Top Five Global Medication-related Controversies in 2019

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. 

Disney, measles, and parents’ choice not to vaccinate: Who’s to blame?

Guest bloggers: Brittany Seymour and Rebekah Getman

The recent challenges surrounding childhood vaccinations in the United States have received notable attention in both popular and scientific press, illustrating a spectrum of parental concerns and resultant attitudes ranging from vaccine hesitancy to outright refusal. The current measles outbreak traced to Disneyland has contributed to the highest number of US measles cases in fifteen years and resulted in the Centers for Disease Control and Prevention’s release of an official CDC Health Advisory in January this year. Over half of the individuals who have come down with the illness are unvaccinated; of those, more than 80% are old enough to receive the MMR vaccine but have not, leading many states to reevaluate their personal belief exemption policies. Unsurprisingly, this now multi-state outbreak has reignited the emotional debate over vaccine safety, efficacy, and policy in mainstream and social media. While vaccinations are likely one of the most prominent health debates in the United States right now, health officials are increasingly battling unfounded controversy regarding several of public health’s greatest achievements.  The field that is tasked with controlling global disease epidemics is now up against what have been dubbed “digital pandemics:” the far-reaching, rapid spread of unrestricted, scientifically inaccurate health information across the Internet through social networks.

Researchers at Harvard University recently studied this phenomenon over another common public health intervention: community water fluoridation. A lobby to end fluoridation pushes on in communities across America, despite more than 3,000 studies confirming its safety and benefits. The researchers’ findings indicate that, similar to the anti-vaccination community, a small but vocal and very tightly knit network is driving the anti-fluoridation lobby. A well-known social theory describes individuals in the world as connected by six degrees of separation, and Facebook’s one billion users are four degrees separated; the study found that individuals in the anti-fluoride community are separated by a mere two degrees. Often, highly connected networks develop a strict set of norms and values, and any person or information in violation of those norms, such as scientifically accurate pro-fluoride information, will be quickly rejected, making rational discourse nearly impossible. The researchers also traced online social conversations about fluoride through the network. Members of the anti-fluoride network frequently shared and cited scientific studies to back their arguments; however, in more than two-thirds of conversations, the actual study cited was buried two or three links away from the online discussion, or was not reachable at all. This is concerning because, under these circumstances, the risk of evidence becoming misrepresented or misinterpreted likely increases with each link that takes readers further away from the source.

The researchers’ findings support the theory that highly connected social networks, and not science or evidence, are driving digital pandemics of health information on openly accessible Internet sites. In the digital information age, scientific fact is only one piece of the complex health decision-making process. When capable, intelligent parents encounter the sea of voices online while researching how to make optimal decisions for their children’s health, of course they become concerned with what surfaces to the top of their Google search. The Harvard study suggests that perhaps we need to stop blaming parents for choosing not to vaccinate their children or for lobbying to end fluoridation in their communities, an approach that only alienates parents with questions and shuts down dialogue. Moreover, corrective scientific information inserted into existing social communities without respect for norms and values, even if in response to misinformation, runs the risk of insulting those not readily convinced solely by the prevailing science, an ultimately detrimental approach.  Rather, additional research is needed to discover new, social health communication strategies that are more inclusive and acknowledge social networks’ differing belief systems. Digital pandemics are a part of our current, connected reality. Rather than fight against this trend (which may prove impossible), public health communication approaches must empower and partner with parents so that the voices of expertise, evidence, and experience are the ones they trust, and share within their networks, once again.

Getman HeadshotRebekah Getman is the Senior Program Manager for Education at the Harvard Global Health Institute, tasked with creating and implementing multi-disciplinary curriculum for students that supplements their in-classroom learning. These curricula combine global health knowledge with other disciplines to provide students with a broad lens through which to study and assess global health interventions.

SeymourHeadshotBrittany Seymour is an Assistant Professor of Oral Health Policy and Epidemiology at the Harvard School of Dental Medicine’s Department of Oral Health Policy and Epidemiology and the Inaugural Harvard Global Health Institute Fellow. Her research includes interdisciplinary global health curriculum development and pedagogy, capacity strengthening for oral health delivery systems in resource-challenged regions, and digital information transfer and impacts on health.

