Category Archives: Food and Drug Administration (FDA)

FDA ends emergency use authorization for hydroxychloroquine

Posted on by • Posted in 2020 Election Issues, Chloroquine, Coronavirus, Crisis, Crisis Management, Emergency Use Authorization, False Hope, False Narrative, Food and Drug Administration (FDA), Health Policy, Hydroxychloroquine, Infection Control, Infection Control Plan, Infectious Virus, Mislead, Misleading, Mortality, Pandemic, Pharmaceutical Industry, Public Health, Public Safety • Leave a comment

https://www.axios.com/hydroxychloroquine-fda-ends-emergency-use-authorization-f5353a2c-115a-4a57-b8e2-360b735b4937.html?stream=health-care&utm_source=alert&utm_medium=email&utm_campaign=alerts_healthcare

FDA withdraws emergency use authorization for hydroxychloroquine ...

The FDA ended Monday its emergency use authorizations for two controversial drugs, hydroxychloroquine and chloroquine, as a potential coronavirus treatment.

Why it matters: Despite gaining President Trump’s adamant support and use, the drugs have failed in several clinical trials and have been found to possibly cause serious heart problems.

What they’re saying: The FDA said it believes the drugs “are unlikely to be effective in treating COVID-19” under the emergency use authorization.

  • It also said that “in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of [the drugs] no longer outweigh the known and potential risks for the authorized use.”

Read the letter and memo regarding the revocation:

 

 

 

Optum says payers should keep a close eye on these 3 drugs. Here’s why

Posted on by • Posted in Antibody-Drug Conjugate (ADC) Therapy, Clinical Research, Duchenne Muscular Dystrophy (DMD), Food and Drug Administration (FDA), Health Policy, Health System, Hospital, Hospital Industry, Non-Orphan Drugs, Orphan Drugs, Pharmaceutical Industry, Pharmacy Benefits Management, Risdiplam, Spinal Muscular Atrophy (SMA), Trodelvy, Viltolarsen • Leave a comment

https://www.fiercehealthcare.com/payer/optum-says-payers-should-keep-a-close-eye-these-3-drugs-here-s-why?mkt_tok=eyJpIjoiTXpReVptRTBOemxoWW1OaCIsInQiOiJcL0FZVXVvVmhwQWpxdFBoV1VKRjhON29CaWhLY3g2bXFhT0doXC9tWVFpWTd0blh3TEY3MTN0M3lsZEs3K002d0hLS25BNld4dlk0b3NhWDBYaUhWYkNTUGc5SVRlRjBEMERoS01kWlZER1hVMmhFTkczdTAzMDhxWWpIaWxORk1mIn0%3D&mrkid=959610

The outside of Optum's headquarters

OptumRx researchers are highlighting three more drug products that payers should be keeping an eye on in 2020. 

Experts said in the pharmacy benefit manager’s second-quarter drug pipeline report echoed expectations from the first quarter that orphan drugs will be a major trend to watch as the year continues. Sumit Dutta, M.D., chief medical officer at OptumRx, wrote in the report these drugs will likely account for close to 40% of Food and Drug Administration approvals this year. 

Dutta said Optum is seeing more drug manufacturers jump into developing orphan drug products, which are generally considered less appealing as their market—and thus financial value—is more limited. 

“What is new is that we now are starting to see the development of orphan drugs become more competitive, increasing the potential for reduced costs and broader patient accessibility,” he wrote.

In 2018, the FDA approved more orphan drugs than non-orphan drugs for the first time. Optum’s first-quarter report also noted that these products are often pricey, as they target specific conditions. On average, orphan drugs cost $147,000 or more per year.

Of the three products highlighted in the second-quarter report, two are orphan drugs. Here’s more on what Optum’s analysts think payers need to know:

1. Risdiplam

If the FDA gives risdiplam a thumbs-up, it would become the first oral therapy for spinal muscular atrophy (SMA), a rare group of severe neuromuscular disorders. SMA is one of the most common genetic causes for infant mortality and affects about 1 in 11,000 babies.

There are only two treatments for SMA that are currently approved by the FDA, meaning there’s a significant unmet need for therapies, particularly oral medications, Optum said. The other treatments available are Spinraza, which requires repeated spinal injections, and gene therapy Zolgensma, the world’s most expensive drug.

Risdiplam would be administered orally once a day, which would likely draw significant interest from patients and their families, according to the report.

“Practically speaking, the competitive advantage for risdiplam will rest mainly in its oral route of administration, and perhaps, a lower cost,” according to the report. 

The analysts did caution that risdiplam is still in clinical trials and while results are promising, long-term outcomes associated with the drug are unclear. 

2. Viltolarsen

Viltolarsen is in development to treat Duchenne muscular dystrophy (DMD), a rare genetic disease that impacts young boys. There is a large unmet need for drugs to treat DMD, Optum said in the report, as it’s linked with significant sickness and death.

About 6,000 people in the U.S. have this disease, according to the report.

Vitolarsen is an “exon-skipping” drug that “short circuits” the genetic mutations that cause DMD. If approved, it would be the third such drug for the disease, and the second targeting a specific mutation that affects about 8% of those with DMD.

The drug has only been tested in small sample sizes, and there are limited safety data available, according to the report. 

3. Trodelvy

Trodelvy, the brand name of an antibody-drug conjugate (ADC) therapy aimed at metastatic triple-negative breast cancer, was approved in April.  

Triple-negative breast cancers test negative for the three most common causes of cancer and are thus untreatable by many front-line therapies, though they are treatable by chemotherapy, according to the report. ADC products like Trodelvy combine genetically engineered antibodies and traditional chemotherapy drugs into one intravenous therapy.

Optum is highlighting Trodelvy as it expects ADC medications to be a trend to monitor in the near future, because they could be applied to conditions outside of oncology, according to the report.

“We can think of ADCs as a refinement or extension of precision medicine, which aims at maximizing therapeutic benefits while minimizing undesired side effects for an individual patient,” the researchers wrote. “As the field advances, we can look for new conjugate ‘payloads’ that will go far beyond hunting cancer cells.”

