This event is no longer selling tickets.
In Collaboration with Canon Master Daniel Linnet, Lisa Wilkinson presents her photographic exhibition "Women of Influence" comprising powerful portraits of ten Australian women who have inspired her and influenced modern Australia. In her own words, Lisa reveals why she is captivated by storytelling through photography and why she chose to photograph Asher Keddie, Deborra-Lee Furness, Dame Marie Bashir, Peta Credlin, Turia Pitt, Evonne Goolagong Cawley, Cate McGregor, Gretel Packer, Mia Freedman and Dr. Susan Carland for this powerful and personal exhibition. As creative director of the shoot, Daniel will be able to answer your questions around the many different elements that need to come together to pull off a shoot of this level.
Lisa Wilkinson: For more than three decades, Lisa Wilkinson has blazed an unprecedented trail through the Australian media landscape, initially in publishing, then on radio and now in television and online. In every forum she has achieved extraordinary success and earned widespread respect.
Following her successful ten years as co-host of the Nine Network's Today Show, Lisa accepted a new challenge in late 2017 by agreeing to join the Ten Network as host of its prime-time award-winning news and current affairs program, The Project.
Daniel Linnet: Canon Master as well as a Master with the AIPP (Australian Institute of Professional Photography), Daniel Linnet began painting landscapes and people as a hobby but upon picking up a camera, fell in love with the immediacy of the medium. His ability to interpret a brief and add that certain creative flair to any assignment has seen him produce images for MasterCard, Pfizer, Castrol, Country Energy, BankWest, Top Gear & Men's Health Magazine.


text:
Сан-Блас () — один из 20-ти муниципалитетов штат Наярит в Мексике. Административный центр муниципалитета — исторический портовый город Сан-Блас.

Муниципалитет Сан-Блас включает часть тихоокеанского побережья Мексики, а также архипелаг Острова Марии, расположенные на расстоянии около 100 км от побережья. Общая площадь территории муниципалитета 823,6 км². Население муниципалитета в 2005 году — 37 478 жителей.

На территории муниципалитета расположены 100 населённых пунктов, самые крупные из которых:

Примечания

Муниципалитеты Наярита

redpajama_set_name: RedPajamaWikipedia


text:
Noah Marger, Director
Photo credit: Shortcake Photo
Noah Marger is a senior at Beaverton's Arts & Communication Magnet Academy (ACMA). He is a writer, actor, and filmmaker, and is at least as funny as Jonah Hill. Coraline (Nov. 14-22) is his main stage directing debut. His YouTube channel offers an informal window on his work and talent. Watch a couple of our favorites below:
AMORÉ, written & directed by Noah Marger
One Time, written & performed by Noah Marger
DIRECTOR'S NOTE
The novel Coraline is prefaced with a quote by G.K. Chesterton that reads, "Fairy tales are more than true: not because they tell us that dragons exist, but because they tell us that dragons can be beaten."
In early 2013, Scott Castner and Kelly Schenk approached me about joining the creative team for the stage adaptation of Coraline, and at that time it seemed so far out, but here we are now. Having directed only once before in our smaller Blue Box theatre, I knew from day one that everything would be a discovery. I would discover the show in a new way by watching what the actors brought to the show, I would discover what kind of director I strived to be, and what kind of director I actively tried to avoid being, but my biggest discovery of all came from the non-artistic aspect of theatre. It was the human part of managing time and energy on the thing that needed the most attention, or learning how to talk to people in different ways to clearly communicate my message. It was the people aspect that took the most getting used to. I was growing up in front of everybody, and instead of being on stage with a director guiding me through it all, I had to rely on myself.
Fortunately we had a cast of people whom I consider it an honor to work with. Everyone brought their hearts everyday, and as a director, that's all you can ask for. Our crew stepped up big time as well, coming to Scott and I with new ideas, and always supporting the vision of the show. This show could've been a disaster. It could've been an indication to "the man" that students can't handle main stage work by themselves, but as G.K. Chesterton said, "Fairy tales tell us dragons can be beaten." Through my art, I grew, and I couldn't have asked for anything more. Thank you for supporting live theatre.
— Noah Marger

redpajama_set_name: RedPajamaCommonCrawl


The MD 28 mm f/2.8 with 7 lens elements is generally considered to be one of Minolta's best 28 mm, very close to the excellent MC W.Rokkor-SI 28 mm f/2.5 and the MD 28 mm f/2. This "plain MD" f/2.8 without Rokkor in the name was succeeded by an MD 28 mm f/2.8 with nearly identical exterior and naming but simpler optics (5/5) and slightly inferior performance. The 7/7 design tested here can be identified by serial (80xxxxx) and by the fact that there are eight tiny steps between name ring and front lens, whereas the 5/5 design (serial 70xxxxx) only has six of them. You cancompare both designs in Ad Dielemann's 28 mm gallery.
At slightly less than 190 g, the MD 28 mm f/2.8 is a very light and compact lens. Focus is very smooth – close to what it used to be in the MC-X style lenses – and handling on a NEX-5T is effortless. The effective focal length of 43 mm on APS-C cameras makes the MD f/2.8 a handy normal lens with excellent performance.
For the MD 28 mm f/2.8 I've created lens correction profiles, which are available for download. For further details on the lens, have a look at its entry in the Minolta SR mount lens database.
Optics: Excellent. No scratches, no visible dust.
Mechanics: Excellent. Focus uniform and very smooth, aperture clean and fast.
Exterior: Very good. Some very small scratches in the finishing, otherwise like new.
The lens starts at f/2.8 with surprisingly good sharpness, no visible haze and only slightly soft corners. At f/4, corner performance catches up and overall contrast improves minimally. Peak sharpness is reached at f/5.6 with very good performance, whilst f/8 is ever so slightly softer due to diffraction. The latter is slightly more pronounced at f/11, visibly softens f/16 and blurs away every detail at f/22.
A slight red and dark cyan glow is visible at f/2.8, but mostly blurred away due to soft corners. From f/4 on, the 28 mm shows medium red/cyan CAs which grow when stopped down up to f/16. Overall, a good but not impressive performance for a wide angle lens.
Vignetting is well controlled with about 1/2 a stop at f/2.8 and practically disappears at f/4. The lens also exhibits a medium barrel distortion of -1.0%. The effective T-stop at f/2.8 is damn close to T2.9 (-0.1 EV), which is excellent.
If you're in the market for a sharp, contrasty 28 mm and don't mind a bit of lateral CA, I can recommend the MD 28 mm f/2.8 (7/7) without hesitation. It does not come as a surprise that the Minolta outperforms contemporary zooms like the Vivitar Series 1 28-90 mm f/2.8-3.5. The optical performance of this 28 mm is very good and it also beats direct competitors like the Kiron 28 mm f/2.0 in terms of sharpness, corner performance and especially CAs at every aperture. In exchange, the Kiron is one full f-stop faster. But I would prefer the Minolta for almost any occasion. That it's pleasantly light and compact doesn't hurt, either.
I'm commenting here because I couldn't find information about some lenses I was looking at, including a late 28mm f/2.8 Celtic MD (super cheap on eBay), and I thought others might want to have this info. I ended up purchasing several lenses to test. All lenses in excellent[++] condition. I tried the MD 28mm f/2.8 (MD-III, 1981 model) tested here, alongside the MC 28mm Celtic f/2.8 (1975 model) and the MD 28mm Celtic f/2.8 (MD-II, 49mm, 1978 model). All are similar 7/7 construction. I also tested the Vivitar 28mm Auto Wide Angle f/2.5 (ca. 1966; my grandfather's old lens). Tested wide open and at f/2.8 to be comparable, as well as at f/4, f/5.6, f/8, and f/16.
All of these lenses are solid and well built. The MD 1978 model Celtic and the 1981 "plain MD" are the lightest and most compact of the lot, virtually indistinguishable in feel to me, though there's a tiny bit of play in the Celtic. The Vivitar is large and heavy. The 1975 MC Celtic feels the best in my hand, all beautifully machined metal.
The Celtic 28mm f/2.8 seems like a great bargain to me, and in almost every way seems identical to the more highly prized "plain MD" model that goes for 4x the price.
Hi, I have MD MINOLTA CELTIC 28mm f2.8 lens Serial #1059036 with 6 tiny steps between name ring and front lens. How many lenses I have?
I'm not sure. The Minolta Celtic lenses had a different exterior design than "regular" Minoltas and sometimes also different optics. For your 28 mm Celtic, the site of Ad Dieleman only lists one variety with the 7/7 design. It's probably best to compare your lenses exterior to the one Ad has in his collection.


