POGO fears disclosure rule is in jeopardy
Filed under: Conflicts of interest, Public records
A database that would document the financial ties between researchers who are funded by the The National Institutes of Health and medical companies is in jeopardy, according to the Project on Government Oversight (POGO).
Under the proposed requirement, NIH-funded researchers at medical schools and universities would have to publicly disclose their financial ties to medical companies. In March, POGO sent a letter to Dr. Francis Collins, the Director of the NIH, urging him to implement this idea, which he had shown support for.
But POGO is concerned that the White House’s Office of Management
and Budget may weaken or block the rule. The organization has sent a letter to the OMB director in support of the rule.
Previously: NIH Proposes Rule to Shine Light on Potential Conflicts of Interest
Top docs spar over Medtronic research, Iraq service
Filed under: Conflicts of interest, Hot Health Headline, Pharmaceuticals
Following up on his work on the dangers of Medtronic’s Infuse spine fusion product and the conflicts of interest that appear to have facilitated its approval and adoption, the Milwaukee Journal Sentinel’s John Fauber has the latest on high-profile sniping between two top orthopedic surgeons over the Spine Journal’s recent Infuse issue devoted to the many complications and conflicts of Infuse.
The combatants in this case are frequent Fauber target and University of Wisconsin-Madison orthopedic surgeon Thomas Zdeblick, who has received $23 million from Medtronic since 2002, and Stanford orthopedic surgery professor and Spine Journal editor-in-chief Eugene Carragee, the Iraq veteran whose research helped spark the recent push against Infuse.
The showdown began with Zdeblick’s defiant response to the Spine Journal’s Infuse research, a letter which included an apparent attempt to discredit Carragee’s review because the surgeon wasn’t performing the elective spine fusion surgeries while he was serving with the American military in Iraq. In response, Carragee says he took no extended leaves of absence during the period covered in his study. For the record, Carragee’s second tour of duty in Iraq was cut short in 2008 after he was injured in an attempted suicide attack.
The full text of Zdeblick’s initial letter and the response of Carragee and his co-authors has been published online, and the medical community has rallied around the decorated veteran.
In an email to the Journal Sentinel, Charles Rosen, president of the Association for Medical Ethics, was sharply critical of Zdeblick’s letter.
“Zdeblick’s assertions are so nonsensical that the whole letter strikes me more like the ravings of a guilty man who’s been cornered,” said Rosen, a clinical professor of orthopedic surgery at the University of California, Irvine.
Fauber’s review included a particularly tidy summary of the overall Medronic fracas, and I have included his wrapup below the fold in case anyone still needs to get up to speed on the issue.
Medtronic attracts attention from Baucus, Grassley
Readers of Covering Health are likely familiar with medical device manufacturer Medtronic and John Fauber’s coverage of conflicts of interest surrounding the company’s Infuse product.
It seems that U.S. Senators Max Baucus (D-Mont.) and senior member Chuck Grassley (R-Iowa) also are aware of the coverage.
The two, leaders of the Senate Finance Committee, have demanded “an extensive trail of documents, including financial records and communications between the company and doctors who have received millions in royalties and other payments.” [See the letter.]
Over the past year, Fauber, of the Milwaukee Journal Sentinel (see update), has reported that the company made payments to surgeons “involved in the clinical testing of Infuse or who wrote positive medical journal articles that failed to link the product to serious complications.” Those complications include unwanted bone growth outside the fusion site and sterility in men.
Infuse is a biological agent used in spinal fusion surgery that stimulates bone growth.
A professor of orthopedics at Dartmouth Medical School is pleased the Finance Committee is investigating, saying it is doing public health work because his profession and the FDA failed to prevent this circumstance.
It appears there is more news to come about Infuse:
Next week, independent researchers are expected to publish more papers revealing additional serious complications with Infuse that were not reported in numerous articles published over the last decade and co-authored by doctors with financial ties to Medtronic. The independent researchers said their research also was prompted in part by Journal Sentinel reports.
Update
This post should have mentioned that the Medtronic coverage is a joint project between the Milwaukee Journal-Sentinel and MedPage Today.
Medical device investigation unearths conflicts, regulatory issues
Filed under: Health journalism, Hot Health Headline, Public health, Public records, Studies
The latest investigation from the Chicago Tribune’s Jason Grotto and Deborah L. Shelton focuses on a single medical device, yet still hits many of the health beat’s biggest narratives, primarily conflicts of interest and government regulation. In their centerpiece, they dig into the tale of a cardiologist who may or may not have tested a device he invented on patients without consent or regulatory approval. It’s in those gray areas that the story takes shape.
The device in question is an annuloplasty ring, which in 2001 was reclassified from class III to class II. In practical medical device terms, this means that new models don’t need clinical trials if they’re similar enough to devices that have already been approved. The reporters write that the rings earned this change of status in part because of the relatively low number of adverse events reported between 1991 and 1995 (465). Unfortunately, as their use has increased, so have the events.
