I found this article by former FDA deputy commissioner Scott Gottleib illuminating on several points. E.g.,
1) why big pharma has little economic incentive to develop new antibiotics
2) why diagnostic companies aren’t incented to develop the rapid infectious-agent detection systems we need.
Excerpt:
…Researchers working at the Centers for Disease Control and Prevention reported this month that nearly 19,000 Americans died in 2005 from MRSA, and about 95,000 were infected. Doctors have been reporting for years that MRSA was cropping up with alarming frequency. The same is true for other bacteria. In Rochester, N.Y., doctors recently reported nine children stricken with a strain of the bacteria that causes ear infections — streptococcus pneumonia — that was resistant to all 18 antibiotics commonly used to treat the condition.
The real news isn’t that these bugs exist, but how woefully unprepared we are to deal with them. As we make progress in fields like cancer, we are taking a U-turn on bacteria. Despite advances in drug development, the bugs have increased their IQ nearly as fast as research, outwitting our medicines. Efforts have turned to preventing bacterial spread and clamping down on antibiotic prescribing.
There’s no question that poor hospital hygiene, overuse — and sometimes misuse — of antibiotics contribute to educating bugs at our expense. But preventative efforts alone won’t solve our bacterial challenges. What we need most are better diagnostic tests and new medicines.
This is high-stakes science, but the pipeline isn’t promising. Since 1998, just 10 new antibiotics have been approved by the the Food and Drug Administration, only two of which work in fundamentally new ways. Only 13 new antibiotics are in development inside big drug companies, compared to an average of 60 more than a decade ago. Since leaving the FDA this year as its deputy commissioner, I’ve advised a few biopharma firms making antibiotics and the venture investors supporting them. Regrettably, however, many big drug makers have followed the lead of Eli Lilly, a pharmaceutical company that once pioneered antibiotics, only to exit the business entirely.
The problem? There’s not a lot of payoff for developing drugs aimed at infections. First, they last only days, or at most weeks, limiting sales. And the better the drug, the more likely doctors and hospitals are to keep it on the shelf as a last resort. Most hospitals require that doctors get special approval to prescribe the best new antibiotics. In that regard, what’s good for public health isn’t necessarily good for antibiotic development.
…Most existing antibiotics are as old as the earth, screened out of nature where they resided, doing battle with bugs for centuries. We need to accelerate this evolution in our laboratories. Public policy mistakes are partly to blame for creating this inhospitable environment for new development, and it will take a concerted effort to improve it. The only sure way to stay ahead of bacterial evolution is by escalating this arms race.
Highly recommended.
Then there is the problem of marketing!
Take a good product… say inhalable insulin which, since the insulin molecule is well known, the crystallization process decades old and all materials off-patent, should be a winner. Only a need for basal insulin and replace fast acting injections with inhaled insulin. Tested, approved, 8 year long term efficacy and safety gives it a green light and…? Pfizer could not figure out how to market it and that lovely insurance system everyone wants to expand didn’t want to cover it: companies just couldn’t figure it out.
Then market it to the wrong market segment! Ah, such a thing to see, something that could have been done by any post-grad for thesis work since… what… 1950? It does take modern manufacturing to get human insulin in such quantities, but the crystallization process for other insulins is also decades old. Basically, if I had taken their kit into a time machine and dropped it off at any of the pharma companies in the 1950’s, it would have been out in a few years using animal insulin. Pfizer could not market itself out of a paper bag and, even worse, they are having to fight off a lawsuit for having violated the lantus basal insulin patent held by Aventis… yes they wanted to make that inhalable, too! They get one market for free and mess it up and then kill any chance at the full market.
So when you see drug companies not doing things, remember they can have really bad management.