text:
Give yourself over to romantic abandon and introspection
By Robyn Sassen on August 8, 2016 • ( Leave a comment )
REACHING the strings of the soul, unfiltered: Alessandro Taverna. Photograph courtesy alessandrotaverna.com
BRITISH MUSIC CRITICS describe Italian pianist Alessandro Taverna (33) as the natural successor to Italy's Arturo Beneditti Michelangeli (1920-1995) who arguably headlined the 20th century in pianistic skill and verve. Since winning the prestigious Minnesota International Piano Competition in 2009, Venice-born Taverna's career has taken off exponentially, with awards, international concerts and significant recording opportunities. He performs this Saturday evening for the Johannesburg Musical Society, and graciously responded to an email interview with My View.
Warming to the expression of a "love affair with the piano" he says a musician is bound to his instrument in something similar to a love relationship. "Often everything in music starts with love at first sight, then comes the passion … sometimes you experience the ups and downs but what you soon understand is that you can't help it". He and his twin brother began music as six-year-olds.
"During the first years of my musical education, I played simply because I liked it and I liked to read as many new pieces as I could, without thinking too much about my future career," he says. But things began to change for him as an adolescent. When he was about 13 or 14, his piano teacher began to forge in him a more mature awareness towards his performed repertoire. It was about diligence, structure and technique, he says, over and above the pressure of competitions and performing in public. He trained at both Imola and on Lake Como (both institutions are famous in Italy and worldwide for their piano academies).
Thirteen years later, Taverna won the Minnesota competition – and was awarded bronze and silver in the London and Leeds piano competitions – which effectively started his international career. Now, he looks back on that "competitions-phase" of his life "in a more disenchanted way, without denying that the competitions have undoubtedly represented a crucial moment of my artistic growth."
Winning competitions "can play just a small part in a career, which must be planned with intelligence, the spirit of sacrifice, and by looking carefully at what's happening around you," he adds. "Competition by itself is not sufficient to open the doors of any career, it's just the first brick. Building a career is a combination of many factors that we must face with wisdom and humility."
But the notion of a big challenge comes in the form of the "necessity to match my practice sessions with the other organisational aspects related to the career: travels, relationships, etcetera … you must find a good timing for each one of these: It's a balancing act."
Taverna has a strong and varied repertoire and significant teaching reputation. He records and performs regularly, but his teaching is for him the most inspiring. "When you teach, you basically speak to yourself. You first see your own weaknesses in your students, before anything else," he adds. "Teaching is probably the last stage to come in an artistic path and it's what fills your performing with a new awareness and understanding, especially regarding the technique.
"What my teachers gave me during the years I was a pupil has come back to me since I started teaching. And indeed only now I can fully understand the meaning of those teachers' words and what they wanted from me. Teaching shouldn't be separated from performing: the two complement each other. Performing is for me the source of my later reflections and inspirations on my new and old repertoire and also on what my pupils play.
On August 13, Johannesburg music lovers will be privileged to hear Taverna perform four ballades by Frédéric Chopin and Franz Liszt's Tarentella di Bravura, Mephisto Waltz and his Concert paraphrase on Verdi's Rigoletto.
"These two composers represent two main sides of my musical soul. The romantic abandon and introspection, and the virtuosic and dramatic way to give voice on the keyboard to the most conflicting of feelings. Liszt has always accompanied me throughout my career, while the idea of presenting Chopin's four Ballades (although they are not conceived as an organic piece) comes from the opportunity to explore the evolution of Chopin's language in a form which is at the same time pastoral-narrative (it seems to tell the story of a people) and also deeply personal."
Taverna's professional repertoire stretches from Johan Sebastian Bach's music composed in the 17th century, to that of Oliver Messiaen of the 20th century. "I wouldn't speak about a 'favourite' composer," he says, "But I feel I express myself better in a certain kind of repertoire, probably because it is better suited to my personality, to my character … and to my fingers. Among them I would certainly mention Liszt, Sergei Rachmaninov, Claude Debussy and Maurice Ravel.
"Twentieth century music and also some contemporary music has, in my opinion, the ability to unexpectedly reach the strings of the soul without filters, with the use of the harmonies and their links, the colours and the effects that arise from the extreme exploration of keyboard possibilities."
Taverna first visited South Africa eight years ago, when he gave a masterclass at the University of the North West. "What I love most about this wonderful country is the genuineness with which music is experienced," he says. "The summer season which follows my visit in South Africa will include concerts and masterclasses in Europe. Among the highlights of the new season, I'll play the two Liszt Piano Concertos at La Scala in Milan with La Scala Philharmonic Orchestra. In November my new all-French recital disc will be available in the United Kingdom and Europe: this album follows my Medtner Sonatas disc, which was well received by international critics. Towards the end of the year, I perform Mozart's Piano Concertos K466 and K467 in Milan, Brescia and Bergamo.
Alessandro Taverna performs for the Johannesburg Musical Society at the Linder Auditorium on Saturday August 13. Contact 011 728 5492 or 083 228 2917 or visit jms.org.za and http://www.alessandrotaverna.com. Please note, there is no credit card facility at Linder Auditorium box office.
Categories: Interview, Music, Robyn Sassen, Uncategorized
Tagged as: Alessandro Taverna, Arturo Beneditti Michelangeli, Concert paraphrase on Verdi's Rigoletto, Franz Liszt, Frederic Chopin, Johannesburg Musical Society, linder auditorium, Mephisto Waltz, Minnesota International Piano Competition, Tarentella di Bravura
Dance to make you proudly South African
Thirty years of gods, bulls and other beasties


text:
S2-EP106 Instagram Tips For 2020 With Estelle Keeber
by Kim Thompson-Pinder | Sep 29, 2020 | Podcast
Have you ever wondered how to use Instagram for your business? Estelle Keeber joins Kim to share the best tips on how you can do that in 2020 including what to put in your bio, how to use Instagram Stories and why you should be using IGTV.
Estelle is one of the UK's leading Instagram experts and is an advocate for mental health awareness. She is a keynote speaker, #1 bestselling author and been featured in Forbes, while also being a mum to 2 energetic boys! Sharing her journey through depression and domestic abuse as well as some fabulous Instagram tips…Estelle shows the world that anything is possible!
www.mumsin.biz
EP 151 Online Resources For Writers With Juanita Wootton-Radko
by Kim Thompson-Pinder | Jan 12, 2021 | Podcast
Writing books and content is not always easy but in today's Writer's Workshop, Juanita shares some great tools that will help you take your writing to the next level!!!
The 150th Episode With Kim Thompson-Pinder and Juanita Wootton-Radko
by Kim Thompson-Pinder | Jan 7, 2021 | Podcast
Kim & Juanita look back over the last 14 months since the show began in November 2019 and talk about favourite episodes, how the show has affected their lives, crazy things that have happened during the show and how consistency and momentum in your business creates success.
What One Thing?
by Kim Thompson-Pinder | Jan 4, 2021 | Blog
Every year, I start out with this humongous goal for my business and all the things that I am going to accomplish. By January 10th, I have already given up on most of them. Why? I never create a doable game plan that I can accomplish every day. I was talking to a good...
EP 149 What One Thing? A Special New Year's Message From Kim
by Kim Thompson-Pinder | Jan 1, 2021 | Podcast, Uncategorized
As we start a New Year, Kim shares a special message on how to start and end the year strong. What is one thing that you can do today that will move your business forward? Every day, if you did one intentional, targeted action you will be amazed at how much your business will grow in 2021.
S2-EP128 How To Get Keep Your Business Open In 2021 With Claudine Pereira
by Kim Thompson-Pinder | Dec 24, 2020 | Podcast
Claudine joins Kim to discuss the current situation for entrepreneurs in 2020 with Covid and how you can change your 2021 so that it is your best year ever!!! Two of the best things you can do is to continue to shine and create an action plan to move forward.
S2-Ep127 Juicy, Effective Communication With Linda Babulic
Linda joins Kim to talk about the difference between communication and conversations, how to introduce yourself, how men and women communicate differently, and her experiences with working with a publisher and not understanding the consequences of it.
S2-EP126 Creating A Content Plan For 2021 With Kim Thompson-Pinder and Juanita Wootton-Radko
Kim & Juanita discuss why you need to have a content plan, how it fits into building Authority, what should be in your plan and how often you need to post.
S2-EP125 How Do Authorities Sell With The Authority Gang
by Kim Thompson-Pinder | Dec 14, 2020 | Podcast, Uncategorized
In today's episode, The Authority Gang share the ins and outs of selling with confidence and are you giving too much information instead of asking for the sale.
S2-EP124 A Strong Finish With Juanita Wootton-Radko
by Kim Thompson-Pinder | Dec 8, 2020 | Podcast
On today's Writer's Workshop episode, Juanita shares how to end your writing strong and not leave your audience feeling like a bad break up and glad to get away from it.
S2-EP123 Email Marketing Basics With Susan Rose
When two word ninjas get together to talk about the power of words you want to listen. Susan joins Kim on the show to talk about email marketing and how you can use it to gain authority and more clientele.
S2-EP105 The 4 Pillars of Clarity With Mike Young
S2-EP104 5 Tips To Get Started When You Don't Feel Like Writing With Juanita Wootton-Radko
by Kim Thompson-Pinder | Sep 22, 2020 | Podcast, Uncategorized
On today's Writer's Workshop episode, Juanita shares great tips on what to do when you are staring at the blank screen and are tempted to let distractions get the better of you.
Juanita Wootton-Radko is an enthusiastic reader, writer, and collector of books. When not at the library, she can often be found lurking about "used book" stores. Her lifelong passion for words has led to an equal passion for the structure of language and the grammatical tools we use to communicate.
Juanita works at RTI Publishing as the Book Project Manager and resident "Grammar Guru". She is the recurring co-host on the Author to Authority Podcast with Kim Thompson-Pinder and hosts the Writer's Workshop episodes.
Want a free sample of Kim's newest book Author To Authority coming out in 2020? Go to www.AuthorToAuthority.com/get-the-book
S2-EP103 The Layer Cake Of LinkedIn With Scott Aaron
What if you could turn LinkedIn into a business producing activity? Scott Aaron Joins Kim on the podcast and lays out a detailed plan on how to use LinkedIn to get clientele including how to start a conversation.
Internationally acclaimed and award-winning online marketer, best-selling author, top podcaster and speaker, Scott Aaron, is the go-to specialist when it comes to converting traffic, establishing connections, creating residual using LinkedIn and building personal brands.
Fully immersing himself in learning LinkedIn and social media strategies, Scott quickly gained traction as a leader in generating big results for other entrepreneurs, online business owners and business coaches.
Scott is passionate about helping fellow entrepreneurs achieve success while building their own network organically and without complicated and costly marketing tactics.
His program has helped thousands experience explosive growth following his program.
People-focused and result-driven, Scott's strategic approach to teaching others how to create wealth online and organic traffic is the game changer when it comes to competing in a saturated digital world.
https://www.linkedin.com/in/scottaaroncoach/
https://www.facebook.com/scott.aaron.33/
https://www.instagram.com/scottaaronlinkedin/
www.scottaaron.net
https://www.amazon.com/Linked-Book-Network-Marketing/dp/1796239925/
https://www.amazon.com/Network-Marketing-Academy-Scott-Aaron-ebook/dp/B085W9JB4P/
Get A Free Chapter From Kim's upcoming book Author To Authority.
Also get updates on Kim's writing journey and training on how to take your business to the next level.
We respect your privacy and your information will not be shared.
S2-EP102 How To Use Social Media To Create Superfans With Kim Thompson-Pinder and Juanita Wootton-Radko
Kim & Juanita continue their series from becoming an Author to going to an Authority in your niche. This episode focuses on how you use social media to create Superfans, your Brand Ambassadors who take your message to the world.
They clarify the goals of Social Media for those in a service-based business and give the first steps to creating and audience of people who know, like and trust you. They also share some ideas learned from Pat Flynn's Superfans book.
Have you ever looked at a blank computer screen in frustration because the words won't come because you are afraid it won't sound right? Or worse, that it won't be received well?
Kim spent many years feeling that way after a teacher told Kim that she was, "No good at writing and should stop." Discouraged, Kim put writing aside. Then, she came to a crossroads in her life and let those painful words go. She set her words free and let her voice to be heard once more. Since then, she has gone on to author five books (with three more on the way this year), two planners and even a collection of Sudoku books. Most importantly, Kim started RTI Publishing and has helped over one hundred entrepreneurs to become authors and taught them how to use their books to become authorities in their niche and open doors to build their business faster.
Kim understands the power of words and can't wait to share them with you on the podcast.
If you love the podcast, then check out the Author To Authority group on Facebook. www.Facebook.com/groups/authortoauthority
Ad Episode
Email Series
Online Network & Learn
Online Network & Learn Summit-TV-May27,2020
Staples Series


