Posts tagged with "FDA"

In controversial decision, FDA approves new Alzheimer’s disease drug

June 9, 2021

On June 7, the U.S. Food and Drug Administration approved the use of the experimental drug aducanumab for patient treatment during the early phases of Alzheimer’s disease—overriding the conclusion of an FDA advisory committee last year that there was not enough evidence to support the effectiveness of the treatment.

According to a report by CNN, the drug was developed for patients with mild cognitive impairment, not severe dementia, and intended to slow progression of Alzheimer’s disease —not just ease symptoms.

The FDA has not approved a novel therapy for Alzheimer’s disease since 2003.

The FDA approved aducanumab, also known as Aduhelm, using its “accelerated approval” program, which allows for the earlier approval of a drug for a serious or life-threatening illness even though more study into the drug’s benefits may be needed.

“There has been considerable public debate on whether Aduhelm should be approved. As is often the case when it comes to interpreting scientific data, the expert community has offered differing perspectives,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in Monday’s announcement.

“At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward,” she said, noting that the FDA ultimately decided to use accelerated approval and “concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.”

“FDA will continue to monitor Aduhelm as it reaches the market and ultimately the patient’s bedside,” Cavazzoni said.

In November, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee was asked to vote on several questions about evidence of the drug’s effectiveness. In response to a question about whether it was reasonable to consider data from one positive study as the primary evidence of aducanumab’s effectiveness for the treatment of early Alzheimer’s disease, none of the committee members voted yes; ten voted no and one was uncertain.

The committee’s opinions were then left with the FDA as the agency mulled whether to approve the drug or pump the brakes.

“In all studies in which it was evaluated, however, Aduhelm consistently and very convincingly reduced the level of amyloid plaques in the brain in a dose- and time-dependent fashion,” Cavazzoni said on Monday. “It is expected that the reduction in amyloid plaque will result in a reduction in clinical decline.”

The pharmaceutical company Biogen and its Japanese partner Eisai developed aducanumab—administered through intravenous infusion to treat early Alzheimer’s disease. The drug was developed for patients with mild cognitive impairment, not severe dementia.

Dr. Richard Isaacson, director of the Alzheimer’s Prevention Clinic at Weill Cornell Medicine and NewYork-Presbyterian in New York, who had patients in the original aducanumab clinical studies, told CNN the drug targets the earliest symptomatic phase of the disease, called mild cognitive impairment due to Alzheimer’s. Treatment of the pre-dementia period was the focus of the FDA’s decision.

“We have to really temper expectations and explain to people that this drug is meant for the earliest symptomatic phases,” he said. “It pains me to say this, but if I have a severe Alzheimer’s patient that can no longer speak or interact much with others and their family member is begging me to give them this drug, I won’t be able to do it.”

Some groups, including the nonprofit Public Citizen’s Health Research Group, argued that the FDA should not approve aducanumab for treatment of Alzheimer’s disease due to lack of evidence of its effectiveness.

There have also been concerns around cost: Biogen announced on Monday that the wholesale cost of treatment with aducanumab—which requires an infusion once every four weeks—is about $4,312 per infusion, making the annual cost around $56,000 for a high dose.

However, the participating companies said, “Biogen and Eisai are committed to providing access to ADUHELM for patients across a spectrum of financial situations,” the company noted in its announcement. “For qualified, commercially insured ADUHELM patients, co-pay and infusion cost assistance programs may reduce out-of-pocket costs to as low as $0. Patients who are covered by Medicare through a Medicare Advantage plan have a maximum annual out-of-pocket cap.”

In May, the Institute for Clinical and Economic Review released a draft report estimating that the drug should cost between $2,560 to $8,290 per year, and noted that “the evidence is insufficient to conclude that the clinical benefits of aducanumab outweigh its harms or, indeed, that it reduces progression” of Alzheimer’s disease.

Other organizations, such as the Alzheimer’s Association, have supported approval of the drug.

“This approval is a victory for people living with Alzheimer’s and their families,” Harry Johns, the association’s president and CEO, said in a post on Twitter on Monday.

Research contact: @CNN

Chlorophyll water is all over TikTok. But is it actually good for you?

My 13, 2021

Chlorophyll water has been gaining popularity since 2016, when celebrities began touting its health and beauty benefits. Now, TikTokers are claiming in viral videos that it can help treat acne and inflamed skin, reduce body odor, prevent cancer, and support gut health, HuffPost reports.

