Consumer group asks feds to lead resistance fight

Another voice added to increasing calls for action

Joining the chorus of clinical concern about preserving the efficacy of antibiotics, a national consumer advocacy group is calling for sweeping medical and government actions to protect the "crown jewels of medicine."

The Center for Science in the Public Interest (CSPI) in Washington, DC - more often associated with nutrition advocacy reports about the dangerous fat content in many widely consumed foods - is now drawing public awareness to antibiotic resistance issues. The group recently issued a report underscoring the critical nature of the issue and is outlining some strong recommendations for government action.¹ The action follows similar dire warnings on antibiotic resistance by the Institute of Medicine (IOM) in Washington DC. (See Hospital Infection Control, July 1998, pp. 97-101.)

"The government should be leading the fight to protect the effectiveness of antibiotics. Yet for 20 years it has done almost nothing," said Michael Jacobson, PhD, executive director of CSPI at a recent press conference to release the report. The call for action was echoed by Sidney Wolfe, MD, director and co-founder with Ralph Nader of Public Citizen Health Research Group.

^{Gross overprescribing}

"It is inevitable that a certain amount of antibiotic resistance will develop even if antibiotics are used only when needed, and when they are, the proper drug is chosen," Wolfe said at the press conference. "But the unacceptable additional amount of antibiotic resistance which currently plagues us is a predictable and inevitable derivative of gross overprescribing and misprescribing of these drugs. There is no possibility that the impending crisis will be averted unless the series of actions outlined this morning are taken, instead of just being talked about."

Additional findings and recommended actions in the CSPI report include:

· Congress should provide funding for public and professional education, national surveillance (of antibiotic use, the prevalence of antibiotic-resistant bacteria, and the diseases they cause), research and development, and immunization, and Congress should support international efforts to reduce antibiotic resistance.

· Current government efforts to protect the effectiveness of existing antibiotics are inadequate. There is no national education program for health care providers, veterinarians, farmers, or the general public on the appropriate use of antibiotics. Research dollars for basic and applied research and vaccine and antibiotic development are inadequate.

· National surveillance of antibiotic-resistant bacteria in humans and in animals would help identify critical situations of resistance and guide future public policy.

· The U.S. Department of Health and Human Services (DHHS) should include in Healthy People 2010 national targets for decreasing inappropriate antibiotic use and reducing antibiotic resistance. Setting nationwide goals to stem antibiotic resistance would spur government efforts to protect the usefulness of antibiotics and provide policy-makers and public health officials with goals by which to gauge progress and evaluate interventions.

· The Food and Drug Administration (FDA) should alter its policies on antibiotic advertising to help reduce inappropriate uses of antibiotics. Restrictions on ads for antibiotics are as - or more - important than for other drugs, because overuse of antibiotics affects not just the patient, but the entire community. The FDA should develop regulations and improve enforcement regarding direct-to-consumer advertising of antibiotics which is likely to increase the demand for inappropriate uses of antibiotics.

· The FDA should add to the list of potential adverse reactions of antibiotics that the use of antibiotics contributes to the spread of antibiotic resistance. That information then would be required to be printed in advertisements and physician information inserts.

· Congress should require Medicare and Medicaid, Veterans Affairs hospitals, and military hospitals - and state governments should require health maintenance organizations and private insurance companies - to cover the costs of bacterial cultures and susceptibility testing for sore throat, cough, and certain other infections, to help ensure that antibiotic prescriptions are necessary and appropriate.

· For bacterial infections for which cultures generally cannot be obtained (otitis media, sinusitis, bronchitis, etc.) and for viral infections (colds and flu), the DHHS should develop and distribute practice guidelines to decrease unnecessary antibiotic prescriptions. The DHHS also should develop and distribute to physicians who oversee nursing-home patients practice guidelines for treatment of infections in the elderly.

· Three-quarters of all antibiotics prescribed for outpatients are for respiratory tract infections, such as ear infections, bronchitis, or sinusitis, for which cultures generally cannot be obtained. Providing guidance to physicians on how to monitor those illnesses and treat symptoms (without automatically resorting to antibiotics) should help curb unnecessary antibiotic use.

· The government should use its own health care facilities - such as VA, Defense Department, and prison medical clinics and hospitals - to serve as showcases for the most prudent antibiotic-use practices.

· The FDA should ban all subtherapeutic uses of antimicrobial agents that (a) are used in human medicine or (b) might select for cross-resistance to antimicrobials used in human medicine. For example, approvals for subtherapeutic use of penicillin and tetracyclines should be revoked. New antibiotics should not be approved for subtherapeutic use, and new formulations of already approved antibiotics should not be approved for subtherapeutic use.

· The Environmental Protection Agency should ban the use of antibiotics as pesticides. Currently, 40,000 to 50,000 pounds of antibiotics are used each year for controlling bacterial infections in fruit trees.

Fruits and vegetable have been found to contain 10,000 to 100,000 antibiotic-resistant bacteria per gram. Those bacteria, which themselves do not usually cause human disease, might transfer antibiotic resistance genes to disease-causing bacteria in the human gut.

· The DHHS should fund research on the impact of agricultural antibiotic use on human health, as recommended in 1995 by the Office of Technology Assessment. The research should include identifying associations between antibiotics used in animal feed and antibiotic-resistant bacteria in humans.

^References

1. Lieberman PG, Wootan MG. Protecting the Crown Jewels of Medicine: A Strategic Plan to Preserve the Effectiveness of Antibiotics. Washington, DC: Center for Science in the Public Interest; 1998.

2. Institute of Medicine. Antimicrobial Resistance: Issues and Options. Washington, DC: National Academy Press; 1998.