text:
Protecting People w Mental Disabilities & Impairments against Biomedical Research Abuse
Protecting People with Mental Disabilities and Impairments against Biomedical Research Abuse[*]
John H. Noble, Jr., Ph.D, The Catholic University of America, Washington, DC, USA
Vera Hassner Sharav, MLS, Alliance for Human Research Protection, New York, USA
People with mental disabilities and impairments historically have been targeted by biomedical researchers and their governmental and industrial sponsors for exposure to experiments that impose high risks without offsetting therapeutic benefits on the theory that the future good of society justifies what was done to them. The final report of the Advisory Committee on Human Radiation Experiments (ACHRE)[1] systematically reviewed and condemned much of what was done to institutionalized persons with mental retardation in such places in the United States as Willowbrook in New York State and the Walter Fernald School in Massachusetts. Abusive biomedical research has continued to this day since the publication of the ACHRE report.
This paper reviews several recent cases, including symptom provocation experiments on schizophrenic patients, respirator tidal volume experiments on cognitively-impaired and unconscious patients with Acute Lung Infection (ALI) and Acute Respiratory Distress Syndrome (ARDS), experiments on children with HIV under municipal or state guardianship, and lead poisoning experiments on healthy poor children that caused ensuing neurological impairments. It notes the ubiquitous invocation of "surrogate consent" to enrol persons incapable of understanding the risks and benefits of the research to which they are subjected. Accordingly, we make a number of recommendations to strengthen the protections afforded to people with mental disabilities and impairments, including the definition of these human subjects as members of a protected class who require judicial registration and appointment of a court officer to assess the benefits and risks of the proposed research and to monitor how the research is actually conducted.
Existing Ethical Standards
The sources of ethical standards governing U.S. research that involves human subjects are: the Nuremberg Code,[2] the Declaration of Helsinki,[3] and the Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research,[4] on which current federal law and regulations are based.[5]
The Nuremberg Code was enacted by the WWII war crimes tribunal in reaction to the atrocities committed by Nazi physicians on concentration camp inmates before and during the war. The Code lays down the basic conditions and limits under which experiments on human subjects are permitted. First and foremost is that the human subject be legally capable of giving voluntary informed consent to participation "without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision" (Principle 1). Second, the human subject "should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible" (Principle 9). Third, the experiment must offer the prospect of yielding "fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature" (Principle 2). Fourth, the risk entailed should "never exceed that determined by the humanitarian importance of the problem to be solved by the experiment" (Principle 6). Fourth, the experiment should be terminated if the scientist in charge "has probable cause to believe, in the exercise of good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject" (Principle 10). 3
The Declaration of Helsinki of the World Medical Association builds on the Nuremberg Code and amplifies its provisions with respect to the conduct of (1) medical research combined with professional care and (2) non-therapeutic research involving human subjects. Generally, Principle 6 of the Declaration enunciates "the right of the research subject to safeguard his or her integrity" and the duty of the scientifically qualified persons under the supervision of a clinically competent medical person "to respect the privacy of the subject and to minimize the impact of the study on the subject¹s physical and mental integrity and on the personality of the subject." Principle 7 indicates that "physicians should abstain from engaging in research involving human subjects unless they are satisfied that the hazards involved are believed to be predictable" and that they "should cease any investigation if the hazards are found to outweigh the potential benefits." Principle 9 affirms that "each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail; that he or she is at liberty to abstain from participation in the study and that he or she is free to withdraw his or her consent to participation at any time."
The Declaration addresses a number of issues on which the Nuremberg Code is silent. Principle 8 requires that the physician "preserve the accuracy of the results" in publications and that reports "not in accordance with the principles laid down in this Declaration should not be published." With respect to medical research combined with professional care, the Declaration states that "the potential benefits, hazards and discomfort of a new method should be weighed against the advantages of the best current diagnostic and therapeutic methods" and that "every patient, including those in a control group, if any, should be assured of the best proven diagnostic and therapeutic method." With respect to non-therapeutic biomedical research involving human subjects, the Declaration asserts that the physician is "to remain the protector of life and health of that person on whom biomedical research is carried out;" that the subjects should be volunteers regardless of health status; and that "the interest of science and society should never take precedence over considerations relating to the well-being of the subject."2
The Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research expands the scope of the Nuremberg Code and the Declaration of Helsinki to include behavioural research involving the use of human subjects. It adopts a three-fold classification of the basic ethical principles governing biomedical and behavioural research involving use of human subjects in terms of (1) respect for persons, (2) beneficence, and (3) justice. The Belmont Report concern for "justice" goes beyond the provisions of the Nuremberg Code and the Declaration of Helsinki‹explicitly reflecting sensitivity to the infamous Tuskegee Institute study of the progression of untreated syphilis among poor African-American males well after the discovery of penicillin.[6]
Under the rubric, "respect for persons," the Belmont Report recognizes two related ethical values‹(1) the human subject¹s right to autonomy or self-determination in deciding whether or not to participate in a specific biomedical or behavioural research endeavour and (2) the need to protect those with diminished ability to decide. In doing so, the Belmont Report reformulates Principle 1 of the Nuremberg Code and combines Principles 6 and 9 of the Declaration of Helsinki.
According to the Belmont Report, "beneficence" is the obligation to do no harm and to maximize possible benefits while minimizing possible harms. The obligation extends beyond the immediate human subject. Specific research endeavours are justified by future benefit to society through discovery of new and better ways of preventing or treating illness or by promoting healthy development‹even though the human research subject may not directly benefit. The Belmont Report recognizes the ethical dilemma that arises when exposing healthy human subjects with no prospect of direct benefit to more than minimal risk for the possible future good of society.4
By permitting possible harm to occur to otherwise healthy human subjects‹albeit for the possible future good of society‹the Belmont Report qualifies and curtails the application of both Principle 4 of the Nuremberg Code that research is to be conducted so as to avoid all unnecessary physical and mental suffering and injury3 and Principle 6 of the Declaration of Helsinki which unambiguously declares that "the interests of the subject must always prevail over the interests of science and society."2 By permitting individual researchers to take into account the always speculative "possible future good of society" when deciding to do research on otherwise healthy human subjects, the Belmont Report opened the Pandora¹s Box of rationalizations in the United States about what constitutes "minimal" and "more than minimal risk" in such research. At the same time, it raised a red flag about the ethics of research that cannot provide an answer to the question that justified its undertaking because of poor design or faulty implementation and, increasingly, the suppression, misrepresentation, or paring of findings in published reports.[7] [8] [9] [10] [11] [12] Faulty or distorted research cannot contribute to the possible future good of society and thus fails the test of beneficence.
The Belmont Report defines "justice" as "fairness in distribution" of the benefits and burdens of research. It also states that "equals ought to be treated equally." Examples of inequalities are offered to give context and clarity to what is meant by the fair and unfair distribution of benefits and burdens. They include selection of vulnerable populations, such as welfare patients, specific racial and ethnic minorities, or institutionalized populations, for research use. Easy availability, compromised status, and manipulability are the cited reasons for their selection. It is unfair that human research subjects be used to create high quality medical care for which others can afford to pay but they cannot. Unfortunately, "justice" in the selection of research subjects remains an elusive goal‹given the economics of medical care in the United States that depends largely on the ability to pay to ration a scarce resource.[13] Easy availability, compromised status, and manipulability of human subjects are an ever-present moral hazard for biomedical researchers in the search for a sufficient number to populate expanding clinical trials.
Recent Research Abuses
We describe as abusive any research that violates the normative standards of the Nuremberg Code, the Declaration of Helsinki, or the Belmont Report. We use the three-fold Belmont Report classification to denote the kind of violation‹dignity, beneficence, justice, or a combination.
Abuse of Dignity
Psychiatric symptom provocation experiments: In direct violation of Principle 1 of the Nuremberg Code and Principle 6 of the Declaration of Helsinki a large number of symptom provocation experiments have been conducted in various places[14] to induce psychosis and "flash-back" in severely disabled psychiatric patients, many of whom were incoherent and psychotic when recruited at the time of admission to a state mental hospital. Principle 1 of the Nuremberg Code states: "The voluntary consent of the human subject is absolutely essential . . . the person involved should have legal capacity to give consent." Principle 6 of the Declaration of Helsinki states: "The right of the research subject to safeguard his or her integrity must always be respected. Every precaution should be taken . . . to minimize the impact of the study on the subject¹s physical and mental integrity and on the personality of the subject."
Clearly, patients who are subjected to abrupt withdrawal or washout of their prescribed anti-psychotic medications to induce a reported 40% to 67% rate of relapse suffer an assault on their physical and mental integrity and personality. Some symptom provocation experiments have used chemical probes, such as amphetamine, L-dopa, methylphenidate and the PCP-derivative, ketamine, among others, to provoke psychosis. Other experiments have exposed detoxified U.S. war veterans to the addictive drugs amphetamine and cocaine. None of these experiments has served a therapeutic purpose but rather has diminished the health status of patients who mistakenly perceived their physician-researcher as healer.[15] Indeed, the legal capacity of mentally impaired patients to give informed consent, as required by Principle 1 of the Nuremburg Code, is arguably suspect in many if not most cases.
Ventilation Pressure Experiments: In direct violation of Principle 1 of the Nuremburg Code and Principle 6 and Clinical Research Principle 3 of the Declaration of Helsinki, the National Institutes of Health (NIH) and private, for-profit sources funded 12 major American research centers to conduct an experiment[16] to compare the effects of two static extreme ventilator tidal volume levels on 861 critically ill patients with acute respiratory distress syndrome (ARDS). Most patients were too incapacitated to give informed consent. There was no control group receiving the individualized standard treatment provided by primary care physicians. Clinical Research Principle 2 of the Declaration of Helsinki states: "The potential benefits, hazards and discomfort of a new method should be weighed against the advantages of the best current diagnostic and therapeutic methods." A formal complaint by the Alliance for Human Research Protection (AHRP) about the ethics and methodology of the study led to its suspension and that of another related one involving patients with Acute Lung Injury (ALI).[17] Investigation by the Office of Human Research Protection (OHRP), the ethics oversight agency of the U.S. Department of Health and Human Services (HHS), found that many ARDS patients had been enroled without personal informed consent or surrogate consent by a legally-authorized agent.
Internal NIH critics[18] of the experiment argued that both the extreme low tidal volume and the extreme high tidal volume, which the researchers defined as "traditional," were outside of the range of what most physicians normally prescribe and, therefore, incorrectly characterized. In effect, the study compared two static experimental treatments without benefit of a control group providing the individualized standard treatment of a primary care physician. The critics argued further that all human subjects in the study might have been endangered by random assignment to the static experimental ventilator tidal volumes higher or lower than prescribed by the individualized standard of care. Reanalysis of the original data by these same critics[19] confirmed that some ARDS patients had indeed been harmed. The critics also offered an explanation. After enrollment in the trial, earlier routine care for patients was stopped. Patients who received high tidal volumes had a mortality rate of 41 percent compared to the lower rate of 32 percent among eligible patients who received routine standard care. In patients with more injured, less elastic lungs, increasing tidal volumes from routine care levels after randomization increased mortality rates. Similarly, in patients with less injured, more elastic lungs, reducing tidal volumes from routine care also increased mortality.[20]
Foster Care Children Experiments: In direct violation of Principle 1 of the Nuremberg Code and Principle 6 of the Declaration of Helsinki, more than four dozen Phase I and Phase II drug trials were conducted on infants and children who were either diagnosed with HIV infection or, in some cases, "presumed" to be infected. These children were in foster care guardianship of the New York City Agency for Children's Services (ACS) and in at least seven states‹Illinois, Louisiana, Maryland, New York, North Carolina, Colorado and Texas. Phase I and Phase II experiments serve to test the safety, toxicity, and maximum dose tolerance of drugs and are not meant to have therapeutic value for the patient. They present the greatest level of risk and discomfort for human subjects. Contrary to Clinical Principle 5 of the Declaration of Helsinki, the studies neither obtained informed consent nor communicated the fact and rationale for not doing so to an independent committee for consideration, comment and guidance. Contrary to Clinical Principle 6, the studies could not be justified by reference to the potential diagnostic or therapeutic value for the patient. The estimated 700 to 1,400 largely African-American foster children enrolled in the experiments were reported to have suffered rashes, vomiting, precipitous drops in infection-fighting blood cells, and in one study a very much higher death rate among those who received larger drug doses.[21]
