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FDA opens portal to future science and tech trends
October 25, 2016 by Anthony Nguyen
The FDA is lending additional support behind "horizon scanning," a practice in which government and business entities collaborate to gather information broadly about emerging trends in science and technology. Horizon scanning helps these entities develop better capabilities to react to the quickly changing field. The FDA set up its own intra-agency horizon scanning group back in April 2015 – the Emerging Sciences Working Group – comprised of representatives from various FDA product and research centers.
Along those lines, the FDA is asking science and technology experts in the private sector to submit predictions on the next "new" items in their field of specialization. The agency stressed that it is not looking for advances already under discussion, but instead is seeking information about scientific and technological advances under the radar–so far under that a web search would have difficultly finding it. The FDA's ability to achieve its stated agency mission relies on awareness of, and proactive preparedness for, emerging issues and scientific advances, which will impact the development of regulated products well in advance of formal FDA regulatory submissions, which can be anywhere from five to 10 years prior to when the regulatory submissions arrive at the FDA.
The information should be submitted electronically to the FDA's Emerging Sciences Idea Portal. The portal is public, so confidential information should only be provided in writing. The FDA makes no promises on response, but did note that it would ask for more information if the submission sufficiently interested the agency. The FDA will use this information gathering to assist in the agency's science-based planning, programs, policies, reporting, and communication within and outside the FDA. The public docket will be available for comment submissions through October 2019.
Filed Under: Biotech, Devices, Drugs, Food & Drug Administration, HHS, Patents Tagged With: Emerging Sciences Working Group, emerging technology, FDA, horizon scanning, private industry, research, science, technology
Supreme Court lets patent invalidation stand, generic Cubicin® could be coming
June 6, 2016 by Sarah Baumann
The U.S. Supreme Court will not hear a brand-name antibiotic manufacturer's appeal of a decision invalidating its patents, meaning that a competitor can proceed with its plans to manufacture a generic version of the drug. A federal district court determined that four patents for the injectable drug Cubicin® were invalid for obviousness. Cubist Pharmaceutical, Inc., later acquired by Merck & Co., Inc., appealed the decision to the Federal Circuit, which sided with the district court in November 2015 (Cubist Pharmaceuticals, Inc. v. Hospira, Inc., Fed. Cir., November 12, 2015). Cubist sought certiorari, arguing that the Federal Circuit's rules on patents were too restrictive regarding obviousness. Hospira had opposed the petition because it would result in the High court conducting its own factual analysis on the validity of the patent. The High Court's denial of certiorari means that Hospira, Inc., acquired by Pfizer, Inc. in 2015, may pursue authorization to sell a generic version of the daptomycin product.
Cubicin (daptomycin for injection) is an injectable antibacterial product used to treat complicated skin and structure infections (cSSSI) and staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis. Hospira filed an abbreviated new drug application (ANDA) with the FDA in 2011 to sell a daptomycin product equivalent to Cubicin before the expiration of the Cubist patents. Cubist filed suit pursuant to the Hatch-Waxman Act (P.L. 98-417) alleging that Hospira had infringed on its five patents. Although the court found Hospira infringed on one patent, it determined that the remaining four patents were invalid because they were based, in part, on less frequent administration of a drug, and the benefit of less frequent administration would have been obvious to a person of skill in the art.
The fifth patent expires in June 2016. Upon its expiration, Hospira can move forward with plans to sell a generic daptomycin product.
Filed Under: Cases, Drugs, Food & Drug Administration, HHS, News, Patents, SCOTUS Tagged With: abbreviated new drug application, ANDA, Cubicin, Cubist Pharmaceuticals v Hospira, daptomycin, generic drugs, Hatch-Waxman
TPP: years in the making, years to go
February 16, 2016 by Anthony Nguyen
The Trans-Pacific Partnership (TPP) was signed by the trade ministers of 12 nations on February 4, 2016, in New Zealand, and thus, the world's largest trade deal is now waiting for ratification of the treaty's text in each nation. Here in the United States, President Obama has called upon Congress to vote on and pass the TPP before he leaves office in early 2017. In 2009, the U.S. began negotiating the TPP, seeking to boost U.S. economic growth with Canada, Mexico, and several Asian and Pacific countries considered key destinations for U.S. manufactured goods, agricultural products, and services suppliers. As a group, the TPP countries are the largest goods and services export market of the U.S., accounting for $698 billion in 2013, or 44 percent of total U.S. goods exports. U.S. exports of agricultural products to TPP countries totaled $58.8 billion in 2013, 85 percent of total U.S. agricultural exports. The TPP seeks to slash tariffs and trade barriers in this region, but pointedly does not include China.
At the core of the debate over the TPP, concerns have been raised about its application and impact on countries' regulations—in particular the TPP's key feature of regulatory coherence for the promotion of trade. For the pharmaceutical industry, issues concerning intellectual property (IP) protection in the TPP have focused primarily on patents, but there are concerns that the patent protection schema is not as effective for some classes of drugs such as biosimilars because these products do not require exact identity with the reference product. The Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) established a pathway for biologics that employs a 12-year exclusivity period, which is in stark contrast to the five years for generic small-molecule drugs.
A difficult question to answer is whether an inventor of a new drug measures the cost of invention against the revenue that might be made in the "poor" world in calculating whether to undertake the research and development of the drug. Supporters of the TPP argue that the greater cost and difficulties involved in research and development of biologics required a longer exclusivity period as incentive for innovation. Critics look at the TPP as an attempt to use trade law and treaties to extend the "rich" world IP protections to the "poor" world.
