GAO: FDA designation doesn’t ensure safety
Filed under: Government, Hot Health Headline, Studies
On his blog Cold Truth (and on AOL News), Andrew Schneider brought our attention to the GAO’s recent investigation into the well-known FDA loophole created by the “generally regarded as safe” or GRAS designation.
The GRAS designation is meant to spare manufacturers lengthy and expensive testing that might otherwise slow the flow of new products to market. It’s conferred, Schneider writes, as long as a “scientific panel selected by the manufacturer can rule that no harm will result from the intended use of an additive.”
Schneider’s version of the highlights of the GAO report:
- The FDA generally doesn’t know about most of these determinations of “generally regarded as safe,” or GRAS, because companies are not required to inform the agency.
- The FDA has not taken steps that could help ensure the safety of additives listed as GRAS.
- Food products may contain numerous ingredients, including GRAS substances, making it difficult, if not impossible, for public health authorities to attribute a food safety problem to a specific GRAS additive.
- The FDA does not systematically reconsider the safety of GRAS substances as new information or new methods for evaluating safety become available.
The GAO said nanomaterials and imported additives were of particular concern.
(Hat tip to OMB Watch in general and Matthew Madia in particular)
WebMD, Eli Lilly and a quiz about depression
Filed under: Conflicts of interest, Health journalism
Sen. Chuck Grassley, the prolific writer of public letters who often assumes the mantle of health consumer advocate, is at it again. This time he’s taking on consumer health information giant WebMD, whose ties with Eli Lilly seem to stretch back for some time. At issue is a WebMD quiz that purported to determine a user’s risk of depression. The fishy part? Until WebMD modified the quiz following Grassley’s letter and other outcry, even users who answered “no” to every question would be given the warning that “You may be at risk for major depression.”
As Daniel Carlat points out on his blog, the following disclaimer appeared at the top of the page: “This content is selected and controlled by WebMD’s editorial staff and is funded by Lilly USA.” As Carlat points out, 9 of the 10 symptoms in the quiz are taken from standard diagnostic criteria, but the one that isn’t (which relates to physical pain) just happens to dovetail perfectly with the pain-relief market Lilly is trying to carve out for Cymbalta.
Because Lilly markets Cymbalta as the “go to” antidepressant for patients who have both depression and physical pain. This is not really a “depression screening test” at all. Instead, it is a “Cymbalta-requester” screening test.
WebMD is telling the public a big lie. The say that “this content is selected and controlled by WebMD’s editorial staff” when in fact the crucial aches and pains questions was selected by Eli Lilly’s marketing team to encourage patients to ask their doctors for Cymbalta.
Grassley’s letter requested that WebMD respond with the details of their relationship to Eil Lilly by March 4. I didn’t find any evidence that such a response has yet been received.
Express-News investigates Texas nursing homes
Filed under: Hospitals, Hot Health Headline, Public records
San Antonio Express-News reporters Karisa King, John Tedesco and Melissa Fletcher Stoeltje took advantage of a number of tools to assemble a broad investigation into the city’s nursing homes.
Slow action on nursing home problems
In the package’s centerpiece, the reporters plowed through 2,200 claims filed against the town’s 55 licensed nursing homes from 2006 to 2009 and found that investigators arrived long after the incidents in question and marked so many claims “unsubstantiated” that the state attorney general posted a notice advising residents that they should take even unsubstantiated claims into account when evaluating nursing homes. They also consulted ratings and visited 10 local nursing homes.
With the ratings as a guide, the newspaper examined more than 3,000 pages of abuse and neglect investigations and annual inspections of 10 nursing homes with the lowest scores. It also reviewed dozens of wrongful-death lawsuits filed against local nursing homes to examine how Texas watches over its elderly.
In addition to a few dangerous homes and some disquieting anecdotes, the reporters found an unenforced reporting law:
(Department of Aging and Disability Services) also is failing to enforce a state law that requires nursing homes to report details about every resident who dies. State officials are supposed to analyze the fatality reports to publicize problems and trends, but that research isn’t being done.
To top off this tale of dysfunction, they also unearthed at least five cases in which would-be nursing home whistle blowers were fired.
Stoeltje added a sidebar on nursing home rating systems, their utility and their shortcomings. She addresses both the local Texas system and the federal Nursing Home Compare database. She talks to both nursing home operators and patient advocates; the operators tend to dwell on ratings’ weaknesses while advocates spoke on their strengths.
LIST: Examples of problems found at nursing homes
Six more examples culled from complaints and often backed with interviews.
