A pledge by the world's biggest drug companies to develop new antibiotic drugs as a war to battle “superbug infections” is reviving the debate over what market models might best incentivize manufacturers.
“Antibiotics have been around for a long time and I think there's an element of people taking them for granted,” said David Payne, vice president and head of the antibiotics discover performance unit for GlaxoSmithKline. “I think as we go in the future, I think the whole analogy of one of preparedness and having them there even though you may not need them as an individual today is a good one.”
GSK was one of more than 80 signatories of a declaration released Thursday at the World Economic Forum in Davos, Swtizerland, where pharmaceutical firms called for more government financial support in developing new antibiotics as a step toward addressing the lack of innovation and the growing resistance to current antibiotics.
Infectious disease experts say the problem has grown worse in recent years because of overuse of current medicines and declining investment into new therapies, which can cost millions of dollars to produce and up to 10 years to see federal approval. Drugmakers can't make big profits on relatively cheap drugs that are used for a short while.
Payne said the traditional market model that bases revenue on demand should not be applied to antibiotics. He thinks that if governments paid a lump sum amount to stockpile antibiotics, drugmakers would get a return for research and development costs while reducing the risk of their overuse.
“If that model is worked out in an optimal way, there should be no need for the company to promote or market an antibiotic,” Payne said.
But in 2011, the Centers for Disease Control and Prevention made the point that government incentives might prompt manufacturers to push their current products as competitors entered the market. The CDC brief reminded readers that overuse of antibiotics diminished their effectiveness.
Financial considerations aside, it's hard to develop a new class of antibiotics to treat highly resistant infections such as those caused by gram-negative bacteria, which are extremely virulent.
“Scientifically, a lot of the low-hanging fruit has been picked,” said Elizabeth Jungman, director of public health for the Pew Charitable Trusts. “Many experts would say the most recent class of antibiotics was discovered in the 1980s, so we're kind of doing variations on themes at this point.”
The problem lies in the fact that some of the newest, most dangerous drug-resistant threats are resistant to even modified or combined forms of existing antibiotics. One promising and inexpensive product is a compound that works to increase the effectiveness of existing antibiotics.
A new analysis released this week by the Natural Resources Defense Council reported bacterial resistance recently found to colistin, considered to be a last-resort antibiotic used to treat multidrug-resistant forms of pneumonia.
GSK has one antibiotic that is near completion of Phase 2 clinical trials, Payne said. According to the Pew Charitable Trusts, it is one of about 37 new antibiotics in clinical trial phase for the U.S. market.
Dr. Helen Boucher, a professor of infectious disease at Tufts University School of Medicine, said any plan moving forward will need collaboration between public and private parties.
She said such partnerships could take a variety of forms. One short-term possibility could be to expand existing programs, such as the Biomedical Advanced Research and Development Authority within HHS, which provides grant funding toward development of necessary vaccines, drugs, therapies for public health emergencies.
Another possibility could come from President Barack Obama's National Strategy to Combat Antibiotic-Resistant Bacteria, which seeks to improve stewardship, accelerate the development of new antibiotics and strengthen detection of resistant-bacteria infection outbreaks over the next five years.
“Anytime colleagues and different stakeholders can come together and sort of make a commitment—that can only strengthen the progress in advancing toward meeting the president's goals,” Boucher said.