In addition, there is strong opposition from many congressional Democrats and some Republicans, which could mean a vote on the TPP is unlikely before President Obama leaves office. These concerns and a myriad of others will still require years of tough negotiations before the TPP becomes a reality.
Filed Under: Biotech, Drugs, Food & Drug Administration, HHS, Patents, Patient Protection & Affordable Care Act Tagged With: affordable care act, FDA, pharmaceutical industry, pharmaceuticals, PPACA
Generic drug prices skyrocket, lack of alternatives lead to costly choices
December 16, 2015 by Kayla Bryant
Typically, providers and patients search for a generic equivalent of a drug to reduce costs. Yet generic drug prices are, in some cases, becoming cost prohibitive. Recently, the University of Utah Health Care system told US News it has removed a generic drug from its crash cart because of the price. Calls for investigation into the problem have been surfacing for years, and perhaps the public relations nightmare a company recently underwent after announcing a huge price hike will get the ball rolling.
High costs, higher stakes
Limiting access to these high cost drugs can lead to life-or-death decisions. Erin Fox, director of University of Utah's drug information service, tracks drug shortages and found that isoproterenol hydrochloride (brand name Isuprel®) jumped to $2,700 a vial from its $50 price two years ago. Most of the network's patients are covered by managed care plans, which do not pay enough to cover the $1.6 million needed to provide the drug. She notes that the hospital has managed even though critically ill heart patients would benefit from the drug, and that doctors still use it if a patient's life is at stake.
Isuprel's huge price hike caught the eye of the Heart Rhythm Society (HRS), which published a special notice in April 2015 about the price increase. The HRS noted that the price increase was due to changes in ownership. When Hospira owned the drug, the dosage price was $44.50. Marathon Pharmaceuticals bought the drug and increased the price to $218.30 per dose. In February 2015, Valeant Pharmaceuticals International, Inc. (Valeant) purchased the drug and increased the dosage to $1,200. Apparently, the price more than doubled by the time Fox was interviewed by US News. The HRS notice called for action, seeking help gathering information about Valeant's price increase and advising members to collaborate with their local pharmacies in finding alternatives. It committed to working with the American Medical Association (AMA) to lobby for fair and accurate pricing.
Bad PR for drug companies
Although generic price hikes have been happening for some time, the media latched onto the story of Daraprim® several months ago. Turing Pharmaceuticals (Turing), a start-up company, acquired the rights to the drug, an antibiotic that treats a parasitic infection. The drug is many decades old, and cost $13.50 per tablet. Turing immediately jacked the price up to $750 a dose. This drug is vital for those who become infected with toxoplasmosis during pregnancy or for those with AIDS and certain cancers that suppress the body's immune response. Martin Shkreli, Turing's founder, said that the drug is rarely used and the company would use the money it collects to develop better toxoplasmosis treatments.
Despite Shkreli's claims, the backlash was loud and fast. Some doctors stated that a new therapy option was not vital, and the switch from drugstores to controlled distribution made it harder for other companies to get enough samples to make their own copies. Like with Isuprel, some hospitals began questioning if it made fiscal sense to stock the drug, and others began reviewing every case. Express Scripts, a pharmacy benefit company, announced its decision to partner with Imprimis Pharmaceuticals to offer a compounded oral form of the primary ingredient in Diaprim for $1 per capsule. After the media hoopla, Shkreli decided to reduce Diaprim to a more affordable price.
Patients and insurers can breathe a sigh of relief when a drug patent runs out and the exclusivity period is exhausted, allowing new, cheaper generic options to flood the market. Pharmaceutical companies have long been known to do whatever they can to extend the life of their brand-name drugs. So why the price hike for generics? Forbes looked into the matter in February 2015, finding staggering numbers of generic drug use: nearly 80 percent of all prescriptions. These drugs are about 80 to 85 percent cheaper than brand name counterparts. In 2012 and 2013, $33 billion and $47.5 billions of sales value, respectively, lost their patents. Generics have saved the health care system over a trillion dollars since 2003, but 222 drug groups at least doubled in price between 2013 and 2014.
Forbes identified several sources of the problem. When the generic drug market was saturated in 2009, manufacturers began consolidating to achieve larger portions of the market. Fewer manufacturers producing each drug leads to less competition and less of an incentive to reduce prices. Then when one of these few manufacturers run low, rules of supply and demand cause the prices to rise. Some retailers have gone so far as to drop certain generics from their drug discount programs.
