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NIH UNVEILS DATABASE ON CLINICAL TRIALS
NEWS DR. MOORE HONORED AS LÖE SCHOLAR
Dr. Paul A. Moore, JADA’s associate editor for Clinical Pharmacology, was named The Harald Löe Scholar for 2000 at the recent meeting of the International Association for Dental Research. Named for Dr. Harald Löe, past director of the former National Institute of Dental Research, the award enables the recipient to spend three months in Washington, D.C., working with the American Association for Dental Research, the National Institute of Dental and Craniofacial Research and the American Association of Dental Schools. The award is funded by the Procter & Gamble Co. Dr. Moore, a professor of Dr. Moore pharmacology, Department of Public Health, University of Pittsburgh School of Dental Medicine, will be working on a project entitled “Medical and Oral Health Partnerships: Mechanisms for Collaborations in Clinical Epidemiology.” GUARD AGAINST MISUSE OF ANTIBIOTICS, AUTHOR WARNS
When antibiotics are prescribed, six things can happen and only one of them is good. In one of several articles he prepared for the March Journal of the California Dental 572
Association, Dr. Thomas J. Pallasch spelled out the six possible outcomes when antibiotics are used, with only the first one being positive. dThe antibiotic may aid the immune system to gain control of the infection; dtoxicity or allergy may occur; dalready resistant microbes may be selected for, and a superinfection may result; dthe antimicrobial may promote microbial chromosomal mutations; dgene transfer may be encouraged from resistant to nonresistant microbes; dlatent-resistance genes may be expressed. “The global problem of microbial resistance to antibiotics is serious, not only in its extent, but also in the rapidity with which microorganisms are attaining and maintaining resistance,” warns Dr. Pallasch, a professor of pharmacology and periodontics at the University of Southern California School of Dentistry, and contributing editor to the CDA Journal. He notes that dentists prescribe about 10 percent of all the common antibiotics, including penicillins, cephalosporins, macrolides and tetracyclines. Antibiotic misuse in dentistry, he says, mainly involves prescribing them in “inappropriate situations” or for too long. He says inappropriate uses include: dgiving antibiotics after a dental procedure is complete in an otherwise healthy patient to “prevent” an infection, which in all likelihood will not occur anyway (read: to “prevent a lawsuit,” in many cases);
dusing antibiotics as “analgesics,” particularly in endodontics; demploying antibiotics for prophylaxis in patients not at risk for metastatic bacteremias; dusing antimicrobials to treat chronic adult periodontitis, which almost totally is responsive to mechanical treatment; dusing antimicrobial therapy in lieu of mechanical therapy in periodontitis management; dusing antibiotics and antimicrobials chronically in periodontitis; dusing antibiotics instead of surgical incision and drainage of infections; dusing antibiotics to “prevent” claims of negligence. “It is not time to panic,” Dr. Pallasch assures, “but it is time for all to realize that the problem cannot be solved without a concerted effort on the part of all concerned: patients, parents, health professionals, veterinarians, food producers and governments.” NIH UNVEILS DATABASE ON CLINICAL TRIALS
Interested in who’s conducting clinical trials, where they’re doing it and on what products and procedures? If so, visit “http:// clinicaltrials.gov/”—the first phase of a new database being introduced by the National Institutes of Health, with information on more than 4,700 federal and private medical studies underway at more than 47,000 sites nationwide. “Through this new database, NIH offers up-to-date information on promising patientContinued on page 576
JADA, Vol. 131, May 2000 Copyright ©1998-2001 American Dental Association. All rights reserved.
