Identical tubing demonstrates FDA’s inaction
In The New York Times, Gardiner Harris outlines the problem of medical tubing that looks very similar – leading to medical errors – then deftly works his way up the chain in an attempt to find the source of device regulator’s failure to solve a problem that seems entirely solvable.
Many medical device tubing looks the same, which leads to horrific mix-ups like the delivery of food straight into the bloodstream. In 2007, The Wisconsin State Journal’s David Wahlberg earned first place in the medium newspapers category of AHCJ’s Awards for Excellence in Health Care Journalism for his Medical Misconnections series, which detailed the same problems. He even wrote an AHCJ article teaching journalists how to investigate patient safety problems.
Photo by bennylin0724 via FlickrSince then, not much has changed. Which is not all that surprising, when you consider that not much had changed in the decades before Wahlberg’s story either. Harris’ mission is to dig past the finger-pointing and figure out why. In the end, it all seems to point to some remarkable systemic flaws in the FDA’s device approval system, as well as an unwillingness on the industry to change without the threat of brute regulatory force. In addition to compelling analysis, Harris punctuates each argument with a few spicy quotes.
You’ll have to read Harris’ story to truly understand the perversity of the FDA system and how its lent such inertia to the status quo, but here’s a sample:
Dr. Robert Smith, an F.D.A. device reviewer who left the agency on July 31 and was among nine agency employees who in 2009 decried the agency’s device approval process as illegal and dangerous, said that the tubing problem, which has gone on for decades, was another example of how the agency failed to protect the public. “F.D.A. could fix this tubing problem tomorrow, but because the agency is so worried about making industry happy, people continue to die,” Dr. Smith said.
And, from Nancy Pratt, a senior vice president at Sharp HealthCare in San Diego who believes that “Nurses should not have to work in an environment where it is even possible to make that kind of [tubing] mistake.”
“The regulators have been waiting for the manufacturers to come up with a solution,” Ms. Pratt said, “and the manufacturers won’t spend the money to design and produce something different until the regulators force them to. And now the international standards organization is taking forever to get the whole world onto the same page.”
AHCJ pushes for access to publicly funded research
Filed under: Government, Health data, Health journalism, Public records, Studies
The strong public interest in “direct, free and full text access to research articles” prompted the Association of Health Care Journalists to send comments to the House Oversight and Government Reform committee.
The letter [PDF] was in support of full-text access to the fruits of publicly-funded research to members of Congress considering H.R.5037 – Federal Research Public Access Act of 2009. One section of that bill would require researchers who receive funding from federal agencies to provide free online public access to final peer-reviewed manuscripts or published versions as soon as practicable, but not later than six months after publication in peer-reviewed journals.
While AHCJ did not take a position on the specifics of the bill, the group highlighted the strong public interest in “direct, free and full text access to research articles,” noting that for journalists to be able to provide readers and audiences with accurate and comprehensive reporting, they need to be able to see the full details of research reports, not merely the highlights contained in abstracts or news releases.
“The fundamental principle at issue is the public’s right to examine both the evidence produced by research studies and the methods employed by researchers. When the researchers are supported by taxpayers, the public’s claim is even stronger,” AHCJ’s statement read in part.
The statement took note of the concerns of some publishers who fear the mandate could cut into their income, while also pointing out that other publishers already provide free online access to the full text of research articles within six months of publication.
Related:
Bill would require public access to research
Journalists visit CDC to learn latest about flu
Filed under: Government, Health journalism, Public health
Fourteen journalists, sponsored by AHCJ, are wrapping up a two-day workshop at the CDC about covering influenza. The workshop included a series of on-the-record sessions with CDC experts to prepare front-line journalists for the upcoming flu season. Public health experts are providing a primer on the flu, examine how it is being tracked, expectations for vaccines and antivirals, and what communities can do to deal with the fallout.
Speakers included CDC Director Thomas Frieden and Anne Schuchat, M.D., director, National Center for Immunization & Respiratory Diseases, as well as a number of other experts.
The AHCJ-sponsored journalists are:
- Diane Chun , health and science writer, The Gainesville (Fla.) Sun
- Tom Corwin, science and medicine reporter, The Augusta (Ga.) Chronicle
- Dawn Davis, writer, Caribbean Today
- Dana Felty, features reporter, Savannah (Ga.) Morning News
- Karen Garloch, medical writer, The Charlotte (N.C.) Observer
- Joe Goldeen, health-care reporter, The (Stockton, Calif.) Record
- Nina Hemphill Reedern, health and fitness editor, Upscale Magazine
- Sandy Kleffman, health care reporter, Contra Costa Times/Bay Area News
- Valerie Lego, health reporter, WZZM-Grand Rapids, Mich.
