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Health at a Glance 2011: OECD Indicators

November 30th, 2011 by Bruce Abbott

 Cover of Health at a Glance

The OECD (Organisation for Economic Co-operation and Development) has just released its latest compilation of health statistics, showing comparisons among member countries and selected other countries.  The site also provides a chartbook of downloadable PowerPoint slides (http://www.oecd.org/dataoecd/24/8/49084488.pdf)

From the website :

(http://www.oecd.org/document/11/0,3746,en_2649_37407_16502667_1_1_1_37407,00.html)

This sixth edition of Health at a Glance provides the latest comparable data on different aspects of the performance of health systems in OECD countries. It provides striking evidence of large variations across countries in the costs, activities and results of health systems. For the first time, it also features a chapter on long-term care.
This edition presents data for all OECD member countries. Where possible, it also reports data for Brazil, China, India, Indonesia, the Russian Federation and South Africa, as major non-OECD economies.

This publication takes as it main basis OECD Health Data 2011, the most comprehensive set of statistics and indicators for comparing health systems across the 34 OECD member countries.

Table of contents
Chapter 1. Health Status

  • Life expectancy at birth
  • Premature mortality
  • Mortality from heart disease and stroke
  • Mortality from cancer
  • Mortality from transport accidents
  • Suicide
  • Infant mortality
  • Infant health: Low birth weight
  • Perceived health status
  • Diabetes prevalence and incidence
  • Cancer incidence
  • AIDS incidence and HIV prevalence

Chapter 2. Non-medical Determinants of Health

  • Tobacco consumption among adults
  • Alcohol consumption among adults
  • Overweight and obesity among adults
  • Overweight and obesity among children

Chapter 3. Health Workforce

  • Employment in the health and social sectors
  • Medical doctors
  • Medical graduates
  • Remuneration of doctors (general practitioners and specialists)
  • Gynaecologists and obstetricians, and midwives
  • Psychiatrists
  • Nurses
  • Nursing graduates
  • Remuneration of nurses

Chapter 4. Health Care Activities

  • Consultations with doctors
  • Medical technologies
  • Hospital beds
  • Hospital discharges
  • Average length of stay in hospitals
  • Cardiac procedures (coronary angioplasty)
  • Hip and knee replacement
  • Treatment of renal failure (dialysis and kidney transplants)
  • Caesarean sections
  • Cataract surgeries
  • Pharmaceutical consumption

Chapter 5. Quality of Care

  • Care for chronic conditions
    – Avoidable admissions: Respiratory diseases
    – Avoidable admissions: Uncontrolled diabetes
  • Care for acute exacerbation of chronic conditions
    – In-hospital mortality following acute myocardial infarction
    – In-hospital mortality following stroke
  • Patient safety
    – Obstetric trauma
    – Procedural or postoperative complications 
  • Care for mental disorders
    – Unplanned hospital re-admissions for mental disorders
  • Cancer care
    – Screening, survival and mortality for cervical cancer
    – Screening, survival and mortality for breast cancer
    – Survival and mortality for colorectal cancer
  • Care for communicable diseases
    – Childhood vaccination programmes
    – Influenza vaccination for older people

Chapter 6. Access to Care

  • Unmet health care needs
  • Coverage for health care
  • Burden of out-of-pocket health expenditure
  • Geographic distribution of doctors
  • Inequalities in doctor consultations
  • Inequalities in dentist consultations
  • Inequalities in cancer screening
  • Waiting times

Chapter 7. Health Expenditure and Financing

  • Health expenditure per capita
  • Health expenditure in relation to GDP
  • Health expenditure by function
  • Pharmaceutical expenditure
  • Financing of health care
  • Trade in health services (medical tourism)

Chapter 8. Long-term Care

  • Life expectancy and healthy life expectancy at age 65
  • Self-reported health and disability at age 65
  • Prevalence and economic burden of dementia
  • Recipients of long-term care
  • Informal carers
  • Long-term care workers
  • Long-term care beds in institutions and hospitals
  • Long-term care expenditure)