“Various manufacturers are exploring how to leverage the ADC approach to produce vaccines, radiological treatments, immunosuppressive, cardiovascular and more,” they wrote.

 

 

Huge Study Throws Cold Water on Antimalarials for COVID-19

Posted on by • Posted in 2020 Election Issues, Chloroquine, Clinical Research, Clinical Trials, Coronavirus, Credibility, False Hope, Food and Drug Administration (FDA), Health Policy, Hydroxychloroquine, Mislead, Misleading, Mortality, Pandemic, Public Health, Public Safety, Trust, Truth, Wishful Thinking • Leave a comment

https://www.medpagetoday.com/infectiousdisease/covid19/86642?xid=nl_mpt_DHE_2020-05-23&eun=g885344d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%20Top%20Cat%20HeC%20%202020-05-23&utm_term=NL_Daily_DHE_dual-gmail-definition

Huge Study Throws Cold Water on Antimalarials for COVID-19 ...

— No support for continued use seen in analysis of 15,000 patients who got controversial drugs

Chloroquine or hydroxychloroquine (HCQ), with or without an antibiotic, in hospitalized COVID-19 patients were associated with increased risk of death in the hospital and higher rates of arrhythmias, analysis of outcomes in nearly 100,000 patients indicated.

The 15,000 patients who received HCQ or chloroquine were about twice as likely to die compared to controls who did not receive these agents after adjusting for covariates (18.o% for hydroxychloroquine and 16% for chloroquine versus 9.3% for controls), reported Mandeep Mehra, MD, of Brigham and Women’s Hospital in Boston, and colleagues.

The drug was also associated with a higher risk of ventricular arrhythmia during hospitalization (6.1% for hydroxychloroquine, 4.3% for chloroquine versus 0.3% for controls), the authors wrote in The Lancet.

Moreover, risks for both in-hospital mortality and ventricular arrhythmia were even higher compared to controls when either drug was combined with a macrolide antibiotic, they noted.

Mehra said in a statement these drugs should not be used as treatments for COVID-19 outside of clinical trials.

“This is the first large scale study to find statistically robust evidence that treatment with chloroquine or hydroxychloroquine does not benefit patients with COVID-19,” he said. “Instead, our findings suggest it may be associated with an increased risk of serious heart problems and increased risk of death. Randomised clinical trials are essential to confirm any harms or benefits associated with these agents.”

Mehra’s group analyzed some 96,000 patients from 671 hospitals on six continents with COVID-19 infection, from Dec. 20 to April 14, all of whom had either died or been discharged from the hospital by April 21.

Overall, 14,888 patients were treated with hydroxychloroquine, chloroquine, hydroxychloroquine with a macrolide antibiotic or chloroquine with an antibiotic, and their results were compared to 81,144 controls who did not receive these drugs.

Authors adjusted for demographic factors, as well as cardiovascular disease, diabetes, lung disease, smoking, immunosuppressed conditions and baseline disease severity.

The estimated excess risk attributable to the drug regimen rather than other factors, such as comorbidities, ranged from 34% to 35%.

Arrhythmia’s greatest risk was in the group who received hydroxychloroquine and a macrolide antibiotic such as azithromycin (8% versus 0.3% of controls), and this regimen was associated with a more than five-fold risk of developing an arrhythmia while hospitalized, though cause and effect cannot be inferred, the group noted.

“Previous small-scale studies have failed to identify robust evidence of a benefit and larger, randomised controlled trials are not yet completed,” said co-author Frank Ruschitzka, MD, Director of the Heart Center at University Hospital Zurich in a statement. “However, we now know from our study that the chance that these medications improve outcomes in COVID-19 is quite low.”

An accompanying editorial by Christian Funck-Brentano, MD, PhD, and Joe-Elie Salem, MD, PhD, of Sorbonne Université in Paris, noted limitations of the observational data, but said the authors “should be commended for providing results from a well designed and controlled study … in a very large sample of hospitalized patients.”

They also cautioned against attributing the increased risk of hospital deaths to the higher incidence of arrhythmias, noting that “the relationship between death and ventricular tachycardia was not studied and causes of deaths (i.e., arrhythmic vs non-arrhythmic) were not adjudicated.”

The editorialists nevertheless concluded both hydroxychloroquine and chloroquine, with or without azithromycin, “are not useful and could be harmful in hospitalized patients with COVID-19,” and stressed the importance of clinical trials for these drugs.

“The global community awaits the results of ongoing, well powered randomized controlled trials showing the effects of chloroquine and hydroxychloroquine on COVID-19 clinical outcomes,” they wrote.

 

 

 

 

Perspective: The Pandemic Has Created a Food Insecurity Crisis. The Federal Response Has Been Swift, but Is it Enough?

Posted on by • Posted in 2020 Election Issues, Child and Adult Care Food Program (CACFP), Coronavirus, Coronavirus Food Assistance Program (CFAP), Crisis, Crisis Management, Economic Crisis, Economic Recovery, Economic Stimulus, Employee Furlough, Employee Hiring Freeze, Employee Layoffs, Employee Pay Cuts, Employee Protections, Food and Drug Administration (FDA), Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, Health Policy, National School Lunch Program (NSLP), Pandemic, Pandemic EBT (P-EBT), Public Health, Public Safety, Safety Net Hospitals, Safety-Net Providers, Social Determinants of Health, Supplemental Nutrition Assistance Program (SNAP), Supplemental Nutrition Program for Women Infants and Children (WIC), Unemployment, Unemployment Insurance • Leave a comment

https://altarum.org/news/pandemic-has-created-food-insecurity-crisis-federal-response-has-been-swift-it-enough?utm_source=Altarum+Updates&utm_campaign=05b6c1511b-EMAIL_CAMPAIGN_2020_05_20_07_13&utm_medium=email&utm_term=0_4220252dfe-05b6c1511b-347615961

The Pandemic Has Created a Food Insecurity Crisis. The Federal ...

Our ability to access nutritious food is a critical factor to our health and well-being, which is why it has been alarming to see images in recent weeks of cars lining up by the thousands at food banks across the country. Indeed, a university survey taken since the onset of the crises found nearly 4 in 10 Americans reported having moderate to high levels of food insecurity, compared to 11 percent of households who were food insecure in 2018, according to the USDA Economic Research Service.

