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Archive for the ‘Uninsured and Underinsured’ Category


Victoria Hale: Pharmaceutical Pioneer

Larry H. Bernstein, MD, FCAP, Curator

LPBI

 

Bringing Life-Saving Medicine to Those Who Can Least Afford It

http://www.genengnews.com/insight-and-intelligence/victoria-hale-pharmaceutical-pioneer/77900545/

The quest for innovative, affordable, and sustainable medical solutions for women has driven Victoria Hale, Ph.D., to start multiple companies. [iStock/© zodebala]

http://www.genengnews.com/media/images/AnalysisAndInsight/Oct27_2015_iStock_22080713_FamilyPoverty1381802542.jpg

http://www.genengnews.com/Media/images/AnalysisAndInsight/oct27_2015_VictoriaHale_Headshot5521815813.jpg

  • Three years into working for Genentech, Victoria Hale, Ph.D., faced a pivotal moment. Her career was on track to becoming a high-ranking, well-paid executive in one of the major pharmaceutical companies. Instead, she quit her job to create a whole new model for the way pharmaceuticals are developed.

Prior to Genentech, while working at the FDA, she witnessed an example of what happens to medicines for unprofitable markets. A pharmaceutical company was developing one new drug for two promising indications, one a potential blockbuster and the other an orphan disease. Corporate executives decided to focus on the blockbuster and abandon the orphan disease because it distracted the team from the more profitable indication.

Dr. Hale saw this as a glaring injustice.

“I felt that it was important to make drugs for everyone who needs them, regardless of whatever level they can pay,” she says. “People cannot develop medicines themselves. Experienced, trained professionals are the only ones who know how to do this. There are people who have medicines for any disease here, while 5,000 miles away babies are dying for lack of simple medications.”

Observing the inequities in how drugs were distributed, she asked a fundamental question: “What if we removed the profit requirement? What if we created a nonprofit model for developing pharmaceuticals?”

As someone with a Ph.D. in pharmaceutical chemistry from the University of California San Francisco, Dr. Hale was well aware that bringing a new drug to market can cost in the billions. Her strategy, with a future nonprofit, was to find drugs with patents that had expired or which were not being used because of low profit margins. Even so, getting governmental approval for a new use for an existing drug can cost $50 million.

  • Struck a Chord

Nevertheless her vision of creating a nonprofit model for addressing injustices in how drugs are distributed began attracting donors. Her first major fundraising success came when the Gates Foundation provided her with a $4.7 million check for seed money. In the years since, she has been granted $150 million in total for several programs. Other philanthropic organizations have continued to fund her efforts, and, surprisingly, if not amazingly, Dr. Hale was able to find an anonymous donor who provided an $82 million grant to fund low-cost highly effective contraception efforts.

Dr. Hale can point to many examples of how this nonprofit approach has successfully played out in practice. One example is the work that the company she founded in 2000, OneWorld Health, is doing in providing a cure for black fever. This is a disease that has historically infected a million people a year in India leading to 300,000 death annually.

Black fever, or visceral leishmaniasis, is a disease of the poor. A malnourished person may have a compromised immune system, making him or her vulnerable to the parasite that causes leishmaniasis.

“When I was first looking into black fever,” remembers Dr. Hale, “there was a treatment available, but the cost was more than $100, and families faced the choice of going into debt for three generations or allowing the family member to die.”

Dr. Hale learned of an injectable antibiotic, paromomycin, that was apparently effective against the parasite in the laboratory setting. It hadn’t been formally studied in people for use against black fever, and there was no money to continue further research on it, so although a cure existed, it hadn’t been proven and it wasn’t available for those who needed it. However, using her nonprofit approach, Dr. Hale and her colleagues were able to raise the $50 million from the Gates Foundation for clinical trials in India, and succeeded in demonstrating efficacy and safety.

Today, Dr. Hale, who was awarded the 2015 Award for Leadership in Women’s Health Worldwide at the 23rd Annual Congress of the Academy of Women’s Health, and her colleagues are able to produce paromomycin for $10 per treatment. As a result, and combined with other public health interventions, India may soon be free of this scourge.

Another of Dr. Hale’s concerns is unwanted pregnancy. Her organization Medicines360 is able to provide an IUD that has a 40-fold greater success rate than the pill, it lasts for three years, and is sold for $50 each to women who lack adequate insurance. Medicines360 makes it available to family planning clinics that provide services to low-income women. The consequences for women and for society are incalculable.

Like OneWorld Health, Medicines360 is also a new approach to pharmaceuticals. Medicines360 is particularly aimed at pharmaceuticals for women, and it has a unique operating model: it reinvests profits generated through commercial sales revenue and puts these profits into advocacy, education, research, and development. The goal is to provide innovative, affordable, and sustainable medical solutions for women.

For Medicines360, profits aren’t the motive; they’re the means to a mission. Dr. Hale believes that her nonprofit can be a model for other nonprofit pharmaceutical companies and also for hybrid companies that could get part of their funding from philanthropists and part from traditional sources. She already knows that there are young idealistic people who will carry the model forward and who are pushing this agenda.

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Stress and Anxiety

Writer and Curator: Larry H Bernstein, MD, FCAP

 

Introduction

This article follows immediately after two on diet and obesity and diet and exercise. The hypothalamus has been discussed in some detail, although There is more that needs to be said about glutamate receptors, which is a topic in itself. However, this material fits in place quite well.  There is a considerable amount of obesity, and exercise is limited by time and commitment.  The shrinking middle class and the working poor, and the unemployed poor as well, have a struggle to make ends meet, and with the divorce rates that we are seeing, it is stressful for a single mother to carry on a complete life as mother and caregiver, and it is not unusual to see one or both couples in a household, regardless of sex, to hold two jobs.  Students enter colleges for higher education and leave with significant debts.  Graduates with advanced degrees may have to compete with a crowd of qualified applicants for an academic position, or even for a job in technology.  In addition, there is an increase in stress related disorders in the   pre-school, elementary and middle school population.  We no longer have to read the front pages to learn that a violent act has been carried out somewhere, in some neighborhood in our great nation that has experienced a great civil war, two world wars, the Mc Carthy hearings, the Cold War, and Vietnam, and the Iraq War, all of which was accompanied by migrations, immigration, and outsourcing of jobs.  The following is another look at how we are adjusting.

 

Effectiveness of a meditation-based stress management program as an adjunct to pharmacotherapy in patients with anxiety disorder

Sang Hyuk Lee, Seung Chan Ahn, Yu Jin Lee, Tae Kyu Choi, et al.
J Psychosomatic Research 62 (2007) 189–195
http://dx.doi.org:/10.1016/j.jpsychores.2006.09.009

Objective: The objective of this study was to examine the effectiveness of a meditation-based stress management program in patients with anxiety disorder.
Methods: Patients with anxiety disorder were randomly assigned to an 8-week clinical trial of either a meditation-based stress management program or an anxiety disorder education program. The Hamilton Anxiety Rating Scale (HAM-A), the Hamilton Depression Rating Scale (HAM-D), the State–Trait Anxiety Inventory (STAI), the Beck Depression Inventory, and the Symptom Checklist- 90 — Revised (SCL-90-R) were used to measure outcome at 0, 2, 4, and 8 weeks of the program. Results: Compared to the education group, the meditation-based stress management group showed significant improvement in scores on all anxiety scales (HAM-A, P=.001; STAI state, P=.001; STAI trait, P=.001; anxiety subscale of SCL-90-R,P=.001) and in the SCL-90-R hostility subscale (P=.01). Findings on depression measures were inconsistent, with no significant improvement shown by subjects in the meditation-based stress management group compared to those in the education group. The meditation-based stress management group did not show significant improvement in somatization, obsessive–compulsive symptoms, and interpersonal sensitivity scores, or in the SCL-90-R phobic anxiety subscale compared to the education group. Conclusions: A meditation-based stress management program can be effective in relieving anxiety symptoms in patients with anxiety disorder. However, well-designed, randomized, and controlled trials are needed to scientifically prove the worth of this intervention prior to treatment.

 

Evidence and Potential Mechanisms for Mindfulness Practices and Energy Psychology for Obesity and Binge-Eating Disorder

Renee Sojcher, Susan Gould Fogerite, and Adam Perlman
Explore 2012; 8(5):271-276
http://dx.doi.org/10.1016/j.explore.2012.06.003

Obesity is a growing epidemic. Chronic stress produces endocrine and immune factors that are contributors to obesity’s etiology. These biochemical alsocan affect appetite and eating behaviors that can lead to binge-eating disorder. The inadequacies of standard care and the problem of patient noncompliance have inspired a search for alternative treatments. Proposals in the literature have called for combination therapies involving behavioral or new biological therapies. This manuscript suggests that mindbody interventions would be ideal for such combinations. Two mind body modalities, energy psychology and mindfulness meditation, are reviewed for their potential in treating weight loss, stress, and behavior modification related to binge-eating disorder.

