[Press release] NIH to partner with biopharmaceutical companies and nonprofits to diagnose/treat diseases
The Accelerating Medicines Partnership (AMP) is a bold new venture between the NIH, 10 biopharmaceutical companies and several non-profit organizations to transform the current model for developing new diagnostics and treatments by jointly identifying and validating promising biological targets of disease. The ultimate goal is to increase the number of new diagnostics and therapies for patients and reduce the time and cost of developing them.
[At the risk of breaking copyright, this came via Twitter]
AMP will begin with three to five year pilot projects in three disease areas:
- Alzheimer’s disease
- type 2 diabetes
- autoimmune disorders of rheumatoid arthritis and systemic lupus erythematosus (lupus)
For each pilot, scientists from NIH and industry have developed research plans aimed at characterizing effective molecular indicators of disease called biomarkers and distinguishing biological targets most likely to respond to new therapies.
Through this cross-sector partnership, which will be managed through the Foundation for the NIH (FNIH), NIH and industry partners are sharing expertise and resources — $230 million — in an integrated governance structure that enables the best informed contributions to science from all participants. A critical component of the partnership is that industry partners have agreed to make the AMP data and analyses publicly accessible to the broad biomedical community. These pilot projects will set the stage for broadening AMP to other diseases and conditions.
Government Industry Non-Profit Organizations FDANIH AbbVieBiogen Idec
Johnson & Johnson
Alzheimer’s AssociationAmerican Diabetes Association
Lupus Foundation of America
Foundation for the NIH
Geoffrey Beene Foundation
Rheumatology Research Foundation
Budget: 5 years [$230 Million (Rounded) Total Project Funding]
($Millions) Total Project Total NIH Total Industry Alzheimer’s Disease 129.5 67.6 61.9 Type 2 Diabetes 58.4 30.4 28 Rheumatoid Arthritis and Lupus 41.6 20.9 20.7 Total 229.5 118.9 110.6
[Magazine article] Long-Term Disease Database Proves the Value of Vaccines | Observations, Scientific American Blog Network
To find out when whooping cough started making a comeback in Ohio, or how often measles kills in America, we turn to historical records. But those records aren’t very useful when they’re squirreled away in a distant office basement. The same goes for when they are embedded in a report—you can only look at them in the same way you might admire a painting, but you cannot drop the data into a spreadsheet and hunt for statistical significance. If you are only looking at a couple years’ worth of information that formatting dilemma is not such a big deal. You can scour the data and manually punch it into your analysis. It only becomes a huge problem when you are looking at hundreds or thousands of data points.
Such is the problem that public health experts at University of Pittsburgh encountered when they were exploring old medical data and developing models that predict future outbreaks. “We found ourselves going back and pulling out historical datasets repeatedly. We kept doing it over and over and finally got to the point where we thought it would be not only a service to ourselves but everybody if all the data was made digital and open access,” says Donald Burke, the dean of Pittsburgh’s graduate school of public health.
Four years ago, buoyed by funds from the National Institutes of Health and the Gates Foundation, they started the process of digitalizing 125 years worth of medical records. The endeavor was dubbed Project Tycho, named for the Danish nobleman Tycho Brahe who made the voluminous astronomical observations that Kepler later tapped to develop the laws of planetary motion. (But no pressure, right?)
The online, open-access resource now features accounts of 47 diseases between 1888 and today. It includes data from the weekly Nationally Notifiable Disease Surveillance reports for the United States, standardized in such a way that the data can be immediately analyzed.
In the research world, that’s a big accomplishment. Making this data usable takes more than casually monitoring a scanner while sipping coffee. The data has to be made uniform, a tedious process of manual input with unenviable tasks like removing periods, dashes and other inconsistencies while identifying data gaps.
Pittsburgh researchers also gave their new data trove a test drive to illustrate what could be done with the data. They mined Tycho for information on eight common diseases detailed in the records—polio, measles, rubella, mumps, hepatitis A, diphtheria and pertussis. Looking at available records before and after vaccines were discovered for those diseases, they estimated that 103 million cases of those contagious diseases have been prevented since 1924, (assuming the reductions were all attributable to vaccination programs). Their findings are published in this week’sNew England Journal of Medicine. The data also points to what can happen when communities become too lax about vaccinations (among other factors). They quantified the resurgence in recent years of pertussis throughout the country, particularly in the Midwest to Northwest and in the Northeast and also ongoing cases of mumps. “Reported rates of vaccine refusal or delay are increasing,” the authors write. “Failure to vaccinate is believed to have contributed to the reemergence of pertussis, including the large 2012 epidemic.”
When vaccines work well, sometimes “people no longer fear the disease and they undervalue the vaccine and in some ways that is what is going on right now,” says Burke, pointing to the discredited vaccine-autism link which prompted some parents to turn away from childhood vaccines. With this newly available data collection, more can be done than simply looking at where the disease is happening—or not happening. Researchers can begin looking for drivers of disease and identifying patterns about the burden of disease by say, climate or socioeconomic-status.
Flip through some of the data yourself here after it becomes searchable to the public on November 28.
[One has to register to view data, for institution I just entered private citizen and my registration was accepted. The database interface is very user friendly!]
- Vaccines work. Period. (sciencebasedmedicine.org)
- Researchers develop massive database to help fight deadly diseases… (medicalxpress.com)
- A rebuke to the antivaccine movement: A hundred million cases of disease prevented and millions of lives saved by vaccines [Respectful Insolence] (scienceblogs.com)
- Childhood vaccines prevent disease but risks remain (triblive.com)
- FDA scientist discusses recent pertussis vaccine study (theglobaldispatch.com)
- Trove of Public Health Data Unlocked by Pitt Researchers to Help Fight Deadly Contagious Diseases (medindia.net)
- Anti-Vaxxers Take Note: Vaccines Have Prevented 100 Million Serious Childhood Diseases In U.S. Since 1888 (reason.com)
- Katie Couric promotes dangerous fear mongering with show on the HPV vaccine (richarddawkins.net)
The release and publication of Project Tycho™ data has been featured in an article of the New York Times online and print version of Thursday November 28th entitled “The Vaccination Effect: 100 Million Cases of Contagious Disease Prevented”. It emphasizes that the large amount of data digitized by the project provides an invaluable resource for science and policy and the importance of vaccination programs in the United States.