NEWS
Continued from page 572 oriented research of hundreds of diseases and conditions,” reported Acting Director of NIH Ruth L. Kirschstein, M.D. The database resulted from 1997 legislation requiring the U.S. Department of Health and Human Services, through NIH, to broaden public access to information about clinical trials on a wide range of diseases and conditions. The database is maintained under NIH’s National Library of Medicine. “If we are to continue making the giant strides in diagnosis, treatment and cure of illness that marked the last century, we must have active participation in clinical trials by wellinformed volunteers,” said the library’s director, Donald A.B. Lindberg, M.D. In the project’s first phase, the database is focusing on clinical trials either being funded by NIH or conducted on the NIH campus in Bethesda, Md. In the second phase, the database will broaden its scope to include trials sponsored by other federal agencies and private industry. Researchers use clinical trials to test the safety and efficacy of new drugs and procedures or other means of treating, diagnosing or preventing diseases. Such investigations help researchers understand how different people respond to medications and other therapeutic approaches, sometimes leading to new or improved treatments. NIH has pledged that visits to the database are confidential, requiring no registration or identification of any kind, and that site visitors will not be contacted by the sponsors of clinical trials or by anyone else. 574
PHYSICIANS NOT LEGALLY BOUND TO DISCLOSE INCENTIVES, AMA SAYS
In a brief filed in the Illinois Supreme Court, the American Medical Association and the Illinois State Medical Society contend that physicians should have no legal duty to inform patients of managed care financial incentives to limit care. The two physician groups argue that doctors may have an ethical obligation to make such disclosures, but not a legal duty. Imposing such a legal requirement, they say, would create “insurmountable burdens” for physicians who, themselves, may not be fully aware of all the provisions in managed care contracts. AMA and ISMS filed their friend-of-the-court brief in connection with Theresa Neade vs. Steven Portes, M.D., and Primary Care Family Center, a case that, at press time, was before the Illinois Supreme Court. In the case, Therese Neade, widow of Anthony Neade, alleged that Dr. Portes had breached his fiduciary duty to her husband by not telling him that the doctor’s medical group of which he was president received a 60 percent share of any funds not used on referrals to specialists. The plaintiff argued that if she and her husband had known about the incentive, they would have questioned Dr. Portes’ refusal to approve an angiogram for Mr. Neade, who later died of a heart attack. In their brief, AMA and ISMS underscore their belief that “the physician has a legal duty to provide services to patients within the standard of care, and an ethical duty to dis-
close matters pertinent to the care and treatment of the patient that affect care, and even a further duty to advocate for medically necessary care for a patient.” Beyond that, however, “a physician should have no legal duty as a fiduciary to disclose incentives to limit care in the context of the compensation for health care services by the patient’s chosen managed care organization.” In a 1997 opinion, the AMA’s Council on Ethical and Judicial Affairs observed that “physicians must assure disclosure of any financial inducements that may tend to limit the diagnostic and therapeutic alternatives that are offered to patients or that may tend to limit patients’ overall access to care.” The AMA and ISMS insisted in their brief that the council’s standard does not impose a legal obligation. Compiled by James Berry. MEETINGS
dThe Semi-Annual Scientific Meeting of the Dental Association of Thailand will be held May 15-17 in Bangkok. For more information, contact the DAT by phone at 011-66-2-5394748 or by fax at 011-66-2-5141100. dThe Academy of Prosthodontics will hold its annual scientific meeting May 18-22 in Le Chateau Frontenac, Quebec, Canada. For more information, contact Dr. Gary Rogoff by phone at 1-202-342-0442 or by fax at 1-703-450-0563. dThe American Academy of Pediatric Dentistry will hold its annual session May 23-30 in Nashville, Tenn. For more information, contact Janice
JADA, Vol. 131, May 2000 Copyright ©1998-2001 American Dental Association. All rights reserved.
Dr. Paul A. Moore, JADA’s associate editor for Clinical Pharmacology, was named The Harald Löe Scholar for 2000 at the recent meeting of the International Association for Dental Research. Named for Dr. Harald Löe, past director of the former National Institute of Dental Research, the award enables the recipient to spend three months in Washington, D.C., working with the American Association for Dental Research, the National Institute of Dental and Craniofacial Research and the American Association of Dental Schools. The award is funded by the Procter & Gamble Co. Dr. Moore, a professor of Dr. Moore pharmacology, Department of Public Health, University of Pittsburgh School of Dental Medicine, will be working on a project entitled “Medical and Oral Health Partnerships: Mechanisms for Collaborations in Clinical Epidemiology.” GUARD AGAINST MISUSE OF ANTIBIOTICS, AUTHOR WARNS
When antibiotics are prescribed, six things can happen and only one of them is good. In one of several articles he prepared for the March Journal of the California Dental 572
Association, Dr. Thomas J. Pallasch spelled out the six possible outcomes when antibiotics are used, with only the first one being positive. dThe antibiotic may aid the immune system to gain control of the infection; dtoxicity or allergy may occur; dalready resistant microbes may be selected for, and a superinfection may result; dthe antimicrobial may promote microbial chromosomal mutations; dgene transfer may be encouraged from resistant to nonresistant microbes; dlatent-resistance genes may be expressed. “The global problem of microbial resistance to antibiotics is serious, not only in its extent, but also in the rapidity with which microorganisms are attaining and maintaining resistance,” warns Dr. Pallasch, a professor of pharmacology and periodontics at the University of Southern California School of Dentistry, and contributing editor to the CDA Journal. He notes that dentists prescribe about 10 percent of all the common antibiotics, including penicillins, cephalosporins, macrolides and tetracyclines. Antibiotic misuse in dentistry, he says, mainly involves prescribing them in “inappropriate situations” or for too long. He says inappropriate uses include: dgiving antibiotics after a dental procedure is complete in an otherwise healthy patient to “prevent” an infection, which in all likelihood will not occur anyway (read: to “prevent a lawsuit,” in many cases);
dusing antibiotics as “analgesics,” particularly in endodontics; demploying antibiotics for prophylaxis in patients not at risk for metastatic bacteremias; dusing antimicrobials to treat chronic adult periodontitis, which almost totally is responsive to mechanical treatment; dusing antimicrobial therapy in lieu of mechanical therapy in periodontitis management; dusing antibiotics and antimicrobials chronically in periodontitis; dusing antibiotics instead of surgical incision and drainage of infections; dusing antibiotics to “prevent” claims of negligence. “It is not time to panic,” Dr. Pallasch assures, “but it is time for all to realize that the problem cannot be solved without a concerted effort on the part of all concerned: patients, parents, health professionals, veterinarians, food producers and governments.” NIH UNVEILS DATABASE ON CLINICAL TRIALS
Interested in who’s conducting clinical trials, where they’re doing it and on what products and procedures? If so, visit “http:// clinicaltrials.gov/”—the first phase of a new database being introduced by the National Institutes of Health, with information on more than 4,700 federal and private medical studies underway at more than 47,000 sites nationwide. “Through this new database, NIH offers up-to-date information on promising patientContinued on page 576
JADA, Vol. 131, May 2000 Copyright ©1998-2001 American Dental Association. All rights reserved.
