10 million: the number of new cases of active tuberculosis (TB) in 2017.

TB is one of the top ten leading causes of death from a singular infectious agent worldwide. With 1,600,000 TB-related deaths in 2017, it ranks above HIV/AIDS. South-East Asia, Africa and the Western Pacific are the most severely affected, but there is an annual incidence of over 1,326,000 cases throughout the Eastern Mediterranean, the Americas and Europe. These statistics clearly illustrate the need for effective – and immediate – global intervention.

Bedaquiline

Since the development of rifampicin in the late 1960s, there has been little progress regarding drug treatments for multi-drug-resistant tuberculosis (MDR-TB). Furthermore, rates of resistance to rifampicin and isoniazid (another first-line anti-TB treatment) have steadily increased since the start of their usage.

The breakthrough drug bedaquiline was recently developed by the drug company Janssen in 2012. A diarylquinoline, it is the first new effective treatment against MDR-TB. In many cases, it is the only drug left able to treat severe MDR-TB. Bedaquiline works by inhibiting mycobacterial adenosine triphosphate synthase, thus interrupting the bacterium’s replication.

Of course, treatment providers wish to prescribe the most effective treatment to patients with MDR-TB with the fewest side effects. Bedaquiline is a curative treatment for MDR-TB, and does not cause many of the terrible side effects of the previous anti-TB drugs, such as permanent deafness and psychosis.

Although it is largely safer, bedaquiline has been shown to degrade the liver and the heart (especially when used in combination with certain drugs used in the treatment of HIV), so the conditions under which bedaquiline is prescribed should be carefully monitored. Active pharmacovigilance will mean that patients are safely treated when the drug becomes more accessible.

J&J’s monopoly

Janssen, the drug’s developer, is a pharmaceutical company of Johnson & Johnson (J&J), the multinational corporation that owns a multitude of well-known brands from Band-Aid to Nicorette, Neutrogena to Benadryl. A giant in the industry, J&J have patented bedaquiline until 2023 in a number of countries in which access is needed most (such as in India). Thus, they greatly control the distribution of bedaquiline worldwide.

Injustice

Bedaquiline is a drug for the people, funded by the people. Taxpayers paid for its development via research funded in the US. Philanthropists and non-profit organisations donated money to the cause. Vital work was conducted in the TB research community, including clinical trials conducted by treatment providers – including MSF. The fact that those whose lives depend on accessing this core new drug treatment for MDR-TB cannot access it is an injustice, and it is costing people their lives. Something must be done.

The access campaign

Médecins Sans Frontières (MSF) is the largest non-governmental provider of treatment for TB worldwide, providing specific aid in over 25 countries for the treatment of MDR-TB. MSF launched a global campaign on the 10th October this year demanding that J&J lower the price of bedaquiline to $1 a day. This is half of the lowest price that J&J currently sell the drug for and is still unaffordable for many people who need it. Although there are now effective treatments for MDR-TB - such as bedaquiline - the price of these drugs remains one of the key barriers against treating everyone, and remains a vital target for change.

Frustratingly, J&J have refused to share their financial information regarding the production of bedaquiline, but external researchers have calculated that the drug could be produced for as little at 25 cents per day. Thus, J&J’s statement that they are already losing money by selling bedaquiline at their ‘special effort’ price of $2 may well be untrue. Without transparency in the pharmaceutical industry, the fair distribution of drugs becomes even more challenging than it already is. The patent that J&J holds means that generic manufacturers cannot produce an affordable version of the drug for distribution, which continues to prevent access to bedaquiline.

What can you do now?

Join the protest on Twitter, Facebook or Instagram using the hashtags #NoMoreTears and #JnJCanYouHearUs. Stay informed and updated, and – if you are able – take part in your local global day of action whenever they happen.

TB is a curable disease and must stop being a death sentence. Let us hold J&J to account for their dangerous greed.

Sources:

• https://en.wikipedia.org/wiki/Category:Johnson_%26_Johnson_brands

• https://www.who.int/tb/challenges/mdr/bedaquilinefaqs/en/

• https://www.tballiance.org/portfolio/compound/bedaquiline

• http://unitaid.org/assets/TMC_207_Patent_Landscape.pdf

• https://en.wikipedia.org/wiki/Category:Johnson_%26_Johnson_brands

• http://nomoretears.msfaccess.org/why-should-johnson-johnson-listen-us

• http://nomoretears.msfaccess.org/

• https://doi.org/10.1093/jac/dkw522