Through a collaboration with the Open Government Initiative, Project Tycho™ data have been listed on HealthData.gov as new open access resource for governmental data. In addition on the listing, HealthData.gov has agreed to host Project Tycho™ level 1 and level 2 data that can each be downloaded from this site as a one CSV file with a single click. Comments on this release have been made in the HealthData.gov blog.
After four years of data digitization and processing, the Project Tycho™ Web site provites open access to newly digitized and integrated data from the entire 125 years history of United States weekly nationally notifiable disease surveillance data since 1888. These data can now be used by scientists, decision makers, investors, and the general public for any purpose. The Project Tycho™ aim is to advance the availability and use of public health data for science and decision making in public health, leading to better programs and more efficient control of diseases. Read full press release.
Three levels of data have been made available: Level 1 data include data that have been standardized for specific analyses, Level 2 datainclude standardized data that can be used immediately for analysis, and Level 3 data are raw data that cannot be used for analysis without extensive data management. See the video tutoral.
November 28, 2013 |A Project Tycho™ study estimates that 100 million cases of contagious diseases have been prevented by vaccination programs in the United States since 1924
In a paper published in the New England Journal of Medicine entitled “Contagious diseases in the United States from 1888 to the present,” aProject Tycho™ study estimates that over 100 million cases have been prevented in the U.S. since 1924 by vaccination programs against polio, measles, mumps, rubella, hepatitis A, diphtheria, and pertussis (whooping cough). Vaccination programs against these diseases have been in place for decades but epidemics continue to occur. Despite the availability of a pertussis vaccine since the 1920s, the largest pertussis epidemic in the U.S. since 1959 occurred last year. This study was funded by the Bill & Melinda Gates Foundation and the National Institutes of Health and all data used for this study have been released through the online Project Tycho™ data system as level 1 data.
“Historical records are a precious yet undervalued resource. As Danish philosopher Soren Kierkegaard said, we live forward but understand backward,” explained Dr. Burke, senior author on the paper. “By ‘rescuing’ these historical disease data and combining them into a single, open-access, computable system, we can now better understand the devastating impact of epidemic diseases, and the remarkable value of vaccines in preventing illness and death.” See an interview with the authors and an animation on the analysis.
Just had to repost this. Last week at the Area Office on Aging (where I volunteer 6 hours or so a week), one of my clients was a 70 year old woman. She voiced much of what the woman below said, including feeling unwelcome. And this after 30+ years with the company! Maybe all workplaces should have time to read and discuss the article below…Multigenerational Teams Work best.
Thank you Marti Weston, thank you.
Last Thursday, on the Washington DC Metro, a woman sitting in front of me spoke to a seat mate about ageism, a term first coined by Dr. Robert Butler, the first director of the National Institute of Aging (NIA).
As I eavesdropped, the woman on the Metro spoke about comments from younger colleagues, the tendency of some to roll their eyes when she speaks, and remarks about her retirement, still about five years away if she waits until she is 65. “I feel so unwelcome,” she commented,” that sometimes I make jokes about my own retirement just to counteract what I hear.”
Yet as the conversation went on — my apologies for listening in — it was clear that this woman loved her job and was engaged in her work. Lots of people in their late 50s and 60’s can identify with this situation.
So I read with interest the November 10, 2013, Washington Post article, In an Era Plagued by Ageism, NIH Prizes Older Workers. Written by Post reporter Tara Bahrampour, the report details how the National Institutes of Health (NIH) has created a work environment that accepts — and even celebrates — its older and veteran staff members. The article also includes a link to the AARP 2013 list of best employers for people over age 50.
A Few Interesting Excerpts
- This year, NIH topped AARP’s list of best employers for workers over 50, based on criteria including career development opportunities, workplace accommodations, flexible scheduling, job sharing and other employee benefits.
- NIH offers perks with particular appeal for older employees, including flexible work schedules, generous telecommuting policies, opportunities to mentor younger workers and fitness programs geared for older bodies.
- The benefits were not part of a master plan but rather something that evolved, said Phil Lenowitz, deputy director of NIH’s office of human resources.
- A big draw for scientists such as Waldmann is the ability to view a project in terms of decades, rather than years.
Read the entire article to learn much more.
A Few More Links Where You Can Learn About Ageism
- Dr. Robert Butler, Founding Director of the National Institute on Aging - July 2010, AsOurParentsAge
- Multigenerational Teams Work Best - June 2011, AsOurParentsAge
As summed up by Marti -
Two broad reasons that a variety of age groups work together well and produce better results are:
- Every generation has its blind spots so the different ages and perspective help to avoid problems and compensate for them.
- Each generation can shine based on individuals’ experience.
- Ageism in Action – September 2013, Huffington Post,
- Readers Offer Tales of Silicon Valley Ageism – August 2013, SF Gate (San Francisco Chronicle)
- Ageism and Millennials – Part I and Part II - Dr. Bill Thomas’ Changing Aging blog
- Ageism in America – 2006, A PDF of a comprehensive report published by Dr. Robert Butler and the International Longevity Center (also founded by Dr. Butler).
- Raising Awareness about Ageism through Art ! (sharingconnection.wordpress.com)
- Ageism in the Workplace: A Growing Issue (mtannler.wordpress.com)
- Ageism: the Silent Killer (veteranstoday.com)
- Why the Tech Industry Needs to Deal With Its Ageism Problem (simplicity.laserfiche.com)
- Tapping into the Creative Potential of our Elders (3quarksdaily.com)
- Why Old Age Is Really Not For Sissies (agelessmarketing.typepad.com)
- Ageism: Its Effect On Seniors (awalker20099.wordpress.com)
Greetings from the National Library of Medicine and MedlinePlus.gov
Regards to all our listeners!
I’m Rob Logan, Ph.D. senior staff National Library of Medicine for Donald Lindberg, M.D, the Director of the U.S. National Library of Medicine.
