Ahead of President Donald Trump's Monday discharge from the care of Walter Reed Medical Center, where hehad been treated forthree days for symptoms of COVID-19, came atweet.
"Don't be afraid of Covid," the presidentclaimed, inpart because the country had developed "some really great drugs."
However, the president himself who once suggested injecting household disinfectants to treat the deadly disease had just become one of thefirst 10 patients granted anextraordinarily rare level of access toan experimental antibody infusion to combathis COVID-19 infection, Salon hasconfirmed.
The treatment, a cocktail of human antibodies and anti-bodies cloned from stem cells, was manufactured by Regeneron. The pharmaceutical company onlyannouncedthe results of a phase 1/2/3 trial onSept. 29, or two days before the president tested positive. The treatment, which is still pending approval from the Food and Drug Administration,proved most effective for patients with weak immune systems.
Hours afterreceiving the treatment on Friday, Trump was flown from the White House to Walter Reed Medical Center. The White House saidat the time that the president had"mild symptoms." Trump's personal physician, Dr. Sean Conley, later acknowledged that he exhibited low oxygen levels and a fever.
But Conley would not disclose the results of Trump's lung scans, only saying they showed "expected findings." Experts noted that Conley did not say the president's lungs appeared healthy,leaving open the possibility ofinflammation or pneumonia.
Trump returned to the executive mansion three days later. After a balcony photo-op appearance, during which time his breathing appeared labored, the president remains at 1600 Pennsylvania Ave. Conley says Trump reports no symptoms medically different from "showing signs," which are noticed and reported by an attending physician.
After his experience at Walter Reed, Trump declared that Americans should not let the coronavirus, which has killed more than 210,000 people in the U.S. over the last seven months, "dominate your life."
Outside of clinical trials, almost no American has access to the treatments which were available to the president.The Food and Drug Administration limits compassionate use ("expanded access")to patients with "animmediately life-threatening condition or serious disease or condition" when "no comparable or satisfactory" alternativesare available.
Patients often wait for approval, which can includean involved review and regulatory processbetween the patient, the physician, the pharmaceutical company and the government. Typically, companies grant compassionate use free of charge, but other monoclonal antibodies currently on the market cost thousands of dollars.
"All we can say is that they asked to be able to use it, and we were happy to oblige," RegeneronCEO Dr. Leonard Schleifer toldThe New York Times. Though Trump was not the first patientgranted expanded access to the drug, Schleifer said, "When it's the president of the United States, of course, that gets obviously gets our attention."
"Presidential medicine is and has been unique," Arthur L. Caplan, professor of medical ethics at the N.Y.U. Grossman School of Medicine, toldThe Times. "If his doctors think an intervention might be helpful, and if that judgment is confirmed by outside experts they talk to and if things look dire or serious, then the president will get access to any and all agents."
Schleiferhas been a member atTrump's Westchester, N.Y., golf club,and his companytook$450 million in federalfunding this summer from Operation Warp Speed, which is the administration's moonshot projectto fast-trackCOVID-19 vaccines andtreatments, according toCNN Business.
"Len and President Trump are acquaintances from both living in the Westchester area for many years but didn't have any regular contact until this year, when they've discussed matters around COVID on occasion," a Regeneron spokesperson told CNN Business.
Schleifer is an active political donor, who predominantly gives to Democratic candidates. In 2016, Schleifergave more than $55,000 to committees supporting Hillary Clinton, but he has not yet donated to Democratic nominee Joe Biden, per FEC records. Hisson, Adam,lost a Democratic primary bid this summer for New York's 17th Congressional District.
"We don't share details on who has/hasn't submitted a compassionate use request, but as we've stated, only a small number of these requests have been approved forrareand exceptional circumstances, and that will continue to be the case," a Regeneron spokesperson told Salon in an email.
The spokesperson said the company was notaware of any side effectsoccurring in compassionate use cases and referred Salon to the FDA. The FDA did not reply to Salon's requests for comment.
In order to qualify for compassionate use, the FDA says, patients must meet a number of requirements: the disease or condition must be seriousor "immediately" life-threatening;there can be "no comparable or satisfactory alternative therapy to diagnose, monitoror treat the disease or condition"; clinical trials must be out of the question; potential benefitsmust justifypotential risks; and the treatment must not interfere with clinicaltrials that could supportproductdevelopment "or marketing approval for the treatment indication."
Given its extremely limited supply, Schleifer told CNBC that the international headlines put his company in a "very tough situation."
"Giving it to [Trump] or to others who might not be able or don't qualify for clinical trials is the right use of compassionate use. That's for small numbers of people, for these exceptions,"he said. "We want everybody to be potentially able to benefit. We understand we don't make that decision. This is a decision the FDA has to make."
Through no fault of Regeneron's own, however, the company may have harnessed one of the most powerful marketing platforms on the planet Trump's Twitter feed.
