Day: 03/29/2013

Two Oral MS Drugs Recommended by European Regulators.

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European Union (EU) drug regulators yesterday announced that they are recommending approval of 2 new oral drugs — dimethyl fumarate (Tecfidera, Biogen Idec) and teriflunomide (Aubagio, Genzyme/Sanofi) — to treat adult patients with relapsing-remitting multiple sclerosis (MS).

The US Food and Drug Administration (FDA) just approved teriflunomide in September 2012. The agency now is considering whether to greenlight dimethyl fumarate, also called BG-12, as well. If that happens, it would be the third oral agent for this indication here, joining teriflunomide and fingolimod (Gilenya, Novartis).

Two clinical trials, CONFIRM (Comparator and an Oral Fumarate in Relapsing–Remitting Multiple Sclerosis) and DEFINE (Determination of the Efficacy and Safety of Oral Fumarate in Relapsing–Remitting MS), funded by Biogen and published last September in the New England Journal of Medicine, found that dimethyl fumarate reduced relapse rates, disease activity on imaging, and, in 1 trial, the progression of disability.

The European Medicines Agency (EMA) said in a press release that its Committee for Medicinal Products for Human Use (CHMP) deemed the “benefit-risk balance” to be favorable for the MS drug.

Flushing and gastrointestinal problems, such as diarrhea, nausea, and abdominal pain, are the drug’s most common adverse events.

The CHMP recommendation of teriflunomide follows positive findings from the clinical trial TOWER (Teriflunomide Oral in People with Relapsing-remitting Multiple Sclerosis). The final results of TOWER, released last fall, confirmed that, like dimethyl fumarate, the drug reduces the rate of relapse and disability progression in patients with MS. TOWER was 1 of 3 clinical trials that figured into the FDA’s approval of teriflunomide last year.

The most common adverse events with teriflunomide are upper respiratory and urinary tract infections, diarrhea, nausea, paraesthesia, alopecia, and an increase in alanine aminotransferase.

The CHMP recommendations on teriflunomide and dimethyl fumarate go to the European Commission, the executive branch of the EU, for approval.

Source: Medscape.com

Find Zebra

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FindZebra is a specialised search engine supporting medical professionals in diagnosing difficult patient cases. Rare diseases are especially difficult to diagnose and this online medical search engines comes in support of medical personnel looking for diagnostic hypotheses. With a simple and consistent interface across all devices, it can be easily used as an aid tool at the time and place where medical decisions are made. The retrieved information is collected from reputable sources across the internet storing public medical articles on rare and genetic diseases.

The name of FindZebra

The term “zebra” is a medical slang for a surprising diagnosis. Physicians are taught since medical school to concentrate on the more common diseases: “when you hear a gallop, you should think about a horse, not a zebra”.

“I look for zebras because other doctors have ruled out all the horses.” — Dr. Gregory House

Indexed medical sources

We index over 31,000 medical articles focused on rare and genetic diseases from reputable sources on the internet. The articles are collected from the following sources:

·         Orphanet: an online rare disease and orphan drug data base. Copyright, INSERM 1997. Available on http://www.orpha.net

·         Wikipedia: The free encyclopedia. Wikimedia Foundation, Inc., Category Rare Diseases. Available on en.wikipedia.org/wiki/Category:Rare_diseases

·         NORD Rare Disease Database and Organizational Database. The National Organization for Rare Disorders (NORD). Available on rarediseases.org/

·         The Genetic and Rare Diseases Information Center (GARD). Available on rarediseases.info.nih.gov/GARD

·         Swedish Information Centre for Rare Diseases. Swedish National Board of Health and Welfare. Available on http://www.socialstyrelsen.se/rarediseases

·         m-Power Rare Disease Database. Madisons Foundation. Available on http://www.madisonsfoundation.org/

·         Health On the Net Foundation. Available on http://www.hon.ch/HONselect/RareDiseases/