In response, the federal government has given states administrative relief and funding through various Covid-19 response packages. USDA also has authorized temporary waivers that grant states greater flexibility to address the increased demands and to align with shelter-in-place and social-distancing orders.

USDA also created two new programs: the Pandemic EBT (P-EBT) and the Coronavirus Food Assistance Program (CFAP). P-EBT allows states to issue eligible households an EBT card, a type of debit card used to purchase food, with the value of the free school breakfast and lunch reimbursement rates for the number of weekdays that schools are closed due to Covid-19 (estimated to be around $5.70 per day).

As of the first week of May, 18 states have been approved to provide benefits through P-EBT and 20 additional states have submitted plans for approval. CFAP aims not only to assist families in accessing food but also ranchers and farmers who have an excess supply. Through CFAP, the USDA will procure an estimated $100 million per month of fresh fruits and vegetables and $300 million per month in dairy and meat products for food banks and other nonprofits providing food to Americans in need.

Are these measures enough? Let’s examine the changes, particularly the USDA waivers for the federal food assistance programs.

The Supplemental Nutrition Assistance Program (SNAP), formerly known as food stamps, provides financial support to supplement the food budget of needy families. USDA waivers that increased flexibility in the administration of SNAP include:

  • waived the requirements for in-person interviews during the SNAP enrollment process,
  • provided emergency supplementary benefits up to the maximum benefit a household can receive for up to two months,
  • removed the requirement for SNAP recipients to re-certify midway through their participation,
  • provided flexibility for jobless workers to remain eligible, and
  • expanded the SNAP online grocery purchase pilot from the original eight states adding an additional 12 states and the District of Columbia.

These efforts are a step in the right direction to ease family burdens, but the supplemental benefits and program flexibilities are time-limited by the federal public health emergency declaration for Covid-19. Also, the 40 percent of SNAP households who already receive the maximum benefit are excluded from the supplemental benefits. Especially as we are experience the sharpest increase in food costs in decades, we need to provide additional support to the lowest income SNAP recipients. To assist families during the longer economic recovery, advocates and policy experts are calling for the following expansions to ensure these benefits cover a larger share of the people who need them:

  • boost the benefit for households by 15 percent (an additional $25 per person per month),
  • increase the minimum benefit per month from $16 to $30, and
  • suspend implementation of all administrative rules that restrict access for millions of Americans.

The Supplemental Nutrition Program for Women Infants and Children (WIC), a public health nutrition program that provides nutrition education, breastfeeding support and nutritious foods to low-income pregnant women and mothers of small children, has been providing services remotely. USDA waivers that increased flexibility in the administration of WIC include:

  • waived requirements for the physical presence for certification,
  • waiver for deferment of measurements and blood tests,
  • ability to issue benefits remotely, and
  • food package substitutions.

That’s a good start and more can be done. The Center on Budget and Policy Priorities recommends temporarily extending WIC certification periods for infants to two years as well as extending WIC eligibility from age five to age six. The National WIC Association is also advocating for an increase in the Cash Value Benefit to enhance fruit and vegetable purchases by WIC families.

The National School Lunch Program (NSLP) and Breakfast Programs, Summer Food Service Program, and the Child and Adult Care Food Program (CACFP), which serve low-income school children, quickly revamped and developed innovative ways to distribute meals to families, often expanding their regular productions. USDA waivers that increased flexibility to help better serve families during the pandemic include:

  • ability to serve non-congregate meals,
  • allowing for pick-up and delivery of meals,
  • allowing modification in the meals components requirements,
  • waiving time elements and meal spacing requirements,
  • allowing virtual desk enrollment of new CACFP providers, and
  • waive requirement that afterschool meals and snacks be accompanied by educational activities.

CACFP provides meals to preschool-aged children in Child Care Centers and licensed child care family homes.  During the pandemic, most centers have been closed, while a majority of family homes remained open and provided services for essential workers.

According to Paula James, director of child health and nutrition at CocoKids in northern California, about 68 percent of the Contra Costa county’s family homes participating in CACFP remained open in April, and these waivers were helpful. Moving forward, she believes CACFP should continue the allowance of virtual enrollment and expand the use of that technology to regular monitoring site visits, specifically in rural areas or locations where safety could be a concern.  While the pandemic has provided the opportunity to test technological advances that could streamline program operations in the future, it also revealed some systemic weaknesses, including that CACFP has no centralized database system, which is needed at the state level and requires federal guidance. Lack of technology throughout the program was a hinderance to providing additional services to families during COVID-19.  “Continued use of technology into the future will be very important,” said James.

What more can be done? The federal government should extend COVID-19 related waivers for all nutrition programs until September 30, the date provided by congressional authority. While the public health restrictions may be lifting across the states, the economic fallout will likely be felt by families for many months to come.

In addition, states should leverage communication, technology, all federal supports, and evaluation to ensure they are successfully reaching as many in need as possible. This includes:

  • conducting a public information campaign to alert newly unemployed families in need about available food assistance programs and how to apply and access benefits;
  • utilizing technology solutions to provide remote program services and enrollment including mobile uploading of required documents;
  • taking advantage and apply for all available waiver options from the federal government; and
  • evaluating the revised work systems and if appropriate, take actions to allow for permanent program changes.

This week House Democrats passed the Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, the fifth Covid-related legislative package, which includes a boost in funding for SNAP, WIC, and Child Nutrition Programs. The bill also provides support to local food banks and emergency food providers. Any bill that goes to the president should include these food access supports.

It is critical to strengthen federal food assistance programs and the social safety net while working to address the root causes of poverty to reduce health and social disparities. To learn how Altarum can assist your state in program assessment, planning, evaluation, training and analytic support for quality services, contact Tara Fowler, PhD, director of the Center for Healthy Women and Children, at tara.fowler@altarum.org.