The most popular TikToks―which have garnered 1.5 million to 2 million “likes” to date―promote chlorophyll water’s transformative effects on the skin. In the videos, TikTokers show their skin’s progress over time and advise adding liquid chlorophyll drops to water rather than applying chlorophyll topically or swallowing a chlorophyll pill.

“Drinking liquid chlorophyll seems to hit on people’s intuitions about naturalness and purity, because you are taking water and adding something that comes from plants, which are instinctively viewed as pure,” noted Andrew Shtulman, a professor of Psychology at Occidental College in Los Angeles.

It is also easier to swallow chlorophyll than, say, cook green vegetables or exercise. After all, these health-boosting activities “take more effort, or we might not have the resources to purchase the materials or access to a space where we need to do them,” Shtulman said.

That said, HuffPost cautions, don’t expect it to be the cure TikTok users are making it sound. Like most things related to your well-being, there isn’t one magical solution or a quick fix. Here’s what to know:

First, it is important to remember that dietary supplements are not regulated or required to undergo Food and Drug Administration approval, said Judy Simon, a registered dietitian and nutritionist and adjunct faculty member at the University of Washington.

“Anyone can make all kinds of claims about chlorophyll supplements,” said Simon, so approach cautiously when you see them on your TikTok “For You” page.

To assess the true effectiveness of liquid chlorophyll, you need to look at chlorophyllin, a semi-synthetic form of chlorophyll found in liquid chlorophyll that is different from the natural version contained in plants, Simon said. This form allows it to be mixed into water and dissolve well.

However, HuffPost reports,the limited number of human studies on chlorophyllin’s effect on skin focus on topical application, as opposed to ingestion, and these studies involve only 10 people or fewer.

Board-certified dermatologist Joyce Park emphasized that better research is needed to uncover the benefits of using topical or liquid chlorophyll supplements.

While she did note that chlorophyll may hold potential benefits for the skin because “its antioxidant properties help with anti-aging and it also has anti-inflammatory properties to help treat acne,” the research remains limited.

Ultimately, Park advised against relying on chlorophyll as your sole antioxidant or acne treatment. And you can reap the benefits of natural chlorophyll by eating green vegetables, drinking matcha, or consuming spirulina, Simon said.

Existing studies are still inconclusive when it comes to drinking liquid chlorophyll for other health reasons. Some viral videos claim it can do everything from reduce body odor to prevent types of cancer, but there’s no solid evidence to suggest this is true.

A single study on mice did find that drinking chlorophyllin mixed with water may regulate the gut microbiome. But Simon said this doesn’t provide enough evidence for her to recommend it to her clients to boost their gut health.

After drinking chlorophyll water, you may experience side effects such as diarrhea or green-colored stools. Some experience an allergic reaction or have stomach cramps, prompting some people to seek medical help.

Drinking chlorophyll water isn’t likely to damage your skin, Park said. But it is still unclear whether chlorophyllin has other adverse impacts on your body when you use it long-term, since the only safety data that currently exists is for taking 300 milligrams daily for up to three months, Simon said.

And for those who are pregnant or breastfeeding, safety data does not yet exist, Simon said. If you fall into one of these groups, your doctor will likely advise you to avoid drinking chlorophyllin during these periods.

You also may be advised to avoid it if you take medications that increase your sensitivity to sunlight, like some antidepressants or blood pressure medication, as chlorophyllin can increase your chances of sunburn.

Research contact: @HuffPost

Pfizer’s new at-home pill to treat COVID could be available by the end of this year

April 28, 2021

Pfizer’s experimental oral drug to treat COVID-19 at the first sign of illness could be available by the end of the year, CEO Albert Bourla told CNBC on Tuesday, April 27.

In March, the company—which developed the first FDA-authorized COVID-19 vaccine in the United States in cooperation with German drugmaker BioNTech—began an early-stage clinical trial testing a new antiviral therapy for COVID. The drug is part of a class of medicines called protease inhibitors and works by inhibiting an enzyme that the virus needs to replicate in human cells.

Protease inhibitors are used to treat other viral pathogens, such as HIV and hepatitis C.

If clinical trials go well and the Food and Drug Administration approves it, the drug could be distributed nationwide by year-end, Bourla told CNBC’s “Squawk Box.”

Health experts say the drug, taken by mouth, could be a gamechanger because people newly infected with the virus could use it outside of hospitals. Researchers hope the medication will keep the disease from progressing and prevent hospital trips.

