Do the Hazards of Sunbed Use Merit Legislation?David Gennert
Recently, the use of indoor tanning booths has come under intense scrutiny from researchers and governmental groups, including an FDA advisory committee in late March that recommended that minors be banned from using the devices. The committee cited a “growing body of literature” suggesting a link between indoor tanning and skin cancer risk. The situation is especially worrisome in the UK, where a recent survey puts the prevalence of tanning bed use among those under 18 higher than the prevalence in the United States and other European countries.
A major problem is the misuse of tanning devices through the lack of compliance with regulations regarding device operating specifications and information given to consumers. The British Medical Journal article cites studies in Europe that show the UV intensity for many tanning facilities was over the recommended limit, and 71% of sunbed facilities in Ireland did not know the type of UV light used. It is also cited findings in Britain that described that many users of tanning facilities were not given information about potential harms, and substantial numbers have used tanning beds at home or in unsupervised facilities.
One possibility to help decrease this misuse of tanning facilities is to instigate a voluntary code of practice for operators of tanning facilities, but the article cites a study in Australia that described the number of facilities that disregarded regulations regarding age restrictions (more than half of facilities), skin type of users allowed to tan (90% of facilities ignored the code), and eye protection (14% gave inadequate or no eye protection).
With European nations starting a trend to ban access to those under 18– France and Scotland have banned it to this age group and the EU has passed regulations limiting access to those under 18– it seems important to also include the enforcement of any regulations as a priority as well.
Reference: BMJ 2010;340:c990.
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The Importance of Informed Consent
Priya Larson
Improving patient-centered care is an under-publicized aspect of health care reform, but Dr. Harlan Krumholz of Yale University School of Medicine calls for a standardized method of informing patients about treatment options, risks, and benefits. Informed consent is the term for the process of providing patients with detailed information about treatment so that they can choose to agree to undergo medical procedures. Krumholz advocates for the use of a standardized informed consent document that could be tailored to individual patients’ situations. The document would have space for background information and risks for their health condition, the procedure suggested, and other available treatments. The form would also educate patients on the frequency that their doctor performs the procedure, and the exact cost associated with it.
Krumholz believes that increasing the quality of informed consent would lend more legitimacy to clinics and hospitals that claim to focus on patient-centered care. A standardized informed consent procedure would help to ensure that all patients know exactly what undergoing a medical procedure entails. Studies show that such forms would improve the consent process and lessen patient anxiety. However, an increase in knowledge could also cause patients to become more nervous about the procedure, but this is not a proven effect of the informed consent process. Krumholz also points out that a standardized form might decrease the personalization of care, contrary to the original goal of the whole initiative. In the grand scheme, however, the form should improve patient-doctor trust and communication, thus improving patient-centered care.
Reference: JAMA. 2010;303(12):1190-1191.
Ensuring Primum Non Nocere
Virginia Saurman
Physicians, whether as researchers or clinicians, must do no harm to their patients. However, the case of GlaxoSmithKline’s (GSK) inappropriate conduct surrounding its company-sponsored clinical trial of Avandia (rosiglitazone) is a clear example of corporate motives outweighing scientific and ethical standards, thus potentially putting patients at risk.
The US Senate Committee on Finance investigated GlaxoSmithKline and Avandia and found that GSK exerted an unacceptable amount of influence over the RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes) drug trial. This behavior included attempting to undermine the authority and responsibilities of the study’s steering committee, rushing publication of an unscheduled interim analysis to suppress findings that suggested Avandia increased cardiovascular (CV) risk, and having employees highly involved with the statistical analysis and the production of the manuscript. After reviewing over 250,000 pages of documents from GSK, the FDA, universities, and others, and conducting interviews for 2 years, the US Senate Committee on Finance concluded that GSK knew of the potential cardiac risks associated with Avandia years before other studies suggested this. However, GSK did not air their concerns to the FDA and patients—instead executives focused on obscuring findings that showed Avandia may increase CV risk while at the same time attempting to downplay findings that a competitor drug Actos (pioglitazone) might reduce CV risk.
Given the implications of GSK’s data collection methods and their resultant behavior in the RECORD trial, perhaps all editors of journals should require that academic researchers have “full-access to all trial data, and that all industry-sponsored trials include independent statistical analysis and assurance.” This would, in theory, prevent repeats of GSK’s actions, and maintain that physicians must do no harm.
Reference: JAMA. 2010;303(12):1196-1198.
Eriene-Heidi Sidhom is the 2009-2010 News and Analysis Editor.
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