The European Union Thursday will pledge funds to find new antiobiotics, its first attempt to help drugmakers develop medicines to fight increasingly drug-resistant superbugs that are taking more lives every year and adding to rising health costs across the region.
The European Commission has teamed up with a handful of pharmaceutical and biotech companies to launch a new research program that will see the drugmakers and scientists share information that could be useful in developing new drugs, the first step in a wider initiative that European authorities hope will drive the development of a new generation of bacteria-killing medicines.
Europe's move comes amid growing efforts to try and get the first all-new antiobiotics onto the market for 30 years. The U.S. is also considering new rules that could make it more profitable for drugmakers to develop these key drugs. However, drugmakers say they need more than these initial steps if they are going to launch into very expensive research and development programs.
The problem of drug-resistant infections is growing fast. Drug resistance among microbes responsible for common infections is threatening to turn them into untreatable diseases and overuse of existing antibiotics has made them less effective. About 25,000 people in the EU and 63,000 people in the U.S. die each year due to infections caused by multi-drug resistant bacteria, according to official data.
"Antibiotics are fundamental for the practice of medicine," says John Rex, vice-president of clinical infection at AstraZeneca." Without them you cannot get your heart valve replaced, take care of a premature infant, get your cancer treated, or take care of a motor vehicle accident victim. None of those things are possible unless you have good quality antibiotics."
First discovered in the 1940s, antibiotics have allowed the development of modern medicine. But a lack investment by the pharmaceuticals sector into research in the area over the past twenty years has meant only two classes of antibiotics have been brought to market in the past 30 years. The problem is that antibiotics, although one of the most widely used medicines, don't generate the returns that pharmaceutical companies get from other drugs. They are taken only for a short period and the commercial returns are low. The companies have therefore focused on chronic diseases, where returns are higher and risks of product failure are lower.
Concerned about the growing problem, the EU Commission last November launched a plan to deal with the rising threats of antimicrobial resistance. The initiative set to be announced later Thursday is the first part of the plan and involves a new research program, called NewDrugs4BadBugs, which will see drugmakers, scientists and public bodies pool information that they'd otherwise have kept to themselves.
The Innovative Medicines Initiative, Europe's largest public-private partnership which is funded by both the European Union and the drug industry, will put EUR109 million into the project, with drugmakers providing research and development facilities and other assets to bring the total value to nearly EUR224 million.
The drugmakers include British companies GlaxoSmithKline PLC (GSK) and AstraZeneca PLC (AZN), two of the few global drug makers with an active antibiotic pipeline, as well as Sanofi SA (SNY) of France, Johnson & Johnson's (JNJ) Janssen Research & Development LLC, and Basilea of Switzerland, along with regional public research organisations, academics and other scientific experts.
An information hub will be set up to allow the sharing of knowledge and data between the program's partners and across the wider antibiotic research community.
"The central theme of this research project is the sharing of information," said David Payne who heads anti-biotic discover at Glaxo. "For example, some of the information that we used to keep locked away from everybody else is the sort of information that we're now going to be sharing with partners in this consortium, such as experiences that we've had, various drug discovery strategies that we've had. And the failures are probably one of the most important parts of how we can improve what we do as an industry and improve our overall efficiency on anti-bacterial R&D," Payne told Dow Jones Newswires in an interview.
The U.S. approach to helping the drugmakers make antibiotic research and development profitable is different. Congress is currently considering ways to address the underlying problem through the Generating Antibiotic Incentives Now Act, or GAIN. Both chambers are considering extending an antibiotic's period of patent exclusivity to make R&D in the area more attractive for drug makers.
Experts say the quest to find new antibiotics will ultimately need to address underlying economic issues.
"What we have is a clear imbalance of risk-sharing. There's the high risk on the pharma industry to invest the money in development and because many of anti-biotic processes are still not well understood at a fundamental level there is a high risk in these development programs," said Dean Summerfield, managing director for Quintiles Consulting in Europe.
"If there isn't a degree of co-risk sharing from the payers, from the providers, from the government there's still the disincentive, an imbalance preventing the industry from investing in these programs. So this is an area where a radical new approach is required," Summerfield said.
The industry says the initiatives in both the US and EU are helpful, but much more will be needed.
"We are not convinced that patent term extension, as is essentially the US proposal, will work in practice," says Richard Bergstrom, director general of the European Federation of Pharmaceutical Industries and Associations.
"Imagine that you have developed a new antibiotic against a multi-resistant bacteria: You would be expected by everyone to be prudent with your marketing and control the usage to "reserve" your new antibiotic. Even with 100 year patents, you will not make any money if you do not sell," he said. "Some kind of advanced purchase commitment or "innovation procurement" is probably required."
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dhutton replied on Permalink
Pharmaceutical industry cannot be trusted with public health
It is absurd for EU taxpayers to subsidize the pharmaceutical industry to develop new antibiotics simply because these massively profitable companies claim they cannot afford to do so.
Yet at the same time these companies sabotage the human efficacy of the few precious antibiotics that remain effective -- by selling an estimated 70% of their product for agricultural use (to fatten animals quicker), thus breeding antibiotic resistant superbugs.
These companies also spend far more money on marketing than on R&D, and focus their research on products will bring in even bigger profits but are of diminishing value to society -- such as patentable 'me-too' versions of existing drugs, and lifestyle drugs like Viagra that can be marketed to perfectly healthy people and consumed regularly for years.
Meanwhile less profitable products -- such as life-saving drugs for rare conditions, or for the diseases of the third world poor -- are neglected, plagued by shortages, or even discontinued.
This is what the corporatization of medicine looks like: immensely profitable for the companies and their shareholders, costly for both patients and taxpayers, and dangerous to the health of citizens.
We won't get the new antibiotics we need until the control of such vital medical research is clawed back from big pharma, made industry-independent and focused on public health goals.
David Hutton