Pharmaceutical Market Europe • December 2021 • 13
POLICY AND PUBLIC HEALTH
Why the new oral pills from Pfizer and Merck are clouding our judgement
You may have been vaguely paying attention recently when both pharmaceutical giants Merck and Pfizer announced the results, regulatory filings and impending availability of their new oral pills in the fight against SARS-CoV-2.
Certainly, the mainstream media seems to have been paying attention, judging by the copious coverage these medications have received. But, alas, it seems that we may have lost sight of some important facts.
While we are spending much of our time dissecting the merits of each of these pills and trumpeting the fact that they reduce hospitalisations by 90% and 50% respectively, we have forgotten to stop and think for a moment: these pills are only indicated to be used in unvaccinated people. The very same people we are screaming at to get vaccinated. Now we’re telling these people ‘hey, don’t worry, it’s all good, if you don’t want to get vaccinated, we’ve got a pill you can take that’ll keep you out of hospital’. This is completely backwards and will result in even more vaccine hesitancy, or what might be the more apt descriptor of vaccine apathy, than we’ve already seen throughout this pandemic. Of course, this is not literally what we are saying to these people, but the figurative implications are no less alarming.
But quite frankly I digress. Forget about all the politicisation of COVID-19 and the anti-vaxxers vs the science believers. Let’s just stop and think about the practical day-to-day utilisation of these new medications. Let’s think about how these pills actually get into a patient’s body.
First, you have to figure out whether you need one of these Pfizer or Merck pills (ie, are you sick?). In other words, you need to have symptoms that are consistent with COVID-19 that would be indicative of needing to test for infection. Which means that you need to know that you should take a rapid antigen test or a PCR test. While recognition of symptomology and understanding the need for formal testing are not overly complex activities, they do both require some introspection and awareness. Let’s assume both of these qualities are plentiful.
Now comes the hard part. At this point, you have to actually find a test and, hopefully, one that you can afford (because they’re not all free). In some parts of North America, finding a rapid antigen test or booking a PCR test can be extremely challenging. The European experience with mostly abundant and accessible testing has been decidedly different than we here in North America have faced. So, if those hurdles are cleared and you take a rapid antigen test, one must hope that if the results of the test come back as ‘positive’ or ‘negative’, that they are actually a true positive or true negative (which is not a given). In other words, we need tests with really high sensitivity and specificity.
If you take a PCR test instead, you better hope you initiated the testing process to get your results within three days of symptoms developing because these pills only work if the patient takes them within ~three days of symptoms starting. By now, you should be getting the picture I’m painting. But that’s not all.
Keep in mind that these pills were only tested on and approved for patients with mild-to-moderate disease and not severe disease. In other words, the people who are most in need of advanced care weren’t studied in the trials of these pills.
So, it’s a bit odd to say that 90% and 50% of patients showed reductions in hospitalisation when the patients tested in the studies were at lowest risk of needing hospitalisation in the first place. And by the way, let’s assume that you’ve traversed the gauntlet of points I’ve described. Now you are at the mercy of your pharmaceutical wholesaler and retail pharmacy actually having these pills in stock. And if they do have these pills in stock and are able to dispense them to you, you have to take between 30 and 40 pills over five days in order for these regimens to work. You can’t stop taking them after three days and 18 pills because you feel better. So patient compliance is a huge factor in the overall successful roll-out of these pills.
Are these pills great weapons in our arsenal against COVID-19? Absolutely.
Have we gotten ahead of ourselves with the excitement about these medications’ immediate impact and ease-of-use? Absolutely.
Rohit Khanna, MBA, MSc, MPH is the Managing Director of Catalytic Health, a leading healthcare communication, education & strategy agency. He can be reached at: rohit@catalytichealth.com or you can learn more about him at rohitkhanna.com