Filed Under: Drugs, Health care spending, Patents


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Home > Faith Helps 'Ice Castles' Star Taylor Firth Overcome Setbacks
Published April 12th, 2010 by Peter Elliott
Faith Helps 'Ice Castles' Star Taylor Firth Overcome Setbacks
Taylor Firth is anything but a stranger to the pressure cooker of elite figure skating ranks. Being on screen is a different story and she is looking forward to see how the two blend together. Firth plays the lead role of Lexi Winston in the remake of "Ice Castles" one of the most well-known sports and romance movies of the 1970s. The 18-year-old Firth comes at the role from a Christian background as well, crediting God for the opportunities she has had on the ice and, now, in front of the camera. A native in of Grand Island, N.Y., Firth trains in nearby Jamestown and is working on climbing the ladder to the top rungs of the skating ladder. She placed 13th at the 2009 U.S Figure Skating Championships and qualified for the 2010 North Atlantic Regional Championships, held last year. Success at the event would have put her on the path to the U.S. Figure Skating Championships and a shot at the U.S. Olympic Team, but she had to pull out of the competition. She said in a telephone interview with Everyday Christian that recurring problems with asthma forced her to withdraw. She said her faith was a factor in helping her overcome the disappointment and hope for better things to come. "It was very tough but it showed me that my future is in God's hands," Firth said. "I've been blessed with so many opportunities." Firth was homeschooled for much of her early education growing up with sisters Shannon, Sierra and Chelsea, who is also a competitive skater. She graduated from high school during the filming of "Ice Castles," which came about in an unusual way. Director Donald Wrye directed the original "Ice Castles" in 1978 starring skater Lynn-Holly Johnson and teen heartthrob Robbie Benson. The film centers around Firth's character coming from a small town to reach skating stardom only to be blinded in a fall and later regain her skating skills and her confidence through the help of her coach and her boyfriend. Wrye contacted Firth's coaches as part of a search to find a skater to star in a contemporary adaptation of the film. Even without formal experience in front of the camera Firth jumped at the chance and spent time filming in Nova Scotia last spring, including during her high school graduation. "It was really a cool experience," Firth said. "(Wrye) gave me so many tips and helped keep me focused on what we needed to work on. It went really smoothly.' Firth said she found plenty of correlation between her experience of skating before large crowds and working in front of a camera. "It was really equal how I felt about acting and skating," Firth explained. "In figure skating there is a lot of performance involved in playing to the crowd and to the judges. The skating scenes were just as difficult as the acting scenes because I'm used to training three hours a day for five days a week. "During the film it was more like nine hours a week skating, so I really had to be focused on what I was working on as far as the consistency with my jumps and showing my skills." Firth attends The Chapel at CrossPoint in Getzville, N.Y., and said she doesn't shy away from expressing her faith in the competitive atmosphere she often finds herself in. "The Lord has been a source of strength for me," she said. "If being on this stage, whether it is acting or skating, is how I can use it as a platform for God then I'm comfortable with that. To me it's more than just wearing a sweatshirt that says, 'I'm a Christian.' I want people to know how He has given me a sense of peace that even though I can't see it, I can feel it." In addition to anxiously awaiting the release of the film on DVD on Tuesday, Firth is looking forward to watching the Winter Olympics which kick off in Vancouver on Friday with a trained skater's eye. "Of course I'm a little biased because I love our country and I think our team has a chance of doing very well," she said. "The judging system has changed (in recent years) and I still see some of the kinks being worked out of it. What I will look for and what I hope other people will see is the athleticism of the skaters. It's not just jumps and spins and looking good on the ice. The ability of the skaters to work through their routines so carefully is exhilarating to watch." Links: Ice Castles trailer: http://www.sonypictures.com/homevideo/icecastles/player/ The Chapel at CrossPoint: http://www.thechapel.com/index.html
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Geoff's show is great for writers - ★★★★★ review of eBook Revolution!
Excellent show on writing, and the writer's life in our current state of eBooks, social media, and blogging. Excellent conversations and helpful advice.


perhaps it was the night before last, when I saw it behind my eyelids swimming amongst my confusing dreams.
or perhaps it was dancing on my ceiling when my phones persistent hum woke me this morning.
or maybe I saw it painted on the road, etched into a metal sign, emblazoned by a plane into the afternoon sky, when I was driving from here to somewhere.
but i saw it so very clearly, like a new and wonderful color, like a siren interrupting your sleep, like jumping into the air and landing in a pool of icy water.


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Citizens and communities
Owner of wind farms
Wind energy: frequently asked questions
In a few years' time renewable energies will be the most important energy sources in Germany. Wind energy forms the backbone of the energy revolution.
In comparison to fossil fuels, as well as other renewable energy sources, wind energy is the most economically efficient way of generating electricity. Wind turbines already produce energy more cost-efficiently than new fossil fuel power stations. Moreover, in contrast to finite energy resources such as coal, oil and gas, wind energy is available on an unlimited basis. If we factor in the consequential costs of final disposal for nuclear, or the detrimental impact on the environment and health from fossil fuel sources, onshore wind energy can be shown to be the cheapest source of energy available today.
92 per cent of Germans endorse increased development of renewable energies, according to a representative survey conducted by TNS Emnid (2014). Despite this affirmation and its potential as an environmentally friendly alternative to energy sources that harm the environment, in many places in Germany the planning and installation of wind energy projects is accompanied by mistrust, fears and concerns.
Yet is there actually any truth in the perceived threat for people, animals and the environment? We have put the most important assertions about wind energy under the microscope to enable you to form your own opinion on the subject based on empirically proven figures and facts:
Myth 1: wind turbines endanger the environment
Wind turbines kill large numbers of birds and bats.
Incorrect: although building wind turbines, like any form of energy generation, is a form of interference in nature, numerous studies have repudiated the accusation of "bird strikes". Further research is needed into the impact of wind energy on bats. It is only on a very few wind farms that increased numbers of corpses have been found.
Besides this, climate protection also means protecting nature and its species. Climate change is shown to lead to significant changes in behaviour in birds. Wind energy is the driving force of the energy revolution, of the largest climate protection programme in history.
Up to five birds a year fall victim to a wind turbine. Around 150,000 birds on average die due to the circa 28,200 wind generators installed in Germany (2016 figures).
120 times more birds are put at risk by glass façades on buildings. 18,000,000 birds die each year in Germany after colliding with glass.
As part of the site selection and authorisation process checks are carried out to assess the possible impact of wind generators on the habitat of birds.
Conservation areas as well as breeding and resting zones for birds are generally not considered as possible sites. Where wind generators are located in birds' migratory corridors the turbines must be switched off as required (e.g. in gusty weather conditions) in order not to put the birds at risk.
During the wind turbine planning process the following therefore applies: negative consequences on affected populations can be minimised or even avoided altogether by carrying out extensive investigations, selecting a good site, taking suitable precautions and sustainable compensation measures.