Whereas mindfulness meditation and practices show more compelling evidence, energy psychology, in the infancy stages of elucidation, exhibits initially promising outcomes but requires further evidence-based trials. “Diets Don’t Work” has been a mantra repeated over and over in the media. In fact, in a 2006 study in which investigators compared several popular diets comprising either high carbohydrates, high protein, or high fat, they found a rapid regression of compliance after six months, to the extent that it did not matter which diet had initially been more effective. In another study, authors examined a combination of diet and exercise compared with diet alone and observed that 50% of their subjects in both groups regained the weight that they lost after one year, despite their having lost more weight with the combination therapy. Despite the failure of diet alone in most studies, strategies incorporating both diet and exercise can be effective: a Cochrane review on exercise for overweight or obesity concluded that exercise had a positive effect on body weight and cardiovascular risk factors and that this effect was enhanced by a combination of exercise with dietary interventions.

The authors of a more recent study found that the benefits of exercise in inducing weight loss may come through psychological pathways rather than through actual energy expenditure. These factors include self-regulation and self-efficacy, which may mediate the relationship between exercise and weight change. Psychological interventions, particularly behavioral therapy and CBT, have been shown to be effective, especially when combined with diet and exercise. However, these interventions are costly and require extensive clinical contact for long durations to achieve efficacy. The authors of a recent randomized controlled trial (RCT) with a three-year follow-up period looked at a new form of CBT that addresses patients’ overeating and low level of activity, as well as factors that impede weight maintenance, and found that this form of therapy did not result in improved weight maintenance. These authors concluded that CBT is not sufficiently effective in helping patients maintain their weight loss in the long term. Although 20% of people will not change their eating behaviors under stress, most do; approximately 40% will increase and 40% will decrease their eating.

The emotional eaters, who tend to increase food intake, are more likely to crave high-fat/sweet and rewarding comfort foods. The basis for this behavior is becoming understood to entail brain pathways that involve learning and memory of reward and pleasure. Habit formation and decreased cognitive control are also involved. These habits form the basis of BED. Binge eating occurs when a person eats larger amounts of food than normal in a short amount of time. It therefore involves a loss of control and is often precipitated by a range of negative emotions, such as anxiety, depression, anger, and loneliness. Overweight subjects may or may not be characterized as binge eaters.

The stress response, also known as the “fight or flight response,” involves the interaction of the autonomic nervous system, which includes the sympathetic and the parasympathetic nervous systems, the hypothalamic pituitary adrenal axis and endocrine secretion. Together, these systems comprise neuro-endocrine pathways that collaborate to maintain the body’s regulation of homeostasis. This mechanism is very effective when stress is acute, but in the case of chronic stress, the effect can be injurious to one’s physiological state. Over time, chronic exposure to stress hormones contributes to“ allostatic load.” The stress hormones released by the body, mostly cortisol, can alter the body’s fuel metabolism, especially by adipose tissue, leading to an increase in upper-body obesity. Furthermore, hormones such as leptin, ghrelin, and neuropeptide Y can affect appetite and cause changes in fat mass storage. This results in the linking of stress and obesity.

Given the limited success of conventional approaches and the new information about the psychological and physiological mechanisms underlying obesity, we propose that a specific sub-group of mind-body therapies, including energy psychology and mindfulness-based approaches, could add an important new dimension to the integrative treatment of eating disorders. Energy psychology refers to a family of therapies that are used for treating physical disorders and psychological symptoms, which includes Thought Field Therapy, Emotional Freedom Techniques (EFT), Eye Movement Desensitization and Reprocessing, and Tapas Acupressure Technique (TAT). These therapies incorporate concepts originating from non-Western healing and spiritual systems, including acupuncture, acupressure, yoga, meditation, and qigong, and they combine physical activity with mental activation on the basis of the premise that the body is composed of electrical signals or energy fields. Energy psychology has been quite controversial among psychotherapists and has been the subject of much heated debate in the literature. Nonetheless, the clinical application of these practices is growing and is beginning to be investigated for efficacy. Mindfulness-Based Eating Awareness Training (ie,MB-EAT) involves the cultivation of mindfulness, mindful eating, emotional balance, and self-acceptance.

A pilot trial of a six-week group curriculum for providing mindfulness training to obese individuals, called Mindful Eating and Living (ie,MEAL), showed significant increases in measures of mindfulness and cognitive restraint around eating and significant decreases in weight, eating disinhibition, bingeeating, depression, perceived stress, physical symptoms, negative affect ,and C-reactive protein. In a recent systematic review of eight studies, authors examined a variety of mindfulness techniques in treating eating disorders, including anorexia, bulimia, and BED. Because trial quality varied and sample sizes were small, the researchers concluded that mindfulness may be effective in treating eating disorders but that further research was needed. The authors noted, however, that all of the articles that met the study’s criterion reported positive outcomes for the mindfulness intervention. Two additional studies recently addressed the treatment of obesity with a combination of mindfulness strategies and ACT. Lillis et al. conducted a RCT on 87 subjects who had all completed at least a six-month weight loss program. Using a wait list control against treatment of the experimental group through a one-day workshop, the authors found that, compared with the control group, the experimental group showed greater improvements in obesity-related stigma, quality of life, psychological distress, and reduction of body mass in a three-month follow-up. Alberts et al. conducted an RCT on 19 participants in a 10-week dietary group treatment that examined the effect of mindfulness plus ACT on food cravings. Experimental subjects underwent an additional seven-week, manual-based mindfulness/acceptance training. The control group received information on healthy food choices. The experimental group showed significantly lower food cravings, a lower preoccupation with food in four subscales, less loss of control, and better positive outcome expectancy, as compared with the control group. There was no significant effect observed for emotional craving. The authors of both of these studies conclude that mindfulness strategies combined with acceptance are effective in reducing the behaviors that lead many obese patients to overeat. With regards to stress, mindfulness can reduce psychological factors that have been shown to contribute to obesity.

In a recent well conducted systematic review, Mars and Abbey examined 22 studies with conditions ranging from participants with Axis I disorders, various diagnosed medical disorders, and healthy subjects. Axis I disorders include a range of psychopathologies such as childhood developmental and adjustment abnormalities, adult anxiety, and mood, sleep, and sexual disorders. Subjects with BED are known to have greater comorbidity forAxis I disorders. The authors report that five studies examining Axis I disorders showed statistically significant results for an eight-week, two hours per week MBCT program in reducing psychological stress, recurring bouts of depression, and pain. They conclude that, despite some methodological difficulties in the trials, mindfulness therapy may have a positive impact on reducing stress and depression. Despite increasing public awareness of obesity’s detrimental effects on health, the conventional approaches to managing this condition have not been effective. The recommended standard care for overweight and obesity, namely diet and exercise, are for the most part ineffective in the long term. Behavioral therapy and CBT may have some effect but are costly and difficult to implement. Issues with bariatric surgery and pharmacological therapies attributable to cost and the potential for harm, as well as lack of long-term efficacy, have limited their utility.

The effectiveness of a stress coping program based on mindfulness meditation on the stress, anxiety, and depression experienced by nursing students in Korea

Yune Sik Kang, So Young Choi, Eunjung Ryu
Nurse Education Today 29 (2009) 538–543
http://dx.doi.org:/10.1016/j.nedt.2008.12.003

This study examined the effectiveness of a stress coping program based on mindfulness meditation on the stress, anxiety, and depression experienced by nursing students in Korea. A nonequivalent, control group, pre-posttest design was used. A convenience sample of 41 nursing students were randomly assigned to experimental (n=21) and control groups (n=20). Stress was measured with the PWI-SF(5-point) developed by Chang. Anxiety was measured with Spieberger’s state anxiety y inventory. Depression was measured with the Beck depression inventory. The experimental group attended 90-min sessions for eight weeks. No intervention was administered to the control group. Nine participants were excluded from the analysis because they did not complete the study due to personal circumstances, resulting in16 participants in each group for the final analysis. Results for the two groups showed

(1) a significant difference in stress scores (F=6.145,p=0.020),

(2) a significant difference in anxiety scores (F=6.985,p=0.013), and

(3) no significant difference in depression scores (t=1.986,p=0.056).

A stress coping program based on mindfulness meditation was an effective intervention for nursing students to decrease their stress and anxiety, and could be used to manage stress in student nurses. In the future, long-term studies should be pursued to standardize and detail the program, with particular emphasis on studies to confirm the effects of the program in patients with diseases, such as cancer.

 

 

Meditation and Anxiety Reduction: A Literature Review

M. M. Delmonte Clin
Psychol Rev 1985; 5: 91-102
Meditation is increasingly being practiced as a therapeutic technique. The effects of practice on psychometrically assessed anxiety levels has been extensively researched. Prospective meditators tend to report above average anxiety. In general, high anxiety levels predict a subsequent low frequency of practice. However, the evidence suggests that those who practice regularly tend to show significant decreases in anxiety. Meditation does not appear to be more effective than comparative interventions in reducing anxiety. There is evidence to suggest that hypnotizability and expectancy may both play a role in reported anxiety decrease. Certain individuals with a capacity to engage in autonomous self-absorbed relaxation, may benefit most from meditation.

