Clinical Trial Transparency, Medicines Access On Agendas Today

The World Health Organization today issued a call for disclosure of results from clinical trials for medical products, no matter what the results of the trials were. And a variety of events and publications are addressing medicines access today.

Also today, intellectual property industry group FICPI is holding its 2015 World Congress in Cape Town, South Africa. The programme includes a panel on access to medicines, with a representative of Novartis expected to be joined by Ellen ‘t Hoen, founder of the Medicines Patent Pool. Intellectual Property Watch is on the ground reporting on this event.

And today the Carnegie Endowment for International Peace in Washington, DC is holding an event entitled, “Strengthening the U.S.-India Partnership: Fostering Innovation and Expanding Healthcare Access Worldwide.”

A representative of Gilead was scheduled to participate in the Carnegie event, alongside access to medicines advocate James Love of Knowledge Ecology International. Gilead is the producer of a new drug for hepatitis C, sofosbuvir, which is sold for US$ 84,000 for a 12 week course, or US$ 1,000 a pill.

Today the intergovernmental South Centre today re-issued a statement by its Director Martin Kohr, singling out Gilead for excessive pricing, saying that, “Access to medicines, even if a person is too poor to afford it, is a cornerstone to the realization of the right to health and life. There has been significant progress in new and better medicines. However prices of the medicines are often priced so high so as to be out of reach of the poor or even the middle classes in many countries, not only in developing but also in developed countries.”

“A major reason for this is the monopoly granted to drug companies through patents, which prevents competition. Sometimes the prices are so astronomical so as to make super profits for the companies.”

What Patients Want

And elsewhere, the results of patient survey were published today, entitled, “What the public knows and wants to know about medicines research and development: a survey of the general public in six European countries.” According to a release, researchers at the University of Manchester and Central Manchester University Hospitals NHS Foundation Trust (CMFT) published data for the first time about public knowledge of and interest in the process of medicines research and development (R&D).

“The survey was completed by 6931 members of the public, over 75% of whom reported having no or less than good knowledge of medicines R&D,” a summary states.

The study is part of a wider European Patients Academy on Therapeutic Innovation (EUPATI) project.

“By providing an extensive insight into people’s knowledge and interests, the researchers hope the data will help drive public involvement in medicines R&D, which is the main objective of the EUPATI project,” the press release says. “Increased engagement and involvement of patients in research has been shown to increase study recruitment/retention and improve patient experience2, supporting the delivery of better healthcare through the development of new diagnostics, medicines and devices. It is thought that the information will also be useful to pharmaceutical companies wishing to involve the public in medicines research.”

WHO Call for Clinical Trials Transparency

The WHO call is intended to ensure that decisions related to the safety and efficacy of vaccines, drugs and medical devices for use by populations are supported by the best available evidence, WHO said in a press release.

“Our intention is to promote the sharing of scientific knowledge in order to advance public health,” Marie-Paule Kieny, WHO assistant director general for health systems and innovation, said in the release. “It underpins the principal goal of medical research: to serve the betterment of humanity.”

“Failure to publicly disclose trial results engenders misinformation, leading to skewed priorities for both R&D and public health interventions,” Kieny said. “It creates indirect costs for public and private entities, including patients themselves, who pay for suboptimal or harmful treatments.”

WHO said its recent move expands on a 2005 call for all clinical trials to be registered, and the subsequent establishment of the International Clinical Trials Registry Platform. This registry platform regularly imports trial records from Clinicaltrials.gov, ISRCTN, EU Clinical Trials Register, Australia New Zealand Clinical Trial Registry, Pan African Clinical Trial Registry and Clinical Trial Registries from China, India, Brazil, Republic of Korea, Cuba, Germany, Iran, Japan, Sri Lanka, The Netherlands and Thailand.