Obama releases documents from advocacy groups
Jennifer LaFleur at ProPublica points out that “President-elect Barack Obama’s transition team seems to be following through with its promise of transparency by posting documents from its meetings with industry and advocacy groups.”
There are some health-related documents among the postings:
AIDS in America: An agenda endorsed by 15 national organizations that calls for “the development of a National AIDS Strategy for the U.S. that is designed to lower HIV incidence, increase access to HIV care, and reduce racial disparities in the epidemic and integrate HIV with STD, viral hepatitis and TB programs at the local level.”
Asian Pacific Islander American Health Forum: “Priorities for the new administration to improve the health and well-being of Asian Americans, Native Hawaiians and Pacific Islanders”
Analysis of HIV/AIDS Priority Issues for Immediate Action: List of issues for “immediate action” from the AIDS Action Council
Advancing Reproductive Rights and Health in a New Administration: Agenda from a coalition of about 60 medical, public health, research, religious and religiously affiliated, women’s health, legal, and other advocacy organizations.
National Water Policy Dialogue: The American Water Resources Association, the Environment and Water Resources Institute of the American Society of Civil Engineers and the National Wildlife Federation submitted a summary of the National Water Policy Dialogues conducted by AWRA at the request of 10 federal water agencies. Water quality is among their concerns.
Ombudsman explores nuances of science writing
Making sense of health reporting is not always easy, especially when clinical trials are concerned. Results may be interpreted in different ways to suit different views. Agendas of those involved may not always be evident. And sometimes, even expert sound bites oversimplify any murkiness. That was the takeaway from a recent column by Deborah Howell, The Washington Post ombudsman, who cited the recent debate over the results of a study of the widely used Crestor cholesterol fighter.
That particular study, known as Jupiter, highlighted the difficulties that can arise when weighing competing statistics. In this case, the debate was over relative risk versus absolute risk, two very different ways to measure whether Crestor can reduce the likelihood of a cardiovascular event compared with a placebo. Howell notes that media coverage was chastised for highlighting the measure touted by AstraZeneca, which sells Crestor and funded the research. Critics say that by describing drug as a blockbuster and emphasizing relative risk overstated the case in favor of the drugmaker. In fact, the Post’s own story was mentioned.
Her weekend essay raised the delicate and difficult balancing act that can occur when coverage requires a nuanced approach to often complicated data and concepts. In the end, she suggests something most health journalists, hopefully, know already - above and beyond anything else, look for and examine the evidence.
Just in case, here are some tip sheets:
- Evidence-based medical reporting: A brief primer
- Evidence-based medical reporting
- Understanding the scientific article
- Understanding medical publications
- What you need to know about risks, rates and ratios
- Medicine 101: Words, numbers and journals
- Lies, damned lies and medical statistics - how to interpret the evidence
AHCJ fellows hear from CDC experts
Filed under: Government, Health journalism, Member news
AHCJ’s Midwest fellows just spent three days in Atlanta meeting with experts at the Centers for Disease Control and Prevention and the Carter Center on a variety of health issues.
The Midwest fellows, from left to right: Elana Gordon, KCUR-Kansas City; Morgan Smith, KCTV-Kansas City; Alan Bavley, The Kansas City Star; Kathleen O’Dell, The Springfield (Mo.) News-Leader; Jeannine Koranda, The Wichita Eagle; Sandra Jordan, St. Louis American; Tammy Worth, independent journalist; Liz Zamora, KTKA-Topeka; Duane Schrag, Salina Journal.
Highlights included a discussion with CDC Director Julie Gerberding about efforts and goals to collaborate with other nations – addressing climate change, poverty, food safety, illness and disaster response. Another CDC priority focuses on reducing health and economic consequences of the leading causes of death and disability.
In CDC laboratories, fellows stood 30 feet away – through thick walls and windows – from deadly diseases from around the world. In a different lab, where viruses such as SARS were originally identified, fellows used an electron microscope to see slides of infected tissues and heard step-by-step explanations of lab procedures. Labs at the CDC’s Environmental Health Labs gave the fellows a chance to see the facilities where the CDC detects deadly toxins. In one special room, the fellows saw hundreds of cartons of cigarettes, ready for testing on sensitive equipment for levels of nicotine, tar and other ingredients.
The fellows visit included a tour of the CDC Director’s Emergency Operations Center, a secured series of rooms that allow CDC employees to monitor disasters or disease outbreaks and manage response.
CDC speakers unveiled a preview of an embargoed report on childhood injuries and deaths, including statistics by state. Other experts gave a primer on public health and the latest developments and research on vaccines, obesity, autism, climate change and genetic testing.
