Diane E. Hoffmann

Testing Children for Genetic Predispositions: Is it in Their Best Interest?

Researchers summoned a Baltimore County woman to an office at the Johns Hopkins School of Public Health last spring to tell her the bad news. They had found a genetic threat lurking in her 7-year-old son’s DNA-a mutant gene that almost always triggers a rare form of colon cancer. It was the same illness that led surgeons to remove her colon in 1979. While the boy, Michael, now 8, is still perfectly healthy, without surgery he is almost certain to develop cancer by age 40.

Achieving the Right Balance in Oversight of Physician Opioid Prescribing for Pain: The Role of State Medical Boards

ncertainty regarding potential disciplinary action may give physicians pause when considering whether to U accept a chronic pain patient or how to treat a patient who may require long-term or high doses of opioids. Surveys have shown that physicians fear potential disciplinary acrion for prescribing controlled substances and that physicians will, in some cases, inadequately prescribe opioids due to fear of regulatory scrutiny. Prescribing opioids for long-term pain management, particularly noncancer pain management, has been controversial; and boards have investigated and, in some cases, disciplined physicians for such prescribing. While in virtually all of these cases the disciplinary actions were successfully appealed, news of the success was not often as well-publicized as news of the disciplinary actions, leaving some physicians confused about their potential liability when prescribing opioids for pain. The confusion has perhaps increased as a result of two relatively recent cases, one where a physician was successfully disciplined by a state medical board for undertreatment of his patients’ pain, and another where the physician was successfully sued for inadequate pain treatment. In the first case, in September 1999, the Oregon Medical Board disciplined a physician for failure to adequately treat several of his patients for pain. Less than two years later, a California physician was successfully sued for his undemeannent of a patient’s pain. These cases reflect a changing attitude toward pain treatment in the United Statesa recognition that patients, especially patients at the end of life, have a right to adequate pain treatment. This shift in thinking appears to have begun in the late 1980s. Prior to this time, “according to established medical opinion, the likelihood of addiction to opioids was considered too great

Probiotics: Finding the Right Regulatory Balance

Some products marketed as drugs should be excused from Phase I trials, but safety and efficacy claims for dietary supplements should be more tightly regulated. Initial findings of the Human Microbiome Project (HMP), funded by the U.S. National Institutes of Health (NIH), raise important questions about the role and variation of microorganisms within individuals and across populations (1). One related area of growing research and commercial interest is the development and use of probiotics, substances containing live microorganisms that have a beneficial effect when taken in sufficient quantities (2) and “designed to intentionally manipulate microbiome and host properties” (3). We offer observations about the regulatory process for probiotics and potential areas for reform.

Are Ethics Committee Members Competent to Consult

The authors describe research conducted to assess the skills and knowledge base of individuals who perform ethics consultations in Maryland hospitals. The findings indicate a lack of formal educational preparation on the part of those who perform consults, and a general lack of institutional support for ethics committees.

Pain Management and Palliative Care in the Era of Managed Care: Issues for Health Insurers

Author reports on empirical study of medical directors at Blue Cross Blue Shield Plans regarding their awareness of and response to issues of pain management and palliative care for their insured populations.

Does legislating hospital ethics committees make a difference? A study of hospital ethics committees in Maryland, the District of Columbia, and Virginia.

Nationally, the number of hospital ethics committees grew dramatically during the 1980s. The motivation for establishing such committees, however, was not only internal but included court cases, federal regulations and a Presidential Commission report urging the establishment of such committees by hospitals. While each of these external forces added to the pressures for hospitals to establish their own ethics committees, the establishment of these committees was voluntary in every state until 1987 when the Maryland Patient Care Advisory Committee Act1 became effective. The Act requires all hospitals within Maryland to establish their own patient care advisory committees or ethics committees, as most hospitals refer to them.2 Specifically, the Act provides that a t the request of a petitioner, these committees must offer advice in cases involving individuals with life-threatening conditions. The committee must consist of at least four members, including a physician, a nurse, a social worker, and a hospital’s chief executive officer or designee. Other individuals may also be added as the hospital chooses including representatives of the community and ethical advisors or clergy. There is no mention of any lawyers on the committee. In terms of function, in addition to consultation on cases involving life-threatening conditions, the statute provides that the committees may (1) educate hospital personnel, patients and patients’ families concerning medical decision-making, and (2) review and recommend institutional policies and guidelines concerning the withholding of medical treatment. The statute also sets forth certain additional requirements of the committee. For example, the committee must have a written procedure setting forth how it shall be convened and must make a good faith effort to notify patients and their immediate family members of their rights to “be a petitioner; to meet with the advisory committee concerning the options for medical care and treatment; and to receive an explanation of the basis of the advisory committee’s advice.” The statute further requires that as part of its deliberations the advisory committee must consult all members of the patient’s treatment team; the patient; and the patient’s family. Finally, the Act provides that members of these committees who give advice in good faith may not be held liable in court for the advice given, that the proceedings of the committee are confidential, and that the advice of the committee must become part of the patient’s medical record. In January, 1989, the University of Maryland’s Law and Health Care Program was awarded a grant to conduct a study of the use of hospital ethics committees in Maryland, D.C., and Virginia. The goals of the study were twofold: (1) to assess the effectiveness of the Maryland Patient Care Advisory Committee statute, i.e.

