Deadly superbug sends feds scrambling

The finding last month has health officials, who have been warning about such a development for years, scrambling to contain the bacteria and lawmakers wondering if the federal government is doing enough to fight the problem.

They also are using the headlines to press for more funding to combat superbugs and spur initiatives to produce more antibiotics, legislation to curb antibiotic use among animals and ways to get doctors to stop prescribing so many drugs.

The antibiotic-resistant bacteria was found in a 49-year-old Pennsylvania woman who was in the hospital for an E. coli infection when a test on a urine sample discovered the presence of the mcr-1 gene.

The Department of Agriculture also has identified mcr-1 in two samples of pig intestines. That is a critical development in the fight against superbugs, as the mcr-1 gene makes the infection resistant to colistin, an antibiotic usually employed as a last resort after other antibiotics have failed.

Bacteria containing the gene had been discovered in Europe and China, but until now, never in the U.S.

For the Centers for Disease Control and Prevention, the discovery of the gene is a stark reminder of the need for funding and more resources to fight superbugs.

“It reinforces the importance of everything we have been saying,” CDC Director Tom Frieden told the Washington Examiner. “We know this is coming and we hope to have a robust response to it.”

The spending bill approved in December included more than $375 million in new funding for federal agencies to combat superbugs. Frieden said that funding has enabled the CDC to expand testing to find resistant bacteria much faster. He added he hopes to get more funding next year.

“We hope the 2017 budget will further expand the generous support Congress gave in 2016,” he said.

The CDC has said about 2 million people get infections from antibiotic-resistant bacteria each year and at least 23,000 people die as a result of the infections.

Meanwhile, a growing number of common infections such as pneumonia and tuberculosis are becoming harder to treat as the antibiotics used to treat them become less effective, according to the World Health Organization.

A growing number of common infections such as pneumonia and tuberculosis are becoming harder to treat as the antibiotics used to treat them become less effective, according to the World Health Organization. (iStock Photo)

An infectious disease expert said the government has made some great steps to address antibiotic resistance, but it now “needs to follow through,” said Dr. Barbara Murray, chief of infectious diseases at the University of Texas Health Sciences Center.

The government has to “not take away money that has been designated for antibiotic resistance,” said Murray, a former president of the Infectious Diseases Society of America.

Whether lawmakers are amenable to more new funding is another story. President Obama’s fiscal 2017 budget includes $877 million, an increase of $43 million over current levels, which would help implement the White House’s action plan to combat antibiotic resistance.

Congress has not taken up the president’s budget proposal, but lawmakers have been interested in attacking the problem.

Too many antibiotics

A major contributor to antibiotic resistance is doctors giving patients the drugs unnecessarily, the CDC says. For example, doctors give antibiotics to children for a common cold or bronchitis, which are viruses that cannot be treated with the drugs.

At least 30 percent of antibiotic prescriptions are unnecessary, according to CDC data released last month.

And that’s a problem.

“Antibiotic resistance is one of the biggest threats to global health today. It can affect anyone, of any age, in any country,” the World Health Organization said in October. “Antibiotic resistance occurs naturally, but misuse of antibiotics in humans and animals is accelerating the process.”

But lawmakers have criticized parts of the CDC’s educational efforts to get doctors to not prescribe as many antibiotics.

Rep. Tim Murphy, R-Pa., questioned whether a CDC educational program called “Get Smart” has been working. The CDC has been trying to get doctors to avoid prescribing antibiotics for cases that they aren’t needed, but the results haven’t been effective, as Murphy said prescriptions are still being made at a high rate.

Part of the problem is the pressure doctors feel. Parents want their sick child to get better, and doctors fearful of looking unresponsive to their patients’ needs give them antibiotics, accelerating resistance.

In recent years, the CDC has been pushing for hospitals to adopt antibiotic stewardship programs that govern antibiotic use in the facilities.

The CDC pointed to a 2012 study that showed the impact of an antibiotic audit that compared antibiotic prescribing rates among doctors to rates based on clinical guidelines.

The study found that after showing doctors their prescribing rates compared to lower clinical standards, the doctors began prescribing fewer antibiotics in the intensive care unit.

Some lawmakers questioned whether other CDC programs are adequate.

During a hearing two weeks ago, Murphy cited the CDC’s data on unnecessary antibiotics.

“That doesn’t sound like it’s working to me,” he told a CDC official at the hearing.

The agency is now trying to attack antibiotic prescribing on different fronts, while the initial Get Smart campaign was focused on just one area, responded Beth Bell, director of the National Center for Emerging and Zoonotic Infectious Disease.

She said the CDC is trying to educate patients as well now and that Get Smart was only focused on doctors.

Antibiotics in animals

Democrats have supported legislation to curb the use of antibiotics among meat and poultry producers, since a major contributor to antibiotic resistance is the unnecessary use of antibiotics to make livestock resist disease or grow bigger, according to the CDC.

Antibiotics can kill most bacteria, but resistant bacteria can survive and multiply. The resistant bacteria can be transmitted from animals to humans once they are consumed. (iStock Photo)

Some Democrats reacted to the emergence of the mcr-1 gene by again calling for restrictions to antibiotic use for livestock.

“The United States is light years behind what many European countries have done in banning the use of many medically important antibiotics in agriculture,” Rep. Louise Slaughter, D-N.Y., told the Examiner. “It’s past time for the United States to catch up.”

Slaughter reintroduced a bill last year that would curb the use of antibiotics in livestock. She has introduced the bill five times in Congress, but has gotten major pushback from pharmaceutical companies that sell the drugs to farmers and ranchers and agribusiness that want to grow livestock.

