Blumenthal backs measure to promote drug development

There’s an arms race going on, Sen. Richard Blumenthal said Monday, and we’re losing.

“We’re in an arms race with pathogens that are evolving faster than we are developing drugs to treat them,” the Connecticut Democrat said during a press conference at Hartford Hospital.

Blumenthal at Hartford Hospital 10-24-11

Sharon Ladin, Jamel Sawyer, Dr. Juan Salazar, Dr. Michael Lindberg, Blumenthal

He was there to tout his support for a measure aimed at encouraging drug makers to develop new antibiotics that can combat drug-resistant bacteria. The GAIN Act–Generating Antibiotic Incentives Now–would extend the patent on antibiotics by five years, giving drug companies more time to exclusively market the medications they develop. It would also give qualifying drugs priority review by the Food and Drug Administration, and would allow pharmaceutical companies to seek guidance from the FDA sooner in designing clinical trials.

The measure was introduced in the House in June by representatives from both parties. Blumenthal and Tennessee Republican Sen. Robert Corker introduced it in the Senate last week.

Blumenthal has drawn ire from infectious diseases doctors in the past for his advocacy for the existence of chronic Lyme disease–a form of the disease that mainstream physicians say doesn’t exist. But in tackling drug-resistant infections, Blumenthal has found an issue high on the agenda of many in public health.

Studies suggest that infections caused by antibiotic-resistant pathogens cost the U.S. health care system $21 billion to $34 billion a year, and account for more than 8 million hospital days, according to the Infectious Diseases Society of America, which has warned that without intervention, “we face a future that may resemble the days before these ‘miracle’ drugs were developed; one in which people die of common infections, and where many medical interventions we take for granted–including surgery, chemotherapy, organ transplantation and care for premature infants–become impossible.”

Dr. Juan Salazar, director of pediatric infectious diseases at Connecticut Children’s Medical Center, said he and his colleagues have seen a dramatic increase in patients admitted to the hospital with life-threatening infections in the past decade. And because the development of antibiotics has not kept pace with the pathogens, physicians have fewer options to treat them.

“Many children who in the past would have been treated with simple oral antibiotics at home now must be hospitalized to receive intravenous therapy,” he said.

Sharon Ladin, director of the Pew Health Group’s antibiotics and innovation project, noted that between 1935 and 1968, there were 13 new classes of antibiotics brought to market, each of which attacked bacteria in a unique way. Since 1968, as bacteria have continued to evolve, only two classes of antibiotics have been introduced and developed.

There are three main challenges to innovation in antibiotics, Ladin said. They’re expensive and difficult to develop, and because they are usually prescribed for short courses, antibiotics tend produce lower revenues than drugs that treat chronic conditions like high cholesterol or high blood pressure.

In addition, Ladin said, it’s difficult to develop clinical trials for antibiotics since researchers can’t give placebos to patients with active infections as a way to compare the effect of a drug being developed. The regulatory pathways could use more clarity, she said.

There’s also a scientific challenge: As bacteria becomes more advanced, they become more difficult to fight. The low-hanging fruit have already been picked, she said.

“All the easy ones have been found,” said Paul Pescatello, president of Connecticut United for Research Excellence, which advocates for bioscience research.

Pescatello called the proposal “critical to antibiotic research” and pointed to two companies in New Haven developing antibiotics, BioRelix and Rib-X Pharmaceuticals. Developing antibiotics can cost as much as developing more lucrative drugs, and the time spent working on them can eat into the time companies have exclusive rights to sell the drugs. Extending the patent time for antibiotics could make companies better able to raise money from investors for their research, allowing them to remain independent–and local–rather than being pressured to sell out to a larger company, Pescatello said.

“Antibiotics are not blockbuster or miracle drugs that produce blockbuster profits,” Blumenthal said. “They are the workhorse medicines that are prescribed for 10 days or two weeks, not for chronic illnesses over a lifetime, and therefore the profit or revenue from them is likely to be lower per pill.”

“Incentives are necessary, as well as removing unnecessary regulatory obstacles,” the former Connecticut attorney general added.

Blumenthal said he hopes the bill will pass the House and Senate early next year, and noted that it has support from medical, pharmaceutical, children’s and military groups.

But not everyone sees the effort as the right one. Jean Rexford, executive director of the Connecticut Center for Patient Safety, said the focus should instead be on preventing infections, particularly those that patients get in hospitals or other health care settings. She said speeding up the FDA approval process was not a patient-centered idea.

“A new antibiotic will be overused and it will become ineffective,” she said.

Joseph Kuti, associate director of the Center for Anti-Infective Research and Development at Hartford Hospital, called the GAIN Act an important first step, but not the only one that’s needed. Financial incentives are important, he said, “but we need the researchers there, we need smart folks doing anti-infective research,” something he said will require efforts from academia and government.

In addition, he said, the process for getting drugs approved by the FDA can be a barrier to antibiotic development. Many companies don’t know how to develop molecules and products in ways that will give them the greatest chance of success in the approval process, and Kuti said the industry needs more clear guidance from the FDA to make investment in antibiotic development more palatable.

Beyond that, he said, there need to be efforts to ensure that hospitals and communities can identify drug resistance faster and make sure that antibiotics are used better.

“I think it’s a pretty scary scenario that we’re in, where we’re obviously doing a lot of catch up,” he said. “The organisms are clearly developing resistance much faster than we can develop drugs for them.”

Blumenthal was joined at the press conference by Jamel Sawyer, 21, a former college football player who lost the use of his legs after developing an infection known as MRSA–methicillin-resistant Staphylococcus aureus–last November. He spoke of feeling his legs leaving him, having surgery and receiving treatment.

“They were giving me antibiotics, but what they were giving me wasn’t working because the MRSA was so immune to it, it wouldn’t knock it out or anything,” he said.

He still takes antibiotics four times a day, but the infection is still in his system.