MAP: Quality of nursing homesA Yahoo! map linking nursing home location, size and rating.
Texas Public Radio
Terry Gildea, host of a news discussion program called “The Source,” interviewed all three Express-News reporters about their investigation.
Slim guide:
Covering the Health of Local Nursing Homes
This reporting guide gives a head start to journalists who want to pursue stories about one of the most vulnerable populations – nursing home residents. It offers advice about Web sites, datasets, research and other resources. After reading this book, journalists can have more confidence in deciphering nursing home inspection reports, interviewing advocacy groups on all sides of an issue, locating key data, and more. The book includes story examples and ideas.
AHCJ publishes these reporting guides, with the support of the Robert Wood Johnson Foundation, to help journalists understand and accurately report on specific subjects.
• More investigations of nursing homes
• Aging Nation: Troublesome Health Care Issues
• Headlines an advocate for seniors would like to see
• The impact of aging upon health care
• Covering nursing homes and other issues of aging
• How will retiring boomers affect the national health agenda?
• You Can Run, but You Can’t Hide: Policy and Problems in Long-Term Care
• Biology of Aging: Sources and Resources
Google charts health data from CDC, World Bank
Google has removed another step between people and information with the release of its new Public Data Explorer. It’s a service through which Google links neat, tidy and reputable sets of data with a beefed-up version of its chart programs.
Right now it’s limited to 13 data sets, though Google implies that it will continue to expand those offerings based on demand. Those data sets include three that are powered by the CDC’s WONDER data delivery platform.
Data from the World Bank includes international numbers on things such as fertility rates, births attended by skilled health staff, rates of immunization against measles, prevalence of HIV, life expectancy and more. You also can find statistics on the U.S. population from the Census Bureau.
At present, the limited selection mean that it probably won’t be useful for more than a handful of stories, but it’s something to keep an eye on as Google continues to add data and customization options.
Here’s a quick example mapping U.S. cancer rates (circle color) and number of cases (circle size) by state.
NOTE: If you can’t see the visualization, you’ll probably need to upgrade your browser.
Schneider: FDA lacks resources to keep food safe
Writing for AOL News (and his blog, Cold Truth) Andrew Schneider writes that the hydrolyzed vegetable protein recall reminds us that, no matter what was said in the wake of last year’s peanut butter recall, the FDA still doesn’t have the ability to pay close attention to source foods that are destined to end up in hundreds of different products.
In this most recent case, it was a test by a supplier, not an FDA representative, that caught the contaminated additive.
The FDA conducted an investigation at the company’s Las Vegas facility after a food producer that bought the flavoring from Basic Food Flavors notified federal agents that it had found Salmonella Tennessee in the vegetable protein.
In answer to the criticism about its actions during the peanut episode, FDA officials said they have no way knowing to whom suppliers sell their food products, what those products are and where they’re sold. The FDA says it doesn’t have the personnel or the needed regulations to handle the millions of shipments made within the food industry every week.
But what was seen with the dangerous peanuts, and what we’re beginning to see with the flavoring agent, is that producers of end products — those items that actually reach store and warehouse shelves — are declaring their own voluntary recalls.
Patient data errors force VA to close EMR system
Nextgov’s Bob Brewin reports that errors in patient data have forced the Department of Veterans Affairs to close access to the Bidirectional Health Information Exchange, the Defense Department’s vast electronic medical record system. The bug first surfaced in February when a physician noticed that the system claimed one of his female patients had been prescribed an erectile dysfunction drug. The errors have been blamed on old code in the six-year-old system which could not handle peak usage rates.
The glitch did not cause harm to any patient, but “the potential exists for decisions regarding patient care to be made using incorrect or incomplete data,” said Jean Scott, director of the Veterans Health Administration’s Information Technology Patient Safety Office, in the alert issued on Wednesday.
… The VA clinician may see the patient’s data during one session, but another session may not display the data previously seen,” the alert noted. “This problem occurs intermittently and has been reported when querying DoD laboratory, pharmacy and radiology reports.”
The system is expected to go back online March 9. Until then, Brewin writes, “VA doctors will have to obtain a patients’ health information from their paper medical files, faxes or PDF attachments that are e-mailed to the physicians.”
According to its tagline, Nextgov focuses on “Technology and the Business of Government.”
Kidney swap connects six in small Mo. town
Filed under: Health journalism, Hospitals, Hot Health Headline
Joy Robertson of KOLR-Springfield, Mo., tells the story of the coincidences and generosity that led to six residents of Licking, Mo., (population 1,471) swapping kidneys in a St. Louis hospital. Here’s a quick timeline, to give you an idea of how it all came together.
