone hand in hand with vaccines, meaning the scope of the problem is more deep-seated and intractable than many understand — even as social media is used to spread such sentiments further than ever before. That means the country almost certainly can’t rely on soft tools such as education and incentives alone to get sufficient numbers of people vaccinated.

The Chinese practiced smallpox inoculation as early as 1500 by inhaling powder made from the crusts of smallpox scabs in order to protect themselves from the disease. That was nearly 300 years before Edward Jenner founded vaccinology in the West in 1796 by taking the fluid from a cowpox blister and scratching it into the skin of a patient. There was such staunch resistance by individuals who were skeptical, given the many medical quacks of the day and their fears about endangering their children, that the English government made Jenner’s inoculation procedure mandatory for its citizens at the beginning of the next century.

When these innovations landed in the New World, they brought fears about the practice with them. “Since the founding of the American colonies, anti-vaccine sentiments have been widely expressed,” notes Dr. Peter J. Hotez, co-director of the Texas Children’s Hospital Center for Vaccine Development.

As one early example, he pointed to an instance in which a Puritan minister and his physician were attacked in Boston for trying to use inoculation to combat the smallpox epidemic of the early 1720s. The Washington Post described the attack as sparked by “Fear of science, suspicion of the ruling elite, and a belief that medicine might meddle with God’s will.”

“Interestingly, the points anti-vaxxers made in the 1800s are not much different from points being made today,” notes Elizabeth Jacobs, a professor of epidemiology and biostatistics at the University of Arizona. Anti-vaxxers have always had to rely on confirmation bias outlier data to support their cause. To them, the focus can’t ever be on the number of people who are dying or becoming hospitalized as a result of the disease that vaccines are known to prevent; today, for instance, they have to focus on the 1 in 200,000 people who have a serious adverse — even if nonlethal — reaction to a vaccine instead of the 1 in 150 people who die from Covid-19.

Vaccine superstitions particularly track with a lack of trust in government, according to Janet Golden, an emeritus history professor at Rutgers University–Camden. Though these superstitions have been present in every American century, political trust has been in sharp decline in modern America.

The upheavals of the 1960s, the fiascos of the Vietnam War and Watergate in the 1970s, and the anti-government movement under President Ronald Reagan in the 1980s all fed this sentiment, which was then intensified by the tea party and Trumpism.

Into this brew dropped a television documentary that claimed the whooping cough vaccine caused permanent brain damage. Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, pinpoints the birth of the modern American anti-vaccine movement in 1982 with the release of the production, which he says led to a flood of lawsuits against pharmaceutical companies and advocacy groups spreading misinformation that vaccines do more harm than good.

The idea that the measles, mumps and rubella (MMR) vaccines cause autism was stoked by a discredited academic and former British physician who published a wildly controversial and since discredited study in The Lancet in 1998. Unfortunately, that motivated a growing group of parents to oppose vaccines, particularly those on the left who eschew Western science and embrace alternative medicine.

According to Hotez, the “anti-vaccine health freedom movement” attained more power and funding beginning in 2015 with the rise of the tea party on the right, which he blames for recent measles outbreaks and for perpetuating the myth that vaccines are connected to autism.

And of course, religious beliefs have continued to play a part in vaccine hesitancy as well, morphing as the science has changed. While many religious leaders have encouraged parishioners to become vaccinated against Covid-19, some today have objected on the grounds that certain vaccines have been developed using fetal cells. Previously, some ultra-Orthodox rabbis and other religious leaders have cited debunked information that vaccines are “experimental,” making them akin to “child sacrifice,”while in Nigeria, Muslim communities boycotted polio vaccination when religious leaders told their followers they may be contaminated with anti-fertility agents, HIV and cancerous agents.

The modern age has brought new reasons for vaccine hesitancy as well. Ironically, thanks to the success of vaccines, few people today have witnessed firsthand the consequences of the diseases vaccines are known to prevent. “The out-of-sight, out-of-mind principle applies to vaccine hesitancy,” says Dr. Martin Myers, the former director of the National Vaccine Program Office of the U.S. Department of Health and Human Services.

Because vaccines work, Myers says, modern parents are no longer gripped by the terrible fears that were so common when parents recognized symptoms of meningitis, polio or rubella in their children. While these diseases have essentially been eradicated — leaving no devastating examples to imprint on parents’ minds — the number of children with developmental and autoimmune disorders, such as autism and asthma, have risen in visibility.

Then, of course, there’s social media. “Social media is the single greatest contributor to anti-science attitudes and the anti-vaccine movement,” Jacobs calculates. She explains that such platforms amplify the problem by acting as echo chambers, by creating a financial model that rewards posts that are widely shared (even if they’re false or misleading) and by creating spaces and groups for anti-vaxxers to gather around misinformation.

Of course, some vaccine hesitancy is understandable. Offit says even he’s a skeptic until he sees the data (in the case of Covid vaccines, the data “couldn’t be more encouraging”). He says what’s important is to keep the rare vaccine side effects in proper perspective with the deadly diseases they protect against. As the centuries-long resistance to vaccines makes clear, however, this compelling logic still isn’t enough to persuade everyone to get the shots.

Offit says the only option that remains for today’s holdouts are government mandates at the federal level or requiring proof of entry into stores and events by local businesses. “When logic and reason don’t matter to someone,” he said, “you have to find something they do care about.”

https://www.nbcnews.com/think/opinion/covid-vaccine-resistance-nothing-new-anti-vaxxers-are-old-vaxxing-ncna1284828

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Setting Our Agenda–Coalition Releases the First Ever NYC Hispanic/Latinx Health Action Agenda: “Our Health. Our Future”

By admin | October 30, 2021

We are proud that Latinos for Healthcare Equity is part of the Steering Committee that created this important agenda.

