A guide to the anti-innovation "pharmaphobia" narrative for the aspiring innovator.

Thomas P. Stossel is an American Cancer Society Professor of Medicine Emeritus at Harvard Medical School, Honorary Physician in the Hematology Division of Brigham & Women's Hospital, founding scientist of BioAegis Therapeutics, Visiting Scholar of The American Enterprise Institute and cofounder of Options for Children in Zambia.

Pediatric Dentists' Knowledge Concerning the Physician Payments Sunshine Act and Their Predictions of its Effects on Their Interactions with the Industry and its Impact on Patient Care.

PURPOSE: This study surveyed pediatric dentists' knowledge of the Physician Payments Sunshine Act (PPSA) and their impressions of its effect on their future interactions with the dental products industry and on their clinical practice. METHODS: Seven hundred seventy four practicing dentists responded to a survey, with 13 responding to a follow-up survey. RESULTS: Most respondents were unfamiliar (43 percent) or only vaguely familiar (33 percent) with the PPSA. In response to the required PPSA disclosures, 62 percent said they would see company representatives less often (37 percent indicated no change); 50 percent said they would attend fewer industry-sponsored continuing education events (49 percent indicated no change); and 57 percent indicated they would attend fewer promotional speaking events (43 percent indicated no change). Respondents indicated that self-banning detailing (68 percent), samples (72 percent), industry-sponsored continuing education events (81 percent), and promotional speaking (82 percent) would negatively impact the quality of care they are able to provide their patients. CONCLUSION: Pediatric dentists anticipate reducing or severing their existing ties to pharmaceutical, biotechnology, and device manufacturers in response to the Physician Payments Sunshine Act, despite believing that interactions with the dental products' industry enhance the quality of patient care they are able to provide their patients.

From the bench to the field in low-cost diagnostics: two case studies.

Despite the growth of research in universities on point-of-care (POC) diagnostics for global health, most devices never leave the laboratory. The processes that move diagnostic technology from the laboratory to the field--the processes intended to evaluate operation and performance under realistic conditions--are more complicated than they might seem. Two case studies illustrate this process: the development of a paper-based device to measure liver function, and the development of a device to identify sickle cell disease based on aqueous multiphase systems (AMPS) and differences in the densities of normal and sickled cells. Details of developing these devices provide strategies for forming partnerships, prototyping devices, designing studies, and evaluating POC diagnostics. Technical and procedural lessons drawn from these experiences may be useful to those designing diagnostic tests for developing countries, and more generally, technologies for use in resource-limited environments.

Evaluation of a density-based rapid diagnostic test for sickle cell disease in a clinical setting in Zambia.

Although simple and low-cost interventions for sickle cell disease (SCD) exist in many developing countries, child mortality associated with SCD remains high, in part, because of the lack of access to diagnostic tests for SCD. A density-based test using aqueous multiphase systems (SCD-AMPS) is a candidate for a low-cost, point-of-care diagnostic for SCD. In this paper, the field evaluation of SCD-AMPS in a large (n = 505) case-control study in Zambia is described. Of the two variations of the SCD-AMPS used, the best system (SCD-AMPS-2) demonstrated a sensitivity of 86% (82-90%) and a specificity of 60% (53-67%). Subsequent analysis identified potential sources of false positives that include clotting, variation between batches of SCD-AMPS, and shipping conditions. Importantly, SCD-AMPS-2 was 84% (62-94%) sensitive in detecting SCD in children between 6 months and 1 year old. In addition to an evaluation of performance, an assessment of end-user operability was done with health workers in rural clinics in Zambia. These health workers rated the SCD-AMPS tests to be as simple to use as lateral flow tests for malaria and HIV.

Association of Clinical Researchers and Educators a statement on relationships between physicians and industry.

Collaborations between physicians, particularly those in academic medicine, and industries that develop pharmaceutical products, medical devices, and diagnostic tests have led to substantial advances in patient care. At the same time, there is a strong awareness that these relationships, however beneficial they may be, should conform to established principles of ethical professional practice. Through a writing committee drawn from diverse disciplines across several institutions, the Association of Clinical Researchers and Educators (ACRE) has written a code of conduct to provide guidance to physicians in observing these principles. Our recommendations are not intended to be prescriptive or inflexible, but rather to be of assistance to physicians in making their own personal decisions on whether, or how, to be involved in research, education, or other collaborations with industry.

Time to 'walk the walk' about industry ties to enhance health.

Overwhelming evidence that relationships between universities, physicians and the medical products industry benefit patients explains the ubiquitous calls to encourage such relationships. Yet accumulating 'conflict of interest' regulations in academic health centers, government and industry have had the opposite effect. Justifications underlying the regulations lack quantitative rigor, and the rules they enforce impose costly bureaucratic requirements of dubious benefit. Evidence shows that they have diminished the collaborations deemed beneficial to health enhancement.

Overregulation of conflicts hinders medical progress.

The revolution in medicine and technology over the past few decades is largely the result of partnerships--or a "harmony of interests"--between private companies and entrepreneurial scientists and clinicians. Regulations to prevent conflicts of interest by restricting medical education, medical research, expert advisory functions, or researcher ownership of inventions may have the unintended consequence of slowing medical progress.

Regulation of financial conflicts of interest in medical practice and medical research: a damaging solution in search of a problem.

The free market, which includes most practicing physicians, publicly supported biomedical researchers, and private drug and device companies, has succeeded spectacularly in delivering new medical technologies to the public. Increased interactions between doctors (physicians and biomedical researchers), epitomized by the founding of the biotechnology revolution, have and can continue to accelerate this delivery. A powerful anti-commercial advocacy movement that has blossomed over the past 20 years threatens this momentum. This movement has succeeded in inverting reality by demonizing the market and by promoting distorted and damaging views of professionalism and of science. Most ominously, it has imposed onerous and counterproductive regulations on medical education and translational research.