As part of long-standing, ongoing efforts to be better prepared to save lives following radiological and nuclear emergencies, the U.S. Department of Health and Human Services is purchasing a supply of the drug Nplate from Amgen USA Inc; Nplate is approved to treat blood cell injuries that accompany acute radiation syndrome in adult and pediatric patients (ARS).
Amgen, based in Thousands Oaks, California, developed Nplate for ARS with support from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Administration for Strategic Preparedness and Response (ASPR), as well as the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
BARDA is using its authority provided under the 2004 Project Bioshield Act and $290 million in Project BioShield designated funding to purchase this supply of the drug. Amgen will maintain this supply in vendor-managed inventory. This approach decreases life-cycle management costs for taxpayers because doses that near expiration can be rotated into the commercial market for rapid use prior to expiry and new doses can be added to the government supply.
ARS, also known as radiation sickness, occurs when a person’s entire body is exposed to a high dose of penetrating radiation, reaching internal organs in a matter of seconds. Symptoms of ARS injuries include impaired blood clotting as a result of low platelet counts, which can lead to uncontrolled and life-threatening bleeding.
To reduce radiation-induced bleeding, Nplate stimulates the body’s production of platelets. The drug can be used to treat adults and children.
Nplate is also approved for adult and pediatric patients with immune thrombocytopenia, a blood disorder resulting in low platelet counts. Repurposing drugs for acute radiation syndrome that also are approved for a commercial indication helps to sustain availability of the product and improves healthcare provider familiarity with the drug.
Here’s an idea, maybe we just skip the entire nuclear war deal. Just not a good look and lots eggs broken. No omelette at the end.
That looks like a large amount, but the contract also covers storage and rotation( maintaining a ready number of doses). Not terribly familiar with that particular drug, Others like it, Procrit and Neulasta for example , aren’t cheap. Timing may be coincidental, looking for any recent studies.
Certainly raises the eyebrows though.
Initial reports of this purchase said it must be held in specific cold storage and yet it still has an 18 month shelf life at a cost of $290 million. I hope I’m understanding that the 290 buys us a guarantee of a stockpile at all times during the contract and not just one purchase that will be useless 18th that after delivery.
That’s how I understood it as well. A little more research showed a Jan’21 approval by the FDA for ARS/BMS, cost of over $1100 per 125mcg vial of powdered injectable- dosage runs from 1 to 50mcg/kg per week ,initial dose at 1 then increasing 1 per week titrating to effect, 2mcg/kg/week is avg effective dose. So not millions of doses, and timing given approval really looks like would have happened regardless threat level.