Merck Asks FDA for Crisis Approval of New COVID Drug Despite Safety Concerns
Medication could cause cancers and birth defects
Despite warnings from scientists that will its new COVID drug could have seriously harmful negative effects like causing cancers plus birth defects, Merck officially posted the drug, Molnupiravir, to the FDA for approval.
Whether it’s approved, it would be the first antiviral pill to treat the virus.
According to the NYT, the drug would better COVID treatment since it could relatively inexpensively treat many more high-risk patients sick with COVID, especially those that haven’t been vaccinated (the medication was only tested on patients who hadn’t been vaccinated).
Still, the drug will be a cash cow for Merck, since Merck will be planning to charge customers 40x the cost to help make the drug.
Regardless of the price, countries are lining up for deals with Merck could the drug has been approved. Merck has struck works with the US government, as well as South Korea, Singapore, Malaysia, Australia as well as others.
The $700 course of the pill is intended to be taken at home as four capsules twice a day with regard to five days, constituting an overall total of 40 pills. For each the trial data released by Merck – which was greeted with fawning from doctors and scientists – it halved hospitalizations and deaths (though the test was cut short by a supervisory board who claimed the data was so positive it would be unethical to hold back the drug from the placebo group). The approval can come within weeks, per the NYT.
As many as 10MM Americans would be eligible for the drug if approved, but the supply will likely be slim initially; the US has ordered 1 . 7MM programs already.
Fortunately, other companies are nearly prepared to release data from their personal antiviral pill trials. An antiviral pill being produced by Pfizer and one from Atea Pharmaceuticals teamed up with Roche will report study results in the next months.
The FDA has many choices to make beyond just approving the drug, or not. It must decide whether women that are pregnant – and any other at-risk groups – will be entitled. Initially, Merck is seeking authorization for its pill to be given only to high-risk grown ups, including people with any of the following characteristics: over 60, have got obesity, diabetes or heart disease.
Unvaccinated Australians are now prisoners in their own nation.