[e-drug] Are antibiotics neglected essential medicines?

E-DRUG: Are antibiotics neglected essential medicines?
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[Anti-microbial resistance is a fast growing and very serious problem that needs more analysis in E-drug. It is clear that industry is not very eager to develop new antibiotics, as the immediate response will be to keep them as a last resort and use them as little as possible to delay the forming of resistance (which is probably related to over-use). This does not bring them enough turnover within the patent period. Another complication is that it also more difficult to find new antibiotics. The golden days of antibiotics are clearly over.

Trying to motivate big farma to start researching again with more (financial) incentives is one approach. See the newspaper article below. Obviously we need new antibiotics, but is this the right approach?

More info on the EU/EFPIA initiative at http://www.imi.europa.eu/ E-drug welcomes debate on this topic.

We should also look at reasons why we are losing our current (more affordable?) antibiotics so fast! Can we still delay the loss of these life-saving products? Mankind is very irresponsible.

Our grand children may never see effective antibiotics any more if we continue like this. Mankind will in 30 years remember the period in which we still had effective, safe and affordable antibiotics, and wonder why we misused and overused them so much (not only humans, also animal industry is a big user for commercial reasons). On 18 November, when E-drug was busy working at ICIUM, the EU also had an “Antibiotics awareness day”. Check out http://ecdc.europa.eu/en/EAAD/Pages/Home.aspx/. There are toolkits for the general public, primary care prescribers and hospital-based prescribers.

Can organisations like ReAct and APUA present themselves at the E-drug platform?

And maybe also some action groups who think that financial incentives and professional guidelines alone are not enough?

Article below posted as fair use. WB]
   
Drug Sales Help Fund R&D: Europe to Fight Antibiotic-Resistant Infections
   
http://www.bioworld.com/content/drug-sales-help-fund-rd-europe-fight-antibiotic-resistant-infections

By Nuala Moran
BioWorld Today Correspondent

LONDON – Europe's pharmaceutical companies have thrown their weight behind a European Commission action plan to pool efforts in the fight against antibiotic-resistant infections, and are demanding higher prices for their drugs in return for this support.

Andrew Witty, CEO of GlaxoSmithKline plc, said the industry will work with the commission and others to find a "new approach" that will allow research in the field to be "re-stimulated" and "re-started." The platform for doing this will be the €2 billion (US$2.69 billion) Innovative Medicines Initiative (IMI), which is funded half by the European Commission, with the balance coming from in-kind contributions by the industry.

At present big pharma has little interest in developing antibiotics, but the IMI is now drawing up a new large-scale program in the discovery and development of antibiotics, to "kick start" the process of reviving research in the field. At the same time, the commission pledged more public money for research and said it will encourage national R&D funding bodies to set up joint research programs.

Richard Bergström, director-general of the European Federation of Pharmaceutical Industry Association (EFPIA) welcomed the commission's plan and said the IMI program needs to involve large and small pharmaceutical companies and academic researchers.

"Above all, we need to ensure that investment in antibiotic R&D is strengthened," said Bergström.

One of the main ways of ensuring that happens will be higher prices for antibiotic drugs, Bergström, said, noting, "there are contradictions in relying on volume sales to earn revenue" when preserving the effectiveness of antibiotics depends on limiting their use. The industry wants to see an alternative approach in which it is engaged with public health bodies in monitoring use, incentivized to conserve effectiveness of existing antibiotics and adequately rewarded for developing new ones.

Bergström said the IMI antibiotics program needs to involve large and small pharma and researchers in a collaboration that enhances efficiency and has the potential to lead to "unprecedented sharing" of information about success, failures and older products.

As the current president of EFPIA, a body which represents 2,000 pharma companies, Witty said antibiotic resistance "is a challenge that the pharmaceutical industry wants to be part of solving." GSK is one of the few large pharma companies to have retained an interest in antibiotics and currently has a couple of programs in Phase II.

Antibiotic-resistant infections are now responsible for 25,000 deaths per annum in the European Union, said John Dalli, health commissioner, announcing the commission's Strategy and Action Plan to Tackle the Threat of Antibiotic Resistance. Resistance is easily spread across borders and between veterinary and human medicines, underlining the need for cooperation and a coordinated policy, Dalli said. Apart from spurring development of new drugs, the program also seeks to ensure antibiotics are used appropriately and to improve infection control. "[Coming out] with new antibiotics is important, but it is not the solution. The solution is in the use of antibiotics," Dalli said.

Over the past seven years, the European Commission has awarded €600 million for R&D in antimicrobial resistance and antibiotic drugs, noted R&D Commissioner Maire Geoghegan-Quinn.

"Excellent research is being carried out across Europe, but efforts are still too fragmented," she said at the launch of the plan.

Geoghegan-Quinn called on EU member states to develop a common program around which to coordinate national research efforts.

"There is a clear need for an effective strategy to combat antimicrobial resistance. It is increasingly difficult both strategically and commercially to develop new antibiotics," she said. The next round of grants awarded under the EU's R&D Framework Program 7 will include money for antibiotics, with the aim of "mobilizing [biotechs] to carry out research in this area," Geoghegan-Quinn said.

E-DRUG: Are antibiotics neglected essential medicines? (2)
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We have substantial evidence that antibiotics are indeed too cheap - that the private value is far less than the social value (shorter Health Affairs version here http://content.healthaffairs.org/content/29/9/1689.abstract?sid=3924bfb8-40c7-4399-ba6b-5204a7fd9a6d; much longer Yale J Health Policy Law & Ethics version here http://ssrn.com/abstract=1716942).

The most important proviso- any new incentives must be conditioned on companies meeting antibiotic conservation targets. Otherwise, we are just boosting incentives to quickly exhaust a precious resource. Unlike all other intellectual property, antibiotic IP is exhaustible http://ssrn.com/abstract=873401. Unlike every other drug class in history, for anti-infectives we want carefully sequenced innovation.

Kevin Outterson
BU Law
"Outterson, Kevin" <mko@bu.edu>