Controversy over breast implants spreads across Europe
Filed under: Europe, Government, Pharmaceuticals, Public health
In the wake of the discovery that a leading international manufacturer was found to be using industrial-grade silicone in its breast implants, questions have emerged about the regulatory process that allowed the implants and who is responsible for removing the substandard implants from women who spent thousands to get them.
John Lister
John Lister, the web coordinator of AHCJ’s focus on Europe, explores the controversy surrounding the implants, including the lack of data on how many women in the United Kingdom received them, how the United Kingdom’s National Health Service has been drawn into the business of removing the implants and the regulatory system that allowed the implants in the first place. Lister reports:
But when it came to ascertaining the numbers of women who may have had PIP implants in British private clinics, it became clear there was no comprehensive or reliable data. A working estimate of 40,000 women potentially at risk eventually emerged, while the private clinics said they were not required to remove the suspect implants or replace them with safe ones. Yet the figures that were available showed that for one clinic as many as 7 percent of PIP implants had leaked, well above initial claims of a failure rate of about one percent.
The Reuters enterprise team has a special report on the breast implant scandal and a piece that shows how the regulatory system may be another scandal waiting to happen. It also looks at how, in the United States, the FDA handled an application from that company in 2000.
The history of breast implants is littered with flawed devices, a colorful cast of intertwined players and billion-dollar lawsuits. Reuters reviewed hundreds of pages of police investigation transcripts and financial documents, and interviewed former PIP employees, the company’s suppliers, customers and health experts, to piece together this latest chapter in that history.
Experts offer story ideas for covering health reform
Filed under: Health care reform, Health journalism
More than 30 attendees heard local experts sketch the particular challenges and issues presented by the Affordable Care Act in California in the latest “Implementing health reform in the states” panel, hosted by AHCJ’s San Francisco Bay Area chapter on Wednesday night at the San Francisco Chronicle.
The panel, one of a series sponsored by AHCJ, the Alliance for Health Reform and the Robert Wood Johnson Foundation, began with an explanation of exchanges and what’s happening with their implementation (or lack thereof) around the country by Larry Levitt of the Kaiser Family Foundation.
He posed some story ideas, such as: How vigorously will the states promote enrollment through the exchanges? What sort of variations to the ACA might emerge once states have the ability to ask for waivers in 2017?
Kim Belshe, a board member of the California exchange, and Marian Mulkey of the California HealthCare Foundation discussed the California scene, with lots of detail, touching on the state’s large undocumented immigrant population, the challenge of getting people enrolled (since the law of the land is now “performance” – which means maximum participation), new opportunities for medical professions, such as nurses, to fill gaps in care delivery, and how to ensure coordinated care during the transition period to exchanges so no patient is harmed. This is the accountability part of the ACA, and needs thought and new procedures, Belshe stressed.
Belshe noted that Medicaid (Medi-Cal) is the foundation of reform, a subject which reporters sometimes overlook. Both she and Mulkey noted that California is a national pacesetter when it comes to reform implementation - a story idea in itself.
The session was moderated by Ed Howard, executive vice president of the Alliance for Health Reform.
On Tuesday night, a similar briefing was held at the University of Southern California, featuring Walter Zelman, Ph.D., a professor and director of health science at California State University-Los Angeles; Daniel Zingale, senior vice president of the Healthy California program at The California Endowment; Anthony Wright, executive director for Health Access, a California health care consumer advocacy coalition; and Deborah Crowe, the health care and biotechnology industry reporter for the Los Angeles Business Journal. Howard, of the Alliance for Health Reform, moderated the session.
Zelman posed a number of questions about reform, mostly about exchanges. To a reporter from Orange County, he suggested a story about the origin of the individual mandate – an idea championed by Republicans early on, he noted, and opposed by Obama and many Democrats. To a question about accountable care organizations and bundling, he suggested stories about how fee-for-service medicine is anything but dead.
Wright offered a look at what’s happening in Sacramento, including a hearing held just a few hours before the briefing.
Zingale mentioned the importance of prevention, and how the ACA encourages prevention. He too pointed out how nonprofits in the state can team up with reporters to educate people about the ACA. He said that the more people know about the law, the better they like it.
