The era of modern medicine begins in the winter of 1941, when an English policeman named Albert Alexander lay in a hospital, dying of a skin infection.
Before antibiotics, death by infection felled many — including young, healthy men like Alexander. But on Feb. 12, he was given penicillin as part of a war effort to find a useful treatment for bacterial infections. By Day Four, in the first clinical trial of penicillin, Alexander’s temperature broke.
The world had changed. Today, millions of Americans will develop a cough or a rash, take medicine for a week or so, and think nothing of it.
But will the world now change back? The Food and Drug Administration approved only five new antibiotics from 2003 through 2007, down from 16 in the period from 1983 through 1987. The FDA commissioner herself calls the number of antibiotics in development “distressingly low.”
We may be losing the battle: Bacteria are growing more and more resistant to our treatments. Superbugs like MRSA now kill more people than AIDS. And, looking at new superbugs springing up in countries like India, the worst may yet be coming.
It’s not surprising, then, that some in Washington are clamoring for action. Rep. Henry Waxman (D-Calif.), the outgoing chairman of the House Energy and Commerce Committee, complains, “There is a market failure.” Democrats in Washington have gone so far as to tout the idea of subsidizing drug companies to develop antibiotics.
There is, of course, great irony here: For more than a decade, Democrats and Republicans have criticized the profitability of pharmaceutical firms. Now, with an eye on the bleak antibiotic pipeline, they want to throw money at those companies.
But the problem isn’t a market failure, and the solution won’t be found in another giveaway of taxpayers’ money.
Here’s the basic issue: In recent decades, the FDA has set the regulatory bar higher and higher for drug approval. Since 1964, the total time required for drug development (from synthesis of the molecule to marketing approval) has more than doubled, now topping 15 years.
It’s not just the incredible delay that’s problematic. According to the Tufts Center for the Study of Drug Development, pharmaceutical companies spend more than a $1 billion to bring a new drug to market. Thirty years ago, it was a small fraction of that, $138 million (adjusted for inflation).
Part of the cost issue is that the FDA demands more patients be tested and in more complex ways. In the mid-1980s, the average drug trial involved 1,300 patients; today, more than 4,000 people. The FDA is even stricter with applications for primary-care drugs, reasoning that new meds in these areas are unlikely to offer treatment breakthroughs and thus safety must be a greater priority. A recent trial for a blood thinner involved some 30,000 people.
As a result of these heightened costs, drug companies focus their research on areas likely to bring in higher profits, like cancer. They also favor blockbuster drugs — pharmaceuticals that will achieve $1 billion a year or more in sales.
So, despite the threat of drug-resistant superbugs, pharmaceutical companies push in other areas.
What’s to be done? Forget the Waxman tax giveaway.
First things first: Washington needs an immediate plan to get drug companies back into the antibiotic development game. For HIV and other diseases, the FDA successfully used a variety of incentives to reward innovation with great success, like offering faster approvals and longer patents. It’s a good strategy and should be used in our war against superbugs.
And Washington should look to more far-reaching ideas to make the agency more effective. Some changes will involve new technology (like the use of biomarkers in drug approval); others can be low-tech (like allowing companies to pay for stipends for clinical-trial volunteers).
Finally, Washington can re-approve legislation next year allowing the agency to collect fees from drug companies — making it possible to hire more drug reviewers and (modestly) speed the approval process.
In the end, though, Washington needs to take a careful look at the FDA and reconsider the entire approach to drug approvals. Under Democratic and Republican administrations, reforms have been slow — and the agency has become painfully slow.
Albert Alexander received cutting-edge medicine for his infection. Will you?
David Gratzer, a physician, is a senior fel low at the Manhattan Institute.