The pervasiveness and policy consequences of medical folk wisdom in the U.S.

Medical folk wisdom (MFW) refers to widely held, but factually inaccurate, beliefs about disease, immunity, pregnancy, and other medically-relevant topics. Examples include the idea that fasting when feverish ("starving a fever") can increase the pace of recovery, or that showering after sex can prevent pregnancy. The pervasiveness of MFW, and whether or not it-like other forms of medically-relevant misinformation-shapes Americans' health behaviors and policy preferences is an important and under-studied question. We begin this research by proposing and validating a novel measure of MFW; including a short-form scale suitable for administration in public opinion surveys. We find that nearly all Americans-irrespective of socio-economic status, political orientation, and educational background-endorse at least some aspects of MFW. Concerningly, and consistent with the idea that folk wisdom challenges scientific expertise, we additionally find that those highest in MFW tend to place less value on medical expertise and the role experts play in shaping health policy. However, this skepticism does not appear to translate to peoples' health actions, as MFW appears to have an inconsistent effect on public participation in healthy behaviors.

Integrative medicine or infiltrative pseudoscience?

Evidence-based medicine, first described in 1992, offers a clear, systematic, and scientific approach to the practice of medicine. Recently, the non-evidence-based practice of complementary and alternative medicine (CAM) has been increasing in the United States and around the world, particularly at medical institutions known for providing rigorous evidence-based care. The use of CAM may cause harm to patients through interactions with evidence-based medications or if patients choose to forego evidence-based care. CAM may also put financial strain on patients as most CAM expenditures are paid out-of-pocket. Despite these drawbacks, patients continue to use CAM due to media promotion of CAM therapies, dissatisfaction with conventional healthcare, and a desire for more holistic care. Given the increasing demand for CAM, many medical institutions now offer CAM services. Recently, there has been controversy surrounding the leaders of several CAM centres based at a highly respected academic medical institution, as they publicly expressed anti-vaccination views. These controversies demonstrate the non-evidence-based philosophies that run deep within CAM that are contrary to the evidence-based care that academic medical institutions should provide. Although there are financial incentives for institutions to provide CAM, it is important to recognize that this legitimizes CAM and may cause harm to patients. The poor regulation of CAM allows for the continued distribution of products and services that have not been rigorously tested for safety and efficacy. Governments in Australia and England have successfully improved regulation of CAM and can serve as a model to other countries.

Complementary medicine products: interpreting the evidence base.

Many patients use complementary medicine (CM) products, such as vitamins, minerals and herbs as part of self-care without professional advice or disclosure to their doctors. While use of CM products is gaining awareness by the medical community and there is mounting evidence for their safety, efficacy and cost-effectiveness, there is also the potential for adverse events from inappropriate use and/or withdrawal, as well as interactions with other medicines. Due to the unique and complex properties of many CM products, research evidence is specific to individual preparations and this can lead to confusion when assessing label claims and interpreting the results of clinical trials and systematic reviews. While the Australian regulatory environment for CM products is the same as for prescription medicines and is based on risk, there is a great need for consumers and clinicians to have access to easily understood, evidence-based information to facilitate informed decision-making.

Delivering an action agenda for nutrition interventions addressing adolescent girls and young women: priorities for implementation and research.

Adolescent nutritional behaviors are assuming considerable importance in nutrition interventions given their important relationships with medium- and long-term outcomes. This is the period when young people undergo major anatomical and physiological maturational changes in preparation for adulthood. Nutritional requirements during puberty are higher during adolescence than during the prepubertal stage and during adulthood. A significant proportion of adolescents also become parents, and hence the importance of their health and nutritional status before as well as during pregnancy has its impact on their own health, fetal well-being, and newborn health. In this paper, we describe the evidence-based nutrition recommendations and the current global guidance for nutrition actions for adolescents. Despite the limitations of available information, we believe that a range of interventions are feasible to address outcomes in this age group, although some would need to start earlier in childhood. We propose packages of preventive care and management comprising nutrition-specific and nutrition-sensitive interventions to address adolescent undernutrition, overnutrition, and micronutrient deficiencies. We discuss potential delivery platforms and strategies relevant to low- and middle-income countries. Beyond the evidence synthesis, there is a clear need to translate evidence into policy and for implementation of key recommendations and addressing knowledge gaps through prioritized research.

[Naturheilkunde und Komplementärmedizin in medizinischen Leitlinien - eine medizinrechtliche Perspektive].

Jeder Vertragsarzt ist schon konfrontiert worden mit der Diskrepanz zwischen leitliniengerechter Behandlung und Ausschlüssen in der Gesetzlichen Krankenversicherung (GKV). Um der wirtschaftlichen Gefahr durch Regresse, Honorarkürzungen und Plausibilitätsprüfungen zu entgehen, haben die Regeln der GKV Vorrang. Droht dann aber bei Abweichung von Leitlinien die zivilrechtliche oder gar strafrechtliche Haftung? Immer wieder fragen sich Ärzte, wie verbindlich Leitlinien sind und wie weit sie die Therapiefreiheit einschränken können.

Breast cancer screening in the era of density notification legislation: summary of 2014 Massachusetts experience and suggestion of an evidence-based management algorithm by multi-disciplinary expert panel.