New York, NY, October 28, 2021—NYC Hispanic/Latinx and Latino-serving clinical and non-clinical professionals, faith-based representatives, community leaders, community-based organizations and public health advocates have recognized the importance of coming together from all five boroughs under the theme “Our Health. Our Future.” The purpose of coming together through a community-led model is to develop a NYC Hispanic/Latinx Health Action Agenda 2021-2025 on action-driven key health recommendations.

The process engaged in to develop this important agenda had two phases. The first phase, which began last fall, consisted of developing a series of community consultations in Spanish and English and several working committees on health issues and populations. The second phase focused on coalition meetings to prioritize recommendations and finalize: Setting Our Agenda: NYC Hispanic/Latinx Health Action Agenda 2021-2025. This agenda clearly outlines short, mid and long term goals to address the health challenges in our diverse Hispanic/Latinx communities.

The Setting our Agenda Coalition effort has been facilitated by the Hispanic Health Network, the Hispanic Federation, the Latino Commission on AIDS, a broad community steering committee, and a diverse planning committee in New York City.

“The coronavirus pandemic has exposed persistent health disparities that have long affected our community. To begin our healing, it is imperative that we address the long-standing inequities that pervade the health care system and society at large,” stated Bethsy Morales-Reid, Assistant Vice President for Programs, Hispanic Federation.

“In 2021, we can shape our future. Our community-led model in developing our health action agenda will have an impact on ensuring healthy outcomes for our communities,” stated Guillermo Chacon, founder of the Hispanic Health Network and President of the Latino Commission AIDS. “Our health counts, we need to proactively seek solutions to the historic health disparities, social stigmas and health challenges affecting Hispanics/Latinx as well as to the devastation of COVID-19.”

“Unveiling an inclusive health action agenda is just the beginning. With our collective effort, along with the support from our elected officials, we will begin to see the necessary change for healthy and protected Hispanic/Latinx communities,” added Cristina Herrera, Executive Director of Translatinx Network.

“Now more than ever we need to be proactive and take our health into our hands. We are in our communities every day and understand what our community needs are. We offer those insights in this action agenda,” added Rosita Romero, Executive Director, Dominican Women’s Empowerment Center.

“The health disparities among NYC Hispanic/Latinx communities have been exacerbated by COVID-19. However, there is hope that by unveiling a community-led agenda, and with the commitment and will of our elected officials on November 2nd, we will be able to come together to create healthier communities,” said Susana Morales, M.D., Vice Chair for Diversity, Weill Cornell Medicine.

“Our informed and collective process highlighted the many needs in NYC’s Hispanic/Latinx communities, but we offer recommendations that can bring more opportunities for our communities to have a healthy future for all,” said Yesenia Mata, Executive Director of La Colmena.

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Setting Our Agenda Coalition is a unique community effort to have a collective and proactive voice on the policies and programs shaping the health and wellbeing of the Hispanic/Latinx community in New York City.   Our Agenda aims to inform policymakers, key institutions, elected and appointed officials, media and others of our health needs, our own recommendations for solutions, and the urgency to set a path to change our future. Setting Our Agenda is widely distributed with the intention of impacting the NYC elections in November 2021. Please join us in creating and implementing this important health action agenda and making history by taking charge in seeking responsible solutions

[Download Agenda]

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The Puerto Rico Medicaid Five-Year Deal

By admin | August 12, 2021

Center for a New Economy—7/20/2021

As we near the end of the federal fiscal year, Puerto Rico faces yet another potential shortage of funds to keep operating its healthcare system. The severity of the threat is very real. A drop in federal funding from $2.8 billion to approximately $400 million, a reduction of about 85%, could result in a failure to provide critical services to thousands of people, a reduction of the eligible population, and/or a drastic reduction of provider reimbursement rates, all of which may result in the flight of more primary care physicians and other health care providers from the island. With approximately 1.4 million Medicaid beneficiaries, about 46% of Puerto Rico’s population could be affected by the changes in funding at a time when the world is undergoing a public health crisis. Therefore, it is imperative to provide Puerto Rico with full federal Medicaid funding over time. This means allowing the federal share of the program, known as the federal medical assistance percentage (FMAP), to be calculated for Puerto Rico on the basis of relative per-capita income (as it is in the states) and eliminating the arbitrary cap on funding set by federal law.

Concerned that a recovery package will not come through before the end of September, the House Energy and Commerce Committee started working with Republicans to strike a bipartisan deal on Medicaid funding. The bill, the “Supporting Medicaid in the U.S. Territories Act of 2021” (H.R. 4406), was marked up last week by the subcommittee on Health of the House Energy and Commerce Committee.  

 While the proposed bill ensures we avoid yet another funding cliff in the short term, it also, unfortunately, perpetuates long-standing inequities by essentially extending the currently inadequate funding levels for another five years. In this sense, recent coverage of the prospective Medicaid deal for Puerto Rico has been misleadingly portrayed as a big victory for the island by Puerto Rico’s leaders. In fact, though, when we consider the current political dynamic in Washington, this was a lost opportunity to obtain a more sustainable funding stream for Puerto Rico and the other territories, if not full parity with the United States.

The H.R. 4406 bill helps Puerto Rico avoid a short-term Medicaid funding cliff and provides some stability by setting forth clear funding levels for the next five years. However, the proposed five-year deal falls short of parity with the states, is not a permanent fix, and perpetuates the “separate and unequal” treatment of Medicaid beneficiaries in the territories, who are being told, once again, to accept a “good enough” deal.

Perhaps more important from a long-term policy perspective, the compromise set forth in H.R. 4406 represents the loss of a once-in-a-generation opportunity to end federal healthcare discrimination against the residents of the U.S. territories.

Early into its term, the Biden Administration stated its commitment to ensuring Puerto Rico is enabled to participate in the Medicaid program as other jurisdictions in the United States do. The President doubled down on that statement with the release of his first budget where he explicitly called for “eliminating Medicaid funding caps for Puerto Rico and other territories while aligning their matching rate with states.” Just two years ago, under a Republican majority, Puerto Rico received a generous two-year package.

