Between 1945 and 1968, drug companies invented 13 new categories of antibiotics, said Allan Coukell, director of medical programs at the Pew Health Group.
Between 1968 and today, just two new categories of antibiotics have arrived.
In 2011, the Food and Drug Administration approved one new antibiotic, which fights one of the many bacteria, Clostridium difficile, causing deadly hospital-borne infections.
“What kept us out of trouble for the last 60 years is that every time drug resistance caught up to us, the pharmaceutical companies would go back to the drawing board and develop the next generation of drugs to keep us ahead of the game,” said Brad Spellberg, an infectious diseases physician in Los Angeles who heads a microbial resistance task force for the Infectious Diseases Society of America. “That’s the part of the equation that’s changed. Drug companies are no longer trying to get one step ahead.”
But why is that?
Experts point to three reasons pharmaceutical companies have pulled back from antibiotics despite two decades of screaming alarms from the public health community: There is not much money in it; inventing new antibiotics is technically challenging; and, in light of drug safety concerns, the FDA has made it difficult for companies to get new antibiotics approved.
As a result, only four of the world’s 12 largest pharmaceutical companies are researching new antibiotics, said David Shlaes, a drug development veteran and consultant.
The first reason is certainly true enough -- bringing a new drug to market is an expensive proposition and you can get screwed up a number of different ways before it ever gets there. And if one thing goes wrong, the lawyers will take you for millions. The second reason is true, but we've never shied away from technical challenges if there was enough reward in it, so it's more a problem related to the first. And as for the third reason, well, that would be easy enough to change except that bureaucrats are even more ferocious than personal injury lawyers where turf is involved.
So how do you solve the problem? Either you let the pharmaceutical companies make more money and simplify the regulatory process, or you drive them out of business and turn things over to the feds. Which one do you think will work better? And which one do you think the respective presidential candidates will choose?
On such considerations elections turn. Or should, at least.