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.
NIH on Wikipedia: If you can’t beat ‘em…
The Washington Post’s Ibby Caputo reports that the National Institutes of Health, upon realizing that more folks are looking for health information online and that many of those folks are ending up on Wikipedia, has started to teach its scientists how to create and edit Wikipedia entries.
Rather than trying to compete with the free online encyclopedia, NIH seems to have chosen to embrace the inevitability that users will turn to Wikipedia for health advice. If they’re going to go there anyway, then NIH is at least going to try to make sure they’re getting the best possible information.
To this end, the NIH and the Wikimedia Foundation (the nonprofit which publishes the encyclopedia) hosted a workshop attended by about 100 NIH scientists this month in which they learned how to edit and even create Wikipedia entries.
Progress on open access issue not what it seems
A press release from the Alliance for Taxpayer Access yesterday raised hopes that permanent open access to federally funded research through the National Institutes of Health had been assured by President Obama.
As the release pointed out, on Wednesday, Obama signed the 2009 Consolidated Appropriations Act (PDF), which includes a provision making the NIH Public Access Policy permanent (section 217 on page 621 of this PDF document). The NIH policy that had been in place requires eligible NIH-funded researchers to deposit electronic copies of their peer-reviewed manuscripts into the National Library of Medicine’s online archive, PubMed Central, but the provision had to be renewed every year.
That sounds like a positive step toward ensuring public access to publicly funded research, right?
Well, not so fast.
The Fair Copyright in Research Works Act, HR 801, introduced by U.S. Rep. John Conyers Jr. and others, is still active and has been referred to the House Committee on the Judiciary.
AHCJ opposes that bill because it would completely reverse the NIH’s open access policy and would essentially nullify the provision that Obama just signed into law. As Gregg Leslie of the Reporters Committee for Freedom of the Press said, “… any later piece of legislation modifies the current law, so Obama could sign something into law and then soon invalidate it by signing a new bill sent to him after approval by Congress.”
15 areas get a share of NIH’s stimulus funding
The NIH has designated $200 million of its stimulus money for 200 or more “Challenge Grants” in specific areas where NIH has judged the money will have the most immediate impact.
“Challenge Areas” in which funds will be available:
- Behavior, Behavioral Change, and Prevention
- Bioethics
- Biomarker Discovery and Validation
- Clinical Research
- Comparative Effectiveness Research
- Enhancing Clinical Trials
- Enabling Technologies
- Genomics
- Health Disparities
- Information Technology for Processing Health Care Data for Research
- Regenerative Medicine
- Science, Technology, Engineering and Mathematics (STEM) Education
- Smart Biomaterials - Theranostics
- Stem Cells
- Translational Science
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Spend a week at the CDC studying public health, meeting sources. Apply for the AHCJ-CDC Health Journalism Fellowships today!
- Reporting on the intersection of health, environment
- Tip sheet: Covering cuts to Medicare reimbursements
- Briefing: Reporting on health reform between now and 2014
- Covering high-risk insurance pools: Tips for reporters
- Health care reform has passed: What's next?
- Health and education: Covering these intersecting beats
- Reporting on the business of health care
- Health reporting resources for journalists on state and local government beats
