14 meds used off label need further study
Researchers have assembled a list of 14 widely prescribed drugs they believe urgently need additional study to determine safety and effectiveness for off-label use. Their list, which specifically targets meds that are widely used off-label without proper scientific backing, include a number of popular antidepressants and antipsychotics. And the most common off-label use for six of the drugs was for bipolar disorder.
“Off-label prescribing means that we’re venturing into uncharted territory where we lack the usual level of evidence presented to the FDA that tells us these drugs are safe and effective,” Randall Stafford, associate professor of medicine at the Stanford Prevention Research Center, who is the senior author of the study, says in a statement. “This list of priority drugs might be a start for confronting the problem of off-label use with limited evidence.”
At the top of the list was AstraZeneca’s Seroquel antipsychotic, which was approved by the FDA to treat schizophrenia. Not only did this drug lead all others in its high rate of off-label uses with limited evidence (76 percent of all uses of the drug), the researchers say it raised additional concerns because of its high cost at $207 per prescription, heavy marketing and the presence of a “black-box” warning from the FDA.
The study, which appears in Pharmacotherapy, appears only days after an FDA advisory committee criticized the growing off-label use of antipsychotics in children and amid an investigation by a group of state Medicaid directors. The consortium is evaluating the use of the drugs in children on state Medicaid rolls to ensure they are properly prescribed. The growing use of the medicines has been driven partly by the sudden popularity of the diagnosis of pediatric bipolar disorder.
Dingell jockeys to chair health subcommittee
John Dingell may have been ousted as chairman of the powerful House Energy & Commerce Committee, but he may already be angling to retain some clout. In fact, the Michigan Democrat, who lost his throne in a powerplay with Henry Waxman last week, may make a bid for another, albeit less prestigious position, according to The Hill.
John Dingell
Dingell’s supporters on the committee are said to be encouraging the 82-year-old congressman to take the chairmanship of the panel’s Health subcommittee, which would give him a platform to introduce his version of univerisal healthcare. In every Congress since being elected in 1955, Dingell has introduced universal healthcare reform legislation, The Hill points out.
“Healthcare has been his passion since he was elected,” according to a top aide to one of the lawmakers who pitched Dingell on the idea. “National healthcare is his life’s dream.”
Presumably, this does not thrill Frank Pallone Jr., the New Jersey Democrat who chairs the Health panel. A spokesman tells The Hill that he had not heard about the possibility of Dingell taking the gavel, and adds that Pallone doesn’t want to give it up. Pallone supported Waxman over Dingell, by the way. Meanwhile, a Dingell spokesman did not comment.
The musical chairs occur against a backdrop of confused maneuvering among committee staffers who are jostling for jobs amid the regime change.
Health policy news is just 1 percent of all news
A study from the Kaiser Family Foundation and the Pew Research Center’s Project for Excellence in Journalism found that news about health and health care made up 3.6 percent of all news content from January 2007 through June 2008.
It found that 42 percent of stories were about specific diseases or conditions, with cancer receiving the most attention (10 percent of all health coverage).
Thirty-one percent of health news focused on public health issues, including potential epidemics and contamination of food and drugs.
The smallest category of stories focused on health policy or the health care system (27 percent) of all health news, or less than one percent of all news content. This category includes stories on topics such as Medicare and Medicaid, the uninsured, health care costs, and proposals for reform of the health care system.
For the study, 3,513 health stories were analyzed from 48 news outlets, including newspapers of all sizes, network newscasts, cable programmingand online news sites.
Study: Health journalists face ‘entanglements’
A paper just published in BMJ discusses financial ties between medical journalists and the companies they cover. The authors look at three areas of “entanglement”: education of journalists, awards for journalists, and the actual practice of journalism.
The paper points out that industry sponsorship of training of journalists can raise concerns, pointing specifically at the University of North Carolina’s master’s degree in medical journalism, the American Medical Writers Association and the Unity convention.
It also looks at sponsored award programs, such as those sponsored by Eli Lilly, Boehringer Ingelheim and Roche, and says “journalists who accept such prizes may be engendering conflicts of interest.”
The third area of concern, according to the paper, involves “entanglements” - including situations in which companies or their public relations firms provide patients for journalists to interview or when journalists quote sources without disclosing their financial ties to the industry. It also says that television network Accent Health, which is owned by CNN, “overtly offers sponsors, including drug companies, the chance to boost sales of their products.”
