Increasingly, the public distrusts science and medicine. Much of the reason has been due to lawsuits, some of it has been due to strange beliefs among wealthy elites in well-defined parts of the United States. Due to popularized concerns about the safety of medicine, the approval cycle and the cost is longer than ever - billions of dollars and a dozen or more years unless a disease like Ebola gets into corporate media headlines.
The result is a lack of new development for anything that is not a "home run" product, and antibiotics are too expensive in the current regulatory climate, especially when politicians will solicit votes claiming drugs should be the same as generics in cost. We've had shortages this century, and is only going to get worse according to a paper in Clinical Infectious Diseases which analyzed shortages of gold-standard therapies and drugs used to treat highly resistant infections from 2001 to 2013.
Analyzing data from the University of Utah Drug Information Service database, a national database of drug shortages, the researchers found that 148 antibiotics experienced shortages during the study period, with an upward trend starting in 2007. Almost half -- 46 percent -- of the shortages involved antibiotics used to treat high-risk pathogens, including C. difficile, carbapenem-resistant Enterobacteriaceae (CRE), methicillin-resistant Staphylococcus aureus (MRSA), and Pseudomonas aeruginosa, among others.
Shortages, as defined by the Food and Drug Administration (FDA), are situations in which the total supply of all clinically interchangeable versions of an FDA-regulated drug product is inadequate to meet the projected demand. A shortage can occur for several reasons, including manufacturer mergers, facility consolidation, manufacturing quality issues, and narrow profit margins for generic drugs.
In the study, a high proportion of recent antibiotic shortages affected broad-spectrum antibiotics, injectable drugs, medications with no alternative sources, or those used to treat infections with limited alternative treatment options or pediatric patients. Many involved gold-standard therapies, such as aztreonam, which treats serious infections in patients allergic to penicillin, and trimethoprim/sulfamethoxazole for the treatment of pneumocystis pneumonia.
Thirty-two antibiotics (22 percent) experienced multiple shortages, with a median duration of more than six months. At the end of the study period in December 2013, 26 antibiotics were still in short supply or not available. 148 antibiotics experienced shortages between 2001 and 2013, with an upward trend in shortages starting in 2007. Almost half of the shortages involved antibiotics used to treat high-risk pathogens, including C. difficile, CRE, MRSA, and Pseudomonas aeruginosa.