Emergency room use and hospitalization rates for diabetes patients declined after a large California medical provider introduced an electronic health records system, finds a five year study recently published in the Journal of the American Medical Association.
The study of 170,000 Kaiser Permanente Northern California diabetes patients (from 2004-2009) found an average of 501 emergency department visits per 1000 patients declined to 490 after Kaiser’s clinics began to use an electronic health records system (EHR) for outpatient treatment.
The study found an average of 252 hospitalizations per 1000 diabetes patients declined to 238 per 1000 after Kaiser Permanente’s clinics used the health care provider’s EHR. The specific hospitalizations for ambulatory care-sensitive conditions also fell from a mean of 67 per 1000 to about 60 per 1000 diabetes patients after the use of an EHR for diabetes outpatient treatment.
The comparative, overall declines in emergency department visits and aforementioned hospitalizations among Kaiser Permanente’s diabetes patients were statistically significant, or did not occur by chance. There was no overall difference in the frequency of patient visits to a physician’s office after Kaiser’s clinics began to use the health system’s EHR.
The study’s nine authors estimate Kaiser’s cost savings from reduced emergency department and hospitalizations were about $158,478 per 1000 patients each year. Overall, they write (and we quote): ‘the estimated reductions in emergency department (ED) visits and hospitalizations that we identified for patients with diabetes may have potential to affect ED and hospitalization costs’ (end of quote).
The authors acknowledge future research needs to provide a more comprehensive assessment of the cost savings after the implementation of an EHR. They add the findings are limited to diabetes patients within one large health care provider (within one U.S. state) and may not be generalizable to other states and different medical systems. For example, the authors explain the reductions in emergency department use and reduced hospitalizations were not uniform among all of the 17 Kaiser Permanente clinics where the five year study was conducted.
On the other hand, the authors note the study is the most comprehensive to date about the impact of outpatient EHR use on adverse health outcomes. The authors explain they assessed diabetes patients in order to observe the impact of EHR use on an outpatient basis among adults with a chronic (or ongoing) medical condition over time.
The authors conclude (and we quote): ‘We extend the evidence of EHR-related improvements in care delivery by further describing statistically significant modest reductions in downstream adverse health outcomes measured by ED visits and hospitalizations’ (end of quote).
Meanwhile, MedlinePlus.gov’s personal health records health topic page provides information about the physician adoption of EHRs in the ‘statistics’ section. Information about the adoption of EHRs within residential care communities and office-based physicians also is provided within the same section.
A overview that explains how and why EHRs are implemented in medical centers is available in the ‘MedlinePlus Magazine’ section of MedlinePlus.gov’s personal health records health topic page.
A helpful explanation (from the National Institutes of Health) about how to protect the privacy and security of your health information is available in the ‘related issues’ section of MedlinePlus.gov’s personal health records health topic page.
MedlinePlus.gov’s personal health records health topic page also provides links to the latest pertinent journal research articles, which are available in the ‘journal articles’ section. Links to clinical trials that may be occurring in your area are available in the ‘clinical trials’ section. You can sign up to receive updates about personal health records (and EHRs) as they become available on MedlinePlus.gov.
To find MedlinePlus.gov’s personal health records health health topic page, type ‘personal health records’ in the search box on MedlinePlus.gov’s home page. Then, click on ‘personal health records (National Library of Medicine).’
Before I go, this reminder… MedlinePlus.gov is authoritative. It’s free. We do not accept advertising …and is written to help you.
To find MedlinePlus.gov, just type in ‘MedlinePlus.gov’ in any web browser, such as Firefox, Safari, Netscape, Chrome or Explorer. To find Mobile MedlinePlus.gov, just type ‘Mobile MedlinePlus’ in the same web browsers.
We encourage you to use MedlinePlus and please recommend it to your friends. MedlinePlus is available in English and Spanish. Some medical information is available in 43 other languages.
Your comments about this or any of our podcasts are always welcome. We welcome suggestions about future topics too!
Please email Dr. Lindberg anytime at: NLMDirector@nlm.nih.gov
That’s NLMDirector (one word) @nlm.nih.gov
A written transcript of recent podcasts is available by typing ‘Director’s comments’ in the search box on MedlinePlus.gov’s home page.
The National Library of Medicine is one of 27 institutes and centers within the National Institutes of Health. The National Institutes of Health is part of the U.S. Department of Health and Human Services.
A disclaimer — the information presented in this program should not replace the medical advice of your physician. You should not use this information to diagnose or treat any disease without first consulting with your physician or other health care provider.
It was nice to be with you. I look forward to meeting you here next week.
National Institute of Environmental Health Sciences (NIEHS) – A US Government Environmental Health Resource
In the spirit of back to school, here is a great source for homework help in environmental health studies.
The National Institute of Environmental Health Sciences (NIEHS), located in Research Triangle Park, North Carolina, is one of 27 research institutes and centers that comprise the National Institutes of Health (NIH) , U.S. Department of Health and Human Services (DHHS) . The mission of the NIEHS is to discover how the environment affects people in order to promote healthier lives.
The NIEHS traces its roots to 1966, when the U.S. Surgeon General announced the establishment of the Division of Environmental Health Sciences within the NIH. In 1969, the division was elevated to full NIH institute status. Since then, the NIEHS has evolved to its present status as a world leader in environmental health sciences, with an impressive record of important scientific accomplishments and a proud history of institutional achievements and growth.
Today the NIEHS is expanding and accelerating its contributions to scientific knowledge of human health and the environment, and to the health and well-being of people everywhere (229KB)
Some Web sites/pages of interest
- Brochures and fact sheets - for general information or background information for a presentation
Topics include substances (as formaldehyde) , manufactured products (as cell phones),medical conditions (as asthma) and general health (as children’s health).
- Environmental Health topics include conditions/diseases, environmental agents (as radon), exposure routes (as airways) and population research (as occupational health).
- Environmental Health Science Education website provides educators, students and scientists with easy access to reliable tools, resources and classroom materials.
- Kids’ Pages provide fun and engaging activities, songs, stories, jokes, and other resources designed to introduce children to the concept of how they interact with their environment and how the environment may affect their health.