Robotics Meets Neurology, UC Davis Style, with Dr. Sanjay S. Joshi

November 23rd, 2011 by

To introduce the Robotics component for the Virtual Reality, Simulation and Robotics course, the Health Informatics class welcomed Dr. Sanjay S. Joshi, a UC Davis, Associate Professor, in the Department of Mechanical and Aerospace Engineering.  Dr. Joshi heads the Robotics, Autonomous Systems, and Controls Laboratory, an interdisciplinary laboratory consisting of researchers from Mechanical and Aerospace Engineering, Electrical Engineering, Computer Science, and Biomedical Engineering.

To access the full text articles via the links in this blog post, you will need to be either on campus or logged in via the wireless or the virtual private network (VPN) from off campus using your UC Davis login ID and Kerberos pass phrase or password.

Robotics research

"The Rat Pup Robots: the Robots that Act Like Rat 7-10 day old Rat Pups"

The Rat Pup Robots: the Robots that Act like Rats. Dr. Sanjay Joshi’s earlier research covered by UC Davis News and Information.

Chueh, M.; Au Yeung, Y.L.W.; Lei, K.-P.C.; Joshi, S.S. (2008). Following Controller for Autonomous Mobile Robots Using Behavioral Cues. Industrial Electronics, IEEE Transactions on , vol.55, no.8, pp.3124-3132, Aug. 2008. doi: 10.1109/TIE.2008.922605

Or through IEEE Xplore database if you are logged into the VPN from off campus with your UC Davis ID and Kerberos pass phrase or password.

After an introduction to the tiny robots, namely, the Rat Pup Robots, We were introduced to his team’s current research into Brain-Muscle-Computer Interface (BMCI) for severely paralyzed persons.  The team’s research includes a mobile phone Prototype where EMG activity on the surface of a single face muscle site is recorded with a standard electrode.  The researchers then import the analog electrical signal  into an Android based mobile phone and it is digitized via an internal A/D converter.

Dr. Joshi’s research interests include:  Autonomous Systems/Control, Neuro-engineering and  Biorobotics.

He has recently returned from a sabatical appointment at Columbia University, where he held the post of Visiting Associate Professor with the College of Physicians and Surgeons, Department of Neurology.  In the recent publications of Dr. Joshi and his research team, we see the intersection of Neurology, Mechanical and Aerospace, and Electronic Engineering, Computer Science, BioMedical Engineering and great promise for future BMCI research here at UC Davis.<

Current Research Introduced During the Seminar:

Joshi, S. S., Wexler, A. S., Perez-Maldonado, C., & Vernon, S. (2011, April 27 2011-May 1 2011). Brain-muscle-computer interface using a single surface electromyographic signal: Initial results. Paper presented at the Neural Engineering (NER), 2011 5th International IEEE/EMBS Conference on… doi: 10.1109/NER.2011.5910557

Lucas, S. M., Gilley, D. A., Joshi, S. S., Gardner, T. A., & Sundaram, C. P. (2011). Robotics training program: evaluation of the satisfaction and the factors that influence success of skills training in a resident robotics curriculum. J Endourol, 25(10), 1669-1674. doi: 10.1089/end.2010.0713

Perez-Maldonado, C., Wexler, A. S., & Joshi, S. S. (2010). Two-dimensional cursor-to-target control from single muscle site sEMG signals. IEEE Trans Neural Syst Rehabil Eng, 18(2), 203-209. doi: 10.1109/tnsre.2009.2039394

Vernon, S., & Joshi, S. S. (2011). Brain-Muscle-Computer Interface: Mobile-Phone Prototype Development and Testing. Information Technology in Biomedicine, IEEE Transactions on, 15(4), 531-538. doi: 10.1109/TITB.2011.2153208 URL: http://ieeexplore.ieee.org/stamp/stamp.jsp?tp=&arnumber=5765686&isnumber=5954041

For the more Complete Bibliography of Publications, see Dr. Joshi’s website.