Now, while Democrats control the House, Senate, and the White House, Puerto Rico is coerced to settle for less generous treatment for a longer period of time. Making matters worse, the deal went through not despite but in the absence of a more forceful push from Puerto Rico officials. In their eagerness to promote an ideological agenda, officials have bartered the healthcare needs of low-income Puerto Ricans in favor of political expediency, by accepting the “second best” option once again. The White House now has an opportunity to push Congressional leaders for a more generous package.

Furthermore, the differences in year-out funding between Puerto Rico and the territories mean we’ll lose leverage when we face another funding cliff once again in five years, or sooner as the capped amount is not indexed to inflation. The amount of funding included in this five-year deal will likely fall short of what is needed to sustain the eligibility expansion achieved under the latest packages (essentially cutting people off healthcare during a pandemic) and Puerto Rico will be put in a bind when deciding how to make across the board reductions.  This take-it-or-leave-it approach is morally reprehensible especially when it affects coverage for millions.

https://grupocne.org/2021/07/20/the-medicaid-five-year-deal/

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Pharma-Friendly Stance After Millions in Gifts From Drugmakers

By admin | August 12, 2021

Kaiser Health News—August 12, 2021

To several U.S. senators, it looked wasteful, even outrageous. Every year, taxpayers pay for at least $750 million worth of expensive pharmaceuticals that are simply thrown away. Companies ship many of the drugs in “Costco”-size vials, one lawmaker said, that once opened usually cannot be resealed or saved for other patients. Yet pharma gets paid for every drop.

So Congress turned to the prestigious National Academies of Sciences, Engineering and Medicine for advice, given its reputation for “independent, objective reports” on such matters. The national academies’ influential report, released in February, struck physicians who’ve tracked the issue as distinctly friendly to Big Pharma. It advised against an effort to recoup millions for the discarded drugs. It concluded that Medicare should stop tracking the cost of the drug waste altogether.

Yet the report left out a few key facts, a KHN investigation has found.

Among them: One committee member was paid $1.4 million to serve on the board of a pharmaceutical corporation in 2019 and in 2020 joined the board of a biotechnology company that lists government “cost containment” efforts as a risk to its bottom line.

Another committee member reported consulting income from 11 to 13 pharmaceutical companies, including eight that Medicare records show have earned millions billing for drug waste. His pharma ties were disclosed in unrelated publications in 2019 through this year.

Those committee members said they reported relevant relationships to the national academies and that the information is readily available outside of the report.

What’s more: The National Academy of Sciences itself for years has been collecting generous gifts from foundations, universities and corporations, including at least $10 million from major drugmakers since 2015, its treasurer reports show. Among the donors are companies with millions to retain or lose over the drug waste committee’s findings.

The fact that those relationships were not disclosed in the final report by an organization charted in 1863 to advise the nation amounts to “egregious” failures, said Sheldon Krimsky, a Tufts University professor and expert on conflicts of interest in science.

“The amount of money you’re reporting is really substantial,” he said. “It really raises questions about the independence” of the national academies.

In a statement emailed to KHN, the national academies said the two members with undisclosed board and consulting roles had “no current conflicts of interest during the time the [drug waste] study was being conducted” from January 2020 through February. The report did disclose conflicts for two others on the 14-member board. The report in question was paid for by federal officials, and “funds from for-profit organizations with a direct financial interest in the outcome of a study may not be used to fund advisory consensus studies, except in rare circumstances,” national academies spokesperson Dana Korsen said in the emailed statement.

She also said the organization is implementing a new conflict-of-interest policy that will be fully in place this fall.

“Protecting the integrity, independence, and objectivity of our study process is of the utmost importance to the National Academies,” her statement said.

The committee’s failure to call for concrete changes — and the millions in gifts from pharmaceutical companies to the national academies — looked familiar to David Mitchell, president of Patients for Affordable Drugs and a cancer patient who relies for his survival on a drug with high waste costs.

“We have found in our work that pharma is like an octopus,” he said, “and at the end of each tentacle is a wad of cash.”

Waste Shocked Policymakers in 2016

Dr. Peter Bach and colleagues published an explosive paper in 2016 that for the first time showed that taxpayers and health insurance rate payers were bankrolling an estimated $2.8 billion a year in drug waste. The findings encompassed all U.S. health care — not just what’s reported by doctor’s offices to Medicare — and were covered widely in the news.

Bach, a researcher with the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, found that medications infused in doctors’ offices often arrived in vial sizes fit for a linebacker but might be given to a waif. Given sterility and other concerns, the extra milligrams, often for cancer therapies that can cost thousands of dollars per dose, were typically discarded.

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Congress and policymakers took notice.

In 2017, Sens. Amy Klobuchar (D-Minn.) and Chuck Grassley (R-Iowa) introduced a bill urging health care agencies to develop a “joint action plan” to address the waste. Sens. Dick Durbin (D-Ill.) and Rob Portman (R-Ohio) introduced an even stronger measure in 2019 and again this year that would allow Medicare to recoup the cost of the wasted drugs. None of the bills has passed.

The refund mandate made it into a broader drug pricing measure that also failed, but not before the Congressional Budget Office took a close look in 2020 and estimated $9 billion could be saved over a decade.

Medicare officials also urged doctors to use a billing code to document the amount taxpayers were spending on wasted drugs each year — which amounted to $753 million in 2019 alone, Medicare data shows.

Before and while Bach’s paper was making waves, physicians who would eventually be on the national academies committee were forging alliances with the pharmaceutical industry.