In a side trip to The Carter Center, fellows heard details of international efforts to eradicate diseases and improving mental health and toured the presidential museum.
When is an embargo not an embargo?
How about when a press release was never issued? None was available when the UK media reported results of a study about the effects of caffeine in pregnancy - before BMJ had a chance to publish online. Just the same, BMJ editor Fiona Godlee is a bit peeved. She acknowledges that, technically, there was no breach, but she maintains coverage still amounted to publicity before publication.
How did this happen? The UK’s Food Standards Agency, which funded the study, held a stakeholders meeting before BMJ issued its embargoed press release. “It was probably from this meeting that the study’s findings, and the government’s new guidelines on caffeine intake during pregnancy, were leaked,” she writes in an editorial. In this case, she continues, there was no harm done - the media got the story right.
Godlee was responding, in part, to an earlier BMJ blog post by FSA communications director Terrence Collis, who wrote the agency was less than “delighted” to get its study published in BMJ. Why? The FSA wants to show its research is high quality, but “we are even keener that the advice that reaches consumers is as clear as possible - and gets there as quickly as possible. This makes waiting around for journals to decide whether they are going to publish a real pain.” And that, he acknowledged, left time for leaks.
Some other thoughts about embargoes:
- Slate’s Jack Shafer writes about the punishment The New York Times received from WHO after breaking an embargo on a story about measles. AHCJ board member and former Scientist Deputy Editor Ivan Oransky, M.D., blogged about WHO’s action and the larger issue of embargoes.
- In April 2007, the NEJM punished Martin Leon, a cardiologist at the Cardiovascular Research Foundation, for breaking an embargo.
- Vincent Kiernan’s 2006 book, Embargoed Science, argues against embargoes. Kiernan is an instructor of journalism at Clarion University of Pennsylvania. An excerpt was published by Inside Higher Ed.
What do you think about embargoes and, specifically, this situation?
Calls for FDA reform are building
Former FDA staffers and consumer advocacy groups are pointing to reforming the FDA as something the Obama administration should make a priority. Rob Stein of The Washington Post writes that “the FDA needs an infusion of strong leadership, money, technology and personnel - and perhaps a major restructuring, say former officials, members of Congress, watchdog groups and various government reports.”
An FDA chemist conducts a rapid screening to detect cell surface antigens of Salmonella on food. Photo by Black Star/Michael Falco for FDA
Bill Powell, in Time magazine, reports on tainted foods, drugs, pet foods and toys imported from China and that FDA inspections of Chinese plants is spotty.
Sam Roe of the Chicago Tribune recently investigated food recalls and found that “the government rarely inspects food to find problems and doesn’t punish companies that repeatedly violate labeling laws.” The Tribune created a database of 2,800 recalls related to food allergies over the past 10 years and “found that roughly five products a week are recalled because of hidden allergens, making it one of the top reasons any consumer product in America is recalled.”
Roberta Baskin of WJLA-Washington, D.C., reports that the FDA does not regulate the caffeine content of energy drinks. She says, “Last year the National Capital Poison Center logged 65 calls from people worried about a caffeine overdose. Half were referred to emergency rooms… .” and that “the $5 billion energy drink industry is aggressively adding more caffeine with virtually no regulation. The FDA does require prescription and over-the-counter drugs like NoDoz to list how much drug is in a package. But there’s no requirement to list how big a dose goes into foods and drinks.”
Kent Garber reported in U.S. News & World Report that third-party “food-safety consultants” are increasingly taking over the job of making sure food manufacturers meet federal guidelines as the job grows larger and the FDA remains underfunded and understaffed.
Daschle uses video to discuss suggestions
Last week, the Obama team started a ‘community discussion‘ on its Web site about health care. Well, former Sen. Tom Daschle, who will head Health & Human Services, was so happy with the results - more than 3,500 responses - that he and Laura Arnonson, a member of the health policy team, filmed a short video that they posted yesterday to quickly review a couple of key issues and the overall response to their effort.
To be candid, there wasn’t much said that we don’t already know. Daschle, at various turns, says things such as, “We need to really put the emphasis on prevention” and later, “We need to contain costs.” To be fair, the willingness to engage the public in this way is worth noting. After all, when was the last time that HHS Secretary Mike Leavitt deliberately spoke to Americans by way of YouTube? Send us a clip if you have one. Meanwhile, Daschle promises more online discussions are forthcoming.
The Obama team also uses a “word cloud” to illustrate “the 100 most commonly used words in the healthcare discussion.”
