POGO fears disclosure rule is in jeopardy
Filed under: Conflicts of interest, Public records
A database that would document the financial ties between researchers who are funded by the The National Institutes of Health and medical companies is in jeopardy, according to the Project on Government Oversight (POGO).
Under the proposed requirement, NIH-funded researchers at medical schools and universities would have to publicly disclose their financial ties to medical companies. In March, POGO sent a letter to Dr. Francis Collins, the Director of the NIH, urging him to implement this idea, which he had shown support for.
But POGO is concerned that the White House’s Office of Management
and Budget may weaken or block the rule. The organization has sent a letter to the OMB director in support of the rule.
Previously: NIH Proposes Rule to Shine Light on Potential Conflicts of Interest
Video, presentations from comparative effectiveness conference available online
Filed under: Government, Health care reform, Health data, Public health, Studies, Tools
Earlier this month, ECRI’s 17th annual conference tackled the thorniest detail of comparative effectiveness research, namely that it’s rarely a simple matter of A > B. Groups and individuals respond differently.
With a theme of “Comparative Effectiveness and Personalized Medicine,” the nonprofit and its partners at NIH and Health Affairs, among others, sought to better understand how big research ideas will interface with the person-by-person decisions through which such work will ultimately be implemented.
The conference has a detailed postmortem online, including two days of video (Fair warning: Together, they’re a good 700+ minutes of conference) and slides from a number of the presentations. I strongly recommend using the conference schedule listed on the slides page as a rough guide to finding the most relevant bits of video.
In case you’re looking for a place to start, here are two of the most relevant presentations:
- Keeping the comparative effectiveness debate rational
- Comparative effectiveness research in the Veterans Health Administration (and in Kaiser Permanente, which references patient preference and participation)
The online Q and A is also interesting, though there are only a handful of answers up at present. The most relevant one so far comes from Vivian Coates (Vice President, Information Services and Health Technology Assessment, ECRI Institute), in response to a query about a central listing of comparative effectiveness projects.
The CER inventory contract was awarded to the Lewin Group Center for Comparative Effectiveness Research (CER) in June, 2010. Over the 27 month period of the contract, Lewin will design, build and launch a web-based inventory that catalogs CER outputs and activity, including research studies, relevant research methods, training of researchers, data infrastructure and approaches for dissemination and translation of comparative effectiveness research to health care providers and patients.
$95 million to figure out proper doses for kids
On The Wall Street Journal’s Health Blog, Katherine Hobson profiles the Pediatric Trials Network, a seven-year, NIH-funded effort to determine pediatric dosing information for things like hypertension drugs and antibiotics. The $95-million initiative will fund 16 clinical trials, most of which will enroll 100 to 200 participants, Hobson reports.
Even then, Hobson said, the new study will only make a “dent” in the larger problem. She found that, at present, “virtually all” pediatric drug use is off-label, and that physicians get pediatric dosing wrong about a third of the time. The FDA already does some baseline work to make sure drugs are kid-safe, but the PTN represents a large step beyond present efforts.
Some brand-name drugs do get scrutinized under a program that gives drug makers an extra 6 months of patent protection for conducting FDA-requested studies in kids. And experimental drugs up for FDA approval must assess the effects in kids if they’re likely to use them. But that leaves a big knowledge gap for the host of generic drugs used to treat everything from infectious diseases to cancer.
Gays excluded from clinical trials
Thanks to an awards announcement from the National Lesbian & Gay Journalists Association, we just noticed Jen Colletta’s story in the Philadelphia Gay News about the exclusion of gays from clinical trials. Colletta won an Excellence in News Writing Award. The exclusion of gays in clinical trials is an issue that hasn’t received much mainstream attention, apart from a letter from Colletta’s sources in NEJM, a write-up by Ed Silverman and a story in The Philadelphia Inquirer.
According to Colletta, the data behind the story grew out of a chance discovery by researchers at the Fox Chase Cancer Center in Philadelphia.
“We review all the different trials that are proposed here, and they don’t necessarily open here, but a lot of them are multi-center trials so we do look at them. And I saw that we had been looking at a number of clinical trials that explicitly excluded gay people, and they didn’t necessarily open at Fox Chase, but I started to become more attuned to this and realized that this is a bigger, national issue,” (Brian Egleston, assistant research professor of biostatistics at the center) said.
The researchers analyzed trials listed in the ClinicalTrials.gov database, maintained by the National Institutes of Health and the Food and Drug Administration.
In particular, Colletta reported, homosexuals are excluded from studies about couples, especially those dealing with erectile dysfunction, which are often related to treatments for prostate cancer. It’s entirely normal for a drug trial to have exclusion criteria, but an oversight in NIH regulations mean that the exclusion of homosexuals, unlike exclusion along racial lines, can be implemented arbitrarily.