- EHP Science Education
- Toxnet - Databases on toxicology, hazardous chemicals, environmental health, and toxic releases.
- LactMed -A peer-reviewed and fully referenced database of drugs to which breastfeeding mothers may be exposed. Among the data included are maternal and infant levels of drugs, possible effects on breastfed infants and on lactation, and alternate drugs to consider.
- Hazardous Substances Data Bank (HSDB) - Comprehensive, peer-reviewed toxicology data for about 5,000 chemicals.
- TOXMAP:® Environmental Health e-Maps -Geographic representation of estimated US releases of certain toxic chemicals reported annually to the US Environmental Protection Agency (EPA Toxics Release Inventory/TRI)
- Household Products -links over 12,000 consumer brands to health effects from Material Safety Data Sheets (MSDS) provided by manufacturers and allows scientists and consumers to research products based on chemical ingredients
- ToxTown -uses color, graphics, sounds and animation to add interest to learning about connections between chemicals, the environment, and the public’s health. Tox Town’s target audience is students above elementary-school level, educators, and the general public.
- Environmental Health Disparities & Environmental Justice Meeting (July 29-31,2013) -focused on identifying priorities for action to address environmental health disparities (EHD) and environmental justice (EJ). This meeting brought together researchers, community residents, healthcare professionals, and federal partners committed to addressing EHD and EJ, in particular the grantees funded by NIEHS, EPA, NIMHD, CDC, OMH, and IHS. For the purposes of this meeting, EHD is defined as the unique contribution of the environment to health disparities.
Includes links to meeting materials and additional resources
- 3-D images show flame retardants can mimic estrogens in NIH study (eurekalert.org)
- Alternative Testing Strategies Needed to Cope With New Wave of Emerging Nanomaterials (azonano.com)
- Study: No link between mercury exposure and autism-like behaviors (eurekalert.org)
- Nanotechnology safety: New tests for determining health and environmental effects (nanowerk.com)
From the 22 July 2013 EurekAlert article
[Please note that I added emphasis to some sentences!]
Study published in Mayo Clinic Proceedings documents reversal of established medical practices in last decade
Rochester, MN — While there is an expectation that newer medical practices improve the standard of care, the history of medicine reveals many instances in which this has not been the case. Reversal of established medical practice occurs when new studies contradict current practice. Reporters may remember hormone replacement therapy as an example of medical reversal. A new analysis published in Mayo Clinic Proceedings documents 146 contemporary medical practices that have subsequently been reversed.
A team of researchers led by Vinay Prasad, MD, Medical Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, reviewed ten years of original articles published in the New England Journal of Medicine testing standard of care.
“The purpose of our investigation was to outline broad trends in medical practice and identify a large number of practices that don’t work,” says Dr. Prasad. “Identifying medical practices that don’t work is necessary because the continued use of such practices wastes resources, jeopardizes patient health, and undermines trust in medicine.”
Dr. Prasad and his investigative team evaluated 1,344 original articles published in the New England Journal of Medicine between 2001 and 2010 that examined a new medical practice or tested an established one. This included assessment of a screening, stratifying, or diagnostic test, a medication, a procedure or surgery, or any change in health care provision systems.
Dr. Prasad and colleagues made several interesting findings. First, only a minority of studies over the last 10 years even tested current medical practices. Dr. Prasad found that only 27% (363/1344) of articles that tested a practice tested an established one. Instead, the vast majority of such studies, 73% (981/1344), tested a new medical practice. Dr. Prasad says, “While the next breakthrough is surely worth pursuing, knowing whether what we are currently doing is right or wrong is equally crucial for sound patient care.”
Dr. Prasad’s major conclusion concerns the 363 articles that test current medical practice — things doctors are doing today. His group determined that 146 (40.2%) found these practices to be ineffective, or medical reversals. Another 138 (38%) reaffirmed the value of current practice, and 79 (21.8%) were inconclusive — unable to render a firm verdict regarding the practice.
Dr. Prasad comments, “A large proportion of current medical practice, 40%, was found to offer no benefits in our survey of 10 years of the New England Journal of Medicine. These 146 practices are medical reversals. They weren’t just practices that once worked, and have now been improved upon; rather, they never worked. They were instituted in error, never helped patients, and have eroded trust in medicine.”
Dr. Prasad adds, “Health care costs now threaten the entire economy. Our investigation suggests that much of what we are doing today simply doesn’t help patients. Eliminating medical reversal may help address the most pressing problem in health care today.”
Key examples of medical reversal include the following:
Stenting for stable coronary artery disease was a multibillion dollar a year industry when it was found to be no better than medical management for most patients with stable coronary artery disease. Hormone therapy for postmenopausal women intended to improve cardiovascular outcomes was found to be worse than no intervention. The routine use of the pulmonary artery catheter in patients in shock was found to be inferior to less invasive management strategies.
Other instances pertain to the use of the drug aprotinin in cardiac surgery, use of a primary rhythm control strategy for patients with atrial fibrillation, use of cyclooxygenase 2 inhibitors, early myringotomy procedures, and application of recommended glycemic targets for patients with diabetes.
Says Dr. Prasad, “To our knowledge, this is the largest and most comprehensive study of medical reversal. The reversals we have identified by no means represent the final word for any of these practices. But, the reversals we have identified, at the very least, call these practices into question.”
In an accompanying editorial, John P. A. Ioannidis, MD, DSc, of the Stanford Prevention Research Center, Department of Medicine and the Department of Health Research and Policy at Stanford University School of Medicine, comments on the work of Prasad and his team and evaluates it within a broader context.
“The 146 medical reversals that they have assembled are, in a sense, examples of success stories that can inspire the astute clinician and clinical investigator to challenge the status quo and realize that doing less is more,” notes Dr. Ioannidis. “If we learn from them, these seemingly disappointing results may be extremely helpful in curtailing harms to patients and cost to the health care system.”
According to Dr. Ioannidis, it is just as important to promote and disseminate knowledge about ineffective practices that should be reversed and abandoned. Given the widespread attention that practice guidelines typically receive, particularly when published by authoritative individuals or groups, he questions whether a generally higher level of evidence should be required before these guidelines are recommended and can impact clinical practice.