·         Rare Diseases. About.com Health. Available on rarediseases.about.com/

·         Genetics Home Reference: A service of the U.S. National Library of Medicine. Available on: ghr.nlm.nih.gov/BrowseConditions

·         Wikipedia: The free encyclopedia. Wikimedia Foundation, Inc., Category Syndromes. Available on en.wikipedia.org/wiki/Category:Syndromes

·         Online Mendelian Inheritance in Man, OMIM. McKusick-Nathans Institute of Genetic Medicine, Johns Hopkins University (Baltimore, MD) and National Center for Biotechnology Information, National Library of Medicine (Bethesda, MD). Available on http://www.ncbi.nlm.nih.gov/omim/

·         Wikipedia: The free encyclopedia. Wikimedia Foundation, Inc., Selected pages on rare diseases. Available on en.wikipedia.org/

Target end-users

FindZebra should only be used by medical professionals. Although the articles indexed by the system have been written by medical professionals or reviewed by medical associations, it is strongly recommended that, as a patient, you consult you local health care provider. FindZebra does not replace professional health care, and cannot be held responsible for erroneous use of the information provided through the system.

Logging of user information

We only log the query text, its results, and an IP address. We do not store any other information that can lead to the identification of the person running the query request. We reserve the right to use the logged information for statistical analysis in published articles and as input for further improvements of the system.

Citing the work

When referencing the search engine, you can also cite one of our publications:

·         Radu Dragusin, Paula Petcu, Christina Lioma, Birger Larsen, Henrik L Jørgensen, Ingemar Cox, Lars K Hansen, Peter Ingwersen, and Ole Winther, FindZebra: a Search Engine for Rare Diseases, in International Journal of Medical Informatics, IJMI (2013)

·         Radu Dragusin, Paula Petcu, Christina Lioma, and Ole Winther, Zebra: Searching for Rare Diseases A Case of Task-Based Search in the Medical Domain, in Proceedings of the ECIR 2012 Workshop on Task-Based and Aggregated Search (2012)

·         Radu Dragusin, Paula Petcu, Christina Lioma, Birger Larsen, Henrik Jørgensen, and Ole Winther, Rare Disease Diagnosis as an Information Retrieval Task, in Proceedings of 3rd International Conference on the Theory of Information Retrieval 2011, Lecture Notes in Computer Science, Springer (2011)

Check also our university project website for a brief overview of the theory behind the search engine.

Getting in contact

If you want to know more about this project, or have some bright ideas you would like to share, see the contact information.

Using FindZebra on my mobile devices

If you are using an iOS mobile device, open the mobile Safari browser and navigate to our homepage. The FindZebra icon can be added to the home screen on all iOS devices by using the share button from inside the Safari browser.

If you are using an Android-based mobile device, in the default Android web browser bookmark our site and then create a shortcut on the home screen by selecting the bookmark shortcut to FindZebra (“Add to home screen”->”Shortcuts”->”Bookmark”->”FindZebra”).

In the future, you might be able to download the FindZebra mobile app from your app store, so stay tuned for updates by following us on the social media channels.

Advanced search functionalities

Well, for most of your searches you might be satisfied with the default search setting. This means that the search is performed on ALL articles indexed by the system (about both rare and genetic diseases).

However, in some cases, you might want to exclude genetic diseases from your search and thus focus specifically on the rare diseases. You do this by selecting the “restrict to rare disease resources” option from the advanced search settings dialog box.

Another option would be to search on the index that includes UMLS metadata (“search with UMLS medical concepts”). The same articles as for the default setting are used for search, but these now also include UMLS concepts associated to the title of each article. A good usage scenario for this option is concept searching.

We also provide two experimental search options that use the UMLS metadata for clustering the results. The benefits of using these two are the streamlining of the search process and the possibility of a more diverse set of results.

Promoting FindZebra’s logo on your site

Please contact us before doing that, but in general that should not be a problem!

Current status of this project

Get in touch with us and follow our social media accounts if you want to find out more. We would love to hear your opinion and your ideas! We also have a lot of ideas ourselves and we try to gradually integrate them in the current system.

