By Tracy Waller, Esq., MPH
“If it’s COVID, Paxlovid.” Or is it? Pfizer launched its most recent commercial for Paxlovid in February 2023 and has gone full throttle into its advertisement of the drug. Pfizer first received Emergency Use Authorization (“EUA”) for Paxlovid in December 2021 and then received a revised EUA in February 2023. The commercial touts the drug as a “miracle” drug of sorts. On November 6, 2022, the Office of Veterans Affairs released a study showing that Paxlovid can reduce the risk of symptoms of long COVID. Pfizer includes in its commercial for the drug, as required, that certain classes of people are excluded from taking Paxlovid based on negative drug interactions; however, the gravity of the number of people who are ineligible to take the drug is not readily apparent and leaves large swaths of the United States’ (“US”) and global populations without access to this life-saving drug. The lack of access to Paxlovid for the people most vulnerable to COVID-19- the elderly, people with disabilities, and other immunocompromised people – emphasizes the need for pharmaceutical companies to focus on developing treatment options that meet the needs of so many of those left behind.
Drug Interactions
According to the Paxlovid Interaction Checker on drugs.com, there are 643 drugs known to interact with Paxlovid (nirmatrelvir/ritonavir), along with five disease interactions, and two alcohol/food interactions. Of the total drug interactions, 239 are major, 364 are moderate, and 40 are minor. “Some of the more common ones are cholesterol medications known as statins, antiplatelet medications given after a heart attack or stent placement, cardiac medications that treat abnormal heart rhythms, medications that treat seizure disorders, birth-control medications, and opioid pain relievers.” Paxlovid is considered an antiviral drug. Comparing the drug interaction list for Paxlovid with that of Tamiflu, another antiviral often used to treat high-risk cases of the flu, provides context for how massive the drug interaction list is for Paxlovid. According to the Interaction Checker on drugs.com, there are eight drugs known to interact with Tamiflu (oseltamivir), along with two disease interactions. Of the total drug interactions, two are major, four are moderate, and two are minor. While there are various other drugs[1] to treat other viruses and diseases that also have large amounts of interactions, Paxlovid’s alarming amount of significant drug interactions combined with a lack of effective alternative options[2] presents several issues within the aging and disability communities.
Drug Management
Some people take daily medications that they can easily self-manage and temporarily pause, but often, drug management is complicated and requires access to a doctor for consultation. In the case of contracting COVID-19, that consultation must occur quickly after contracting COVID-19 if a person hopes to take Paxlovid: “Paxlovid should be administered as early as possible following the appearance of any symptoms and needs to be initiated within 5 days of symptom onset.” For example, Paxlovid can have dangerous interactions with many common heart medications. When President Biden tested positive for COVID-19 in July 2022, his doctor temporarily took him off of his heart medications. While he could not be off these medications long-term, the short-term benefits of Paxlovid outweighed the risk of not taking his medications. President Biden was fortunate to have both a doctor to consult and the ability to temporarily pause his medications.
Complications[3]
Not all people are able to pause their medications. For example, for patients with heart transplants or kidney transplants or disease, there may be significant risk for dangerous side effects caused by drug interactions, “including kidney injury, seizures, posterior reversible encephalopathy, and even death.” If a kidney patient requires Paxlovid, doctors must make a substantial number of medication adjustments and closely monitor patients—and even adjust their renal filtration rates. Another concern with patients who are prescribed Paxlovid is that a patient may call and consult their primary care provider instead of their specialist who may need to discuss or adjust the use of medications. This can create a situation where a patient needs to coordinate with several physicians of varying specialties to quickly adjust their existing medications, while ensuring they are able to begin Paxlovid within five days after initial COVID-19 symptoms. Due to physician shortages and the US’ decentralized health system, coordinating medication adjustments at this speed is often difficult or impossible.
Paxlovid is recommended for people who are at higher risk for progression to severe COVID (ages 50+), but older adults are also more likely to be taking multiple medications—meaning they are more likely to be taking a medication that may negatively interact with Paxlovid.
