Pharmaceutical companies were quick to jump on the swine flu (H1N1) bandwagon and develop a vaccine -- attracting hundreds of millions of dollars of contracts from governments around the world in the process. But when it comes to antibiotics and fighting the growing problem of antibacterial resistance, the world doesn't seem as interested. The AAM's findings adds its voice to recent warnings on antibiotic research from the London School of Economics and Political Science, which agrees that Big Pharma needs better incentives for developing antibiotics.
The human and financial tolls
Antibiotic resistance arises mostly from random mutations in the bacteria genes. Some species or subspecies are "naturally resistant"; others develop an "acquired resistance" to antibacterial drugs. Both types can spread their resistance determinants through horizontal gene transfer or replication.
Bacterial and parasitic diseases are the second-leading cause of death worldwide. The LSE reports that 175,000 die from infections acquired in hospitals in Europe every year. ("Antibiotic resistance is never going to go away," the AAM notes.) Yet the number of available antibiotics is declining, because many can no longer combat common diseases. And there's a dire shortage of alternatives.
It gets worse. Drug-resistant superbugs like Methicillin-resistant Staphylococcus aureus (MRSA) can't be stopped by traditional antibiotics, making penicillin and its derivatives increasingly obsolete. Childhood pneumonia, dysentery, and tuberculosis no longer respond to first-line antibiotics in some parts of the world.
These diseases create serious economic costs on lost productivity, longer hospital stays, and more expensive treatments. And increasing resistance is erasing the gains (made through massive global spending) on malaria, tuberculosis, and HIV prevention.
Big Pharma's financial motivations
Such heavy social and economic costs -- and such lucrative opportunities for pharmaceutical companies -- would make research and development on vaccines seem like a no-brainer. But pharmaceutical companies don't invest in researching or developing better antibiotics or vaccines, partly because of regulatory issues, and partly because there's little financial incentive. Only a handful of companies have small R&D operations, with few drugs in the first stages of development.
Because developing drugs takes years, the costs of antibiotic discovery and development and the need for long-term clinical trials outweigh any profits. That's why companies prefer developing drugs for chronic diseases, whose customers need the drug for longer terms. But a tougher problem for pharmas is that its product becomes obselete once a resistance is built.
Both reports suggest incentives for pharmaceutical companies to invest in antibiotic research. One is to extend the patents given for antibiotics, especially for those aimed at the developing world, which would give the company longer exclusivity on the product and would give the company incentive to manage the disease's resistance to the drug. (Once an antibiotic goes off-patent, pharmas have little financial incentive to manage resistance.)
Experts criticize the U.S. regulatory system -- the "approval process for new antibiotics is unduly time-consuming and expensive" -- and often leaves pharmas hanging. Companies who pay large fees for a speedy process often get flummoxed by the slow-acting FDA to respond (or to change regulations and requirements midstream).
The AAM report also recommends diverting resources to pursue alternative approaches including vaccines, antisense therapy, and public-health initiatives. But much-needed research bridging medical, chemical, and environmental disciplines is often blocked by scientific obstacles that no financial incentives could remove.
In addition, the experts recommend several strategies to deal with the problem, including improved diagnostics, surveillance, control and containment, communication, guidance and implementation of "judicious and prudent use" of antibiotics, and control of generic antibiotics. This way, while resistance "will always prevail," at least we will "coexist."
The road ahead
Given the AAM's finding that "it's virtually impossible to conceive of any solution, or combination of solutions, that will have a significant global impact," our hopes lie with Sweden, pushing for legislation on antibiotic development in Europe. Swedish officials will also meet with U.S. counterparts in December to push for U.S. legislation.
Other signs of progress are emerging. Swiss-based Basilea Pharmaceutica, one of the few pharmaceutical companies concentrating on antibiotic development, recently began selling an antibiotic against MRSA and other superbugs in a few markets, and it has submitted applications with U.S. and European authorities. GlaxoSmithKline (GSK) has an Antibacterial Discovery Performance Unit, and some pharmas have indeed tried to aide the developing world in different ways. With the patent cliff approaching and pharmas looking to supplement lost revenue, steering them toward the developing world could be useful to all.