Problems go beyond budget cuts at NIH, but creative solutions exist.
Though the U.S. health care system will prevent Ebola from becoming epidemic here, we could still face large outbreaks. At some point, the only thing that will reverse the global tide could be a vaccine or a drug that can treat infected patients.
The good news is that there's nothing inherently complex about the Ebola virus that should make it an elusive target for modern medicines. The bad news is that developing such a drug or vaccine, as National Institutes of Health chief Francis Collins said this week, has been woefully slow.
In large part, Collins noted, this owes to failures of policy, not science. In NIH's case, Collins blamed cuts to its $30 billion budget. He said those cuts forced NIH to take its eye off of developing a promising Ebola vaccine.
A broad problem
This lack of political focus is a problem that plagues not only drugs aimed at rare diseases such as Ebola, but also medicines targeted to more immediate maladies, say antibiotic-resistant bacteria.
Scan the doctor's bible of medicines, the Physicians' Desk Reference, and you'll find 33 drugs to treat high cholesterol, 71 to help you sleep and more than 200 to treat high blood pressure. But why aren't there more drugs that can thwart deadly bugs?
In the case of Ebola, I wrote a column on these pages in October 2002 discussing two drugs that are now being used experimentally to treat some of the Ebola-infected Americans. One is an anti-viral medicine called cidofovir. The other is a class of drugs that mimic certain immune cells, called antibodies, and can directly target Ebola virus.
At that time, my focus was on developing therapeutics for the potential agents of would-be bioterrorists. Ebola was on that list. Why, 12 years later, have drugs that were easily identified as potential remedies for Ebola in 2002 still languishing?
Regulatory barriers are one reason. In the case of very rare and deadly pathogens, the procedure for testing new drugs is painstakingly slow and expensive. It's hard to test a drug against a deadly disease in conventional "placebo" trials, where patients are randomly selected to receive a medicine. It's harder still to get regulators to adapt these traditional requirements.
But economics is an equally profound impediment. For a rare disease such as Ebola, there's little economic incentive to invest an estimated $1.2 billion to develop a new drug. In fact, most of the money that supported development of the Ebola therapeutics has come from government grants such as those supplied by NIH. But the grants were never enough to advance these drug programs.
What to do
The failings go beyond Ebola. We haven't developed a new class of antibiotics since 1987. By asking doctors to constrain the use of the most potent and novel antibiotics to treat resistant organisms, we also limit the economic incentive to develop the drugs.
There are solutions in which government can help. One idea is to use lucrative prizes to lure drug developers. If someone creates a therapeutic that meets certain uncommon but pressing public health needs, he or she could earn a prize equal to the return on a drug that successfully treats a more common malady.
Another option is to change the way we pay for medicines. Instead of paying a defined price for each unit of the drug, purchasers such as hospitals can pay for a license to use however many doses they might require. The license can afford a market-based return. The economic return to the drug maker is detatched from selling more doses of a drug when public health needs dictate holding a drug in reserve.
We're ill-prepared to deal with Ebola and a host of other dangerous bugs. We shouldn't be. The technology exists to defeat these organisms. We just need to find new economic and political ways to fund these public investments, and muster the appropriate sense of urgency to advance them past regulatory hurdles.
Scott Gottlieb, a physician and resident fellow at the American Enterprise Institute, was Food and Drug Administration deputy commissioner from 2005-07. He advises life science companies.http://www.usatoday.com/story/opinion/2014/10/15/ebola-drug-medication-antibiotics-treatment-funding-research-economics-column/17326827/
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