New York City, NY, United States
New York City, NY, United States

Time filter

Source Type

Bielory L.,Rutgers University | Lyons K.,Rutgers University | Goldberg R.,Center for Medicine in the Public Interest
Current Allergy and Asthma Reports | Year: 2012

Allergies are prevalent throughout the United States and impose a substantial quality of life and economic burden. The potential effect of climate change has an impact on allergic disorders through variability of aeroallergens, food allergens and insect-based allergic venoms. Data suggest allergies (ocular and nasal allergies, allergic asthma and sinusitis) have increased in the United States and that there are changes in allergies to stinging insect populations (vespids, apids and fire ants). The cause of this upward trend is unknown, but any climate change may induce augmentation of this trend; the subspecialty of allergy and immunology needs to be keenly aware of potential issues that are projected for the near and not so distant future. © Springer Science+Business Media New York 2012.


Becker S.,University of Duisburg - Essen | Brandl C.,RWTH Aachen | Meister S.,Fraunhofer Institute for Software and Systems Engineering | Nagel E.,University of Duisburg - Essen | And 6 more authors.
PLoS ONE | Year: 2015

Purpose: A wealth of mobile applications are designed to support users in their drug intake. When developing software for patients, it is important to understand the differences between individuals who have, who will or who might never adopt mobile interventions. This study analyzes demographic and health-related factors associated with real-life "longer usage" and the "usage-intensity per day" of the mobile application "Medication Plan". Methods: Between 2010-2012, the mobile application "Medication Plan" could be downloaded free of charge from the Apple-App-Store. It was aimed at supporting the regular and correct intake of medication. Demographic and health-related data were collected via an online questionnaire. This study analyzed captured data. Results: App-related activities of 1799 users (1708 complete data sets) were recorded. 69% (1183/1708) applied "Medication Plan" for more than a day. 74% were male (872/1183), the median age 45 years. Variance analysis showed a significant effect of the users' age with respect to duration of usage (p = 0.025). While the mean duration of use was only 23.3 days for users younger than 21 years, for older users, there was a substantial increase over all age cohorts up to users of 60 years and above (103.9 days). Sex and educational status had no effect. "Daily usage intensity " was directly associated with an increasing number of prescribed medications and increased from an average of 1.87 uses per day and 1 drug per day to on average 3.71 uses per day for users stating to be taking more than 7 different drugs a day (p<0.001). Demographic predictors (sex, age and educational attainment) did not affect usage intensity. Conclusion: Users aged 60+ as well as those with complicated therapeutic drug regimens relied on the service we provided for more than three months on average. Mobile applications may be a promising approach to support the treatment of patients with chronic conditions. © 2015 Becker et al.


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.


Jones D.L.,University of Miami | Cook R.,University of Miami | Potter J.E.,University of Miami | Miron-Shatz T.,Ono Academic College | And 4 more authors.
PLoS ONE | Year: 2016

Objective Rates of pregnancy among women living with HIV (WLHIV) have increased with the availability of effective HIV treatment. Planning for pregnancy and childbirth is an increasingly important element of HIV care. Though rates of unintended pregnancies are high among women in general, among couples affected by HIV, significant planning and reproductive decisions must be considered to prevent negative health consequences for WLHIV and their neonates. To gain insight into this reproductive decision-making process among WLHIV, this study explored women's knowledge, attitudes and practices regarding fertility planning, reproductive desires, and safer conception practices. It was hypothesized that pregnancy desires would be influenced by partners, families, the potential risk of HIV transmission to infants, and physicians' recommendations. Methods WLHIV of childbearing age were recruited from urban South Florida, and completed an assessment of demographics (N = 49), fertility desires and a conjoint survey of factors associated with reproductive decision-making. Results Using conjoint analysis, we found that different decision paths exist for different types of women: Younger women and those with less education desired children if their partners wanted children; reproductive desires among those with less education, and with less HIV pregnancy-related knowledge, displayed a trend toward additional emphasis on their family's desires. Conversely, older women and those with more education appeared to place more importance on physician endorsement in their plans for childbearing. Conclusions Results of this study highlight the importance of ongoing preconception counselling for all women of reproductive age during routine HIV care. Counselling should be tailored to patient characteristics, and physicians should consider inclusion of families and/or partners in the process. © This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.


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.


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.