In the mid-1990s, Congress mandated that NIH establish a set of guidelines that would prevent it from excluding minorities, such as women and African Americans, from federally funded clinical trials unless there was a significant reason. There are currently no such rules regulating the inclusion of LGBT individuals.
The distribution of exclusionary studies is particularly interesting. To put it in perspective, here’s a quick visualization of the data put forth in the NEJM letter:
Ruling puts stem cell research on hold
A federal judge’s ruling has, at least temporarily, blocked efforts to expand stem cell research, based on a decision that says “regulations designed to expand federal funding for embryonic stem cell research violated a law [the Dickey Wicker Amendment] prohibiting destruction of embryos for research purposes.”
When stem cells like these human embryonic stem cells divide, each new cell has the potential to remain a stem cell or become a cell with a more specialized function, such as a muscle cell or a red blood cell. Photo: National Institutes of Health
It’s yet to be determined what the implications of this ruling [PDF] will be if it stands, but it could affect millions of dollars of federally-funded research. AHCJ has some background and links to help reporters who might be looking at how this will affect local researchers.
- PBS’ Newshour has a roundup of some of the coverage.
- The Scientist Who Helped Stall Stem Cell Research
- Obama order expected to increase speed, efficiency of stem cell research (April 2009)
- Covering stem cells: Background on science, politics and global competition: Terri Somers, who was then biotechnology writer for the San Diego Union-Tribune, wrote a primer on stem cell research for AHCJ members. (Note: Somers is now director of communications for BIOCOM, an industry association based in Southern California.)
- Mark Johnson of the Milwaukee Journal Sentinel wrote a three-part series detailing the discovery of how to create embryonic stem cells out of normal cells. One of the key labs in the research is located at the University of Wisconsin-Madison. The online package includes a time-lapse video of an embryo’s first five days of development and links to a discussion about the ethics of stem cell research.
- Stem cell research in California: A presentation by Zach W. Hall, president of the California Institute for Regenerative Medicine, offered at a plenary on stem cell policy at Health Journalism 2007.
- National Center for Biotechnology Information
- NIH Stem Cell Information
- Embryonic Stem Cell Research: A Decade of Debate from Bush to Obama; Yale Journal of Biology and Medicine (2009)
AHCJ has resources for World Tuberculosis Day
Filed under: Hot Health Headline, Public health, Studies, Tools
In honor of World Tuberculosis Day, an awareness day organized by the Stop TB Partnership, here’s a roundup of the latest in TB as well as some handy background information.
AHCJ New York City Metro chapter’s discussion on TB as a global health problem: Discussion covered all strains of tuberculosis and considered the root socioeconomic causes of the disease. The article is accompanied by audio from expert presentations given at the meeting, as well as copies of the presentations themselves. Article by Sibyl Shalo, presenters included Chrispin Kambili, M.D., (assistant commissioner and director, Bureau of Tuberculosis Control, New York City Department of Health and Mental Hygiene), Donald J. McNeil Jr. (science and health reporter for The New York Times), Lee Reichman, M.D., M.P.H., (executive director, New Jersey Medical School Global Tuberculosis Institute), Mel Spigelman, M.D., (president and CEO, Tuberculosis Alliance) and Janice Hopkins Tanne (journalist and co-author with Reichman of “Timebomb: The Global Epidemic of Multi-Drug Resistant Tuberculosis”).
Decrease in Reported Tuberculosis Cases
From the CDC’s weekly Morbidity and Mortality Report
Read it because: It’s a comprehensive summary of the present state of TB in America, packed with stats and even a little analysis.
Key paragraph:
For 2009, a total of 11,540 tuberculosis cases were reported in the United States. The TB rate was 3.8 cases per 100,000 population, a decrease of 11.4% from the rate of 4.2 per 100,000 reported for 2008. The 2009 rate showed the greatest single-year decrease ever recorded and was the lowest recorded rate since national TB surveillance began in 1953.
Drug-resistant tuberculosis now at record levels
From the World Health Organization
Read it because: It’s 71 pages (the important stuff begins on page 13) of statistics, research and anecdotes covering drug-resistant strains of tuberculosis worldwide.
Key paragraph:
… it is estimated that 440 000 people had MDR-TB worldwide in 2008 and that a third of them died. In sheer numbers, Asia bears the brunt of the epidemic. Almost 50% of MDR-TB cases worldwide are estimated to occur in China and India. In Africa, estimates show 69 000 cases emerged, the vast majority of which went undiagnosed.
And, some quick fact sheets:
World Health Organization TB resources
NIH: Definitions of different TB strains
NIH: Roundup of current TB research efforts
CDC tuberculosis resources
Third-party PubMed video tutorials in plain English
PubMed’s fantastic, but it can also be mighty frustrating. Maintained by the National Library of Medicine, it’s the interface through which folks can search or browse their way through NIH’s vast repository of health-related research articles.
