The biotechnology industry has failed to live up to its promise of delivering cheaper and better drugs, according to researchers in Italy, who suggest only a quarter of the biologics licensed since the formation of the European Medicines Agency (EMEA) were a real advance over existing treatment.
The research team, headed by Silvio Garratini of the Mario Negri Institute for Pharmacological Research in Milan, found that of 61 products licensed by the EMEA for therapeutic use between 1995 and 2003, only 15 “were for diseases without effective treatment, more effective than existing treatment, or active in patients resistant to current treatment.”
They conclude that 22 of the biologics offer limited non-therapeutic advantages over existing products, 10 in terms of safety (for example by replacing animal-derived proteins with those made by recombinant techniques) and 12 in terms of convenience, usually a reduction in dosing frequency. The remaining 24 are simply ‘me too’ products, they said.
The study, reported in the British Medical Journal (October 15) also suggests that some of the methodologies used to evaluate these new biologics have not been as robust as they should be. For example, a number of the drugs were compared to placebo in pivotal testing, even though an active comparator drug existed. This indicates that “commercial priorities come before the sound development of drugs in the interest of patients,” according to the researchers.
In addition, the promises of biotechnology substances to be more effective and less toxic than conventional drugs have been only partially fulfilled, add the researchers, who say the key difference between biologics and chemical drugs - their cost - also deserves evaluation.
On a more positive note, the team concedes that biotechnology has made it possible to make available drugs that would otherwise be impossible to obtain in large amounts as well as research tools that are useful for discovering new drugs.
“Let us hope that in future biotechnology will better live up to its promises,” they conclude.