The Pipeline Problem

Antibiotic resistance is gaining alarming momentum, yet effective antibiotic medicines are increasingly hard to come by. Why is that and where does it leave us?

Antibiotics are not like other medicines. The more you use them, the less effective they become. Think of it like telling someone you love them: that’s a pretty impactful statement; yet, if you start to say it all day long the effect of the words will soon wear off – the person you’re speaking to will become immune to them. And that is exactly what has happened with antibiotics – the pathogens have become increasingly immune to them, and this has been happening from the moment we began using antibiotics back in the 1940s.

Even though the bacteria always develop resistance to antibiotic drugs, the pharmaceutical industry had always come to the rescue by developing the next generation of drugs to deal with the previously resistant bacteria. This system worked fine for decades, but then, something happened: the pharmaceutical bailout started to come to a halt around the turn of the century. Now, over a decade later, “It’s getting harder and harder if not impossible to find new antibiotics,” according to Dr. Stuart Levy, professor of medicine at Tufts University, Boston.  And, “We are facing a huge crisis worldwide not having an antibiotics pipeline,” according to Dr. Jane Woodcock, the Food and Drug Administration’s head of drug evaluation and research. “It is bad now,” she says, “and the infectious disease docs are frantic. But what is worse is where we will be 5 to 10 years from now.”

Today, close to 100,000 people die every year in just the U.S. alone from infectious disease that is resistant to antibiotic treatment. A “post-antibiotic” era, in just a few years from now, would mean death from everyday infections – strep throat, say; and from routine surgeries like a hip or knee replacement.

So how did we get ourselves into this jam? What happened to the 60-year trend of bailouts by the pharmaceutical industry?

Dr. Brad Spellberg, an infectious disease expert at the Harbor-UCLA Medical Center in Los Angeles, says it boils down to 2 basic reasons. The first is mostly economic. It costs almost 1 billion dollars to develop a new drug. Companies need to recoup that money and so they want a drug that will last, not a drug that a pathogens could develop resistance to some 2 years after usage begins. And they also want a drug that a patient will have to use for a long time, not the typical 7 day regime for most antibiotics. So for example, since heart disease can last a lifetime, the patient would require a drug to control cholesterol levels for just as long. So too with diabetes, arthritis, high blood pressure, depression, and so on: in each case the drug company gets a fee-paying client for life. So if you’re in charge of R & D at a pharmaceutical company, it’s easy to see where the research effort is going to go: it will follow the money.

The second reason alleges government regulatory incompetence.  Dr. Spellberg says the FDA “have been rethinking the standards by which clinical trials should be conducted to show that antibiotics work. And right now we don’t know what the standards are and companies don’t know how to design clinical trials to meet regulatory standards to get antibiotics approved anymore.” This apparently involves complex statistical analysis, but the upshot is that that drug companies are saying even if we wanted to develop an antibiotic there’s no point because the FDA hasn’t told us how to prove to them that the drug is safe and effective.

So if the drug companies, the scientists, the FDA, and Congress, can’t figure a way to resolve these issues and open the pipeline, what’s in store for us?

There’s a precedent we might want to think about. In 1942 in Boston, a 16 year old barboy carelessly tossed aside a match that caused the Cocoanut Grove Nightclub to burn to the ground, killing 450 people and severely burning hundreds more. The survivors were succumbing not to the burns per se, but to infection caused by the bacterium Staphylococcus aureus. Though penicillin existed at the time, it was a highly guarded secret and reserved for military use only. However, the front page stories about the incident attracted the attention of the pharmaceutical giant Merck & Company who, just 3 days after the fire, rushed a large supply of the drug under police escort to the Massachusetts General Hospital in Boston. In stopping the s. aureus in its tracks and saving hundreds of lives, this single event has been labeled “crucial” in prompting the U.S. government to back pharmaceutical houses in their production of penicillin in large amounts.  And thus began the Antibiotic Age.

So what we know for sure is that tragedy can get results. What we don’t know is whether it will take yet another such tragedy to open, once more, the antibiotic pipeline. The answer to that question, however, will tell us one thing – it will tell us something about who we are as a people.

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