Research shows that the costs of developing new medicines can be much lower than the industry claims
Doctors have released details for the first time about their spending on a major clinical trial, revealing that the true cost of developing a drug could be much lower than the billions of dollars claimed by the pharmaceutical industry.
Médecins Sans Frontières (MSF) is challenging pharmaceutical companies to be transparent about the costs of trials, which have always been shrouded in secrecy. Its own bill for groundbreaking trials of a four-drug combination treatment for drug-resistant tuberculosis was €34 million (£29 million).
Current estimates for research and development of new drugs range from €40 million to €3.9 billion. The excessive costs of trials are used to justify the high prices of new drugs, but companies publish neither sales nor an overview of their expenses. Doctors Without Borders says this opacity must end. It has developed a toolkit for drug researchers that categorizes each expenditure item and allows costs to be collected throughout the process, which can take years.
MSF’s research, called TB Practecal, has changed the outlook for people with drug-resistant forms of tuberculosis, which have high mortality rates and are untreatable in some countries due to the high price of the few drugs that still work.
Dr. Bern-Thomas Nyang’wa, Medical Director of Médecins Sans Frontières and principal investigator of the study, said: “We hope that our disclosure of the costs of clinical trials to identify an improved regimen for drug-resistant tuberculosis will serve as a signal to other public opinions. and nonprofits to join us and publicly share their clinical trial costs to ensure broader transparency in medical R&D costs.”
He added: “We encourage sponsors and clinical trial conductors to trial our Transparency Core toolkit, and build on it as a guide to facilitate the publication of cost data. While transparency in R&D spending remains largely elusive, transparency in clinical trial costs is a transformative step toward uncovering what medical innovation actually costs and building a future where access to medicines and medical devices is unhindered due to high prices.”
The two antimicrobial drugs that have been the basic treatment for tuberculosis for decades, isoniazid and rifampin, no longer work as well as they used to. The outlook for patients with drug-resistant tuberculosis is bleak in middle- and low-income countries. Even if alternative medications 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 US Food and Drug Administration in 40 years. But the costs were unaffordable for many of the hardest-hit countries. It took the activists a long struggle to get the price lowered. The cost of R&D was a key factor. It was eventually revealed by academics that the drug was developed thanks to public funding five times more than private investment.
MSF has tested the use of a combination of four oral drugs, including bedaquiline, against drug-resistant tuberculosis. Its success led the World Health Organization (WHO) to recommend six months of treatment with the combination for rifampicin-resistant tuberculosis. It is now used in 40 countries.
Roz Scourse, policy advisor at MSF’s Access Campaign, said: “The global movement calling for a significant price reduction of the life-saving tuberculosis drug bedaquiline has shown that transparency of R&D costs can lead to better access to medical devices and help save more lives.
“The unsubstantiated but 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 crucial piece of the policy puzzle that can determine the price of medical products, and who benefits gets access to. ”
The MSF paper, presented Thursday at a WHO conference on drug pricing, showed that it is possible to collect good data on research spending, Scourse said. She urged disclosure so that governments and communities can have the evidence they need to discuss pricing and work to ensure access for all who need the drugs.
Although MSF’s studies took place in middle-income countries, the costs were not low, Scourse says, as they had to invest significant amounts of money to modernize infrastructure – such as TB clinics – to conduct high-quality research.
The trade body for the pharmaceutical industry, the International Federation of Pharmaceutical Manufacturers and Traders (IFPMA), said most estimates for the cost of an approved drug ranged from $2.2 billion to $3.2 billion (£1.7 billion to £ 2.5 billion), and pointed to a 2022 Deloitte analysis report showing that an average of $2.3 billion.
“The pharmaceutical industry invests approximately $200 billion in research and development each year,” said James Anderson, IFPMA’s executive director of global health. “In the past decade alone, companies have developed more than 470 drugs to treat diseases such as cancer, cardiovascular disease 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 should reflect the value a medicine delivers to societies in different countries. This can only be achieved by recognizing the value of medicines while engaging in dialogue about how innovations can be made more affordable and accessible to all.”