Not only did the foster care children experiments violate Principle 1 of the Nuremburg Code and Principle 6 of the Declaration of Helsinki, they also ignored the U.S. Code of Federal Regulations (45 CFR 46.409 and 21 CFR 50.56) prohibition against the use of children who are wards of the state from being subjected to experiments involving greater than minimal risk, as well as related provisions for granting an exception‹subject to the appointment of an independent qualified advocate for each child in addition to any other individual acting on behalf of the child as guardian or in loco parentis.[22]
Lead Poisoning Experiments: In direct violation of Principle 1 of the Nuremberg Code and Principle 6 and Non-Clinical Biomedical Research Principles 1-4 of the Helsinki Declaration, the Kennedy-Krieger Institute and Johns Hopkins University conducted an experiment on 108 poor, primarily African-American children to test the effects in their blood of varying levels of household lead paint dust exposure at 2, 6, 12, and 18 months compared to unexposed children. The developing brains of children under 5 years of age are known to be particularly sensitive to even low blood levels of lead and linkage to reduced intelligence (IQ).[23] Sadly, the experiment was jointly sponsored by the U.S. Environmental Protection Agency and the Maryland Department of Housing and Community Development. The economic payoff for slum landlords and the taxes they pay to city governments throughout the U.S. would be enormous if less than a 100 percent lead paint abatement policy could be justified by research that disclosed a possible minimal safe level.
Two families sued the Kennedy-Krieger Institute for negligent harm and were initially rebuffed by a lower court even before the attorneys of the plaintiffs could complete gathering information. On appeal the Maryland Court of Appeals sent their cases back to the lower court for trial with scathing criticism of the Kennedy-Krieger Institute and Johns Hopkins University, under whose supervision the study was conducted.[24] The Court of Appeals reaffirmed the applicable provisions of the Nuremburg Code and the Declaration of Helsinki‹especially as they relate to non-therapeutic research on healthy human subjects.[25] Non-therapeutic research still requires that: (1) "the physician to remain the protector of the life and health of that person on whom biomedical research is being carried out," (2) "subjects should be volunteers," (3) initiated research should be discontinued if later determined that it may be harmful to the individual, and (4) "the interest of science and society should never take precedence over considerations related to the well-being of the subject."
The Maryland Court of Appeals explicitly compared the lead-poisoning experiment to the infamous Tuskegee, Alabama, experiment that withheld effective treatment from black men infected with syphilis. It further castigated the Kennedy-Krieger Institute for failing to inform parents of the risks of participation‹in effect, using their children as "canaries in the mine." Particularly telling was the Court¹s criticism of the researchers and the Johns Hopkins University Institutional Review Board (IRB) for working together "to miscast the characteristics of the study in order to avoid the responsibility inherent in non-therapeutic research involving children." In the Court¹s opinion, this was no case of mistaken error but one of calculated malfeasance. The Court further dismissed the argument of the defendants that the parents had given their consent for the children to participate in the study by denying the right of parents to put their children in harm¹s way:
Otherwise healthy children, in our view, should not be enticed into living in, or remaining in, potentially lead-tainted housing and intentionally subjected to a research program, which contemplates the probability, or even the possibility, of lead poisoning or even the accumulation of lower levels of lead in blood, in order for the extent of the contamination of the children's blood to be used by scientific researchers to assess the success of lead paint or lead dust abatement measures. Moreover, in our view, parents, whether improperly enticed by trinkets, food stamps, money or other items, have no more right to intentionally and unnecessarily place children in potentially hazardous nontherapeutic research surroundings, than do researchers. In such cases, parental consent, no matter how informed, is insufficient.25(para. 21)
Abuse of Beneficence
As previously mentioned, faulty or misrepresented research cannot contribute to the future good of society and thus fails the test of beneficence. Unfortunately, faulty and misrepresented research is a growing rather than diminishing problem in the biomedical research community.7-12 One recent survey8 indicates that, overall, one-third of biomedical researchers admit to engaging in one or more kinds of unethical behaviour in the previous three years‹scientists in early career reporting 28 percent and those in mid-career reporting 38 percent. Perversely, practice makes perfect the bad behaviour of scientists as they gain experience. The survey data calls into question the common belief of many U.S. government funding and regulatory agency officials that ethics education is the key to improving the protection of human research subjects. Truth be known, scientists cannot help but notice the lack of consequences for ethics violations and may well be encouraged by current policy and practice to adopt a cavalier attitude toward both the protection of human subjects and the integrity of science. They may be adopting the prevailing business practice that calculates the net cost compared to profit of settling lawsuits for harm done to consumers or the environment.
Unethical or marginally ethical behaviours erode the integrity of science and should be of great concern for everybody who values the scientific enterprise. Such behaviour obstructs scientific progress by encouraging false leads or permanently or temporarily blocking a promising avenue for investigation. Particularly obnoxious is the trade secret status of adverse events in U.S. law that threatens the life-safety of human subjects and the public health.7 Physicians and consumers are owed full, complete, and accurate information about the benefits and risks of drugs and medical devices to guide their safe use. The too-often practice of changing the design, methodology or results of a study under pressure from a funding source or non-disclosure of the use of flawed data or questionable interpretation of data by others suggest widespread collusion in deceit and deception.8 Public reaction to increased scientific abuse revealed by multiple sources could result in major cuts in the government research budgets. Fraud and abuse in public programs invite disillusionment, cutbacks and disinvestments in needed biomedical science and thereby threaten the future well-being of society.
Abuse of Justice
Despite the ACHRE1 exposure and condemnation of research abuses at the Walter Fernald School and Willowbrook, vulnerable institutionalized populations subject to the surrogate consent of their caretakers are still viewed as targets of opportunity by some members of the biomedical research community. Many of the psychiatric symptom provocation experiments targeted institutionalized psychiatric patients or WWII veterans who were served by the U.S. federal government Veterans Administration (VA) facilities and programs. The AIDS child experiments recruited poor African-American children in foster care who had been placed by family courts into the protective custody of state or municipal governments. While not institutionalized, the child lead poisoning experiment recruited poor, primarily African-American children, whose surrogate-consenting parents were susceptible in the opinion of the Maryland Court of Appeals to enticement by trinkets, food stamps, money or other items. By way of exception, poverty and race did not figure into the recruitment of patients for the ARDS ventilator tidal volume experiment. The inclusion and exclusion criteria were strictly physiological.[26] It was the severe cognitive impairment or the unconscious state of the subjects that was the source of the exploitable vulnerability and moral hazard for the researchers.
In each of these cases of research abuse, the responsible Institutional Review Board (IRB) failed its duty to apply and oversee implementation of applicable U.S. law and regulations governing the protection of human research subjects. Media and congressional attention[27] to research abuses in the U.S. and elsewhere, some believe, is increasing the difficulty and cost of recruiting sufficient numbers of human subjects for government and private enterprise biomedical research‹so much so that American pharmaceutical companies are planning to move new clinical trials overseas to locations in Eastern Europe, South America and India.[28] Notwithstanding the possible explanation, the trend portends a worsening of biomedical research abuses of human subjects outside of the U.S and, indeed, may represent a new form of colonialism in view of India¹s recent loosening of rules governing clinical trials in response to demands from multinational drug companies seeking relief from the "strict regulations, elaborate safety and compensation requirements, and small populations" in Western countries.[29] Africa¹s scientific elite is being asked to speak out against new clinical trials that exploit vulnerable populations of their countries.[30]
Recommended System Reforms
Grouped by reference to the Belmont Report ethical principle primarily addressed, we make a number of recommendations for system reform and give their rationale. There is no claim of originality. Others have recognized the same flaws in the structure and functioning of the existing system of protection for human subjects in biomedical and behavioural research. Resistance to the adoption of these recommendations is expected from those who benefit from the system as it now operates. The opposition has "deep pockets" and is well-positioned to resist.[31] [32] As recently as June 28, 2005 the U.S. Environmental Protection Agency issued proposed regulations that would permit testing the safety of pesticides on children, pregnant women, and newborns while rejecting establishment of an independent ethics review board because it would "unnecessarily confine EPA¹s discretion."[33]
1. Define vulnerable populations, including persons requiring surrogate consent because of cognitive impairment, as a protected class in need of judicial oversight under uniform federal law.
Rationale: While current federal regulations define "vulnerable subjects" who require "additional safeguards" (45 CFR 46.111; 21 CFR 56.111), including informed consent from a "legally authorized representative" (45 CFR 46.116; 21 CFR 56.116), the safeguards are unclear, and most states have not specified who is authorized to provide informed consent.[34] As our case examples illustrate, continuing uncertainty permits variable interpretations, which often reflect the interest of the researchers and their sponsors rather than the best interest of the human subjects.
2. Require appointment by a court of an ombudsman for members of vulnerable populations, including those who require surrogate consent, to assure Institutional Review Board (IRB) and researcher compliance with all federal regulations, from inception of the research to publication and archiving of reported findings and the original data on which statistical or other inferences rely.
Rationale: The 30-year history of IRB review and oversight of biomedical and behavioural research reveals weaknesses that require an additional overlay of protections for human subjects. There was IRB review and approval in all of our case examples. In the child lead-poisoning case the Maryland Court of Appeals castigated the Johns Hopkins University IRB for coaching the researchers on how to evade federal regulations to protect human subjects.25 Located in the very institutions that compete for government and private, for-profit research funds, the IRBs are not free and independent agents that can look solely to the protection of the best interest of human subjects. One might legitimately ask about the feasibility of creating a new layer of protection for vulnerable populations. Existing federal regulatory and oversight agencies are not adequately funded and staffed to monitor IRB performance and rely instead on outside complaints to detect flagrant ethics violations.
What would the new layer of protection add and how could it be financed? First, it would add a second opinion and thereby break the IRB monopoly in determining compliance with federal law and regulations. Further, the threat of being found wanting would likely improve the quality of IRB review and oversight of individual research projects. Second, the sponsors of biomedical research have enormous resources at their disposal and can well afford to pay for court-appointed ombudsmen and associated administrative cost. Some of the millions of dollars that are now spent on product advertising and promotion by pharmaceutical companies can be diverted to improving protections for the human research subjects that made possible their marketing in the first place. If existing federal law permits industry to reimburse the U.S. Food and Drug Administration (FDA) for the expense of review of applications for approval of new drugs or medical devices,[35] why not permit payment for additional needed protections of human research subjects?
A low-cost complementary additive would be strengthening of Qui Tam[36] and whistle-blower protection laws, which encourage insiders to reveal violations of federal law and regulations. The federal False Claims Act of 1863, as amended in 1986, could be interpreted or extended by defining violation of 45 CFR 46 and 21 CFR 50 human research subject protection provisions as evidence of "fraud and abuse." This change would reward whistle-blowers, including employees of private, for-profit and non-profit entities that benefit from FDA approval of applications for new drug or medical devices, who come forward to reveal research abuses.
3. Amend existing Social Security Act Titles IV-B and IV-E child protection and foster care provisions to require training of child protection and foster care agencies and workers about the appropriate use of surrogate consent for enrolment of children in foster care in biomedical and behavioural research.
Rationale: As the unethical experiments involving foster care children clearly demonstrate, the child protection agencies involved were either ignorant of or chose to ignore the relevant federal regulations (45 CFR 46.409 and 21 CFR 50.56) that specify the conditions under which children who are wards of the state or any other agency, institution, or entity can be included in greater than minimal risk research. They should have known that the children could have been legitimately enrolled only if the research had been approved under 45 CFR 46.406 or 45 CFR 46.407 as (1) related to their status as wards or (2) conducted in schools, camps, hospitals, institutions, or similar setting in which the majority of children involved as subjects were not wards. They should also have known that the federal regulations require, in addition to any other individual acting on behalf of the child as guardian or in loco parentis, appointment by the IRB of a qualified, independent advocate for each child who is a ward to assure that the child¹s best interests are served during the time of participation in the research.
4. Abolish trade secret status for adverse events.