"They gave me Regeneron. It's called Regeneron," the president said in a Wednesday video published tohis feed, erroneouslynaming the drug company instead of its treatment."And other things, too. But I think this was the key. But they gave me Regeneron. And it was,like, unbelievable. I felt good immediately."
Trump claimed that he had "authorized" the treatment.However,it wasunclear what steps, if any, had been taken to expand its availabilityto more Americans.
Here is the original post:
- Signal of Benefit for Stem Cell Therapy in Progressive MS - Medscape - March 7th, 2024
- The Controversies Surrounding Stem Cell Therapy for Autism - The Portugal News - February 24th, 2024
- Benefits of Stem Cell Therapy - News Channel 5 Nashville - February 7th, 2024
- What is Stem Cell Therapy & How It Helps Others - Publicist Paper - January 31st, 2024
- A guide to stem cell therapy in Thailand - Thaiger - January 4th, 2024
- Half of pediatric patients with aHUS benefit from Soliris after... - AHUS News - December 21st, 2023
- Real world analysis on the determinants of survival in primary ... - Nature.com - December 5th, 2023
- The Best Beauty Gifts According To People Who Really Know Skin Care - HuffPost - December 5th, 2023
- The Eyepopping Factory Construction Boom in the US - WOLF STREET - December 3rd, 2023
- Benefit of Neoadjuvant Therapy Illustrated During ESMO Congress ... - Targeted Oncology - December 1st, 2023
- Benefits Outweigh Risks as FDA Inspects CAR-T Cell Therapy ... - Curetoday.com - December 1st, 2023
- Review What Real Cavityn Customers Say About Benefits and Side ... - Seattle Weekly - December 1st, 2023
- 'There is a Scientific Fraud Epidemic' - Slashdot - Slashdot - December 1st, 2023
- 15 Best Hydrating Serums to Soothe Any Skin Type 2023 - Town & Country - December 1st, 2023
- Innovations in Cosmetic Dermatology: A Glimpse into the Future - APN News - December 1st, 2023
- FDA Probes New Cases of Cancer That May Stem From Cancer Cell ... - MedCity News - November 29th, 2023
- Use of plant stem cells in topical formulations on the rise - CosmeticsDesign.com USA - November 29th, 2023
- Stem cell-based treatment controls blood sugar in people with Type ... - EurekAlert - November 29th, 2023
- Biologics Market is projected to grow at a CAGR of 8.5% by 2034: Visiongain - Yahoo Finance - November 29th, 2023
- Scientists devise new technique that can pinpoint the causes and ... - EurekAlert - November 29th, 2023
- Global Advanced Therapy Medicinal Products Market is on the brink ... - PharmiWeb.com - November 29th, 2023
- Introducing Orgavalue - The 2023 EIT InnoStars Awards winner - EU-Startups - November 29th, 2023
- Episode 160: Euan Ashley discusses precision medicine and the ... - IHMC - November 29th, 2023
- Is Phenq Right For You? Review The Facts Before Making a ... - Vashon-Maury Island Beachcomber - November 27th, 2023
- Cavityn Reviews - Does It Work? Cheap Scam or Effective ... - The Daily World - November 25th, 2023
- Trend Hunting With Beautystreams At Cosmoprof Asia 2023 - BeautyMatter - November 25th, 2023
- FDA Considers First CRISPR Gene Editing Treatment That May ... - Slashdot - November 25th, 2023
- How Do Plants Determine Where the Light Is Coming From? - Lab Manager Magazine - November 25th, 2023
- Deaths From Coal Pollution Have Dropped, But Emissions May be ... - Slashdot - November 25th, 2023
- Stem cell-based therapies for stroke in newborns - Cochrane - November 23rd, 2023
- Dr Leslie on Outpatient CAR T-Cell Therapy Programs for ... - OncLive - November 23rd, 2023
- Human Milk-Based Therapy May Be Beneficial in Blood Cancers - Curetoday.com - November 23rd, 2023
- Oncological Horizons: The Synergy of Medical and Surgical ... - Cureus - November 23rd, 2023
- Human and environmental safety of carbon nanotubes across their ... - Nature.com - November 23rd, 2023
- Immix Biopharma to Host KOL Event to Discuss its BCMA-Targeted ... - BioSpace - November 23rd, 2023
- #HearTheMarsdenKids call on NHS London to reconsider cancer ... - Metro.co.uk - November 23rd, 2023
- Diagnosis and Management of Cardiovascular Risk in Patients with ... - Dove Medical Press - November 23rd, 2023
- BioLineRx Reports Third Quarter 2023 Financial Results and ... - PR Newswire - November 21st, 2023
- Why our Award Winners Beauty Box is the ultimate beauty gift (for ... - Yahoo Singapore News - November 21st, 2023
- SightCare Reviews - Is Official Website for Sight Care Legit to Try or ... - Vashon-Maury Island Beachcomber - November 21st, 2023
