Josh Bloom in The Wall Street Journal, "A Welcome Boost in the Race for New Antibiotics"
The members of the "I hate the pharmaceutical industry" club must be beside themselves. And the anti-big-government folks are probably not terribly happy either.
For the first time ever, the U.S. government is giving money to a drug company to help pay for its research. And it's not even an American company. British drug giantGlaxoSmithKline GSK.LN -1.42% will get about $200 million over the next five years from American taxpayers to assist in its search for new antibiotics.
While many will bemoan this precedent, I maintain that it is not only long overdue but also absolutely essential and maybe even too late.
Antibiotic research in the U.S. came to a sudden halt in the 1990s when the Food and Drug Administration decided to impose a set of rules on drug developers that would make Joseph Heller smile. Under then-FDA Commissioner David Kessler, a group of FDA statisticians decided that it was important to have better "statistical power" for trials, especially when comparing new antibiotic candidates with older ones. One such idea and there were plenty of other bad ones was to require a control group of patients in clinical trials that had never taken any antibiotics. Good luck finding such a person.
In Dr. David Shlaes's 2010 book "Antibiotics: The Perfect Storm," the author, an expert in the field, discussed how the FDA policy hampered the search for antibiotics to treat pneumonia. He described drug trials where "about 40% of patients had received at least one dose of another antibiotic before being enrolled in the trial. If those 40% had to be replaced with those who had no prior antibiotic, the trial would take much longer. For more serious cases of pneumonia, such as those now required by the FDA, it will be even harder to ï¬nd patients with no prior antibiotic at all."
Moreover, Dr. Shlaes noted, "the number of patients required has skyrocketed into the thousands, further increasing the cost and the time it will take to run such a trial."
Predictably, drug companies have dropped out of the field. In 1990, 18 major pharmaceutical companies had antibacterial programs. Now there are four, and the results speak for themselves: Between 2010 and 2012, the FDA approved 95 new drugs. Of these, exactly one was a new systemic antibiotic.
The inherent difficulty of discovering new antibiotics, coupled with the lack of financial incentives even for companies that succeed, presents an ideal opportunity for a public-private partnership. Academic and government institutions may be excellent in establishing the underlying biology that is crucial to understanding infectious diseases, but they do not have the ability to turn this knowledge into a drug. That requires a complex set of skills that only drug companies have.
The $200 million government subsidy over five years will cover some of the costs for Glaxo to conduct clinical trials for potential drug candidates a drop in the bucket for the U.S. federal budget, and potentially a life-saving bargain for many Americans. The threat of drug-resistant infections is growing so fast that it may soon become the country's No. 1 public-health problem.
Consider that even though the U.S. has yet to see anything close to the worst, 90,000 Americans died last year from drug-resistant infections more than the number for breast and prostate cancer combined.
And the worst is coming. In the past decade, a microscopic monster called carbapenem-resistant Enterobacteriaceae, or CRE, has emerged that could create a scenario to rival the most terrifying of science-fiction movies think "Contagion."
CRE is fast moving and deadly. It makes the much-feared methicillin-resistant Staphylococcus aureus, better known as MRSA, seem like a hangnail. The incidence of CRE has increased four-fold over the past 10 years. And with a mortality rate of 50%, CRE could turn routine hospital stays especially when catheters and ventilators are used or minor surgical procedures into Russian Roulette. With multiple bullets in the gun.
So, yes, giving money to private companies to try to head off a certain catastrophe is exactly what is needed. And the more the better, at least until companies have the opportunity and incentive to make up the precious time lost to FDA policy blunders. Privately, FDA administrators admit that changes should be made, and they are starting to ease off on what many see as unnecessary requirements. Congress could certainly bring pressure to bear, hastening the restoration of sanity to the FDA rules on developing antibiotics.
In the meantime, the important thing is that the research gets done. Otherwise, we will surely see increasing numbers of deaths for previously routine surgeries and hospital stays.
Dr. Bloom is the director of chemical and pharmaceutical sciences at the American Council on Science and Health in New York City.
A version of this article appeared May 31, 2013, on page A13 in the U.S. edition of The Wall Street Journal, with the headline: A Welcome Boost in the Race for New Antibiotics.
