Health matrix (Cleveland, Ohio : 1991)最新文献

Biologic drugs represent an important new category of drugs in the effort to improve health outcomes in this country. Yet, thesecutting-edge drugs are often cost prohibitive, preventing access for many Americans. Recognizing the need for more affordable, genericsubstitutes for biologic drugs—or biosimilars—Congress recently created a biosimilars approval pathway that would enable thesecheaper biologic drugs to obtain FDA approval and reach patients more quickly. Unfortunately, original biologics manufacturers havesought to extend their current monopoly profits by erecting various legal and regulatory barriers to entry. Their legal maneuvers takemany forms, from delaying approval of safe biosimilars to abrogating previous commitments to international drug-naming protocols, andeven circumventing Congressional intent for biosimilar substitution. Regrettably, these policies reduce competition in the market forbiologic drugs, impede drug innovation, increase drug costs, and limit patient access to these important medications. This article exploresthe conflict between biologics and biosimilars, and the consequences that barriers to biosimilar entry in this market will create.

Dissatisfaction with the industrial model of food production has caused many consumers to seek out food produced on local, family-scalefarms that use U.S. Department of Agriculture certified organic or other sustainable practices to grow their food and raise theirlivestock. While almost all of the types of food that are available at the grocery store can also be found at the local farmers market, onefood that is difficult to find in many states is raw milk—that is, milk that has not undergone pasteurization (heat treatment). Thisdifficulty lies in the fact that most states prohibit the direct retail sale of raw milk to the final consumer because public health officials andstate legislators fear that raw milk may contain bacteria harmful to human health such as E. coli, Campylobacter, and Listeria. However,some consumers reject these warnings and instead believe that raw milk possesses both nutritional and medicinal qualities. Indeed, anever-increasing body of scientific research published in peer-reviewed journals supports the claim that raw milk consumption can mitigateor prevent some allergies and infections, especially in young children. In order for consumers to obtain raw milk in states where its sale isprohibited, some consumers have entered into arrangements with farmers known as “herd sharing,” through which the consumereffectively becomes an owner of the herd of cows or goats. For the price of the share and a monthly boarding fee, the shareholder canreceive a weekly distribution of the herd’s primary dividend, namely the raw milk. Several states expressly permit this practice while mostare silent and still a few prohibit it outright. The three courts in the United States that have ruled on herd share agreements have split,with two courts rejecting the agreements as a circumvention of the state’s prohibition on the sale of raw milk, and the other courtassuming the agreement’s validity in light of the state’s failure to adequately define “sale.” I argue that courts should consistentlyuphold properly written herd share agreements where such agreements are not prohibited because such agreements are deeplyrooted in the longstanding practice of shared ownership agreements for livestock found throughout the agriculture industry. Furthermore,raw milk has been found by some researchers to be a low-risk food that may actually have some nutritional and even medicinal qualitiesnot found in pasteurized milk. And to the extent that raw milk consumption could cause harm, the risk of a large-scale outbreak frommilk obtained through a herd share is slight considering how few participants are in any given herd share.

One of the plots of the Canadian science fiction thriller Orphan Black involves a scheme to create dozens of siblings by harvesting theeggs of one woman, fertilizing them with the sperm of a single man, and implanting them for gestation in dozens of apparently willingsurrogates.¹ The casualness of the procedure speaks to how comfortable we have all become with reproduction by technology. Yetthere are still aspects of this process that remain outside the normative boundaries of most of our worldviews. This articleconsiders recent advances in assisted reproductive technology (ART) that can result in a viable, fertilized embryo even when the mother isherself either permanently unconscious from a severe injury or has actually lost all brain function and therefore meets the legal criteriafor brain death. It reviews these advances and applies them to four scenarios, or vignettes, that represent different concerns about theprospective mother’s intent to reproduce before losing her ability to give consent.

Biomedical research provides a core social good by enabling medical progress. In the twenty-first century alone, this includesreducing transmission of HIV/AIDS, developing innovative therapies for cancer patients, and exploring the possibilities of personalizedmedicine. In order to continue to advance medical science, research relies on the voluntary participation of human subjects. Becauseresearch is inherently uncertain, unintended harm is an inevitable part of the research enterprise. Currently, injured researchparticipants in the United States must turn to the “litigation lottery” of the tort system in search of compensation. This state of affairs failsresearch participants, who are too often left uncompensated for devastating losses, and makes the United States an outlier in theinternational community. In spite of forty years’ worth of Presidential Commissions and other respected voices calling for the development ofa no-fault compensation system, no progress has been made to date. One of the reasons for this lack of progress is the failure to develop acoherent ethical basis for an obligation to provide compensation for research related injuries. This problem is exacerbated by the lack of aclear definition of “compensable injury” in the biomedical research context. This article makes a number of important contributions to thescholarship in this growing field. To begin, it examines compensation systems already in existence and concludes that there are four maindefinitional elements that must be used to define “compensable injury.” Next, it examines the justifications that have been put forthas the basis for an ethical obligation to provide compensation, and settles on retrospective nonmaleficence and distributive andcompensatory justice as the most salient and persuasive. Finally, it uses the regulatory elements and the justifications discussed in thefirst two sections to develop a well-rounded definition of “compensable injury” that is tailored to the biomedical researchcontext. Using this definition, it argues for the development of a first-of- its-kind no-fault compensation system in the United States.

A simple change to the Medicare and Medicaid outpatient prescription drug billing systems could improve patient safety and the systems' long-term fiscal stability. Including diagnosis codes on prescription drug claims (codes already in use for other billing purposes) would transform the Medicare Part D and Medicaid prescription drug claims databases into powerful public health research tools--ones that could provide much-needed (and, to date, elusive) information on how prescription drugs work in vulnerable patient populations underrepresented in clinical research. Achieving the full potential of this proposal, though, depends upon the federal agency responsible for Medicare and Medicaid, the Centers for Medicare and Medicaid Services (CMS), maintaining its current reimbursement policy, which is perhaps best characterized as one of benign neglect of the statutory standard for coverage. If, instead of continuing coverage for the vast majority of prescription drugs, CMS decided to deny payment for the millions of prescriptions falling short of the statutory standard (and thus avoid spending billions of federal health care dollars), prescribers would find themselves in an ethical dilemma between truth-telling and effectively treating their patients. Due to the systemic incentives for prescribers and pharmacists to miscode diagnoses in order to get CMS to pay for the prescription drugs needed by patients, the decision to treat patients effectively in the short-term under a strict coverage enforcement policy would undermine the potential to more effectively treat vulnerable patients, reduce prescription errors, and properly allocate federal health care dollars in the future. Even in the midst of a financial crisis, or perhaps especially because of our current financial crisis, we cannot afford to sacrifice improved patient safety and better informed long-term management of federal health care dollars for a short-term reduction in federal spending on prescription drugs.