- Legend Biotech Reports Third Quarter 2023 Results and Recent ... - StreetInsider.com - November 21st, 2023
- Lorenzo's Oil: Can It Really Treat ALD? - Verywell Health - November 19th, 2023
- Doctor Says Living To 120 By End Of Decade Is Possible What's the Secret? - Benzinga - November 19th, 2023
- The week in pharma: action, reaction and insight week to ... - The Pharma Letter - November 19th, 2023
- Race Cannot Be Used To Predict Heart Disease, Scientists Say ... - Slashdot - November 19th, 2023
- SpaceX's Starship Reaches Outer Space Before Intentional ... - Slashdot - November 19th, 2023
- Mesenchymal Stem Cells Market is projected to reach USD 3,319 million by 2030 according to a new research r... - WhaTech Technology and Markets News - November 17th, 2023
- LMRUK: Protecting the next generation through cord blood - Charity Today News - November 17th, 2023
- Anti-aging molecule discovered that extends lifespan - Earth.com - November 17th, 2023
- Montana State researcher envisions living building materials that ... - Montana State University - November 17th, 2023
- OxyHelp Explores the Benefits of Hyperbaric Oxygen Therapy for ... - StreetInsider.com - November 15th, 2023
- Health benefits of bone marrow - Pakistan Observer - November 15th, 2023
- Evolving the standard of care: What is next for functional ... - NeuroNews International - November 15th, 2023
- Affimed Reports Third Quarter 2023 Financial Results and ... - BioSpace - November 15th, 2023
- Meet the World's First Whole-Eye Transplant Recipient - TIME - November 15th, 2023
- Calidi Biotherapeutics Reports Third Quarter 2023 Operating and ... - Business Wire - November 15th, 2023
- 10 Asia-Pacific biotech companies leading innovation in the region - Labiotech.eu - November 15th, 2023
- Fitspresso Reviews (November Update) Natural Ingredients That ... - Bainbridge Island Review - November 15th, 2023
- 2seventy bio Reports Third Quarter Financial Results and Recent ... - Business Wire - November 15th, 2023
- Japan To Create $6.6 Billion Fund To Develop Outer Space Industry ... - Slashdot - November 15th, 2023
- Be The Match, Healthcare Marketing Impact Awards 2023 - Ad Age - November 13th, 2023
- Medicare coverage saves lives. Enrolling shouldn't be this ... - Kevin MD - November 13th, 2023
- Future Ocean Foods: 36 Global Alt-Seafood Startups Form Association To Tackle Overfishing, Microplastics & More - Green Queen Media - November 13th, 2023
- Orchard Therapeutics Reports Third Quarter 2023 Financial Results ... - StreetInsider.com - November 13th, 2023
- Celebrity doctor reveals Hollywoods hidden trend of stem cell antiaging therapies - Longevity.Technology - November 11th, 2023
- Amazon Expands Healthcare Push With One Medical Benefits For ... - Slashdot - November 11th, 2023
- Bene Meat Technologies becomes the first to receive EU approval ... - Pet Food Processing - November 11th, 2023
- FDA Grants Orphan Drug Designation to MAIA Biotechnology for THIO as a Treatment for Glioblastoma - Yahoo Finance - November 11th, 2023
- MaaT Pharma Provides Third Quarter 2023 Business Update and ... - Business Wire - November 11th, 2023
- IN8bio Reports Third Quarter 2023 Financial Results and Provides ... - GlobeNewswire - November 11th, 2023
- Fast Lean Pro Reviews - Overpriced or Optimal Ingredients That ... - Journal of the San Juan Islands - November 11th, 2023
- Fate Therapeutics Reports Third Quarter 2023 Financial Results and ... - GlobeNewswire - November 11th, 2023
- Worlds first whole-eye and partial face transplant gives Arkansas man new hope - CNN - November 9th, 2023
- Glowing Fingertips And Green Eyes: First-of-Its-Kind Monkey ... - ScienceAlert - November 9th, 2023
- 10 Natural Body Scrubs That Exfoliate And Invigorate My Skin - PINKVILLA - November 9th, 2023
- CRISPR Therapeutics Provides Business Update and Reports Third ... - StreetInsider.com - November 9th, 2023
- Fate Therapeutics Reports Third Quarter 2023 Financial Results and ... - StreetInsider.com - November 9th, 2023
- Sight Care Reviews - Overpriced or Worth the Hype? SightCare Pills ... - Journal of the San Juan Islands - November 9th, 2023
- 6 Amazing Health Benefits Of Giloy (Tinospora cordifolia) - WION - November 9th, 2023
- The Global Market for Bispecific Antibody Therapeutics Contract Manufacturing 2023-2030: Driven by Demand for Innovative Therapies and Promising... - November 7th, 2023
Recent Comments