IH News Global Health Weekly News Round-Up

  • First UN International Day of fistula marked in Ghana to ensure that victims were treated and re-integrated into society in Ghana.

Politics and Policies:

  • The government of Mauritius is preparing to enforce new laws for more graphic warnings on cigarette packs.
  • Voters in Portland have defeated measures to add fluoride to water supply.
  • The Texas House passed a measure that would prevent the state from expanding its Medicaid program.
  • Abortion Law (procedure at the 12th week of pregnancy) in Arkansas is temporarily blocked by a federal judge.

Programs:

  • The World Bank has announced $1 billion in a proposed new funding to help countries in the Africa’s Great Lakes Region to provide better health and education services besides targeting energy, roads, agriculture, cross-border trade and jobs.
  • United Nations Family Planning Innovation to launch two new initiatives that will increase access to family planning and improve maternal health in the world’s most marginalized areas.
  • The Business of a Better World (BSR) has launched an online platform to create culturally accurate training materials on women’s health in developing countries.
  • GlaxoSmithKline (GSK) has announced its contribution of $750,000 to the One Million Community Health Workers Campaign in sub-Sahara Africa.
  • Power to childcare centers ban unvaccinated children in Queensland.
  • An independent organization, Save the Children has received a contribution of $500,000 to support its ongoing flood relief efforts in Mozambique.
  • An emergency preparedness ad response center is being launched by the experts from the United Nations International Atomic Energy Agency (IAEA) in Fukushima, Japan.
  • United Nations refugee agency is working to help to contain cholera epidemic in Niger by implementing emergency sanitation and prevention measures.
  • UNICEF is working to prevent further spread of measles in the Central African Republic.
  • Mass vaccination campaign contained the spread of meningitis in South Sudan. The meningitis outbreak was declared by the ministry of health on April 30.

 Research:

  • According to the reports the World Health Organization has applauded Eritrea on its accomplishments in combating malaria.
  • Most EU beaches get clean bill of health, by the European Environment Agency. It says vast majority are clean and safe.
  • According to a new study relaxation of marijuana laws in Colorado has caused significant spike in number of young children treated for accidentally eating marijuana-laced cookies, candies, brownies and beverages.
  • A report by Substance Abuse and Mental Health Services Administration (SAMHSA) says that one in ten parents did not talk to their teen children about dangers of consuming drugs, alcohol etc.
  • In the 66th World Health Assembly, the WHO has praised Thailand for the world’s best governance for medicine.
  • According to the United Nations Report, the number of people in Africa receiving antiretroviral treatment has increased from less than 1 million to 7.1 million over the seven years.
  • According to a report released by the United Nations Japan must continue efforts to deactivate Fukushima nuclear plant.
  • In a report released by the United Nations greater efforts and more resources are needed to improve health of Palestinian refugees.
  • A study shows that potatoes and beans provide most nutrients per penny.
  • According to a study conducted by Dr. Bassiouny at Kornberg School of Dentistry, diet soda might be as bad for teeth health as taking methamphetamines or crack cocaine.
  • According to a study published in The Journal of Alzheimer’s Disease, two compounds found in cinnamon can play a role in delaying the onset of Alzheimer’s disease.
  • A research presented at the Heart Failure Congress 2013, heart failure accelerates the aging process and brings on early andropausal syndrome (AS).
  • The scientists at the Massachusetts Institute of Technology (MIT) have developed an injectable nanogel that can monitor blood-sugar levels and secrete insulin when treated.
  • A study revealed that the people who were interviewed while eating at fast food restaurants typically underestimate the calorie count of the meal in front of them by a large margin.

Diseases & Disasters:

  • A category EF-5 storm killed 24 people, injured many and damaged and estimated 12,000 homes in Moore, Oklahoma on May 20.
  • A parliamentary committee has revealed that since last year in Zimbabwe, more than 45,000 people have died due to HIV-related ailments and around 1.2 million people are living with this virus.
  • Disease kills children, causes miscarriages in camps near Nyala, South Darfur.
  • According to Tunisia Ministry of Health, SARS- like virus is being reported spreading among the people of country.