In addition to the drug, Pfizer is still testing its vaccine in 6-month to 11-year-old children. Vaccinating children is crucial to ending the pandemic, public health officials and infectious disease experts say.

Earlier this month, the company asked the FDA to expand its vaccine authorization to adolescents ages 12 to 15 after the shot was found to be 100% effective in a study.

Bourla told CNBC on Tuesday he is “very optimistic” that the FDA will approve the use of the shot in adolescents.

Research contact: @CNBC

Johnson & Johnson COVID-19 vaccine pause likely to last only a few days

April 14, 2021

On Tuesday morning, federal officials said they expected the recommended pause in administration of the Johnson & Johnson COVID-19 vaccine to last only a few day—and said it should not impact the United States’ vaccination goals, Roll Call reports.

The Food and Drug Administration and the Centers for Disease Control and Prevention announced early on March 13 that the they were recommending a pause in Johnson & Johnson COVID-19 vaccinations after six female patients out of the 6.8 million Americans who had received the vaccine to date reported the development of a rare type of blood clot six to 13 days after vaccination. The women were between the ages of 18 and 48.

The Director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, told reporters on a call that the pause is necessary to educate providers about the type of blood clot caused by the Johnson & Johnson vaccine, called a cerebral venous sinus thrombosis.

Standard blood clot treatment does not work for this type of clot, which, according to Johns Hopkins Medicine, occurs in the brain’s venous sinuses. Such a clot prevents blood from draining out of the brain. As a result, blood cells may break and leak blood into the brain tissues, forming a hemorrhage—and leading tio a life-threatening stroke.

The experts warn that, if the standard course of treatment is followed for a cerebral venous sinus thrombosis, it could cause further harm or even be fatal, Roll Call reports.

Marks said there is no known link to birth control or contraceptives. The only hypothesis health officials mentioned is that the adenovirus vaccine creates an extreme immune reaction in some people that causes platelet clots.

The CDC’s Vaccine Advisory Committee on Immunization Practices is set to meet on Wednesday, March 14, to review these cases and discuss the potential significance.

CDC Principal Deputy Director Anne Schuchat told reporters that anyone who was vaccinated with this one-shot vaccine a month ago or more should not worry. But anyone who received the Johnson & Johnson coronavirus vaccine in the past few weeks should watch for symptoms including severe headaches, leg pain, or abdominal pain that differs from typical post-vaccination symptoms.

Acting FDA Commissioner Janet Woodcock said these reactions are extremely rare and should not deter Americans from getting vaccinated for COVID-19. The pause is due to regular safety monitoring, she said.

“The message to patients who haven’t been vaccinated is to continue to get vaccines that may still be available to them,” Woodcock said.

White House COVID-19 Response Coordinator Jeff Zients told reporters the delay would not have a significant impact on the U.S. vaccination plan. The one-shot vaccines from Johnson & Johnson make up less than 5% of recorded shots in arms to date.

The U.S. has secured enough doses of the COVID-19 vaccines from Moderna and Pfizer to continue vaccinating 3 million people per day, Zients said. States and the federal government plan to work quickly to get anyone scheduled for a Johnson & Johnson vaccine rescheduled for a two-dose shot by Moderna or Pfizer.

The pause will immediately impact the places that receive vaccines directly from the federal government: retail pharmacies, community vaccination clinics, mobile vaccinations units and FEMA-run sites.

The move could shutter some mass vaccination sites. The Federal Emergency Management Agency said it is working with states to find other vaccines.

“FEMA is committed to helping the President’s goal to ensure everyone who wants to be vaccinated can be. In alignment with the Centers for Disease Control and Prevention and Food and Drug Administration’s recommendation to pause the use of the Johnson & Johnson vaccine, effective immediately FEMA will stop administering this vaccine at our pilot Community Vaccination Clinics, as well as via our Mobile Vaccine Units,” said Acting Administrator Bob Fenton in an emailed statement. “We are working with our state partners to determine the path forward and find alternative vaccine options for these sites.”

Georgia, North Carolina, and Colorado have reportedly shut vaccination sites because of adverse events experienced by people receiving the Johnson & Johnson vaccine.

Several states—including Maryland, New York, and Ohio—confirmed Tuesday morning that they would pause administering the vaccine.

