Rollout of the COVID Antivirals: Clown Show #2

The good news? There's a very effective antiviral drug called Paxlovid that will keep you alive and out of the hospital when/if omicron gets you, and a second drug, molnupiravir, which doesn't work as well, but can still be helpful. The bad news? Good luck getting either one, thanks to the FDA and the mess it has created because of some screwy details in Paxlovid's Emergency Use Authorization (EUA). More on that later.

Although the rollout of the first vaccines was difficult and frustrating (especially getting an appointment), the problems were more a function of a very limited supply than administrative screw-ups. The actual process of getting the shot once you got an appointment was surprisingly efficient, something I wrote about in January 2021.

Clown Show #1 - Booster Anarchy

In August, the Biden administration announced that boosters would be available for certain people beginning on September 20, 2021. But the criteria for the who did and did not qualify for the shots were deeply flawed, something that Dr. Jeffrey Singer and I wrote about in the New York Daily News in August.

Not surprisingly, "booster anarchy" ensued. The administration's criteria for who should receive the boosters were not followed. How could they be? The CDC recommended that "people with certain health conditions" should receive the booster. What conditions? (Note that smokers made it onto this list. Speechless.)

• Cancer
• Chronic kidney disease
• Chronic liver disease
• Chronic lung diseases
• Dementia or other neurological conditions
• Diabetes (type 1 or type 2)
• Down syndrome
• Heart conditions
• HIV infection
• Having HIV (Human Immunodeficiency Virus) can make you more likely to get severely ill from COVID-19.
• Immunocompromised state (weakened immune system)
• Mental health conditions
• Overweight and obesity
• Pregnancy
• Sickle cell disease or thalassemia
• Smoking, current or former
• Solid-organ or blood stem cell transplant
• Stroke or cerebrovascular disease, which affects blood flow to the brain
• Substance use disorders
• Tuberculosis

Do you see how unmanageable this is?

"Even with an adequate supply, it will be impossible to apply CDC criteria. Will the workers who are vaccinating thousands of people really be able to check to see whether a 55-year old man who wants the vaccine actually has any of the conditions listed by the CDC? People who desperately want the vaccine fill out the screening forms using the “honor system.”'

J. Singer, J. Bloom, NY Daily News

The result? As I wrote this past August, I was able to secure an appointment for the booster on the CVS website. They were not concerned about any of the diseases listed above, only whether I was immune-compromised. No, that's wrong. They really weren't, as evidenced by the one multiple-choice question I had to answer: 

• I am immune-compromised
• I am not immune-compromised
• I do not know whether I'm immune-compromised

Of course, I tried each choice and was taken to the appointment page every time. The obvious conclusion: People who are, are not, or are unaware of the status of their immune system are all eligible for boosters. Good plan, right?

No. Pretty much whoever was in the mood went waltzing into a pharmacy and got the booster. Booster anarchy.

Clown Show #2 - Antiviral Drugs (Same Old Song)

From the FDA's Emergency Use Authorization [emphasis added]:

"The EUA authorizes the emergency use of the unapproved product Paxlovid (nirmatrelvir co-packaged with ritonavir) for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death."

A couple of problems should be immediately obvious:

1. "...who are at high risk"

As was the case with boosters, this is a subjective criterion. What is "high risk" and who makes that determination? Your primary care physician? What if you're one of the 25% of the people in the US who don't have one? An urgent care center? Good luck with that. The pharmacist? No way. In reality, there is no system in place to determine high risk; the criteria for qualifying for the drugs are so vague as to render them useless. So, the same policy that failed for the boosters is being used for the drugs. Splendid.

But it gets worse.

2. "...with positive results"

Of all the deficiencies in the "system," this is the worst. First, how is a positive result determined? Let's say you're feeling sick and immediately go to get tested and... Whoa! That's not gonna work, at least not in New York. According to the New York Health and Hospital website, which was set up to let people know wait times at different facilities. Great resource, right?

"NYC Health + Hospitals offers testing at hospitals, health centers, and new pop-up locations across the five boroughs at no cost to you. Just walk-in – no appointment needed! NYC Health + Hospitals also offers antibody testing at 11 hospitals and select Gotham Health centers. Test results are available in 24 to 48 hours at the city-run NYC Health + Hospitals locations."

No.

Here's what I got when I went online:

And it's not just New York. According to a national survey, the average waiting time for test results is four days for the PCR test (the most accurate). Since the drugs must be taken within five days of the appearance of symptoms, it's already too late, and this doesn't even count the time waiting in line to be tested, which can be 10 hours, depending on what part of the country you live.

What about home testing kits instead? This introduces a different set of problems. Virtually all pharmacies in the New York area have "We Are Out of COVID Test Kits" signs taped to the pharmacy window. And if you're lucky enough to spend two hours on the phone and find a store that just got in a shipment of kits, you'd better move fast – they don't last long. (Online is still an option. As of today, different brands of test kits are available on Amazon, but some are of questionable quality.)

But does it matter whether you test yourself? I would argue no. Suppose you feel sick and take the home test, and it's positive, then what? Does your doctor take your word for this, or do they want to see you first? I'm betting on the latter. This is important because CVS will not fill a prescription without a positive test, which, you better believe, is going to have to come from your doctor, who, if he has any sense, will not sign off based on a home test and phone call. (1)

If you can find one that is open (and without a line around the block), an urgent care center could, at least theoretically, be of some use. They can administer the test and (especially if it's the same-day test) presumably give you the results quickly. Will they write a script then? According to the FDA, they should not; they will probably not be able to determine if you are at "high risk." So, a reasonable question is: how does anyone who is sick get these drugs within the five-day timeframe during which they must be taken? Beats me.

To be fair

The COVID drugs are NOT meant to be taken prophylactically, even if you know you've been exposed, so the FDA rules do ensure that the drugs won't be misused in this way. But in doing so, the FDA also made it essentially impossible for the drugs that will keep people out of the hospital to get to the people who need them.

The incompetence here is staggering (2).

NOTE:

(1) Another reason your that a doctor who doesn't know you will be reluctant to call in a script for Paxlovid: the drug can cause some dangerous drug-drug interactions, something I wrote about recently. 

(2) "A physician could see a patient and order a PCR and have it all done within 24 hours with good coordination, but that is lacking because of the overwhelming of the test system by asymptomatic patients who need a negative test to participate in flying, school, work, etc. Additionally, primary care doctors are overwhelmed and can't coordinate those activities even if you can get an appointment. You could go to urgent care and the physician could use an algorithm to define high-risk, immunocompromised, etc - the list you give, but with time being of the essence it is not a practical policy. If I need to get a COVID test for a procedure on Wednesday, in addition to the hassle of getting an appointment, I have to worry if Labcorp will process the result in time. I have a five-day window and Labcorp has a 4-day turnaround. If they do not have a result who do I turn to?"

Dr. Chuck Dinerstein, ACSH Director of Medicine