Results from research carried out by ornithologists over many years also show that, besides this, only the behaviour of a few species is negatively affected by wind turbines.
Conversely: since 1990 the population of white-tailed eagles has grown in parallel with the construction of onshore wind energy, especially in Lower Saxony, Schleswig-Holstein and Brandenburg – that is, in the German Länder with the most wind turbines.
Kohle, O. (2016). Windenergie und Rotmilan/Mäusebussard. Ein Scheinproblem. Available in german at: www.hans-josef-fell.de/content/index.php/dokumente/studien-und-analysen/912-windenergie-und-rotmilan-maeusebussard-ein-scheinproblem/file
Hauff, P. (2009). Zur Geschichte des Seeadlers Haliaeetus albicilla in Deutschland, Linz/Austria 2009, S. 11; available in german at: issuu.com/hinschethomas/docs/geschichte_des_seeadlers_in_deutschland
National Environmental Research Institut (2005). Avian collision risk at an offshore wind farm, Biodiversity, Denmark.
Bundesverband WindEnergie (2005). Vogelschutz und Windenergie, BWE-Hintergrundpapier (5).
Swedish Energy Agency (2005). The Impact of Offshore Wind Farms on Bird Life in Southern Kalmar Sound - Sweden.
Michael-Otto-Institut im Naturschutzbund Deutschland (2004), Auswirkungen der regenerativen Energiegewinnung auf die biologische Vielfalt am Beispiel Vögel. Fakten, Wissenslücken, Anforderung an die Forschung, ornithologische Kriterien zum Ausbau von regenerativen Energiegewinnungsformen.
Bund für Umwelt und Naturschutz Deutschland (2004). Vögel und Fledermäuse im Konflikt mit der Windenergie Erkenntnisse zur Empfindlichkeit. Bremer Beiträge für Naturkunde und Naturschutz, Heft 7.
Arsu GmbH (2004). Langzeituntersuchung zum Konfliktthema "Windkraft und Vögel", 3. Zwischenbericht Oldenburg.
Büros für faunistische Fachfragen Linden, Matthias Korn u.a. (2003). Stellungnahme Regionalplan Oberpfalz-Nord – Ausschusskriterien für Windenergieanlagen im Vorkommensgebietgefährdeter Großvogelarten.
Technische Universität Berlin (2002). Windenergie und Vögel – Ausmaß und Bewältigung eines Konfliktes (Tagungsband).
Frank Bergen (2001). Untersuchungen zum Einfluss der Errichtung und des Betriebs von Windenergieanlagen auf Vögel im Binnenland (Diss.), Bochum.
Ihde, S. u.a. (1999),Vogelschutz und Windenergie – Konflikte, Lösungsmöglichkeiten und Visionen, Osnabrück. Available in german at: www.bund-rvso.de/windenergie-windraeder-voegel-fledermaeuse.html
Wind turbines harm wild animals and livestock.
Incorrect: there has been no evidence so far to suggest that animals in nearby paddocks, pasture or stables suffer from behavioural issues on account of the wind turbines being in operation. Wild animals, too, quickly become accustomed to the turbines rather than seeing them as a threat.
Further informationen
Research and surveys of German hunters show that neither small game such as foxes or rabbits nor deer are troubled by the wind turbines and that they do not eschew their habitat because of them. Studies have not yet been carried out into the effects on big game; however experience suggests that the effects here are similar.
The construction of wind turbines is, on the other hand, often bound up with a revaluation of the animals' habitat. A new source of food can, for example, be created by planting over the base of the foundations. The paths that are necessary for construction are also often refashioned afterwards, often using deciduous trees. This increases levels of biodiversity in monocultures.
Arnett, E. B. (Bat Conservation International Technical Editor and Project Coordinator) (2005). Relationships between Bats and Wind Turbines in Pennsylvania and West Virginia.
Sedding, A. (2004). Windenergieanlagen und Pferde. Gutachten, Bielefeld.
Hensen, F. (2004). Gedanken und Arbeitshypothesen zur Fledermausverträglichkeit von Windenergieanlagen.
Elsam Engineering A/S (2004). Horns Rev. Annual status report for the environmental monitoring programme (1.1.–31.12.2003), Fredericia.
Institut für Wildtierforschung an der Tierärztlichen Hochschule Hannover (2001), Projekt "Windkraftanlagen". Raumnutzung ausgewählter heimischer Niederwildarten im Bereich von Windkraftanlagen, Hannover.
Wind turbines destroy semi-natural forests.
Incorrect: wind energy projects are implemented in intensively managed commercial forests that represent a cultivated landscape that has already been shaped by people. Semi-natural and vulnerable areas are excluded from the choice of wind energy locations.
Areas cleared as part of the construction process are also subject to stipulated compensatory measures – e.g. reforestation or forest restructuring measures. For every square metre of cleared forest another is planted at other locations on a 1:1 basis.
Every fifth new turbine in Germany is installed in a forest setting. If we compare Germany's Länder we see that Baden-Württemberg and Rhineland-Palatinate have the most forest-based wind generators with a quarter of turbines are already situated in forest locations.
Even if building wind turbines always represents an intervention in nature, forests possess great potential for the development of wind energy. They offer both the necessary designation of new areas for the energy revolution as well as protection for inhabitants. The trees in a forest offer effective, natural privacy, screening the turbine from sight. Towers and rotors are hardly noticeable at close range thanks to being shaded from view by the trees.
The natural background noise of the forest usually blocks out that from the wind turbines. The 140 metre high tower ensures that the yield-diminishing turbulence of the treetops is virtually eliminated. The rotors are situated in an air layer that is characterised by high wind velocities – which makes energy generation in a forest extremely effective and economical.
