Genetic (Un)certainty and the Law: The Legal and Ethical Implications of Reconceptualizing Genetic Disease

Posted on: January 21, 2008  |   Author: Jennifer
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Today, there are a wide range of genetic tests available for a myriad of markers. This testing is changing the way in which private decisions are made regarding diseases and disability in addition to causing drastic changes in the societal sphere. Genetic tests attempt to determine whether an individual possess a genetic mutation or variation. A disease is considered genetic when a person with a particular genetic variation has a greater than average chance of devolving the correlated disease. Testing may be performed either through the direct analysis of DNA, or by looking to other factors such as RNA, chromosomes, proteins, and certain metabolites. Sometimes a range of these tests may used in combination of each other. The request for a genetic test may be may be done for diagnostic, predictive, or reproductive goals, to determine the likelihood that either the individual or their offspring will manifest the genetic mutation or variation.

Although current focus is often on genetic diseases in which the consequences can be predicted with almost certainty, these diseases are in fact less common throughout society. There are two situations which yield to less than certain correlation between genetic mutation and manifestation of the disease: 1.) Single gene diseases with a low level of “penetrance” and varying degrees of severity of symptoms and 2.) Multi-factoral genetic disease. First, even if there are some diseases in which there may be an inevitable connection between the genetic variation and the physiological defect, the disease may not manifest in an injurious manner. Therefore although the disease may be a single genetic disease, the degree to which the disorder may be disabling is unknown. This differs from the traditional paradigm diseases such as Huntington’s where, although the date of onset is unknown, the manifestation of the disease is certain to follow if the genetic variation is present.

The focus of this note is to examine the legal and ethical implications of most common yet underemphasized complexities of genetic diseases, genetic markers and conditions which are not black and white but result in various levels and impacts of the disease. As stated by Edward Larson, “finding a ‘disabling’ gene does not necessarily indicate the physical manifestation of disability.” What follows is an examination of the current landscape after we break down the conception of a single gene with certain and complete expressivity. This article examines genetic markers which have less than perfect correlation between the genotype and the phenotypic expression. Part I of this note introduces the science behind genetic testing and PGD. Viewing the vast majority of genetic variation under the more tentative correlation between mutation and disease, Part II then examines current disability theory. Part III discusses the current legal landscape of discrimination and tort law to examine the way in which these laws aid in the conceptualization of complex genetic diseases.

Reversing the Trend of Increasing Information Transparency: States Move to Limit Pharmaceutical Industry Access to Physician Prescription Histories

Posted on: January 21, 2008  |   Author: Garrett
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In the last year New Hampshire and Maine became the first two states to pass legislation either outright banning, in the case of New Hampshire, or allowing physicians to opt out of allowing, in the case of Maine, their prescription information to be sold to the pharmaceutical industry for the purpose of marketing. It is a practice that is by no means new, although technology has greatly facilitated access to any kind of information. Yet, many physicians have no idea that pharmaceutical representatives, or detailers as they are often called, hold their entire prescribing history in their personal computers. Since the development of a national market for pharmaceuticals following World War II, pharmacies have been selling prescription information, deidentified as to the patient, to intermediary companies who compile this information. They then combine information from pharmacies with physician information from the American Medical Association’s Masterfile and sell these databases to the pharmaceutical industry. Pharmacies, the AMA, and the intermediaries all make a profit from the sale of their information. In the end, pharmaceutical companies possess a database that includes the prescription history of nearly every physician in the United States. Theoretically, this information can be used to pressure physicians to prescribe more of a particular drug if these databases show that they are instead prescribing a generic or a competitor’s drug. The argument of state legislatures, such as New Hampshire’s and Maine’s, has been that this ability to pressure physicians to prescribe certain namebrand drugs drives up the cost of pharmaceuticals and the mere ability to look into the prescribing of physicians is an invasion of their privacy. However, the pharmaceutical industry and information intermediaries have been quick to point out that these presciption information databases also allow the industry to identify physicians who are quick to prescribe new drugs, while also facilitating drug recalls. Even the strongest opponents of the practice of detailing admit that some, if not the majority, of detailing is beneficial in the sense that it educates physicians about new drugs and keeps them up to date on the most recent developments.

These competing arguments have been analyzed in detail during two cases in the federal district courts of Maine and New Hampshire, where the two largest information intermediaries, IMS and Verispan, brought suits seeking injunctions against the enforcement of the statutes passed in each state which limited the ability of these companies to collect prescription information. Each court concluded that the sale of prescription information constitutes commercial speech protected by the 1st and 14th Amendments. Therefore, the respective statutes were held to be unconstitutional under the intermediate scrutiny due to statutes that restrict commercial speech. The reasoning and interpretation of case precedents that resulted in the conclusion that the sale of prescription information constitutes commercial speech was a stretch both legally and logically. Each state legislature has demonstrated sparse understanding of the actual effects of these laws, and has made nearly irrational claims of miraculously reduced costs. The courts, as well, have chosen to nullify the statutes on shaky grounds at best. If either court had applied the standard two prong test to the activity at question, they should have concluded that the act of selling prescription information does not sufficiently constitute an “expression” to qualify as speech protected by the 1st Amendment.

EMTALA: When On-Call Physicians Fail To Respond

Posted on: January 20, 2008  |   Author: Julia
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Emergency Medical Treatment and Labor Act (EMTALA), was enacted as “anti-dumping” law to prevent the transfer of patients unable to pay for the cost of treatment. EMTALA provides for stabilization and treatment of an emergency medical condition and regulates the duties of on-call physicians. The Act provides for a private cause of action against a hospital but not against individual physicians and congressional history indicates that the legislature was concerned with establishing a federal malpractice cause of action against physicians. The paper examines the duties of-call physicians under EMTALA and analyzes the factors that affect physician’s ability to comply with EMTALA regulations. Studies indicating that lack of knowledge of EMTALA duties and responsibilities expose a hospital to increased liability under EMTALA are examined. Relying on the empirical studies, the paper also determines that lack of compensation for on-call coverage contributes to the on-call coverage crisis and causes specialty physicians to avoid accepting on-call responsibilities. Lucrative positions in small specialty hospitals with no requirement for on-call coverage are also mentioned as one of the causes of specialist shortage in some areas of the country. The note looks at the conditions of emergency departments in California as an indicator of the nationwide on-call coverage crisis. An alternative approach to the financial compensation of on-call physicians, in the form of physician and hospital incentive system, is proposed. In addition, the note rejects a private cause of action against individual physicians, as it will not serve as a deterrent, as suggested in literature, but will create a federal cause of action against individual physician, thereby contributing to the specialist shortage and on-call coverage crisis.

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