Cost of developing new drugs may be lower than industry claims: trial

Doctors have for the first time released details of their spending on a major clinical trial, demonstrating that the true cost of developing a medicine may be far less than the billions of dollars claimed by the pharmaceutical industry. Médecins Sans Frontières is challenging drug companies to be transparent about the cost of trials, which has always been shrouded in secrecy. Its own bill for landmark trials of a four-drug combination treatment for drug-resistant tuberculosis came to €34m. Current estimates for research and development of new medicines range from €40m to €3.9bn. The extortionate cost of trials is used to justify high prices of new medicines, but companies do not publish either the topline or a breakdown of their spending. Dr Bern-Thomas Nyang'wa, MSF's medical director and the chief investigator of the trial, said: "We hope that our disclosure of clinical trial costs for identifying an improved regimen for drug-resistant tuberculosis will serve as a clarion call for other public and nonprofit actors to join us and publicly share their clinical trial costs to ensure broader transparency in medical R&D costs." He added: "We encourage clinical trial sponsors and implementors to try our Transparency Core toolkit, and to build on it as a guide to facilitate the publication of cost data. While transparency in R&D expenditure remains largely elusive, transparency in clinical trial costs is a transformative step towards exposing what medical innovation actually costs and building a future where access to medicines and medical tools is not hindered by high prices." Bedaquiline, a new drug with a different mechanism against drug-resistant TB, was developed by Johnson & Johnson and, in 2012, became the first TB drug to be approved by the Food and Drug Administration in the US in 40 years. The pharmaceutical industry trade body, the International Federation of Pharmaceutical Manufacturers and Traders, said most estimates for the cost of an approved drug ranged from $2.2bn-$3.2bn, and pointed to a Deloitte analysis from 2022 which put the average at $2.3bn. "The pharmaceutical industry invests around $200bn every year on research and development," said James Anderson, IFPMA's executive director of global health.