The respective heights of the Black Forest and the Swabian Alb record the highest wind speeds in Baden-Württemberg. In order to be able to utilise this potential in harmony with nature UKA works together with both nature conservation authorities and the forestry office responsible when it comes to planning wind energy projects. Nature conservation reports ensure that any adverse effects on plants and animals are minimised as far as possible.
We continue to look after the forest after using it for wind energy, too: decommissioned turbines must be dismantled and may not be left to decay as ruins in the landscape. The entire wind turbine is removed; the foundations are dug out to a depth of 1.2 metres; holes are filled in with fill soil and topsoil is added on top.
If wished, paved access routes can also be removed. The turbine operator's declaration of commitment regarding this dismantling process is incorporated during the initial planning phase as a condition of admissibility required in order to attain an operating licence in the first place.
FA Wind (2016). Entwicklung der Windenergie im Wald - Ausbau, planerische Vorgaben und Empfehlungen für Windenergiestandorte auf Waldflächen in den Bundesländern. Available in german at: www.fachagentur-windenergie.de/fileadmin/files/Veroeffentlichungen/FA-Wind_Analyse_Wind_im_Wald_06-2016.pdf
Myth 2: wind energy is dangerous and makes you sick
Wind turbines are loud and disturb residents.
Incorrect: modern wind turbines have been developed to be noise-minimising: they have sonically optimised rotor blades, which allows them to emit less noise. Moreover, ambient noise such as road noise, the rustling of leaves on the trees or everyday sounds overlay the noise emitted by wind turbines.
The whirring noise caused by the rotor blades is already imperceptible from just a few 100 metres away. In addition, work is going on to minimise light emissions caused by the obstruction lighting for the turbine. Besides this, legal provisions governing the planning phase mandate that residents are protected from shadows being cast on their homes.
45 dB(A) amounts to the noise exposure of a modern wind turbine at a distance of 200 metres. That is 5 dB(A) less than, for example, the hum of a fridge.
By contrast, sitting in a car moving at 100 km/h a person is exposed to 100 dB(A).
When it comes to wind turbines there are two sources of noise: noise from the mechanical components such as gearboxes and generators, and the aerodynamic sound emitted by the movement of the rotors. The Technical Instructions on Protection Against Noise (Technische Anleitung zum Schutz gegen Lärm, TA-Lärm DIN ISO 9613-2) stipulates the extent to which these may be audible. The limit values lie between 35 dB(A) in residential areas and 45 dB(A) in mixed-use areas. A minimum distance from the nearest housing development must be maintained in accordance with this. To gain building approval, an independent report must be conducted to document that these values have been adhered to.
In Germany, wind turbines with a total height of 100 meters or more must be marked as an obstacle to aviation. However, residents are often bothered by the flashing red light of wind farms. In order to solve this frustration, future wind farms will be required by law to flash in the dark only when an aircraft is approaching. For residents, this means the following: Both existing and newly erected wind farms will be equipped with a so-called on-demand night-time identification (BNK) and will then only flash in specific cases.
Overshadowing
According to the guidelines set out by the Federal/State Working Group on Light Imission (Arbeitskreis Lichtimmissionen der Bund/Länder-Arbeitsgemeinschaft Immissionsschutz), the shadow cast by wind turbines may not overshadow a dwelling for more than 30 hours a year and 30 minutes a day. The construction or Federal Immission Control Act (Bundes-Immissionsschutzgesetz) authorisation stipulates that the turbine must be equipped with an automatic shut-off control in this case. The limit value is the result of a theoretical maximum possible shadow area. The duration calculation is based on ideal conditions: if the sun were to shine constantly, the rotor to turn non-stop and if it was always positioned cross-ways to the sun. In real conditions at a site with a hypothetical shadow duration of 30 hours per year we can assume an actual shadow duration of eight hours per year. An automatic shut-off control is used to ensure that the period of overshadowing is restricted to these eight hours per year.
Deutscher Naturschutzring DNR (2005). Umwelt- und Naturverträgliche Windenergienutzung in Deutschland (onshore) – Analyseteil, Lehrte.
Landesumweltamt Nordrhein-Westfalen (2002). Windenergieanlagen und Immissionsschutz (Materialien Nr. 63), Essen.
Gesetz zur Umsetzung der UVP-Änderungsrichtlinie, der IVU-Richtlinie und weiterer EG-Richtlinien zum Umweltschutz, BGBl. I, Nr. 40 vom 2.8.2001.
Sechste Allgemeine Verwaltungsvorschrift zum Bundes-Immissionsschutzgesetz (Technische Anleitung zum Schutz gegen Lärm – TA Lärm) vom 26. August 1998, GMBI 1998, S. 503-515
Fördergesellschaft Windenergie (1998). Technische Richtlinien zur Bestimmung der Leistungskurve, des Schallleistungspegels und der elektrischen Eigenschaften von Windenergieanlagen, Brunsbüttel.
The infrasound from the wind turbines causes illness.
Incorrect: Scientific studies show that infrasound only affects humans if it can be heard or felt. There are no known negative effects below this perceptibility threshold. However, the infrasound generated by wind turbines does not reach this perceptibility threshold even at close range and is therefore harmless. A long-term study by the VTT Technical Research Centre of Finland on the effects of infrasound from wind turbines, for example, concludes that there is no evidence of health risks to residents.
The perceptibility threshold defines noise levels above 20 Hz and 130 dB of sound pressure. The background noise produced by wind turbines is considerably less than this.
