To Fight ‘Superbugs,’ Drug Makers Call for Incentives to Develop Antibiotics
More than 80 pharmaceutical and diagnostic companies from around the world are calling for new economic models to spur development of badly needed new antibiotics and to fight the rising global threat of drug-resistant “superbugs.”
In a declaration that is being released on Thursday at the World Economic Forum in Davos, Switzerland, the companies say that governments must work with companies to fight the problem of antimicrobial resistance, in which many germs are no longer killed by common antibiotics and in some cases even by last-ditch options, turning once-treatable infections into life-threatening events.
The signers of the declaration include such big pharmaceutical companies as AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Merck and Pfizer as well as some smaller biotech companies and some generic manufacturers in India.
The number of new antibiotics being approved has dwindled over the last two decades, because of scientific challenges but also financial ones. Many big pharmaceutical companies, including some of those that signed the new declaration, have de-emphasized or dropped development of antibiotics for business reasons.
Antibiotics are typically used for a week or two to cure an infection and generally have low prices. It is far more lucrative to develop drugs for cancer or chronic diseases that can be used for months or even a lifetime and which typically have much higher prices.
“We support the increasing recognition that the value assigned to antibiotics and diagnostics often does not reflect the benefits they bring to society, nor the investment required for their creation,” the document says. It calls for “prompt reimbursement” at prices that reflect such value.
But it also says that other “transformational commercial models” might be needed to spur development and also to cut down on unnecessary use of antibiotics, which contributes to the development of antimicrobial resistance. One idea is to have governments or a global organization pay a drug company a big lump sum when an antibiotic is developed. That could reduce the need for pharmaceutical companies to promote their products to spur sales.
The declaration also calls for enhanced use of diagnostic tests that can rapidly identify the infecting organism. That can help make sure, for instance, that antibacterial drugs are not used needlessly to treat a viral infection, for which they would not work.
The ideas have been discussed before, including by the Review on Antimicrobial Resistance, an activity commissioned by David Cameron, Britain’s prime minister, in 2014. That organization helped develop the declaration being released at Davos. The World Health Organization and the G-7 have also discussed ways to fight antibiotic resistance.
In the United States, Congress in 2012 enacted the GAIN Act, standing for Generating Antibiotic Incentives Now, which provided five extra years of protection from generic competition for certain antibiotics and also made it easier for new antibiotics to win approval from the Food and Drug Administration.
Allan Coukell, an antibiotics expert and senior director of health programs at the Pew Charitable Trusts, said what was most noteworthy in the declaration was that the companies were jointly acknowledging industry’s responsibility for helping to make sure antibiotics were used properly. "They are saying we need new ways to pay for the drugs, but we also have a role to play in ensuring they are not overused,” he said.
David Shlaes, a retired consultant to antibiotic developers, said the important question was whether the incentives outlined in the declaration would be enough to get some big drug companies to re-enter the field. "If this comes to pass, will they get off the bench and get back into the game?” he asked.
By ANDREW POLLACKJAN. 20, 2016http://www.nytimes.com/