View the Poster Presentation [PDF] of their recent work on a new brain-muscle-computer interface at the IEEE Neural Engineering Conference in Cancun, Mexico.

Recent Published Research on the Measuring of Electrical Activity in the Brains of Patients in Vegetative States:

Cruse D, Chennu S, Chatelle C, Bekinschtein TA, Fernández-Espejo D, Pickard, JD, Laureys S, Owen AM. (2011). Bedside detection of awareness in the vegetative state: a cohort study. Lancet. Nov 9. [Epub ahead of print] PubMed PMID: 22078855. DOI: 10.1016/S0140-6736(11)61224-5

Comment on Cruse, et.al. Article:

Overgaard M, Overgaard R. (2011). Measurements of consciousness in the vegetative state. Lancet. Nov 9. [Epub ahead of print] PubMed PMID: 22078856. DOI: 10.1016/S0140-6736(11)61591-2

Boly, Melanie, et al. (2011). Preserved Feedforward But Impaired Top-Down Processes in the Vegetative State. Science 332, 858 DOI: 10.1126/science.1202043

Available via the Science Magazine website: http://www.sciencemag.org/content/332/6031/858.full.pdf [PDF]

Feedback on the Boly article, along with supporting online material on methodology:

To learn more about the Health Informatics Program (Masters Degree and Certificate Program) .

MHI289h is taught by Alberto Odor, MD, as an elective course in the Masters of Health Informatics Program, at UC Davis Medical Center.

Large Dataset Inventory

November 23rd, 2011 by Bruce Abbott

UCSF, specifically CTSI’s CELDAC initiative, has created an inventory, or catalog, of publicly available datasets.
The link to the search form is:

http://accelerate.ucsf.edu/research/celdac

Among the criteria which can be searched:

By Domain:

Health Care (including utilization, costs, and quality) 
Health Status
Health Risk Behaviors
Children’s Health
Cancer
Population Characteristics
Infectious Disease
Global Health
Cardiovascular Health

By Population:

Configuring your EndNote Library to work with UC-eLinks & Google Scholar

November 22nd, 2011 by
Configure Google Scholar Preferences to work with UC-eLinks

Google Scholar works with University of California's UC-eLinks!

Options for your EndNote Library

Create a link to the article with DOI number = http://dx.doi.org/(input DOI number here)

This will create a link to the article: e.g.:

http://dx.doi.org/10.1186/1472-6920-9-53

The link will work for open access articles, or those to which you or your institution has authorization.

Configure UC-eLinks within Endnote

To use UC-eLinks from within EndNote, make the following modification. Open EndNote:

On the top menu, select Edit | Preferences | Find Full Text (tab)

In the OpenURL Path text box, type in this URL: http://ucelinks.cdlib.org:8888/sfx_local and click OK.

In the URLs & Links (tab) | OpenURL argument:

Replace WoS with the term EndNote as shown below. Then click Apply.

There can be no spaces in the OpenURL argument:

?sid=ISI:EndNote&aufirst=AUFIRST&aulast=AULAST&issn=ISSN&isbn=ISBN&atitle=ATITLE &title=TITLE&volume=VOLUME&issue=ISSUE&date=DATE&spage=SPAGE&epage=EPAGE

How to use the UC-eLinks feature from within your EndNote Library:

In your EndNote Library, highlight a citation. Then, on the top menu select:

References |  URL | OpenURL Link (shortcut= ctrl-G)

Configure Google Scholar Preferences to work with UC-eLinks & EndNote

To do so: Access Google Scholar at http://scholar.google.com/scholar_preferences

Or locate the Scholar Preferences by clicking on the wrench icon at the top right side of screen.

Scroll down to Library Links.

WorldCat (a global catalog of library collections) is selected by default.

  1. University of California Davis | select checkbox to activate it
  2. California Digital Library | select checkbox to activate it

Scroll down to Bibliography Manager.