 

Meta-analysis on the effectiveness of mindfulness-based stress reduction therapy on mental health of adults with a chronic disease: What should the reader not make of it?

Ernst Bohlmeijer, Rilana Prenger, ErikTaal
Letters to the Editor/J Psychosom Res 69 (2010) 613–615
http://dx.doi.org:/10.1016/j.jpsychores.2010.09.005

In a letter to the editor, Nyklíček et al. discuss the study of Bohlmeijer et al. [1]on the meta-analysis on the effectiveness of mindfulness-based stress reduction (MBSR) therapy on mental health of adults with a chronic disease. They claim that the effects of MBSR are underestimated in this meta-analysis due to the inclusion of a study using an active education support group as control group and to the omission of some subscales for which larger effect sizes have been found. We do not agree that the study using an active education support group as a control group should not have been included in the meta-analysis. It is a common procedure to include studies with various types of control groups, e.g., waiting-list, placebo, minimal interventions, or evidence-based treatment. Normally, subgroup analyses can be conducted, contrasting studies that use differen ttypes of control groups. As seven studies used a waiting-list control condition and only one study used an education support group, this subgroup comparison was not useful. However, when we conducted a meta-analysis of the seven RCTs using a waiting-list control group an overall effect size of 0.30 instead of 0.26 was found. In addition, it is often found in meta-analyses that the largest effect sizes are reported in studies that use waiting-list control groups, e.g. ,Refs.[2,3]. The fact that almost all studies included in our meta-analysis in fact used waiting-list control groups makes it unlikely that the effects of MBSR were underestimated. As to the second claim by Nyklíček e tal.that some outcomes were selectively omitted from the meta-analysis, we can state that the subscales of the POMS were included in the meta-analysis.The program that was used in our study, Comprehensive Meta-Analysis, combined the scales that measure the same outcome, e.g., anxiety in one study. So the larger effects sizes for the subscales of the POMS were included in the meta-analysis. Lastly, Nyklíčeketal. State that ‘decentering’ is not an exclusive process of MBCT but is a central feature of MBSR as well. MBCT was specifically developed for people with recurrent depression and on the basis of a thorough analysis of the role of specific cognitions in people with recurrent depression. In ouropinion, this may explain the large effect sizes that have been found in randomized controlled trials, e.g., [4]. In general, other studies have shown that integrating MBSR in behavioral therapy is a very promising strategy for enhancing the efficacy of treatments of psychological  distress[5,6]. However, more studies with different target groups are needed to answer the question as to which mindfulness-based intervention is most effective for which target group in which setting. Overall, in response to the letter to the editor by Nyklíček et al. we cannot corroborate their claim that the effects of MBSR were underestimated and have to stand with our conclusion that, on the basis of current RCTs, MBSR has small leffects on depression and anxiety in people with chronic medical diseases.

[1] BohlmeijerET, PrengerR, TaalE, CuijpersP.
The effects of mindfulness-based stress reduction therapy on the mental health of adults with a chronic medical disease: A meta-analysis.
JPsychosom Res 2010; 68:539–44.

[2]Powers MB, Zum Vörde Sive Vörding MB, Emmelkamp PMG.
Acceptance and commitment therapy: A meta-analytic review.
Psychoth Psychosom 2009; 78:73–80.

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Peer Review and Health Care Issues

Larry H. Bernstein, MD, FCAP, Reporter

https://pharmaceuticalintelligence.com/12/1/2014/Peer-Review-and-Health-Care-Issues

(Medscape – Dec 1, 2014)

Peer-reviewed journals retracted 110 papers over the last 2 years. Nature reports the grim details in “Publishing: the peer review scam”.

When a handful of authors were caught reviewing their own

papers, it exposed weaknesses in modern publishing systems.

Editors are trying to plug the holes.

 

The Hill reports that the FDA may lift its ban on blood donations from gay men. The American Red Cross has voiced its support for lifting of the ban.

Advisers for the Food and Drug Administration (FDA) will meet this week to decide whether gay men should be allowed to donate blood, the agency’s biggest step yet toward changing the 30-year-old policy.

If the FDA accepts the recommendation, it would roll back a policy that has been under strong pressure from LGBT advocates and some members of Congress for more than four years.

“We’ve got the ball rolling. I feel like this is a tide-turning vote,” said Ryan James Yezak, an LGBT activist who founded the National Gay Blood Drive and will speak at the meeting. “There’s been a lot of feet dragging and I think they’re realizing it now.”

Groups such as the American Red Cross and America’s Blood Centers also voiced support of the policy change this month, calling the ban “medically and scientifically unwarranted.”

The FDA will use the group’s recommendation to decide whether to change the policy.

“Following deliberations taking into consideration the available evidence, the FDA will issue revised guidance, if appropriate,” FDA spokeswoman Jennifer Rodriguez wrote in a statement.

This reporter has more than 20 years of Blood Bank experience.  The factor in favor of the recommendation is that the HIV 1/2 and other testing is accurate enough to leave the question of donor lifestyle irrelevant.  However, it remains to be seen whether the testing turnaround time is sufficient to prevent the release of units that may be contaminated prior to transfusion, which is problematic for platelets, that have short expirations. In all cases of donor infection, regardless of whether units are released, a finding leads to not releasing the product or to recall.

 

Democrats made a strategic mistake by passing the Affordable Care Act, Sen. Charles Schumer (N.Y.), the third-ranking member of the Senate Democratic leadership, said Tuesday.

Schumer says Democrats “blew the opportunity the American people gave them” in the 2008 elections, a Democratic landslide, by focusing on healthcare reform instead of legislation to boost the middle class.

“After passing the stimulus, Democrats should have continued to propose middle class-oriented programs and built on the partial success of the stimulus,” he said in a speech at the National Press Club.

He said the plight of uninsured Americans caused by “unfair insurance company practices” needed to be addressed, but it wasn’t the change that people wanted when they elected Barack Obama as president.

“Americans were crying out for an end to the recession, for better wages and more jobs; not for changes in their healthcare,” he said.

This reader finds the observation by Senator Schumer very perceptive, regardless of whether the observation in hindsight might have had a different political outcome.  It has been noted that President Obama had a lot on his plate.  Moreover, we have not seen such a poor record of legislation in my lifetime.  There are underlying issues of worldview of elected officials that also contribute to the events.

 

THE PEER-REVIEW SCAM

BY CAT FERGUSON, ADAM MARCUS AND IVAN ORANSKY

N AT U R E |  2 7 N O V  2 0 1 4; VO L 5 1 5 : 480-82.

Most journal editors know how much effort it takes to persuade busy researchers to review a paper. That is why the editor of The Journal of Enzyme Inhibition and Medicinal Chemistry was puzzled by the reviews for manuscripts by one author — Hyung-In Moon, a medicinal-plant researcher then at Dongguk University in Gyeongju, South Korea.

The reviews themselves were not remarkable: mostly favourable, with some suggestions about how to improve the papers. What was unusual was how quickly they were completed — often within 24 hours. The turnaround was a little too fast, and Claudiu Supuran, the journal’s editor-in-chief, started to become suspicious.

In 2012, he confronted Moon, who readily admitted that the reviews had come in so quickly because he had written many of them himself. The deception had not been hard to set up. Supuran’s journal and several others published by Informa Healthcare in London
invite authors to suggest potential reviewers for their papers. So Moon provided names, sometimes of real scientists and sometimes pseudonyms, often with bogus e-mail addresses that would go directly to him or his colleagues. His confession led to the retraction of 28 papers by several Informa journals, and the resignation of an editor.

Moon’s was not an isolated case. In the past 2 years, journals have been forced to retract more than 110 papers in at least 6 instances of peer-review.

PEER-REVIEW RING
Moon’s case is by no means the most spectacular instance of peer-review rigging in recent years. That honour goes to a case that came to light in May 2013, when Ali Nayfeh, then editor-in-chief of the Journal of Vibration and Control, received some troubling news. An author who had submitted a paper to the journal told Nayfeh that he had received e-mails about it from two people claiming to be reviewers. Reviewers do not normally have direct contact with authors, and — strangely — the e-mails came from generic-looking Gmail accounts rather than from the professional institutional accounts that many academics use (see ‘Red flags in review’).
Nayfeh alerted SAGE, the company in Thousand Oaks, California, that publishes the journal. The editors there e-mailed both the Gmail addresses provided by the tipster, and the institutional addresses of the authors whose names had been used, asking for proof of identity and a list of their publications.ew rigging. What all these cases had in common was that researchers exploited vulnerabilities in the publishers’ computerized systems to dupe editors into accepting manuscripts, often by doing their own reviews. The cases involved publishing behemoths Elsevier, Springer, Taylor & Francis, SAGE and Wiley, as well as Informa, at least one of the systems — could make researchers vulnerable to even more serious identity theft. “For a piece of software that’s used by hundreds of thousands of academics worldwide, it really is appalling,” says Mark Dingemanse, a linguist at the Max Planck Institute for Psycholinguistics in Nijmegen, the Netherlands, who has used some of these programs to publish and review papers.

