The FDA strikes again

Feds block trials for immunoglobulin serum

It almost seems like the Feds are trying to kill me.

I’ve had immunoglobulin shots before, when exposed to Hepatitis A, to prevent an infection, and it worked. Almost any heath care professional will have used the measure some time in their career. IG therapy has been a standard for short term prevention for 50 years.

IG injections essentially give you 2 to 3 months of passive immunity, like a temporary vaccine. There are no doubt millions of high risk people who live with school age children who face very likely exposure in September who could avoid a life threatening disease course by making this available.

The doctors currently working in the IV Convalescent Plasma trial endorse the idea and manufacturers are ready to scale up the production, but the FDA refuses to allow it.

 

9 thoughts on “The FDA strikes again

  1. There seems to be some conflicting reasons for the lack of IG shots for COVID.

    “On March 27, he and Dr. John Zaia, the director of City of Hope’s Center for Gene Therapy, submitted a proposal to the federal Biomedical Advanced Research and Development Authority, or BARDA, urging the rollout of IG shots for first responders and members of other high-risk groups.

    The agency granted $12.5 million to Grifols and $14.5 million to Emergent BioSolutions to produce plasma-based COVID-19 medicines in IV form drips, among more than 50 different biomedical partnerships to fight the pandemic. But the immunity shot proposal was rejected.“

    Rejected by whom? It sounds like the Pharma companies.

    “Financial calculations may be another factor for companies. Intravenous plasma products are traditionally the main economic driver for the industry, supply experts said, in part because vaccines have replaced many short-term immunity shots over the years. The money-making antibodies are also far more diluted in intravenous drugs than in injectable ones, which boosts profit margins.

    “They charge a fortune off of intravenous drugs in the hospital. They don’t want to devote the manufacturing plant to something that won’t make oodles of money,” said one infectious disease expert, who has advocated for coronavirus IG shots but asked not to be publicly identified.

    Researchers also said industry executives have little incentive to produce the immunity shots for the coronavirus, given the possibility that a longer-lasting vaccine could replace it within a year.“

    I am not sure what the administration is rejecting. The FDA said in your link that they don’t tell companies what drugs to develop.

    Liked by 1 person

    1. I have written to Dr Joyner to find out, but the article clearly said the Federal Government blocked the trials and two companies who produce IG products were seeking authorization to proceed.

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      1. Puzzling or just a misinformed author.

        “ Federal officials have twice rejected requests to discuss the proposal, and pharmaceutical companies — even acknowledging the likely efficacy of the plan — have declined to design or manufacture the shots, according to a Times investigation. The lack of interest in launching development of immunity shots comes amid heightened scrutiny of the federal government’s sluggish pandemic response.”

        That seems to indicate that both the administration and Big Pharma are blocking the IG shot development.

        Liked by 1 person

    1. The FDA has a great deal of autonomy by act of Congress. Trump can only overrule them by declaring a national emergency. The bureaucracy operates pretty much independently.

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          1. I don’t see any complaints about the politicization of the Department of Justice. Just a whole bunch of whining about the FDA, which Trump has been able to control however he wants.

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