Rationale: Granting protected trade secret status for adverse events that must otherwise be reported pursuant to 21 CFR 312.32 investigational new drug (IND) safety reports contradicts the very purpose of the provision to secure the public health. As argued by Dr. Jerome Hoffman, Professor of Medicine and Emergency Medicine, University of California, Los Angeles, it is "unconscionable that the FDA appears to be prevented by law from carrying out what we all surely believe is its primary role in this process, which is to safeguard the interests of the public. The fact that the law not only does not make this a requirement‹of the drug company itself, no less of the FDA‹but that it actually makes it forbidden, clearly turns the function of this government agency on its head from protector of the public health to protector of industry."7 Publication of partial or "asymmetrical" data in medical journals to protect trade secrets violates Principle 8 of the Declaration of Helsinki and blocks independent observation and replication of reported findings‹one of the cardinal principles of empirical science.[37] The law in this regard makes worse an already compromised situation wherein the typically underpowered clinical trial with a small sample size is biased toward reporting "no statistically significant" evidence of adverse events.[38] As previously noted, trade secret status also frustrates communication of what physicians need to know about the benefits and risks of new drugs and medical devices in reaching decisions about their use for specific patients‹a judgment in each case about the potential benefit versus the likely risk of an adverse reaction.
5. Mandate open-access publishing and archiving of original data for reanalysis and meta-analysis.
Rationale: Beneficence requires transparency and full disclosure of the knowledge that is obtained by use of human subjects in biomedical and behavioural research. To withhold or misrepresent the findings of such research is to render futile the risks and burden of the human subjects who made it possible, and flies in the face of Principle 2 of the Nuremberg Code that "the experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study . . ." Further, in the view of a recent report of the UK House of Commons Health Committee,[39](p. 98) "traditional secrecy in the drug regulatory process" and "closeness between regulators and pharmaceutical companies" have "deprived the industry of rigorous quality control and audit." It has also been argued that full and open access to reported research findings and the original data on which they depend is needed to facilitate meta-analysis or systematic reviews of the primary research on which the evidence-based practice of medicine depends.38 Open-access publication policy assures unfettered communication of the results of research for use by all.[40]
6. Promote systematic end-product peer review and cumulative meta-analysis of biomedical research for dissemination by the Cochrane Collaboration.
Rationale: Despite billions of dollars per year outlays for biomedical and behavioural research, there is insufficient investment in documenting the quality of the output. The size of the problem is large and growing larger, if one considers the following recently published statistics8 about the behaviour of biomedical scientists in the previous three years: Failing to present data that contradict one¹s previous research, 6%; overlooking others¹ use of flawed data or questionable interpretation of data, 12.5%; changing the design, methodology or results of a study in response to pressure from a funding source, 15.5%; inappropriately assigning authorship credit, 10%; withholding details of methodology or results in papers or proposals, 10.8%; using inadequate or inappropriate research designs, 13.5%; dropping observations or data points from analyses based on a gut feeling that they were inaccurate, 15.3%. Generally, mid-career scientists admitted these behaviours more frequently than early careerists.
End-product peer review taking the threats-to-inference approach[41] to documentation of the quality of government-funded research with wide dissemination of the results of review[42] might well provide powerful incentive for researchers to avoid being exposed as guilty of any of the aforementioned problem behaviours. The threats-to-inference approach focuses on research design elements as well as on how the study was actually conducted to determine whether there may be more plausible alternative explanations for the study¹s findings than the one presented by the investigator. Correlatively, greater investment by government funding agencies in cumulative meta-analysis of reported findings by studies in their research portfolios‹again, taking the threats-to-inference approach‹could take advantage of the capabilities of the Cochrane Collaboration[43] to conduct and disseminate systematic reviews for use in evidence-based medical practice.
Such systematic reviews could be expanded to incorporate the requirement that reviewers check and control for author authenticity and financial conflicts‹perhaps going so far as to suggest that some or all of these tainted reports be either thrown out or discounted by means of a suitably-weighted sensitivity analysis. Indeed, the most conservative approach for combining studies in meta-analysis is to employ the laboratory or researcher as the smallest unit of analysis.[44] Contemporary information technology permits tagging of compromised authors and research institutions for use in evaluating subsequent publications. In this regard, the meta-analyst can utilize available reports of violations of the International Committee of Medical Journal Editors (ICMJE) accountability standards, access to data, and control of publication.[45]
It is well known that commercialization of the biomedical research enterprise is the principal source of flawed research designs and manipulated presentation of findings.[46] [47] Government regulatory decisions have been known to facilitate the marketing strategies of individual companies. Most recently, the U.S. Food and Drug Administration (FDA) permitted a confounded study of a new drug, torcetrapib, only in combination with another patented drug, atorvastatin (Lipitor). The FDA decision created a monopoly by preventing sale of torcetrapib for separate use or in combination with a generic statin or with one available from a competing source.[48]
Systematic end-product peer review and meta-analysis taking the threats-to-inference approach are among the few non-draconian antidotes to behaviours that undermine the integrity of science while violating the ethical principle of beneficence required by the Nuremburg Code, the Declaration of Helsinki and the Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
7. Adopt deterrents in the form of monetary penalties for non-compliance with law and regulations for the protection of human research subjects to compel fair and honest practice.
Rationale: As these examples of research abuse illustrate, Institutional Review Board (IRB) voluntarism and self-policing have repeatedly failed to protect human subjects in biomedical and behavioural research. Practices which erode the integrity of science increase rather than decrease as biomedical scientists advance in their careers.8 If nothing more punishing than a slap on the wrist can be expected, why change behaviour? Deterrents in the form of monetary penalties and suspension of research privileges for major non-compliance with law and regulations for the protection of human subjects seem needed to reinforce education in how to conduct ethical biomedical and behavioural research.
Given the poor track record of the existing U.S. system of human research subject protection, there is need for an additional layer of protection that defines people with mental disabilities and impairments as a protected class of vulnerable subjects who require the appointment of a court officer to oversee their enrolment and treatment in research. It is the most important of our recommendations for needed reform. At stake in all of this is the public trust that is absolutely essential for the advancement of biomedical science and the future good of society.
[*]Presented at the 29th International Congress on Law and Mental Health, Paris, France, July 6, 2005
[1]Final Report of the Advisory Committee on Human Radiation Experiments. No. 061-000-00-848-9. Washington, DC. U.S. Government Printing Office, October 1995. Available at: http://www.eh.doe.gov/ohre/roadmap/achre/index.html Accessed June 30, 2005.
[2]The Nuremberg Code (1947) In: Mitscherlich A, Mielke F. Doctors of infamy: the story of the Nazi medical crimes. New York: Schuman, 1949: xxiii-xxv. Available at: http://www.cirp.org/library/ethics/nuremberg/ Accessed June 30, 2005.
[3]World Medical Organization. Declaration of Helsinki. British Medical Journal (7 December) 1996; 313(7070):1448-1449. Available at: http://www.cirp.org/library/ethics/helsinki/ Accessed June 30, 2005
[4]The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. No. (OS) 78-0014. Washington, DC: U.S. Government Printing Office, April 18, 1979. Available at: http://ohsr.od.nih.gov/guidelines/belmont.html Accessed June 30, 2005.
[5]45 CFR 46 and 21 CFR 50.
[6]Jones JH. Bad blood: the Tuskegee syphilis experiment. New York: The Free Press, 1993. Tuskegee study historical timeline available at: http://www.cdc.gov/nchstp/od/tuskegee/time.htm Accessed June 30, 2005.
[7]Lenzer J, Pyke N. Was Traci Johnson driven to suicide by anti-depressants? That¹s a trade secret, say U.S. officials. On-line Independent (UK), 19 June 2005. Available at: https://ahrp.org/infomail/05/06/19.php Accessed June 30, 2005.
[8]Martinson BC, Anderson MS, deVries R. Scientists behaving badly. Nature 435, 737-738 (9 June 2005). Available at: http://www.nature.com/nature/journal/v435/n7043/full/435737a.html Accessed June 30, 2005.
[9]Flanagin A, Carey LA, Fontanarosa PB, Phillips SG, Pace BP, Lundberg GD, Rennie D. Prevalence of articles with honorary authors and ghost authors in peer-reviewed medical journals. JAMA 1998; 280: 222-224.
[10]Schulman KA, Seils DM, Timbie JW, Sugarman J, Dame LA, Weinfurt KP, Mark DB, Califf RM. A national survey of provisions in clinical trial agreements between medical schools and sponsors. New Engl. J. Med. 2002; 347: 1335-1341.
[11]Melander H, Ahlqvist-Rastad J, Meijer G, Beermann B. Evidence b(i)ased medicine‹selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ 2003; 326: 1171-1173.
[12]Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systemic review. BMJ 2003; 326: 1167-1170.
[13]Ramsay M. Ethical dilemmas in health care rationing. Newcastle-upon-Tyne, UK: Political Studies Association, 2005. Available at: http://www.psa.ac.uk/cps/1995%5Crams.pdf Accessed June 30, 2005.
[14]Sharav VH. Federally-funded relapse producing experiments in psychiatry: drug washout/chemical provocation‹a partial bibliography, January 2000. Available at: https://ahrp.org/testimonypresentations/InducedPsychosisBiblio.php Accessed June 30, 2005.
[15]Sharav VH. Chemically induced psychosis experiments: an inhumane paradigm in psychiatric research. Testimony for the record of the Public Health & Safety Subcommittee of the Senate Health, Education, Labor & Pensions Committee Hearing, February 2, 2000. Available at: https://ahrp.org/testimonypresentations/InducedPsychosis.php Accessed June 30, 2005.
[16]Acute Respiratory Distress Syndrome Network. Ventilation with lower tidal volumes compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med 2000; 342:13011308.
[17]AHRP testimonies re: fatal ARDS lung experiment, June 26, 2003. Available at: https://ahrp.org/infomail/0603/26.php Accessed June 30, 2005.
[18]Eichacker, PQ, Gerstenberger, EP, Banks, SM, Cui, X, Natanson, C. Meta-analysis of acute lung injury and acute respiratory distress syndrome trials testing low tidal volumes. Am J Respir Crit Care Med 2002; 166:1510-1514. Available at: http://ajrccm.atsjournals.org/cgi/search?fulltext=eichacker&volume=166&issue=11&journalcode=ajrccm Accessed June 30, 2005.
[19]Deans K, Minneci P, Cui X, Banks S, Natanson C, Eichacker P. Editorial: Mechanical ventilation in ARDS: One size does not fit all. Crit Care Med 2005; 33: 1141-1143.
[20]AHRP. Mechanical ventilation in ARDS: One size does not fit all_Editorial AJCCM, May 20, 2005. Available at: https://ahrp.org/infomail/05/05/20.php Accessed June 30, 2005.
[21]Solomon J. Researchers tested AIDS drugs on children. Associated Press, May 4, 2005. Available at: https://ahrp.org/infomail/05/05/04.php Accessed June 30, 2005.
[22]AHRP letter of complaint to Dr. Michael Carome, Chief Compliance Officer, Office of Human Research Protection, DHHS, March 10, 2004. Available at: https://ahrp.org/ahrpspeaks/HIVkids0304.php See also: https://ahrp.org/infomail/05/04/23a.php Accessed June 30, 2005.
[23]National Institute of Environmental Health Sciences. Lead and your health, 2005. Available at: http://www.niehs.nih.gov/oc/factsheets/pdf/lead.pdf Accessed June 30, 2005.
[24]Roig-Franzia M. My kids were used as guinea pigs. Washington Post, August 2001. Available at: http://www.sskrplaw.com/publications/pigs.html Accessed June 30, 2005.
[25]Grimes v. Kennedy Krieger Institute, Inc., No. 128 September Term, 2000 (Md. 08/16/2001. Available at: http://biotech.law.lsu.edu/cases/research/grimes_v_KKI.htm Accessed June 30, 2005.
[26]ARDS Clinical Network. ARDSNet study 03, version I: A phase II/III, randomized, double-blind, placebo-controlled trial of Lisofylline in patients with acute lung injury and adult respiratory distress syndrome, January 5, 1998.
[27]AHRP. Senator Grassley to offer mandatory drug data registry bill, December 10, 2004. Available at: https://ahrp.org/infomail/04/12/10.php Accessed June 30, 2005.
[28]Kaufman M. Clinical trials of drugs fewer, study says: report also notes decline in number of principal investigators in U.S. Washington Post, May 4, 2005, A2. Available at: https://ahrp.org/infomail/05/05/04a.php Accessed June 30, 2005.
[29]Nundy S, Gulhati CM. A new colonialism?‹conducting clinical trials in India. N Engl J Med 2005; 352: 16.
[30] Richards T. Conduct of drug trials in poor countries must improve. BMJ 2005; 330: 1466. Available at: http://bmj.bmjjournals.com/cgi/content/full/330/7506/1466-a Accessed June 30, 2005.
[31]Mulkern AC. When advocates become regulators: President Bush has installed more than 100 top officials who were once lobbyists, attorneys or spokespeople for the industries they oversee. The Denver Post, May 24, 2004. Available at: https://ahrp.org/infomail/04/05/24.php Accessed June 30, 2005.
[32]Willman D. Stealth merger: Drug companies and government medical research: some of the National Institutes of Health's top scientists are also collecting paychecks and stock options from biomedical firms. Increasingly, such deals are kept secret. Los Angeles Times, December 7, 2003. Available at: https://ahrp.org/infomail/03/12/07.php Accessed June 30, 2005.
[33]Eilperin J. EPA proposal would allow human tests of pesticides: draft rule omits some recommended safeguards. Washington Post, June 28, 2005, A13.
[34]Karlawish JHT. Research involving cognitively impaired adults. N Eng J Med 2003; 348:1389-1392.
[35]McCabe AR. A precarious balancing act‹the role of the FDA as protector of public health and industry wealth. Suffolk U Law Rev 2003; 36: 787-819.
[36] Who can file a Qui Tam action, June 28, 2005. Available at: http://www.quitam.com/quitam4.html Accessed June 30, 2005.
[37]Hammerschmidt DE, Franklin M. Secrecy in medical journals. Minnesota Medicine March 2005; Commentary: 34-35.
[38]Noble JH. Meta-analysis: methodology, strengths, weaknesses, and political uses. Unpublished manuscript. Washington, DC: Catholic University of America, April 8, 2005.
[39]House of Commons Health Committee. The influence of the pharmaceutical industry: fourth report of session 2004-2005, volume I. London: United Kingdom Parliament, 2005. Available at: http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf Accessed June 30, 2005.
[40]Pincock S. Wellcome insists on open access. The Scientist, May 19, 2005. Available at: http://www.the-scientist.com/news/20050519/01 Accessed June 30, 2005.
[41]Campbell D, Stanley, J. Experimental and quasi-experimental designs for research. Chicago: Rand McNally, 1963.
[42]Noble JH. Peer review: quality control of applied social research. Science 1974; 185: 916-921.
[43]Cochrane Collaboration: the reliable source of evidence in health care, June 29, 2005. Available at: http://www.cochrane.org/index0.htm Accessed June 30, 2005.
[44]Cooper H. The integrative research review. Beverley Hills: Sage Publications, 1997: 15.
[45]Schulman KA, Seils DM, Timbie JW, Sugarman J, Dame LA, Weinfurt KP, Mark DB, Califf RM. A national survey of provisions in clinical trial agreements between medical schools and s