 

 

 

New Coronavirus Vaccine Candidate Shows Promise In Early, Limited Trial

Posted on by • Posted in Clinical Research, Clinical Trials, Coronavirus, Food and Drug Administration (FDA), Pandemic, Vaccination, Vaccine, Vaccine RNA • Leave a comment

https://www.npr.org/sections/coronavirus-live-updates/2020/05/18/857997341/new-coronavirus-vaccine-candidate-shows-promise-in-early-limited-trial

Moderna's coronavirus vaccine shows promise in first human trial ...

A vaccine manufacturer is reporting preliminary data suggesting its COVID-19 vaccine is safe, and appears to be eliciting in test subjects the kind of immune response capable of preventing disease.

Moderna, Inc., of Cambridge, Mass., developed the vaccine in collaboration with the National Institute of Allergy and Infectious Diseases. The results reported Monday come from an initial analysis of a Phase I study primarily designed to see if the vaccine is safe.

The company reports no serious side-effects; however, modest side-effects included redness at the injection site, headache, fever and flu-like symptoms, although none of these lasted more than a day.

The first 45 volunteers for the vaccine trial were divided into three groups, with each group getting a different dose of the vaccine. All groups got an initial shot, followed by a booster shot a month later.

In addition to safety, the company also looked at the vaccine’s ability to induce antibodies to the coronavirus — what’s known as its immunogenicity. It did, for all subjects at all dose levels. In addition, eight of the subjects were tested for the presence of neutralizing antibodies that prevent the virus from infecting cells in the laboratory. All eight did.

The Food and Drug Administration has given Moderna the green light to begin a Phase II study expected to enroll an additional 600 volunteers — half older than 55 — to provide additional immunogenicity data. The company hopes by July to begin a Phase III study, aimed at showing that the vaccine can actually prevent disease.

The Moderna vaccine is made using messenger RNA, or mRNA, a molecule containing the genetic instructions to make a protein on the coronavirus surface that is recognized by our immune systems. Although mRNA vaccines have been studied for several years, so far none has been licensed by the FDA.

The advantage of mRNA vaccines over more traditional vaccines is they can be made quickly. The company says it was just 63 days from the time Chinese scientists revealed the genetic sequence to the time a vaccine was injected into the first volunteer.

Moderna’s is one of about a dozen COVID-19 vaccine candidates that have begun studies in humans.

 

 

 

If the White House is struggling, how will ordinary businesses fare? 

Posted on by • Posted in 2020 Election Issues, Clinical Testing, Contact Tracing, Coronavirus, Crisis, Crisis Management, Economic Crisis, Economy, Economy Reopening, Emergency Preparedness, Employee Benefits, Employee Furlough, Employee Hiring Freeze, Employee Layoffs, Employee Pay Cuts, Employee Protections, Food and Drug Administration (FDA), Health Policy, Infection Control, Infectious Virus, Job, Job Market, Job Search, Job Security, Leadership Decentralized, Mortality, Pandemic, Public Health, Public Safety, Quarantine, Social Distancing • 1 Comment

https://mailchi.mp/f4f55b3dcfb3/the-weekly-gist-may-15-2020?e=d1e747d2d8

The RAOI Advisory Opinion: A Transformative Moment or a Bump in ...

In a week that saw reopening activity pick up across the country, drawing even more attention to the need for sufficient testing to give employers and workers confidence in returning to work, a new study from researchers at New York University (NYU) suggested that a widely-hailed rapid testing machine from Abbott Labs may be unreliable.

The Abbott ID NOW COVID-19 test produced false negatives a third of the time using nasopharyngeal swabs, and 48 percent of the time with less-invasive “dry nasal swabs”, according to the study, which has not yet undergone peer review. The five-minute, point-of-care test received emergency use authorization from the Food and Drug Administration (FDA) in late March and has been touted as a “great test” by President Trump, whose White House relies on it to test the President and those around him.

On Thursday, the FDA issued a warning about the potential for false negative results using the Abbott test. The company disputes the findings and sent a list of questions to the NYU researchers for clarification. Meanwhile, two White House staffers—an aide to the President and the Vice President’s press secretary—tested positive for coronavirus, causing the White House to mandate masks for all employees starting this week.

The uncertainty around test results, and the ensuing concern about safety at the White House, provides a foretaste of the difficult road ahead for thousands of employers nationwide as stay-at-home orders are lifted, and companies consider when and how to reopen workplaces.

If the White House is struggling, how will ordinary businesses fare?

US coronavirus update: 1.46M cases, 87K+ confirmed deaths, 10.2M total tests conducted.

 

 

 

 

States build contact tracing armies to crush coronavirus

Posted on by • Posted in 2020 Election Issues, Clinical Testing, Contact Tracing, Coronavirus, Crisis, Crisis Management, Emergency Preparedness, Food and Drug Administration (FDA), Health Policy, Infection Control, Infectious Virus, Leadership Decentralized, Mortality, Pandemic, Public Health, Public Safety, Quarantine, Social Distancing, World Health Organization (WHO) • Leave a comment

States build contact tracing armies to crush coronavirus

Coronavirus: Why are there doubts over contact-tracing apps? - BBC ...

State governments are building armies of contact tracers in a new phase of the battle against the coronavirus pandemic, returning to a fundamental practice in public health that can at once wrestle the virus under control and put hundreds of thousands of newly jobless people back to work.

California is already conducting contact tracing in 22 counties, and it eventually plans to field a force of 10,000 state employees, who will be given basic training by University of California health experts.

Massachusetts and Ohio have partnered with Partners in Health, a global health nonprofit originally established to support programs in Haiti, to field teams of contact tracers. Maryland will partner with the University of Chicago and NORC, formerly the National Opinion Research Center, to quadruple its contact tracing capacity.

Washington, West Virginia, Iowa, North Dakota and Rhode Island are using their National Guards to trace contacts of those who have been infected with the coronavirus. In Kansas, 400 people have volunteered to trace contacts; in Utah, 1,200 state employees have raised their hands.

Contact tracing is a pillar of basic public health, a critical element in battling infectious disease around the globe. The goal is to identify those who have been infected with a virus and those with whom the infected person has come into contact. 

If those contacts then come down with the virus, they can be quickly isolated so they do not spread it further. They can also be treated, making it less likely they develop the most severe symptoms.