A 14-month investigation that came to involve about 20 people from SAGE’s editorial, legal and production departments. It showed that the Gmail addresses were each linked to accounts with Thomson Reuters’ ScholarOne, a publication-management system used by SAGE and several other publishers, including Informa. Editors were able to track every paper that the person or people behind these accounts had allegedly written or reviewed, says SAGE spokesperson Camille Gamboa. They also checked the wording of reviews, the details of author-nominated reviewers, reference lists and the turnaround time for reviews (in some cases, only a few minutes). This helped the investigators to ferret out further suspicious-looking accounts; they eventually found 130.

SAGE investigators came to realize that authors were both reviewing and citing each other at an anomalous rate. Eventually, 60 articles were found to have evidence of peer-review tampering, involvement in the citation ring or both. “Due to the serious nature of the findings, we wanted to ensure we had researched all avenues as carefully as possible before contacting any of the authors and reviewers,” says Gamboa. When the dust had settled, it turned out that there was one author in the centre of the ring: Peter Chen, an engineer then at the National Pingtung University of Education (NPUE) in Taiwan, who was a co-author on practically all of the papers in question.

PASSWORD LOOPHOLE
Moon and Chen both exploited a feature of ScholarOne’s automated processes. When a reviewer is invited to read a paper, he or she is sent an e-mail with login information. If that communication goes to a fake e-mail account, the recipient can sign into the system under whatever name was initially submitted, with no additional identity verification. Jasper Simons, vice-president of product and market strategy for Thomson Reuters in Charlottesville, Virginia, says that ScholarOne is a respected peer-review system and that it is the responsibility of journals and their editorial teams to invite properly qualified reviewers for their papers.

ScholarOne is not the only publishing system with vulnerabilities. Editorial Manager, built by Aries Systems in North Andover, Massachusetts, is used by many societies and publishers, including Springer and PLOS. The American Association for the Advancement of Science in Washington DC uses a system developed in-house for its journals Science, Science Translational Medicine and Science Signaling, but its open-access offering, Science Advances, uses Editorial Manager. Elsevier, based in Amsterdam, uses a branded version of the same product, called the Elsevier Editorial System.

Usually, editors in the United States and Europe know the scientific community in those regions well enough to catch potential conflicts of interest between authors and reviewers. But Lindsay says that Western editors can find this harder with authors from Asia — “where often none of us knows the suggested reviewers”. In these cases, the journal insists on at least one independent reviewer, identified and invited by the editors.

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Photo

Dr. Peter Eisenberg, left, said people with less money were treated differently by doctors.
Credit Preston Gannaway for The New York Times

When Dr. Jeffery Ward, a cancer specialist, and his partners sold their private practice to the Swedish Medical Center in Seattle, the hospital built them a new office suite 50 yards from the old place. The practice was bigger, but Dr. Ward saw the same patients and provided chemotherapyjust like before. On the surface, nothing had changed but the setting.

But there was one big difference. Treatments suddenly cost more, with higher co-payments for patients and higher bills for insurers. Because of quirks in the payment system, patients and their insurers pay hospitals and their doctors about twice what they pay independent oncologists for administering cancer treatments.

There also was a hidden difference — the money made from the drugs themselves. Cancer patients and their insurers buy chemotherapy drugs from their medical providers. Swedish Medical Center, like many other others, participates in a federal program that lets it purchase these drugs for about half what private practice doctors pay, greatly increasing profits.

Oncologists like Dr. Ward say the reason they are being forced to sell or close their practices is because insurers have severely reduced payments to them and because the drugs they buy and sell to patients are now so expensive. Payments had gotten so low, Dr. Ward said, that they only way he and his partners could have stayed independent was to work for free. When he sold his practice, Dr. Ward said, “The hospital was a refuge, not the culprit.”

When a doctor is affiliated with a hospital, though, patients end up paying, out of pocket, an average $134 more per dose for the most commonly used cancer drugs, according to a report by IMS Health, a health care information company. And, the report notes, many cancer patients receive multiple drugs.

“Say there was a Costco that had very good things at reasonable prices,” said Dr. Barry Brooks, a Dallas oncologist in private practice. “Then a Neiman Marcus comes in and changes the sign on the door and starts billing twice as much for the same things.” That, he said, is what is happening in oncology.

Chemotherapy drug

Pertuzumab (breast cancer)
Rituximab (lymphoma, leukemia)
Bevacizumab (several cancers)
Cetuximab (head, neck, colorectal)
Trastuzumab (breast, stomach)
Fulvestrant (breast)
Leuprolide Acetate (prostate)
Epirubicin (breast)
Interferon alfa-2B (lymphoma, others)
Mitoxantrone (prostate, leukemia)
Doxorubicin (leukemia, others)
Goserelin (prostate, breast)
Daunorubicin (leukemia)
Idarubicin (leukemia)
Mitomycin C (stomach, pancreas)

Sources: IMS Institute for Healthcare Informatics; RxList
By The New York Times

A Quirk in Drug Pricing

Insurers pay hospitals and doctors affiliated with hospitals more to adminster chemotherapy drugs than they pay independent doctors.

 

Insurance reimbursment per dose in a hospital or hospital-affiliated office Reimbursment per dose in a private practice

Chemotherapy drug

(and some cancers it can treat)

SEE FIGURE in article

http://www.nytimes.com/2014/11/24/health/private-oncologists-being-forced-out-leaving-patients-to-face-higher-bills.html?_r=0

The situation is part of the unusual world of cancer medicine, where payment systems are unique and drive not just the price of care but what drugs patients may get and where they are treated. It raises questions about whether independent doctors, squeezed by finances, might be swayed to use drugs that give them greater profits or treat poorer patients differently than those who are better insured.

But one thing is clear: The private practice oncologist is becoming a vanishing breed, driven away by the changing economics of cancer medicine.

Practices are making the move across the nation. Reporting on the nation’s 1,447 independent oncology practices, the Community Oncology Alliance, an advocacy group for independent practices, said that since 2008, 544 were purchased by or entered contractual relationships with hospitals, another 313 closed and 395 reported they were in tough financial straits. In western Washington, just one independent oncology group is left.

Christian Downs, executive director of the Association of Community Cancer Centers, said that although there are no good data yet, he expected the Affordable Care Act was accelerating the trend. Many people bought inadequate insurance for the expensive cancer care they require. Community doctors have to buy the drugs ahead of time, placing a burden on them when patients cannot pay. The act also requires documentation of efficiencies in medical care which can be expensive for doctors in private practice to provide. And it encourages the consolidation of medical practices.

The American Hospital Association cites advantages for patients being treated by hospital doctors. “The hassle factor is reduced,” said Erik Rasmussen, the association’s vice president of legislative affairs. Patients can have scans, like CT and M.R.I., use a pharmacy and get lab tests all in one place instead of going from facility to facility, he said.

And, he added, there is a reason hospitals get higher fees for their services — it compensates them for staying open 24 hours and caring for uninsured and underinsured patients.

For doctors in private practice, providing chemotherapy to uninsured and Medicaid patients is a money loser. As a result, many, including Dr. Ward before he sold his practice, end up sending those patients to nearby hospitals for chemotherapy while keeping them as patients for office visits.

“We hate doing it, I can’t tell you how much we hate doing it,” said Dr. Brooks, the Texas oncologist. “But I tell them, ‘It will cost me $200 to give you this medication in my office, so I am going to ask you to go to the hospital as an outpatient for infusions.’ ”

Dr. Peter Eisenberg, in private practice in Marin County in Northern California, said: “The disgrace is that we have to treat people differently depending on how much money they’ve got. That we do diminishes me.”

Hospitals may be less personal and less efficient, said Dr. Richard Schilsky, chief medical officer at the American Society of Clinical Oncology. Many private practice oncology offices, he said, “Run on time, they are efficient, you get in, you get out, as opposed to academic medical centers where they may be an hour and a half behind.”

Dr. Ward and others in private practice said they tried for years to make a go of it but were finally defeated by what he described as “a series of cuts in oncology reimbursement under the guise of reform to which private practice is most vulnerable.”

Lower reimbursements have two effects. One is on overhead. Unlike other doctors, oncologists stock their own drugs, maintaining a sort of mini-pharmacy. If a patient gets too sick to receive a drug or dies, the doctor takes the loss. That used to be acceptable because insurers paid doctors at least twice the wholesale price of drugs. Now doctors are reimbursed for the average cost of the drug plus 4.3 percent, there are more and more drugs to stock, and drugs cost more.

