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Generic BedaquilineFollowing recent negotiations between the Johnson & Johnson company and the Stop TB Partnership, generic bedaquiline will become available and affordable to millions of people. Bedaquiline is a crucial medication in treating multidrug-resistant tuberculosis which affects hundreds of thousands of people per year. Johnson & Johnson held a 20-year primary patent on the drug which was set to expire on July 18, 2023. 

Unaffordable Treatment

Hundreds of thousands of people globally contract multi-drug resistant tuberculosis with an estimated 450,000 in 2021 alone. While tuberculosis is relatively treatable, the vast majority of deaths from the disease occur in the global south due to unaffordable treatment pricing. As a result of the Johnson & Johnson patent on bedaquiline, tens of thousands of people were unable to afford life-saving treatment for tuberculosis. 

Despite being largely treatable, thousands of people continued to die from the disease due to this lack of access and affordability. The global south, experiencing higher rates of multi-drug-resistant tuberculosis, was particularly impacted. Despite this, Johnson & Johnson continued to apply for ‘secondary’ patents in countries around the globe. As a result, numerous organizations including Doctors Without Borders (MSF) called upon Johnson & Johnson to withdraw any ‘pending secondary patents’ and not enforce any approved secondary patents ‘for the drug in any country with a high burden of TB.’ If agreed upon, this arrangement could save thousands of lives within a short period.

Successful Negotiations

Following said negotiations between Johnson & Johnson and the Stop TB Partnership, the Global Drug Facility (GDF) was granted the licenses to procure and supply generic versions of bedaquiline to a majority of low or middle-income countries that are most impacted by the disease, including some countries where Johnson & Johnson’s patents remain in effect. However, this agreement is only a ‘partial solution.’ It doesn’t apply across the board and Johnson & Johnson still holds secondary patents in 34 of 49 countries most impacted by tuberculosis. Nevertheless, it could still have a massive impact globally on thousands of people who can afford treatment. 

A Collective Effort

The availability of generic bedaquiline can potentially save thousands of lives. This also highlights the importance of putting pressure on companies and governments to ‘do the right thing.’ Organizations like Doctors Without Borders have been instrumental in persuading Johnson & Johnson to allow cheaper and more accessible tuberculosis treatment to be produced and circulated. It also shows the impact of individuals like popular YouTuber and author John Green who used his influence to spread information about the situation and negotiations, encouraging his followers to contact Johnson & Johnson about their views on a recent YouTube video that was viewed more than 1.3 million times. 

The agreement between Johnson & Johnson and the Stop TB Partnership likely benefited from the involvement of various organizations and individuals who shared their perspectives and advocated for this collaboration. This cooperative effort demonstrates the influence of collective voices in advocating for the interests of many. Consequently, the Johnson & Johnson bedaquiline agreement represents a significant advancement in ensuring accessible and effective care for numerous individuals, showcasing the impact of advocating for the needs of the broader community.

– Jaydin Ruch
Photo: Unsplash

tuberculosis in SomaliaTuberculosis is a disease caused by bacteria that spreads through the air. While it can also be spread through the consumption of unpasteurized milk contaminated with the bacteria, the most prevalent form of the TB infection is pulmonary TB. In rare cases, TB can also affect the lymphatic system, central nervous system, urogenital region, joints and bones.

In Somalia, one of the world’s most poverty-stricken nations, less than half of estimated cases of TB are detected. Not all tuberculosis strains are equal, making diagnosis and treatment more difficult. While antibiotics typically treat TB, studies have shown that the prevalence of drug-resistant TB has increased. Somalia has a recent history of a tumultuous political climate, exacerbating obstacles that might prevent the delivery of efficient healthcare, like fund allocation and accessibility.

Diagnosis

In a cultural profile of Somalia conducted in 2006, many believed the disease was spread through airborne particles resulting from coughing or sneezing. These same people often believed that the contraction of TB also comes from a variety of things including it being inherited or the result of a loss of faith, creating stigmas around the disease.

Many people distinguished TB from other ailments with respiratory symptoms through weight loss and the presence of blood in the mucus. Until these symptoms are found in addition to an existing cough, it is assumed to be a chest infection. In cases when a fever is apparent, some confuse TB with malaria.

While the primary symptoms (cough, weight loss and bloody mucus) follow the same way the west symptomatically views TB, Somalians understand the progression of symptoms and the disease a little differently. For example, they separate coughing as a symptom into different phases based on the nature of the cough. They focus on whether or not chest pains accompany a cough, or how it sounds. Based on what phase the symptom is in, it might dictate different treatment plans.

Drug-Resistant Tuberculosis

As of 2011, 5% of first-time infected tuberculosis patients had a drug-resistant strain of TB. In comparison, 41% of previously infected patients had this more robust form of TB. These strains are resistant to several drugs used in the treatment of TB. This resulted in the highest recorded instances of multidrug-resistant TB in Africa at the time.