Dr. Kavita Patel reported earning a speaking fee in 2015 from the Pharmaceutical Research and Manufacturers of America, or PhRMA, of $5,001 to $15,000. She also accrued assets valued at more than $50,000 for her role as a pharmaceutical company board member, according to 2015 and 2018 disclosures filed with the Government Accountability Office.

Dr. Anupam Jena, who also served on the committee, wrote a 2018 article with staff members of PhRMA arguing that medications should be valued not for their actual benefit, but rather for the potential for innovation that comes with making new therapies.

The ‘Kiss of Death’

In 2016, lawmakers called for an independent study of the drug waste. In September 2019, the National Academy of Sciences was awarded $1.2 million to complete the report.

At the outset of its study in January 2020, national academies committee members declared their potential conflicts of interest in a closed session, according to the meeting agenda.

Bach was among the physicians and other experts who later presented to the national academies committee. He said his team had laid out two possible solutions from the start: Have companies make a variety of vial sizes to minimize waste, or pursue refunds.

Former Medicare administrator Donald Berwick presented to the committee at a June 2020, virtual meeting, exhorting its members to defy the expectation that they’d be one more committee that failed to do anything meaningful about health costs.

“Someone’s got to begin to set a standard and say, ‘Nope, this money is too important for … us to accede to this,’” Berwick told the committee.

The report’s recommendations were “the result of extensive fact-finding, full committee discussions and unanimous consensus,” said committee chairperson Dr. Edward Shortliffe, chair emeritus and adjunct professor in the Department of Biomedical Informatics at Columbia University.

The report, though, did not meet Berwick’s call to action. In a webinar summarizing the report findings, Jena described the drugs as valuable enough to justify the total cost of each vial, completely used or not. Patel and others summarized the findings in a STAT opinion piece, saying the committee argued against tracking the money wasted and instead called for a “whole of government” approach.

Bach said the conclusions were “better than pharma could have ever hoped for” and called the whole-of-government idea the “kiss of death.”

Berwick said that he was “disappointed” by the conclusions and that all committee members’ industry relationships should have been reported. He noted that, in his experience, committee members have been very open about conflicts and the national academies dismissed those who had them.

Presented with KHN’s findings about certain committee members’ undisclosed pharmaceutical company income and consulting relationships, Bach said they raise serious concerns.

“The conflicts align just way too closely with the results,” he said. “That’s what makes it hard to ignore.”

‘Current’ Conflicts Don’t Tell Full Story

Conflicts of interest became a hot topic more than a decade ago, amid a series of scandals over Big Pharma quietly backing influential doctors.

Reforms followed, with countless medical journals, nonprofits and government agencies strengthening their conflict-of-interest policies.

The national academies came under scrutiny in 2014 and 2016 for failing to disclose conflicts among committee members advising federal officials on opioid use and in 2017 on genetically modified crops.

Its webpage on conflicts underscores why strong disclosure rules are important: “The institution should not be placed in a situation where others could reasonably question, and perhaps discount or dismiss, the work of the committee simply because of the existence of such conflicting interests.”

Yet conflict-of-interest experts interviewed by KHN said the national academies stands out by considering only “current” conflicts and not those going back three years, as is more typical. Korsen said the National Academy of Sciences is working toward requiring five years of disclosures.

Several experts said that, given the trust placed in — and $200 million in federal funding awarded to — the national academies, a number of conflicts should have been disclosed in the report.

They include those of Patel, who is described in her report biography as a Brookings Institution fellow, a primary care physician in Washington, D.C., and former Obama administration policy adviser.

The national academies declined to provide the conflict-of-interest form that Patel or any other member filled out at the outset of the committee’s work in early 2020.

Unrelated Securities and Exchange Commission records show that, before she joined the committee in 2020, Patel’s role as a board member for Tesaro, a developer of cancer medications, became very lucrative when GlaxoSmithKline bought the company. At the time of the 2019 sale, Patel was in line to receive an estimated $1.4 million for her shares and stock options, according to a December 2018 Tesaro securities filing.

Also in 2020, Patel was appointed to the board of Sigilon Therapeutics, a biotech company with no product on the market. The company awarded her stock options then worth an estimated $369,000, an SEC filing shows.

Sigilon described state and federal efforts to control costs as a risk to its business in an annual report to investors: “Any cost containment measures could significantly decrease … the price we might establish for our products.”

The national academies’ lack of disclosure of those roles “to me is a violation of almost all the standards that I’m aware of for disclosing conflicts of interest,” said Krimsky, of Tufts.

Patel told KHN she “fully and transparently participated” in the disclosure process and “provided all of the information requested.” She said: “In addition, many of the financial relationships incurred over the course of my work had already been disclosed in the public record.”

Patel was the lead writer on the Feb. 25 opinion piece in STAT that summarizes the committee’s report as focusing on the need to reduce inefficiencies, “rather than on trying to recover from pharmaceutical companies the financial worth of the portion of drug that was not used.”

Patel said she was “objective in all of my contributions” to the national academies report.

The national academies — as an organization — reported in its 2016 treasurer report that while 84% of its funding in 2011 was from federal agencies, the amount was failing. So it was working to “grow the non-federally sponsored work.”

“It will be very important for the future of the institution to continue vigorous efforts to diversify its sources of income,” the treasurer report says.

A KHN review of treasurer reports from 2015 through 2020 shows that pharmaceutical companies have given consistently to the national academies. Drugmakers donated at least $10 million over those years. Their giving is reported in ranges, often $100,000 to $500,000, and that total assumes they gave the lowest amount in each range each year.

A 2018 treasurer report recognized Merck & Co. for more than $5 million in cumulative giving and 10 other drugmakers for donating more than $1 million.

None of those donations was listed in the drug waste report. But listing them would reassure readers, said Genevieve Kanter, a University of Pennsylvania assistant professor of medical ethics and health policy.

“If the national academies is interested in producing a credible, independent report,” she said, “I think they would report all of those donations in the report itself.”

