OUT OF MIND
Would you like to react to this message? Create an account in a few clicks or log in to continue.
Latest topics
» “Putting up tens of millions of 5G antennas, without a single biological test of safety, has to be about the stupidest idea anyone has had in the history of the world”
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy EmptyYesterday at 12:35 pm by PurpleSkyz

» The “Great Zero Carbon” Conspiracy and the WEF’s “Great Reset”
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy EmptyYesterday at 11:58 am by PurpleSkyz

» The Most Perniciously Perfect Piece of Propaganda: The Covid Face Mask
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy EmptyYesterday at 11:55 am by PurpleSkyz

» How Do You Attract Rare Birds and Bees to Your Garden? Add Rare Plants
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy EmptyYesterday at 11:50 am by PurpleSkyz

» Spain Admits Spraying Deadly Chemtrails as Part of Secret UN Program: One Month after March 2020 Covid-19 Lockdown
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy EmptyYesterday at 11:41 am by PurpleSkyz

» Incoming Huge Solar Storms Could Destroy Many Satellites, U.S. Gov’t Scientist Warns
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy EmptySat Aug 13, 2022 11:27 am by PurpleSkyz

» Salman Rushdie Stabbed On Stage During Speech
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy EmptySat Aug 13, 2022 10:50 am by PurpleSkyz

» Uninformed Consent - Official Full Documentary Release - Watch Now!
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy EmptySat Aug 13, 2022 10:47 am by PurpleSkyz

» They weren’t supposed to find that
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy EmptySat Aug 13, 2022 10:42 am by PurpleSkyz

» CDC Drops Quarantine, Distancing Recommendations, as 1.3 Million COVID Vaccine Injuries Reported to VAERS
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy EmptySat Aug 13, 2022 10:30 am by PurpleSkyz

» EXCLUSIVE: Warrant and Property Receipt from Mar-a-Lago Raid
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy EmptySat Aug 13, 2022 10:27 am by PurpleSkyz

» Roger Waters Destroys CNN Host About Ukraine & Taiwan
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy EmptySat Aug 13, 2022 10:24 am by PurpleSkyz

» Judge Orders DOJ to Respond to Judicial Watch’s Motion to Unseal Mar-a-Lago Search Warrant Materials by 5p.m. EST on August 15
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy EmptyFri Aug 12, 2022 11:00 am by PurpleSkyz

» Crop Circles 2022 - Etchilhampton Hill (2), Nr Devizes, Wiltshire. Reported 8th August
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy EmptyFri Aug 12, 2022 10:50 am by PurpleSkyz

» Crop Circles 2022 - Woodborough Hill, Nr Alton Priors, Wiltshire. Reported 3rd August.
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy EmptyFri Aug 12, 2022 10:48 am by PurpleSkyz

» The Perseid Meteor Shower Will Peak This Week: Here's How to Watch!
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy EmptyFri Aug 12, 2022 10:39 am by PurpleSkyz

» Rainwater No Longer Safe to Drink Anywhere on Earth Due to Cancer-Causing Chemicals, Scientists Warn
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy EmptyFri Aug 12, 2022 10:20 am by PurpleSkyz

» Former College Football Coach Fired for Refusing COVID Vaccine Files $25 Million Claim Against Washington State
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy EmptyFri Aug 12, 2022 10:12 am by PurpleSkyz

» CDC Covid Guideline Update Finally Allows “Individuals” To Make Their Own Decisions
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy EmptyFri Aug 12, 2022 10:06 am by PurpleSkyz

» I Personally Approved The Decision To Seek A Search Warrant” The Internet Reacts To Garland Press Conference After Mar-a-Lago Raid
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy EmptyFri Aug 12, 2022 10:00 am by PurpleSkyz

» The hypocrisy of the Assange case
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy EmptyThu Aug 11, 2022 9:34 am by PurpleSkyz

» Is the Untested and Dangerous Monkeypox Vaccine About to get an EUA to Avoid Legal Liability for Deaths and Injuries?
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy EmptyThu Aug 11, 2022 9:28 am by PurpleSkyz

You are not connected. Please login or register

OUT OF MIND » BREAKING NEWS & HOT TOPICS » THE GREAT DIE OFF » FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy

FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy

Go down  Message [Page 1 of 1]

PurpleSkyz

PurpleSkyz
Admin

FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy



The U.S. Food and Drug Administration on Monday approved the use of the antiviral therapy, remdesivir, to treat COVID-19 in infants 4 weeks and older, despite having no evidence the treatment is effective or even safe for young children.

By 
  Madhava Setty, M.D.  

Link copied
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy FDA-Remdesivir-infants-feature-800x417


Miss a day, miss a lot. Subscribe to The Defender's Top News of the Day. It's free.
The U.S. Food and Drug Administration (FDA) on Monday approved the use of the antiviral therapy, remdesivir, to treat COVID-19 in infants four weeks and older.
Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a press release:
“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population.
“Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”
According to the press release, the FDA’s decision to approve the therapy, marketed under the name Veklury, is supported by a clinical study conducted on infants 4 weeks and older weighing a minimum of 6.6 pounds.
The study is underway and will not be completed until February 2023. There are no published results.
However, Gilead Sciences, maker of remdesivir and sponsor of the study, provided the following details in a company press release:
  • A total of 53 hospitalized pediatric patients were enrolled in the clinical study.
  • 72% suffered adverse events.
  • 21% suffered serious adverse events determined to be unrelated to the drug.
  • Three children died from either underlying conditions or COVID-19.