Infrasound is often present in our environment. Natural sources of infrasound include storms, marine surf or strong winds. Other man-made causes, in addition to wind turbines, include air-conditioning and ventilation systems, transport systems such as trains or ships and events in clubs or outdoors.
When it comes to wind turbines, measurements indicate that the infrasound in their environment is considerably lower than the audio or perceptibility threshold. This is the case even in close proximity to the turbines (200 metres away, see illustration on left). When measurements are taken in residential areas (800 metres away, see illustration on right), it is no longer possible to differentiate whether the turbine is operating or switched off.
Landesanstalt für Umwelt, Messungen und Naturschutz Baden-Württemberg (2014). Tieffrequente Geräusche inkl. Infraschall von Windkraftanlagen und anderen Quellen. Bericht über Ergebnisse des Messprojekts 2013-2015. Available in german at: http://www4.lubw.baden-wuerttemberg.de/servlet/is/257896/tieffrequente_geraeusche_inkl_infraschall.pdf?command=downloadContent&filename=tieffrequente_geraeusche_inkl_infraschall.pdf
Illustration: Bayerisches Landesamt für Umwelt (2016). Windenergieanlagen – beeinträchtigt Infraschall die Gesundheit. Available in german at: www.lfu.bayern.de/umweltwissen/doc/uw_117_windkraftanlagen_infraschall_gesundheit.pdf
You can find further research studies in german at: https://www.energieland.hessen.de/aktion/zukunftswerkstatt/faktencheck/Faktenpapier_Windenergie_und_Infraschall_Mai_2015.pdf
In severe, stormy weather wind turbines simply fall over.
Incorrect: as with any technical structure the risk of accident can never be categorically ruled out, however it is extremely small. Should malfunctions still occur these would only affect the immediate vicinity. Homes and residential areas are never at risk, thanks to the legal provisions on required distances.
The foundations of onshore wind turbines are modified to suit the conditions on the individual site. Spread foundations made from concrete and steel are most commonly used. When the subsoil is weak piled foundations are also used. The foundation secures the turbine against sinking or falling over.
Other potential hazards are largely eliminated in modern turbines: burning off caused by lightning strikes is nowadays virtually impossible thanks to lightning and surge protection. Furthermore, specialised ice sensors and rotor blade heaters can prevent ice being released from the blades in winter or in cold regions. Other fault scenarios can be identified early on by automatic, computer-controlled management systems.
Seifert, H. (2005). Eiszeit am Standort, DEWI Magazin, 2/2005
Seifert, H. (1996). Rotorblätter eiskalt erwischt, DEWI-Magazin, 2/1996
Gesamtverband der deutschen Versicherungswirtschaft (2003). Gesamtüberblick über den technologischen Entwicklungsstand und das technische Gefährdungspotenzial, 3/2003.
Myth 3: wind turbines disfigure the landscape
In Germany wind turbines are built at random.
Incorrect: even when still in the planning phase the wind energy project must overcome all manner of legal hurdles to obtain building approval. Right from the off, all the relevant authorities, local organisations and associations are informed of the plan and they can then influence the process. Since 1 July every wind turbine must receive individual authorisation.
It takes five years on average to move from project development to operation. It takes a little over four years for the turbine to receive authorisation.
With the help of the local urban land use plan and preparation of a land use planning process or development plan communities can create priority areas for wind energy and thus manage and control construction in a focused way. In this urban land use plan citizens can get involved and express their opinions in the early stages of public participation. In many parts of Germany the regional planning authorities take over the process, with the involvement of local communities, ensuring a regulated spatial distribution of the wind turbines.
Alongside existing legal provisions the planning authorities can also stipulate their own criteria for the construction of wind turbines, such as, for example, a greater distance from housing developments. Conservation areas and regions of special cultural and historical worth are excluded from the areas in which wind turbines can be installed and operated. Furthermore, investigations are also carried out into the local conditions – such as housing, animals and plants – as part of the authorisation process.
Planning is subject to the regulations of the Building Code (Baugesetzbuch) and the Federal Immission Control Act (Bundes-Immissionsschutzgesetz), the Federal Nature Conservation Act (Bundesnaturschutzgesetz) and the law regarding the impact on environmental sustainability.
Fachagentur Windenergie an Land (2015). Dauer und Kosten des Planungs- und Genehmigungsprozesses von Windenergieanlagen an Land. Available in german at: www.fachagentur-windenergie.de/fileadmin/files/Veroeffentlichungen/FA-Wind_Analyse_Dauer_und_Kosten_Windenergieprojektierung_01-2015.pdf
Änderung der 4. Bundesimissionsschutzverordnung zum 1.7.2005, BWE-Hintergrundpapier, 6/2005.
Baugesetzbuch (BauGB)
Bundesemmissionsschutzgesetz (BimSchG)
Bundesnaturschutzgesetz (BNatSchG)
Gesetz über die Umweltverträglichkeitsprüfung (UVPG)
Wind turbines put off tourists.
Incorrect: wind generators change the look of the landscape. Of course, this will not please everyone. So far, however, there is no significant evidence that wind turbines have a negative effect on tourism. Empirical surveys conducted by tourism research institutes have demonstrated this sufficiently.
99 per cent of those surveyed in the Analysis of the Influence of Renewable Energies on Tourism in Schleswig-Holstein (Einflussanalyse Erneuerbarer Energien und Tourismus in Schleswig-Holstein) (2014) indicated that the look of the landscape was not a reason for staying away from a holiday destination in future.
94 per cent of visitors feel generally unaffected by the wind turbines.
Studies have shown that, in fact, although some tourists dislike wind turbines in the landscape to a greater or lesser degree, for the most part this would not deter them from selecting a particular holiday destination. Even regions on the North Sea and Baltic Sea are continuing to see increasing visitor numbers, despite the wind turbines built there over the past few years.