World Vision

World Vision is a global poverty mitigating initiative with boots-on-the-ground efforts. The organization provides healthcare resources, clean water and education to impoverished communities around the world.

Partnering with the Global Fund to Fight AIDS, Tuberculosis and Malaria, the organization has created 33 tuberculosis grants valued at a total of $160.6 million. World Vision has been the primary recipient of tuberculosis grants in Somalia.

In Somalia, World Vision works to fight the frequency of tuberculosis and its drug resistance. With the help of the Global Fund, the organization has treated more than 115,000 people. Additionally, it has trained 132 health professionals in DOTS, the directly observed treatment, short course, as recommended by the WHO. The organization has also helped 30 laboratories with TB microscopy, which resulted in the national health authority documenting 6,505 cases. World Vision continues to strive to strengthen resources within Somalia so that the government and community have a better capacity in which to deal with TB.

– Catherine Lin 
Photo: Flickr

tuberculosis in Eastern Europe
One of the oldest diseases, tuberculosis is still prevalent in hundreds of countries and nearly every continent. Although many countries have been able to reduce their number of cases through medical intervention and policies, Eastern Europe remains affected by the disease. Despite the rising cases of tuberculosis in Eastern Europe, European and other governments are coming up with new solutions to better treat individuals with TB and potentially eradicate the disease. Here are five facts about tuberculosis in Eastern Europe.

5 Facts About Tuberculosis in Eastern Europe

  1. Most of Europe’s tuberculosis cases are in Eastern Europe. According to the World Health Organization (WHO), Europe has the lowest incidence of tuberculosis in the world. However, the cases that do exist concentrate in Eastern Europe. The WHO found that 18 countries in Eastern Europe bear 85% of the tuberculosis burden for the continent. Over the past decade, cases of tuberculosis have halved throughout Europe. Despite this decrease, however, the number of cases in Eastern Europe is almost eight times higher than that of Central and Western Europe.
  2. Eastern Europe has the highest rates of drug-resistant tuberculosis. Multidrug-Resistant Tuberculosis (MDR tuberculosis) is currently the most prevalent form of TB in Eastern Europe. MDR tuberculosis occurs when the bacteria that causes tuberculosis becomes resistant to at least isoniazid and rifampin, the two most common drugs doctors use to treat tuberculosis patients. Typically, this resistance occurs when patients do not finish their antibiotics or when tuberculosis infects a person more than once. In all of Europe, 99% of MDR tuberculosis cases occur in Eastern Europe. As a result, scientists need to develop new antibiotics or treatments for patients in that region.
  3. Tuberculosis outbreaks are more common in poorer regions. In general, researchers tend to find tuberculosis in poorer and developing countries. Similarly, the levels of TB in Eastern Europe could connect to the overall poverty rates in the region. The poverty rates in Central and Western European countries such as the Czech Republic are as low as 10%. However, in Eastern European countries, such as Romania, the poverty rates are as high as 25%. In poorer countries, access to medical treatment and preventative care decreases. Thus, in Eastern Europe, a common struggle for individuals with tuberculosis is finding health care that is effective and affordable.
  4. Problems with tuberculosis are worsening due to COVID-19. The COVID-19 pandemic has led countries to implement social distancing and stay-at-home policies. As a result, the circumstances for individuals with tuberculosis in Eastern Europe may worsen. A recent modeling study looked at the rate of incidence of tuberculosis and the tuberculosis mortality rate during the lockdown. The study predicted that both the number of cases and the number of deaths will rise as people remain in close quarters. For example, imagine the lockdown in a high-risk country such as Ukraine lasting for 3 months with a 10 month recovery period. The rate of incidence would increase by 10.7% and the mortality rate would increase by 16%. One reason for this increase is the lack of medical care available during the pandemic. As more supplies and medical officials go towards fighting COVID-19, other diseases such as tuberculosis could go unchecked during the lockdown.
  5. Better diagnostic services are currently in progress. This year, in 2020, the European Lab Initiative (ELI) on tuberculosis, HIV and Viral Hepatitis, a regional center that has dedicated itself to the treatment of those three diseases, released its goals for 2020 and 2021. These goals, which include improved drug treatments and better tracking algorithms, hope to allow doctors in Eastern Europe to diagnose patients with tuberculosis faster. By diagnosing people earlier, the transmission of tuberculosis will slow, and those who test positive for tuberculosis will have a higher chance of recovery.

Although the rates of TB continue to drop in Western and Central Europe, wealth inequality and the COVID-19 pandemic are keeping the number of cases up in Eastern Europe. However, if progress on better diagnostic services continues, the occurrence of tuberculosis there will decrease.

– Sarah Licht 
Photo: Flickr

TreatmentThe World Health Organization (WHO) recently recommended two changes in the treatment of MDR-TB (multidrug-resistant tuberculosis): a new rapid diagnostic test and a shorter, cheaper treatment regimen.