- Licking resident Stephanie Hood needed a kidney.
- Friends Randy and Melissa Lewis wanted to donate one for her, but neither was a match.
- Randy decided to donate his kidney anyway.
- Carrie Goforth, a 29-year-old Licking mother on dialysis, was a match for Randy.
- Meanwhile, Melissa Lewis decided to donate her kidney as well.
- Hers went to Gern Beasley, another Licking resident.
- Finally, Stephanie Hood, the patient who started it all, also got the kidney she needed. Her donor? Her cousin Diane. From Licking.
Reporting on kidney donation
Josephine Marcotty of the Minneapolis Star Tribune recently wrote a series addressing the increasing demand for kidneys, a need spurred by an aging population, increases in diabetes, obesity and high-blood pressure. In a recent AHCJ article, she explained how the story came together and how other reporters can follow in her footsteps and expand upon her work.
Health care reporting among SABEW winners
Health care reporting fared well in this year’s Society of American Business Editors and Writers Best in Business Writing competition as the business of health care took center stage in many publications and earned awards for both breaking news and in-depth packages. The health-related winners:
Breaking news
Real-time News Organizations
- Dow Jones Newswires: “Deep Coverage On Drug Deal”
- Reuters: “H1N1 Flu: The Global Story”
Enterprise
Small Publications
- Sarasota Herald-Tribune: “Contaminated Chinese drywall”
Weekly Publications
- Pittsburgh Business Times: “Eli Lilly details payments to docs”
Projects
Giant Publications
- The New York Times: “Toxic Waters”
Large Publications
- Dallas Morning News: “The Cost of Care”
Magazine Enterprise
Small
- Bloomberg Markets: “Big Pharma’s Crime Spree”
Mental health parity law implementation evolves
Filed under: Government, Health care reform, Hot Health Headline
Writing for Kaiser Health News and The Washington Post, Sandra Boodman considers the effect that the American mental health parity law has had since it went into effect on Jan. 1.
The law applies to about 140 million Americans, Boodman writes, most of whom are insured by employers with more than 50 employees. For qualifying groups, “Higher deductibles, steeper co-pays and other restrictions are no longer allowed for mental health and substance abuse treatment.” It doesn’t apply to individual policies and doesn’t require employers to offer mental health coverage of any kind.
There are still questions about the implementation of the law, many of which are addressed in the Obama administration’s implementation plan (PDF), which should take effect on July 1.
Officials of key business and insurance industry groups said they were displeased that the regulations were “more expansive” than they believe lawmakers intended. Mental health advocates applauded the rules, which they said would help ensure that Americans battling schizophrenia, for example, receive the same level of care provided to those facing leukemia.
Federal officials estimate that complying with the law will increase premiums nationwide by four-tenths of 1 percent, or about $25.6 billion over 10 years. Employers are free to drop mental health and substance abuse coverage and are allowed to manage claims to determine if treatment is medically necessary, just as they do now for physical ailments, but the standards can no longer be more stringent. Plans are also allowed to exclude treatment for certain illnesses, such as eating disorders, as long as state law does not mandate coverage. There is also an escape hatch: Plans that can prove that their costs increased by more than 2 percent in the first year can file for an exemption.
Fortunately, it looks like that sort of cost increase will be rare, based on research that shows similar rules improved access without increasing cost.
For some background on the mental health parity law, check out MIWatch.org.
Sourcebook expands ideas for local reporting
The latest version of the Covering Health Issues sourcebook has been updated with even more examples of how reporters have used it for local stories. For example, the section on Mental Health and Substance Abuse links to nine related stories and four additional related resources. Those stories included cuts to Tennessee’s mental health agency, a profile of aMichigan troupe that blends acting and therapy and possible changes to mental health care for inmates in California’s Ventura County.
It’s a handy place to check when you’re looking for examples of how to localize certain topics, especially since you’ll also be to pull relevant facts and background from the accompanying chapter of the sourcebook.
The print version of the sourcebook was distributed to AHCJ members last year.
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Health Journalism 2010, AHCJ's annual conference, features a world-class program with story ideas, sources, stronger reporting skills, chances to meet newsmakers and network with other journalists.
- 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
- Shortened Lives: How location, lifestyle affect health
- Covering a complex story for the long haul
- Aging in the 21st Century: Presentations and tip sheets
- AHCJ calls for better information from Joint Commission Web site