Pitts P.J.,Center for Medicine in the Public Interest
Journal of Commercial Biotechnology | Year: 2016

Much ado about pharma freebies to physicians. Much ado about nothing medically and everything politically. A new study published by JAMA Internal Medicine (Pharmaceutical Industry-Sponsored Meals and Physician Prescribing Patterns for Medicare Beneficiaries) makes it sound (as Meagan McArdle has written for Bloomberg), that your doctor is "willing to sell you out for the price of a sandwich." It's not that simple... or true. A valuable takeaway from the new JAMA study should be that wide adoption of Open Payments reporting has led to transparent interactions and value exchanges of education, money and meals between the pharmaceutical industry and prescribers. These data are now available to inform and improve educational efforts to meet the treatment needs of patients using the latest advances in medicine and science. However, such data must be cautiously interpreted with full acknowledgement of study limitations and author bias.


Pitts P.J.,Center for Medicine in the Public Interest
Journal of Commercial Biotechnology | Year: 2015

Let it be said that the spark that ignited the flame was when FDA leadership asked, "Do we know enough about the quality of drugs that are sold in the United States." In 2009, the FDA announced its Safe Use of Drugs Initiative. The theory being that one way to make drugs safer is to ensure that they are used as directed. The main strategy was education and the agency's efforts were (and are) aimed at physicians, nurses, pharmacists, and patients. Earlier this year, the agency announced not just an office, but a Super Office of Pharmaceutical Quality, further underscoring that the FDA operates not under a two-dimensional system of safety and efficacy, but a threedimensional approach that includes quality with a capital (indeed a "super") Q. Since there is no such thing as a safe substandard product, the agency is putting time, resources, and the use of the bully pulpit to go beyond cGMPs, API and excipient sourcing to develop a risk-based approach that includes data gathered from a variety of sources including manufacturing inspections, adverse event reporting, and substandard pharmaceutical events as evidenced in the agency's bioequivalence-driven actions with bupropion in 2012, metoprolol in 2014, and methylphenidate in 2015. So, in many respects, pharmaceutical quality is both a pre and post-licensure endeavor and, like Safe Use, a scientific and educational enterprise that requires close coordination with many stakeholders. And it won't come easily or inexpensively. As Aristotle said that, "Quality is not an act, it is a habit.".


Pitts P.J.,Center for Medicine in the Public Interest | Goldberg R.M.,Center for Medicine in the Public Interest
Journal of Commercial Biotechnology | Year: 2015

As stated in a recent article in the Journal of Clinical Oncology, ASCO established a Value in Cancer Care Task Force, with the goal of "developing a framework for comparing the relative clinical benefit, toxicity, and cost of treatment in the medical oncology setting. " In developing this framework or tool, the Task Force runs roughshod over basic facts to create a metric that while established to promote patient centered care strives mightily to achieve the exact opposite outcome.


Pitts P.J.,Center for Medicine in the Public Interest
Journal of Commercial Biotechnology | Year: 2015

Healthcare innovation sav es lives, saves money, promotes economic growth, and provides hope for hundreds of millions of people (both patients and care-givers) in the United States and around the world. But innovation isn't easy. There are many roadblocks beyond those of discovery and development. The complicated and conflicting dynamics of politics, perspectives on healthcare economics, of friction between payers, providers, manufacturers, and regulators, the battle for better patient education, and the need for a more forceful and factual debate over the value of innovation all create the need for a more balanced and robust debate. The public policy essays in this paper present some of the key obstructions to maximizing healthcare innovation. The Center for Medicine in the Public Interest is dedicated to addressing these problems head-on and providing practical opportunities to overcome them. Specifically: · The importance of understanding and rewarding incremental innovation. · The price/value debate. Rather than focusing on the short-term costs of healthcare, what are the long-term benefits to both patients and society? We will examine this issue through the lens of the Solvadi debate. · Value-based insurance design. How a more personalized approach to reimbursement matches up well with advances in personalized medicine. · The dynamic and distressing link between co-pays and outcomes and how this relationship must be understood and recalibrated. · The urgent need for transparency in insurance choices within the Affordable Care Act in order to provide the right medicine to the right patient at the right time in a transparent and affordable manner. · How to reach best clinical practice more swiftly through electronic preauthorization and the increasing empowerment of physicians. · Addressing the problem of medication compliance through innovative approaches such as apps and more user-friendly patient education. · How "the story of innovation" can be more clearly and powerfully communicated to various constituencies so that we can narrow the "misperception gap." · Rather than playing the "blame game," how we can advance healthcare innovation by working together to advance the public good.

Loading Center for Medicine in the Public Interest collaborators
Loading Center for Medicine in the Public Interest collaborators