A recent shortage of the antibiotic amoxicillin has put a spotlight on an urgent global threat: the world's diminishing arsenal of potent antibiotics and the lack of incentives to develop them.
There is debate over a bill in Congress that would change the way antibiotics are discovered and sold in the United States.
The Pasteur Act would change the way antibiotics are marketed by giving pharmaceutical companies an upfront payment in exchange for unlimited access to a drug once it is approved by the FDA.
The model for antibiotics is being called theNetflix model.
The measure attempts to address the vexing economics of antibiotics, which often gather dust on pharmacy shelves because health providers prefer to save them for patients who don't respond to existing ones. The more frequently an antibiotic is used, the more quickly it will lose its punch.
Drug companies can't earn back their initial investment due to the high cost of new antibiotics, which makes it even harder for them to do so. 10 million people are estimated to be killed by drug-resistant pathogens by the year 2050.
Kevin Outterson is the executive director of CARB-X, a nonprofit that provides funding for small biotechs developing novel antibiotics.
Supporters of the bill hope that prescribers will save new drugs for patients with infections that are resistant to existing drugs if they separate profits from sales volume. Experts say that limiting their use can help prolong the life of a new antibiotic before it's too late.
The bill is supported by researchers, health care policy experts and drug company executives. A small group of doctors and health care advocates are opposed to the bill because of it. The bill is not likely to address the issue of antibiotic resistance.
Lawmakers often race to push through unfinished legislation in the final weeks of a session, and the legislation's prospects seemed grim. Congress has been anxious to push through a final spending deal before the holidays because of concerns over cost.
Todd Young, an Indiana Republican and one of the bill's co-sponsors, said in an email that the Covid-19 epidemic demonstrated America's vulnerability to catastrophic public health crises. The emergence ofbacteria resistant to antibiotics is the next public health crisis.
In a letter to Congress in November, opponents of the measure said it would encourage the development of ineffective drugs because of flaws in the F.D.A.'s approval process for antibiotics. They wrote that the Pasteur Act would waste taxpayer dollars as a blank check to pharmaceutical manufacturers.
The bill leaves in place a regulatory regimen for antibiotics that allows companies to market drugs of questionable value according to one of the signers. The F.D.A. uses a concept known as noninferiority to allow new drugs to be less effective than existing ones. The F.D.A. should adopt a system that requires drugmakers to prove that new antibiotics are superior to current ones according to a group of doctors.
"As a clinician, it's a huge concern for me that we could have new costly drugs on the market without regulatory oversight to make sure they are clinically meaningful or that they even address resistant infections."
The approach is impractical and raises ethical questions according to many experts. To establish whether a new antibiotic is superior to existing ones, researchers would have to conduct clinical trials that test the new therapy against a placebo. If a study participant gets a placebo or inferior drug, it could be fatal.
It makes no sense. Kenneth E. Thorpe is a health policy official in the Clinton administration who is an adviser to the advocacy group Partnership to Fight infectious disease. If we don't spur innovation and get as many novel antibiotics as we can, we will face a threat to human health.
Critics overlook a key provision of the legislation, which states that the decision to fund any antibiotic must consider whether it meets a critical need. A panel of experts from the Department of Health and Human Services, the Centers for Disease Control and Prevention, and a half a dozen other federal health agencies will make the determination. The advisory committees at the F.D.A. would be mirrored in the system.
The bill's components are designed to make sure the funding goes to the right drugs.
The federal government would make payments ranging from $750,000 to $3 billion over the course of the legislation. According to an analysis by the Center for Global Development, the $6 billion price tag for the legislation would yield $32 billion in savings over a decade and save 20,000 lives in the US and around the world.
It can cost a billion dollars to bring a new drug to market, but earning back that investment has become more difficult. Most antibiotics are prescribed for a short period of time. Hospitals that don't want to pay high prices for new therapies prefer to use cheaper but less effective options.
A number of antibiotic start-ups have gone out of business.
Many of those who succumb to drug-resistant infections are already battling other health problems. Family members are likely to blame the cancer for the patient's death.
Diane Shader Smith knows how difficult it is to draw attention to abstract threats. Five years ago, her daughter died from a drug-resistant lung infections at the age of 25. Her cause of death was listed by the coroner.
Ms. Smith knows what it's like to live with a superbug and the damage it does to patients and their families.
Ms. Smith wrote a column last month urging Congress to pass the Pasteur Act, which she said would prevent her from contracting a superbug. Drug-resistant infections are a threat that many of us will face in the future. It's hard to get that threat to Americans.
She reported from Washington, D.C.
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