Increasing Access to Dental and Medical Care by Allowing Greater Flexibility in Scope of Practice

In recent years, advocates for increasing access to medical and oral health care have argued for expanding the scope of practice of dentists and physicians. Although this idea may have merit, significant legal and other barriers stand in the way of allowing dentists to do more primary health care, physicians to do more oral health care, and both professions to collaborate. State practice acts, standards of care, and professional school curricula all support the historical separation between the 2 professions. Current laws do not contemplate working across professional boundaries, leaving providers who try vulnerable to legal penalties. Here we examine the legal, regulatory, and training barriers to dental and medical professionals performing services outside their traditional scope of practice.

Improving regulation of microbiota transplants

Policy should balance safety, efficacy, access, and research The Human Microbiome Project and similar research has generated great interest in potential health benefits of microbiota transplantations (MTs). The use of fecal microbiota transplantation (FMT), the transfer of stool from a human donor to a human recipient, for recurrent Clostridium difficile infection (CDI) is considered by many to be standard-of-care therapy, and data on its safety and effectiveness are accumulating (1–3). Yet, although some physicians are practicing FMT using stool from donors known to the physician or patient, stool is inconsistently screened for infectious pathogens. The use of prescreened stool obtained from a stool bank and shipped to the physician is increasing, but the stool banks are not regulated. Patients who self-administer FMT using unscreened stool sourced from family or friends is also widely described. In consideration of these and other particular characteristics and challenges of MT, and the nascent regulatory landscape, we convened human microbiome researchers, legal experts, and others to explore regulatory pathways for MT (4). We believe our proposed approach is an improvement on the U.S. Food and Drug Administrations (FDA) current and proposed scheme and could provide a model for other countries that are contemplating regulatory frameworks for FMT.

Health claim regulation of probiotics in the USA and the EU: is there a middle way?

In both the USA and Europe, supermarkets and pharmacies are brimming with probiotics - products containing live micro-organisms claiming they improve health. The availability of these products corresponds to a growing consumer demand for foods that improve or maintain health and wellness. The most persuasive include claims that consumption may confer health benefits. While some of these claims may have merit, others have not been substantiated. For a number of products, claims are based on insufficient research, underpowered studies, or mixed research results, yet individual consumers find that the product is of benefit to them. In attempting to regulate health claims, as distinct from safety, government entities may take positions which represent opposite ends of a philosophical spectrum. On one end of the spectrum they may take a limited approach to regulation relying primarily on the marketplace that respects individual autonomy and assumes a sophisticated consumer and honest sellers; alternatively they may choose substantial regulation based on a belief that consumers need protection from profit-seeking manufacturers. The USA and the European Union have taken two different approaches on this regulatory spectrum.

A Statewide Survey Identifying Perceived Barriers to Hospice Use in Nursing Homes

This article reports on findings from a cross-sectional survey the authors conducted to identify perceived barriers to hospice referrals of nursing home residents. Respondents from 25 of 28 licensed Maryland hospices participated in a telephone survey, and respondents from 108 of 248 licensed Maryland nursing homes took part in a mail-in survey in 2001-2002. Nursing home and hospice respondents differed in their perceptions of the primary obstacles to nursing home referral to hospice. Nursing home respondents were more concerned about financial disincentives and difficulty determining hospice eligibility, whereas hospice respondents were more concerned with lack of knowledge about hospice and attitudes toward hospice and end-of-life care. In order to increase referrals to hospice, the following barriers must be addressed: hospice knowledge deficits and negative attitudes toward hospice among nursing home staff and residents/families, disparity between hospice and nursing home organizational cultures, financial disincentives to refer some nursing home residents to hospice, and ambiguity regarding Office of the Inspector General requirements for nursing home-hospice relationships.