Research contact: @rollcall

Waste is a terrible thing to waste: Ikea’s glossy (and free) new cookbook puts food scraps on the menu

April 6, 2021

Summery corncob soup, ‘plantcakes’ made with broccoli and carrot greens, and corn husk smoked chicken with fried corn silk are just a few of the inventive recipes in Ikea’s “The Scraps Book”—a cookbook dedicated to food preparation with the little things we usually throw away, The Chicago Tribune reports.

The Swedish home design brand collaborated with ten renowned chefs to address food waste and to show how easy it is to use food scraps like kale stems, banana peels and spent coffee grounds to create show-stopping meals. The beautifully designed ebook is full of stunning food photos of the 50 easy-to-follow recipes, along with tips like how to build your own backyard compost.

According to a Food and Drug Administration report, food waste is estimated at between 30% and 40% of the food supply in the United States, and the report lists wasted food as the single largest category of material placed in municipal landfills.

In 2016, the Department of Agriculture and Environmental Protection Agency announced the formation of the U.S. Food Loss and Waste 2030 Champions group and set a goal of reducing food waste by 50% by the year 2030, the Tribune notes.

.“ScrapsBook” is free for download at Apple Books, Google Play, and Ikea.com. The eBook is available to everyone, and Ikea Family members will be automatically entered to win a limited edition hardcover copy of the 214-page book. As Ikea says, “Waste is a terrible thing to waste”

Research contact: @chicagotribune

GlaxoSmithKline requests emergency authorization from FDA for COVID monoclonal antibody drug

March 29, 2021

On Friday, March 26, GlaxoSmithKline and Vir Biotechnology  applied for an emergency use authorization from the Food and Drug Administration for their monoclonal antibody drug, CNBC reports.

The companies are requesting clearance for use by high-risk patients, age 12 and older.

The FDA submission is based on an interim analysis of a phase three trial that evaluated the drug for the early treatment of COVID-19 in adults at high risk of hospitalization. The drug reduced hospitalizations or death from COVID by 85% compared with a placebo. The trial results were based on 583 patients.

“As a result, the Independent Data Monitoring Committee recommended that the trial be stopped for enrolment due to evidence of profound efficacy,” the companies said in a statement.

The companies started testing the antibody on early-stage COVID patients in August, CNBC notes—hoping to keep symptoms from progressing. Antibody drugs gained attention after they were used to treat former President Donald Trump last year.

U.S. health officials say antibody drugs already authorized for use—from Regeneron and Eli Lilly—are being underutilized.

GSK said the companies will also continue discussions with the European Medicines Agency and other global regulators to make the drug available to COVID patients as soon as possible.

Research contact: @CNBC

Pfizer asks FDA to approve ‘not-so-cold storage’ for its vaccine

February 22, 2021

Pfizer announced on February 19 that  it is seeking permission from the Food and Drug Administration to store its COVID-19 vaccine for two weeks at temperatures that still are extremely cold, but that are commonly found in pharmaceutical freezers and refrigerators, CNBC reports.

The vaccine, which was developed with German drugmaker BioNTech, currently needs to be stored in ultra-cold freezers that keep it between minus 112 and minus 76 degrees Fahrenheit, according to the FDA.

Pfizer said it submitted new data to the U.S. agency that demonstrates that the vaccine is stable at between minus 13 and minus 5 degrees Fahrenheit, according to CNBC.

If the FDA grants the request, it could simplify logistics for distribution of the vaccine. U.S. federal and state officials are trying to pick up the pace of vaccinations as the virus spreads.

“We have been continuously performing stability studies to support the production of the vaccine at commercial scale, with the goal of making the vaccine as accessible as possible for healthcare providers and people across the [nation] and around the world,” Pfizer CEO Albert Bourla said in a release. “If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply.”

Medical experts had warned that Pfizer’s vaccine would present logistical challenges because of the need for ultracold temperatures. In December, U.S. officials said they quarantined several thousand doses in California and Alabama after an “anomaly” in the transportation process caused the storage temperature to get too cold, CNBC notes.

The vaccine is shipped in a special thermal container that can be used as temporary storage for up to 30 days , if it is refilled with dry ice every five days. Before mixing with a saline diluent, the vaccine also may be refrigerated for up to five days at standard refrigerator temperature, between 36 degrees and 46 degrees Fahrenheit, according to the company.

By comparison, Moderna’s vaccine needs to be shipped at between minus 13 and minus 5 degrees Fahrenheit. It has said its vaccine remains stable at 36 to 46 degrees Fahrenheit, the temperature of a standard home or medical refrigerator, for up to 30 days. It can be stored for six months at minus 4 degrees Fahrenheit.