Controversy arises over residents’ sleep
Fatigued medical residents need protected sleep periods and increased supervision of work-hour limits to improve patient safety and their training environment, according to a new Institute of Medicine report.
The study, which was funded by the Agency for Healthcare Research and Quality, reviewed the relationship between resident work schedules, their performance and the quality of care they provide. Not surprisingly, the study confirms that scientific evidence shows fatigued residents are more likely to make mistakes.
Recommendations include changes to the existing 80-hour-per-week limit on work hours, such as protected sleep periods. The Accreditation Council for Graduate Medical Education’s rules allow residents to work a maximum 30-hour shift. The IOM recommends a change to require residents who complete a 30-hour shift to only treat patients for up to 16 hours. They must then have a five-hour protected sleep period between 10 p.m. and 8 a.m.
However, Public Citizen Health Research Group chastised the IOM approach. “Giving the ACGME, a group with neither the appetite nor the ability to enforce significant work-hour reductions, the primary authority over resident work hours creates an irresolvable conflict of interest,” the group says.
The consumer group also complains that ACGME enforcement of existing guidelines has been lax and enforcing a guideline on sleep within shifts will be even more difficult by maintaining that sleep will not be “protected,” and that “protected sleep” programs have limited impact on total sleep time and no impact on objective measures of alertness and performance.
Deadline approaches to enter your top work
Recently, AHCJ’s principles were cited as a positive way to avoid conflicts of interest for health reporting in a paper published in BMJ. One of the possible conflicts of interest discussed in BMJ was sponsored awards offered to journalists, such as those cosponsored by Eli Lilly, Boehringer Ingelheim and Roche.
Marina Walker-Guevara accepts a 2006 Award for Excellence in Health Care Journalism on behalf of the Center for Public Integrity.
That’s just one more reason to enter AHCJ’s Awards for Excellence in Health Care Journalism. The awards were created by journalists for journalists and are not influenced or funded by commercial or special-interest groups. Get the recognition you deserve from a highly respected awards program.
Last year’s winners included stories about patient safety, mistreatment in mental hospitals, health care reform and much more.
The early-bird deadline - with discounted entry fee - is just two weeks away so prepare and mail your entry today.
2008 Deadlines
Early-bird: Postmark by Dec. 17, 2008
Regular: Postmark by Jan. 26, 2009
More trials with favorable outcomes get published
An observational study published in PLoS Medicine finds that not all trial results in New Drug Applications for new drugs submitted to the FDA are published in medical journals. Researchers from the University of California, San Francisco, examined efficacy trials between 2001 and 2002, and searched for discrepancies between trial data included in NDAs and in published articles between July 2006 and June 2007.
New drug applications
They found that “only three-quarters of the efficacy trials in the NDAs were published; trials with favorable outcomes were nearly five times as likely to be published as those without favorable outcomes. Although 155 primary outcomes were in both the papers and NDAs, 41 outcomes were only in the NDAs.
Just the same, they offered some optimism: “The recent introduction in the US and elsewhere of mandatory registration of all clinical trials before they start and of mandatory publication in trial registers of the full results of all the predefined primary outcomes should reduce publication bias over the next few years and should allow clinicians and patients to make fully informed treatment decisions.”
But in an accompanying editorial, An-Wen Chan, who previously worked as a scientist with the World Health Organization’s International Clinical Trials Registry Platform and is now at the Mayo Clinic, writes that “much remains to be done - not only to establish reliable, comprehensive registration and results disclosure processes worldwide, but also to start heeding the calls for increased access to full protocols and regulatory agency submissions….”
Last-minute rules would affect health care
ProPublica, which is tracking last-minute rulemaking by the Bush Administration, reports on one rule that would make it more difficult for the Occupational Safety and Health Administration to regulate toxins.
Fire and emergency response personnel practice techniques for hazardous materials containment and removal. Photo: Jim Gathany/CDC
ProPublica, which also links to coverage in The Washington Post and The New York Times, says “OSHA has issued just one significant health standard” in the past eight years - and that it did that under court order.
Another rule the administration is pushing forward is would require federally funded health care facilities to allow employees to refuse to provide services at odds with their moral or religious beliefs, such as abortion.
David G. Savage of the Los Angeles Times reports that “For more than 30 years, federal law has dictated that doctors and nurses may refuse to perform abortions. The new rule would go further by making clear that healthcare workers also may refuse to provide information or advice to patients who might want an abortion.”
Savage writes that the rule, as written, could extend to other procedures, including prescribing birth control or providing artificial inseminination. A lawyer for the National Women’s Law Center said the law also could affect decisions about end-of-life care.
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