Now that you have some idea of what they were up against, here’s a healthy excerpt from their “how we did it” sidebar, which is almost always Covering Health’s favorite part of a major investigative package.
The first hurdle in stories like these is understanding the medical science behind the device in question, which required us to gather up dozens of studies and reports on annuloplasty rings and the heart valve disease the device is intended to cure. We sifted through government documents and researched regulations as well as the history of the rings.
But writing about heart valve repair rings involves more than researching a disease and a device.
We also spent a lot of time with the patients in our stories because there is a level of trust that must be built up before people are willing to share personal information about their health. The same goes for Northwestern Memorial Hospital and surgeon, Dr. Patrick McCarthy.
We had to assure each of them that their viewpoint would be reflected in the stories. It’s a difficult balancing act that we tried to buttress with reams of documents, studies and interviews with independent sources.
For more on how Grotto and Shelton reported the story, watch for a “How we did it” article on the AHCJ website in the next couple of weeks.
If the issue sounds familiar, the storyline is similar to a 2005 investigation from The Wall Street Journal’s David Armstrong, which found a partnership between the Cleveland Clinic – and some prominent staff members – and companies manufacturing devices used in clinical trials there.
South African academic: Conflict of interest went unnoticed in obesity stories
Filed under: Conflicts of interest, Health journalism
In a column for South Africa’s The Media magazine, Harry Dugmore, MTN Chair of Media and Mobile Communication at the School of Journalism and Media Studies at Rhodes University, tries to figure out why it is so difficult to produce good journalism. Yes, he writes, it has something to do with the need for constant devotion to the facts and numbers and science, but that’s true of many beats.
For health, he writes, there are simply deeper forces at work. They relate to the sky-high stakes that come with health care’s status as a multibillion-dollar, life-and-death industry, but run deeper (emphasis mine):
What might be different in health journalism is that there are additional scientific and technical challenges. And, beyond these, there are also all sorts of biases and beliefs (both of journalist and audiences) that have to be unpacked and often confronted. Our existential duel with our own mortality; our views on what makes us ill and what gets us better, are ingrained in cultural practice, power relations, and ideological positioning.
Nothing is uncontested.
To illustrate his point, Dugmore examines a recent set of headlines that mushroomed across the country detailing the nation’s obesity. The stories all reported on a well-known phenomenon and had the ring of truth, but neglected to mention that they were based on the results of a 500-person survey conducted by GlaxoSmithKline to coincide with the new availability of the South African equivalent of Alli as an over-the-counter drug.
What’s scary is that no journalist at all looked at the now freely available weight-loss drug, its purported efficacy, its side effects and real dangers, and the international controversy over its shift from prescription to non-prescription status. Arguably, that is neither GlaxoSmithKline’s nor its public relations company Magna Carta’s fault. They were, after all, just doing their jobs.
For more on the center which employs Dugmore, which he concedes is not without its own conflicts of interest, see our coverage of the work of his colleague, Guy Berger.
Ex-pharma rep talks about pressure, tactics to sell
Filed under: Conflicts of interest, Health journalism, Hot Health Headline, Pharmaceuticals
A story reported and produced by Gerri Shaftel at KTTV-Los Angeles (and presented by Christine Devine) gives viewers a look into the world of pharmaceutical representatives, a world of former beauty queens and long lists of off-label uses and side effects.
It’s based around a former pharmaceutical rep and cheerleader named Jennifer Shaw, and opens with the standard portrait of reps as former models with short skirts and even shorter scientific résumés, but also goes into how reps get the information about doctors’ prescribing habits.
Confessions Of A Pharmaceutical Rep: MyFoxLA.com
Over the course of the story, viewers learn how pharmaceutical companies track every prescription a doctor writes, press doctors to raise specific prescription numbers, and rank physicians on a scale of 1 to 100, then reward them accordingly with speaking engagements and the like. Even Jennifer, the rep turned tell-all author, has a compelling story about how she left the industry when her company pushed her to sell a reformulated drug despite the alarming side effects that were cropping up along her sales route.
It may come in a fancy package, but it’s wholesome stuff.
APA ghostwriting/COI scandal simmers quietly
Filed under: Conflicts of interest, Health journalism, Hot Health Headline
For folks who have had trouble keeping up, MIWatch.org’s Phyllis Vine has pieced together a particularly readable roundup of where the American Psychiatric Association’s Nemeroff/Schatzberg/Glaxo ghostwriting controversy now stands.
Alan Schatzberg (a former APA president) and Charles Nemeroff are, of course, prominent psychiatrists who, in 1999, put their names on the APA-published Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care. Recent discoveries seem to show that the book, intended to teach primary care physicians about certain new pharmaceuticals, was actually penned by the ghostwriters over at Scientific Therapeutics Inc. Not only that, but the book was bankrolled by an unrestricted grant from the company that’s now GlaxoSmithKline. In other words, it’s double-decker scandal including both ghostwriting and conflicts of interest.
