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.
BMJ analysis reveals widespread publication/selection bias in research
Filed under: Conflicts of interest, Government, Health data
Reporting on a study released by BMJ and characterized as an almost existential threat to the medical research system by Dr. Harlan Krumholz, the Milwaukee Journal Sentinel’s John Fauber writes that “Drug research, even from clinical trials sponsored by the federal government, routinely is suppressed, harming patients and increasing health care costs.” The emphasis is mine, the strong language Fauber’s.
The conclusions are based on a survey of meta-analyses of individual participant data, which the authors broke down by data source characteristics and publication status. The work is heavy on statistical analysis, but even lay readers can understand the broad strokes of what appears to be a widespread issue.
Steve Nissen, the lead author of the analysis, said 35 of the 42 studies he looked at were unpublished and were obtained only because a court case required the drug’s maker, GlaxoSmithKline, to turn over the data.
And it isn’t just pharmaceutical companies’ financial concerns driving the suppression, Nissen and his coauthors found. At that point, it may more of an issue of confirmation bias and other problems which have always lurked within academic research.
A surprising finding in the BMJ analysis was that serious lapses occurred even in clinical trials funded by the National Institutes of Health.
That research showed that less than half of NIH-funded clinical trials were published in a medical journal within 30 months of the completion of the trial and after 51 months, one-third of trials remained unpublished.
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.)
Project looks at problems in how deaths are investigated
Filed under: Aging, Conflicts of interest, Health data, Health policy, Hot Health Headline, Public health, Public records
The results of a yearlong joint investigation of the American autopsy system by ProPublica, Frontline and NPR show that problems in the death investigation system throughout the country have led to innocent people being sent to prison, “allowed the guilty to go free and left some cases so muddled that prosecutors could do nothing.” When autopsies aren’t done, diagnostic errors go undetected and opportunities to learn more about medicine are lost.
One story of patient rights and legal wrangling sports the remarkable headline “Why Can’t Linda Carswell Get Her Husband’s Heart Back?” It hinges, among other things, on the simple fact that “Even though the Institute of Medicine has reported that medication errors affect an estimated 1.5 million patients per year, it is not typical to conduct toxicology tests as part of clinical autopsies. They are routine in forensic autopsies.”
Another piece takes a broader view, exploring the reasons behind and consequences of the fact that autopsies are performed on only about one in 20 patients who die in hospitals when, 50 years ago, the rate was one in two.
Hospitals aren’t required to perform autopsies – the Joint Commission hasn’t included autopsy rates in its accreditation process since 1971 – and neither Medicare nor private insurers reimburse hospitals for the procedures, which Allen found cost about $1,275 each. The implications of these financial disincentives, combined with related factors such as some physicians’ confidence that new diagnostic tools such as MRIs and CT scans provide such accurate results that they obviate the need for postmortem work, are far-reaching.
Diagnostic errors, which studies show are common, go undiscovered, allowing physicians to practice on other patients with a false sense of security. Opportunities are lost to learn about the effectiveness of medical treatments and the progression of diseases. Inaccurate information winds up on death certificates, undermining the reliability of crucial health statistics.
Furthermore…
A 2002 review of academic studies by the federal Agency for Healthcare Research and Quality found that when patients were autopsied, major errors related to the principle diagnosis or underlying cause of death were found in one of four cases. In one of 10 cases, the error appeared severe enough to have led to the patient’s death.
Other stories in the project report that suspicious deaths of the elderly are rarely investigated and that the deaths of children “pose special technical challenges for forensic pathologists.”
Watch the full episode. See more FRONTLINE.
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.
Medicaid programs slow to act against system exploiters
Filed under: Conflicts of interest, Health data, Hot Health Headline, Public records
At ProPublica, senior reporters Charles Ornstein and Tracy Weber have published the latest turn in their ongoing analysis of conflicts of interest, problem physicians and the disciplinary systems meant to reign them in. This time, they look at Medicaid in Florida and find at least three instances when the state “allowed physicians to keep treating and prescribing drugs to the poor amid clear signs of possible misconduct.”
Their piece revolves around those key examples – two of which were, in all seriousness, brought to their attention by a Scientologist-run watchdog website – and I strongly recommend you read the whole thing for the details. Below, I’ve just highlighted the bigger picture.
In general, Ornstein and Weber found, state Medicaid programs, as well as the federal Centers for Medicare and Medicaid Services, which doesn’t track relevant state data, have failed to act on information which seems to strongly indicate that certain physicians are abusing or exploiting state programs.
Medicaid programs across the country have long had evidence that physicians have been prescribing risky drugs in excess and perhaps to the wrong patients. These prescriptions also racked up huge bills for the programs.
But like Florida, many states did not act on that evidence. Last year, (Sen. Charles) Grassley demanded data from each state about its highest prescribers of pain pills and antipsychotics, and he asked state and federal officials to determine whether the prescriptions written by these doctors were legitimate.
KevinMD: Media is key to curbing MRI overuse
Filed under: Conflicts of interest, Health journalism, Health policy, Hospitals
On the MedPage Today outlet KevinMD.com, Dr. Kevin Pho himself writes that media coverage of the overuse of certain screening procedures is “long overdue,” and praises The New York Times‘ recent coverage of a study showing that in some cases MRIs can lead to more harm than good.
