ON April 22, 2022 WHO (World Health Organisation) endorsed the newest combination anti-retrovirals, nirmatrelvir and ritonavir, made by Pfizer under the trade name Paxlovid. This product was deemed the best therapeutic option for the highest risk patients, as evidenced from two randomised controlled trials which engaged just over 3000 participants.
Those classified as highest risk were the immunocompromised, elderly and the unvaccinated. This category of persons is estimated to make up just 10 per cent of the riskiest hospital admissions. Paxlovid has been notably successful in 84 per cent of those cases, which translates to reducing hospital admission for 84 out of 1,000 cases if implemented.
However there are a few barriers for middle and low income countries, such as timely testing, cost of treatment and the licence agreement between the original manufacturer Pfizer and the Medicines Patent Pool, enabling the availability of cheaper generics.
Treatment success is hinged on the equitable and universal access of such medications and the quick and accurate testing and diagnosis to catch the disease soonest. However, it was noted that testing was very slow (80 times slower) in low income countries when compared to more privileged countries. Best results were noted for this combination drug when administered at the commencement of the disease. Hence, it is recommended for the mild or moderate cases, thus preventing the advancement to a more severe form of the disease for high risk patients.
Remdesivir, another antiretroviral, is currently under review by the WHO for use in critically ill COVID-19 patients. However, it has been recommended only now for mild and moderate cases who are high risk for hospitalisation, after evaluation of clinical data.
The FDA had issued an EUA (emergency use authorisation) on December 23, 2021 for molnupiravir, an antiretroviral manufactured by Merck and Ridgeback Biotherapeutics and indicated for patients who are at high risk of progressing to severe COVID-19 disease. However it was only recommended as the second option, according to the treatment protocol, for cases where Paxlovid and remdesivir cannot be used.
Until the trade agreements are ironed out, a gap is left in the system and a business opportunity for unscrupulous giant drug dealers, who may falsely produce and sell “look alike” versions to the unsuspecting general public for huge sums of money, under the same trade name or the generic names once approval is granted.
As long as demand exceeds supply, there will always be an opportunity for fake products. When this demand is for life saving medicines, the merchandise value becomes a matter of interest to the unlicensed non-professionals, who are involved in organised crime.
Illegal importation and evasion of mandatory regulatory requirements by a well organised criminal network are other factors to promote counterfeiting. Hence regulatory oversight at the importation levels must be sharp and consistent, on alert at all times through the known and unknown channels. Anti-corruption programs and law enforcement agencies must be activated to root out all guilty offenders and collaborators from the system with stringent penalties so as to set the correct tone for business. Also, the infrastructure and technology to detect fake pharmaceuticals is an absolute necessity, as highlighted by a CNN production, 60 Minutes.
Three years ago, Forbes estimated that the counterfeit pharmaceutical business was about USD 200B annually. As reported in the British Medical Journal in November 2021, a seizure worth USD3.5M with fake vaccines, face masks and COVID-19 tests was conducted by an Interpol operation in Southern Africa where 179 suspects were arrested.
In January 2022, Gilead Sciences had announced another seizure of some 85,000 bottles of counterfeited antiretrovirals used in HIV treatment and sold through the state of the art United States supply chain.
Substandard or falsified quality antiretrovirals pose a public health threat, especially when used for contagious viral infection such as the COVID-19 pandemic, since resistance may be developed to the best medications. Life threatening side effects from contaminants used to manufacture these counterfeits may add fuel to fire since apart from the prevailing illness, the other organs can be compromised. Hence, if systems are not instituted now, it can erode all the efforts made by the majority of healthcare workers and undermine the public safety.
More vigilance is required as novel treatment options are introduced for COVID-19. This new dynamic situation which has evolved, allows individualised freedom with self-testing and now outpatient treatment. Safety and effectiveness must be the watchword even in the face of limited available resources with overwhelmed hospital systems.
So to guarantee the acclaimed benefits of these breakthrough discoveries as seen from clinical data presented, the regulatory and overall health systems must preserve the authenticity, affordability and widespread geographical distribution for all humanity.
For further pharmacological guidance and physician referral, contact the pharmacist of Medicine Express PHARMACY located at 223 Camp Street, between Lamaha and New Market Streets. If you have any queries, comments or further information on the above topic kindly forward them to medicine.express@gmail.com or send them to 223 Camp Street, N/burg. Tel #225-5142.