Bacterial resistance is a devastating problem. Over two-million Americans suffer from antibiotic-resistant infections every year, causing about 23,000 deaths. And the World Health Organization warns that a post-antibiotic era may be upon us, when common infections and minor injuries can kill. Yet, the WHO also reports that there have been no new major types of antibiotics developed since the 1980s. And the FDA approved only three new molecular entities (drugs with new and innovative chemical structures) between 2011 and 2013, the lowest number since the 1940s.
Eduardo Porter, who writes the Economic Scene column for The New York Times explores the reasons for this. Due to bacterial resistance, many drugs have become ineffective. And the drug companies that produced these drugs in the past have exited the market. Dr. Mikael Dolsten who oversees worldwide research and development at Pfizer says, It has become very difficult to find new drug classes to fight infections. There haven t been enough incentives for the industry to take on 10 to 15 years of research. This points to the exorbitant costs of developing new drugs. According to scientists from Eli Lilly, the total cost is around $1.8 billion for just one new drug. And then there s also the problem that new antibiotics will only be used as a drug of last resort to prevent bacteria from developing resistance. By the time it [the drug] became a mass-market drug, companies fear, it could be already off-patent and subject to competition from generics that would drive its price down.
This lack of innovation is also present in the fields of HIV/AIDs drugs, as well as drugs to treat neuropsychiatric diseases. Instead, drug companies are now more focused on individualized therapies and drugs aimed at treating orphan diseases. This line of research is cheaper and insurance companies are willing to cover the cost of the drug, making this class of drugs more appealing to industry.
So what should be done? Porter highlights a few suggestions including tweaking the patent system for drug innovation. He says, research on new antibiotics could be encouraged by allowing shorter clinical trials for the promising molecules or guaranteeing minimum returns for groundbreaking drugs. Or he suggests maybe taking a note from Britain s National Institute for Health and Care Excellence, which determines what therapies will be covered, based on their efficacy and their price.