IH News Global Health Weekly News Round-Up

  • The Ministry of Health and Social Welfare (Gambia) in collaboration with WHO UNICEF, Rotary International and other partners  observe  the week of May 2013 (from 24- 27) as National Immunization (NIDs) days against poliomyelitis.
  • May is skin Cancer Awareness Month.
  • May 19 was observed as National Asian & Pacific Islander HIV/AIDS Awareness Day.

Politics and Policies:

  • Kenya is the first country to protect girls against cervical cancer with GAVI- supported human papillomavirus (HPV) vaccines.
  • The government of Canada has announced its support in the fight against tuberculosis, malaria and HIV/AIDS.
  • India’s health ministry is tying itself in knots over the ban of drugs that are banned in some countries and some cases for some population segments.
  • The Illinois Senate has voted to approve the use of marijuana for medical purposes.

Programs:

  • Zambia- Zimbabwe Cross Border Malaria Initiative, a joint co-ordination launched by Zambia and Zimbabwe to control malaria and accelerate reduction of its transmission among the border communities.
  • Merck and Glaxo cut price of Human Papilloma Virus drug in the poorest countries. This cut is more than 95%.
  • Nigeria seeks support on guinea worm eradication.
  • Ghana Health Service has launched the country’s first online based health service which allows patients to engage with doctors online over minor ailments.
  • The Gambia and the World Health Organization (WHO) has launched a Comprehensive Tobacco Control formulation in Bakau.
  • India develops cheap vaccine (against Rotavirus) against major cause of diarrhea deaths in children.
  • The Child Division at the Ministry of Health and Population (MoHP) is working to introduce pneumococcal vaccine against pneumonia– major cause of death among children less than five years of age in the country.

 Research:

  • According to Cervical Cancer Crisis card that used data from official reports by the World Health Organization, Africa has the highest cervical cancer deaths.
  • According to the 2011 National HIV Indicator Survey, prevalence rates among the Ugandans between ages of 15 to 19 are rising.
  • The Annual State of the World’s Mothers report states that every year three million babies die within the first month of life.
  • A study published shows that HIV prevalence and late diagnosis of HIV infection is high among young women with sexual risk behavior in Beira, Mozambique.
  • According to a Global Mother’s Wellbeings ranking report, Ghana ranks 146th out of 176 countries.
  • According to the Maternal and Neonatal Tetanus Elimination Initiative partners, landmark has reached in fight against tetanus. It has been eliminated in over half of 59 priority countries.
  • According to a study, number of Australian parents with mental illness has increased by 3% every year from 1990 to 2005.
  • The findings of a study published in the World Allergy Organization Journal, children dwelling in commercial areas of New Delhi, India are most susceptible as compared to those living in other parts of the capital, to the respiratory ailments followed by industrial and residential areas.
  • A study shows that the paradoxical TB-IRIS frequently complicates HIV-TB therapy in India.
  • A paper published in The Lancet Oncology, say that if current trends in cancer among the people of Latin America and Caribbean continue, the region will see cancer cases soaring by third each year to reach 16.8 million in total by 2020.
  • According to a study health of the immigrants suffer as they live longer in the U.S.
  • According to a study, newer whooping cough vaccine is as protective as was thought to be.

Diseases & Disasters:

  • According to the reports Zambia is facing shortage of HIV medicines.
  • Heavy rains have caused flooding of both Nyamamba and Nyamugasani rivers in Uganda. It has caused heavy flooding which has displaced thousands of people.
  • Two cases of wild polio virus have been recorded in Tafa Local government area of Niger and Fagge in Kano respectively in Nigeria.
  • Reports have indicated that African mineworkers are at significant risk of becoming resistant to tuberculosis treatment.
  • Body of a man who died in an unnamed hospital as having suffered from Creutzfeld –Jakob disease has been identified by the L. Greenberg Forensic Institute at Abu Kabir.  According to the Health Ministry danger of being infected under normal conditions are negligible.
  • A travel alert has been issued for dengue fever in Thailand. About 33 deaths have been reported since April of this year, particularly in northeastern part of the country.
  • According to the reports more than 1200 new cases of measles have been reported this year. Health officials are scrambling to catch up and stop a growing this growing epidemic.

