Monday, December 20, 2010

Beating resistance? Yes it can be done!

Dr. Steven J. Projan is the Senior Vice President of Research and Development and Innovative Medicines Head of Infectious Diseases and Vaccines at MedImmune.

The question posed is: In an ideal world, what would be your approach to accelerating drug development and strengthening antibiotic stewardship? First and foremost we need to do a better job of encouraging basic research in microbiology because it is from a profound understanding of the underlying biology that all drug discovery comes. The good news is that funding in this area has improved (although given the recent political events this may be a transitory phenomenon) and technology marches on allowing new insights on the microbial ecology of the human being. And when those novel discoveries are made we need a far more sophisticated approach to both drug development and regulatory processes such as basing decisions on “Real World Evidence” rather than the artificiality of Phase III clinical trials. But in terms of stewardship it is becoming increasingly clear that the best way to deal with infections due to resistant bacteria is to prevent them in the first place. As such an increased emphasis on prophylaxis is the best approach from a public health point of view. The success of the pneumococcal conjugate vaccine in reducing the use of antibiotics has been well documented; however another important way to curtail the use of antibacterial drugs is to prevent viral respiratory infections, especially lower respiratory infections (it should be noted that 1/3rd to 2/3rd of the mortality in H1N1 influenza patients was due to secondary bacterial pneumonias and other respiratory viruses such RSV or human rhinovirus type C are likely to play role here as well). Therefore vaccines and immunoprophylactics for both viral and bacterial infections should play an increasing role in both public health practices and industrial research. To further focus our industrial efforts (and stimulate additional research) I support the Infectious Disease Society of America’s call for longer periods of market exclusivity for novel infectious disease products.