From a reporter’s perspective, Crowe offered several practical story ideas that reporters can start writing about today.
John Gonzales of the California HealthCare Foundation Center for Health Reporting wrote about the panel and Michelle Levander of the California Endowment Health Journalism Fellowships program offers some of the story ideas mentioned by the panelists.
Special thanks to Colleen Paretty, chair of the Bay Area chapter, and Bill Erwin, of the Alliance for Health Reform, for contributing details about the panel discussions for this post.
Recognizing best health journalism can be inspiring
One of the best things about working at AHCJ is the chance to see the broad range of really strong coverage our members produce.
Whether I’m reading stories about the ways money influences how medicine is practiced, uncovering the mistreatment of vulnerable people, looking at how pollution is affecting public health or investigating flawed health care systems, I am consistently awed by the work health journalists are doing.
I have the opportunity to see this work day in and day out, which is what helps keep me optimistic about the future of journalism. No doubt, we face many challenges, but take a look at the winners of last year’s Awards for Excellence in Health Care Journalism and I promise you will feel better about our business.
That’s why I want to encourage everyone to submit entries for this year’s contest. We re-vamped the categories this year to reflect changes in how news content is being delivered. We recognize that great reporting is being done across platforms and through new partnerships and collaborations.
We want to honor that reporting and make sure the rest of the world sees the value in independent, quality coverage of health and health care issues. Please consider entering your best work of 2011 and encourage your colleagues to do so as well so we can share it and we can learn from it.
Entries must be submitted by 5 p.m. ET this Friday, Feb. 3. Our online entry system makes it easier than ever and our contest committee is standing by to answer last-minute questions.
Share your thoughts on database design for tracking pharma payments to doctors
Filed under: Government, Health care reform, Health data
Curtis Brainard of Columbia Journalism Review reminds reporters that their input is needed on the design of a federal database that will track payments from drug and device makers to doctors.
Investigations and databases, such as Dollars for Docs by Propublica, have revealed payments to doctors who had been accused of professional misconduct, had been disciplined or lacked credentials. Researchers have found evidence that payments can influence doctors’ treatment decisions (PDF).
Provisions in the Affordable Care Act mean that companies will have to report such payments to the Centers for Medicare & Medicaid Services, which will post the data on a public website. CMS has asked for “comments on how to structure this Web site for ultimate usability.”
There are a number of ways to submit your comments, detailed in this Federal Register announcement. Comments must be received by 5 p.m. EST on Feb. 17.
PLoS Medicine article advocates using legal system to stem ghostwriting
An essay published by PLoS Medicine makes the case that the “guest” authors of ghostwritten articles – typically academic researchers who provide little or no input – in medical journals should be held legally liable for damages or deaths caused by the drug or device that is the subject of articles they sign their names to.
The article points out that ghostwriting “openly infringes academic standards and … contributes to fraud” but that journal editors have been ineffective at putting a stop to it.
We argue that when an injured patient’s physician directly or indirectly relied upon a journal article containing false/manipulated safety and efficacy data, then pursuant to the legal authority outlined above, the authors of that article, including guest authors, are legally liable for patient injuries and could be named as defendants.
Xavier Bosch, Bijan Esfandiari and Leemon McHenry, authors of the PLoS Medicine piece, even endorse the theory that the Racketeer Influenced and Corrupt Organizations Act (RICO) could be used, something that was mentioned in an article last year. Other recourses the authors recommend include the False Claims Act and the Anti-Kickback Statute.
See, follow AHCJ’s newest members
Please welcome AHCJ’s newest members. All new AHCJ members are welcome to stop by this post’s comment section to introduce themselves.
- Orly Avitzur, medical editor, Consumer Reports, Tarrytown, N.Y. (@OrlyA)
- Massimo Cecaro, national councillor, Italian Association of Medical Press, Macerato, Italy
- Sylvia Davis, senior editor, WebMD, Atlanta
- Ira Dinerman, independent journalist, Brooklyn, N.Y.
- Marissa Donovan, student, Syracuse, Rensselaer, N.Y. (@MarissaDonovan1)
- Helen Driediger, independent journalist, Bancroft, Ontario, Canada
- Micky Duxbury, independent journalist, Berkeley, Calif. (@mickydux)
- Lisa Eramo, independent journalist, Cranston, R.I. (@Lisa_Eramo)
- Sari Harrar, independent journalist, Quakertown, Pa.
