Analysis of FDA's Vuse market authorisation: limitations and opportunities.

This special communication provides a physicians' critique of the US Food and Drug Administration (FDA)'s decision to authorise the Vuse Solo (Vuse) Premarket Tobacco Application (PMTA). The PMTA authorisation represents the first time that FDA has authorised an Electronic Nicotine Delivery System (ENDS) for marketing in the USA. Using the FDA Decision Summary, the special communication identifies significant unanswered public health and scientific questions that prevent the authors from reaching FDA's conclusion that Vuse meets the Appropriate for the Protection of the Public Health (APPH) standard. The authors recommend FDA suspend the market authorisation and use these questions to re-evaluate the PMTA, and to prospectively monitor whether Vuse meets APPH standard. The special communication advances the ENDS harm reduction conversation because it calls for national tobacco regulators to develop an epidemiological prediction of ENDS impact on the population and to expand the scope of their analysis to evaluate the impacts of ENDS on congenital birth defects, abuse liability and non-flavour drivers of youth usage. Through learning from the American experience regulating Vuse, national tobacco regulators around the globe will be better equipped to evaluate the impact of ENDS on the public health.

Electronic nicotine delivery systems: the need for continued regulatory innovation.

The recent surge in electronic nicotine delivery systems (ENDS) or electronic cigarette use among both adolescents and adults challenged tobacco regulatory frameworks worldwide. In this article, we review recent US Food and Drug Administration regulatory approaches to tobacco products, including attempts to regulate nicotine concentration and address youth use. We examine recent drives to promote a harm reduction approach in other product markets such as opioids, where the use of methadone and related therapies promote the public health. We describe the potential of a harm reduction framework for ENDS regulation based on tiered nicotine exposure standards coupled with risk-based product distribution controls that would enable ENDS products to meet the 'Appropriate for the Protection of the Public Health' standard required for tobacco product market entry. A harm reduction approach to ENDS regulation could help countries achieve the laudable public health goals of transitioning existing combustion cigarette users to ENDS products while preventing adolescent ENDS use and subsequent nicotine addiction.

Financing Preventive Medicine Graduate Medical Education.

Financing US preventive medicine residency programs has been a persistently difficult issue. The unique nature of preventive medicine renders training more burdensome and costly than other specialties. This article describes the numerous and varied federal sources of Graduate Medical Education funding to outline available residency financing options for the specialty of preventive medicine. This information could be utilized by various preventive medicine organizations in their efforts to strengthen the specialty.

Preventive medicine's equivalence problem.

The structure of preventive medicine residency training in the U.S. warrants serious examination. U.S. public health and general preventive medicine residencies have suffered a 17% decline in the number of residency programs since 2000, and current residency programs are, on average, half-empty. The required clinical year is not unique to preventive medicine, a basic, undifferentiated MPH for preventive medicine doesn't distinguish the preventive medicine specialist, and practicum year requirements are overly broad and not necessarily specific to the specialty, leaving the specialty vulnerable to equivalence by most other specialties. Strategies including creation of an additional preventive medicine-specific clinical year, developing a new public health degree for the specialty, and more specific practicum rotations, as well as potentially changing the specialty's name and altering the annual structure of training, are proposed along with an equivalence test.

Credentialing and privileging the preventive medicine physician.

The practice of preventive medicine remains ill-defined, and the specialty is threatened by a void in the definition of the specialty's practice. The authors propose a cohesive, active identification of skills provided by trained preventive medicine physicians through the credentialing and privileging process. The privileging process should incorporate clinical skills specific to the provider and non-clinical skills based on preventive medicine residency training competency requirements, preventive medicine board certification examination requirements, and the ten essential public health services. The specialty may benefit from development of clinical training based on public health clinical services as well as privileging of physicians in health organization leadership positions.

Do preventive medicine physicians practice medicine?

As some preventive medicine physicians have been denied medical licenses for not engaging in direct patient care, this paper attempts to answer the question, "Do preventive medicine physicians practice medicine?" by exploring the requirements of licensure, the definition of "practice" in the context of modern medicine, and by comparing the specialty of preventive medicine to other specialties which should invite similar scrutiny. The authors could find no explicit licensure requirement for either a certain amount of time in patient care or a number of patients seen. No physicians board certified in Public Health and General Preventive Medicine sit on any state medical boards. The authors propose that state medical boards accept a broad standard of medical practice, which includes the practice of preventive medicine specialists, for licensing purposes.

Biomonitoring of chemical exposure among New York City firefighters responding to the World Trade Center fire and collapse.