Johnson & Johnson’s vaccine, which is expected to be authorized for emergency use by the FDA as early as this month, has said it plans to ship its vaccine at 36 to 46 degrees Fahrenheit.

As additional stability data is obtained, Pfizer said it anticipates the shelf life could be extended, and alternate short-term temperature storage may be considered.

Research contact: @CNBC

 

Trump and friends got ‘special treatment’—COVID care that many Americans cannot access

December 11, 2020

HUD Secretary Ben Carson, former New Jersey Governor Chris Christie, and President Donald Trump are not the strongest candidates to survive the coronavirus: They are older, in some cases overweight, male, and not particularly fit. Yet all seem to have come through COVID-19—thanks to access to an antibody treatment that is in such short supply that some hospitals and states are doling it out by lottery, The New York Times reports.

Now RudyGiuliani, the latest member of President Trump’s inner circle to contract the coronavrius, has acknowledged that he received at least two of the same drugs the president received. He even conceded that his “celebrity” status had given him access to care that others did not have.

“If it wasn’t me, I wouldn’t have been put in a hospital frankly,” Giuliani, the president’s personal lawyer, told WABC radio in New York. “Sometimes when you’re a celebrity, they’re worried if something happens to you they’re going to examine it more carefully, and do everything right.”

According to the Times report, Giuliani’s candid admission once again exposes that COVID-19 has become a disease of the haves and the have-nots. The treatment given to President Trump’s allies is raising alarms among medical ethicists as state officials and health system administrators grapple with gut-wrenching decisions about which patients get antibodies in a system that can only be described as rationing.

We should not have Chris Christie and Ben Carson—and in the case of Carson, with intervention by the president—get access,” said Arthur Caplan, a medical ethicist who works with drug companies on how to ration scarce medicines, referring to the secretary of housing and urban development’s admission that the president “cleared” him for the therapy. “That is not the way to secure public support for difficult rationing systems.”

The treatments — a monoclonal antibody developed by Eli Lilly and a cocktail of two monoclonal antibodies developed by Regeneron — won emergency use authorization, or an E.U.A., from the Food and Drug Administration last month for outpatients with “mild to moderate” disease who are at high risk for progressing to severe disease or for being hospitalized.

With cases soaring, the pool of potential patients is vast.

“One of the challenges is the E.U.A. criteria really are so broad, it could be half of the people with COVID could qualify, but there is clearly not enough,” Erin Fox, the senior pharmacy director for University of Utah Health, who has helped her state draft criteria to determine who is eligible for the drugs, told the Times. “Unfortunately, that leaves each hospital or each state to develop their own rationing criteria.”

Even some top officials at the F.D.A —both career employees and political appointee —have privately expressed concern in recent months that people with connections to the White House appeared to be getting access to the antibody treatments, according to three senior administration officials.

Giuliani, 76, appeared unaware of the scarcity issues, telling interviewers that politicians have taken masks and business closures too far now that COVID-19 is “a treatable disease.”

Research contact: @nytimes

The buddy system: Provider of Trump COVID drug is president’s golf pal

October 11, 2020

New questions have emerged over the circumstances under which Donald Trump was prescribed an experimental antibody drug cocktail to treat his coronavirus infection now that the public knows that the source of the pharmaceuticals was the president’s golfing buddy.

As Trump wrongly hailed his treatment–which included a drug called REGN-COV2 produced by Tarrytown, New York-based Regeneron—as a “cure”, it emerged that the company’s CEO Leonard Schleifer  is a member of the Trump National Golf Club in Westchester County, New York, and had met the president in May to talk about drugs his company was developing The Guardian reports.

REGN-COV2 is a combination of two monoclonal antibodies designed to both treat people with coronavirus and to prevent Sars-CoV-2 infection. The antibodies are designed to prevent the coronavirus spike protein from attaching to Ace2 receptors in the body–the path the virus uses to infect people.

While some ethicists have defended Trump’s privileged access as president to experimental treatments, others have suggested it raises questions of fairness among other concerns, including his history of touting unproven treatments.

Trump’s relationship with Schleifer, whom he reportedly calls “Lenny,” adds to growing questions over the president’s almost exclusive access to experimental treatments unavailable to most other Americans, even as he has continued to downplay the threat of coronavirus based on his own experience.

