The FDA’s harmful restrictions on two new COVID drugshttps://www.nydailynews.com/opinion/ny-oped-the-fdas-harmful-restrictions-on-two-new-covid-drugs-20220113-r4zywn2oxvf47hgdqyfj7oakge-story.htmlThe Food and Drug Administration recently granted Emergency Use Authorization (EUA) to Paxlovid and molnupiravir, two lifesaving, direct-acting antiviral drugs that are effective in preventing both hospitalization and death of people who have contracted COVID-19. They are effective against all variants so far, including omicron ... .
Unfortunately, two requirements that the agency put in place in authorizing these drugs will all but guarantee that most people who need them will not be able to get them in time. And time is of the essence since the drugs are only effective when taken within five days of initial symptoms.
First, the FDA lists numerous health criteria as prerequisites for a prescription, repeating the same mistake the agency made when it first approved the Pfizer and Moderna vaccines. While health considerations may seem reasonable, perhaps even wise, the logistics of applying existing health risks as a condition for dispensing the drug make the process cumbersome and unworkable.
The list of conditions is itself arbitrary and vague. It includes people with “heart disease,” which can be minor or serious; current or former smokers, regardless of how much they smoke or whether they quit; and dementia or other neurological conditions. The list is so broad and poorly defined as to make it medically arbitrary and impractical. .. .
For the 25% of Americans who do not have primary care physicians, access to these drugs will be next to impossible. During “normal” times, urgent care facilities and walk-in clinics could potentially diagnose COVID and provide prescriptions when appropriate, but these are anything but normal times. ...
The FDA’s second requirement to receive the antivirals is arguably worse: a positive COVID-19 test. This makes it virtually impossible for a patient to have access to the drugs during the five-day timeframe during which they are effective.
Re the second requirement, if a positive
PCR test is required, the time necessary to get an appointment (or find a site that accepts walk-ins) and to get test results will consume most of the 5-day window of opportunity.
As for people with heart disease being excluded, that excludes many/most seniors and many who are in their 40s or 50s. And ignoring degree of seriousness? Sorry for using myself as an example, but every time I step up to the starting line of a running event I know there is at least one walker/runner who has heart disease, and knowing the breadth of the running community, I am certain that dozens or scores of the other walkers/runners do as well.
Bureaucrats are amazingly estranged from the real world.