“Finally, are there incentives and anything else we can do to promote testing of seemingly established practices and identification of more practices that need to be abandoned? Obviously, such an undertaking will require commitment to a rigorous clinical research agenda in a time of restricted budgets,” concludes Dr. Ioannidis. “However, it is clear that carefully designed trials on expensive practices may have a very favorable value of information, and they would be excellent investments toward curtailing the irrational cost of ineffective health care.”
Why You Should Care About the Drugs Your Doctor Prescribes (healthcare blog)
We have now taken the data and put it into an online database that allows anyone to look up a doctor’s prescribing patterns and see how they compare with those of other doctors.
This information is just a start. It can’t tell you if your doctor is doing something wrong, but it can give information that allows you to ask important questions.
- Potential neurological treatments often advance to clinical trials on shaky evidence, study says (eurekalert.org)
- Potential Neurological Treatments are Often biased in their interpretation (medindia.net)
- Is your doctor receiving Big Pharma payoffs? Here’s how to find out (talesfromthelou.wordpress.com)
A free source of evidence-based information for health care professionals and for researchers studying liver injury associated with prescription and over-the-counter drugs, herbals, and dietary supplements is now available from the National Institutes of Health. Researchers and health care professionals can use the LiverTox database to identify basic and clinical research questions to be answered and to chart optimal ways to diagnose and control drug-induced liver injury.
Drug-induced liver injury is the leading cause of acute liver failure in the United States, accounting for at least half of cases. It occurs at all ages, in men and women, and in all races and ethnic groups. Drug-induced liver disease is more likely to occur among older adults because they tend to take more medications than younger people. Some drugs directly damage the liver, while others cause damage indirectly or by an allergic reaction. The most important element to managing drug-induced liver injury is to identify the drug that’s causing the problem and appropriate steps to eliminate or reduce damage to the liver.
“Because drug-induced liver disease is not a single, common disease, it is very difficult to diagnose, with each drug causing a somewhat different pattern of liver damage,” said Jay H. Hoofnagle, M.D., the major creator of LiverTox and director of the Liver Disease Research Branch at NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). “Doctors have to rule out all other causes of liver disease before saying that a patient has drug-induced injury liver.”
LiverTox has a searchable database of about 700 medications available in the United States by prescription or over the counter. Over the next few years, another 300 drugs will be added. The database offers these features:
- An overview of drug-induced liver injury, including diagnostic criteria, the role of liver biopsy, descriptions of different clinical patterns and standard definitions.
- A detailed report of each drug, including background, case study, product package insert, chemical makeup and structure, dose recommendations and references with links.
- An interactive section, allowing users to report cases of drug-induced liver injury to the LiverTox website. Reports will be automatically forwarded to the Food and Drug Administration’s (FDA) MedWatch program. MedWatch allows the public and health care professionals to report adverse events, product defects, or product use errors. The FDA uses the information to monitor product safety.
“LiverTox is the result of a significant scientific collaboration between the national and international clinical and research communities, the NIDDK and the National Library of Medicine (NLM),” said Steven Phillips, M.D., co-sponsor of LiverTox and director of NLM’s Division of Specialized Information Services. “LiverTox demonstrates the importance of using informatics to provide easy access to evidenced-based information to clinicians and researchers that will improve the health and well-being of all and help prevent unnecessary morbidity and mortality, worldwide. I hope the dynamic LiverTox model can be used to create a new suite of databases that can identify drug-induced injury to other organs such as the heart, kidney, and lung. The National Library of Medicine is honored to be part of this significant scientific endeavor.”
- NIH launches LiverTox a free database of drugs linked to liver injury (hslnews.wordpress.com)
- NIH launches free database of drugs associated with liver injury (medicalxpress.com)
- Drug Induced Liver Dysfunction Lab Values (jessicamhpower.wordpress.com)
Many NIH-funded clinical trials go unpublished over two years after completion (with ClinicalTrials.gov link for many trial study results)
[Flahiff's note: It is possible that many of these unpublished clinical trial results would have made a positive difference in many people's lives. These unpublished results have the potential of aiding many researchers. They can prevent unnecessary duplicate trials, point to areas needing more research, and potentially provide groundwork for collaboration.
On another note, it is good to see that published research papers are now more accessible to all. As of 2008, research papers based on NIH grants must be submitted to PubMed Central (PMC) when those papers are accepted for publication in a peer-reviewed journal. PMC will then make the papers freely available to the public within 12 months of publication.
I look forward to the day when all research papers are freely available to the public. There are a myriad of issues, as who pays for the publishing, the peer review process, and where the research papers should be "housed". However, I believe the more scientific research results are disseminated in easily accessible format, the more we can advance in technology applications and filling in knowledge gaps.]
In a study that investigates the challenges of disseminating clinical research findings in peer-reviewed biomedical journals, Yale School of Medicine researchers have found that fewer than half of a sample of trials primarily or partially funded by the National Institutes of Health (NIH) were published within 30 months of completing the clinical trial.
These findings appear in the January issue of the British Medical Journal, which focuses on the topic of unpublished evidence.
“When research findings are not disseminated, the scientific process is disrupted and leads to redundant efforts and misconceptions about clinical evidence,” said Dr. Joseph Ross, first author of the study and a Yale assistant professor of medicine. “Such inaction undermines both the trial in question and the evidence available in peer-reviewed medical literature. This has far-reaching implications for policy decisions, and even institutional review board assessments of risks and benefits associated with future research studies.”…
Ross said that there may be many reasons for lack of publication, such as not getting accepted by a journal or not prioritizing the dissemination of research findings. Still, he said, there are alternative methods for providing timely public access to study results, including the results database at ClinicalTrials.gov** that was created in response to Federal law.
[From the About Page at Clinical Trials.gov
US Public Law 110-85 (Food and Drug Administration Amendments Act of 2007 or FDAAA), Title VIII, Section 801 mandates that a "responsible party" (i.e., the study sponsor or designated principal investigator) register and report results of certain "applicable clinical trials" that were initiated or ongoing as of September 27, 2007...]