  • Select the option: “Show links to import citations into” and select EndNote from the drop down menu.
  • Click on the Save Preferences button at the bottom right.

Health Data Tools and Statistics

November 17th, 2011 by Bruce Abbott

The Partners in Information Access for the Public Health Workforce (or “PHPartners”) alliance has recreated its webpage and pulled together a comprehensive collection of resources.

From the announcement:

The Health Data Tools and Statistics page on the PHPartners.org website, http://phpartners.org/health_stats.html, has been recently reorganized to make public health data and statistics easier to find and use.

New Public Health Data Tools and Statistics Categories:

* County and Local Health Data
* State Health Data
* Individual State Data
* National Health Data
* Global Health Data
* Statistical Reports
* Demographic Data
* Geographic Information Systems (GIS)
* Training and Education
* Health Information Technology and Standards
* Tools for Data Collection and Planning

Google Scholar Citations

November 17th, 2011 by Bruce Abbott

Google Scholar has just turned on a new feature (which previously had been in limited beta-testing) that allows authors to compute their citation metrics.
The link to the announcement is:
http://googlescholar.blogspot.com/2011/11/google-scholar-citations-open-to-all.html

An example of how an author can collect their articles in an author profile and track their metrics is:
http://scholar.google.com/citations?user=kStFxtkAAAAJ&hl=en

UC Davis licenses several resources which track authors’ research and include additional features:
SciVal: http://www.experts.scival.com/ucdavis/
Web of Knowledge: http://isiknowledge.com/wos

Health Informatics MHI289: Virtual Reality, Simulation and Robotics and Research across the Disciplines

November 16th, 2011 by

The MHI289h course, Virtual Reality, Simulation and Robotics, an elective in the Masters of Health Informatics Program, gives Alberto Odor, MD, a chance to transmit the use of computer graphics and virtual reality use both physically and virtually for clinical applications.  The virtual reality related courses (MHI289 and MHI214)  are offered on site and around campus through the Health Informatics Master’s Degree, and virtually through the UC Davis Extension  Certificate Program’s Online Learning Campus (with Peter Yellowlees, MD).  The courses draw full-time graduate students and working staff and students from across the medical, IT, informatics, computer science, engineering, library and nursing disciplines.

Although the MHI289 class  meets physically in the Education Building at the UC Davis Medical Center twice per week, the students have  been introduced  to virtual patients, including “METI man” the hospital’s Virtual Patient in the  Center for Virtual Care. They have also toured the virtual medical campus of Imperial College London in Second Life where UK medical student avatars interact with a room full of  scripted  virtual patients through the Second Life Viewer, streamed in realtime via the web.

Back at the UCDMC Center for Virtual Care, an assortment of patient simulators are used, including: adult human patient simulators, pediatric and emergency patient care simulators, and number of focused clinical skills simulators. The physical tours of the Center are led by UC Davis medical faculty and the virtual tours of  both Davis Island and the builds in the NHS funded virtual medical training environment are similarly led by UC Davis medical faculty with the help of avatars and the client viewers used to login to the virtual environments.

Exploring Virtual Environments and Research on the Davis Campus:

More local virtual environments, namely the KeckCAVES were the topic and tour for this week’s classes. The W. M. Keck Center for Active Visualization in the Earth Sciences (KeckCAVES) is a joint project between the UC Davis Department of Geology, IDAV, and the UC Davis Computational Science and Engineering Center (CSE). The MHI289h class will experience the state-of-the-art immersive visualization facility used by earth science researchers from Davis and afar. We had the great  honor of meeting and viewing the research of Dr. Oliver Kreylos, hero to all Kinect  hackers and followers, since his work went viral shortly after the release of Microsoft’s $150.00 Kinect Controller for XBox360 (“where you are the controller”).