Jena, a Harvard Medical School associate professor, physician at Massachusetts General Hospital and an economist, also had no conflicts disclosed in the report.

Jena has disclosed consulting fees from a dozen major pharmaceutical companies, articles in the Journal of the American Medical Association and The BMJ show. Most of those companies have a direct financial interest in the drug waste matter, a KHN review of Medicare data shows. He said he disclosed all his consulting relationships to the national academies.

After the report came out, he took the lead on a Health Affairs article that says Medicare should stop tallying the waste money.

“Attempts by public payers to recoup overpayments are unlikely to be successful since they may simply end up paying higher prices” if drugmakers raise the price tag for the medications.

That article initially omitted his consulting relationships with numerous pharmaceutical companies — but journal editors updated the disclosures after KHN inquired.

https://khn.org/news/article/national-academies-big-pharma-support-drug-waste-report/?utm_campaign=KHN%3A%20Daily%20Health%20Policy%20Report&utm_medium=email&_hsmi=148836997&_hsenc=p2ANqtz-_-OmyViPlfCPPn32x-QvGhsrMYDosRHdpRMtwbZLiPGcfm6fMVxiezE5uoKofTMlNQ3Y-ZnDIpKH0aarr9qLELE9YkyA&utm_content=148836997&utm_source=hs_email

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Approval of a Questionable Treatment for Alzheimer’s

By admin | June 15, 2021

It is very rare for the agency to ignore an overwhelmingly negative advisory recommendation.

By Michael Specter

June 14, 2021 The New Yorker

My father died of Alzheimer’s disease in 2010. Since April, my mother has lived in the memory-care unit of a nursing home in Connecticut. She is lucid at times, but more often she has trouble remembering whether I am her son, her husband, or her father. I have covered wars and riots and a long string of epidemics. None of them frightened me the way that Alzheimer’s does. I am far from alone. More than six million Americans are living with Alzheimer’s, a number that is certain to grow as more people survive into their eighties and nineties. But tens of millions of their family members, colleagues, and friends also struggle every day with the reality of this wholly disabling disease.

Last week, in what should have been truly exciting news, the Food and Drug Administration approved aducanumab, the first new drug in nearly twenty years that is designed to treat Alzheimer’s patients. But, in doing so, the agency ignored the overwhelmingly negative recommendation of the Peripheral and Central Nervous System Drugs Advisory Committee, none of whose members found sufficient evidence that the drug could slow the cognitive decline that is a hallmark of dementia. Ten members voted against approval; one voted “uncertain.” Another member abstained because he had been an investigator on one of the drug’s two major trials.

By the end of the week, three of the committee members had resigned, and many experts suggested that the new drug, which Biogen will market as Aduhelm, could cause more problems than it will solve, both for people with Alzheimer’s and for the nation’s health-care system. “This might be the worst approval decision that the F.D.A. has made that I can remember,” Aaron Kesselheim, a professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, told the Times. He resigned from the committee on Thursday, after having served on it for six years.

Another member who resigned, David S. Knopman, a neurologist at the Mayo Clinic, wrote to the F.D.A. that “the whole saga of the approval of aducanumab . . . made a mockery of the committee’s consultative process.” (The F.D.A. is not bound by any committee recommendation. Usually, when the agency disagrees with its advisory boards, it does so to reject a drug that has been endorsed. It is very rare for the agency to ignore such an overwhelmingly negative recommendation.)

The decision will have implications that reach far beyond the introduction of a single drug designed to treat one disease. In the past, the F.D.A. approved several therapies aimed at relieving symptoms of Alzheimer’s; these medications attempt to regulate chemicals that ferry messages between nerve cells. But none of those drugs stop the damage to the brain. At best, they have proved moderately successful for a few months.

Until now, there have been no drugs that treat an underlying cause of the disease. Aducanumab, which has been in clinical trials for years, attacks the amyloid-protein plaques that many researchers believe impair the cognitive function of the brain. Scientists regard those plaques as clear biological markers of Alzheimer’s, and they have tried for decades to demonstrate that reducing those amyloid levels could help patients to regain their cognitive abilities, or at least to halt their decline. None of the drugs in those past studies had any impact on the progress of the disease.

The two clinical trials that led the F.D.A. to approve aducanumab achieved the same indirect goal: showing the drug’s ability to reduce plaques that accumulate in the brain. But the initial data on slowing patients’ cognitive decline was so poor that, in 2019, the company halted the studies. It was only after researchers from Biogen, in consultation with the F.D.A., reëxamined the data later in the year, and included more than three hundred additional participants who completed the studies after the initial data was evaluated, that they noticed something they regarded as promising. In one of the two studies, the drug seemed to slow cognitive decline in a number of early-stage patients who were treated with a high dose of the drug. The difference between the effect of aducanumab and the placebo was a fraction of a point, on an eighteen-point scale. The second study found that the drug offered no benefit.

Nonetheless, instead of evaluating this medicine solely on whether it affects cognition, the F.D.A. granted conditional approval based on aducanumab’s ability to reduce those amyloid plaques. It’s not unusual for the F.D.A. to grant early access to drugs that seem to work on surrogate markers, like the plaques or blood levels, rather than on the direct improvement of a patient. The agency has granted what is generally known as accelerated approval to more than two hundred drugs since 1992. Most are for rare diseases, which affect few patients, or, as is the case with Alzheimer’s, those for which there is no other available treatment. The agency requires that pharmaceutical companies conduct additional clinical trials to prove that the treatment works. For a drug like aducanumab, such a study will take years—and it will remain on the market throughout that study. Since previous clinical trials that linked reducing plaques to improved brain function have uniformly failed, experts were seeking a more promising result. They did not find it.