- Laura Kebede, student, University of Missouri, Columbia, Mo. (@kebedefaith)
- Martin Kilgus, editor, SWR Public Radio, Stuttgart, Germany
- Beth Kitchin, assistant professor, University of Birmingham, Nutrition Sciences, Birmingham, Ala.
- Ricki Lewis, independent journalist, Scotia, N.Y. (@rickilewis)
- Teresa Mahoney, student, Columbia University, New York (@TheresaMahoney)
- Matt McMillen, independent journalist, Portland, Ore.
- Becky Oskin, independent journalist, Davis, Calif.
- Bonnie Schultz, independent journalist, Princeton, N.J.
- Lesley Simon, independent journalist, Westfield, N.J.
- Kavin Sundaram, student, University of Iowa, Cedar Falls, Iowa
If you haven’t joined yet, see what member benefits you’re missing out on: Access to more than 50 journals and databases, tip sheets and articles from your colleagues on how they’ve reported stories, conferences, workshops, online training, reporting guides and more. Join AHCJ today to get a wealth of support and tools to help you.
AHCJ opposes taking taxpayer-funded research out of public’s reach
Filed under: Government, Health journalism, Public records, Studies
Congress should not roll back public access to taxpayer-funded research reports, AHCJ wrote in a letter to members of Congress (PDF).
AHCJ is opposing the Research Works Act (H.R. 3699), which would remove the public’s access to medical journal articles about publicly funded research. They are currently available for free to the public no more than 12 months after their publication in a medical journal.
“Our board of directors believes strongly that more transparency, not less, is vital for the public to assess how funds are spent and to benefit from and learn about the research underwritten by the government,” board president Charles Ornstein wrote in a letter to the House Committee on Oversight and Government Reform. “The recently introduced Research Works Act is a step in the wrong direction.”
In the letter, AHCJ rebutted medical publishers’ assertions that the current system doesn’t work.
“We understand the objections of such publishers, who contribute editorial support and fear loss of income,” Ornstein wrote. “But it’s worth noting that much of that support comes from unpaid peer reviewers. And publishers still maintain a year of exclusivity, enabling them to reap profits during the time when interest in research is highest.”
In 2010, AHCJ voiced concerns about a similar bill, which did not become law.
AHCJ weighs in on FCC broadcast transparency proposal
Filed under: Conflicts of interest, Health journalism
AHCJ is supporting a new effort to require broadcasters to report their funding sources online, because that would make it easier for people to recognize infomercials that masquerade as news.
The practice of broadcasting reports that, unbeknownst to viewers or listeners, are paid for by hospitals or other health-care organizations has long been a concern. For example, in 2010 a health reporter for a CBS affiliate in Los Angeles appeared in a segment interviewing a hospital’s chief medical officer – paid for by that hospital. The segment looked like news but the hospital considered it advertising. Viewers were left to guess.
Now, the Federal Communications Commission is proposing rules requiring that sponsorships be posted online in a searchable database. Currently, such information is available only to people who go to the station and ask to review paper files.
In comments filed Thursday with the FCC, AHCJ President Charles Ornstein wrote that AHCJ’s principles oppose giving favored treatment to advertisers and special interests, and having a personal or financial interest in a company being covered.
“Such practices are especially pernicious when applied to matters of health and health care – as they often are – because people make decisions affecting their well-being based on such reports,” Ornstein wrote. “The result is harm to individuals who make the wrong choice based on biased information and increased costs in the health care system that we all pay for.
“Such deceptiveness also threatens the credibility of all journalism. A bright line must be drawn between those who say what they’re paid to say and those who make an independent effort to find out what’s true.”
In 2008, AHCJ joined with the Society of Professional Journalists to provide guidelines opposing what has been called “pay for play.”
For more information about the FCC rules and the issues that prompted them, see this Washington Post story and this column in Columbia Journalism Review. The rules can be found here, and if you’d like to file your own comment, go here. (Use proceeding number 00-168.)