Surveys have even shown that wind turbines give the adjacent municipalities a positive, 'green' image and can thereby promote new forms of tourism. This has resulted, for instance, in a special travel guide by Baedeker: "Deutschland. Erneuerbare Energien entdecken" (Germany. Discover renewable energy.) Wind turbines are consequently not just the carthorse of the energy revolution but also a popular attraction for holidaymakers.
NIT Institut für Tourismus- und Bäderforschung in Nordeuropa GmbH (2014). Einflussanalyse Erneuerbare Energien und Tourismus in Schleswig-Holstein.
Institut für Regionalmanagement (2012). Besucherbefragung zur Akzeptanz von Windkraftanlagen in der Eifel.
Offshore-Park Nysted ist eine Touristen-Attraktion, Ostsee-Zeitung, 11.09.2004.
Windkraft-Tourismus, neue energie, Heft 7/2004.
Ostseeinstitut für Marketing, Verkehr und Tourismus an der Universität Rostock (2003). Wirkungseffekte von Offshore-Windkraftanlagen in Mecklenburg-Vorpommern auf touristische Nachfrage- und Angebotsstrukturen.
Soko-Institut GmbH (2003). Windkraftanlagen und Tourismus. Bevölkerungsumfrage, Bielefeld.
Institut für Tourismus- und Bäderforschung in Nordeuropa GmbH N.I.T. (2000). Touristische Effekte von On- und Offshore-Windkraftanlagen in Schleswig-Holstein, Kiel.
Wind turbines reduce quality of life and lead to losses in the value of land and property.
To date there is no proof that wind turbines have a direct, negative long-term effect on property prices.
It is often claimed that property near the wind farm could suffer a permanent drop in value, even when legal immission values and minimum distances to residential areas are complied with. In actual fact, the value of properties is determined by a variety of different factors. The presence of wind turbines is only one factor in this mix.
Just how big an impact this factor has depends on the requirements of the potential buyers of the properties. Demand determines the price. Factors such as the proximity to conurbations or the infrastructure locally play an increasingly important role in times of urbanisation – especially in rural areas in which wind generators are also often present. Studies from East Frisia and Aachen have shown that there can be a positive impact on property prices in areas with a high density of wind generators. By creating jobs, influx or the possibility of involvement in a citizens' wind farm project this can create values in economically underdeveloped regions.
Local businesses, too, can get involved in the construction of the wind farm or in carrying out compensatory measures (e.g. reforestation, renaturation of water networks). In many cases citizens who live near wind farms are, moreover, granted access to opportunities for financial involvement.
Furthermore, the revenue that property owners gain from hiring and leasing land for wind turbines can offer young families the chance to take on a job with lower earning potential in their home town rather than moving to a bigger city. This enables them to actively counteract the cycle of migration and property price falls in rural areas.
Stadt Aachen (2011). Untersuchung: Hat der Windpark "Vetschauer Berg" Auswirkungen auf den Grundstücksmarkt von Wohnimmobilien in den Ortslagen Vetschau und Horbach. Available in german at: www.windenergie.at/MEDIA/Studie%20Immobilienpreise%20und%20Windenergie%20Aachen.pdf [10.02.2017].
Troff, Herbert (2013).Einflüsse von Windkraftanlagen auf den Wert von Immobilien und Grundstücken. Available in german at: www.energieagentur-goettingen.de/fileadmin/files/downloads/131022_Troff_Wertentwicklung_Immobilien_01.pdf
Myth 4: wind energy harms the economy and wastes resources
Wind energy puts jobs at risk.
Incorrect: wind energy is a driver of jobs: 371,400 people are currently employed in Germany in the renewable energy sector. The wind energy segment accounts for the largest proportion of 37 per cent, equating to 137,800 employees. 119,000 of these work in onshore wind energy. The number of people employed by the sector has more than doubled in the last 10 years.
Forecasts predict that, by 2030, there will be 500,000 people employed in the renewable energy sector in Germany.
The wind energy sector creates numerous jobs and strengthens the economy long-term, including in economically underdeveloped regions. Alongside manufacturers, service providers, planning offices, technical experts and surveyors, multiple engineering and plant construction suppliers are also involved, as well as those in the electronics and metal industries. UKA often relies on cooperation with locally based companies when constructing the wind farm and implementing compensatory measures (e.g. reforestation, renaturation of water networks).
The stable domestic market also provides the basis for successfully doing business in the international market, which promises high export figures for German wind industry products.
https://www.unendlich-viel-energie.de/themen/wirtschaft/arbeitsplaetze/zwiespaeltige-arbeitsplatzentwicklung-in-der-erneuerbaren-branche
Studie im Auftrag des Bundesministeriums für Wirtschaft und Energie (2015). Beschäftigung durch erneuerbare Energien in Deutschland: Ausbau und Betrieb, heute und morgen. Available in german at: www.bmwi.de/Redaktion/DE/Publikationen/Studien/beschaeftigung-durch-erneuerbare-energien-in-deutschland.pdf [06.02.2017].
Studie im Auftrag des Bundesministeriums für Umwelt, Naturschutz und Reaktorsicherheit (2011). Kurz- und langfristige Auswirkungen des Ausbaus der erneuerbaren Energien auf den deutschen Arbeitsmarkt. Available in german at: elib.dlr.de/69042/1/ee_arbeitsmarkt_final.pdf
Wind turbines demonstrate a negative eco-balance.
Incorrect: an onshore wind turbine generates enough energy within the space of three to twelve months to cover that required for its production, operation and disposal. With an average operational life of 20 years the resulting economic and ecological balance is an overwhelmingly positive one.