Compilation of novels, essays of the last decades of 20th century. First book of collective works. On stays in Africa, life and death of my mother. The title in English: The great reconciliation. Biography with a touch of fiction.


text:
Weekend Violence Surges, No Word Yet on Asphalt Temperatures
Friday, MAY 14 AT APPROXIMATELY 11:40 HOURS:
At 11:39 AM on Friday May 14th, 2021, members of the District B-3 (Mattapan) and District C-11 (Dorchester) Drug Control Units executed a search warrant as part of an ongoing investigation in the area of 29 Southern Avenue in Dorchester.
As a result, officers were able to safely recover a loaded 9mm Taurus handgun, 9 plastic bags containing cocaine, an assorted variety of prescription pills, a large bag of marijuana, $4,094 in U.S. Currency, along with a scooter which was towed after officer's confirmed it had previously been reported stolen.
Two suspects have been identified and will be summonsed to appear in Dorchester District Court on numerous charges including Unlawful Possession of a Firearm, Possession with Intent to Distribute Class B Drugs and Possession of Class B and E Drugs.
Shortly before 18:00 hours Friday night, Boston Police Officers assigned to District B-2 responded to a 911 call for over 20 rounds shot with a possible victim in the area of Vine Street and Forest Street in Roxbury.
Officers arrived on scene and did not locate any victims, however they did locate multiple spent shell casings in the street and recovered a moped of one of the shooters. Security cameras in the area showed a black SUV fleeing the scene. District Detectives were called in to photograph and process ballistic evidence.
No further information is available at this time. Any community members wishing to assist can do so by anonymously by contacting the CrimeStoppers Tip Line at 1 (800) 494-TIPS or by texting the word 'TIP' to CRIME (27463).
At 8:38PM on Friday, May 14th, 2021, officers assigned to District D-4 (South End) responded to a radio call for a person stabbed in the area of West Newton Street and Shawmut Avenue, in Boston.
On arrival, officers located an adult male victim suffering from an apparent stab wound. Boston EMS transported the victim to a local hospital where he was pronounced deceased. The victim has since been identified as Gerie Acevedo, 24, of the South End.
The Boston Police Department is actively reviewing the facts and circumstances surrounding this incident and is asking anyone with information relative to this investigation to contact Boston Police Homicide Detectives at (617) 343-4470.
Shortly after the stabbing off Shawmut Ave, Officers assigned to District D-4 responded to a ShotSpotter activation in the area of Washington Street and E. Lenox Street, in the South End, for at least 17 rounds.
Officers arrived on scene and located multiple spent shell casings in the street, at least 14 of which were in the area of 91 Washington Street. Witnesses in the area reported two men exchanging gunfire in the street. The victim was found walking to a local area hospital after suffering non-life-threatening gunshot founds.
At this time the investigation is still ongoing and no arrests have been made as of yet. As always, community members wishing to assist are encouraged to do so by anonymously by contacting the CrimeStoppers Tip Line at 1 (800) 494-TIPS or by texting the word 'TIP' to CRIME (27463).
At 22:05 hours, Officers assigned to District C-11, responded to calls for shots fired in the area of 24 Norton Street in Dorchester.
Police Officers arrived to find a person shot. That person was transported with serious but non-life-threatening injuries to local area trauma center by Boston EMS. Ballistics were recovered and District Detectives were called in to process the evidence.
A mere 10 minutes later, again shots were fired, and Boston Police Officers assigned to C-11 responded to the area of East Street and Church Street in Dorchester.
While officers were on their way, a 911 caller reported a person shot at 12 East Street. Police arrived and confirmed the person shot, calling for EMS. Boston EMS quickly arrived on scene and began to render aid to the victim who had suffered a gunshot wound to the head. Luckily, the victim was still conscious and able to talk, and the injury was quickly deemed non-life-threatening.
Witnesses told Officers that two men ambushed the victim before shots broke out. Detectives were called to the scene to process evidence. The investigation is still ongoing, with no arrests being made at this time and no further information released.
Around 22:40 hours, Officers assigned to District D-4 responded to a ShotSpotter activation in the area of 895 Mass Ave for 9 rounds.
Saturday, MAY 15 AT APPROXIMATELY 00:30 HOURS:
At 00:30 hours, a 911 caller reported hearing 3+ gun shots in the area of 85 Allston Street. Officers from District D-4 responded. No further information is available.
Nearly an hour later, at approximately 01:15 hours, a 911 caller reported hearing 5+ gun shots in the area. Officers from District C-6 responded. No further information is available.
Shortly before 03:30 hours, Officers assigned to District A-7, responded to a 911 call for 4-5 shots fired in the area of 32 Sumner Street in East Boston. Officers responded and located spend shell casings, and called in District Detectives to process the scene as well as ballistic evidence. No further information is available.
The following evening, at approximately 17:45 hours, Officers from District C-11 responded to the area of 280 Park Street in Dorchester, for a ShotSpotter activation. No further information is available.
At roughly 18:20 hours, Officers assigned to District E-18, responded to a 911 call for over 10 shots fired in the area of 155 Garfield Ave in Hyde Park. No further information is available.
At 20:30 hours, Officers assigned to District A-7, responded to a 911 call for active shots fired in the area of Landing Street and Liverpool Street, in East Boston. Officers responded and reported active shoots being fired, with units already in the area being able to hear the gunfire. Ballistics were recovered in the area of Porter Street and London Street. A vehicle was also located with ballistic damage. District Detectives were called in and processed the scene and ballistic evidence. No victims were found and there is no suspect information at this time. No further information is available
Shortly before 21:45 hours, Boston Police Officers assigned to District C-11 responded to the area of 19 Oakly Street, in Dorchester, for a ShotsSpotter activation of 2 rounds. Officers arrived on scene and found no victims, but did locate spent shell casings. District Detectives were called in and processed the scene and ballistic evidence. Nothing further at this time.
Also around 21:45 hours, Boston Police Officers assigned to District B-2 responded to the area of 73 Magazine Street, in Roxbury, for a ShotsSpotter activation. A 911 call reported the shots coming from the area of 121 Shirley Street nearby. Nothing further at this time.
Sunday, MAY 16 AT APPROXIMATELY 01:25 HOURS:
Shortly before 01:30 hours, Boston Police Officers assigned to District C-11 responded to the area of 132 Brook Ave, in Dorchester, for a ShotsSpotter activation of 3 rounds. Officers arrived on scene and found no victims, but did locate spent shell casings. District Detectives were called in and processed the scene and ballistic evidence. Nothing further at this time.
Sunday, MAY 16 AT APPROXIMATELY 21:45 HOURS
At roughly 21:45 hours, Officers assigned to District C-11, responded to a 911 caller reporting 15 rounds fired in the area of 38 Pleasant Street in Dorchester. No further information is available.
Shortly before 00:00 hours, Officers assigned to District C-11, responded to a 911 call for shots fired in the area of 34 Hancock Street in Dorchester. Ballistic evidence was recovered and processed by District Detectives. No further information is available.
As always community members wishing to assist can do so by anonymously by contacting the CrimeStoppers Tip Line at 1 (800) 494-TIPS or by texting the word 'TIP' to CRIME (27463).