The practice works even in areas where health systems are thin at best and nonexistent at worst.

Tracking down those who had the Ebola virus in Guinea, Liberia and Sierra Leone, three of the poorest nations on Earth, was critical to ending the world’s largest outbreak of the deadly hemorrhagic fever in 2015. World Health Organization trackers and health officials in Congo have tracked as many as 25,000 people at a time during an Ebola outbreak that is still simmering in an eastern province, even as they face the threat of what is an almost active war zone.

“Our ability to suppress transmission relates to our ability to detect the virus,” Maria Van Kerkhove, the American who leads the World Health Organization’s technical team studying the coronavirus, told reporters last week.

The focus on contact tracing comes as public health experts warn that the coronavirus will not end as a threat to humankind until so many people have become infected that the virus has nowhere else to turn — a terrifying prospect that conjures images of overwhelmed health systems and death on a mass scale — or until scientists develop and distribute an effective vaccine to billions of people across the globe.

There are more than 100 vaccines in some stage of testing, though determining their effectiveness is still months away, and production at a mass scale is months beyond that. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and the country’s most well-known infectious disease expert, has estimated that a vaccine could be as close as 18 months away, though he has acknowledged that would blow the old record for speedy development out of the water.

“We have to fundamentally do everything possible to get a safe and effective vaccine as quickly as possible. At the same time, we have to assume that it’s not around the corner,” said Tom Frieden, former director of the Centers for Disease Control and Prevention who now runs Resolve to Save Lives, a global health nonprofit.

In the meantime, the federal government has largely left it up to the states to build their contact tracing capacity. 

Sen. Elizabeth Warren (D-Mass.) and Rep. Andy Levin (D-Mich.) have proposed adding a massive nationwide federal contact tracing program to the next round of coronavirus-related relief funding. In a nod to the New Deal-style scale such a program would require, they call the program the Coronavirus Containment Corps.

“Establishing a nationwide contact tracing program is the only way we can truly know the progress we’ve made in containing the virus, and how far we have left to go before we can transition back to normal life,” Levin said in a statement.

But contact tracing can work only if the number of new cases the United States confirms every day begins to bend down to a manageable number. The number of cases confirmed in the United States has grown by at least 25,000 on all but two of the first eight days of May.

And tracing will become an effective tool only when those who are conducting the tracing have the ability to test people broadly and to get the results of those tests back quickly. The Food and Drug Administration said Friday it had approved both the first diagnostic test that could be conducted using home-collected saliva samples and the first antigen test, a type of test that delivers results much faster than others on the market.

The lack of available tests at the earliest stages of the coronavirus outbreak has hidden the true extent of the virus’s spread around the United States. While some countries have the capacity to test huge percentages of their population on a given day, the United States is still testing only about 250,000 people per day, a level far short of the capacity necessary to conduct widespread contact tracing.

“Right from the start there has been a tremendous undercounting of cases, and that had to do with our now infamous slow testing rollout,” said Paul Sax, clinical director of the division of infectious diseases at Brigham and Women’s Hospital in Boston. 

President Trump has touted the raw number of tests performed — he rightly claims that the United States conducts more tests on a given day than any other country. But on a per capita basis, the United States is testing fewer of its residents than countries such as the United Kingdom, Italy and Estonia.

Until that changes, public health experts worry the United States will be stuck at a dangerous plateau.

“We’re doing deeply inadequate testing and functionally no tracing,” said Jeremy Konyndyk, a former head of the Office of Foreign Disaster Assistance at the U.S. Agency for International Development and now a senior fellow at the Center for Global Development. “We’re not going to half-ass our way out of a pandemic, and that’s where we are, and that’s why we’re stuck.”

 

 

 

 

Whistleblower alleges Trump administration ignored coronavirus warnings

Posted on by • Posted in 2020 Election Issues, Clinical Research, Clinical Research Funding, Clinical Testing, Clinical Trials, Conflicts of Interest, Coronavirus, Credibility, Crisis, Crisis Management, Dept of Health and Human Services (HHS), Food and Drug Administration (FDA), Health Policy, Hydroxychloroquine, Misinformation, Mislead, Misleading, Mistake, Mistrust, Scientists, Transparency, Trust, Truth, U.S. Biomedical Advanced Research and Development Authority (BARDA) • Leave a comment

https://www.axios.com/coronavirus-rick-bright-whistleblower-f48cc9c6-8e6e-4662-a127-03e51f323288.html?stream=health-care&utm_source=alert&utm_medium=email&utm_campaign=alerts_healthcare

Whistleblower alleges Trump administration ignored coronavirus ...

Rick Bright, the former director of the U.S. Biomedical Advanced Research and Development Authority (BARDA), filed a whistleblower complaint Tuesday alleging that the Department of Health and Human Services failed to take early action to mitigate the threat of the novel coronavirus.

Flashback: Bright said last month he believes he was ousted after clashing with HHS leadership over his attempts to limit the use of hydroxychloroquine to treat the coronavirus.

What’s new: In his complaint, Bright claims he was excluded from an HHS meeting on the coronavirus in late January after he “pressed for urgent access to funding, personnel, and clinical specimens, including viruses” to develop treatments for the coronavirus should it spread outside of Asia.

  • Bright alleges it “became increasingly clear” in late January that “HHS leadership was doing nothing to prepare for the imminent mask shortage.”
  • Bright claims he “resisted efforts to fall into line with the Administration’s directive to promote the broad use of chloroquine and hydroxychloroquine and to award lucrative contracts for these and other drugs even though they lacked scientific merit and had not received prior scientific vetting.”
  • He adds that “even as HHS leadership began to acknowledge the imminent shortages in critical medical supplies, they failed to recognize the magnitude of the problem, and they failed to take the necessary urgent action.”

The White House declined to comment. HHS did not immediately respond to a request for comment.

https://www.documentcloud.org/documents/6882494-NEW-R-Bright-OSC-Complaint-Redacted.html

 

 

 

 

The Health 202: Social distancing hasn’t been as effective in stemming U.S. coronavirus deaths as policymakers had hoped.