NEWS
Continued from page 572 oriented research of hundreds of diseases and conditions,” reported Acting Director of NIH Ruth L. Kirschstein, M.D. The database resulted from 1997 legislation requiring the U.S. Department of Health and Human Services, through NIH, to broaden public access to information about clinical trials on a wide range of diseases and conditions. The database is maintained under NIH’s National Library of Medicine. “If we are to continue making the giant strides in diagnosis, treatment and cure of illness that marked the last century, we must have active participation in clinical trials by wellinformed volunteers,” said the library’s director, Donald A.B. Lindberg, M.D. In the project’s first phase, the database is focusing on clinical trials either being funded by NIH or conducted on the NIH campus in Bethesda, Md. In the second phase, the database will broaden its scope to include trials sponsored by other federal agencies and private industry. Researchers use clinical trials to test the safety and efficacy of new drugs and procedures or other means of treating, diagnosing or preventing diseases. Such investigations help researchers understand how different people respond to medications and other therapeutic approaches, sometimes leading to new or improved treatments. NIH has pledged that visits to the database are confidential, requiring no registration or identification of any kind, and that site visitors will not be contacted by the sponsors of clinical trials or by anyone else. 574
PHYSICIANS NOT LEGALLY BOUND TO DISCLOSE INCENTIVES, AMA SAYS
In a brief filed in the Illinois Supreme Court, the American Medical Association and the Illinois State Medical Society contend that physicians should have no legal duty to inform patients of managed care financial incentives to limit care. The two physician groups argue that doctors may have an ethical obligation to make such disclosures, but not a legal duty. Imposing such a legal requirement, they say, would create “insurmountable burdens” for physicians who, themselves, may not be fully aware of all the provisions in managed care contracts. AMA and ISMS filed their friend-of-the-court brief in connection with Theresa Neade vs. Steven Portes, M.D., and Primary Care Family Center, a case that, at press time, was before the Illinois Supreme Court. In the case, Therese Neade, widow of Anthony Neade, alleged that Dr. Portes had breached his fiduciary duty to her husband by not telling him that the doctor’s medical group of which he was president received a 60 percent share of any funds not used on referrals to specialists. The plaintiff argued that if she and her husband had known about the incentive, they would have questioned Dr. Portes’ refusal to approve an angiogram for Mr. Neade, who later died of a heart attack. In their brief, AMA and ISMS underscore their belief that “the physician has a legal duty to provide services to patients within the standard of care, and an ethical duty to dis-
close matters pertinent to the care and treatment of the patient that affect care, and even a further duty to advocate for medically necessary care for a patient.” Beyond that, however, “a physician should have no legal duty as a fiduciary to disclose incentives to limit care in the context of the compensation for health care services by the patient’s chosen managed care organization.” In a 1997 opinion, the AMA’s Council on Ethical and Judicial Affairs observed that “physicians must assure disclosure of any financial inducements that may tend to limit the diagnostic and therapeutic alternatives that are offered to patients or that may tend to limit patients’ overall access to care.” The AMA and ISMS insisted in their brief that the council’s standard does not impose a legal obligation. Compiled by James Berry. MEETINGS
dThe Semi-Annual Scientific Meeting of the Dental Association of Thailand will be held May 15-17 in Bangkok. For more information, contact the DAT by phone at 011-66-2-5394748 or by fax at 011-66-2-5141100. dThe Academy of Prosthodontics will hold its annual scientific meeting May 18-22 in Le Chateau Frontenac, Quebec, Canada. For more information, contact Dr. Gary Rogoff by phone at 1-202-342-0442 or by fax at 1-703-450-0563. dThe American Academy of Pediatric Dentistry will hold its annual session May 23-30 in Nashville, Tenn. For more information, contact Janice
JADA, Vol. 131, May 2000 Copyright ©1998-2001 American Dental Association. All rights reserved.