ClinicalTrials.gov offers up-to-date information for locating federally and privately supported clinical trials for a wide range of diseases and conditions.
ClinicalTrials.gov currently contains 118,682 trials sponsored by the National Institutes of Health, other federal agencies, and private industry.
**Here is how one can check for study results
(remember, researchers are not mandated to submit study results to ClinicalTrials.gov, they are voluntary)
ClinicalTrials.gov records with published results listed via the PubMed medical literature search service.
- Use the Advanced Search with the search phrase clinicaltrials.gov[si]
Use the Builder limit results by topics (as a disease, medical device), year(s), name of researcher/invesitator)
- Need help searching? PubMed has tutorials , including a YouTube at the Advanced Search Page
Ask for assistance from a reference librarian at your local public, academic, hospital, or medical library.
Many academic, hospital, and medical libraries offer at least basic search help to all. Call ahead and ask
about their services. You may be pleasantly surprised.
- Many NIH-funded clinical trials go unpublished over 2 years after completion (eurekalert.org)
- The White House Calls for Information on Public Access to Publications and Data (The Scholarly Kitchen)
- How to obtain free/low cost medical and scientific articles(jflahiff.wordpress.com)
- Patients want to understand the medical literature (with links to resources for patients) (jflahiff.wordpress.com)
- Missing trial data threatens the integrity of medicine (eurekalert.org)
- Poor patient recruitment cited in call for trial disclosures (fiercebiotechit.com)
- A Present for NIH: President Signs Law Creating New Translational Center (news.sciencemag.org)
- NIH and Non-profits Sign Research and Development Agreement (kauffman.org)
- NIH establishes National Center for Advancing Translational Sciences (jflahiff.wordpress.com)
In a move to re-engineer the process of translating scientific discoveries into new drugs, diagnostics, and devices, the National Institutes of Health has established the National Center for Advancing Translational Sciences (NCATS). The action was made possible by Congress’ approval of a fiscal year 2012 spending bill and the president’s signing of the bill, which includes the establishment of NCATS with a budget of $575 million.
NCATS will serve as the nation’s hub for catalyzing innovations in translational science. Working closely with partners in the regulatory, academic, nonprofit, and private sectors, NCATS will strive to identify and overcome hurdles that slow the development of effective treatments and cures.
“Congressional support for the National Center for Advancing Translational Sciences marks a major milestone in mobilizing the community effort required to revolutionize the science of translation,” said NIH Director Dr. Francis S. Collins, M.D., Ph.D. “Patients suffering from debilitating and life threatening diseases do not have the luxury to wait the 13 years it currently takes to translate new scientific discoveries into treatments that could save or improve the quality of their lives. The entire community must work together to forge a new paradigm, and NCATS aims to catalyze this effort.”
A prime example of the type of innovative projects that will be led by NCATS is the new initiative between NIH, the Defense Advanced Research Projects Agency, and the U.S. Food and Drug Administration to develop cutting-edge chip technology. This new technology will allow researchers to screen for safe and effective drugs far more swiftly and efficiently than current methods. A great deal of time and money can be saved testing drug safety and effectiveness much earlier in the process.
To meet the goals of NCATS, NIH is reorganizing a wide range of preclinical and clinical translational science capabilities within NIH into an integrated scientific enterprise with new leadership and a bold new agenda. While the effort to recruit an NCATS director continues, organizational changes and realignment of resources will move forward under the leadership of Acting Director Thomas R. Insel, M.D., and Acting Deputy Director Kathy Hudson, Ph.D. Dr. Insel is the director of the National Institutes of Mental Health and Dr. Hudson is the deputy director for science, outreach, and policy at the National Institutes of Health.
The following programs will comprise NCATS:
- Bridging Interventional Development Gaps, which makes available critical resources needed for the development of new therapeutic agents
- Clinical and Translational Science Awards, which fund a national consortium of medical research institutions working together to improve the way clinical and translational research is conducted nationwide
- Cures Acceleration Network, which enables NCATS to fund research in new and innovative ways
- FDA-NIH Regulatory Science, which is an interagency partnership that aims to accelerate the development and use of better tools, standards and approaches for developing and evaluating diagnostic and therapeutic products
- Office of Rare Diseases Research, which coordinates and supports rare diseases research
- Components of the Molecular Libraries, which is an initiative that provides researchers with access to the large-scale screening capacity necessary to identify compounds that can be used as chemical probes to validate new therapeutic targets
- Therapeutics for Rare and Neglected Diseases, which is a program to encourage and speed the development of new drugs for rare and neglected diseases
The budget for NCATS is primarily a reallocation of funds from programs previously located in the NIH Office of the Director, National Human Genome Research Institute, and National Center for Research Resources. NIH is committed to both basic and applied research and has maintained a relatively stable ratio of funding across these two areas of focus. The funding ratio will not be disturbed by the establishment of this new center.
The formation of NCATS has been a methodical process highlighted by the recommendation of the NIH Scientific Management Review Board in December 2010 to create a new center dedicated to advancing translational science. This recommendation was followed by a year of intensive feedback and expert insight from all sectors of translational science through advisory meetings and extensive public consultation.
“I am deeply grateful for the expertise and insight provided by the many researchers, industry executives, patients, voluntary organizations, and NIH staff that helped NIH evaluate NCATS’ purpose and crystallize its vision,” said Dr. Collins.
To learn more about the impetus and development of NCATS, go to:
- NCATS web page: http://www.nih.gov/about/director/ncats/index.htm.
- NCATS on the Feedback NIH website: http://feedback.nih.gov/index.php/category/ncats/
About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visitwww.nih.gov.
- NIH Director Jumps the Gun With Memo Announcing New Center (news.sciencemag.org)
- NIH Chided on Translational Center, Warned of More Budget Cuts (news.sciencemag.org)
- NIH centre faces spell in limbo (nature.com)
- White House Boosts Translational Medicine, Drug Chip Project (news.sciencemag.org)
- US biomedical and energy budgets inch toward resolution (blogs.nature.com)
- Senate Panel Trims NIH Budget By $190 Million (news.sciencemag.org)
- New drug-discovery center lost in translation (fiercebiotechresearch.com)
- NIH launches $140M drug tox project, hunts for translational R&D chief (fiercebiotechresearch.com)
- Departing Director Reflects on NCRR Breakup (news.sciencemag.org)
- IEA Places 18 Employees within the National Institutes of Health (NIH) (prnewswire.com)
[On a somewhat related note...
