Tag Archives: nih

$95 million to figure out proper doses for kids

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

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.

runoff
Photo by woodleywonderworks via Flickr

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

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

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:

exclusion

Ruling puts stem cell research on hold

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates AHCJ's social media efforts and edits and manages production of association guides, programs and newsletters.

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

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.

AHCJ has resources for World Tuberculosis Day

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

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

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

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:

full-screen-modeNote 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.

  • PubMed Tutorial #1: Main PubMed page layout, differences from old PubMed layout
  • PubMed Tutorial #2: From a citation to the full text: Single Citation Matcher and PubMed search box
  • PubMed Tutorial #3: Parts of a PubMed record–order of retrieval, citation information, journal abbreviations, and non-English citations
  • PubMed Tutorial #4: Controlled Vocabulary Part 1: general explanation. Controlled v. natural language, Hierarchical tree structure
  • PubMed Tutorial #5: Controlled Vocab Part 2: Mesh Part 1, medical examples of entry terms and tree structure, how to get from PubMed to MeSH
  • PubMed Tutorial #6: Mesh Part 2: searching for MeSH terms to then search PubMed
  • PubMed Tutorial #7: MeSH terms to search in PubMed, PubMed Display and Send To features
  • PubMed Tutorial #8: Advanced search: Search History, Details, Limits, Additional Fields
  • PubMed Tutorial #9: Topic-Specific Queries–How to Find them, the specific ones for Public Health, demonstrates Health Services Research Queries and Health Disparities
  • (Hat tip to Eagle Dawg)

    NIH updates stimulus grant info, releases database

    Andrew Van Dam

    About Andrew Van Dam

    Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

    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?

    nih-grant-money-total

    And how does all of that money break down on a per-person basis?

    nih-grant-money-per-capita

    What about individual NIH grants?

    total-grants

    And what’s the per-capita on those?

    nih-grants-per-capita

    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.