Stemming from breast density notification legislation in Massachusetts effective 2015, we sought to develop a collaborative evidence-based approach to density notification that could be used by practitioners across the state. Our goal was to develop an evidence-based consensus management algorithm to help patients and health care providers follow best practices to implement a coordinated, evidence-based, cost-effective, sustainable practice and to standardize care in recommendations for supplemental screening. We formed the Massachusetts Breast Risk Education and Assessment Task Force (MA-BREAST) a multi-institutional, multi-disciplinary panel of expert radiologists, surgeons, primary care physicians, and oncologists to develop a collaborative approach to density notification legislation. Using evidence-based data from the Institute for Clinical and Economic Review, the Cochrane review, National Comprehensive Cancer Network guidelines, American Cancer Society recommendations, and American College of Radiology appropriateness criteria, the group collaboratively developed an evidence-based best-practices algorithm. The expert consensus algorithm uses breast density as one element in the risk stratification to determine the need for supplemental screening. Women with dense breasts and otherwise low risk (<15% lifetime risk), do not routinely require supplemental screening per the expert consensus. Women of high risk (>20% lifetime) should consider supplemental screening MRI in addition to routine mammography regardless of breast density. We report the development of the multi-disciplinary collaborative approach to density notification. We propose a risk stratification algorithm to assess personal level of risk to determine the need for supplemental screening for an individual woman.

The new regulation to investigate potentially beneficial diagnostic and therapeutic methods in Germany: up to international standard?

Funding of diagnostic and therapeutic methods in Germany's statutory health insurance (SHI) follows a dichotomy: in outpatient care, only methods with proven benefit are reimbursed while in inpatient care, all methods may be provided unless they are excluded due to proven harm or lack of benefit. In January 2012, a new section 137e was added to the Social Code Book V (SGB V), allowing for the inclusion of innovative and potentially beneficial diagnostic or therapeutic methods in the SHI benefit basket, while additional evidence regarding their effectiveness and safety must be gathered. In 2013, the Federal Joint Committee (G-BA) has specified the details of this new approach, which can be considered a variety of "Coverage with Evidence Development" (CED). Our comparison with CED schemes in selected countries reveals a dependence of the CED implementation on the encompassing healthcare system. However, we identify a clear legislative foundation, a definitive decision-making body, the possibility to obtain public funding, and the preference for high quality study designs as constituting factors of an emerging international standard for CED. In addition, it is necessary to ensure the suitability of circumstances and technologies for the successful application of CED in a clear and transparent way.

[The costs of new drugs compared to current standard treatment]. / Die Preise neuer Arzneimittel im Vergleich zu ihren therapeutischen Alternativen.

BACKGROUND: Until AMNOG came into effect Germany had free pricing of new drugs. Our exemplary work investigates the costs of new drugs that were licensed in the two years prior to AMNOG, and compares them to the costs of standard treatment that has been used in pivotal trials. Also, the important components of pharmaceutical prices will be illustrated. METHOD: We retrospectively analysed the European Public Assessment Reports of proprietary medicinal products that the European Medicinal Agency initially approved in 2009 and 2010 and that were tested against an active control in at least one pivotal trial. RESULTS: If the standard treatment was a generic, the average pharmacy retail price of new drugs was 7.4 times (median 7.1) higher than that of standard treatment. If the standard treatment was an originator drug the average price was 1.4 times (median 1.2) higher than that of the new drug. There was no clear correlation of an increase in costs for new drugs and their "grade of innovation" as rated according to the criteria of Fricke. Our study shows that prices of new drugs must be linked to the evidence of comparative benefit; since German drug pricing is complex, cost saving effects obtained thereby will depend on a range of other rules and decisions.

FDA oversight of cell therapy clinical trials.

The U.S. Food and Drug Administration applies regulatory flexibility to balance benefits and risks to subjects in cell-therapy clinical trials.

The unregulated commercialization of stem cell treatments: a global perspective.

Research into the biological properties and clinical potential of stem cells has spurred strong public investment, industry development, media coverage, and patient interest in recent years. To date, however, few clinical applications of demonstrated safety and efficacy have been developed with the exception of uses of hematopoietic stem cells in the treatment of diseases of the blood and immune systems. This lack of an evidence basis notwithstanding, hundreds of companies and private clinics around the world now sell putative stem cell treatments for an enormously broad range of medical and quality-of-life conditions. This represents a major challenge for legitimate scientists working in the field, for authorities seeking to protect their constituencies, and for patients and consumers targeted by such companies' marketing strategies. In this review, I provide an overview of the global industry in pseudomedical stem cell treatments, with an investigation of claims in a single disease area (amyotrophic lateral sclerosis), and make recommendations for the introduction and enforcement of appropriate regulatory responses to this problem.

[Is "evidence-based medicine" followed by "confidence-based medicine"?]. / Folgt auf die "Evidence-based Medicine" eine "Confidence-based Medicine"?

In an appeal concerning accusations of defamation, the England and Wales Court of Appeal Decisions determined that evidence-based statements are to be judged as opinions and not statements of fact. Since the authors consider it probable that this legal judgment will exert influence on physicians' decisions about the provision of health care services, they have compiled the implications of the judgment and discuss its consequences. The own analyses and considerations lead to the conclusion that confidence-based medicine follows evidence-based medicine. This extension is necessary because evidence-based medicine has not been able to generate the required trust. Therefore, it will be demanded to underpin the existing concept with additional data. These data will be necessary because it is no longer sufficient to convince scientists with data which are obtained under ideal conditions, but to convince critical members of society with additional data which have been obtained under everyday conditions.