Agriculture and meat producers have pushed back against any restrictions. A spokesman for the National Pork Producers Council previously said that Slaughter’s bill is unnecessary as farmers are already working to reduce the use of antibiotics in their livestock.

Antibiotics can kill most bacteria, but resistant bacteria can survive and multiply. The resistant bacteria can be transmitted from animals to humans once they are consumed.

Cooking meat normally can kill the resistant microbes. However, Murray said antibiotic-resistant microbes could be spread to humans when they are handling uncooked or unprepared meat.

“How sterile is your cooking environment?” she asked, noting that people could come into contact with the microbes if the meat isn’t cooked well.

Resistance to antibiotics also can be spread through produce from contaminated water or soil, the CDC said.

The FDA created a voluntary program in 2013 that meat suppliers can agree to use to phase out certain antibiotics in feed.

Some major fast food chains such as McDonald’s have pledged to phase out buying meat from suppliers that use human antibiotics on their products. Major chicken suppliers Perdue and Tysons have agreed to phase out the use of unnecessary antibiotics over the next several years.

Fragile drug pipeline

Lawmakers for both parties have supported legislation to give drugmakers incentives to create more antibiotics. The pipeline has dwindled as drugmakers have flocked to more profitable diseases.

A major problem is profits, Murray said.

Antibiotics are generally cheap and taken over a shorter period of time. Drug companies have to choose between developing products for diabetes, hypertension or psychiatry that people might take for the rest of their lives versus an antibiotic taken for five days, Murray said.

“This is a huge problem,” she added. “They don’t make money off antibiotics these days, and the clinical trials to develop them are very expensive.”

The top U.S. official in charge of drug approvals recently told Congress that the pipeline for new antibiotics is “very fragile.”

While there has been some progress to spur development, it hasn’t been enough, government officials said.

“We need a full panoply of investment, research and basic science in drug discovery and drug development that lasts over decades,” said Janet Woodcock, director of the Food and Drug Administration’s Center for Drug Research, which approves new products. “We don’t just need a few antimicrobials.”

In 2012, Congress approved a law that gives drugmakers an extra five years of market exclusivity for antibiotics. That means that drugmakers would have a longer monopoly on sales on a new product before it goes generic.

The top U.S. official in charge of drug approvals recently told Congress that the pipeline for new antibiotics is “very fragile.” (AP Photo)

The House last year passed a bill that would let the FDA approve new antibiotics using less data. The bill, part of a larger package of biomedical research legislation called the 21st Century Cures Act, would allow data from trials with fewer patients than normal to be used for approval.

The Senate hasn’t taken a vote on the package due to disagreements over funding for the National Institutes of Health. But Rep. Diana Degette, D-Colo., said the emergence of the mcr-1 gene in the U.S. could change that.

“Maybe this urgent issue can be used to enact this important law,” she said during a House hearing.

Other ideas include having the federal government buy up doses of a new antibiotic to spur interest in producing them. The idea is there would be a ready-made market for the antibiotics, which would generate enough incentive for a drugmaker to make them.

What the CDC is doing

Top CDC officials said they were surprised by certain elements of the case surrounding the mcr-1 gene.

“We don’t know how she became infected with this bacteria,” Dr. Jean Patel, director of the CDC’s Office of Antibiotic Resistance, told the Examiner. “I think it just reinforces why we have to be so vigilant and why we have to keep looking for resistance in the general population.”

What made the situation more concerning is that the woman, who has not been identified, had not traveled for more than five months. That reduces the likelihood that she contracted the infection from another country.

The CDC is working with Pennsylvania healthcare workers to try to contain any spread of the mcr-1 gene, which can jump to other bacteria and spread resistance.

Colistin has been around for decades, but it isn’t used much because it can cause liver problems. However, the drug has been used in animal feeds overseas, leading to resistance in meat, Murray said. Mcr-1 has been found in the intestines in two pigs in the U.S.

Patel noted that the mcr-1 gene does give scientists a way to study how superbugs become resistant to colistin.

“We had a nice genetic target, and then we could use that target to search [and] isolate this new type of resistance,” she told the Examiner.

Frieden said the $375 million in new funding for federal agencies to combat superbugs has enabled the CDC to expand testing to find resistant bacteria much faster. (AP Photo)

In the fall, the CDC plans to implement new genetic testing that is quicker and more comprehensive than current tests employed at state health labs.

The samples sent to the health labs would come from bacteria that hospital workers believe is resistant to antibiotics.

“In a public health laboratory, we want to understand if that bacteria is part of an outbreak and if it is part of a resistance,” Patel said.

She said the new testing techniques look at the DNA of the sample at the most basic level.

“We look at DNA within bacteria and can analyze whether that DNA is resistant for things like mcr-1,” she said.

The testing could help determine the best antibiotic to use on a patient and help to identify an outbreak much faster to track patterns of antibiotic resistance, Patel said.

State and regional labs can be part of a greater network that will be able to “investigate emerging resistance in ways currently unavailable, generating better data for stronger infection control among patients,” the Department of Health and Human Services said in a related press release.

The CDC is also putting together regional labs to help hospital laboratories that discover drug-resistant bacteria. Once a hospital finds such bacteria, it would send samples to a CDC regional lab for confirmation.

Researchers and drug companies can then use the samples to develop and test new antibiotics, the CDC said.

The federal government had been on the lookout for mcr-1 after the emergence in China in November. The government is using the same gene-testing technique to search for mcr-1 in sources of meat.

As of April, more than 44,000 salmonella and E. coli bacteria didn’t show the presence of the gene, according to the Department of Health and Human Services.

Patel noted that even though superbugs are most potent for people who have weak immune systems or the elderly, it could grow to affect a larger, general population.

“We need to ensure that when we have infections and we have antibiotics, that they are going to work,” she said.