The onslaught of biomedical interventions has allowed healthcare professionals globally to provide more effective & efficient treatment. Medications, in particular, have equipped healthcare systems with chemical entities to combat infectious diseases, manage chronic disease states, and provide targeted oncology therapy. However, these synthetic agents are not without controversy or significant glitches. Despite the intention to do no harm, humanity is often burdened with the negative consequences of the biomedical age. As the global health community reflects on this past year, there is substantial insight to be gained by reviewing these controversies that occurred in 2019. The following five issues encompass a few of the biomedical controversies in 2019, so that internationally, our fragile species can learn and grow to further improve the lives around the globe.
#1: Global Drug Deaths – Opioid Pandemic
In June of 2019, the United Nations Office on Drugs and Crime (UNODC) released the 2017 World Drug Report that highlighted the reach drug addiction has on humanity. The UNODC found that 35 million individuals were suffering from drug use disorders and required addiction treatment services. This is a 30% rise from near the end of the last decade. Of the deaths that occurred due to drug use disorders, 2/3rds were attributed to opioids alone which include both heroin and legal pain relievers. An increase of opioid use in Africa, Asia, Europe, and North America in concert with the single largest yearly production of cocaine – 2000 tons – are thought to explain this rise in opioid deaths. In addition, this study discovered that parts of West, Central, and North Africa have been flooded with tramadol leading to this opioid’s abuse and the increase in global figures.
Unfortunately, this study noted that only one in every seven people are receiving effective treatment for their drug-use disorder. Evidence-based interventions are either completely unavailable in their area of inhabitation or inaccessible due to cost, distance, stigma, or saturation of available treatment centers. This report concludes by encouraging nation states and the global community to increase their efforts and funding to providing this vital care to each patient seeking these services.
#2: Medication Recall – Zantac
GlaxoSmithKline (GSK), a UK based pharmaceutical industry, issued an October 2019 statement that informed the public on a recall of a common medication to treat peptic ulcer disease (PUD) – Zantac, also known & sold by its generic name ranitidine. The impurity N-nitrosodimethylamine (NDMA) was found in unacceptable limits as this chemical is known to be a potential carcinogen. All prescription dosage forms were recalled which included tables, syrups, and injections, and changes in the manufacturing process are thought to have caused this increased level. This recall follows the 2018 recall of the class of anti-hypertensive agents called angiotensin II receptor blockers (ARB) that were adulterated with the same unacceptable limits of NDMA.
#3: The Resurrection of Biogen’s Alzheimer’s Medication
In March of 2019, the pharmaceutical industry Biogen announced that it was terminating its phase three clinical trial of a novel entity in the treatment of Alzheimer’s Disease. The termination of the monoclonal antibody, aducanumab, was due to no significant statistical differences between the treatment and placebo study arms. Aducanumab targets beta-amyloid plaque which has been the substiantal focus in Alzheimer’s treatment throughout the last several years. The preliminary results released by Biogen shocked the Alzheimer’s medical community, as this treatment showed so much promise in early stage trials. It was also the last potential target in this medication class, forcing many to believe a novel treatment modality would need to be pursued.
However after a retrospective analysis of the complete data, Biogen reversed its decision in October 2019 and restarted their phase three clinical trials. The company stated that the researchers, initially worried about brain swelling and other side effects, increased the dose of aducanumab late in the study. This increased dosage showed increased effectiveness, 25% reduction in the rate of decline compared to placebo, when the researchers conducted the analysis after the initial cancellation. This increased dosage is still marred in controversy as two different trials, EMERGE & ENGAGE, both utilized the high dose regimen with the EMERGE participants seeing the aforementioned positive results while the ENGAGE participants actually seeing an increase in their cognitive decline. Biogen will file approval for the US Food and Drug Administration (FDA) early in 2020, but experts are split on whether it will be approved or will require additional trial data. Regardless of the decision by the FDA, the success of aducanumab will shape the future of Alzheimer’s treatment and research.
#4: A halt to Pediatric HIV Structural Violence: Quadrimune
Cipla, a generic manufacturing company based out of India, announced in late 2019 that they were going to start production of an antiretroviral pediatric formulation for just $1 per day. Quadriume, which contains ritonavir, lopinavir, abacavir and lamivudine, is strawberry flavored to increase the adherence rates for young children afflicted with this infectious disease. Before the availability of this formulation, UNAIDS estimated that globally 50% of the 160,000 children infected with HIV die each year before the age of two largely from access issues and inability to tolerate the older formulations. The older formulations had tolerance problems such as a metallic taste and need for refrigeration while also encountering HIV resistance. The western world’s pharmaceutical industries has continued to turn a blind eye to this population of humanity for the sake of profits, while Cipla has been undertaking pragmatic approaches to HIV care for several years. Cipla hopes to receive FDA approval followed shortly by the World Health Organization (WHO) approval in May 2020 while Doctors Without Borders has already started clinical trials in Uganda to receive support from African health leaders.
#5: Samoa’s Measles Outbreak: Ill-prepared Vaccines
The island nation of Samoa announced in December 2019 that 53 individuals, 48 being children under the age of five, have died due to large measles outbreak. In total, approximately 4000 measles cases have been reported in a population of 200,000. Throughout the country, public gatherings have been banned and schools/universities has been closed. Although experts believe the myth of autism being caused by vaccines have led to decreased vaccination rates (31% among young children), there may be a more significant reason for distrust in vaccinations. In July 2018, two nurses in Samoa mistakenly reconstituted the Measles, Mumps, Rubella (MMR) vaccine with a muscle relaxer instead of distilled water. This led to two infant deaths, five years in prison for the nurses, and a plethora of misinformation spread to the island’s inhabitations. This Samoan outbreak reflects a trend across the globe with a quadrupled amount of measles cases in the first three months of 2019 compared to the same time frame in 2018.
A Promising Outlook: 2020
Despite these biomedical obstructions to a healthier global society in 2019, 2020 promises great advancements in the way humanity’s well-being is cared for. With the perspectives gained from this past year, the following health innovations are due to be initiated to achieve equitable healthcare for all:
- A novel class of migraine medications, oral calcitonin gene-related peptide receptor antagonists, is due to have its first agent approved in 2020. Ubrogepant, manufactured by Allergan, will offer an effective therapy for those who cannot tolerate the current gold standard migraine agents – triptans.
- The future of the fight against HIV will be equipped with a once-monthly injection of antiretroviral therapy in 2020. The combination therapy of cabotegravir/rilpivirine (Cabenuva) produced by ViiV Healthcare has shown to be as effective as current once daily therapy options.
- The eradication of malaria will discover if a vaccine candidate could add to its arsenal of biomedical interventions. Sanaria has developed the PfSPZ vaccine, and will conduct phase three clinical trials in Bioko, Equatorial Guinea in 2020. This new candidate has, thus far, shown to have a more protective effect (48.3%) than the currently approved RTS,S vaccine.