Personalizing informed consent: the challenge of health literacy

Posted on: January 27, 2009  |   Author: Jessica
Filed Under: Bioethics, Health Information, Liability & Litigation, Public Health Policy, Research Abstracts   |   Leave a Comment

The law does not adequately consider health literacy in informed consent cases, and thus fails to ensure that patients provide genuine informed consent. It has been estimated that approximately 90 million Americans have low health literacy. Health literacy may be significantly worse than general literacy because literacy is context specific and medical information can be full of unfamiliar vocabulary (medical jargon) and concepts. The average adult in the United States reads at an 8th or 9th grade level, and the average patient on Medicaid reads at a 5th grade level. Standard informed consent forms are often written at college or graduate school reading levels. Currently the legal duty of informed consent is significantly different than the ethical theories of informed consent, because instead of encouraging discussion and patient autonomy it emphasizes the formality of obtaining a patient signature. Health literacy can be examined by courts by either extending current theories (advocacy around the definitions of “prudent physician” and “reasonable patient”) or by legislation. As patients take on more personal responsibility for their health care with the rise in popularity of consumer-directed health care it is becoming increasingly more important that the law recognize physicians’ duties to obtain truly informed consent.

Preemption and the Public Health: How Wyeth v. Levine Stands to Change the Face of American Health Policy

Posted on: January 27, 2009  |   Author: Shane
Filed Under: Research Abstracts   |   Leave a Comment

For better or for worse, state-law tort claims have historically been a powerful weapon in the arsenal of public health advocates. These claims have been highly effective in the creation and implementation of sweeping public health policy by indirectly regulating the nation’s industries. However, in recent years, the nation’s largest and most regulated industries have invoked the shield of federal preemption in order to escape liability under state-law tort theories.

Congress, by means of the Supremacy Clause, enjoys the power to preempt state law where it conflicts with federal law. When Congress makes an express declaration of its intent regarding the preemptive effect of a piece of federal legislation, the work of a court reviewing the effect of that intent is typically restricted to whether Congress acted pursuant to one of its enumerated powers. But, when the preemption defense is premised on an inherent conflict between federal and state laws, the court’s analysis can be protracted, and infinitely more complex.

With the Supreme Court poised to hand down a decision in the landmark preemption case Wyeth v. Levine, it becomes increasingly important to reflect upon how tort law has shaped public health policy in the United States, and how Wyeth could affect the ability of states and public health advocates to put into play important health agendas. Some may argue that using the nation’s courts to circumvent the legislative process is undemocratic, and an inappropriate use of judicial power. Should Wyeth come out in favor of the Petitioner, Wyeth Pharmaceuticals, the ability of states to have a say in what pharmaceuticals companies can and cannot do within their borders could be compromised. This could have incredibly deleterious effects not only on the ability of states to indirectly regulate for the public health on a meta scale, but also on the public health in general.

The Skinny on the New Dietary Supplement Regulations in the U.S.

Posted on: January 27, 2009  |   Author: Greg
Filed Under: Drug & Device, Research Abstracts   |   Leave a Comment

In 2007, American consumers spent $23.7 billion on dietary supplements, making up only a fraction of the estimated $182 billion global nutrition industry.  Dietary supplement popularity has now soared to an estimated use by 158 million Americans. In line with their popularity in the United States, dietary supplements are highly popular abroad as well.  Up to 70% of all Canadians take some form of supplement and European consumers are responsible for consuming 17% of the entire global market for dietary supplements. Due to the popularity of dietary supplements and the increasing size of the global industry, the importance of product safety has grown into a main concern for governmental regulatory bodies.

Depending on the country, dietary supplements may have different definitions and different levels of regulation, if any. In the United States, dietary supplements can be generally described as products taken by mouth that contain a “dietary ingredient” intended to supplement the diet.  This includes products like vitamins, minerals, herbs, and amino acids.  Dietary supplements are regulated distinctly from both food regulation on the one hand and pharmaceutical regulation on the other. Regulated primarily under the Dietary Supplement Health and Education Act (DSHEA) of 1994, the dietary supplement industry receives specific guidance for manufacturing, labeling, and selling dietary supplements.  In a stark departure from regulation of pharmaceuticals, dietary supplement manufacturers do not have to prove that their products are safe before entering the market; rather the burden is on the U. S. Food and Drug Administration (FDA) to prove that certain dietary supplements are unsafe for consumers. Unfortunately, there is a subsequent history of unsafe dietary supplement products that have made their way into the market in the last fourteen years only to cause harm and even death to consumers. Public outcry cast a shadow over the industry as a seeming lack of regulation was blamed for the events.

U.S. lawmakers responded in the last few years with the adoption of two important regulations for dietary supplements. In 2006, the Dietary Supplement and Non-prescription Drug Consumer Protection Act (DSNDCPA) was passed requiring dietary supplement manufacturers to report to the FDA any adverse events potentially associated with their products. The DSNDCPA became effective at the beginning of 2008.  Also, in June 2007, Congress adopted FDA’s Dietary Supplement Good Manufacturing Practices Rule (cGMPs). The rule creates the minimum current good manufacturing practices for dietary supplement manufacturing, packaging, labeling, or holding.  The FDA hopes to improve consumer confidence in the purity of the dietary substances consumers purchase and that the new regulations help ensure quality and a level playing field in the dietary supplement industry.

With the passage of DSHEA, DSNDCPA, and the cGMPs, it may appear that the government has a firm grip on the dietary supplement industry’s regulation. But in reality, the level of power over dietary supplement manufacturers is anything but controlling. The passage of DSHEA seemed on its face to create a framework for dietary supplement regulation, when in effect, it did the opposite. DSHEA itself guaranteed that dietary supplement manufacturers would not have to prove their products’ safety before marketing and sale of the dietary supplements to consumers. Even with the passage and implementation of the DSNDCPA and the cGMPs, dietary supplement regulation in the United States is widely open to criticism. Further, when compared to dietary supplement regulations in jurisdictions like the European Union and Canada that are heavily influenced by dietary supplements, current regulations in the United States still appear much more lenient. However, as this comment explains, “more lenient” does not necessarily mean that the regulations are inferior. Therefore, a critique of the new dietary supplement regulations in the United States and a comparison to dietary supplement regulations in the European Union and Canada is necessary in order to provide guidance as to how dietary supplement regulation in the United States should develop, and also provides caution as to problems to avoid.

Part II of this article provides a historical background of dietary supplements’ turbulent past and increasing popularity, and also presents studies on the actual effectiveness of some of the most popular dietary supplements. As much has changed, and continues to change in dietary supplement regulation, Part III provides an overview of current dietary supplement regulations in the United States and analyzes criticisms of the regulatory framework that the laws create. Finally, Part IV discusses how the United States, even with the enactment of its new dietary supplement rules, continues to struggle in developing an efficient mechanism to balance consumer safety and free-market competition, and also looks to dietary supplement regulations in the European Union and Canada for guidance. This paper suggests that the key to improving dietary supplement safety is not going to be found in a broad shift to treat dietary supplements as strictly as pharmaceuticals, or to follow the regulatory mechanisms of Canada or the European Union, but to continue to make industry-specific adjustments that reflect the dietary supplement industry’s needs in the United States, while providing a more stringent regulatory mechanism to promote consumer safety.


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