“The overhead is enormous,” Dr. Schilsky said. “This is one of the reasons why many oncologists are becoming hospital-based.”

The second — and bigger — effect is less profit from selling drugs to patients. For years, chemotherapy drugs provided a comfortable income. Those days are gone, doctors say.

The finances are very different in hospitals, with their

  • higher reimbursement rates for administering drugs,
  • discounts for buying large quantities, and
  • a special federal program that about 30 percent of hospitals qualify for.
  • The program, to compensate research hospitals and hospitals serving poor people,
  • lets hospitals buy chemotherapy drugs for all outpatients at about a 50 percent discount.

In addition, Dr. Schilsky notes, cancer patients at hospitals use other services, like radiation therapy, imaging and surgery.

“A cancer patient is going to generate a lot of revenue for a hospital,” Dr. Schilsky said.

Health care economists say they have little data on how the costs and profits from selling chemotherapy drugs are affecting patient care. Doctors are constantly reminded, though, of how much they can make if they buy more of a company’s drug.

Celgene, for example, in a recent email about its drug Abraxane, told one doctor who had bought 50 vials that he could get a rebate of $647.51 by buying 68 vials. If he bought 175 vials he’d get $1,831.93

This hidden profit possibility troubles Dr. Peter B. Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center.

“When you walk into a doctor’s office you don’t know that in most cancer scenarios there are a range of therapeutic choices,” Dr. Bach said. “Unless the doctor presents options, you assume there aren’t any.”

While individual oncologists deny choosing treatments that provide them with the greatest profit, Dr. Kanti Rai, a cancer specialist at North Shore-Long Island Jewish Cancer Center, said it would be foolish to believe financial considerations never influence doctors’ choices of drugs.

“Sometimes hidden in such choices — and many times not so hidden — are considerations of what also might be financially more profitable,” he said.

A version of this article appears in print on November 24, 2014, on page A13 of the New York edition with the headline: Private Oncologists Being Forced Out, Leaving Patients to Face Higher Bills. 
SOURCE 

http://www.nytimes.com/2014/11/24/health/private-oncologists-being-forced-out-leaving-patients-to-face-higher-bills.html?_r=0 

 

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Reason in Hobby Lobby

Curator: Larry H. Bernstein, MD, FCAP

 

This is a Part 4 followup of the Hobby Lobby legal precedent.

  • Where has the reason gone?

https://pharmaceuticalintelligence.com/2014/07/07/where-has-reason-gone-2/

  • Justice Ginsberg written dissent – Third Part

https://pharmaceuticalintelligence.com/2014/07/08/justice-ginsberg-written-dissent/

  • The physicians’ view of Supreme Court on an issue of public health

https://pharmaceuticalintelligence.com/2014/07/08/the-physicians-view-of-supreme-court-on-an-issue-of-public-health/

  •  Reason in Hobby Lobby

https://pharmaceuticalintelligence.com/2014/07/08/reason-in-hobby-lobby/

 

 Reason in Hobby Lobby

 

 

Reason #1 SCOTUS Will Regret Hobby Lobby byMan from Wasichustan

After oral arguments in the Hobby Lobby case, I wrote a very misnamed but widely read diary in which I echoed Attorney and Ring of Fire radio host Mike Papantonio’s argument that the SCOTUS would never rule in favor of Hobby Lobby for a really Big Business reason: It pierces the corporate veil.  If Hobby Lobby’s owners can give their Corporation religion, their religion gives Hobby Lobby’s owners–and any other owner, shareholder, officer, whatever–liability for the actions of the corporation.  Mr. Papantonio, who happens to be one of America’s preeminent trial lawyers, sees it as an opportunity to sue owners for the company’s negligence. Some other people, it turns out, agree with his assessment and expand on what it means….

That separation is what legal and business scholars call the “corporate veil,” and it’s fundamental to the entire operation. Now, thanks to the Hobby Lobby case, it’s in question. By letting Hobby Lobby’s owners assert their personal religious rights over an entire corporation, the Supreme Court has poked a major hole in the veil. In other words, if a company is not truly separate from its owners, the owners could be made responsible for its debts and other burdens.  So says Alex Park, writing in Salon today.

“If religious shareholders can do it, why can’t creditors and government regulators pierce the corporate veil in the other direction?” Burt Neuborne, a law professor at New York University, asked in an email. That’s a question raised by 44 other law professors, who filed a friends-of-the-court brief that implored the Court to reject Hobby Lobby’s argument and hold the veil in place. Here’s what they argued: Allowing a corporation, through either shareholder vote or board resolution, to take on and assert the religious beliefs of its shareholders in order to avoid having to comply with a generally-applicable law with a secular purpose is fundamentally at odds with the entire concept of incorporation.

Creating such an unprecedented and idiosyncratic tear in the corporate veil would also carry with it unintended consequences, many of which are not easily foreseen. This is definitely going to complicate things for the religious extremists on the SCOTUS and empire wide as these lawsuits inevitably proliferate.  Putting on the popcorn….now.

George Takei’s blistering response to #HobbyLobby: Could a Muslim Corp impose Sharia Law?

byVyan   THU JUL 03, 2014 AT 09:12 AM PDT “The ruling elevates the rights of a FOR-PROFIT CORPORATION over those of its women employees and opens the door to all manner of claims that a company can refuse services based on its owner’s religion,” Takei wrote.

(O)ne wonders,” he said, “whether the case would have come out differently if a Muslim-run chain business attempted to impose Sharia law on its employees.” “Hobby Lobby is not a church. It’s a business — and a big one at that,” he continued. “Businesses must and should be required to comply with neutrally crafted laws of general applicability.

Your boss should not have a say over your healthcare. Just as Justice Ginsberg and Mr Takei have suggested, the Hyper-Religious are already attempting to capitalize on the SCOTUS new granting of the rights of an individual to a corporate entity. In this decision the SCOTUS Majority opinion claimed that they were not granting the equal legitimacy of such follow on requests, but they’ve kicked open the door. Takei – bless his soul – also pointed out the basic hypocrisy of Hobby Lobby’s business practices in regards to religion.  Noting that… …Hobby Lobby has invested in multiple companies that manufacture abortion drugs and birth control. The company receives most of its merchandise from China, a country where overpopulation has led to mandatory abortions and sterilizations for women who try to have more than one child.

What the battle over birth control is really about     byteacherken

in a 2012 piece at Alternet by Sara Robinson. Conservative bishops and Congressmen are fighting a rear-guard action against one of the most revolutionary changes in human history. Robinson suggests 500 years from now looking back, the three great achievements of the 20th Century are likely to be the invention of the integrated circuit (without which the internet does not exist), the Moon landing (which she thinks will carry the same impact as Magellan’s circumnavigation of the globe), and the mass availability of nearly 100% effective contraception.

 Free Birth Control is Emerging Standard for Women   RICARDO ALONSO-ZALDIVAR, Associated Press       07/07/2014

WASHINGTON (AP) — More than half of privately insured women are getting free birth control under President Barack Obama’s health law, a major coverage shift that’s likely to advance. This week the Supreme Court allowed some employers with religious scruples to opt out, but most companies appear to be going in the opposite direction. Recent data from the IMS Institute document a sharp change during 2013. The share of privately insured women who got their birth control pills without a copayment jumped to 56 percent, from 14 percent in 2012. The law’s requirement that most health plans cover birth control as prevention, at no additional cost to women, took full effect in 2013. The average annual saving for women was $269. “It’s a big number,” said institute director Michael Kleinrock. The institute is the research arm of IMS Health, a Connecticut-based technology company that uses pharmacy records to track prescription drug sales. The core of Obama’s law — taxpayer-subsidized coverage for the uninsured — benefits a relatively small share of Americans. But free preventive care— from flu shots to colonoscopies —is a dividend of sorts for the majority with employer coverage.

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Where has Reason Gone?

 

Writer and Curator: Larry H. Bernstein, MD, FCAP

 

UPDATED on  8 July 2014

 

This will be a series of presentations on the Supreme Court decision on Hobby Lobby, it’s impact, and the distamce it places on Chief Justic Roberts’ decision to go with a 5-4 majority after this year achieving a direction of concensus largely undivided decisions.  Both Justice Kennedy and Chief Justice Roberts could have taken a different position with a much appreciated decision, or the alternative was to send the case back to the lower court.  That did not happen, and the consequences are unfolding.

  • Where has the reason gone?

https://pharmaceuticalintelligence.com/2014/07/07/where-has-reason-gone-2/

  • Justice Ginsberg written dissent – Third Part

https://pharmaceuticalintelligence.com/2014/07/08/justice-ginsberg-written-dissent/

  • The physicians’ view of Supreme Court on an issue of public health

https://pharmaceuticalintelligence.com/2014/07/08/the-physicians-view-of-supreme-court-on-an-issue-of-public-health/

  •  Reason in Hobby Lobby

https://pharmaceuticalintelligence.com/2014/07/08/reason-in-hobby-lobby/

 

Where has the Reason Gone?