text:
755 F. 2d 495 - Wages v. Secretary of Health and Human Services
755 F2d 495 Wages v. Secretary of Health and Human Services
8 Soc.Sec.Rep.Ser. 356
Patricia WAGES, Plaintiff-Appellant,
SECRETARY OF HEALTH AND HUMAN SERVICES, Defendant-Appellee.
Sixth Circuit.
Argued Jan. 15, 1985.
Decided Feb. 21, 1985.
William B. Mains (argued), Northeast Kentucky Legal Services, Inc., Morehead, Ky., for plaintiff-appellant.
Louis De Falaise, U.S. Atty., Karl L. Anderson, Asst. U.S. Atty., Lexington, Ky., Paula L. Kocher (argued), Asst. Regional Atty., U.S. Dept. of H.H.S., Atlanta, Ga., for defendant-appellee.
Before LIVELY, Chief Judge, MARTIN and JONES, Circuit Judges.
This case presents the issue of whether a claimant of social security disability benefits who cannot sit or stand for prolonged periods of time, but must alternate between sitting and standing as required for comfort, is capable of performing "sedentary" work as defined by C.F.R. Sec. 404.1567(a) (1984). Answering this question in the negative, we reverse and remand this case for an award of benefits.
Claimant, Patricia Wages filed an application for supplemental security income disability benefits on July 3, 1978. After her application was denied, Wages requested a hearing. The ALJ found that Wages was not disabled, and the Appeals Council's decision became the final decision of the Secretary. Wages then filed a timely complaint for review with the district court. The district court, on May 7, 1984, entered judgment granting the Secretary's motion for summary judgment. On May 29, 1984, Wages filed this appeal.
Patricia Wages was 37 years of age at the time of her administrative hearing on June 6, 1979. Wages has an eighth grade education, and has had no vocational training. Wages has very little work experience. Her last job was as a babysitter in 1971.
Wages testified that her main medical problem is with her spine. She testified that it is stiff, and that she cannot stoop, bend, or lift anything without great difficulty. She testified that her back hurts when she sits for long periods, especially her lower back. She also suffers upper back pain if she tries to do anything while sitting or leaning forward. Wages testified that her eyesight is poor. She stated that she has difficulty judging distances, and that this affects her ability to drive and to do simple tasks such as pouring liquids into a cup.
Wages also testified that she has breathing problems. The record reflects that she occasionally gasped for breath at the hearing, and that she testified that she could not walk up one flight of stairs without being out of breath. She also stated that when she attempts to walk to town, a distance of one-quarter of a mile, she gets out of breath occasionally. To walk this distance she must go slow, and sit to rest on the way. Wages testified that her ribs bother her due to curvature of her spine, and that she has difficulty moving her head back and forth. In addition, she testified that her nerves bother her, that she gets easily upset, and that strangers bother her. Wages testified that she takes valium, dilantin, estrominithin, and other miscellaneous medications. Wages' daily activities are very limited. Her children do most of the house cleaning. She stated that about all she can do is some cooking and dish cleaning.
The most relevant evidence concerning Wages' musculoskeletal impairments is from Drs. Charles Riggsby and R. Thomas Fossett. Dr. Riggsby conducted an "all systems disability examination" on August 28, 1978 for the Kentucky Division of Disability Determinations. He noted the claimant had difficulty bending and turning her head from side to side, and estimated the limitations of motion in her back and neck at 30 to 40 percent. Dr. Riggsby's impression was kyphoscoliosis (lateral curvature of the spine and anteroposterior hump), moderately severe, and pectus excavatum (depressed sternum), moderately severe.
Dr. Fossett, who specializes in orthopedic surgery, conducted an orthopedic evaluation on November 10, 1978. His medical impression was Klippel-Feil Syndrome--a congenital anomaly characterized by a short and wide neck, low hairline, reduction in the number of cervical vertibrae, and fusion of the cervical spine. Dr. Fossett also diagnosed idiopathic thoracic scoliosis. He noted Wages has some limitations due to her congenital abnormalities, and that Wages needed to limit heavy lifting, stooping, and prolonged sitting or standing.
Dr. Robert J. Salisbury treated Wages between 1971 and 1976. In a letter dated April 27, 1979, he stated Wages' condition made it extremely difficult for her to do any type of lifting because her back was not stable enough to allow her to elevate over 15 pounds. He also stated that she should not do manual labor because of her physical condition.
The only evidence concerning Wages' eyesight is from Dr. Brian E. Wentz, an optometrist. He examined her for the Bureau of Rehabilitation on January 9, 1979, and noted a lack of binocularity. Dr. Wentz stated, "This results in a much poorer depth perception ... and may result in a lower performance when it comes to judging distances when driving."
The record reflects a history of psychological problems. As early as 1961, Wages was in Eastern State Hospital in Lexington, Kentucky. Dr. Ranjit Sinha, a psychiatrist, saw Wages in 1975 and 1976. He stated that there was a possibility of schizophrenia, and described Wages as, "basically a neurotic individual with phobic anxious and psychosomatic components. She certainly appears to have a schizoid personality ...".
Consultative psychiatric and psychological examinations were conducted on Wages on July 3, 1979. Dr. Donald I. George, a psychiatrist, diagnosed claimant to have, "psychoneurosis, anxiety reaction with some depressiveness and neurasthenic features." He further stated, "The combination of her physical and emotional problems does add up to a significant handicap." He suggested that with vocational training it may be possible for her to be rehabilitated to the point where she could perform productive work.
Dr. Harold W. Meek, a clinical psychologist, completed a residual functional capacity form regarding Wages' psychiatric impairment. He found it to be moderately severe as it affects her ability to relate to other people, and moderate regarding restriction of daily activities and constriction of interests.
The ALJ found that Wages' non-exertional impairments do not significantly affect the level of work that she can do. This amounts to a finding that these impairments are not severe. 20 C.F.R. Sec. 404.1521. He concluded that her exertional impairments are severe. The ALJ concluded that, despite the severity of her exertional impairments and her need to alternate between standing and sitting, Wages has the residual functional capacity for substantial gainful employment of a sedentary nature.
The district court adopted the magistrate's Report and Recommendation. The magistrate had found that the Secretary properly relied on the medical vocational guidelines despite the fact that Wages has some non-exertional limitations. The magistrate noted that these non-exertional limitations were not found to be severe.
Review of the Secretary's decision to deny disability benefits is limited to determining whether there is substantial evidence to support the Secretary's decision. "The findings of the Secretary as to any fact, if supported by substantial evidence, shall be conclusive...." 42 U.S.C. Sec. 405(g) (1976). Substantial evidence is " 'such relevant evidence as a reasonable mind might accept as adequate to support a conclusion'." Richardson v. Perales, 402 U.S. 389, 401, 91 S.Ct. 1420, 1427, 28 L.Ed.2d 842 (1971) (quoting Consolidated Edison Co. v. NLRB, 305 U.S. 197, 229, 59 S.Ct. 206, 217, 83 L.Ed. 126 (1938)). In determining whether the evidence is substantial we must " 'take into account whatever in the record fairly detracts from its weight.' " Beavers v. Secretary of H.E.W., 577 F.2d 383, 387 (6th Cir.1978) (quoting Universal Camera Corp. v. NLRB, 340 U.S. 474, 488, 71 S.Ct. 456, 464, 95 L.Ed. 456 (1951)).
The ALJ relied on the grid in this case to show that Wages is not disabled. Wages argues that reliance on the grid was improper in her case. She notes that in applying the grid, an ALJ must make specific findings of fact regarding a claimant's residual functional capacity, age, education, and work experience. See Kirk v. Secretary, 667 F.2d 524, 528 (6th Cir.1981), cert. denied, 461 U.S. 957, 103 S.Ct. 2428, 77 L.Ed.2d 1315 (1983). Each of these findings must be based on substantial evidence. Id. at 535.
We find that there was not substantial evidence to support a finding that Wages is capable of performing sedentary work. The record clearly shows that claimant cannot sit or stand for long intervals but must be able to move about as she finds necessary. Her testimony at the ALJ hearing was that she could not sit for very long periods of time without incurring considerable lower back pain. She further testified that her upper back gives her pain when she sits and attempts activity or sits forward. In addition, Dr. Fossett stated Wages should limit lifting, stooping, and prolonged sitting or standing. There is no evidence in the record that contradicts either Wages' testimony or Dr. Fossett's opinion. In fact, the record clearly indicates that Wages suffers from a severe deformity of her back diagnosed as scoliosis by Dr. Fossett. Dr. Sinha described her as having a "hunch-back appearance," and Dr. Riggsby, a consultative physician, stated "she has obvious severe kyphoscoliosis." Even the ALJ noted that her kyphosis was "very apparent." In spite of this evidence, the ALJ, in a conclusionary manner, found that Wages could perform sedentary work. This conclusion was not supported by substantial evidence.
20 C.F.R. Sec. 404.1567(a) (1984) defines sedentary work as follows:
Sedentary work involves lifting no more than 10 pounds at a time and occasionally lifting or carrying articles like docket files, ledgers, and small tools. Although a sedentary job is defined as one which involves sitting, a certain amount of walking and standing is often necessary in carrying out job duties. Jobs are sedentary if walking and standing are required occasionally and other sedentary criteria are met.
The concept of sedentary work contemplates substantial sitting as well as some standing and walking. Alternating between sitting and standing, however, may not be within the definition of sedentary work. Ferraris v. Heckler, 728 F.2d 582, 587 (2d Cir.1984). As the court in Ferraris noted, the Secretary recently suggested in Ruling SSR 83-10 that sedentary work will generally involve sitting for six hours out of an eight hour work day. Id. In SSR 83-12, the Secretary has stated:
In some disability claims, the medical facts lead to an assessment of [residual functional capacity] which is compatible with the performance of either sedentary or light work except that the person must alternate periods of sitting and standing. The individual may be able to sit for a time, but must then get up and stand or walk for a while before returning to sitting. Such an individual is not functionally capable of doing either the prolonged sitting contemplated in the definition of sedentary work (and for the relatively few light jobs which are performed primarily in a seated position) or the prolonged standing or walking contemplated for most light work. (Persons who can adjust to any need to vary sitting and standing by doing so at breaks, lunch periods, etc., would still be able to perform a defined range of work.)
There are some jobs in the national economy--typically professional and managerial ones--in which a person can sit or stand with a degree of choice. If an individual had such a job and is still capable of performing it, or is capable of transferring work skills to such jobs, he or she would not be found disabled. However, most jobs have ongoing work processes which demand that a worker be in a certain place or posture for at least a certain length of time to accomplish a certain task. Unskilled types of jobs are particularly structured so that a person cannot ordinarily sit or stand at will. In cases of unusual limitation of ability to sit or stand, a [vocational expert] should be consulted to clarify the implications for the occupational base.
(Emphasis added).
We recognize that these guidelines are not binding on the ALJ. We note, however, that several courts have held that a claimant cannot perform sedentary work if the claimant must alternate between sitting and standing. In Davis v. Schweiker, 536 F.Supp. 90, 100 (N.D.Cal.1982), it was found to be improper to hold that the claimant could do a full range of sedentary work since the evidence demonstrated the claimant could work only if it permitted him to alternate between sitting and standing as required by his comfort. Likewise, Martin v. Schweiker, 562 F.Supp. 912, 919 (D.Kan.1982), held, "there is no substantial evidence that plaintiff [who must periodically sit, stand, or lie down to relieve pain] can perform even sedentary work of any type, much less the entire range of sedentary work." Deutsch v. Harris, 511 F.Supp. 244, 249 (S.D.N.Y.1981), held that a claimant does not fall within the concept of sedentary work if he can only do work that must allow alternate sitting and standing as required for comfort.
Because the evidence showed that Wages must be allowed to alternate between sitting and standing for her comfort, we find that there was not substantial evidence to support the ALJ's conclusion that Wages could perform sedentary work. Consequently, reliance on the grid was error. Cavitt v. Schweiker, 704 F.2d 1193, 1195 (10th Cir.1983); Martin v. Schweiker, 562 F.Supp. 912, 919 (D.Kan.1982). We, therefore, REVERSE AND REMAND for an award of benefits.