Unfortunately, it’s also not quite like the user-friendly search engines most of us have come to know and love. That’s where third-party tutorials come in.
If you’re looking for a strong distillation of the basics, head straight for AHCJ’s tip sheet. If you prefer more technical info and less hands-on guidance, see Wikipedia. But if you’re looking for an in-depth, easy-to-follow introduction broken into easily digestible chunks, head for this nine-part video tutorial created by an Indiana University medical librarian.
She uses accessible language, analogies and well-paced demonstrations to peel back the layers of the labyrinth and help viewers understand the purpose and relevant applications of the interface’s features. Here’s the first installment:
Note that on Screenjelly webcasts, such as this one, you can click on the “full-screen” icon in the bottom-right corner of the player. Screenjelly looks much better in the full-screen mode than most players.
NIH updates stimulus grant info, releases database
Filed under: Health data, Health journalism, Public records, Tools
We’ve been waiting for this one. The National Institutes of Health have followed through on their promise to release a comprehensive database of NIH grants funded with stimulus money. The new data is up-to-date as of yesterday, you can find it on this page or go directly to the 13mb Excel file. The NIH’s stimulus transparency site has been quite good, in general, but inexplicably lacked key data fields and a way to export more than 500 (of 12,000+) grants at a time. The new database solves those issues.
For a quick picture of where the stimulus cash was headed, we grabbed data for all 50 states as well as D.C. and Puerto Rico, added some recent census estimates, and put together a few top 10 lists. Massachusetts, D.C. and California lead most categories, and per-capita numbers differ pretty significantly from absolute totals.
Which states (etc.) are getting the most NIH grant money?
And how does all of that money break down on a per-person basis?
What about individual NIH grants?
And what’s the per-capita on those?
These are just scratching the surface, the database has a separate entry for each grant, and it’s pretty easy to break it down by institution, research area and a number of other categories.
Does stimulus-funded research stimulate?
Filed under: Government, Hot Health Headline, Studies
Reporter Michelle Breidenbach of the Syracuse, N.Y., Post-Standard considers local academic research being funded by stimulus money and wonders just how much these projects – many of which were turned down previously and selected for stimulus money based partly on timing considerations – are really stimulating the economy. There were no job-creation or buy-American strings attached and, while ostensibly health-related, studies covered such esoteric topics as wild ticks on lab mice and the interaction between marijuana and malt liquor consumption.
With a story localization model that can be applied across the country, Breidenbach used the NIH’s grant-tracking site to check in on stimulus-funded projects getting underway at a number of nearby universities, then contacted researchers and assessed their work’s impact on the local economy and on human knowledge in general.
Collins unanimously confirmed as head of NIH
Francis S. Collins, M.D., Ph.D., has been unanimously confirmed as director of the National Institutes of Health, HHS Secretary Kathleen Sebelius announced today.
“Dr. Collins is one of our generation’s great scientific leaders. A physician and geneticist, Dr. Collins served as Director of the National Human Genome Research Institute, where he led the Human Genome Project to completion,” said Secretary Sebelius. “Dr. Collins will be an outstanding leader. Today is an exciting day for NIH and for science in this country.”
Francis S. Collins
Collins, a geneticist, had received some attention when he was nominated because of his religious beliefs. The evangelical Christian wrote a book, “The Language of God: A Scientist Presents Evidence for Belief.”
Jacob Molyneux, senior editor at the American Journal of Nursing, examined some of what was written about Francis at the time and looked at the then-nominee’s statements and records, including those about the use of embryonic stem cells for research. He concluded that “for Collins, science and the potential for alleviation of human suffering trump moral or religious absolutism and blind adherence to the sanctity of life issue.”
The Los Angeles Times ran a point-counterpoint piece about the topic, Newsweek’s religion editor weighed in, and The New York Times ran an op-ed by an author who is “uncomfortable” with Francis’ nomination. Eric Berger of the Houston Chronicle did a Q&A with Josh Rosenau from the National Center for Science Education, which defends the teaching of evolution in public schools.
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Join us in Atlanta
for Health Journalism 2012
Fellowship applications
due Feb. 27
New at HealthJournalism.org
- Data gives depth to investigation of patient safety
- What reporters should know about Alzheimer’s and related dementias
- Apply for fellowships to attend Health Journalism 2012
- AHCJ asks Supreme Court to permit broadcast of arguments in health reform case
- Tips for print, online journalists to embrace broadcast opportunities
- Numbers reveal how often, or how rarely, states check doctors’ disciplinary records
- How I did it: Falsified charts in nursing homes linked to patient care
- Access Denied: Looking at a lack of health care availability
- Transparency & medical errors: Public reporting of patient harm is a potent force