We are in a period of widespread instability that is bereft of  comprehensibility, not just in Asia, the Middle East, and Africa, but also imposing constrainsts on our constitutional government.  This web sight is concerned with science and also health.  Science is challenged to figure out the complexity of biology and the physical world.  But it has been challenged for centuries by an uncompromizing view of how to organize a society, driven by hatred and violence, and excused by fanatical views. We have a most advanced society in the US, self selected to be the leader of nations.  Yet we have a separation of powers in the presidency, two houses of Congress, and a judiciary that cannot function for the good of the people.  The Congress is at war within itself , unable to carry out its obligations, and only functioning to blockade the presidential authority.

But most disconcerting is a third branch, the judiciary, with Supreme Court Justices, all of whom are political appointmnt for LIFE, and half of who have shown sufficient incompetence to wonder how they can stay in office.  Perhaps, what we don’t have to keep them in line is a periodic review of performance by the American Association of Legal Constitutional Scholars.  What we have is as good as it gets, but not good enough. I refrain from saying more, and proceed to the most recent ABSURD events.   In the Hobby Lobby case, the Court’s conservative majority held that closely held corporations are entitled to some of the same religious rights as people. That means corporations can decide whether or not birth control is covered in the health plans of female employees. Corporations are not people, period. A boss’s religious views should not trump a physician’s medical judgement or a woman’s considered need .

The White House must move fast on expanding contraception coverage.

One proposal…would assign companies’ insurers or health plan administrators for contraceptive coverage… Another would give the administration itself a larger role.” Robert Pear and Adam Liptak in The New York Times.

A rare but potentially important dissent?

“Dissents to Supreme Court orders are rare, and a 17-page dissent to a curt, four-paragraph order is extraordinary. But Sotomayor is on to something: What the majority did in Hobby Lobby, was to allow the plaintiff also to determine what constitutes a ‘substantial burden’ upon it.” Daniel Fisher in Forbes.

Here’s what everyone has been missing in this debate.

“Ginsburg, in her scathing dissent…made an important point about women’s health that’s been almost entirely overlooked elsewhere: For many American women, the birth-control pill has nothing to do with controlling births. It’s a life-saving medicine….The decision…may affect millions of women who suffer from a variety of medical conditions. These women depend on the pill to regulate their hormones and do everything from ease pain to reduce the risk of cancer. These medical benefits have nothing to do with sex or the prevention of pregnancy….Even if these women never have sex once in their lives, they need to be on birth control.” Lucia Graves in National Journal.

“The share of privately insured women who got their birth control pills without a copayment jumped to 56 percent, from 14 percent in 2012. The law’s requirement that most health plans cover birth control as prevention, at no additional cost to women, took full effect in 2013. The average annual saving for women was $269.” Ricardo Alonso-Zaldivar in the Associated Press.

In Hobby Lobby, Supremes grant religious objection rights to for-profit corporations.

by Adam  B In a widely-awaited-but-still-85 percent-as-sucky-as-you-feared 5-4 decision this morning,the Supreme Court of the United States has held that for-profit corporations are “persons” for purposes of the Religious Freedom Restoration Act, and that their religious rights were unduly burdened by the contraceptive mandate provisions of the Affordable Care Act. Because the contraceptive mandate was not the least restrictive means available for the government to provide such coverage—in the Court’s mind, the Government could just assume the costs itself, and already provided an opt-out for religious non-profit employers—the mandate on private employers violates the law. The Court was careful to limit its opinion (in theory) to these facts.

  • It applies only to closely held corporations, and not publicly traded ones.
  • It applies to the contraceptive mandate and
  • not religious objections to all laws in general,

believing that the “compelling interest” struck a sensible balance between religious liberty and competing prior governmental interests. But … we’ll see about that. Justice Ginsburg, writing for the four dissenting Justices, refers to the decision thusly:

In a decision of startling breadth, the Court holds that commercial enterprises, including corporations, along with partnerships and sole proprietorships, can opt out of any law (saving only tax laws) they judge incompatible with their sincerely held religious beliefs.

Compelling governmental interests in uniform compliance with the law, and disadvantages that religion-based opt-outs impose on others, hold no sway, the Court decides,

  • at least when there is a “less restrictive alternative.”

And such an alternative, the Court suggests, there always will be whenever, in lieu of tolling an enterprise claiming a religion-based exemption, the government, i.e., the general public, can pick up the tab….

Religious organizations exist to serve a community of believers.

For-profit corporations do not fit that bill.

Moreover, history is not on the Court’s side. Recognition of the discrete characters of “ecclesiastical and lay” corporations dates back to Blackstone, see 1 W. Blackstone, Commentaries on the Laws of England 458 (1765), and was reiterated by this Court centuries before the enactment of the Internal Revenue Code. See Terrett v. Taylor, 9 Cranch 43, 49 (1815) (describing religious corporations); Trustees of Dartmouth College, 4 Wheat., at 645 (discussing “eleemosynary” corporations, including those “created for the promotion of religion”). To reiterate,

“for-profit corporations are different from religious non-profits in that they use labor to make a profit, rather than to perpetuate [the] religious value[s] [shared by a community of believers].”

Let’s be clear, explains Justice Alito for the five majority opinion, corporations are people too (in aggregate) (for purposes of this statute): As we will show,

  • Congress provided protection for people like the Hahns and Greens by employing a familiar legal fiction: It included corporations within RFRA’s definition of “persons.”

It is important to keep in mind that the purpose of this fiction is to provide protection for human beings. A corporation is simply a form of organization used by human beings to achieve desired ends. An established body of law specifies the rights and obligations of the people (including shareholders, officers, and employees) who are associated with a corporation in one way or another. When rights, whether constitutional or statutory, are extended to corporations, the purpose is to protect the rights of these people. For example, extending Fourth Amendment protection to corporations protects the privacy interests of employees and others associated with the company. Protecting corporations from government seizure of their property without just compensation protects all those who have a stake in the corporations’ financial well-being. And …   protecting the free-exercise rights of corporations like Hobby Lobby, Conestoga, and Mardel protects the religious liberty of the humans who own and control those companies…

This statement extends the rights beyond the statement above in that it cannot apply to a closely held corporation with only the owner having fiduciary interest

Indeed, the opinion claims, you can go back over 50 years and find the Court not questioning that a for-profit corporation’s had religious rightsin that 1961 case, a kosher supermarket seeking the right to be open on Sundays despite Massachusetts blue laws. [To which the dissent counters, “The suggestion is barely there. True, one of the five challengers to the Sunday closing law … was a corporation owned by four Orthodox Jews. The other challengers were human individuals, not artificial, law-created entities, so there was no need to determine whether the corporation could institute the litigation.”]

The Court insists that this isn’t something publicly traded companies are going to get involved in. We could use corporate law principles to suss out what their religious beliefs are: HHS contends that Congress could not have wanted RFRA to apply to for-profit corporations because it is difficult as a practical matter to ascertain the sincere “beliefs” of a corporation. HHS goes so far as to raise the specter of “divisive, polarizing proxy battles over the religious identity of large, publicly traded corporations such as IBM or General Electric.” These cases, however, do not involve publicly traded corporations, and it seems unlikely that the sort of corporate giants to which HHS refers will often assert RFRA claims. HHS has not pointed to any example of a publicly traded corporation asserting RFRA rights, and numerous practical restraints would likely prevent that from occurring. For example,

  • the idea that unrelated shareholders—including institutional investors with their own set of stakeholders—would agree to run a corporation under the same religious beliefs seems improbable. In any event, we have no occasion in these cases to consider RFRA’s applicability to such companies.
  • The companies in the cases before us are closely held corporations, each owned and controlled by members of a single family, and no one has disputed the sincerity of their religious beliefs.

HHS has also provided no evidence that the purported problem of determining the sincerity of an asserted religious belief moved Congress to exclude for-profit corporations from RFRA’s protection…. HHS and the principal dissent express concern about the possibility of disputes among the owners of corporations, but that is not a problem that arises because of RFRA or that is unique to this context. The owners of closely held corporations may—and sometimes do—disagree about the conduct of business. Even if RFRA did not exist, the owners of a company might well have a dispute relating to religion…. Courts will turn to that structure and the underlying state law in resolving disputes.

So, what about the contraceptive mandate?

Interestingly, the Court concedes for sake of argument that it serves a compelling state interest. But, still, that’s not enough. By requiring the Hahns and Greens and their companies to arrange for such coverage, the HHS mandate demands that they engage in conduct that seriously violates their religious beliefs. If the Hahns and Greens and their companies do not yield to this demand, the economic consequences will be severe. If the companies continue to offer group health plans that do not cover the contraceptives at issue, they will be taxed $100 per day for each affected individual. For Hobby Lobby, the bill could amount to $1.3 million per day or about $475 million per year; for Conestoga, the assessment could be $90,000 per day or $33 million per year; and for Mardel, it could be $40,000 per day or about $15 million per year. These sums are surely substantial. … Are their religious beliefs loony? The Court’s not going to look into that.