Many of us became aware of the tele-immersion research of Dr. Oliver Kreylos, after first seeing his work on YouTube and the international Kinect forums.
This year Oliver Kreylos’ team and collaborators from UC Berkeley, received the “CENIC 2011 Innovations in Networking” award, in the category “High-Performance Research Applications,” for “Tele-Immersion for Physicians,” also known as the combination of 3D Video, Vrui’s collaboration infrastructure, and 3D Visualizer.

Using Kinect for 3D video - tele-immersion

Watch the video: "All Quiet on the Martian Front"

View the video on YouTube |  Uploaded: Dec 20, 2010  | 206,383 views

Here are a few monumental breaking news posts from  Dr. Oliver Kreylos’ home page last November , 2010:

11/16/2010: 11:03pm, “one million views. Insane.”

11/22/2010: Since it’s been prominently featured in my most recent Kinect video, I figured I’d finally publicly release the Nanotech Construction Kit. GPL v2, yadda yadda yadda, you know the drill.

11/22/2010: I was featured in an article about Kinect hacking in the New York Times, 3D glasses and all. Yay!

11/25/2010: Vrui 2.0 has finally been released, after a long delay.

12/02/2010: Kinect package 1.2 with support for multiple Kinect cameras released and avaliable for download on the Kinect Hacking page.

More on Dr. Oliver Kreylos’ Research and Development work, publications and Kinect Hacking.

Related articles:

Kurillo, G, Bajcsy, R, Nahrsted, K, et al. (2008). IEEE Virtual Reality 2008, 269-70.

Vasudevan, R, Kurillo, G, Lobaton, E, et al. (2011). High-Quality Visualization for Geographically Distributed 3-D Teleimmersive Applications. IEEE transactions on multimedia, 13(3), 573-84.

Projects Using Kinect & Second Life:

research articles using Kinect and Second Life

Hacking Microsoft's Kinect using the FAAST Toolkit - PDF

Leading the hacking of Kinect to use with Avatars in the proprietary virtual environment of  Second Life, is the Institute for Creative Technologies, University of Southern California. USC and OpenNI have released the FAAST  (Flexible Action and Articulated Skeleton Toolkit) and it is available for download.

So where is the peer reviewed literature on Virtual Worlds?

You’ll find peer reviewed articles from Medical/Health Nursing & Engineering, Computer Science, Education, Sociology and Psychology and Multidisciplinary Databases… and more.
Start with the following databases: PubMed (from the Library website), Cinahl, Academic Source Complete and IEEEXplore, Inspec, Web of Science. The UC Davis Harvest Catalog has a selection of electronic and print resources, some published by UC Faculty. A quick search in Harvest: Using the following query and selecting “Subject Words” from the drop-down menu, retrieves over 500 related items:  “shared virtual environments” OR “Second Life” OR “virtual reality”
Click on the link at the top of the Year column to sort your results by year.
Always go through the Library’s website (using the database direct links, database A-Z listing, or Online Journals link) to reach the Library licensed resources. If you are searching from off campus, be sure to login through the Library’s VPN so that you are authenticated as a UC Davis student, staff or faculty member.

“How do I find the actual article?”

When searching the library licensed databases, always use the UC–eLinks to reach the actual article (whether it’s print or online). If it’s not available, use the request from another campus option on the UC-eLinks page.If you already know which of the 795 databases you would like to use, just type in its name on the Databases A-Z page. For Health Informatics research, you really do need use a few of the Subject Guides that focus on the technology across the related disciplines. To locate a specific subject area and the library licensed resources, take a look at the Subject Guides. They have been created by the Library Subject Specialists and you’ll find their contact names and email easily accessible at the top of each subject guide.For UC Davis students , staff and faculty:

Logging in from Off Campus using the VPN

  • Login to the Virtual Private Network (VPN) using your username and Kerberos pass phrase or password.
  • If you are logged in using CITRIX from the UC Davis Medical Center (UCDMC), be sure to open up another browser and login to the VPN
  • On the VPN welcome screen, copy and paste the URLs for the journal articles into the browse field directly below the VPN taskbar (usually at the top right of your screen).
  • If you are new to the VPN, watch the YouTube video walking you through the UC Davis VPN login and UC-eLinks from off campus

You’ll know you are logged in when you reach the VPN Welcome screen [below] and see the VPN task bar (Home, Help & Logout icons) at the top of your browser window. Choose where you want to start… the Library Home page or the Databases A-Z list, etc. If you have a DOI (digital object identifyer for an article) or want to view an unrelated web page,and remain logged into the VPN, use the ‘Browse’ field below the VPN taskbar.

