The World of International Organizations Explained

WHO says new antibiotics pipeline thins

Amoxicillin capsules used to treat bacterial infections or with other medicines to treat stomach ulcers (ARÊTE/Rob Brewer)

GENEVA — The United Nations’ health agency said on Thursday at least 700,000 people a year die from drug-resistant diseases but there are only 50 antibiotics in the medical research community’s pipeline of potential new drugs.

A dearth of private investment and innovation are “undermining efforts to combat drug-resistant infections,” the World Health Organization warned in a statement. The annual deaths from drug-resistant diseases include 230,000 just from multi-drug resistant tuberculosis.

WHO said the pharmaceutical industry’s “weak” pipeline includes 60 products in development: 50 antibiotics and 10 biologics, which comprise a range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.

“Never has the threat of antimicrobial resistance been more immediate and the need for solutions more urgent,” said WHO’s director-general, Tedros Adhanom Ghebreyesus, a politician and public health expert who has headed Ethiopia’s foreign affairs and health ministries.

“Numerous initiatives are underway to reduce resistance,” he said, “but we also need countries and the pharmaceutical industry to step up and contribute with sustainable funding and innovative new medicines.”

The U.N. health agency, citing two new reports it produced, said new products under development would “bring little benefit over existing treatments and very few target the most critical resistant bacteria (Gram-negative bacteria).” This kind of bacteria can kill people with weak or developing immune systems, such as newborns, the elderly, or people getting surgery or cancer treatment.

It said research and development for antibiotics is primarily driven by small or medium size enterprises as “large pharmaceutical companies continuing to exit the field.” One bright spot in the pipeline, WHO said, is the prospect of antibacterial agents for tuberculosis and Clostridium difficile infection.

A report by WHO last year said growing antimicrobial resistance, which affects everyone, could cause 10 million deaths a year by 2050, triggering a financial crisis. Most at risk are the elderly, people with compromised immune systems and patients getting surgery, chemotherapy or organ transplants.

‘Running out of options’

Numerous outside experts have remarked that the development pipeline is drying up, mainly due to questions about the pharmaceutical industry’s return on investment and the regulatory environment. The industry has been one of the most profitable in the world, with annual sales in the hundreds of billions of dollars.

The market cap of Johnson & Johnson, the biggest company in the top ten, is $345 billion, while the next four biggest — Novartis, Merck, Roche and Pfizer — each exceed $200 billion. The other five — AbbVie, AstraZeneca, Sanofi, GlaxoSmithKline and Eli Lilly — each exceed $100 billion.

Despite their immense size and profitability, their pipelines have been drying up for some time. They face public outcries and political opposition over the high prices of prescription drugs and established treatments. And as the companies bring fewer new drugs into their product pipelines, they also contend with expiring patents on their biggest sellers, resulting in more competition from generics.

A priority pathogens list published by WHO in 2017 to encourage more innovation has 12 classes of bacteria along with tuberculosis that present increasing risk from resistance to most drug treatments. Among the 50 antibiotics in the development pipeline, WHO said, 32 target priority pathogens but would not bring many new benefits beyond those of existing drugs. Two treat Gram-negative bacteria.

Just three antibiotics in the pipeline target the alarming and highly resistant NDM-1, which makes bacteria resistant to a range of antibiotics including Carbapenems — a last resort class of antibiotics used to treat multi-drug resistant bacterial infections.

“It’s important to focus public and private investment on the development of treatments that are effective against the highly resistant bacteria because we are running out of options,” said Hanan Balkhy, WHO’s assistant director-general for antimicrobial resistance.

The world of international organizations explained.

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