The price of Regeneron stocks–which Trump has owned in the past–soared after it was revealed the drug had been made available for his treatment and Trump stated it would be made freely available for all, although he didn’t explain how.

“I call that a cure,” Trump said in a video, adding that everyone should have access to the not-yet-approved drug and that he would make sure it was in every hospital as soon as possible.

Trump’s comments were quickly criticized by doctors treating patients on the frontline of the COVID-19 pandemic in the United States.

Frankly, he is an anecdote, and he is an anecdote meaning he is one person who took this drug, but he has also taken dexamethasone,” said ER professional Dr Rob Davidson, who works in west Michigan, on Twitter.

Davidson added in his interview with the Guardian that Dexamethasone (a corticosteroid that prevents the release of substances in the body that cause inflammation) “makes you feel like a million bucks, it makes you feel like you’re on top of the world”.

He concluded: “Do everything the opposite of what this administration is telling you.”

After the president’s comments, Regeneron announced it had applied to the Food and Drug Administration (FDA) for an emergency use authorization.

“There are doses available for approximately 50,000 patients, and we expect to have doses available for 300,000 patients in total within the next few months,” the company said in a statement.

However, America is seeing more than 50,000 new cases of Covid-19 each day. Further, monoclonal antibody therapies are notoriously difficult to produce and expensive. The median cost of monoclonal antibody therapies approved over the last 20 years is more than $96,000 per treatment course.

Regeneron’s therapy has only been tested in 275 people, in a promising study that some scientists nevertheless said, “doesn’t cut it” for emergency use authorization.

The drug has also stirred debate because of how it was developed, The Guardian notes–using an “immortalized” cell line originally derived from an elective abortion in the Netherlands in the 1970s—a common process that the Trump administration opposes.

Republicans opposes embryonic stem cell research, according to the party platform.

The White House doctor, Sean Conley, said Trump had been given a single 8g dose that was made available under a compassionate use clause. Compassionate use requests are decided on a case-by-case basis—and both the drug company and the FDA must agree.

The Regeneron spokeswoman Alexandra Bowie said fewer than 10 of these requests had been granted, and with the drug in limited supply the priority was to use it in ongoing studies. Emergency access was granted “only in rare and exceptional circumstances”, she said.

Regeneron also contacted the Democratic presidential candidate, Joe Biden, to alert him to the availability of the drug under the compassionate use rule.

Alison Bateman-House, an ethicist at New York University Langone Health, told The Guardian that Regeneron’s overture to Biden should raise concerns.

“That crosses lines of appearing to promote a potentially unapproved product,” she told Associated Press, which would violate FDA rules. Rather than directing people to enrol in studies, she said it suggested that “we’ll cut the line for you”.

New questions have emerged over the circumstances under which Donald Trump was prescribed n experimental antibody drug cocktail to treat his coronavirus infection now that the public knows that the source of the pharmaceuticals was the president’s golfing buddy.

As Trump wrongly hailed his treatment–which included a drug called REGN-COV2 produced by Tarrytown, New York-based Regeneron—as a “cure”, it emerged that the company’s CEO Leonard Schleifer  is a member of the Trump National Golf Club in Westchester County, New York, and had met the president in May to talk about drugs his company was developing The Guardian reports.

REGN-COV2 is a combination of two monoclonal antibodies designed to both treat people with coronavirus and to prevent Sars-CoV-2 infection. The antibodies are designed to prevent the coronavirus spike protein from attaching to Ace2 receptors in the body–the path the virus uses to infect people.

While some ethicists have defended Trump’s privileged access as president to experimental treatments, others have suggested it raises questions of fairness among other concerns, including his history of touting unproven treatments.

Trump’s relationship with Schleifer, whom he reportedly calls “Lenny,” adds to growing questions over the president’s almost exclusive access to experimental treatments unavailable to most other Americans, even as he has continued to downplay the threat of coronavirus based on his own experience.

The price of Regeneron stocks–which Trump has owned in the past–soared after it was revealed the drug had been made available for his treatment and Trump stated it would be made freely available for all, although he didn’t explain how.

“I call that a cure,” Trump said in a video, adding that everyone should have access to the not-yet-approved drug and that he would make sure it was in every hospital as soon as possible.

Trump’s comments were quickly criticized by doctors treating patients on the frontline of the COVID-19 pandemic in the United States.