Though the news really hit the mainstream with Duff Wilson’s November 2010 piece in The New York Times, Vine also points out the dogged work of folks like Paul Thacker over at the Project on Government Oversight and others. Work which, Vine writes, has been met by a concerted APA stonewalling effort which appears to continue straight through to the present, despite many unanswered questions.
A MIWatch request to speak to someone about accusations of stonewalling was returned with an email signed by Ron McMillen and rehashing previous statements. His title, “CEO of the APA Office of Publishing Operations” was amended with the word “retired.”
In other words, while the scandal hasn’t gone away, the APA has thus far managed to keep it in a sort of holding pattern, presumably with the hope that it will soon complete its journey to the back burner.
Drug-funded research group failed to disclose ties to makers of painkillers
In his latest conflict of interest investigation, Milwaukee Journal Sentinel reporter John Fauber takes on a challenge that, even by his standards, is an ambitious one.
He attempts to show the effect pharmaceutical money and the local researchers who received it had on national opinions toward powerful prescription painkillers and how it all influenced the American epidemic of opiate abuse.
He focuses on the University of Wisconsin Pain and Policy Studies Group, which has received millions from painkiller manufacturers while publishing drug-friendly research and warning against increased regulation of OxyContin and its ilk. Many of these millions, Fauber found, appear not to have been disclosed in relevant publications even as the group was paving the way for the rapid rise of painkiller prescriptions in America.
The drugs had initially been approved for a very narrow range of uses, but became extremely popular as off-label use for the management of chronic pain spread like wildfire. It’s not easy to draw clean lines between the Wisconsin group and off-label use, but Fauber’s deft investigative work and careful sourcing make a strong case.
Related
Carlat reviews Dollars for Docs, and the bleak picture it paints
Filed under: Conflicts of interest, Health data, Health journalism, Public records, Tools
Writing on KevinMD.com, psychiatrist and blogger Daniel Carlat reviews ProPublica’s Dollars for Docs database from the perspective of a medical professional, one who has taken a firm stand against drug company money and the conflicts of interest it brings. Carlat’s real focus is not the Dollars for Docs project, but rather the data available from drug companies. He does point out some limitations inherent in the data ProPublica is working with. And he writes about a slightly inverted use of the data, one which caused him to ask “How have we allowed this to happen to our once proud profession?”
There’s another way to use the Dollars for Docs database, although this is not spelled out on the website. If you want to browse for all the doctors in your city or state who are “on the take,” simply leave the “name” field blank, choose a state from the drop down menu, and click search. You’ll get a huge spreadsheet which is arranged alphabetically by last names of the doctors. By clicking on the various columns, you can sort the data by city, drug company, amount of money, or time period of the payments. This is a nice feature that is absent from most of the drug company databases.
Carlat’s data trick is a simple one, and one which local reporters should take a minute to replicate if they haven’t already. After reviewing the mountain of local data revealed by his sorting and the vast armies of conflicted doctors it implies, Carlat reminds us of the power of pharma money then drives home the sheer magnitude of the issue.
The true malfeasance here is in the aggregated effect. The companies are using these legions of doctors to artificially manipulate medical discourse. Any doctor who participates in the enterprise knows exactly how they are being used. You decide whether this is “immoral” or not.
Australian journal says no to pharma ads
Filed under: Conflicts of interest, Health journalism, Hot Health Headline
Emergency Medicine Australasia, an Australia-based medical journal, has declared that it will no longer accept paid advertisements from pharmaceutical companies.
Image by acediscovery via FlickrThe journal’s editors announced their decision in an editorial, and we learned about it from Pharmalot’s Ed Silverman. In the editorial, the editors say they’re drawing a line in the sand and all but dare other publications to join them. Here’s Silverman with the how-and-why:
The ban followed discussions with other emergency medicine specialists, who worried aloud that advertised drugs were supported by evidence that was neither “of reasonable quality, nor independent.” There were cases of “dubious and unethical” research practices by pharma, including ghostwriting. And academics may face pressure to withhold negative research, which could “inflate views of the efficacy” of heavily promoted drugs.
For more, refer to this AAP story. In this case, the acronym refers to the Australian Associated Press, not the physician group. In Australia, medical journals are one of the only places where pharmaceutical advertising is legal.
-
Join us in Omaha to find untold rural health stories
New at HealthJournalism.org
- AHCJ offers financial data about nonprofit hospitals
- Diversity in aging: Putting gray in the rainbow
- Southeast journalists eligible for regional fellowship program
- AHCJ-NLM Health Journalism Fellowship offers hands-on medical research training
- AHCJ announces 2011 winners of top health journalism awards
