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

{"title":"Biologic Drugs, Biosimilars, and Barriers to Entry.","authors":"Joanna M Shepherd","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Biologic drugs represent an important new category of drugs in the effort to improve health outcomes in this country. Yet, these\u0000cutting-edge drugs are often cost prohibitive, preventing access for many Americans. Recognizing the need for more affordable, generic\u0000substitutes for biologic drugs—or biosimilars—Congress recently created a biosimilars approval pathway that would enable these\u0000cheaper biologic drugs to obtain FDA approval and reach patients more quickly. Unfortunately, original biologics manufacturers have\u0000sought to extend their current monopoly profits by erecting various legal and regulatory barriers to entry. Their legal maneuvers take\u0000many forms, from delaying approval of safe biosimilars to abrogating previous commitments to international drug-naming protocols, and\u0000even circumventing Congressional intent for biosimilar substitution. Regrettably, these policies reduce competition in the market for\u0000biologic drugs, impede drug innovation, increase drug costs, and limit patient access to these important medications. This article explores\u0000the conflict between biologics and biosimilars, and the consequences that barriers to biosimilar entry in this market will create.</p>","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35867668","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"\"Don't Have A Cow, Man!\": Recognizing Herd Share Agreements for Raw Milk.","authors":"Timothy J Mayer","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Dissatisfaction with the industrial model of food production has caused many consumers to seek out food produced on local, family-scale\u0000farms that use U.S. Department of Agriculture certified organic or other sustainable practices to grow their food and raise their\u0000livestock. While almost all of the types of food that are available at the grocery store can also be found at the local farmers market, one\u0000food that is difficult to find in many states is raw milk—that is, milk that has not undergone pasteurization (heat treatment). This\u0000difficulty lies in the fact that most states prohibit the direct retail sale of raw milk to the final consumer because public health officials and\u0000state legislators fear that raw milk may contain bacteria harmful to human health such as E. coli, Campylobacter, and Listeria. However,\u0000some consumers reject these warnings and instead believe that raw milk possesses both nutritional and medicinal qualities. Indeed, an\u0000ever-increasing body of scientific research published in peer-reviewed journals supports the claim that raw milk consumption can mitigate\u0000or prevent some allergies and infections, especially in young children. In order for consumers to obtain raw milk in states where its sale is\u0000prohibited, some consumers have entered into arrangements with farmers known as “herd sharing,” through which the consumer\u0000effectively becomes an owner of the herd of cows or goats. For the price of the share and a monthly boarding fee, the shareholder can\u0000receive a weekly distribution of the herd’s primary dividend, namely the raw milk. Several states expressly permit this practice while most\u0000are silent and still a few prohibit it outright. The three courts in the United States that have ruled on herd share agreements have split,\u0000with two courts rejecting the agreements as a circumvention of the state’s prohibition on the sale of raw milk, and the other court\u0000assuming the agreement’s validity in light of the state’s failure to adequately define “sale.” I argue that courts should consistently\u0000uphold properly written herd share agreements where such agreements are not prohibited because such agreements are deeply\u0000rooted in the longstanding practice of shared ownership agreements for livestock found throughout the agriculture industry. Furthermore,\u0000raw milk has been found by some researchers to be a low-risk food that may actually have some nutritional and even medicinal qualities\u0000not found in pasteurized milk. And to the extent that raw milk consumption could cause harm, the risk of a large-scale outbreak from\u0000milk obtained through a herd share is slight considering how few participants are in any given herd share.</p>","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35874868","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sick and Tired of Being Sick and Tired: Putting an End to Separate and Unequal Health Care in the United States 50 Years After the Civil Rights Act of 1964.","authors":"Ruqaiijah Yearby","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35868696","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Toward a Structural Theory of Implicit Racial and Ethnic Bias in Health Care.","authors":"Dayna Bowen Matthew","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35868708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Responding to Requests for Assisted Reproductive Technology Intervention Involving Women Who Cannot Give Consent.","authors":"Jennider S Bard,&nbsp;Lindsay Penrose","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>One of the plots of the Canadian science fiction thriller Orphan Black involves a scheme to create dozens of siblings by harvesting the\u0000eggs of one woman, fertilizing them with the sperm of a single man, and implanting them for gestation in dozens of apparently willing\u0000surrogates.¹ The casualness of the procedure speaks to how comfortable we have all become with reproduction by technology. Yet\u0000there are still aspects of this process that remain outside the normative boundaries of most of our worldviews. This article\u0000considers recent advances in assisted reproductive technology (ART) that can result in a viable, fertilized embryo even when the mother is\u0000herself either permanently unconscious from a severe injury or has actually lost all brain function and therefore meets the legal criteria\u0000for brain death. It reviews these advances and applies them to four scenarios, or vignettes, that represent different concerns about the\u0000prospective mother’s intent to reproduce before losing her ability to give consent.</p>","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35873493","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Public Health Implications of Religious Exemptions: A Balance Between Public Safety and Personal Choice, or Religion Gone Too Far?","authors":"Christopher Ogolla","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35874857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Understanding and Addressing the Common Roots of Racial Health Disparities: The Case of Cardiovascular Disease and HIV/AIDS in African Americans.","authors":"Martha E Lang,&nbsp;Chloe E Bird","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35868713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Defining Compensable Injury in Biomedical Research.","authors":"Megan E Larkin","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Biomedical research provides a core social good by enabling medical progress. In the twenty-first century alone, this includes\u0000reducing transmission of HIV/AIDS, developing innovative therapies for cancer patients, and exploring the possibilities of personalized\u0000medicine. In order to continue to advance medical science, research relies on the voluntary participation of human subjects. Because\u0000research is inherently uncertain, unintended harm is an inevitable part of the research enterprise. Currently, injured research\u0000participants in the United States must turn to the “litigation lottery” of the tort system in search of compensation. This state of affairs fails\u0000research participants, who are too often left uncompensated for devastating losses, and makes the United States an outlier in the\u0000international community. In spite of forty years’ worth of Presidential Commissions and other respected voices calling for the development of\u0000a 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 a\u0000coherent ethical basis for an obligation to provide compensation for research related injuries. This problem is exacerbated by the lack of a\u0000clear definition of “compensable injury” in the biomedical research context. This article makes a number of important contributions to the\u0000scholarship in this growing field. To begin, it examines compensation systems already in existence and concludes that there are four main\u0000definitional elements that must be used to define “compensable injury.” Next, it examines the justifications that have been put forth\u0000as the basis for an ethical obligation to provide compensation, and settles on retrospective nonmaleficence and distributive and\u0000compensatory justice as the most salient and persuasive. Finally, it uses the regulatory elements and the justifications discussed in the\u0000first two sections to develop a well-rounded definition of “compensable injury” that is tailored to the biomedical research\u0000context. Using this definition, it argues for the development of a first-of- its-kind no-fault compensation system in the United States.</p>","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"35874861","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"How Medicare Part D, Medicaid, electronic prescribing, and ICD-10 could improve public health (but only if CMS lets them).","authors":"Jennifer L Herbst","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32575113","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mandatory school-based mental health services and the prevention of school violence.","authors":"Tessa Heller","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2014-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32575115","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}