Frankly, he is an anecdote, and he is an anecdote meaning he is one person who took this drug, but he has also taken dexamethasone,” said ER professional Dr Rob Davidson, who works in west Michigan, on Twitter.

Davidson added in his interview with the Guardian that Dexamethasone (a corticosteroid that prevents the release of substances in the body that cause inflammation) “makes you feel like a million bucks, it makes you feel like you’re on top of the world”.

He concluded: “Do everything the opposite of what this administration is telling you.”

After the president’s comments, Regeneron announced it had applied to the Food and Drug Administration (FDA) for an emergency use authorization.

“There are doses available for approximately 50,000 patients, and we expect to have doses available for 300,000 patients in total within the next few months,” the company said in a statement.

However, Americais seeing more than 50,000 new cases of Covid-19 EaCH day. Further, monoclonal antibody therapies are notoriously difficult to produce and expensive. The median cost of monoclonal antibody therapies approved over the last 20 years is more than $96,000 per treatment course.

Regeneron’s therapy has only been tested in 275 people, in a promising study that some scientists nevertheless said, “doesn’t cut it” for emergency use authorization.

The drug has also stirred debate because of how it was developed, The Guardian notes–using an “immortalized” cell line originally derived from an elective abortion in the Netherlands in the 1970s—a common process that the Trump administration opposes.

Republicans opposes embryonic stem cell research, according to the party platform.

The White House doctor, Sean Conley, said Trump had been given a single 8g dose that was made available under a compassionate use clause. Compassionate use requests are decided on a case-by-case basis—and both the drug company and the FDA must agree.

The Regeneron spokeswoman Alexandra Bowie said fewer than 10 of these requests had been granted, and with the drug in limited supply the priority was to use it in ongoing studies. Emergency access was granted “only in rare and exceptional circumstances”, she said.

Regeneron also contacted the Democratic presidential candidate, Joe Biden, to alert him to the availability of the drug under the compassionate use rule.

Alison Bateman-House, an ethicist at New York University Langone Health, told The Guardian that Regeneron’s overture to Biden should raise concerns.

“That crosses lines of appearing to promote a potentially unapproved product,” she told Associated Press, which would violate FDA rules. Rather than directing people to enrol in studies, she said it suggested that “we’ll cut the line for you”.

Research contact: @GuardianUS

Roll Call exclusive: States plan to independently vet COVID-19 vaccine data

September 18, 2020

Governors, including New York’s Andrew Cuomo, are publicly raising doubts about the FDA’s and the CDC’s ability to withstand pressure from President Donald Trump to develop a coronavirus vaccine at warp speed, Roll Call reported exclusively on September 17.

Those same officials are expressing skepticism about federal reviews of potential COVID-19 vaccines—with some going so far as to plan to independently analyze clinical trial data before distributing a vaccine, in a sign of how sharply trust in federal health agencies has fallen this year.

The wariness—which public health experts call highly unusual if not unprecedented—could undercut the goal of a cohesive national immunization strategy and create a patchwork of efforts that may sabotage hopes of containing the coronavirus.

State plans to review the data indicate how deeply any appearance of political meddling could disrupt vaccination and cost lives Roll Call says.

And it’s not a surprise that some red states appear more likely to rely on the Trump Administration, while blue states may scour the data and be more cautious about vaccinating their residents immediately.

CQ Roll Call contacted state health departments in 50 states and the District of Columbia and received substantive responses from a dozen:

  • Seven jurisdictions indicated that they would analyze the data independently: California, Colorado, the District of Columbia, Michigan, New York, Oregon and West Virginia.
  • Another two—Montana and Wyoming—said they would only administer a vaccine that completed clinical trials and an outside committee’s review.
  • Three states —Arizona, Georgia and Oklahoma— indicated they would accept federal recommendations as usual.

 “The president says he’s going to have a vaccine. CDC is talking about a vaccine in early November. How convenient. It’s going to be an Election Day miracle drug,” New York Gov. Andrew Cuomo, a Democrat, said earlier this month.

Cuomo referenced the FDA’s emergency use authorization earlier this year of a drug touted by Trump, hydroxychloroquine, which the agency later withdrew after finding the drug was not effective against COVID-19 and could lead to dangerous heart conditions. “Some people are concerned that the vaccine may wind up being hydroxychloroquine,” he said, adding that the state health department will review the research before recommending that New Yorkers take any vaccine.

Nearly 200,000 Americans have died of COVID-19, according to the Johns Hopkins University School of Medicine.

Research contact: @rollcall