 

 

Global Health Weekly News Round-Up

 

Politics and Policies:

  • Judge strikes down age restrictions for ‘Morning after’ pill. Now it will be available to girls less than 17 years of age.
  • Health ministry of Liberia has adopted guidelines for mother to baby care with an aim to fight maternal mortality.
  • Health ministry of Rwanda has taken over a 11 year project which cost $ 2,718,000 with a goal of increasing access to and use of Fertility Awareness- based Methods.
  • The World Health Organization has called on the public to remain calm as human infections of new bird flu strain H7N9 are isolated.
  • New food health labeling standard is signed by the Food Safety Minister of New Zealand.

Programs:

  • An NGO of Australia is supporting Ethiopian government to enhance food security and improve maternal and child health in Ethiopia.
  • Targeting the improvement of health sector in Ethiopia, the World Bank and the Ethioian Ministry of Finance & Economic Development (MoFED) signed a 120 million dollar loan and grant agreement.
  • A book on Health promotion in Ghana launched. It evaluated the challenges of health promotion in sub-Saharan Africa.
  • According to the Vatican’s diplomatic mission, Pope Francis has donated $50,000 to help victims of the deadly floods .
  • The United States Agency for International Development (USAID) has shut down seven HIV/AIDS clinics in Kenya.
  • A Danish firm aims to improve health, environment in Mozambique.
  • Australian and local NGOs are working together in Zambia to improve access to water, sanitation and hygiene services in Western Province.
  • Hong Kong has launched fast bird flu tests for H5 and H7 viruses. The government will raise the response from ‘alert’ to ‘serious’ if virus is detected in poultry or people in Hon Kong.

Research:

  • According to a study brisk walking does the same benefit as running in heart disease patient. It reduces the chances of high blood pressure, cholesterol and diabetes.
  • Lack of dental services a factor in grades, attendance in state schools. According to the U.S. Surgeon General, ‘dental disease is at “epidemic” levels among California children’.
  • A study states that balding men are at a higher risk for heart disease. They also found that there was no significant correlation with Chronic Heart Disease.
  • A study published in editorial annals of Internal Medicine found a link between hormone therapy like Hormone Replacement Therapy (HRT) boosts heart disease risk.
  • Studies suggest that happy loving relationships are prescription to a healthy long life.
  • A study published in The Journal of the North America Menopause Society, a Chinese herbal supplement can help to reduce hot flushes of menopause.
  • According to a study, health problems and low income, not xenophobia creates a lack of well- being.
  • According to a study, higher  mercury levels is linked to higher diabetes risk. The team examined the toe nail mercury levels to diabetes risk.

Diseases and Disasters:

  • More than 600 children have been reported to have contracted measles in an outbreak in South Wales.
  • After one of its longtime members nearly died of a lung infection caused by fungi growing inside his bag, a prominent Scottish bagpiping school has warned pipers around the world.
  • The Kenya Red Cross society has warned that the floods in Kisumu may be a health risk due to water borne diseases.
  • According to the reports the death toll in Argentina due to floods rises to 57.
  • China has fast-tracked the approval of a new drug in an attempt to contain an outbreak of a new strain of bird flu known as H7N9.
  • Moderate earth quake measuring 5.8 on Richters scale hits Kashmir valley on Aril 4th. No damage to life or property has been reported.
  • Massive earthquake measuring 7.2 magnitude rocks Indonesia on 6th April. No tsunami warning has been issued.
  • According to the reports from the U.S. Geological Survey, a magnitude -6 undersea earthquake had hit eastern Japan on April 2nd.
  • Mild earthquake measuring 4.5 was felt in Kutch in Gujarat. No reports of casualties or property damage.