One wind turbine generates 40 to 70 times as much energy during its lifetime as is required to manufacture, operate and dispose of it.
A 3 MW wind turbine generates around 180 million kilowatt hours over the 20 years it is in operation. This can cover the energy requirements of approx. 2,600 three-person households a year. Three square metres of a wind turbine's rotor surface area can therefore cover the annual energy requirements of a family of four – in total the rotor surface area (e.g. of the Vesta V126 model turbines) measures 12,469 square metres.
BWE-Service GmbH (2005). Windenergie Marktübersicht, Osnabrück.
TÜV-Verlag (2000). Nutzung der Windenergie, Karlsruhe.
Institut für Energiewirtschaft und Rationelle Energieanwendung (2007). Lebenszyklusanalyse ausgewählter Stromerzeugungstechniken, Stuttgart.
Fachhochschule Würzburg (2004). Energetische Bewertung von Windkraftanlagen (Diplomarbeit), Würzburg.
Ruhr-Universität (2004). Ganzheitliche Energiebilanzen von Windkraftanlagen: Wie sauber sind die weißen Riesen?, Bochum.
Kaltschmitt, M. u.a. (2003). Erneuerbare Energien – Systemtechnik, Wirtschaftlichkeit, Umweltaspekte, 3. Auflage, Berlin.
Wind turbines cannot be disposed of practically.
Incorrect: modern wind generators can be almost entirely recycled. The feasible recycling quota is between 80 and 90 per cent.
Including its gearbox, tubular steel tower and foundation a wind turbine consists of:
60 per cent reinforced concrete
30 per cent steel
2 per cent glass fibre reinforced plastic
as well as small quantities of copper, aluminium, electronic components and fluids required for operation.
The rotor blades, which are constructed from glass fibre reinforced plastic, can be shredded or pulverised. The material can be admixed when manufacturing new rotor blades; used as a filling material in plastics; or the glass fibre components can be reused in cement mixes.
Where transport routes prove to be uneconomic it can alternatively be used as fuel in a combustion plant. The concrete from the foundation can be used as aggregate in road-building. Electronic waste is recycled in refineries and the metallic components melted down in foundries.
These components from the nacelle, the rotor hub and the generator are especially valuable and therefore economically feasible to recycle. If the turbines used are not recycled they occasionally have a second operational life in sites in other countries.
Mühlenabbau – für ein 2. Leben oder die Entsorgung?, Erneuerbare Energien, Heft 6/2004.
Perspektiven eines Recycling von Windkraftanlagen, DEWI Magazin, August 1995.
Myth 5: wind power is unreliable
Too often wind generators do not turn.
Incorrect: the operational duration of a wind turbine is between 7,000 to 8,000 hours a year – this equates to a utilisation capacity of 85 per cent. Some sites reach full capacity at up to 2,000 hours a year. A high yield is still achieved even with only partial performance.
Modern wind turbines work effectively at moderate rotational speeds. At a wind speed of 2.5 metres per second electricity is generated and fed into the local network. In severe storms with wind speeds of 25 to 34 metres per second the turbines are slowed to prevent damage to the wind generators, but also to avoid overloading the network. This is necessary on account of the lack of grid expansion in strong winds. (See Myth "Wind generators offer no guarantee regarding basic supply.")
Other causes for the rotors being at a standstill include maintenance work or repairs; protecting birds and bats during breeding or migration seasons; as well as protecting residents.
Wind generators offer no guarantee regarding basic supply.
Incorrect: precise calculations as to the temporal and local supply of wind power can be made on the basis of meteorological forecasts. This allows drops in performance and surpluses to be evened out across the power grid regionally, nationally and across Europe.
Furthermore, other renewable energy facilities, such as hydroelectric power stations, biogas plants and geothermal power plants, supplement the green energy mix.
In 2015 the circa 28,200 wind generators in Germany delivered 12.3 per cent of the electricity generated. Around 27,270 of these are onshore turbines.
In order to rely entirely on renewable energy in future the power grid needs to be expanded further. Network operators are committed to this objective in accordance with the German Renewable Energy Sources Act (Erneuerbare Energien Gesetz (EEG)).
Only then can individual fluctuations in the electricity feed from wind and solar energy be addressed and the electricity distributed nationally and internationally. This means that, even in strong winds, it is no longer necessary to switch off the wind generators due to the risk of overloading the networks.
More on the topic at: https://www.unendlich-viel-energie.de/strom-report.de/windenergie/
It is not economically viable to store wind energy.
Thanks to meteorological forecasts it is currently possible to store electricity generated by wind power as needed. By managing the energy production and demand the electricity grids can successfully be kept at a stable level despite fluctuations in availability. In addition, in practice many different storage methods have already been researched and tested.
Various solutions are currently in the process of being tested:
The pumped-storage power plant at Geesthacht, which will be used specifically as the mechanical storage facility for North German wind energy
A battery storage system in Schwerin that will secure the network frequency in West Mecklenburg
The power-to-heat method that will store wind energy as heat for use as heat supply
The power-to-gas method, which involves converting electricity into hydrogen and subsequently into methane – a substance that is almost identical to natural gas
More information on the different methods: www.wind-energie.de/sites/default/files/download/publication/z-fakten-zur-windenergie/bwe_abisz_3-2015_72dpi_final.pdf
Operating principle of a wind turbine
Functionality of Photovoltaic Power Stations
Compensatory measures
aktuell: Wind energy: frequently asked questions
The UKA (Umweltgerechte Kraftanlagen) Group implements wind and solar farms in Germany, Europe and the USA.
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