Posted on by • Posted in 2020 Election Issues, Centers for Disease Control & Prevention (CDC), Coronavirus, Crisis, Crisis Management, Expectations, Food and Drug Administration (FDA), Health Policy, Infection Control, Infectious Virus, Leadership Decentralized, Mislead, Misleading, Mortality, Pandemic, Public Health, Public Safety, Quarantine, Social Distancing, Uncertainty, Vaccination, Vaccine, Wishful Thinking • Leave a comment

https://www.washingtonpost.com/news/powerpost/paloma/the-health-202/2020/05/05/the-health-202-social-distancing-hasn-t-been-as-effective-in-stemming-u-s-coronavirus-deaths-as-policymakers-had-hoped/5eb04b6d88e0fa594778ea5e/

Social distancing isn’t having the effects many had hoped for.

Despite encouraging signs on the nation’s East and West coasts, daily diagnosed cases of the novel coronavirus appear to still be on the rise in about 20 states. A number of rural counties have become unexpected hot spots in recent weeks, including in the Black Belt region of Mississippi and Alabama and in communities throughout Iowa and northern Texas around the Oklahoma panhandle. The country’s overall daily figures of diagnoses and deaths have plateaued, worrying health policymakers as many states move to reopen parts of their economy.

That steep curve of covid-19 cases in March and April isn’t receding the way it rose.

Hot spots are shifting geographically from New York City to areas around the country. For the past month, the figures have hovered around 30,000 diagnosed cases and around 2,000 deaths every day, former Food and Drug Administration commissioner Scott Gottlieb noted in a Wall Street Journal op-ed.

“Everyone thought we’d be in a better place after weeks of sheltering in place and bringing the economy to a near standstill,” he wrote. “Mitigation hasn’t failed; social distancing and other measures have slowed the spread. But the halt hasn’t brought the number of new cases and deaths down as much as expected or stopped the epidemic from expanding.”

President Trump, who last week suggested the novel coronavirus would disappear even without a vaccine, has now upgraded his prediction of fatalities to as many as 100,000 people. Nonetheless, he said in a New York Post interview yesterday that Americans are “starting to to feel good now. The country’s opening again. We saved millions of lives, I think.”

A leaked government report, still in draft version, predicts a spike in cases and deaths beginning on May 14.

The report, which the Centers for Disease Control quickly disavowed as an unfinished projection, suggests new cases could surge to 200,000 per day and daily American deaths could number more than 3,000 by June 1. That’s far more than what other models predict, but the Johns Hopkins epidemiologist who prepared it told my colleagues William Wan, Lenny Bernstein, Laurie McGinley and Josh Dawsey that 100,000 new cases per day by the end of the month isn’t out of the realm of possibility.

Former FDA commissioner Scott Gottlieb:

University of Michigan professor Justin Wolfers:

That’s not the only model showing discouraging figures for the month of May. A model out of the University of Washington, relied upon heavily by the administration, yesterday upgraded its U.S. fatality predictions for the virus’s first wave from 72,433 deaths to 134,475 deaths by Aug. 4.

These aren’t the trends many policymakers had hoped to see, after most Americans spent seven weeks at home under an unprecedented lockdown that has torched the once-booming economy and thrust millions into economic uncertainty. Protests against extended lockdowns are starting to mount around the country, and many governors have assembled and even embarked upon gradual plans to reopen businesses, schools and other public areas.

Nonetheless, a new Washington Post-University of Maryland poll out this morning shows sizable majority of Americans oppose the reopening of restaurants, retail stores and businesses.

Executive producer of 7News WHDH in Boston:

Social distancing did accomplish some important objectives. It undoubtedly saved the health-care system from being crushed by an overwhelming caseload of sick patients all at once.

And the United States is still outranked by half a dozen European countries when it comes to deaths per capita. The U.S. death rate is about 206 deaths per million people. That figure is 538 in Spain, 372 in France, 481 in Italy, 432 in the United Kingdom and 207 in Switzerland, according to a tally by Mother Jones.

But distancing clearly hasn’t been enough — at least the way it’s been carried out — to halt the spread of the highly contagious virus in some places.

New cases and deaths across the whole U.S. are about where they were 20 days ago, my colleague Philip Bump reports. He created a graphic where you can view the three-day averages of cases, deaths and tests performed by state (check it out here).

“The back of the mountain doesn’t look the way the front did,” Philip writes. “We saw a steady, exponential rise in confirmed cases and deaths each day for several weeks. But particularly with daily case totals, the period after the peak nationally has looked more like a plateau than a downward slide.”

Daily cases appear to be rising significantly in Delaware, Illinois, Indiana, Minnesota and Virginia. They’re also trending upward in Arizona, Colorado, D.C., Iowa, Kansas, Maryland, Mississippi, Nebraska, New Hampshire, New Mexico, North Carolina, Tennessee, Texas, Utah and Wisconsin.

Andy Slavitt, former head of the Centers for Medicare and Medicaid Services:

“There are so many emerging areas still throughout the country that our group has been trying to wave our hands about,” Marynia Kolak, a health and spatial data science researcher at the University of Chicago, told me.

Kolak and her colleagues are tracking covid-19 cases and deaths at the county level. They’ve been increasingly spotting clusters of the disease in rural areas. Kaiser Family Foundation researchers have also found that rural areas are experiencing a faster growth in cases, even as their total numbers remain far below those seen in urban settings.

One example: Five counties in Minnesota with significant meat-processing plants. State officials said about a quarter of cases reported over the weekend came from those counties.

One is Nobles County, home to a JBS USA pork processing plant in Worthington, with a population of around 22,000. It is scheduled to partially reopen this week, under an order by Trump to keep meat plants open.

The outbreaks in counties with meat-processing plants “illustrates how powerfully situations can change at the community level,” said Jan Malcolm, commissioner of Minnesota’s Department of Health.

Malcolm stressed how hard it is to stem the spread of the virus in these types of facilities.

“These are particularly challenging investigations,” Malcolm said. “Many of the workers involved don’t have phones, don’t provide phone numbers, aren’t answering calls. It’s been a very labor-intensive, shoe-leather kind of an approach.”

