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Grinshpun-Cohen J.,The Danek Gertner Institute of Human Genetics | Grinshpun-Cohen J.,Tel Aviv University | Miron-Shatz T.,Ono Academic College | Miron-Shatz T.,Center for Medicine in the Public Interest | And 3 more authors.
Health Expectations | Year: 2015

Background: Risk for foetal Down syndrome (DS) increases as maternal age increases. Non-invasive screening (maternal serum triple test) for DS is routinely offered to pregnant women to provide risk estimates and suggest invasive amniocentesis for definitive pre-natal diagnosis to high-risk women. Objective: We examined women's decision process with regard to pre-natal screening, and specifically, the degree to which they take into account triple serum screening results when considering whether or not to undergo amniocentesis. Design: Semi-structured phone interviews were conducted to assess recall of DS screening results, understanding of risk estimates and their effect on women's decision whether to undergo amniocentesis. The study included 60 pregnant Israeli women (half younger than 35 and half advanced maternal age - AMA), with normal DS screening results and no known ultrasound abnormalities. Results: Age appeared to determine the decision process. The vast majority of AMA women had amniocentesis, many of them before receiving their DS screening results. Most AMA participants knew that their risk estimate was 'normal', but still considered themselves at high risk due to their age. Procedure-related risk (miscarriage) and other factors only had a minor effect on their decision. A minority of younger women had amniocentesis. Younger women mentioned procedure-related risk and having normal screening results as the main factors affecting their decision not to have amniocentesis. Conclusion: Age 35 is an anchor for the pre-determination regarding performing or avoiding amniocentesis. AMA women mention 'age' as their main reason to have amniocentesis and considered it an independent risk factor. © 2015 John Wiley & Sons Ltd. Source


Pitts P.J.,Center for Medicine in the Public Interest
Journal of Commercial Biotechnology | Year: 2013

On December 7, 2011, Secretary of Health and Human Services Kathleen Sebelius overruled a decision of the Food and Drug Administration (FDA) on the over-the-counter (OTC) status of emergency contraception. What will be the repercussions of Secretary Sebelius's action? Why is the act itself of far greater long-term significance than the transitory regulatory action it impacts? By reversing an FDA decision, the Secretary has set a dangerous precedent for all-comers to lobby Congress, the Department of Health and Human Services (HHS) and the White House on any and all FDA decisions - directly inserting politics into what must be a scientifically driven process. Source


Pitts P.J.,Center for Medicine in the Public Interest
Drug Information Journal | Year: 2012

"Newspeak," as Orwellian cognoscenti know, is the official language of Oceania-the land ruled by Big Brother. Newspeak was designed "not to extend but to diminish the range of thought." Its goal was to "make all other modes of thought impossible." All of which brings us from the nightmare fantasy of 1984 Newspeak to the health care debate of 2012, the concept of "academic detailing," and a new term we must all become familiar with-cost-think (which defines everything that reduces short-term costs as a benefit to the patient). © The Author(s) 2012. Source


Pitts P.J.,Center for Medicine in the Public Interest | Cautreels W.,Selecta Biosciences | Baker M.,European Federation of Neurological Associations
Drug Information Journal | Year: 2011

In the last 50 years the average life span has increased by 10 years, largely due to advancements in pharmaceutical drug development, primarily within the developed world. What will drive this over the next 50 years? Improved patient access to drugs is a critical goal for all stakeholders in drug discovery, development, and delivery. However, drug access levels for patients continue to decrease, driven by, for example, stricter regulatory policies, lower R&D output, stronger payer cost pressures, and a complex legal environment. Given the importance of health and well-being, it is critical for stakeholders to better understand these hurdles and develop high-impact solutions that significantly increase patient access to new medicines. While pharmaceutical companies have had some limited success in overcoming R&D hurdles, a multistakeholder holistic approach is necessary to develop paradigm-changing solutions. A meeting of 12 distinguished health care experts was convened on January 26-27, 2010, in London, UK, to address this issue. The participants included government regulators, health care policy experts, industry leaders, health economists, health care attorneys, patient advocates, and academics. The primary objectives of the meeting were to further understand the hurdles to patient access and to develop high-impact global solutions. Topics discussed included the following: • The nature of the problem • Initiatives currently underway • Insights on the challenges and barriers that inhibit patient access to new and innovative medicines • Prioritizing ideas to facilitate meaningful strategies for expediting patient access to new medicines • A potential path forward for implementing the priority ideas from the meeting Five of the ideas that were discussed are as follows: 1. A nonprofit, independent, patient-driven drug assessment agency to provide an appraisal of risks versus benefits of new drugs to both individuals and the society as a whole, unbiased by nonclinical measurements such as the quality adjusted life year (QALY) 2. An academic institute of regulatory science to drive research into the discipline of drug regulation 3. A new Asia-Pacific panregional regulatory agency to provide centralized regulatory support 4. Better sharing of data within the pharmaceutical industry (eg, safety databases, genomic and small-molecule libraries, negative outcomes) directly, or potentially through government bodies 5. Enhanced use of private-public partnerships in new product development building on learning from organizations such as the Bill and Melinda Gates Foundation, the FDA Critical Path Initiative, the Innovative Medicines Initiatives, and the Cardiac Safety Research Consortium. The column reviews important discussion and insight emerging at the meeting, and is intended as a call to action highlighting the importance of improved global patient access to new medicines. The first two of the ideas just described were viewed as top priority based on feasibility and potential impact. © 2011 Drug Information Association, Inc. Source


Aljadhey H.,King Saud University | Mahmoud M.A.,King Saud University | Alshammari T.M.,Hail University | Al-Dhaeefi M.,King Saud University | And 3 more authors.
Saudi Medical Journal | Year: 2015

Objectives: To explore the challenges facing pharmacovigilance in Saudi Arabia and formulate recommendations to improve it from the perspective of healthcare professionals in Saudi Arabia. Methods: This was a qualitative study of 4 focus group discussions with pharmacists, physicians, and academicians held under the auspices of the King Saud University School of Pharmacy and the Center for Medicine in the Public Interest, Riyadh, Saudi Arabia. A total of 29 eligible healthcare professionals were invited to participate in the discussion. The predefined themes of the study were the current practice and major challenges facing pharmacovigilance in regulatory bodies, hospitals, the community, and academia, as well as recommendations to improve pharmacovigilance practice. Result: Of the 29 participants invited, 27 attended the discussion. Challenges facing regulatory bodies included complicated adverse drug reactions (ADR) reporting forms, lack of feedback on ADRs submitted to the Saudi Food and Drug Authority, lack of decisions from the local authority to withdraw medications, and lack of data on pharmacovigilance. The challenges to pharmacovigilance in hospitals included the lack of knowledge of the significance of ADR reporting, workload, blaming culture, and lack of collaboration between regulatory bodies and hospitals. However, challenges facing pharmaceutical industries included the lack of drug manufacturers in Saudi Arabia and lack of interest in pharmacovigilance. Recommendations to improve pharmacovigilance included the need for communication, stronger regulatory requirements, the need for research, the need for unified ADRs reporting, and continuous education and training. Conclusion: The study has identified the challenges facing pharmacovigilance in Saudi Arabia and made certain recommendations to overcome them. These recommendations might be helpful for regulatory bodies to enhance spontaneous reporting and promote pharmacovigilance. © 2015, Saudi Arabian Armed Forces Hospital. All rights reserved. Source

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