Posted on 06/22/2024 12:18:08 PM PDT by george76
For a third time, Sarepta Therapeutics has convinced a top Food and Drug Administration official to overrule the prevailing view of their staff and approve a drug for Duchenne muscular dystrophy.
On Thursday evening, the FDA announced it expanded the approval of Elevidys, Sarepta’s Duchenne gene therapy, to cover nearly all patients, regardless of age or wheelchair status, despite the fact that the drug failed a large, Phase 3 trial last year.
That decision, documents concurrently released by the agency show, was made almost exclusively by Peter Marks, the agency’s director of the Center for Biologics Evaluation and Research. He overruled three review teams and two top lieutenants, who wrote that the data Sarepta submitted “cast significant uncertainty regarding the benefits of treatment.”
What a shame. All those parents desperately hoping their kids will improve and they are being played for fools.
The Food and Drug Administration expanded approval for a gene therapy to treat Duchenne muscular dystrophy (DMD)—despite the fact that it failed a Phase III clinical trial last year and that the approval came over the objections of three of FDA’s own expert review teams and two of its directors.
The decision to expand the approval of the therapy—called Elevidys (delandistrogene moxeparvovec-rokl)— decided almost entirely by Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research.
https://www.science.org/content/blog-post/sarepta-why
Has anyone checked Marks’s bank account for an odd deposit, say from a company like Sarepta Therapeutics?
Someone should check the directors bank accounts.
In today’s government, I certainly expect bribery.
This one hits home, some members of my family are MD carriers and my Mom suffered with the disease. Time to look into this man’s finances. America is not a monarchy but it sure is full of little kings.
FDA approves expanded use of Sarepta’s Duchenne gene therapy; shares jump. up 36% in extended trading. - $$$$
Of course.
P
I have no problem with giving any drug approval on a compassionate use basis when no other drugs are available for the condition. However, the patient must be fully aware that in effect this is an experimental drug and may help, may harm, or do nothing. A drug of this nature must not be given total FDA approval without restrictions that would allow any doctor to prescribe it.
Think about the Covid Vaccine that was not a vaccine but gene therapy that alters your cellular DNA. It should have never been approved except on a compassionate basis. In fact it approval was contrary to FDA rules and regs. If another drug regime is available and effective for a disease state you can not give emergency approval for another drug to treat the disease. HCQ and Ivermectin worked. This was proven in India that has a health care system that is logical. Despite having a health care system that is very good if you have money, the vast majority of citizens can not access this. India’s rate of death from Covid was far below the USA. They used HCQ, Ivermectin, and oddly nasal cleansing. The nose is where the infection starts.
The whole world became an experimental drug trial for an unproven drug. I am a clinical pharmacist. In the past Pfizer, Merck. Astra etc. were held in high esteem by pharmacists. If they said it, we believed it. WE WERE WRONG, IN THE PAST THEIR WORD WAS GOOD. THEIR WORD IS NO LONGER GOOD. THEY LIED.
Human Guinea Pigs: Experimentation on Man - Maurice Pappworth
Thanks. BUMP!
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