Aducanumab will not be a simple medicine to take, and it will demand many resources. The drug needs to be administered intravenously for an hour; that will almost certainly require a visit to a clinic or doctor’s office. Patients will need regular M.R.I.s, in part to insure that they are not suffering adverse effects from the treatment. About forty per cent of participants in the two studies experienced (mostly mild) brain swelling or bleeding after taking the drug. And the company has said that a prescription will cost fifty-six thousand dollars a year. That figure has already caused outrage. The Institute for Clinical and Economic Review carried out an analysis of the trial results and concluded, as have so many other experts, that “current evidence is insufficient to demonstrate that aducanumab benefits patients.” The organization denounced the pricing structure of what it said “now seems likely to become one of the top selling drugs in the history of the United States.” It is not yet clear which private insurers will pay for it. The vast majority of Alzheimer’s patients are elderly, and many are insured by Medicare. Even if the federal government could negotiate significantly lower prices, Medicare does not have the money to spend billions of dollars a year on one questionable therapy.

Last Monday, Patrizia Cavazzoni, the director of the F.D.A.’s Center for Drug Evaluation and Research, issued a statement attempting to explain the agency’s decision. “We ultimately decided to use the Accelerated Approval pathway—a pathway intended to provide earlier access to potentially valuable therapies for patients with serious diseases where there is an unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit,” she said. “In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.”

Experts have struggled to find a scientific rationale. “I’m quite surprised,” Caleb Alexander, a Johns Hopkins epidemiologist who served on the F.D.A.’s advisory panel and voted against the approval of aducanumab, told Stat News. “The most compelling argument for approval was the unmet need but that cannot, or should not, trump regulatory standards,” he said. “It’s hard to find any scientist who thinks the data are persuasive. Unmet need is an important contextual factor but it’s not an evidentiary threshold.”

Moreover, the studies focussed on people in the early stages of the disease, but the F.D.A. has approved the drug for use by anyone with Alzheimer’s—even though it was not tested on people with more advanced cases. That almost assures that thousands of seriously ill Americans will take the drug without any scientific justification for doing so. Jason Karlawish, a co-director of the University of Pennsylvania’s Penn Memory Center, in Philadelphia, who ran one of the trial sites, told Reuters, “This decision has shaken the foundations of the scientific process and methods.” He added, “It’s a disturbing set of events, scientifically, clinically, politically.”

aids activists began to campaign for earlier access to experimental medicine in the late nineteen-eighties. They argued that people who were almost certain to die and had no alternatives should have the opportunity to take those drugs before trials had proved they were effective. That practice was considered acceptable at the height of the aids epidemic, when so many people resorted to dangerous remedies that caused real harm, even death. It was not until 1987, six years into the epidemic, that AZT, the first drug to treat aids directly, was approved.

The approach soon became routine for many diseases. It has been a largely successful attempt to balance compassion with the need for useful data. Fast-tracking the release of experimental medicines makes sense when the alternative is death. And it makes sense for diseases that affect a small population. Recently, though, an increasing number of drugs have been approved by that process. Critics argue that those approvals are too often based on tangential indicators that do not lead to better health outcomes.

It has only been a year since Donald Trump extolled from the White House podium the virtues of hydroxychloroquine as a preventative against covid-19. There was no acceptable data to suggest that it worked. For some people, the drug was actually dangerous. But the F.D.A., under pressure from the White House, issued an emergency-use authorization. Less than three months later, once the drug’s failure became too clear to ignore, the agency was forced to withdraw the authorization.

This is not how the F.D.A. is supposed to work. Millions of Americans rely on the agency to sift through data and present scientifically valid results. It is there to protect us, not to tell us what we want to hear. Often, this means that agency officials are required to convey bad news rather than hope. Understandably, we all prefer hope, but erasing the distinction between a medicine that works and one that does not will never provide it. And if the F.D.A. doesn’t understand that, who will?

https://www.newyorker.com/news/daily-comment/the-fdas-extraordinary-approval-of-a-questionable-treatment-for-alzheimers

https://www.newyorker.com/news/daily-comment/the-fdas-extraordinary-approval-of-a-questionable-treatment-for-alzheimers

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Territories’ Looming Medicaid “Cliff” Highlights Need for Full, Permanent Funding

By admin | March 24, 2021

By Javier Balmaceda,
Senior Policy Analyst on Puerto Rico CBPP

U.S. territories face yet another sharp drop in federal Medicaid funding this September when a temporary federal funding boost is set to expire, and the stakes are even higher this time due to COVID-19’s health and economic crises. Without more federal funding, hundreds of thousands of Americans living in Puerto Rico and the other U.S. territories (American Samoa, Guam, the Northern Mariana Islands, and the U.S. Virgin Islands) risk losing access to health care.

This latest funding “cliff” again highlights the territories’ need for adequate funding to avoid major disruptions to their health care systems. The best way to avert the looming crisis is for federal policymakers to provide full, permanent Medicaid funding to enable the territories’ Medicaid programs to provide the same coverage that state Medicaid programs provide.

Unlike the states, where federal Medicaid funding covers a specified share (known as the federal matching rate) of their Medicaid spending, the territories receive a fixed block grant that’s unrelated to need. Puerto Rico’s block grant allotment for fiscal year 2020, for instance, was $375.1 million, but the Commonwealth was projected to spend $2.8 billion in its Medicaid program. And while each state’s federal matching rate is tied to its relative per capita income and can go as high as 83 percent, the territories’ matching rate is fixed at 55 percent irrespective of need. Because Puerto Rico’s block grant funding is so small, moreover, without additional federal funds it would receive no federal matching funds at all once its block grant funds run out. Due to all these factors, Puerto Rico’s block grant covered just 15 percent of the Commonwealth’s total annual Medicaid spending on average between 2012 and 2019. As a result, Puerto Rico can’t afford to cover seven of Medicaid’s 17 mandatory services, including nursing home care and nurse practitioner services.