Accessibility
Since doctors, often specialists, must carefully manage certain medications to care for patients who plan on taking Paxlovid, this puts many people with disabilities at a disadvantage for managed care. Many doctors have expressed their discomfort or unwillingness to working with people with disabilities for various reasons—and therefore people with disabilities may not get the best care or have access to the best information regarding taking Paxlovid. Additionally, an intellectually or developmentally disabled person may not fully understand the importance of consulting with specialists regarding Paxlovid. Other patients may have difficulties accessing doctors in the short timeframe Paxlovid requires based on physicians’ attitudes.
Physicians are more likely to downplay women’s health concerns, especially black women’s health concerns regarding pain. Their doctors may be less likely to prescribe them Paxlovid based on the belief that women are not in enough pain to qualify for Paxlovid or they are downplaying their symptoms because they do not fall into a high risk category typically classified by Paxlovid. Two out of every three caregivers in the US are women—a statistic which demonstrates that women are caring for children, adults, or other people with chronic illnesses or disabilities. Women often overlook their own needs to care for others—and doctors downplay their symptoms. Denying women access to Paxlovid or not taking their medical concerns seriously could also have a trickle-down effect.
Men are also less likely to seek medical care than their female counterparts—both for annual checkups and for injuries or illnesses. The delay in seeking medical care could mean that for some men, they are unable to access Paxlovid because they waited too long to access it—by falling outside of the drug’s five-day window.
Why else does it matter?
Pfizer’s clinical trial showed an 89% reduction in the risk of hospitalization and death among high-risk, unvaccinated people with symptomatic COVID-19 and “Mass General Brigham researchers confirmed that the drug is associated with a 44% reduction in hospitalization or death in a highly vaccinated population of adults over the age of 50.” By focusing only on those numbers, and with a growing number of people suffering from “COVID fatigue” and declaring the “end of COVID,” it is not hard to see how many people have deemed Paxlovid a “miracle drug.” The cost of this rhetoric is that when people hear about a “miracle drug” like Paxlovid, they may be less likely to get vaccinated, boosted, or take safety precautions to protect others (such as masking when required, sanitizing/washing hands, and isolating if they have contracted COVID). Many people continue to live in fear of both contracting COVID and knowing that they do not have the same ability to access Paxlovid if they do develop a COVID-19 infection. Until other effective lifesaving treatment options for COVID are available, we must not forget that there are millions of people who remain vulnerable to severe illness, long-COVID, and death as a result of a COVID-19 infection. While Paxlovid is a viable option for many people, society must not devalue or render invisible those who are unable to access or utilize Paxlovid as a treatment option. Each of us has a responsibility to do our due diligence to follow the Centers for Disease Control and Prevention (CDC) Isolation and Precautions for People with COVID-19, get vaccinated, and get boosted. The global research community must prioritize developing therapeutics to benefit those most acutely susceptible to the impacts of COVID-19.
[1] Erythromycin for example, an antibiotic often prescribed to treat bronchitis and other infections, according to the Interaction Checkeron drugs.com has 620 known drug interactions, five disease interactions and two alcohol/food interactions. Of the total drug interactions, 190 are major, 274 are moderate, and 56 are minor. However, there are several alternatives to this antibiotic, including Amoxicillin.
[2] On February 21, 2023, Merck announced that “LAGEVRIO™ (molnupiravir) did not demonstrate a statistically significant reduction in the risk of COVID-19 following household exposure to another individual with COVID-19. The Phase 3 MOVE-AHEAD trial evaluated people who did not have COVID-19 at baseline (confirmed by a negative baseline SARS-CoV-2 test and no signs and symptoms) but lived with someone who was recently diagnosed with COVID-19. In the primary endpoint of participants who did not have evidence of SARS-CoV-2 infection at baseline (confirmed by a negative SARS-CoV-2 test), the LAGEVRIO treated group was observed to be 23.6% less likely than those who received placebo to develop COVID-19 through day 14 (a positive post-baseline SARS-CoV-2 test with evidence of signs and symptoms); the primary endpoint was not met.”
[3] While it is not yet available globally, drug management will be a huge issue that global health leaders will need to grapple with given Paxlovid’s substantial drug interactions and potential for dangerous side effects. This is especially a concern in communities with more limited access to care providers and specialists to coordinate necessary management. The danger is that residents of wealthy countries with more robust healthcare systems will benefit from life-saving drugs such as Paxlovid, while citizens of the global majority will be unable to fully benefit from such advancements due to structural healthcare inequities, resulting in preventable deaths.