About three years ago I created an Online Library Guide entitled Animal Research Alternatives to aid researchers at the university where I worked as a reference librarian. Specifically it aimed to "To support research scientists in searching the literature in order to comply with the Animal Welfare Act (7USC 2131-2156)"
The process of creating the guide was challenging, but very enjoyable.]
From the 18 December 2011 article at AllGov by Noel Brinkerhoff
A panel of experts commissioned by the National Institutes of Health (NIH) has concluded that most of the research involving chimpanzees is not necessary. According to the most recent count, there are 937 chimpanzees being used for research in the United States, including 612 for projects funded by the U.S. government. They are most commonly used for hepatitis-related research.On December 15, the NIH suspended new grants for research that uses chimps.The NIH asked researchers to examine the many ways chimps are utilized in medical and social experiments to determine the value of this work. The panel decided that “while the chimpanzee has been a valuable animal model in past research, most current use of chimpanzees for biomedical research is unnecessary.”However, the study stopped short of recommending that chimps never be used by scientists.They said there is rationale for using the primates in research on: monoclonal antibody therapies; comparative genomics; and non-invasive studies of social and behavioral factors that affect the development, prevention, or treatment of disease.Guidelines also were offered for justifying the use of chimps, these being:· That the knowledge gained must be necessary to advance the public’s health;· There must be no other research model by which the knowledge could be obtained, and the research cannot be ethically performed on human subjects; andThe animals used in the proposed research must be maintained either in ethologically appropriate physical and social environments (i.e., as would occur in their natural environment) or in natural habitats.In April, Sen. Maria Cantwell (D-Washington) introduced the Great Ape Protection and Cost Savings Act of 2011, which would prohibit invasive research on chimpanzees.
- Most Biomedical Research Chimps Can Retire, Panel Finds (organicauthority.com)
- Fewer animal experiments thanks to nanosensors (Eureka alert)
- NIH to Limit Use of Chimps in Research (artofthestem.com)
- Experiments With Chimps (andrewsullivan.thedailybeast.com)
- U.S. report recommends stringent limits on use of chimpanzees in biomedical, behavioural research (thehindu.com)
- Chimpanzee Research on Way Out (bigthink.com)
- Research Chimpanzees Offered Hope (theage.com.au)
- First Guidelines for Lab Chimps Drawn Up (livescience.com)
- NIH Curtails Chimpanzee Research in Wake of IOM Report (news.sciencemag.org)
- Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity (bespacific.com)
A new research program funded by the National Institutes of Health will explore the role that a changing climate has on human health. Led by NIH’s National Institute of Environmental Health Sciences (NIEHS), the program will research the risk factors that make people more vulnerable to heat exposure; changing weather patterns; changes in environmental exposures, such as air pollution and toxic chemicals; and the negative effects of climate change adaptation and mitigation efforts.
In addition to better understanding the direct and indirect human health risks in the United States and globally, one of the program’s goals is to determine which populations will be more susceptible and vulnerable to diseases exacerbated by climate change. Children, pregnant women, the elderly, people from low socioeconomic backgrounds, and those living in urban or coastal areas and storm centers may be at elevated risk. This program will also help to develop data, methods, and models to support health impact predictions.
“Governments and policy makers need to know what the health effects from climate change are and who is most at risk,” said John Balbus, M.D., NIEHS senior advisor for public health and lead for NIEHS’ efforts on climate change. “The research from this program will help guide public health interventions, to ultimately prevent harm to the most vulnerable people.”
The funding program is an outgrowth of two previous efforts led by NIH. A December 2009 workshop, sponsored by a trans-NIH working group, brought leaders in the field together to begin identifying priorities for NIH climate change research. NIH then led the ad hoc Interagency Working Group on Climate Change and Health in developing an outline of research needs, which are described in a report available atwww.niehs.nih.gov/climatereport.
Summaries of supported public health initiatives may be found at Public Health Impacts.
“Discoveries by NIEHS-funded scientists have led to the development of prevention strategies, health and safety guidelines, and potential treatments for asthma, cardiovascular disease, cancer, and other environmentally-related diseases..”
This research has yielded numerous studies on indoor pollution and respiratory health, and led to the development of air sampling techniques used in research settings worldwide.
- Children’s Environmental Health
Research on the annual costs of environmentally-related diseases in American children will be useful in developing new strategies and guidelines for the detection and prevention of childhood illnesses.
- Pesticides & Neurodevelopment
The discovery of an enzyme that provides protection against the toxicity of pesticide compounds has led to the development of new treatments for nerve agent exposures.
NCI announces plans to reinvigorate clinical trials
Consolidation of cooperative group program is designed to bring enhanced efficiencies to oncological sciences
The National Cancer Institute (NCI) has announced major changes to be made in the long-established Clinical Trials Cooperative Group Program that conducts many of the nationwide trials of new cancer therapies. In a major transformation, NCI intends to consolidate the nine groups that currently conduct trials in adult cancer patients into four state-of-the-art entities that will design and perform improved trials of cancer therapies. These changes are designed to provide greater benefits for cancer patients and more information for researchers. These moves come in response to an NCI-requested April 2010 report from the Institute of Medicine (IOM)**, which called for a series of changes to the cooperative groups program, including restructuring….
….The April IOM report noted that the current trials system is inefficient, cumbersome, underfunded, and overly complex. The report recommended consolidating existing adult cooperative groups into a smaller number of groups that could function in a more closely integrated manner….
…For the past several decades, clinical cancer trials have used one or a combination of drugs or other treatment modalities, such as surgery or radiation, in comparison to the prevailing standard of care to see if the new treatment was superior. Recently, some trials have begun to depend on the genetic profiling of tumors. For example, one ongoing NCI-sponsored breast cancer study, called TAILORx, is examining whether genes that are frequently associated with risk of recurrence for women with early-stage breast cancer can be used to assign patients to more appropriate and effective treatments.