The sincerity is what counts, and that creates a burden: …If I may ask—how do you measure sincerity?

How much it will spend on litigating its case!

The Hahns and Greens believe that providing the coverage demanded by the HHS regulations is connected to the

destruction of an embryo in a way that is sufficient to make it immoral for them to provide the coverage.

This belief implicates a difficult and important question of religion and moral philosophy, namely, the circumstances under which it is wrong for a person to perform an act that is innocent in itself but that has the effect of enabling or facilitating the commission of an immoral act by another.

Arrogating the authority to provide a binding national answer to this religious and philosophical question, HHS and the principal dissent in effect tell the plaintiffs

  • that their beliefs are flawed. …
  • we have repeatedly refused to take such a step.

See, e.g., Smith, 494 U. S., at 887 (“Repeatedly and in many different contexts, we have warned that courts must not presume to determine . . . the plausibility of a religious claim”)

Incredible!!      So, RFRA applies,   there’s a burden, and the contraceptive mandate fails the test.

The least-restrictive-means standard is exceptionally demanding, and it is not satisfied here.  HHS has not shown that it lacks other means of achieving its desired goal without imposing a substantial burden on the exercise of religion by the objecting parties in these cases. See §§2000bb–1(a), (b) (requiring the Government to “demonstrat[e] that application of [a substantial] burden to the person . . . is the least restrictive means of furthering [a] compelling governmental interest” (emphasis added)).

The most straightforward way of doing this would be for the Government to assume the cost of providing the four contraceptives at issue to any women who are unable to obtain them under their health-insurance policies due to their employers’ religious objections. This would certainly be less restrictive of the plaintiffs’ religious liberty, and HHS has not shown that this is not a viable alternative. HHS has not provided any estimate of the average cost per employee of providing access to these contraceptives, two of which, according to the FDA, are designed primarily for emergency use. Nor has HHS provided any statistics regarding the number of employees who might be affected because they work for corporations like Hobby Lobby, Conestoga, and Mardel. Nor has HHS told us that it is unable to provide such statistics. It seems likely, however, that the cost of providing the forms of contraceptives at issue in these cases (if not all FDA-approved contraceptives) would be minor when compared with the overall cost of ACA.

According to one of the Congressional Budget Office’s most recent forecasts, ACA’s insurance-coverage provisions will cost the Federal Government more than $1.3 trillion through the next decade. If, as HHS tells us, providing all women with cost-free access to all FDA-approved methods of contraception is a Government interest of the highest order, it is hard to understand HHS’s argument that it cannot be required under RFRA to pay anything in order to achieve this important goal.

HHS contends that RFRA does not permit us to take this option into account because “RFRA cannot be used to require creation of entirely new programs.”  But we see nothing in RFRA that supports this argument, and drawing the line between the “creation of an entirely new program” and the modification of an existing program (which RFRA surely allows) would be fraught with problems. And don’t worry, Justice Alito insists! This is a really, really narrow holding, and doesn’t create religious exemptions to good laws: HHS and the principal dissent argue that a ruling in favor of the objecting parties in these cases will

  • lead to a flood of religious objections regarding a wide variety of medical procedures and drugs, such as vaccinations and blood transfusions,

but HHS has made no effort to substantiate this prediction. HHS points to no evidence that insurance plans in existence prior to the enactment of ACA excluded coverage for such items. Nor has HHS provided evidence that any significant number of employers sought exemption, on religious grounds, from any of ACA’s coverage requirements other than the contraceptive mandate. …

What are the credentials for Alito and associates in the domain of medical therapies?  None!

[O]ur decision in these cases is concerned solely with the contraceptive mandate.

Our decision should not be understood to hold that an insurance-coverage mandate must necessarily fall if it conflicts with an employer’s religious beliefs. Other coverage requirements, such as immunizations, may be supported by different interests (for example, the need to combat the spread of infectious diseases) and may involve different arguments about the least restrictive means of providing them. The principal dissent raises the possibility that discrimination in hiring, for example on the basis of race, might be cloaked as religious practice to escape legal sanction. Our decision today provides no such shield. The Government has a compelling interest in providing an equal opportunity to participate in the workforce without regard to race, and prohibitions on racial discrimination are precisely tailored to achieve that critical goal. Justice Kennedy adds an additional concurrence to remind everyone that Justice Kennedy believes in the Court, America, and his own importance:

In our constitutional tradition, freedom means that all persons have the right to believe or strive to believe in a divine creator and a divine law. For those who choose this course, free exercise is essential in preserving their own dignity and in striving for a self-definition shaped by their religious precepts. Free exercise in this sense implicates more than just freedom of belief. It means, too, the right to express those beliefs and to establish one’s religious(or nonreligious) self-definition in the political, civic, and economic life of our larger community.

But in a complex society and an era of pervasive governmental regulation, defining the proper realm for free exercise can be difficult. … “[T]he American community is today, as it long has been, a rich mosaic of religious faiths.” Town of Greece v. Galloway, 572 U. S. __ (2014) (Kagan, J., dissenting) (slip op., at 15). Among the reasons the United States is so open, so tolerant, and so free is that no person may be restricted or demeaned by government in exercising his or her religion. Yet neither may that same exercise unduly restrict other persons, such as employees, in protecting their own interests, interests the law deems compelling.

In these cases the means to reconcile those two priorities are at hand in the existing accommodation the Government has designed, identified, and used for circumstances closely parallel to those presented here. RFRA requires the Government to use this less restrictive means. Justice Ginsburg writes the principal dissent, and begins by reminding us of the importance of sexual autonomy, and the economic stakes for women in this litigation: “The ability of women to participate equally in the economic and social life of the Nation has been facilitated by their ability to control their reproductive lives.” Planned Parenthood of Southeastern Pa. v. Casey, 505 U. S. 833, 856 (1992).Congress acted on that understanding when, as part of a nationwide insurance program intended to be comprehensive, it called for coverage of preventive care responsive to women’s needs.

… The [ACA] had a large gap, however; it left out preventive services that “many women’s health advocates and medical professionals believe are critically important.” 155 Cong. Rec. 28841 (2009) (statement of Sen. Boxer). To correct this oversight, Senator Barbara Mikulski introduced the Women’s Health Amendment, which added to the ACA’s minimum coverage requirements a new category of preventive services specific to women’s health…Women paid significantly more than men for preventive care, the amendment’s proponents noted; in fact, cost barriers operated to block many women from obtaining needed care at all. See, e.g., id., at 29070 (statement of Sen. Feinstein) (“Women of childbearing age spend 68 percent more in out-of-pocket health care costs than men.”); id., at 29302 (statement of Sen. Mikulski) (“copayments are [often] so high that [women] avoid getting [preventive and screening services] in the first place”). And increased access to contraceptive services, the sponsors comprehended, would yield important public health gains. See, e.g., id., at 29768 (statement of Sen. Durbin) (“This bill will expand health insurance coverage to the vast majority of [the 17 million women of reproductive age in the United States who are uninsured] . . . . This expanded access will reduce unintended pregnancies.”). And the dissenters deride as unfounded the Court’s new recognition of religious rights for for-profit corporations: Until this litigation, no decision of this Court recognized a for-profit corporation’s qualification for a religious exemption from a generally applicable law, whether under the Free Exercise Clause or RFRA.

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Larry H. Bernstein, MD, FCAP, Curator

http://pharmaceuticalinnovation/6/7/2014/Omega-3 fatty acids, depleting the source, and protein insufficiency in renal disease

 

This article is concerned only with updating the importance of key nutrients for maintenance of health. Nutritional losses are associated with memory loss, impaired immunity, and loss of lean body mass.

 

Low levels of omega-3 fatty acids may cause memory problems

Disease and ConditionsGeneral Diet • Tags: Alzheimer’s diseaseAmerican Academy of NeurologyDocosahexaenoic acidMagnetic resonance imagingNeurologyOmega-3 fatty acid, United States Environmental Protection AgencyUniversity of California Los Angeles

09 Mar 2012

 

ST. PAUL, Minn. – A diet lacking in omega-3 fatty acids, nutrients commonly found in fish, may cause your brain to age faster and lose some of its memory and thinking abilities, according to a study published in the February 28, 2012, print issue of Neurology®, the medical journal of the American Academy of Neurology. Omega-3 fatty acids include the nutrients called docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA).

salmon dinner

salmon dinner

 

 

 

 

 

 

 

 

 

“People with lower blood levels of omega-3 fatty acids had lower brain volumes that were equivalent to about two years of structural brain aging,” said study author Zaldy S. Tan, MD, MPH, of the Easton Center for Alzheimer’s Disease Research and the Division of Geriatrics, University of California at Los Angeles.

For the study, 1,575 people with an average age of 67 and free of dementia underwent MRI brain scans. They were also given tests that measured mental function, body mass and the omega-3 fatty acid levels in their red blood cells.