Source: http://findzebra.compute.dtu.dk

EU Committee Rejects Budesonide/Salmeterol Combo for Asthma.

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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a negative recommendation on the marketing application for anti-asthma combination medication budesonide/salmeterol (Labazenit, Laboratories SMB SA).

The marketing application for Labazenit was for the treatment of asthma in adults for whom a combination product containing an inhaled corticosteroid and long-acting beta-2 agonist is required. It was to be available as capsules containing powder for inhalation.

In making their decision, the CHMP considered the results of 2 studies that compared Labazenit with salmeterol alone in a total of 83 asthma patients, and 1 study comparing Labazenit with budesonide alone in 375 patients.

The CHMP also considered 2 larger supportive studies involving 601 patients comparing Labazenit with other corticosteroid-beta-2 agonist combination treatments.

“The CHMP’s main concern was that the study comparing Labazenit with budesonide alone did not prove that the anti-inflammatory effect of Labazenit was sufficient,” the committee said.

“In addition, data from other studies indicated that lower amounts of budesonide may reach the lungs when Labazenit is used. The CHMP therefore concluded that the benefits of the medicine had not been shown to outweigh its risks and recommended that it be refused marketing authorization,” the committee explained.

Source: Medscape.com

World faces decades of climate chaos, outgoing chief scientific adviser warns.

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The world faces decades of turbulent weather even if it takes drastic action to tackle climate change, the Government’s chief scientific adviser said today in a final stark warning as he prepares to step down.

Professor Sir John Beddington said that time lags in the climate system meant that accumulations of greenhouse gases in the atmosphere now will determine the weather we experience for the next 25 years.

Climate change is already manifesting itself in huge variations in the weather, clearly illustrated by the way Britain experienced both drought and extreme rainfall last year, he said.

The scientist said that the international community’s failure to agree binding targets for cutting carbon emissions meant problems were being stored up for the future.

“They may reach agreement, and they may start to reduce greenhouse gases in the next five years, or it may be a little longer,” he told BBC Radio 4’s Today programme.

“But they are still climbing, and when that increase is reversed, we will be left with the weather and the climate for the next 25 years from whenever that happens.”

He added: “The delays in the climate system mean that the greenhouse gases in the atmosphere now will determine climate and therefore weather for the next 25 years.”

Sir John said the world had huge problems of food, water and energy security as the global population increases, all of which will be exacerbated by climate change.

“In 12 years’ time there will be another billion people on the planet and we have big issues of food security, water security and energy security and many, many people will start to be living in cities,” he said.

“These are massive problems. Climate change is just going to make it worse.”

He admitted there were some “uncertainties” in the analysis of climate change but stressed that there was clear evidence that it is happening in the way that climate models suggest.

“For example the Arctic is heating up vastly faster than other parts of the world – this is exactly what the climate scientists are predicting,” he said.

Sir John’s remarks were made as Britain experienced freezing cold weather and snow, with thousands of homes across the UK without power and many roads still impassable.

Almost 8,000 homes and businesses were flooded in 2012, as the UK was battered by repeated heavy rain, storms and floods.

England and Wales experienced 10 separate flooding events between April and December last year after widespread drought gave way to the wettest summer in a century, with unusually high rainfall totals and river levels around the country.

Sir Mark Walport, currently director of the Wellcome Trust, takes over as the Government’s chief scientific adviser on April 1.

Responding to Sir John’s comments, Craig Bennett, policy and campaigns director for the environmental campaign group Friends of the Earth, said: “Climate change is one of the biggest threats the planet faces – and unless we urgently act to cut emissions we face an economic and environmental catastrophe.

“From droughts and floods to snow storms, Britain is increasingly battered by extreme weather.

“Ministers must listen to Professor Beddington and other leading scientists and slash UK emissions – starting with an amendment in the Energy Bill to decarbonise the power sector by 2030.”

Source: http://www.telegraph.co.uk