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    Thursday, May 09, 2024

    Lack of antibiotic research a looming crisis

    U.S. Sen. Richard Blumenthal rightly recognizes the serious consequences if the pharmaceutical industry and medical science community fail to reverse the troubling decline in antibiotic research. The freshman Connecticut Democrat joined Sen. Bob Corker, D-Tenn., last week in introducing in the Senate the Generating Antibiotic Incentives Now (GAIN) Act, initially filed in the U.S. House of Representatives this past summer.

    The good news is that the initiative is one of the few in the current Congress to enjoy bipartisan support in both the House and Senate. Unfortunately, the issue is not getting the priority status it deserves, eclipsed by discordant debates over fiscal and economic policies. The crisis involving a lack of antibiotic research may be among the most under-reported stories in the world today.

    The problem is that bacteria evolve, relatively rapidly. Antibiotic treatments that were once universally effective are now only partially so, unable to eradicate infections caused by bacteria that have evolved to become resistant to their attack. Over- and improper use of antibiotics has contributed to the problem. The failure to take a full regimen of antibiotics leaves behind the toughest bugs, more resistant to later treatment.

    A high percentage of hospital-acquired infections result from these highly resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci. The prevalence of these superbugs, typically acquired in hospital settings, has reached a record high, claiming an estimated 70,000 lives each year.

    Meanwhile, according to the World Health Organization, about 440,000 new cases of multidrug-resistant tuberculosis emerge annually, causing at least 150,000 deaths. To date 64 countries have reported drug-resistant tuberculosis strains.

    In addition to the human toll, the Infectious Disease Society of America estimates treatment of infections caused by antibiotic resistant pathogens costs the U.S. health care system an additional $21 billion to $34 billion annually, adding 8 million days of hospitalization.

    The threat is serious.

    In a worst case scenario an easily acquired and potentially fatal infectious disease, resistant to available antibiotic treatments, could spread through the populace. At the very least, the rise of superbugs is making otherwise routine medical treatments more dangerous and costly.

    "We face a future that may resemble the days before these miracle (antibiotic) drugs were developed; one in which people die of common infections, and where many medical interventions we take for granted, including chemotherapy, organ transplantation and care for premature infants, become impossible," said Sen. Blumenthal in announcing his support for the legislation.

    So why, with such a serious threat, is drug development for new antimicrobial agents at its lowest point? Why would Pfizer Inc. close its antibiotic research division at the Groton campus? (Ostensibly to move it to China, though even that appears uncertain.) Why did Johnson & Johnson, the second largest pharmaceutical firm, also drop antibiotic research?

    There is not enough profit in it.

    Antibiotics are as expensive to develop as other drugs, but do not generate long-term revenues. While a patient will take a cholesterol- or blood-pressure-lowering medication for life, she needs an antibiotic for only a few days until the infection clears.

    Proving the efficacy of antibiotics is difficult. A doctor cannot give a patient with an active infection a placebo to measure how the health outcome compares with that of a patient receiving the real drug.

    The GAIN Act seeks to address these challenges in several ways. It would double market exclusivity for a new antibiotic to 10 years, giving a drug producer more time to earn a return on investment before competing with low-priced generics. It would speed up the Food and Drug Administration review process and require a more cooperative approach by the FDA in the designing of clinical trials.

    While a good start, it is not enough. Drug developers will need more than 10 years of patent protection to make the investment in antibiotic research worthwhile. Tax credits and research subsidies must be added incentives to get Big Pharma back in the game and help smaller biotech companies gain the venture capital they need to develop promising drugs.

    Insurance pricing and the new health care law must recognize that antibiotics able to ward off these super bugs must be priced very high. But is thousands of dollars too much to ask for a drug that saves a life and prevents many days of high-cost medical treatment?

    British Prime Minister Winston Churchill once warned of society's "unwillingness to act when action would be simple and effective … until the emergency comes, until self-preservation strikes its jarring gong."

    Policymakers cannot wait for the coming emergency. They need to incentivize new antibiotic research now.

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