The researchers found that people whose DHA levels were among the bottom 25 percent of the participants had lower brain volume compared to people who had higher DHA levels. Similarly, participants with levels of all omega-3 fatty acids in the bottom 25 percent also scored lower on tests of visual memory and executive function, such as problem solving and multi-tasking and abstract thinking.

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Mechanisms of muscle wasting in chronic kidney disease.

Xiaonan H WangWilliam E Mitch

Nature Reviews Nephrology (Impact Factor: 7.94). 07/2014; DOI: 10.1038/nrneph.2014.112

Source: PubMed

ABSTRACT In patients with chronic kidney disease (CKD), loss of cellular proteins increases the risks of morbidity and mortality. Persistence of muscle protein catabolism in CKD results in striking losses of muscle proteins as whole-body protein turnover is great; even small but persistent imbalances between protein synthesis and degradation cause substantial protein loss. No reliable methods to prevent CKD-induced muscle wasting currently exist, but mechanisms that control cellular protein turnover have been identified, suggesting that therapeutic strategies will be developed to suppress or block protein loss. Catabolic pathways that cause protein wasting include activation of the ubiquitin-proteasome system (UPS), caspase-3, lysosomes and myostatin (a negative regulator of skeletal muscle growth). These pathways can be initiated by complications associated with CKD, such as metabolic acidosis, defective insulin signalling, inflammation, increased angiotensin II levels, abnormal appetite regulation and impaired microRNA responses. Inflammation stimulates cellular signalling pathways that activate myostatin, which accelerates UPS-mediated catabolism. Blocking this pathway can prevent loss of muscle proteins. Myostatin inhibition could yield new therapeutic directions for blocking muscle protein wasting in CKD or disorders associated with its complications.

 

We’re Fishing the Oceans Dry. It’s Time to Reconsider Fish Farms.

Food and Agriculture Organization of the United Nations -State of World Fisheries and Aquaculture  2014

Food and Agriculture Organization of the United Nations -State of World Fisheries and Aquaculture 2014

 

 

 

 

 

 

 

 

 

 

 

 

Aquaculture has gotten much greener, with American innovators leading the way.

— Text by Maddie Oatman; video by Brett Brownell

| Wed Jul. 2, 2014 6:00 AM EDT    MotherJones.com

 

When I meet Kenny Belov mid-morning at San Francisco’s Fisherman’s Wharf, the boats that would normally be out at sea chasing salmon sit tethered to their docks. The steady breeze coursing through the bay belies choppier conditions farther out—so rough that the local fishermen threw in the towel for the fifth morning in a row. Belov scans the horizon as he explains this, feet away from the warehouse of his sustainable seafood company, TwoXSea. Because his business hinges on what local fishermen can bring in, he’s used to coping with wild fish shortages.

If we continue to fish at the current pace, some scientists predict we’ll be facing oceans devoid of edible marine creatures by 2050.

But unlike these fishermen, Belov has a stash of treasure in his warehouse, as he soon shows me: a golf-cart-size container of plump trout, their glossy bodies still taut from rigor mortis. The night before, Belov drove north to Humboldt to help “chill kill” the fish by submerging them live into barrels of slushy ice water. Belov can count on shipments of these McFarland Springs trout every week—because he helped grow them himself on a farm.

For many consumers, aquaculture lost its appeal after unappetizing news spread about commercial fish farms—like fish feed’s pressure on wild resources, overflowing waste, toxic buildup in the water, and displacement of natural species. But consider this: Our appetite for seafood continues to rise. Globally, we’ve hungered for 3.2 percent more seafood every year for the last five decades, double the rate of our population. Yet more than four-fifths of the world’s wild fisheries are overexploited or fully exploited (yielding the most fish possible with no expected room for growth). Only 3 percent of stocks are considered underexploited—meaning they have any significant room for expansion. If we continue to fish at the current pace, some scientists predict we’ll be facing oceans devoid of edible marine creatures by 2050.

Aquaculture could come to the rescue. The Food and Agriculture Organization of the United Nations predicts that farmed fish will soon surpass wild-caught; by 2030, aquaculture may produce more than 60 percent of fish we consume as food.

Food and Agriculture Organization of the United Nations “State of World Fisheries and Aquaculture” 2014 report

One of the most pressing concerns about aquaculture, though, is that many farmed fish are raised on a diet of 15 million tons a year of smaller bait fish—species like anchovies and menhaden. These bait—also known as forage fish—are ground up and converted into a substance called fishmeal. It takes roughly five pounds of them to produce one pound of farmed salmon. Bait fish are also used for nonfood products like pet food, makeup, farm animal feed, and fish oil supplements.

Forage fish are a “finite resource that’s been fully utilized.”

It may appear as though the ocean enjoys endless schools of these tiny fish, but they too have been mismanaged, and their populations are prone to collapse. They’re a “finite resource that’s been fully utilized,” says Mike Rust of NOAA’s fisheries arm. Which is disturbing, considering that researchers like those at Oceana argue that forage fish may play an outsize role in maintaining the ocean’s ecological balance, including by contributing to the abundance of bigger predatory fish.

And that’s where Belov’s trout come in: Though he swears no one can taste the difference, his fish are vegetarians. That means those five pounds of forage fish can rest easy at sea. It also means that the trout don’t consume some of the other rendered animal proteins in normal fishmeal pellets: bone meal, feather meal, blood meal, and chicken byproducts.

Belov and McFarland Springs’ owner David McFarland were inspired to switch to vegetarian feed in part by Rick Barrows, a USDA researcher. About six years ago, recounts Barrows, several USDA studies confirmed that fish rely on nutrients—vitamins, minerals, fatty acids, and protein—rather than fishmeal or fish oil, to thrive. If those nutrients could be found in other products, including purely plant-based substances, then aquaculture might not be so dependent on feeding fish other smaller fish.

Barrows and team began to test about 50 potential materials a year, and now have a database of 140 that anyone can browse through online. Belov was one of their first commercial partners. The plant-based food fed to McFarland Springs’ trout consists of a hearty blend of marine algae, freshwater micro algae, vitamins, minerals, flax, flax oil, corn, and nut waste. The resulting complete protein means the trout’s omega 3s are high and their omega 6s are low—a ratio that’s said to enhance anti-inflammatory properties. And “they don’t have the concentration of heavy metals that come from the bait fish,” Belov says. I took one of his rosy fillets home and turned it into trout lox; find the recipe here.

McFarland Springs manages the trout’s waste by funneling it out into a natural sagebrush pasture where it composts the soil.

Belov’s fish feed includes California nuts that are too broken or disfigured to be sold.

Barrows thinks region-specific material for this type of feed offers the most potential. For instance, his team learned that around 5 percent of California nuts can’t be sold because they’re broken or disfigured. They realized they could repurpose excess nut parts for the trout feed; the nut bits helped round out the complete protein. Lately, Barrows has become especially excited about turning barley surplus from the beer industry—which comes at a cheap price in Montana, where he’s based—into a feed-grade concentrate for trout feed.

“You can get just as much growth rate out of fishmeal-free feeds as fishmeal,” says Barrows. And his lab has proven as much with eight different fish species: cobia, Florida pompano, coho salmon, Atlantic salmon, walleye, yellowtail, and White seabass.

But the price difference still stands in the way for many fish farmers. Belov pays slightly more than $1/pound for his plant-based feed, whereas fishmeal pellets average around $0.71/pound. He sells his trout for $6.95/pound, about a dollar more than conventional. But he’s well positioned in the affluent Bay Area, and he usually sells out of his McFarland Springs trout well before the end of each week. As innovation continues in the realm of plant-based feeds, he’s hopeful, along with Barrows, that the price of the pellets will continue to drop.

Here in the United States, we consume plenty of farmed fish already, but only 5 percent of it is sourced domestically. “If we didn’t import so much farmed seafood,” implored Four Fish author Paul Greenberg in a recent New York Times op-ed, “we might develop a viable, sustainable aquaculture sector of our own.” It doesn’t just boil down to economics: The locations we generally export from, like China and South Asia, don’t have near the stringent environmental and health regulations as the US. “Growing more seafood at home would help with trade deficit, but also we could control the safety more,” says Barrows.

Though our current aquaculture sector is relatively tiny, US farmers are in a better position to innovate, because we have a sophisticated animal nutrition research center and feed sector, says NOAA’s Rust. “We’re the leading technical country in the world on feed.”

Belov wasn’t always open to aquaculture, and he still feels that fish—such as some salmon—with healthy wild fisheries attached to them should never be farmed. That way, environmentally responsible fishermen can stay in business. His long-term strategy for sustainable seafood? Draw from the “amazing [wild] fisheries that exist, and then you backfill with intelligent aquaculture, and yes, you can feed the planet with sustainable marine products.” Which may take more work, but as he puts it, “We depleted the ocean. It wasn’t anybody else’s fault. So it’s our job to fix it.”

 

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