The collapse of the World Trade Center (WTC) on 11 September 2001 exposed New York City firefighters to smoke and dust of unprecedented magnitude and duration. The chemicals and the concentrations produced from any fire are difficult to predict, but estimates of internal dose exposures can be assessed by the biological monitoring of blood and urine. We analyzed blood and urine specimens obtained from 321 firefighters responding to the WTC fires and collapse for 110 potentially fire-related chemicals. Controls consisted of 47 firefighters not present at the WTC. Sampling occurred 3 weeks after 11 September, while fires were still burning. When reference or background ranges were available, most chemical concentrations were found to be generally low and not outside these ranges. Compared with controls, the exposed firefighters showed significant differences in adjusted geometric means for six of the chemicals and significantly greater detection rates for an additional three. Arrival time was a significant predictor variable for four chemicals. Special Operations Command firefighters (n = 95), compared with other responding WTC firefighters (n = 226), had differences in concentrations or detection rate for 14 of the chemicals. Values for the Special Operations Command firefighters were also significantly different from the control group values for these same chemicals and for two additional chemicals. Generally, the chemical concentrations in the other firefighter group were not different from those of controls. Biomonitoring was used to characterize firefighter exposure at the WTC disaster. Although some of the chemicals analyzed showed statistically significant differences, these differences were generally small.

Symptoms, respirator use, and pulmonary function changes among New York City firefighters responding to the World Trade Center disaster.

CONTEXT: New York City firefighters responding to the World Trade Center (WTC) disaster on September 11, 2001, were exposed to numerous hazards. A medical screening program was conducted 3 weeks after the disaster on a sample of firefighters. OBJECTIVES: To determine whether arrival time at the WTC and other exposure variables (including respirator use) were associated with symptoms and changes in pulmonary function (after exposure - before exposure). DESIGN: A cross-sectional comparison of firefighters representing the following groups: (1) firefighters who arrived before/during the WTC collapse, (2) firefighters who arrived 1 to 2 days after the collapse, (3) firefighters who arrived 3 to 7 days after the collapse, and (4) unexposed firefighters. SETTING: Fire Department of New York City (FDNY) Bureau of Health Services on October 1 to 5, 2001. POPULATION: A stratified random sample of 362 of 398 recruited working firefighters (91%). Of these, 149 firefighters (41%) were present at the WTC collapse, 142 firefighters (39%) arrived after the collapse but within 48 h, 28 firefighters (8%) arrived 3 to 7 days after the collapse, and 43 firefighters (12%) were unexposed. MAIN OUTCOME MEASURES: New/worsening symptoms involving the eyes, skin, respiratory system, and nose and throat (NT), and changes in spirometry from before to after exposure. RESULTS: During the first 2 weeks at the WTC site, 19% of study firefighters reported not using a respirator; 50% reported using a respirator but only rarely. Prevalence ratios (PRs) for skin, eye, respiratory, and NT symptoms showed a dose-response pattern between exposure groups based on time of arrival at the WTC site, with PRs between 2.6 and 11.4 with 95% confidence intervals (CIs) excluding 1.0 for all but skin symptoms. For those spending > 7 days at the site, the PR for respiratory symptoms was 1.32 (95% CI, 1.13 to 1.55), compared with those who were exposed for < 7 days. Mean spirometry results before and after exposure were within normal limits. The change in spirometry findings (after exposure - before exposure) showed near-equal reductions for FVC and FEV(1). These reductions were greater than the annual reductions measured in a referent population of incumbent FDNY firefighters prior to September 11 (p or= 450 mL in FEV(1) in those arriving during the first 48 h compared to the referent (p

Evaluation of self-reported skin problems among workers exposed to toluene diisocyanate (TDI) at a foam manufacturing facility.

Toluene diisocyanate, or TDI (CAS 584-84-9) is a well-known asthmagen and respiratory irritant. TDI is also known for its ability to irritate the skin and mucous membranes. To further investigate the dermal effects of TDI, NIOSH investigators conducted a cross-sectional study at a flexible foam manufacturing plant. A total of 114 workers participated in the study. Participants completed a medical questionnaire, provided blood for antibody testing to TDI and other allergens, and a subset of participants reporting skin symptoms underwent skin patch testing to a standard diisocyanate panel. Production line workers were more than twice as likely to report skin problems as those working in nonproduction areas (PRR = 2.66; 95% CI = 1.14-16.32; P = 0.02). Age, gender and duration of employment at the plant were comparable among participants working in production and nonproduction areas. Of the 100 participants who provided blood samples for antibody testing, specific IgG antibody to TDI was detected in two individuals, and none of the samples demonstrated specific IgE antibody to TDI. Of the 26 workers who underwent skin patch testing, none developed reactions to the diisocyanate allergens. These results suggest that the skin symptoms among study participants represent an irritant rather than an immunologic reaction to TDI, or to an unidentified allergen present in the foam.