https://www.theguardian.com/global-development/2024/apr/25/cost-of-developing-new-drugs-may-be-far-lower-than-industry-claims-trial-reveals [p] Skip to main contentSkip to navigation Close dialogue1/3Next imagePrevious imageToggle caption Skip to navigation Print subscriptions Sign in Search jobs Search US edition[ ] * US edition * UK edition * Australia edition * International edition * Europe edition The Guardian - Back to homeThe Guardian [ ] * News * Opinion * Sport * Culture * Lifestyle ShowMoreShow More * [ ]News + View all News + US news + US elections 2024 + Donald Trump trials + World news + Environment + Ukraine + Soccer + Business + Tech + Science + Newsletters + Wellness * [ ]Opinion + View all Opinion + The Guardian view + Columnists + Letters + Opinion videos + Cartoons * [ ]Sport + View all Sport + Soccer + NFL + Tennis + MLB + MLS + NBA + NHL + F1 + Golf * [ ]Culture + View all Culture + Film + Books + Music + Art & design + TV & radio + Stage + Classical + Games * [ ]Lifestyle + View all Lifestyle + Wellness + Fashion + Food + Recipes + Love & sex + Home & garden + Health & fitness + Family + Travel + Money * Search input [ ] google-search Search + Support us + Print subscriptions * [ ]US edition + UK edition + Australia edition + International edition + Europe edition * + Search jobs + Digital Archive + Guardian Licensing + About Us + The Guardian app + Video + Podcasts + Pictures + Inside the Guardian + Guardian Weekly + Crosswords + Wordiply + Corrections * + Search jobs + Digital Archive + Guardian Licensing + About Us * World * Europe * US * Americas * Asia * Australia * Middle East * Africa * Inequality * Global development A doctor holds a patient's hand at a desk [ ] MSF's bill for trialling a four-drug combination treatment for drug-resistant tuberculosis came to EUR34m. Photograph: Oliver Petrie/ MSF View image in fullscreen MSF's bill for trialling a four-drug combination treatment for drug-resistant tuberculosis came to EUR34m. Photograph: Oliver Petrie/ MSF Fair AccessGlobal development Cost of developing new drugs may be far lower than industry claims, trial reveals Exclusive: MSF calls for transparency after its bill for a trial of TB treatment came to a fraction of the billions claimed by pharmaceutical companies Supported by OSF (Fair Access) About this content Sarah Boseley Thu 25 Apr 2024 06.10 EDTLast modified on Thu 25 Apr 2024 07.10 EDT Share 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. Medecins Sans Frontieres (MSF) 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 EUR34m (PS29m). Current estimates for research and development of new medicines range from EUR40m to EUR3.9bn. 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. MSF says this opacity should end. It has produced a toolkit for drug trialists, which categorises each item of expenditure and allows the costs to be collated throughout the process, which can last for years. MSF's trial, called TB Practecal, has transformed prospects for people with drug-resistant forms of TB, which have high mortality rates and in some countries have been untreatable because of the high price of the few drugs that still work. 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." Medical cooler box for the transportation of specimens in the TB Practecal trial. View image in fullscreen The MSF says it hopes its disclosure will act as a 'clarion call' for the industry. Photograph: Alexandra Sadokova/MSF The two antimicrobial drugs that have been the staple treatment for TB for decades, isoniazid and rifampicin, no longer work as well as they did. The outlook for patients with drug-resistant TB has been bleak in middle and low-income countries. Even if alternative drugs were available, they had to be taken regularly for an entire year. 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. But the cost was prohibitive for many of the worst-affected countries. It took a long battle by campaigners to get the price reduced. The cost of R&D was a key factor. Eventually, it was revealed by academics that the drug was developed thanks to public funding, which was five times more than private investment. MSF trialled the use of a combination of four oral drugs, including bedaquiline, against drug-resistant TB. Its success led to the World Health Organization (WHO) recommending six months' treatment with the combination for rifampicin-resistant TB. It is now in use in 40 countries. Roz Scourse, a policy adviser with MSF's Access Campaign, said: "The global movement that pushed for a significant price reduction of the lifesaving TB drug bedaquiline demonstrated that transparency of R&D costs can lead to increased access to medical tools and help save more lives. South Africans take on big pharma for access to 'miracle' cystic fibrosis drug Read more "The unsubstantiated yet dominant narrative that high prices are needed to recoup high R&D costs can no longer remain an evidence-free zone - this information is a critical piece of the policy puzzle that can inform the price of medical products, and who gets access." MSF's paper, presented Thursday at a WHO conference on medicines pricing, showed it was possible to collect good data on spending in trials, Scourse said. She urged public disclosure, so that governments and communities can have the evidence they need to discuss pricing and work towards access for all those who need the medicines. Although MSF's trials took place in middle-income countries, the costs were not low, said Scourse, because they had to invest substantial sums to upgrade infrastructure - such as TB clinics - to be able to conduct high-quality research. Staff members and a woman in traditional Uzbek dress stand outside the entrance to a clinic, with balloons around the door. View image in fullscreen Staff at a clinic in Uzbekistan where the MSF's TB Pracetcal treatment was trialled. Photograph: Alpamis Babaniyazov/MSF The pharmaceutical industry trade body, the International Federation of Pharmaceutical Manufacturers and Traders (IFPMA), said most estimates for the cost of an approved drug ranged from $2.2bn-$3.2bn (PS1.7bn-PS2.5bn), 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. "Over the last 10 years alone, companies have developed over 470 medicines to treat diseases such as cancer, cardiovascular diseases and diabetes, as well as vaccines to protect against significant infections from malaria, RSV and Covid-19, among others. "Medicines should be affordable to healthcare systems, available to patients everywhere, and prices must reflect the value that a medicine delivers to societies in different countries. This can only be achieved by recognising the value of medicines, while engaging in dialogue on how to make innovations more affordable and accessible to all." 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