Use the browse field at top right below the VPN task bar
Note: the VPN Taskbar & Browse field indicated by red arrow

MHI289h: Library related session using Second Life for simulation and research with Bernadette Swanson, Nov. 2011:

Workshop on Virtual Environments: Second Life and OpenSimulator
View the PowerPoint on Slideshare.net

Wired.com goes Creative Commons

November 10th, 2011 by Mary Wood

Creative Commons news from one of Bernadette‘s obscure listservs:

Wired.com goes Creative Commons: 50 great images that are now yours
Evan Hansen, November 7, 2011

Raw File: exposing the wired world, one photo at a time

Wired.com photographers have the enviable job of shooting the coolest stuff and most intriguing people in the technology world.   Now we’re giving away many of those photos to you, the public, for free.

Beginning today, we’re releasing all Wired.com staff-produced photos under a Creative Commons CC Attribution-Noncommercial license (CC BY-NC) and making them available in high-res format on a newly launched public Flickr stream.

Photo: Jim Merithew/Wired.com

.

The Creative Commons turns 10 years old next year, and the simple idea of releasing content with “some rights reserved” has revolutionized online sharing and fueled a thriving remix culture. Like many other sites across the web, we’ve benefited from CC-licensed photos at Wired.com for years — thank you, sharers! It seems only fitting, and long overdue, to start sharing ourselves.

Placing our photos under CC BY-NC license means that designated images are free for all to republish, with minor restrictions.

To tell what’s fair game or not, look for the CC logo in the photo credit on Wired.com stories before using an image, or pull pictures from our Flickr stream, which we’ll be updating continually.”

Flickr’s Creative Commons:
Many Flickr users have chosen to offer their work under a Creative Commons license, and you can browse or search through content under each type of license.

To explore the digital image databases available via the UC Davis Libraries, see the Digital Images Subject Guide created by Subject Specialist Daniel Goldstein

Check required permissions and/or citation methods for proprietary or copyrighted images.

E-Science Day

November 8th, 2011 by Mary Wood

E-Science Day:   An Opportunity for Education & Networking

December 6, 2011
UC Davis Medical Center, Sacramento

Registration due November 10, 2011

The event will be held on Tuesday, December 6, 2011 from 9:30 AM until 4:00 PM at the Medical Education Building, UC Davis Medical Center, Sacramento.

It is hosted by the University of California Davis Health Sciences Libraries and funded by the National Network of Libraries of Medicine Pacific Southwest Region.

There is no cost to attend and the event is approved for 5.0 Continuing Education credits from the Medical Library Association.
Lunch is provided.

For remote participants, the event will also be available through web conferencing.

The event will be a blended format- available both in-person and via web conference- that will feature a keynote and panel presentation; a poster session, lightning rounds, and paper presentations; and afternoon break-out sessions. It is the aim of the event planners to educate regional librarians in what is e-science, why librarians should care about it, and how they can begin supporting it at their own libraries and institutions.

To register, please complete the registration form. Upon registration, you will receive an email confirming your registration. This email will also include a link to a Survey Monkey event pre-assessment survey. The survey and the post-survey will assist event planners in gauging how well the event objectives were met.

The deadline for all registrations is Tuesday, November 8.

For more information on the meeting and to register, please visit the E-Science Day website.