The rapid diagnostic test is a DNA-based test that identifies genetic mutations in MDR-TB strains that make them resistant to second-line drugs. Second-line drugs are the most important drugs used in the treatment of MDR-TB, fluoroquinolones and injectables. If patients resistant to second-line drugs are treated with either the current or the new recommended regimen, then their MDR-TB risks evolving into extensively drug-resistant tuberculosis.

Unlike the previous diagnostic test, which took three or more months to produce results, this new test will deliver results in 24 to 48 hours.

Because the rapid diagnostic test detects how resistant a patient’s tuberculosis is to treatment, it can determine a patient’s eligibility for the new regimen that WHO recommends. Ideally, patients with uncomplicated MDR-TB (patients not diagnosed with a strain of tuberculosis that is resistant to second-line drugs) will be the ones using the new regimen.

The new treatment regimen, which was developed by the International Union Against Tuberculosis and Lung Disease (The Union), takes only half the time and is almost half the cost of the current regimen according to Dr. Mario Raviglione, the director of WHO’s Global TB Program.

Currently, the treatment of MDR-TB takes between 18 to 24 months to complete. Dr. ID Rusen, a senior vice president of The Union, told The Guardian that this equates to 14,000 pills over two years for only one person, all for a regimen that, according to WHO, has a cure rate of less than 50 percent.

WHO stated that the low success rate is due to the side effects patients undergo after taking second-line drugs for an extended period of time. In a Huffington Post article, Dr. Ariel Pablos-Mendez of USAID and Raviglione wrote that the side effects include debilitating nausea, vomiting and heaving, as well as vision loss and depression paired with suicidal thoughts. These difficulties, coupled with the financial difficulties many people experience as they try to pay for the current regimen, often cause people to interrupt their treatment.

The new treatment regimen that WHO recommends takes only nine to 12 months, and it costs less than $1,000. The shorter time frame and lower cost are expected to help people finish treatment, and the rapid diagnostic test will help them receive treatment more quickly. Less time and money spent on treatment for one person also frees up resources, so even more people will be able to receive the necessary care.

Though the new regimen has not gone through formal clinical trials, WHO has confidence the regimen works. It was tried successfully in 515 patients in Bangladesh between 2005 and 2011, then on 408 people in various African nations. Raviglione told The Guardian that WHO was accelerating the procedure because they feel the new regimen has “real potential to save lives immediately.”

Anastazia Vanisko

Photo: Flickr

PakistanOn March 17, Pakistan was honored with an award from the United States, naming the country the most successful in fighting multi-drug resistance tuberculosis (MDR-TB).

The award is significant for Pakistan, the fifth country most highly burdened by TB and the fourth most by MDR-TB, according to the World Health Organization (WHO). Although 9.6 million people globally become sick with TB each year and the number in Pakistan was 298,981 in 2013, the percentage of successful treatments has also continued to increase.

In 2001, Pakistan declared TB a national health crisis, putting the country in a state of emergency. In collaboration with the Ministry of Health and the National TB Control Program (NTP), Pakistan set objectives to facilitate improved treatments and lower incidence rates. NTP vowed to increase the number of notified TB cases, while still maintaining treatment success rate at 91 percent, and to reduce, by at least five percent per year, the prevalence of MDR-TB among TB patients who have never received any TB treatment.

The connection between poverty and TB incidence cannot be overlooked. Ninety-five percent of new TB cases and 98 percent of TB related deaths annually occur in the developing world. In Pakistan, 75 percent of TB cases fall among young people, aged 15-45, in the country’s poorest regions, according to the “TB Patients’ Declaration on TB,” a document signed at the First TB Patient Symposium in October 2014.

Since its pledge, the NTP has successfully treated more than 1.5 million TB cases, free of cost. Strategies for fighting eradication of poverty and the disease, and to minimize economic restraints on the country, have been vital to the movement’s success.

Dr Jim Yong Kim, President of the World Bank, spoke on behalf of the organization in Washington, emphasizing the need for treatment among patients categorized as low economic priority. “I am yet to meet a patient who says, please do not treat me because I am a low priority patient,” he noted.

Other presenters at the ceremony, including Ambassador Jalil Abbas Jilani, winner of the TB Champion Award, and Dr. Ejaz Qadeer, the national manager for the TB Control Programme, emphasized the growing need for not only cost-efficient treatment, but also early detection mechanisms, so as to prevent the virus from transferring from patients in crowded areas. As the country with the highest MDR-TB success rate, Pakistan plans to achieve 80 percent detection by 2020.

Between 1990 and 2015, the TB death rate has dropped 47 percent, according to WHO. With leaders like Pakistan, the rest of the world could hope for a global end of the disease.

Nora Harless

Sources: Dawn News, The Express Tribune, National TB Control Program, Target Tuberculosis, World Health Organization
Photo: Flickr