text:
Q: Why is $U_e=-W$? Electric potential energy $U_e$ is defined as $k_e\frac{Q_1Q_2}{r}$. From that we get:
$$U_e=k_e\frac{Q_1Q_2}{r}=ErQ_2=F_er=W$$
Now, a lot of sources claim that $U_e=-W$. Why is work negative in this case?

A: You have the definitions backwards. The potential energy of a system of 2 charges is defined to be the negative of the work, $W$, done by the field of one charge ($Q_1$) acting on the other charge, $Q_2$, as it changes position (how it changes is irrelevant) from infinity to some finite separation distance, $r$,
\begin{align}U_e &=-W= -\int_{\infty}^r \vec{F}\cdot (\hat{r} \mathrm{d}r). \\
 &= -\int_{\infty}^r k_e \frac{Q_1 Q_2}{r^2}\hat{r}\cdot (\hat{r} \mathrm{d}r). \\
 &= - k_e\left(\left.-\frac{Q_1Q_2}{r}\right|_{\infty}^r\right)\\
 U_e &= k_e\frac{Q_1Q_2}{r}
\end{align}
So we see that the potential energy, defined by the work, gives the result  that you stated as a definition.
And the reason your formula train didn't work is because you missed some negative signs in dealing with vector quantities.

A: $U_e$ is the work done by force you exerted but $W$ is the work done by force of electric field. The relation of $U_e$ and $W$ is
$$U_e=-W$$

redpajama_set_name: RedPajamaStackExchange