1 Million Copies Sold — ‘The Real Anthony Fauci’ — The book that launched a movement. BUY TODAY!  
Nevertheless, Gilead Science assured that “no new safety signals were apparent for patients treated with Veklury.”
The study was of single-arm, open-label design.
A [url=https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3059315/#:~:text=The simplest trial design is,time to observe their response.]single-arm[/url] study has no control group, making it impossible to compare its effectiveness against standard of care.
Open-label means participants and investigators were aware they were receiving the drug, making it impossible to separate placebo from drug effect.
Studies show little or no benefit
Beyond the absence of any publicly available data on the efficacy and safety of this drug in humans of this age, available studies on older subjects indicate remdesivir offers no more than a meager benefit to those who survive its use.
In fact, this is why the World Health Organization (WHO) in November 2020 recommended against the use of remdesivir to treat COVID-19. The WHO only recently (April 22, 2022) updated its recommendation to support the drug’s use in patients who are at high risk for hospitalization.
Nevertheless, the FDA explains its long-standing support of remdesivir use in adults here, citing six studies that had the greatest impact on the agency’s position.
Here is a summary of the findings of each study from the FDA’s webpage:
  1. [url=https://www.nejm.org/doi/10.1056/NEJMoa2007764?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub 0pubmed]ACTT-1 Trial[/url]: Time to clinical recovery was shortened from 15 days to 10 through the use of remdesivir. There was no difference in mortality. The drug was no better than placebo when administered to patients who required high-flow oxygen, non-invasive respiratory support, mechanical ventilation or extracorporeal membrane oxygenation at baseline. A benefit was seen only in patients who required low levels of supplemental oxygen.
  2. Discovery Trial: There was no clinical benefit of remdesivir in hospitalized patients who were symptomatic for >7 days and who required supplemental oxygen. There was no difference in mortality between remdesivir and standard of care. Investigators judged three of 429 participants who received remdesivir died from the drug.
  3. WHO Solidarity Trial: Remdesivir did not decrease in-hospital mortality or the need for mechanical ventilation compared to standard of care. Four hundred and forty patients in this study were also enrolled in the Discovery trial above.
  4. Journal of the American Medical Association (moderate disease): After 10 days of treatment with remdesivir, clinical status was not significantly different from standard of care.
  5. New England Journal of Medicine (severe disease): No difference between five and 10 days of remdesivir treatment. No placebo group, thus “the magnitude of benefit cannot be determined.”
  6. PINETREE study: Three consecutive days of IV remdesivir resulted in an 87% relative reduction in the risk of hospitalization or death when compared to placebo.

As demonstrated, the first five studies used to justify the FDA’s approval of remdesivir showed little, if any, benefit to hospitalized patients with moderate or severe disease.
This is in contrast to the sufficiently proven benefit of off-label use of the previously licensed medications hydroxychloroquine and ivermectin.
Only the PINETREE study investigated the benefit of remdesivir for outpatient use. In that study, the drug provided a substantial benefit in preventing hospitalization when given in three separate doses over three days.
It's Time to Follow the Science. Join our Campaign!  
However, only eight individuals under the age of 18 were enrolled in the study, and none were younger than 12.
The primary endpoint, a composite of COVID-19-related hospitalization or death from any cause, did not occur in the under-18 group.
In other words, the study — funded by Gilead Sciences — showed the drug offered no benefit in this cohort.
Nevertheless, in reporting on the FDA’s approval of remdesivir for infants and young children, CNN found someone to support the FDA’s decision.
CNN wrote:
“The FDA’s approval of remdesivir for young children is ‘great,’ said Dr. Daniel Griffin, an instructor in clinical medicine and associate research scientist in the Department of Biochemistry and Molecular Biophysics at Columbia University.”
Safety ‘not established’ in pediatric patients
Not only is there scant evidence that remdesivir is an effective treatment for COVID-19, the drug’s safety is debatable.
With regard to its use in infants, even the FDA must acknowledge nobody knows how safe it is.
After all, the manufacturer’s label states:
“The safety and effectiveness of VEKLURY (remdesivir) have not been established in pediatric patients younger than 12 years of age or weighing less than 40 kg.”
With regard to pharmacokinetics (where the drug distributes in the body) the label states:
“The pharmacokinetics of VEKLURY in pediatric patients have not been evaluated.”
An indictment of the drug regulatory process
Let’s reflect on what the director of the FDA’s Center for Drug Evaluation and Research said regarding the approval of remdesivir for treating COVID-19 in infants 4 weeks and older :
“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population. Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”
To summarize:
  • Some children do not have a vaccination option.
  • They need a safe and effective treatment.
  • The FDA meets that need by approving a drug with no safety and efficacy record in children.

Safety and efficacy apparently can be conveniently established by fiat, not evidence.
In the end, the FDA’s approval of remdesivir is not an assurance of the drug’s safety and efficacy but an indication the agency is no longer interested in protecting the public from potentially harmful and ineffective therapies — or, in other words, in doing its job.
There will undoubtedly be doctors like Griffin who welcome this approval.
However, I don’t believe every pediatrician will accept the FDA’s guidance so readily.
It’s not easy to place an intravenous line to administer remdesivir in the tiny vein of an irritable baby coming from home with a positive rapid test. And then do it again the next day. And the day after that.
At some point, clinicians’ sensibilities will be challenged enough to compel them to actually examine how the FDA arrived at its conclusions.
Guidelines are meaningless if doctors choose not to abide by them.
The views and opinions expressed in this article are those of the authors and do not necessarily reflect the views of Children's Health Defense.


https://childrenshealthdefense.org/defender/fda-remdesivir-infants-safety-efficacy/?utm_source=salsa&eType=EmailBlastContent&eId=cbe39194-1682-4b3b-bf94-5323a131b06f
Thanks to: https://childrenshealthdefense.org



  

Back to top  Message [Page 1 of 1]

Permissions in this forum:
You cannot reply to topics in this forum