These types of studies necessitate the screening of large numbers of patients in order to find subsets of patients with tumors that demonstrate changes in specific genetic pathways. These trials therefore require acquisition and distribution of many tumor specimens, DNA sequencing, and the matching of genetic information with treatment options. The increased complexity of these trials provides a rationale for modernization and simplification of the current cooperative group structure…..
..On Jan. 1, 2011, NCI will impose new deadlines, formulated by its Operational Efficiency Working Group, which will reduce by half the time to initiate new clinical studies and will terminate studies not begun within two years of concept approval….
**The IOM Web site has over 50 results with the search phrase clinical trials, including the most viewed Biomedical/Health Research report (as of Dec 27, 2010) - Transforming Clinical Research in the US: Workshop Summary
General Information about Clinical Trials (select Web sites)
- Clinical Trials (MedlinePlus) has overviews, related issues (as informed consent and ethics), directories, and more
- Understanding Clinical Trials (ClinicalTrials.gov) answers many basic questions relating to participation, safety, ethics, and types of clinical trials
- ClinicalTrials.gov is a registry and finding aid for clinical trials. It currently has 100,613 trials with locations in 174 countries. One can search by topic (as a particular drug or disease) or use the advanced search to use limiters as location, conditions, age groups, and sponsors. Results give contact information for individual clinical trials.The page How can I find the results of a clinical trial? provides places where they might be found, including the ClinicalTrials.gov Web site.
Herbs at a glance: a quick guide to herbal supplements is a 100 page indexed PDF document which gives the basics on the most common herbs in dietary supplements – historical uses, what they are used for now, scientific evidence on effectiveness, and potential side effects.
It is published by the US National Center for Complementary and Alternative Medicine (NCAAM).
The NCAAM Web site includes links to information under titles as
- Health Topics A-Z with Evidence-based information on treatments and conditions
- Information for Consumers with numerous fact sheets to help you decide if complementary/alternative medicine is right for you. (Don’t forget to consult with your health care providers! These fact sheets can be great discussion starters)
- A good introductory page on What is Complementary and Alternative Medicine?
- News and Events
- Ways to get updates bv email, newsfeed (RSS), Twitter, Facebook, and Youtube
A few related Web sites
- Complementary and Alternative Medicine (MedlinePlus)has links to overviews, specific conditions, tutorials, videos, research, and more
- Herbal Medicine (MedlinePlus) has links to overviews, specific conditions, research, and more
- Complementary Medicine (NetWellness) has links to general information,treatment, and Ask-An-Expert answered questions. One can ask a question at this site, and receive a reply within a few days.
- Alternative Medicine (NIH) contains links to information at US government sites
- Drug Information Portal (NIH) provides a wealth of information for consumers and professionals.
- US Office of Dietary Supplements contains fact sheets, news items, decision making guidance, consumer protection information, nutrient recommendations, and more
and a related news item…
From the December 16, 2010 Health Day news item U.S. Spending Millions to See if Herbs Truly Work
THURSDAY, Dec. 16 (HealthDay News) — People have been using herbal supplements for centuries to cure all manner of ills and improve their health. But for all the folk wisdom promoting the use of such plants as St. John’s wort and black cohosh, much about their effect on human health remains unknown.
But the federal government is spending millions of dollars to support research dedicated to separating the wheat from the chaff when it comes to herbal supplements.
“A lot of these products are widely used by the consumer, and we don’t have evidence one way or the other whether they are safe and effective,” said Marguerite Klein, director of the Botanical Research Centers Program at the U.S. National Institutes of Health. “We have a long way to go. It’s a big job.”
In August, the U.S. National Center for Complementary and Alternative Medicine and the Office of Dietary Supplements awarded about $37 million in grants to five interdisciplinary and collaborative dietary supplement centers across the nation. The grants were part of a decade-long initiative that so far has awarded more than $250 million toward research to look into the safety and efficacy of health products made from the stems, seeds, leaves, bark and flowers of plants.
Reliance on botanical supplements faded in the mid-20th century as doctors began to rely more and more on scientifically tested pharmaceutical drugs to treat their patients, said William Obermeyer, vice president of research for ConsumerLab.com, which tests supplement brands for quality.
But today, herbal remedies and supplements are coming back in a big way. People in the United States spent more than $5 billion on herbal and botanical dietary supplements in 2009, up 22 percent from a decade before, according to the American Botanical Council, a nonprofit research and education organization.
The increase has prompted some concern from doctors and health researchers. There are worries regarding the purity and consistency of supplements, which are not regulated as strictly as pharmaceutical drugs.
“One out of four of the dietary supplements we’ve quality-tested over the last 11 years failed,” Obermeyer said. The failure rate increases to 55 percent, he said, when considering botanical products alone.
Some products contain less than the promoted amount of the supplement in question — such as a 400-milligram capsule of echinacea containing just 250 milligrams of the herb. Other products are tainted by pesticides or heavy metals.
The U.S. Food and Drug Administration warned supplement makers on Dec. 15 that any company marketing tainted products could face criminal prosecution. The agency was specifically targeting products to promote weight loss, enhance sexual prowess or aid in body building, which it said were “masquerading as dietary supplements” and in some cases were laced with the same active ingredients as approved drugs or were close copies of those drugs or contained synthetic synthetic steroids that don’t qualify as dietary ingredients.
But even when someone takes a valid herbal supplement, it may not be as effective when taken as a pill or capsule rather than used in the manner of a folk remedy. For example, an herb normally ground into paste as part of a ceremony might lose its effectiveness if prepared using modern manufacturing methods, Obermeyer said.
“You move away from the traditional use out of convenience, and you may not have the same effect,” he said.
Researchers also are concerned that there just isn’t a lot of evidence to support the health benefits said to be gained from herbal supplements. People may be misusing them, which can lead to poor health and potential interactions with prescription drugs.
“Consumers often are taking them without telling their doctor, or taking them in lieu of going to the doctor,” Klein said……