Over the past decade, federal policymakers have temporarily raised the territories’ Medicaid allotments and matching rates, but those short-term fixes haven’t allowed Puerto Rico to make sustained program improvements. Many health care professionals have left Puerto Rico for the U.S. mainland and the stable funding structure that state Medicaid programs provide. The latest temporary increase, a two-year package that policymakers enacted in 2019, is set to expire fully at the end of September. This funding cliff could force territories to cut benefits such as prescription drugs and dental care, and many people could lose their Medicaid coverage altogether, including over half of enrollees in Guam and the Virgin Islands.

Because the federal funding increases have been temporary, Puerto Rico hasn’t been able to make needed Medicaid improvements such as expanding eligibility by permanently raising the program’s income limits, which are much lower than in the states. The current federal funding increase includes the funds needed to expand eligibility, but the federally mandated Financial Oversight and Management Board for Puerto Rico disallowed a permanent expansion, citing the funding’s short-term nature; it did allow Puerto Rico to expand eligibility through the end of the COVID-19 public health emergency.

President Biden’s forthcoming economic recovery plan gives policymakers an opportunity to enact a permanent fix that would give the territories stable, adequate funding and put them on a path to align their Medicaid programs with state programs as quickly and completely as possible. Bills like this year’s H.R. 1722, which was first introduced as H.R. 3371, in the last Congress, provide one approach to giving Puerto Rico a pathway to funding parity and alignment over ten years.

Policymakers could apply this or a similar approach to the other territories. With inadequate ongoing funding and only temporary additional funds, the other territories’ Medicaid programs also can’t meet all Medicaid standards for coverage and benefits. American Samoa and the Mariana Islands have federal waivers that let them waive some Medicaid standards; the other territories don’t have these waivers, but the Centers for Medicare & Medicaid Services has let them fall short of federal standards due to their inadequate federal funding.

Stable, robust Medicaid funding is especially critical in light of the territories’ recent past, which has seen extended economic decline, devastating natural disasters, and chronically high poverty. The American Rescue Plan Act, which President Biden just signed into law, will provide critical help, such as by enabling families in Puerto Rico to qualify for the Child Tax Credit on the same basis as families in the states. Policymakers should now do the same for Medicaid by enacting permanent and adequate funding that would give territories a stable and robust health care system.

https://www.cbpp.org/blog/territories-looming-medicaid-cliff-highlights-need-for-full-permanent-funding

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Back to ‘normal’ isn’t good enough

By admin | February 10, 2021

With the anticipation of increasing distribution of Covid-19 vaccines, Americans are looking forward to a “return to normal.” We’ve all heard these words, intended to inspire hope. And they do, for some. But the reality is that “normal” is a privilege, one that is out of reach for millions of Americans who had been pushed up against immovable barriers and into systems of oppression long before the arrival of Covid-19.

The coronavirus has killed more than 460,000 Americans as we write this, and the toll continues to climb. Though the virus does not discriminate by race or class or gender or age, its undeniable talent appears to be exposing the devastating inequities that come with being a person of color in America.

The “normal” to which many are so eager to return was the normal that helped pave the path for this devastation. Before Covid-19, normal meant widening racial gaps in income and wealth, higher rates of food insecurity among Black and Latinx households, and less than half of low-wage workers with access to paid sick leave. These are only some of the systemic inequities experienced by people of color who have struggled within a system undergirded by racism.

Covid-19 made these disparities impossible to ignore. Normal was not equitable or just, so back to normal means that the societal vulnerabilities that fueled Covid-19 remain, placing the nation’s collective safety, security, and economic prosperity at risk.

By itself, having a new administration or Congress in place does nothing to change these realities. Temporary measures during public health emergencies do even less because they can generate a false sense of accomplishment and complacency. It’s akin to Newton’s first law: An object at rest will stay at rest and an object in motion will stay in motion unless some force is applied to it.

President Biden has committed to the boldest health equity agenda in our nation’s history. On his first day in office, he signed an executive order titled “Advancing Racial Equity and Support for Underserved Communities Through the Federal Government.” Less than a week later, on a day when the administration’s theme for the day was equity, the president signed executive orders committing the federal government to address and condemn discrimination. This commitment is laudable, but it must be followed by equally bold policies.

Let us be clear: The American people, especially people and communities of color, are in desperate need of immediate economic support and aid. But while necessary, these are transient, temporary solutions necessitated by decades, even centuries, of racist policies. A moratorium on evictions and foreclosures does not address the nation’s housing crisis, which continues to disenfranchise and discriminate against Black and Latinx Americans. An increase in access to food for children whose schools have closed does little to address the hunger that has pervaded communities of color for decades.

These short-term gains are essential, but they fail to address the conditions that created the vulnerabilities upon which Covid-19 preyed.

Normal is merely the uninterrupted systems and policies that prop up and perpetuate inequities. And only policy can fix what policy has broken, like increasing the federal minimum wage, making investments to improve the quality and availability of affordable housing, providing incentives to improve schools, and repairing and rebuilding businesses owned by people of color in underserved communities. These and other policies and plans have been researched, proposed, and researched again. Our elected leaders know what to do. They need the will and support to do it.

A return to normal fails George Floyd, Breonna Taylor, and others killed by police. A return to normal fails the tens of thousands of people of color who were unnecessarily lost to Covid-19. The energy and resolve that fueled every march and every vote in a year of record turnout must now be refocused to apply pressure and demand accountability from every elected leader.

In her inaugural poem, past National Youth Poet Laureate Amanda Gorman reminded us, among countless soul-piercing refrains, that “being American is more than a pride we inherit. It’s the past we stepped into and how we repair it.”

All Americans need to hear and heed her sage and sobering words. To build back better, we must first look back and dig deep to uncover the inequities of U.S. systems and the laws and policies that serve to prop them up — and change them.