 

 

How Long Will a Vaccine Really Take?

Posted on by • Posted in 2020 Election Issues, Clinical Research, Clinical Research Funding, Clinical Testing, Clinical Trials, Contact Tracing, Coronavirus, Expectations, Expert Opinion, Food and Drug Administration (FDA), Health Policy, Infection Control, Infectious Virus, Pandemic, Public Health, Public Safety, Quarantine, Social Distancing, Vaccine RNA • Leave a comment

Health - Digg

A vaccine would be the ultimate weapon against the coronavirus and the best route back to normal life. Officials like Dr. Anthony S. Fauci, the top infectious disease expert on the Trump administration’s coronavirus task force, estimate a vaccine could arrive in at least 12 to 18 months.

The grim truth behind this rosy forecast is that a vaccine probably won’t arrive any time soon. Clinical trials almost never succeed. We’ve never released a coronavirus vaccine for humans before. Our record for developing an entirely new vaccine is at least four years — more time than the public or the economy can tolerate social-distancing orders.

But if there was any time to fast-track a vaccine, it is now. So Times Opinion asked vaccine experts how we could condense the timeline and get a vaccine in the next few months instead of years.

Here’s how we might achieve the impossible.

Normally, researchers need years to secure funding, get approvals and study results piece by piece. But these are not normal times.

There are already at least 254 therapies and 95 vaccines related to Covid-19 being explored.

“If you want to make that 18-month timeframe, one way to do that is put as many horses in the race as you can,” said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine.

Despite the unprecedented push for a vaccine, researchers caution that less than 10 percent of drugs that enter clinical trials are ever approved by the Food and Drug Administration.

The rest fail in one way or another: They are not effective, don’t perform better than existing drugs or have too many side effects.

Fortunately, we already have a head start on the first phase of vaccine development: research. The outbreaks of SARS and MERS, which are also caused by coronaviruses, spurred lots of research. SARS and SARS-CoV-2, the virus that causes Covid-19, are roughly 80 percent identical, and both use so-called spike proteins to grab onto a specific receptor found on cells in human lungs. This helps explain how scientists developed a test for Covid-19 so quickly.

There’s a cost to moving so quickly, however. The potential Covid-19 vaccines now in the pipeline might be more likely to fail because of the swift march through the research phase, said Robert van Exan, a cell biologist who has worked in the vaccine industry for decades. He predicts we won’t see a vaccine approved until at least 2021 or 2022, and even then, “this is very optimistic and of relatively low probability.”

And yet, he said, this kind of fast-tracking is “worth the try — maybe we will get lucky.”

The next step in the process is pre-clinical and preparation work, where a pilot factory is readied to produce enough vaccine for trials. Researchers relying on groundwork from the SARS and MERS outbreaks could theoretically move through planning steps swiftly.

Sanofi, a French biopharmaceutical company, expects to begin clinical trials late this year for a Covid-19 vaccine that it repurposed from work on a SARS vaccine. If successful, the vaccine could be ready by late 2021.

As a rule, researchers don’t begin jabbing people with experimental vaccines until after rigorous safety checks.

They test the vaccine first on small batches of people — a few dozen during Phase 1, then a few hundred in Phase 2, then thousands in Phase 3. Months normally pass between phases so that researchers can review the findings and get approvals for subsequent phases.

But “if we do it the conventional way, there’s no way we’re going to be reaching that timeline of 18 months,” said Akiko Iwasaki, a professor of immunobiology at Yale University School of Medicine and an investigator at the Howard Hughes Medical Institute.

There are ways to slash time off this process by combining several phases and testing vaccines on more people without as much waiting.

Last week the National Academy of Sciences showed an overlapping timeline, describing it as moving at “pandemic speed.”

It’s here that talk of fast-tracking the timeline meets the messiness of real life: What if a promising vaccine actually makes it easier to catch the virus, or makes the disease worse after someone’s infected?

That’s been the case for a few H.I.V. drugs and vaccines for dengue fever, because of a process called vaccine-induced enhancement, in which the body reacts unexpectedly and makes the disease more dangerous.

Researchers can’t easily infect vaccinated participants with the coronavirus to see how the body behaves. They normally wait until some volunteers contract the virus naturally. That means dosing people in regions hit hardest by the virus, like New York, or vaccinating family members of an infected person to see if they get the virus next. If the pandemic subsides, this step could be slowed.

“That’s why vaccines take such a long time,” said Dr. Iwasaki. “But we’re making everything very short. Hopefully we can evaluate these risks as they occur, as soon as possible.”

This is where the vaccine timelines start to diverge depending on who you are, and where some people might get left behind.

If a vaccine proves successful in early trials, regulators could issue an emergency-use provision so that doctors, nurses and other essential workers could get vaccinated right away — even before the end of the year. Researchers at Oxford announced this week that their coronavirus vaccine could be ready for emergency use by September if trials prove successful.

So researchers might produce a viable vaccine in just 12 to 18 months, but that doesn’t mean you’re going to get it. Millions of people could be in line before you. And that’s only if the United States finds a vaccine first. If another country, like China, beats us to it, we could wait even longer while it doses its citizens first.

You might be glad of that, though, if it turned out that the fast-tracked vaccine caused unexpected problems. Only after hundreds or thousands are vaccinated would researchers be able to see if a fast-tracked vaccine led to problems like vaccine-induced enhancement.

“It’s true that any new technology comes with a learning curve,” said Dr. Paul Offit, the director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. “And sometimes that learning curve has a human price.”

Once we have a working vaccine in hand, companies will need to start producing millions — perhaps billions — of doses, in addition to the millions of vaccine doses that are already made each year for mumps, measles and other illnesses. It’s an undertaking almost unimaginable in scope.

Companies normally build new facilities perfectly tailored to any given vaccine because each vaccine requires different equipment. Some flu vaccines are produced using chicken eggs, using large facilities where a version of the virus is incubated and harvested. Other vaccines require vats in which a virus is cultured in a broth of animal cells and later inactivated and purified.

