Preserve and develop.
That’s the two-prong strategy being used by the medical community when it comes to antibiotic use and research.
The strategy is a dual effort to prevent the overuse of antibiotics that lead to so-called “superbugs” as well as to encourage the development of new drugs from pharmaceutical companies that say more incentives are needed in the expensive process of bringing new antibiotics to market.
Preserving What We Have
On the preservation side, medical experts note that adults are prescribed antibiotics for acute respiratory tract infections, most often the common cold, more than any other condition.
Forty-one percent of the more than 100 million emergency care scenarios in the United States involve antibiotics for respiratory infections.
The problem is most of them are caused by viruses, not bacteria, so antibiotics do little to no good at helping the underlying infection. Sometimes, they do more harm than good.
New guidelines on preserving antibiotics’ effectiveness through proper diagnosis were released this past month by the Centers for Disease Control and Prevention (CDC) and the American College of Physicians.
They remind medical professionals not to prescribe antibiotics for the common cold or even bronchitis unless pneumonia is suspected.
These are just some of the efforts the medical community has initiated to prevent outdated practices and preserve what antibiotics are still effective against a growing number of drug-resistant bacteria.
New Antibiotics Needed
Besides the preservation of current prescription medication, new antibiotics are needed to combat the viruses and bacteria that have developed resistance to all available drugs.
The U.S. Food and Drug Administration (FDA) estimates, the majority — approximately 70 percent — of the antibiotics sold in this country go to livestock for growth promotion and disease prevention.
Overall, antibiotic resistant bacteria infect an estimated 2 million Americans each year, 23,000 of whom die, according to the U.S. Centers for Disease Control (CDC). The issue, globally, has been declared a medical emergency by the World Health Organization.
Those of greatest concern are gram-negative bacteria, which cause varying levels of infection in healthcare settings, according to the CDC. They are resistant to several forms of antibiotics and an ever-increasing number are resistant to all available drugs.
The more bacteria are exposed to antibiotics, the more likely they’ll develop resistance to that medication. It’s accelerated when the bugs are exposed to antibiotics but not at levels to kill off all the necessary bacteria.
Essentially, antibiotics remain effective when used the least.
Dr. Henry Chambers, chief of infectious diseases at San Francisco General Hospital and a member of the Infectious Disease Society of America (IDSA), said this is the primary reason why pharmaceutical companies have largely avoided developing antibiotics for more profitable drugs.
“Your target population is often limited,” he told Healthline.
In 2012, President Barack Obama signed new FDA guidelines known as the Generating Antibiotic Incentives Now, or GAIN Act.
It gives antibiotic makers an extra five years of patent protection, allowing pharmaceutical companies more opportunities to recoup the expenses of developing that drug.
It also allows them to fast-track the drugs in the FDA approval process. Under it, necessary antibiotics are able to hit the market after phase II trials.
By September 2014, 39 antibiotics received special designation under GAIN, according to the FDA.
Late last month, 85 drug companies and nine industry associations across 18 countries signed a joint declaration that lay out steps for asking government assistance in discovering new antibiotics.
“The scientific difficulties are formidable and traditional R&D approaches have largely failed: companies, private and public funders have invested billions of dollars over the last 20 years to discover new antibacterials, yet no new class of antibiotic for Gram-negative infections has reached approval in over 40 years,” the declaration states.
In the document, industry leaders, including the IDSA, ask for government funding and support in developing new antibiotics as well as preserving those on the market through rapid diagnostics.
They also call for removing kick-backs for professionals such as doctors, veterinarians, and pharmacists who are encouraged to prescribe antibiotics in high volume.
The collective group requests assistance in mitigating financial risk for entering the antibiotic market, “insurance-like purchase models,” and new approaches and safeguards to intellectual property laws.
Companies will then save money because of the reduced need to promote their products.
They argue for reimbursement prices that “reflect the benefits they bring,” while measures are in place to prevent misuse and lost effectiveness.
“This calls for funding to be allocated and for payers to appropriately assess and value innovative antibiotics and diagnostics, in line with the good progress that has been made by regulatory authorities,” the declaration requests.
Chambers says the current market-driven incentives for developing new antibiotics aren’t working, but effective antibiotics are something within the public trust, so effective therapies should be a concern for all levels from consumer to shareholder.
“There needs to be an incentive to recoup one’s investment,” he said. “At the end of the day, they have to sell drugs to make money. That’s the basics of economics.”
Antibiotics a Rare Breed of Medication
Antibiotics are the only class of medication where use in one person has the potential to make them less successful for others.
This is partially why research and development of new antibiotics are often unprofitable financial gambles.
Other drugs, like statins, are better financial investments because they can be taken daily by people and not lose their therapeutic capability.
While hospital-acquired infections were the main source of drug-resistant bacteria, they’ve spread beyond the healthcare setting.
“For now, most of the antibiotic resistant organisms are isolated. The driver of antibiotic resistance is antibiotics exposure,” Chambers said. “There’s certainly some erosion around the fringe. There’s no one out there who doesn’t think this is a problem.”