In the Times, reporter Gina Kolata explained, when unleashed upon the throwing shoulders of 31 healthy professional baseball pitchers, “M.R.I.’s found abnormal shoulder cartilage in 90 percent of them and abnormal rotator cuff tendons in 87 percent.” It’s a result, Kolata wrote, that shows that MRIs are “easily misinterpreted and can result in misdiagnoses leading to unnecessary or even harmful treatments.”
Back at his web portal, Pho writes that there are two steps that need to be taken to curb the overuse of the MRI. The first is cracking down on physicians who own their own MRI machines or otherwise profit from the tests, and the second is what he calls “adjusting patient expectations.” That’s where, he says, the media comes in.
there are some, but not all, patients who expect a scan and equate an MRI with “being thorough.” In fact, when orthopedic fellows cited in the Times story suggest that patients may not need a scan, patients “look at them like, ‘You don’t know what you’re doing.’”
Doctors can help educate patients away from the mythical benefits of overtesting. But the most effective teacher is the media, which wields significantly more influence. That’s why a story like this in the Times should be applauded, and promoted.
A fun aside? The study was conducted by none other than Dr. James Andrews, whose name will be familiar to anyone with even a passing familiarity with the sports pages.
Ohio’s hospital transparency law under fire
Filed under: Aging, Conflicts of interest, Europe, Government, Health care reform, Health data, Health journalism, Health policy, Hospitals, Hot Health Headline, Member news, Public records, Studies, Tools
Thanks are due to blogger and one-time hospital executive Paul Levy for drawing our attention to the Ohio hospital industry’s recent push to overturn much of the state’s recently passed transparency legislation.
The law required hospitals to post performance data, such as infection rates and patient satisfaction, on the Ohio Hospital Compare site.
According to Brandon Glenn’s report in the MedCity News, the hospital industry opposes the site, online since Jan. 1, 2010, because it serves the same purpose as the federal Hospital Compare site.
The OHA supports the new legislation… because it wants to remove “duplicative” reporting requirements on the state’s hospitals. Ohio hospitals already report the same data to a federal Hospital Compare website maintained for the public by the Centers for Medicare & Medicaid Services, said OHA spokeswoman Tiffany Himmelreich.
The new legislation “doesn’t reduce reporting. It just eliminates reporting the same information to two different places,” she said. “We don’t want the public to feel that this is taking a step backwards in terms of data availability.”
For their part, consumer advocates say website maintenance is not an onerous burden, and that the hospital association’s push is part of a larger, statewide antitransparency trend.
As an interesting side note, Glenn found the Ohio Hospital Compare site to be rendered inoperable by apparent bugs on an initial visit but discovered that, after his inquiries to the state health department, the site was put into working order.
Docs with Medtronic ties failed to disclose cancer case in trial report
Filed under: Conflicts of interest, Hot Health Headline, Public records
In the latest installment of his ongoing investigation for the Milwaukee Journal Sentinel and MedPage Today, John Fauber reports his discovery that physicians writing up a large-scale 2009 study “failed to identify a significant cancer risk” associated with Medtronic’s Amplify, a BMP-2 spine surgery product. At the same time, Fauber observes, Medtronic paid those same physicians millions.
The company and doctors had become aware of information on an additional cancer case, which pushed the concern to a critical level, at least two months before the paper was published, a Journal Sentinel/MedPage Today investigation found. Independent researchers say they had an ethical duty to report the cancer risk.
…
The researchers had information showing that at two and three years after being implanted with the genetically engineered protein, significantly higher numbers of Amplify patients were being diagnosed with cancer, but they did not report it on their paper.
In addition to interviews with experts and ethicists, Fauber’s investigation was heavily informed by his review of federal documents.
The Journal Sentinel found a full airing of the cancer question in more than 1,000 pages of U.S. Food and Drug Administration records. That information included FDA reports and information filed with the agency by Medtronic as part of its application to win approval for Amplify.
Fauber’s Medtronic coverage is a joint project between the Milwaukee Journal Sentinel and MedPage Today.
Fauber finds ‘failed back surgery syndrome’ after off-label use of Medtronic’s Infuse
Filed under: Conflicts of interest, Hot Health Headline
John Fauber follows up his previous investigations into the myriad problems and conflicts of interest surrounding Medtronic’s Infuse product with a story on the emerging national epidemic of what pain specialists are calling “failed back surgery syndrome.” One local pain specialist Fauber contacted said that a full 10 percent to 15 percent of his patients suffered from the condition.
To bring the whole thing full circle, Fauber spends much of the body of this latest installment explaining how conflicts of interest and other questionable ethical situations, including off-label use, propelled the early and sustained success of Medtronic’s spine-fusion blockbuster and set the stage for the emerging pain epidemic.
Fauber’s Medtronic coverage is a joint project between the Milwaukee Journal Sentinel and MedPage Today.
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Join us in Atlanta
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Fellowship applications
due Feb. 27
New at HealthJournalism.org
- Data gives depth to investigation of patient safety
- What reporters should know about Alzheimer’s and related dementias
- 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