- Andy Miller, independent journalist, Atlanta
- Sonia Morgan, assistant editor, CN Media
- Shanderia Posey, healthscene editor, The (Jackson, Miss.) Clarion-Ledger
- Cynthia Roby, journalist, South Florida Times
- Olivier Uyttebrouck , health/general assignment reporter, Albuquerque Journal/Albuquerque Publishing Co.
Some of the journalists have already written about the seminar and they all will take what they learned this week home to help them report on influenza for their local readers and viewers.
- Flu vaccine no longer just for “high risk” groups, Dana Clark Felty, Savannah (Ga.) Morning News
- CDC: Flu vaccine development needs to improve, Valerie Lego, health reporter, WZZM-Grand Rapids, Mich. Lego has been tweeting from the seminar.
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)
PTSD or personality disorder? It matters to soldiers
Filed under: Government, Health journalism, Health policy, Studies
The AP’s Anne Flaherty has put together a story that illuminates the Army’s refusal to admit that it could have misdiagnosed (and discharged) hundreds of soldiers who may have had PTSD or traumatic brain injury instead of a personality disorder. Keep in mind that a discharge for “personality disorder” means no veterans’ benefits and a lifetime of stigma. A diagnosis of PTSD or injury, on the other hand, means treatment will be covered by the government.
Photo by isafmedia via FlickrThe Army, for its part, has decided there’s nothing unusual about the following chain of events (taken from Flaherty’s story):
- The Army “discharged about a 1,000 soldiers a year between 2005 and 2007 for having a personality disorder.”
- In 2007, The Nation’s Joshua Kors writes a cover story exposing the Army’s apparent habit of diagnosing soldiers with a personality disorder instead of considering the possibility of PTSD or traumatic brain injury.
- Soon after, “the Defense Department changed its policy and began requiring a top-level review of each case to ensure post-traumatic stress or a brain injury wasn’t the underlying cause.”
- Sure enough, “the annual number of personality disorder cases dropped by 75 percent.”
- At the same time, the number of post-traumatic stress disorder cases has soared. By 2008, more than 14,000 soldiers had been diagnosed with PTSD — twice as many as two years before.
- Army officials “reviewed the paperwork of all deployed soldiers dismissed with a personality disorder between 2001 and 2006″ and said they “did not find evidence that soldiers with PTSD had been inappropriately discharged with personality disorder.”
EPA changes would improve public access to data
Filed under: Government, Health data, Health policy, Hot Health Headline
A recent OMB Watch story covers the EPA’s latest attempt to leverage the Toxic Substances Control Act to make it easier for the public to access chemical data and harder for manufacturers to hide health and safety related information behind the “trade secrets” label.
Fire and emergency response personnel practice techniques for hazardous materials containment and removal. (CDC photo)
The key is the expansion of the Inventory Update Reporting rule, which requires companies to report toxic substances over a certain weight threshold. According to OMB Watch, the Bush administration bumped this threshold from 10,000 to 25,000 pounds, and decreased reporting frequency from every four years to every five years.
The proposed rule lowers or eliminates thresholds for reporting and increases reporting frequency, moves that should provide the public with more information on more chemicals. The amount of a chemical manufactured at a facility in any given year fluctuates widely. … EPA’s proposed rule would require a manufacturer to submit information on a chemical if the volume exceeds the 25,000-pound threshold for any year since the previous submission. The agency is also proposing to return the reporting frequency to every four years rather than every five. Additionally, EPA is proposing requiring all reporters to submit data on the processing and use of the chemicals. The current program requires such reporting only for chemicals manufactured or imported over 300,000 pounds.
The manufacturers would use EPA-provided software to report their chemical inventory – currently, most manufacturers submit paper reports. The paper reports take years to process and the data-entry process introduces extra error into the system.
Another proposed change would require reporting of a number of valuable pieces of information, such as yearly production volumes, more specific chemical names and numbers to ensure the correct chemical substances are identified, and the approximate number of workers exposed to the chemicals.
Furthermore, manufacturers currently can label just about anything as “confidential business information,” the new rules would place annual limits on the practice and require manufacturers to justify any such designations.
The Society of Environmental Journalists wrote about the issue back in March and included a link to a report [PDF] from the EPA’s Inspector General, as well as other coverage.
Forum offers stats on well-being of elderly
Filed under: Government, Health data, Health journalism, Studies, Tools
AgingStats.gov is an often-overlooked federal clearinghouse of aging-related data from the Federal Interagency Forum on Age-Related Statistics. It focuses on summary reports.
Its latest effort, Older Americans 2010: Key Indicators of Well-Being (174-page PDF), summarizes 37 key indicators it believes are broadly relevant and easy to understand. By my count, 24 of those are explicitly health-related.
Everything is illustrated with an abundance of charts and maps, and an emphasis on bulleted summary and analysis helps keep things accessible. Those looking for a deeper dive into the summary numbers will want to head to the appendix.