FDA: 35 innovative new drugs approved in fiscal year 2011: Press Release

November 4th, 2011 by Bruce Abbott

link to press release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm278383.htm

link to FDA Drug Approvals and Databases webpage: http://www.fda.gov/Drugs/InformationOnDrugs/default.htm

FDA NEWS RELEASE
For Immediate Release: Nov. 3, 2011
Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA: 35 innovative new drugs approved in fiscal year 2011
Report shows quick approvals of safe and effective medicines occur in the United States before other countries

Over the past 12 months, the U.S. Food and Drug Administration approved 35 new medicines. This is among the highest number of approvals in the past decade, surpassed only by 2009 (37). Many of the drugs are important advances for patients, including: two new treatments for hepatitis C; a drug for late-stage prostate cancer; the first new drug for Hodgkin’s lymphoma in 30 years; and the first new drug for lupus in 50 years.

In a report released today, FY 2011 Innovative Drug Approvals, the FDA provided details of how it used expedited approval authorities, flexibility in clinical trial requirements and resources collected under the Prescription Drug User Fee Act (PDUFA) to boost the number of innovative drug approvals to 35 for the fiscal year (FY) ending Sept. 30, 2011. The approvals come while drug safety standards have been maintained.
‬‪
The report shows faster approval times in the United States when compared to the FDA’s counterparts around the globe. Twenty-four of the 35 approvals occurred in the United States before any other country in the world and also before the European Union, continuing a trend of the United States leading the world in first approval of new medicines.

“Thirty-five major drug approvals in one year represents a very strong performance, both by industry and by the FDA, and we continue to use every resource possible to get new treatments to patients,” said Margaret Hamburg, M.D., Commissioner of Food and Drugs. “We are committed to working with industry to promote the science and innovation it takes to produce breakthrough treatments and to ensure that our nation is fully equipped to address the public health challenges of the 21st century.”

Among the new drugs approved in FY 2011, a number are notable for their advances in patient care and for the efficiency with which they were approved:

• Two of the drugs – one for melanoma and one for lung cancer – are breakthroughs in personalized medicine. Each was approved with a diagnostic test that helps identify patients for whom the drug is most likely to bring benefits;

• Seven of the new medicines provide major advances in cancer treatment;

• Almost half of the drugs were judged to be significant therapeutic advances over existing therapies for heart attack, stroke and kidney transplant rejection;

• Ten are for rare or “orphan” diseases, which frequently lack any therapy because of the small number of patients with the condition, such as a treatment for hereditary angioedema;

• Almost half (16) were approved under “priority review,” in which the FDA has a six month goal to complete its review for safety and effectiveness;

• Two-thirds of the new approvals were completed in a single review cycle, meaning sufficient evidence was provided by the manufacturer so that the FDA could move the application through the review process without requesting major new information;

• Three were approved using “accelerated approval,” a program under which the FDA approves safe and effective medically important new drugs quickly, and relies on subsequent post-market studies to confirm clinical benefit. For example, Corifact, the first treatment approved for a rare blood clotting disorder, was approved under this program; and

• Thirty-four of 35 were approved on or before the review time targets agreed to with industry under PDUFA, including three cancer drugs that FDA approved in less than six months.

The Prescription Drug User Fee Act was established by Congress in 1992 to ensure that the FDA had the necessary resources for the safe and timely review of new drugs and for increased drug safety efforts. The current legislative authority for PDUFA expires on Sept. 30, 2012.

“Before the PDUFA program, American patients waited for new drugs long after they were available elsewhere,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “As a result of the user fee program, new drugs are rapidly available to patients in the United States while maintaining our high standards for safety and efficacy.”

In October 2011, the FDA released a new plan, Driving Biomedical Innovation: Initiatives to Improve Products for Patients, to assist companies engaged in new product development, particularly smaller, entrepreneurial companies.

In a separate action, the agency also released a report this week on drug shortages, expanded its current actions to address the problem, and, at the direction of the President, will broaden early notification of drug shortages and work with the Department of Justice to prevent price gouging.

For information:

Report on FY 2011 Innovative Drug Approvals

Driving Biomedical Innovation: Initiatives to Improve Products for Patients