Those factories follow strict guidelines governing biological facilities and usually take around five years to build, costing at least three times more than conventional pharmaceutical factories. Manufacturers may be able to speed this up by creating or repurposing existing facilities in the middle of clinical trials, long before the vaccine in question receives F.D.A. approval.

“They just can’t wait,” said Dr. Iwasaki. “If it turns out to be a terrible vaccine, they won’t distribute it. But at least they’ll have the capability” to do so if the vaccine is successful.

The Bill and Melinda Gates Foundation says it will build factories for seven different vaccines. “Even though we’ll end up picking at most two of them, we’re going to fund factories for all seven, just so that we don’t waste time,” Bill Gates said during an appearance on “The Daily Show.”

In the end, the United States will have the capacity to mass-produce only two or three vaccines, said Vijay Samant, the former head of vaccine manufacturing at Merck.

“The manufacturing task is insurmountable,” Mr. Samant said. “I get sleepless nights thinking about it.”

Consider just one seemingly simple step: putting the vaccine into vials. Manufacturers need to procure billions of vials, and billions of stoppers to seal them. Sophisticated machines are needed to fill them precisely, and each vial is inspected on a high-speed line. Then vials are stored, shipped and released to the public using a chain of temperature-controlled facilities and trucks. At each of these stages, producers are already stretched to meet existing demands, Mr. Samant said.

It’s a bottleneck similar to the one that caused a dearth of ventilators, masks and other personal protective equipment just as Covid-19 surged across America.

If you talk about vaccines long enough, a new type of vaccine, called Messenger RNA (or mRNA for short), inevitably comes up. There are hopes it could be manufactured at a record clip. Mr. Gates even included it on his Time magazine list of six innovations that could change the world. Is it the miracle we’re waiting for?

Rather than injecting subjects with disease-specific antigens to stimulate antibody production, mRNA vaccines give the body instructions to create those antigens itself. Because mRNA vaccines don’t need to be cultured in large quantities and then purified, they are much faster to produce. They could change the course of the fight against Covid-19.

“On the other hand,” said Dr. van Exan, “no one has ever made an RNA vaccine for humans.”

Researchers conducting dozens of trials hope to change that, including one by the pharmaceutical company Moderna. Backed by investor capital and spurred by federal funding of up to $483 million to tackle Covid-19, Moderna has already fast-tracked an mRNA vaccine. It’s entering Phase 1 trials this year and the company says it could have a vaccine ready for front-line workers later this year.

“Could it work? Yeah, it could work,” said Dr. Fred Ledley, a professor of natural biology and applied sciences at Bentley University. “But in terms of the probability of success, what our data says is that there’s a lower chance of approval and the trials take longer.”

The technology is decades old, yet mRNA is not very stable and can break down inside the body.

“At this point, I’m hoping for anything to work,” said Dr. Iwasaki. “If it does work, wonderful, that’s great. We just don’t know.”

The fixation on mRNA shows the allure of new and untested treatments during a medical crisis. Faced with the unsatisfying reality that our standard arsenal takes years to progress, the mRNA vaccine offers an enticing story mixed with hope and a hint of mystery. But it’s riskier than other established approaches.

Imagine that the fateful day arrives. Scientists have created a successful vaccine. They’ve manufactured huge quantities of it. People are dying. The economy is crumbling. It’s time to start injecting people.

But first, the federal government wants to take a peek.

That might seem like a bureaucratic nightmare, a rubber stamp that could cost lives. There’s even a common gripe among researchers: For every scientist employed by the F.D.A., there are three lawyers. And all they care about is liability.

Yet F.D.A. approvals are no mere formality. Approvals typically take a full year, during which time scientists and advisory committees review the studies to make sure that the vaccine is as safe and effective as drug makers say it is.

While some steps in the vaccine timeline can be fast-tracked or skipped entirely, approvals aren’t one of them. There are horror stories from the past where vaccines were not properly tested. In the 1950s, for example, a poorly produced batch of a polio vaccine was approved in a few hours. It contained a version of the virus that wasn’t quite dead, so patients who got it actually contracted polio. Several children died.

The same scenario playing out today could be devastating for Covid-19, with the anti-vaccination movement and online conspiracy theorists eager to disrupt the public health response. So while the F.D.A. might do this as fast as possible, expect months to pass before any vaccine gets a green light for mass public use.

At this point you might be asking: Why are all these research teams announcing such optimistic forecasts when so many experts are skeptical about even an 18-month timeline? Perhaps because it’s not just the public listening — it’s investors, too.

“These biotechs are putting out all these press announcements,” said Dr. Hotez. “You just need to recognize they’re writing this for their shareholders, not for the purposes of public health.”

What if It Takes Even Longer Than the Pessimists Predict?

Covid-19 lives in the shadow of the most vexing virus we’ve ever faced: H.I.V. After nearly 40 years of work, here is what we have to show for our vaccine efforts: a few Phase 3 clinical trials, one of which actually made the disease worse, and another with a success rate of just 30 percent.

Researchers say they don’t expect a successful H.I.V. vaccine until 2030 or later, putting the timeline at around 50 years.

That’s unlikely to be the case for Covid-19, because, as opposed to H.I.V., it doesn’t appear to mutate significantly and exists within a family of familiar respiratory viruses. Even still, any delay will be difficult to bear.

But the history of H.I.V. offers a glimmer of hope for how life could continue even without a vaccine. Researchers developed a litany of antiviral drugs that lowered the death rate and improved health outcomes for people living with AIDS. Today’s drugs can lower the viral load in an H.I.V.-positive person so the virus can’t be transmitted through sex.

Therapeutic drugs, rather than vaccines, might likewise change the fight against Covid-19. The World Health Organization began a global search for drugs to treat Covid-19 patients in March. If successful, those drugs could lower the number of hospital admissions and help people recover faster from home while narrowing the infection window so fewer people catch the virus.

Combine that with rigorous testing and contact tracing — where infected patients are identified and their recent contacts notified and quarantined — and the future starts looking a little brighter. So far, the United States is conducting fewer than half the number of tests required and we need to recruit more than 300,000 contact-tracers. But other countries have started reopening following exactly these steps.

If all those things come together, life might return to normal long before a vaccine is ready to shoot into your arm.