Listed by the World Health Organization as one of the three greatest threats to human health, antibiotic resistance has become a growing concern to infectious disease experts who fear that we are no more than two generations away from being nearly defenseless against various bacterial infections.
At a congressional briefing this week, Rep. Jim Matheson, Utah Democrat, and the Infectious Diseases Society of America tried to bring more exposure to this public health dilemma, recommending more cooperation between government and the private sector to prevent the depletion of our antibiotic arsenal.
“The CDC (Centers for Disease Control) has defined our microbial resistance problem as a major looming public health crisis,” Matheson said. “These [microbial] infections are painful, they are difficult to treat, and cost the U.S. health-care system significant amounts of money every year.”
The reason for all this worry? The more an antibiotic is used, the less effective it will become as bacteria will genetically mutate and develop resistant genes. These genes can be responsible for preventing antibiotics from entering bacterial cells, for breaking down antibiotics or for expelling the drugs from the cells.
Increasing bacterial resistance rates and the decreasing production of new antibiotics by pharmaceutical companies are the major causes of this oncoming problem, according to a presentation given by Dr. Brad Spellberg, an antibiotics resistance expert and assistant professor at UCLA’s David Geffen School of Medicine.
Spellberg discussed the increasing occurrence of Methicillin-resistant Staphylococcus aureus, more commonly known as MRSA, and other highly-resistant infections that are born in and have escaped hospitals around the country. These infections can be lethal to even the healthiest people.
“These are not just infections that hit 95-year-old nursing home patients,” he said. “Everyone is at risk.”
As of 2002 data, about 2 million infections are acquired in hospitals each year, resulting in almost 100,000 deaths. Antibiotic resistance cost the U.S. 8 million additional hospital days and between $21 billion and $34 billion per year, according to a journal article in Clinical Infectious Diseases.
MRSA alone infects 94,000 people per year, and kills 19,000 people per year, according to a 2007 article in the Journal of the American Medical Association. And that only takes into account documented cases of illness.
Acinetobacter, another potentially deadly bacterium, has become a common cause of infection for U.S. soldiers wounded in combat overseas. In 2008 the organism had a 34 percent resistance rate to imipenem, an intravenously administered antibiotic, nearly twice the 2004 rate.
Antibiotic research and development
Perhaps more daunting than the increasing infection rates, is the decreasing production of antibiotics by pharmaceutical companies.
Measured in five-year phases, antibiotic development has decreased since 1983, when the Food and Drug Administration began keeping records of the number of antibiotics produced per year.
From 16 new antibacterial agents created from 1983 to 1987, there has only been one agent created thus far from the period beginning in 2008 (which ends in December 2012).
According to reports from various medical agencies, 15 to 16 antibiotics are in the development process, none of which fight bacteria that is currently resistant to all available drugs.
Spellberg said testing for new drugs generally begins with 5,000 to 10,000 lead compounds. Of these, 10 might enter clinical development, and one might get approved by the FDA. It takes roughly 15 years to develop a new drug, and was estimated to cost about $1.3 billion in 2005.
Pharmaceutical companies have been steering away from antibiotics production because of a lack of financial incentive, according to the IDSA, for the following reasons:
- Antibiotics are generally taken for a short time-span, and thus don’t require repeat purchases on a frequent basis. When compared with drugs that treat long-term illness and chronic diseases, they are not as profitable.
- Resistant microbial strains arise frequently, meaning a drug will likely lose potency as time goes on. Most resistant strains can be detected within a year of the release of a drug, according to Spellberg.
- The attempt by experts to use a new drug sparingly (which preserves its effectiveness), limits a drug’s profitability.
Possible solutions to the problem
Spellberg, a member of IDSA’s Antimicrobial Availability Task Force, proposed decreasing the cost of antibiotic development by offering tax credits, grants, contracts and/or liability protection to the pharmaceutical companies.
He also advocated for the creation of a non-profit organization to foster the growth of antibiotic research and development, as well as to spread the word about the emerging threat.
Lastly he called on the FDA to become clearer and more efficient with regard to its clinical trial standards, which he said in his presentation causes concerns and delays, and that “the resulting uncertainty has crushed antibiotic [research and development].”
FDA spokeswoman Karen Riley said that while the administration acknowledges there is a microbial resistance problem, their first priority is to make sure that new drugs are both safe and effective before they can put them on the market, despite any looming crisis.
Since March the IDSA has been pushing their “10 by ’20” initiative to foster the production of 10 new antibiotics by 2020. Since 2008, there have been no newly developed antibiotics.
For Spellberg, a crisis is emerging, and there is no time to waste.
“The time for debate is over,” he said. “The time to act is now.”
About the STAAR Act
The “Strategies to Address Antimicrobial Resistance Act” has been reintroduced to Congress in order to combat the looming problem of antibiotic resistance. The act is designed to:
- Better coordinate inter-agency coordination within the federal government with the creation of a new office in the Department of Health and Human Services to specifically deal with this problem.
- Create an advisory board, outside of the government, to ensure the proper steps are being taken to combat antimicrobial resistance.
- Create a research network, or “Centers of Excellence,” to expand our knowledge of the subject.
- Increase funding in this field to “supplement, not supplant” current finances.
“It’s an important step to strengthen our nation’s response to pathogens that are increasingly becoming resistant to antibiotics,” said Matheson. “This legislation provides a comprehensive approach to the antimicrobial resistance crisis.”