This weekly column offers opinions on the latest pharmaceutical industry news.
Drug-resistant superbugs account for an estimated 700,000 deaths worldwide today, but that number could rise to 10 million within the next few decades unless new antibiotics are developed.
That’s according to a new report commissioned by the UK government, which is proposing a provocative solution to the problem: a 10-year, $40 billion global fund to provide incentives to develop new superbug-fighting drugs.
Under the proposed scheme, any drug maker that comes up with a useful antibiotic could receive a reward of around $1 billion.
Governments are expected to provide much of the funding. But the report, released last week, also calls for a tax on any drug maker that fails to invest in new antibiotic research — and companies are already balking at the proposal. Industry trade groups quickly denounced the “pay or play” provision as “punitive” and warned it would “undermine goodwill.”
This reaction is most likely a negotiating position, but it sends the wrong message.
By embracing the proposal, the drug industry may be able to deflect withering criticism that it turned its back on promoting public health — an oft-repeated mantra when companies are asked to define their mission — and simultaneously gain an opportunity for a blockbuster payback.
After all, most large drug companies are part of the problem. Their persistent marketing of antibiotics has led to unnecessary usage and overprescribing, fueling the evolution of bacteria that have evolved resistance to our medical arsenal. Such superbugs are now responsible for an estimated 23,000 deaths annually in the United States alone.
At the same time, the biggest industry players have largely abandoned or heavily scaled back on antibiotics research thanks to scientific difficulties that led to insufficient returns. Last year, for example, shortly after buying Cubist Pharmaceuticals and its antibiotics portfolio, Merck eliminated the company’s drug-discovery group — following in the footsteps of Pfizer, Eli Lilly, and others that have also cut back on antimicrobial R&D.
This isn’t to say research is not taking place. But most antibiotic development is focused on modifying existing antibiotics. And according to a report released this month by the Pew Charitable Trusts, small companies with limited resources are doing much of the promising early-stage discovery work.
Kevin Outterson, who codirects the Boston University Health Law program, thinks that billion-dollar payouts could help bring Big Pharma back into the fold. “The proposal offers a solution that tries something novel and keeps the companies in the game in the process,” said Outterson, who served as an adviser for the UK government report and has authored his own ideas for new incentives to develop antibiotics.
Just the same, the proposal needs modification.
For one, the global fund should not automatically dish out suitcases of cash for just any new antibiotic. Some drugs will be deemed more valuable than others, and the terms should be adjusted to reflect innovation and benefits to public health.
“I think we need specific discussions, rather than throwing around large numbers,” said David Payne, who oversees antibiotic discovery work at GlaxoSmithKline. But he described the idea of separating profits from sales as “important,” because many drug makers fear investing in any new product that might reach only a small patient population should resistance crop up.
There will certainly be other points of contention, such as patent rights. Rohit Malpani, a policy director for Doctors Without Borders, cautioned that companies should be required to license all patent rights to the global fund, so that antibiotics remain affordable.
“The concern we have is that a company would be allowed to keep their intellectual property for certain countries that are lucrative markets,” he said. “If a company is going to receive a reward, they should not be allowed to have a monopoly in any country.”
These are the sorts of details that will have to be negotiated. But the pharmaceutical industry should embrace the possibilities. Lives are at stake and profits could be made. This is no time for still more resistance.