As part of its health sections, the report contains seven “Health Status” indicators, including chronic health conditions, depressive symptoms, sensory impairments and oral health, and functional limitations.
One example:
It also includes eight “Health Risks and Behaviors” – things like diet, air quality, mammography and vaccinations – and nine “Health Care” indicators, including expenditures, prescription drugs and residential services.
The forum, which nobody seems to refer to by the acronym FIFARS, has been around since 1986. Participants include the Census Bureau, a number of Health and Human Services departments (AHRQ, CMS, NCHS and others), HUD, the Bureau of Labor Statistics, the Department of Veterans Affairs, the EPA, the Office of Management and Budget, and the Social Security Administration.
Thanks to AHCJ member Eileen Beal for suggesting this as a tool other members might find helpful.
Fraud-busting contractors slow to refer cases
Despite recent high-profile busts, the private contractors hired by Medicare to sniff out fraud cases and refer them to law enforcement seem to be lagging, according to recent government reports. The Associated Press’ Ricardo Alonso-Zaldivar reported on investigations that found that contractors took an average of 178 to refer fraud cases, and that the government was only able to recover a small fraction of the money identified as lost to fraudsters (OIG report | Testimony).
As this letter summarizing the congressional investigation shows, Iowa Sen. Chuck Grassley is on the case. He’s looking to figure out how much the fraud hunters are paid ($102 million in 2005) and how that balances with their benefit to taxpayers ($55 million recovered by the feds in 2007). The numbers are tricky, Alonso-Zaldivar writes, because fraudulent claimants have a habit of closing up shop and disappearing as soon as they’re notified of the pending investigation. Thus, the fraudbusters can’t be blamed entirely for the collection failures, though their tardy referrals are at least partially responsible.
The contractors have widely different track records. One identified $266 million in overpayments in 2007, while another found just $2.5 million, the Health and Human Services inspector general said in May.
Earlier, the inspector general found gaping differences in the number of new cases the contractors generate for law enforcement. Some had hundreds of cases, while others were in the single digits. Most were doing a poor job at spotting new fraud trends, with “minimal results from proactive data analysis,” the inspector general concluded.
The Obama administration says it’s aware of the problem and is close to completing a reorganization of the contractors, to consolidate their work, define their jurisdictions more clearly, and help them coordinate better with claims processors and law enforcement.
The new “Zone Program Integrity Contractors” will cast a somewhat wider net, and be more closely monitored by federal health officials.
Related
- Investigating health care: Essential public records
- Duff Wilson: Investigating health care fraud
- Reporting on the business of health care
- Center for Public Integrity writer says listserv led to Medicare-fraud story
(Hat tip to Ricardo-Alonzo Zaldivar for providing a copy of the Grassley letter)
Health IT moves forward, regulation doesn’t
Filed under: Government, Health policy, Hot Health Headline
Fred Schulte and Emma Schwartz report that while the Obama administration plans to create a digital medical file for every American by 2014, “the administration has established no national mandatory monitoring procedure for the new devices and software. That no process exists to report and track errors, pinpoint their causes and prevent them from recurring is largely the result of two decades of resistance by the technology industry, a review of government records and interviews by the Huffington Post Investigative Fund shows.”
Major HIT malfunctions continue – they focus on one of 10 hospitals in the Trinity Health System in the upper Midwest – and nobody has a grip on their location or frequency. Meanwhile, the administration has issued regulations for HIT implementation that make no mention of safety and quality standards, standards the FDA has been considering for some time.
CDC: Obesity rises unabated, no state meets goals
Filed under: Government, Health policy, Hot Health Headline
According to Vital Signs, a new part of the CDC journal Morbidity and Mortality Weekly Report (more on that in a minute), the number of adults whose self-reported numbers indicated obesity rose 1.1 percent between 2007 and 2009. Nationally, 26.7 percent of adults were obese in 2009, a number that’s even higher for non-Hispanic blacks (36.8 percent), Hispanics (30.7 percent) and folks who didn’t graduate from high school (32.9 percent.) [PDF transcript of today's briefing.]
States ranged from Mississippi (34.4 percent) to Colorado (18.6 percent) and none met the federal Healthy People 2010 obesity target of 15 percent.
Healthy People 2010 was started by the HHS in 2000 as an effort to improve public health and eliminate disparities across the country. Obesity percentages were a key benchmarks, as were tobacco use, access to health care, mental health, environmental quality and immunization.
The objectives for Healthy People 2020 are being considered now. They would keep the obesity-related goals from the 2010 effort and augment them with nutrition-based standards.
The CDC says Vital Signs, which will be published on the first Tuesday of each month, “is designed to provide the latest data and information on key health indicators – cancer prevention, obesity, tobacco use, alcohol use, access to health care, HIV/AIDS, motor vehicle passenger safety, health care-association infections, cardiovascular health, teen pregnancy, infant mortality, asthma and food safety.”
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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
