Free Daily Headlines :

  • COVID-19
  • Vaccine Info
  • Money
  • Politics
  • Education
  • Health
  • Justice
  • More
    • Environment
    • Economic Development
    • Gaming
    • Investigations
    • Social Services
    • TRANSPORTATION
  • Opinion
    • CT Viewpoints
    • CT Artpoints
DONATE
Reflecting Connecticut’s Reality.
    COVID-19
    Vaccine Info
    Money
    Politics
    Education
    Health
    Justice
    More
    Environment
    Economic Development
    Gaming
    Investigations
    Social Services
    TRANSPORTATION
    Opinion
    CT Viewpoints
    CT Artpoints

LET�S GET SOCIAL

Show your love for great stories and out standing journalism

Blumenthal backs measure to promote drug development

  • by Arielle Levin Becker
  • October 24, 2011
  • View as "Clean Read" "Exit Clean Read"

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.

Sign up for CT Mirror's free daily news summary.

Free to Read. Not Free to Produce.

The Connecticut Mirror is a nonprofit newsroom. 90% of our revenue comes from people like you. If you value our reporting please consider making a donation. You'll enjoy reading CT Mirror even more knowing you helped make it happen.

YES, I'LL DONATE TODAY

ABOUT THE AUTHOR

Arielle Levin Becker

SEE WHAT READERS SAID

RELATED STORIES
Is the state’s vaccine rollout leaving behind Black and Latino residents?
by Jacqueline Rabe Thomas, Kasturi Pananjady and Jenna Carlesso

Rolling out the COVID vaccine to older residents first means it's more likely to go to white residents first.

Education is the cornerstone of democracy
by John J. Petillo

The events of January 6 represent an inflection point for our democracy and, in truth, for our concept of civil society. Much has already been written about the political and cultural tides that swept our nation toward these events —and a real understanding of their significance will not be possible for some time, in part because the reactions and responses to these events are still unfolding as I write.

A rebuttal to ‘A call to save arms’
by Tyler David Gavitt

A response to "A call to save arms: is vaccination really the solution?" published January 25: The aforementioned article, written by Genevieve Diamant, stands to do potentially significant damage to the efforts by the citizens and government of the State of Connecticut to bring under control the COVID-19 pandemic.

The Holocaust, history and today’s politics
by Avinoam Patt and Laura Hilton

On January 6 the world watched as domestic terrorists stormed the U.S. Capitol building in Washington, DC.  The pictures seared into our memories of this day are replete with symbols of hatred, racism, and extremism: The Confederate battle flag, the white power hand gesture, and the gallows erected near the Capitol reflecting pool. What many may not have noticed within this sea of white supremacy was the prominence of anti-Semitic images.

Sticker shock
by Eric W. Kuhn

It would award a modest amount to families making less than $203k in the first year of the program, ramping up to as much as $1,800 in year four. On a sliding scale, the money would also go to families making up to $682,000 a year. Really? That's 8.7 times the median household income in America.

Support Our Work

Show your love for great stories and outstanding journalism.

$
Select One
  • Monthly
  • Yearly
  • Once
Artpoint painter
CT ViewpointsCT Artpoints
Opinion Education is the cornerstone of democracy
by John J. Petillo

The events of January 6 represent an inflection point for our democracy and, in truth, for our concept of civil society. Much has already been written about the political and cultural tides that swept our nation toward these events —and a real understanding of their significance will not be possible for some time, in part because the reactions and responses to these events are still unfolding as I write.

Opinion A rebuttal to ‘A call to save arms’
by Tyler David Gavitt

A response to "A call to save arms: is vaccination really the solution?" published January 25: The aforementioned article, written by Genevieve Diamant, stands to do potentially significant damage to the efforts by the citizens and government of the State of Connecticut to bring under control the COVID-19 pandemic.

Opinion The Holocaust, history and today’s politics
by Avinoam Patt and Laura Hilton

On January 6 the world watched as domestic terrorists stormed the U.S. Capitol building in Washington, DC.  The pictures seared into our memories of this day are replete with symbols of hatred, racism, and extremism: The Confederate battle flag, the white power hand gesture, and the gallows erected near the Capitol reflecting pool. What many may not have noticed within this sea of white supremacy was the prominence of anti-Semitic images.

Opinion Sticker shock
by Eric W. Kuhn

It would award a modest amount to families making less than $203k in the first year of the program, ramping up to as much as $1,800 in year four. On a sliding scale, the money would also go to families making up to $682,000 a year. Really? That's 8.7 times the median household income in America.

Artwork Grand guidance
by Anne:Gogh

In a world of systemic oppression aimed towards those of darker skintones – representation matters. We are more than our equity elusive environments, more than numbers in a prison and much more than victims of societal dispositions. This piece depicts a melanated young man draped in a cape ascending high above multiple forms of oppression. […]

Artwork Shea
by Anthony Valentine

Shea is a story about race and social inequalities that plague America. It is a narrative that prompts the question, “Do you know what it’s like to wake up in new skin?”

Artwork The Declaration of Human Rights
by Andres Chaparro

Through my artwork I strive to create an example of ideas that reflect my desire to raise social consciousness, and cultural awareness. Jazz music is the catalyst to all my work, and plays a major influence in each piece of work.”

Artwork ‘A thing of beauty. Destroy it forever’
by Richard DiCarlo | Derby

During times like these it’s often fun to revisit something familiar and approach things with a different slant. I have been taking some Pop culture and Art masterpieces and applying the vintage 1960’s and 70’s classic figures (Fisher Price, little people) to the make an amusing pieces. Here is my homage to Fisher -Price, Yellow […]

Twitter Feed
A Twitter List by CTMirror

Engage

  • Reflections Tickets & Sponsorships
  • Events
  • Donate
  • Newsletter Sign-Up
  • Submit to Viewpoints
  • Submit to ArtPoints
  • Economic Indicator Dashboard
  • Speaking Engagements
  • Commenting Guidelines
  • Legal Notices
  • Contact Us

About

  • About CT Mirror
  • Announcements
  • Board
  • Staff
  • Sponsors and Funders
  • Donors
  • Friends of CT Mirror
  • History
  • Financial
  • Policies
  • Strategic Plan

Opportunity

  • Advertising and Sponsorship
  • Speaking Engagements
  • Use of Photography
  • Work for Us

Go Deeper

  • Steady Habits Podcast
  • Economic Indicator Dashboard
  • Five Things

The Connecticut News Project, Inc. 1049 Asylum Avenue, Hartford, CT 06105. Phone: 860-218-6380

© Copyright 2021, The Connecticut News Project. All Rights Reserved. Website by Web Publisher PRO