Daniel E. Dawes is a lawyer, director of the Satcher Health Leadership Institute at Morehouse School of Medicine, and author of “The Political Determinants of Health” (Johns Hopkins University Press, March 2020). Brian C. Castrucci is an epidemiologist, public health practitioner, and president and CEO of the de Beaumont Foundation.

https://www.statnews.com/2021/02/10/back-to-normal-isnt-good-enough/

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Mental Health Resources for Latino Community

By admin | January 15, 2021

Sunshine Behavioral Health recently created a resource on mental health in the Hispanic-Latino Community (rarely discussed & with statistics).

Here are some Highlights:

Here is the link for these resources:

Mental Health Issues Facing the Hispanic-Latino Community

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Information about the Coronavirus Variant

By admin | January 8, 2021

Since there is so much recent news about a new coronavirus strain that seems to be more contagious, which has led to a third shutdown in the United Kingdom, and was recently found in the United States, we want to send you some information about it.  At this time, scientists are just beginning to gather evidence about the transmissibility of this new variant, but as a whole, they fear it is much more transmissible.  Meanwhile, the main message is that we need to continue to be very vigilant and careful as this research evolves, and the same protocols apply: mask wearing, hand washing, social distancing and staying from crowded places. 

How much more contagious is the new strain?

The strain first identified in the U.K. spreads more easily and quickly than other strains, according to the CDC. The strain was first spotted in September in southeastern England and accounted for a quarter of cases in London by November. By the week of Dec. 9, it was responsible for 60% of cases in the city.

Scientists have been tracking minor changes in the COVID-19 genetic code since the beginning of the pandemic, and at least 1,000 variants have been detected so far. But the change to the spike protein found in southeast England represents one of the first coronavirus mutations that have made it more infectious.

What makes the new strain more contagious?

SARS-CoV-2, the virus that causes the disease COVID-19, acquires about one new mutation in its genome every two weeks, according to the CDC. The U.K. variant has several mutations that affect the “spike protein” on the virus surface that attaches to human cells.  “It’s able to bind to the receptors on cells better, and therefore is transmitted better,” Dr. Anthony Fauci, the nation’s leading infectious disease expert, said last week.  Patients infected with new version of the coronavirus are more likely to have higher viral loads in their noses and throats, which in turn would raise the likelihood that they infect others through breathing, talking, sneezing, and coughing.

There is no certain figure for how much more infectious the variant may be.  Scientists initially estimated that the new variant was 70 percent more transmissible, but a recent modeling study pegged that number at 56 percent.  “The amount of evidence in the public domain is woefully inadequate to draw strong or firm opinions on whether the virus has truly increased transmission,” said Prof Jonathan Ball, a virologist at the University of Nottingham.

Is the new strain more lethal?

There is no evidence that the variant, known as  B.1.1.7, causes more severe illness or increased risk of death, according to the CDC. However, just increasing transmission would be enough to cause problems for hospitals. If the new variant means more people are infected more quickly, that would in turn lead to more people needing hospital treatment.

What do we know about the new mutations?

An initial analysis of the new variant has been published and identifies 17 potentially important alterations.  There have been changes to the spike protein – this is the key the virus uses to unlock the doorway to our body’s cells.  One mutation alters the most important part of the spike, known as the “receptor-binding domain”. This is where the spike makes first contact with the surface of our body’s cells. Any changes that make it easier for the virus to get inside are likely to give it an edge.  

Is the vaccine effective for the new variant?

Researchers believe current COVID-19 vaccines will likely protect against B.1.1.7, but data is needed. The virus would “likely need to accumulate multiple mutations in the spike protein to evade immunity induced by vaccines or by natural infection,” according to the CDC. “From what we know from experience with this mutation and other mutations, it’s unlikely to have a large impact on vaccine-induced immunity, or existing immunity from previous strains,” said Dr. Greg Armstrong, director of the CDC’s Office of Advanced Molecular Detection. Armstrong said it is unclear how the variant may respond to COVID-19 treatments, such as monoclonal antibody treatments.

How long has the variant been in the US?

Researches first identified the B.1.1.7 variant in the U.S. in Colorado on Dec. 28 in a COVID-19 patient with no reported travel history, suggesting that the virus was spreading from person to person in the community. It has also been identified in California, Florida and New York.  New York reported its first case on Jan. 4, a man in his 60s—with no history of recent travel–who is associated with a jewelry store in Saratoga Springs, north of Albany, Gov. Andrew Cuomo said. The person The CDC said it plans to launch a national strain surveillance program this month that requires each state to submit at least 10 samples biweekly for sequencing.

Where else has the new strain been detected?

The strain has been detected in at least 33 countries, including Australia, Belgium, Brazil, Canada, Chile, China, Denmark, Finland, France, Germany, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Malta, The Netherlands, Norway, Pakistan, Portugal, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, the United Arab Emirates, the United Kingdom and the United States.

South Africa has also identified a strain similar to B.1.1.7, but it emerged in October independently of B.1.1.7 and is not related to it, according to the CDC. Like B.1.1.7, the South Africa variant (B.1.351) appears to spread more easily and quickly but is not more severe. U.S. health officials said last week they did not know if the South Africa strain was also circulating in the U.S. “This new variant is highly concerning, because it is yet more transmissible and it appears to have mutated further than the new variant that has been discovered in the U.K.,” British Health Secretary Matt Hancock said.

Sources and links:

A more contagious coronavirus strain has been identified in 4 states and 33 countries. What we know.  — USA TODAY

New coronavirus variant: What do we know?   Why is this variant causing concern? — BBC News

Emergence of a Highly Fit SARS-CoV-2 Variant  — New England Journal Of Medicine

How Does the Coronavirus Variant Spread? Here’s What Scientists Know – New York Times

Viral mutations may cause another ‘very, very bad’ COVID-19 wave, scientists warn

–Science

New COVID Strain Detected in New York: What We Know  — New York Magazine

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