Journalism organizations ask HRSA to clarify how it will exercise restrictions
Filed under: Government, Health data, Health journalism, Public records
The Association of Health Care Journalists and five other journalism organizations asked federal health officials this week to specify how they plan to enforce new rules governing access to the public version of the National Practitioner Data Bank.
In a letter to Mary Wakefield, administrator of the Health Resources and Services Administration, the groups continued to express disappointment in the agency’s restrictions on the data bank’s Public Use File. In the past, reporters have used the file to expose faulty oversight of doctors by state medical boards.
The Health Resources and Services Administration removed the public file from its website in September after a complaint from a doctor who complained information on him was used inappropriately. The agency republished the data last month but put in place restrictions on how the data could be used.
Among the restrictions is a provision that bars users from matching data in the Public Use File with other data sources to identify physicians. If journalists or others are found to have violated the provision, they could be required to return the data and be barred from receiving it in the future.
In the letter to Wakefield, sent Wednesday, the groups asked for answers to several questions:
- What process will HRSA follow to determine whether a reporter has violated the agreement? If a reporter identifies a doctor in a story and also had access to the Public Use File, how will the agency find out whether the reporter used the file to identify the doctor or got the information from another source? Will HRSA ask to see notes and talk to sources? What will the agency do if reporters decline to discuss their reporting methods beyond what appears in their stories?
- What recourse will reporters have if they believe they have been unfairly barred from future access to the file?
- If you ask a reporter to return data, will you take any steps to ensure the data hasn’t been copied or saved elsewhere? If so, what will those steps be?
- How will HRSA address stories written based on copies of the Public Use File downloaded before Sept. 1? Such files are available without restriction on the websites of journalism organizations, and reporters do not need to sign any agreement to access them. Will reporters face penalties if they use the information in a way that HRSA objects to?
AHCJ president Charles Ornstein said he continues to believe that the new restrictions are both ill-advised and likely unconstitutional. But he added, “If HRSA intends to stick to them, it’s imperative that journalists understand how they will be enforced before deciding whether to use this information.”
Other groups signing the letter were Investigative Reporters and Editors, the Society of Professional Journalists, the National Association of Science Writers, the Reporters Committee for Freedom of the Press and the National Freedom of Information Coalition.
Investigative Reporters and Editors, working with AHCJ and the Society of Professional Journalists, has posted the data for download, free to the public.
For more background, please see AHCJ’s Right to Know page or this timeline.
Related
- Secrecy around data bank protects ‘Practitioner No. 222117′
- Numbers reveal how often, or how rarely, states check doctors’ disciplinary records
- Agency’s restrictions on data about disciplined doctors continue to get attention
- Journalism groups protest HRSA restrictions to Sebelius
AHCJ objects to CMS meeting privately with investors
Filed under: Conflicts of interest, Health journalism
Responding to a report that federal health officials met in private with Wall Street investors, AHCJ leadership sent a letter to the acting administrator of the Centers for Medicare and Medicaid Services objecting to the selective release of information to stakeholder groups.
The Project on Government Oversight reported earlier this month that a dozen senior staff at CMS met with five Wall Street professionals for nearly two hours in 2009 and that a senior CMS analyst filed an ethics complaint about it.
AHCJ’s letter, signed by president Charles Ornstein, states, “We feel strongly that journalists should receive information from CMS no later than other groups. If guidance or previews are provided to special interest groups, it also should be provided to journalists, who inform the public.”
The letter to acting CMS administrator Marilyn Tavenner was sent on Dec. 15.
AHCJ does not seek to prevent CMS from meeting with members of the public including stakeholders. Nor is the group asking for journalists to receive confidential information from the agency about pending decisions.
“But we don’t think the public should be the last to know about CMS actions. Journalists should be in the loop when information is released,” the letter said.
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- Apply for fellowships to attend Health Journalism 2012
- AHCJ asks Supreme Court to permit broadcast of arguments in health reform case
- Tips for print, online journalists to embrace broadcast opportunities
- Numbers reveal how often, or how rarely, states check doctors’ disciplinary records
- How I did it: Falsified charts in nursing homes linked to patient care
- Access Denied: Looking at a lack of health care availability
- Transparency & medical errors: Public reporting of patient harm is a potent force