The paper does point to AHCJ and its policies as a “way forward:”
“A way forward may be provided by the Association of Health Care Journalists, which has tough rules barring advertising or sponsorship from private, for-profit healthcare entities, including drug companies, device manufacturers, and insurers. And it is encouraging that some media outlets are now asking reporters to routinely report conflicts of interest of quoted sources.”
Obama picks Daschle to head HHS
Former Senate Minority Leader Tom Daschle (D-S.D.) has accepted the position of Health and Human Services secretary in the coming Obama administration, Roll Call quotes Democratic sources as saying. Daschle was also considered for White House health care czar, reports Politico, but the Obama transition team thought he could be more effective with secretary status. “Of all the proposals that Obama wants to enact, health care requires the most input and tough negotiations,” one of the Democratic officials said. “No one knows the House and Senate like Tom Daschle.”
Tom Daschle
If confirmed, Daschle will replace Mike Leavitt in overseeing a $707 billion budget and 64,000-plus employees across numerous government agencies and health programs. Reporters can always check out his book, “Critical: What We Can Do About the Health Care Crisis,” published in February, for clues as to his thinking.
Update: Jacob Goldstein of The Wall Street Journal’s Health Blog offers a summary of Daschle’s views on health care as expressed in his book, “Critical.”
FDA opens offices in China
Following a series of crises involving food and drug products imported from China, the U.S. Food and Drug Administration is opening offices in Beijing, Guangzhou and Shangai this week.
Two recent articles about the safety of imports from China and the FDA’s lack of oversight provide some background:
- Time: Heparin’s deadly side effects - Reporter Bill Powell follows the manufacturing process of heparin in China, noting that “It is jarring to see where a drug like heparin begins.”
- The New York Times Magazine: The safety gap - Gardiner Harris says he has “rarely written about a subject that both branded and generic drug makers wanted to discuss less.”
Culture, history blamed for ‘fattest city’ status
An AP analysis of CDC data has found that Huntington, W.Va., to be the fattest city in the United States: “Nearly half the adults in Huntington’s five-county metropolitan area are obese — an astounding percentage, far bigger than the national average in a country with a well-known weight problem.”
Health officials cite culture and history as two problems contributing to the area’s obesity.
“Covering Obesity: A Guide for Reporters” offers additional background for reporting on societal factors and their influence on obesity rates. From the guide (page 29):
Through generations of living with food scarcity in harsh environments, the Pimas developed a genetic trait that allowed their bodies to efficiently store extra calories for periods of famine, the researchers believe. This genetic adaptation is known as the ‘thrifty gene theory.’
A virtue amid scarcity, the theory goes, the thrifty gene can become a liability when food is abundant. Calories are still stored as though a shortage is looming, and the pounds accumulate.
Reporter wins free conference registration
Congratulations to James Mulder of The (Syracuse) Post-Standard. By filling out the evaluation of the Urban Health Journalism Workshop, Mulder won the drawing for free registration to Health Journalism 2009 in Seattle!
Google takes step toward outbreak detection
The New York Times and The Wall Street Journal report on Google Flu Trends, a Web site that maps flu outbreaks based on people’s searches for terms related to the flu.
Flu Trends was created with guidance from the CDC’s flu surveillance team and the leader of that group says it “maps very closely to the influenza-like trends that we see in the U.S.”
Easier-to-use Hospital Compare data
The Sarasota Herald-Tribune’s David Gulliver was among several reporters who reported earlier this year about the U.S. Health and Human Services’ release of a new component of its Hospital Compare database - the results of a patient satisfaction survey announced at Health Journalism 2008 in March. He recently followed up using updated data in a more comprehensive story, analyzing all three components of the Hospital Compare database - “process” measures, or accepted standards of care; the patient survey; and “outcome” measures - the percentage of patients who died within 30 days of admission from heart attack, heart failure or pneumonia. HHS now updates the patient survey data quarterly, and AHCJ has made it easier for journalists to make their own comparisons. AHCJ has begun generating spreadsheet files, allowing members to use spreadsheet or database software with precision. AHCJ provides key documentation and explanatory material to help you understand the data possibilities and limits.
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Spend a week at the CDC studying public health, meeting sources. Apply for the AHCJ-CDC Health Journalism Fellowships today!
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