Europeans Seek Lead in New Antibiotics
The European pharmaceutical industry has voiced its support for a European Union-backed plan to combat antibiotic resistance and promote the development of new antibiotics as reports of drug-resistant "super bugs" increase throughout the region.
A new action plan issued by the European Union this week promised streamlined regulations and other government support for diagnostic and drug development aimed at combatting the rise of antibiotic-resistant pathogens.
The report said that drug-resistant bacteria are responsible for 25,000 deaths in Europe each year, at a cost of $1.5 billion.
And a recent report from the European Centre for Disease Control and Prevention (ECDC) said that in some countries, more than 50% of cases of Escherichia coli infections were resistant to antibiotics, as were more than 10% of pneumoniae cases. In addition, 25% of methicillin-resistant Staphylococcus aureus infections were resistant to antibiotics in in 8 eight of 28 European countries.
The European drug industry group -- the European Federation of Pharmaceutical Industries and Associations (EFPIA) -- backed the EU's plan, which calls for accurately diagnosing the presence of a bacteria before starting the patient on antibiotics; putting in place ways to prevent microbial infections and to stop them from spreading; and strengthening research to develop new ways to stop antimicrobial resistance.
"Antibiotic resistance is a major challenge throughout the world and one that we need to take seriously," EFPIA President Andrew Witty said in a press release. "It is a challenge that the pharmaceutical industry wants to be part of solving."
Witty, who is also CEO of GlaxoSmithKline, said his group is committed to working with stakeholders to re-stimulate research into new and effective antibiotics "so that when we do have a fundamental bacterial challenge we are able to protect ourselves."
An infectious disease expert in the U.S. told MedPage Today that while news from Europe is nothing Earth-shattering, it does at least signify that a group of countries formally recognizes the importance of antimicrobial resistance.
"What's happening in Europe is a sign that a collective group of governments understand the severity of the problem and have the political will to make the necessary changes," said Brad Spellberg, MD, of the University of California Los Angeles, and a member of Infectious Diseases Society of America (IDSA) Antimicrobial Availability Task Force.
That political will still seems to be a ways off in the U.S., he said.
Researchers here have long been calling for the creation of new antibiotics in light of antibiotic resistance making older ones less effective. But the pharmaceutical industry here doesn't show signs clear of moving toward increased focus on new antibiotics.
A recent decision by Pfizer to shutter its major research facility in England, shrink its central lab in Connecticut, and move its anti-infective research to China was met with an outcry in the infectious disease community who said the move would dampen already slow progress toward developing new antibiotics.
There is currently legislation in Congress called GAIN, for Generating Antibiotic Incentives Now, that would require the FDA to reevaluate its guidelines for antibiotic drug trials, increase the period of market exclusivity for qualified infectious disease products (including diagnostics), and give them priority review. But that bill hasn't moved in either the Senate of the House of Representatives since it was introduced.
Writing in a column published in The Lancet, Laura Piddock, PhD, of the University of Birmingham in England, highlighted the problem of too few promising new antibiotics in the R&D pipeline.
"Human beings do not live in a sterile world," Piddock wrote. "Food and water can be contaminated and many different events occur that affect sharing of microorganisms between ecosystems and antibiotic-resistance genes between pathogenic and commensal bacteria."
Although researchers have actively been publishing articles and reports on antibiotic resistance, "the demise of antibacterial drug discovery by large pharmaceutical companies has largely gone unnoticed by governments," Piddock wrote. "Even when noted, little effort has been made to resolve this situation."
In academe, the economic recession has led to reduced funding for antibacterial research, Piddock wrote.
One major impediment to antibacterial development is that the drugs don't offer a good return on investment. Unlike major money-makers like cholesterol drugs -- which are taken by some people every day for decades -- the standard course of treatment for antibiotics is about a week. Plus, they are cheap. Piddock advocated higher prices for some antibiotics.
"The price of antibiotics should relate to their value," she wrote. "People in high-income countries expect to be given antibiotics whenever they need them and ease of use has led to a perception of low cost and therefore low value. The price of antibiotics needs to relate to their value to society and should not relate to the price of previous products."
"People will pay $50,000 for a course of chemotherapy that prolongs life by a few weeks, but we don't even like to pay $100 for an antibiotic that can save a life," he told MedPage Today.
The IDSA launched its "Bad Bugs, No Drugs," campaign in 2010 which aims to get 10 new antibiotics on the market by 2020, and has been active in lobbying for increased government research in antibiotics.
Spellberg said while the bills in Congress are a good start, they don't offer enough incentives to drug companies to ramp up development of antibiotics.
Even if new drugs were developed, the FDA makes it difficult to get a new antibiotics approved, Spellberg said.
For instance, he explained, it's FDA policy for clinicians to enroll patients in an agency-approved clinical trial before giving them a single dose of the antibiotic that is being studied so they start with no antibiotic in their systems. But Spellberg said most patients who are sick with pneumonia or a skin infection would not wait the several hours it takes to enroll in a trial before receiving the first dose of antibiotics.
Those kinds of policies impede enrollment in the kind of large-scale trials that would be necessary for the FDA to approve a new antibiotic, Spellberg said.
"They need to stop being so rigidly adherent to these bizarre, byzantine principles," he said of the agency.