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.
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.
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.
Patient gets billed $58k for a dubious airlift
Reporting for WCNC-Charlotte , Stuart Watson starts with a $58,477 air ambulance-related bill and works backward to determine the bewildering market forces that conspired to push a rural stroke victim’s bill into the stratosphere.
After reading or watching his story, most will agree with Watson’s assertion that “The details of Pridmore’s flight from Piedmont Medical to MUSC raise questions about whether the intense competition for patients and their health care dollars infects the decision of where patients are treated and whether they are flown to that treatment.”
The most baffling part of the whole story? That the patient in question was initially transported to a certified stroke center by ambulance, and the flight itself was only spurred by the dire proclamations of a remote doctor speaking over a webcam.
Almost as ridiculous? That the helicopter used for the flight came from 140 miles away and had to refuel en route, when there was another chopper hanging out on standby just 20 minutes from the patient. The final indignity? The patient was stuck with the bill for all these aerial shenanigans because his insurer reckons the flight wasn’t medically necessary.
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.
Medtronic hires Yale researchers to review Infuse data
Medtronic, the manufacturer of spine fusion product Infuse, has hired Yale University researchers to review patient data and adverse event reports for the product.
Photo by planetc1 via Flickr
The review follows months of reporting by John Fauber for the Milwaukee Journal Sentinel and Medpage Today that have raised questions about the independence of doctors involved in clinical trials for the product.
The Wall Street Journal’s John Carreyou and Tom McGinty also used their paper’s Medicare data stockpile to look at the conflicts of interest and royalty money that drive the popularity of spine fusion treatments whose effectiveness has been disputed.
Serious complications involving Infuse have gone unreported in medical journal articles that were written by doctors who have financial ties to Medtronic.
The June issue of The Spine Journal was devoted to unreported complications related to Infuse, revealing that “complication rates … were 10 to 50 times greater than the estimated complication rates revealed” papers co-authored by doctors with financial ties to the company.
In a statement about the review by Yale researchers, Eugene J. Carragee, M.D., editor in chief of The Spine Journal, says “this appears to be a big first step in the right direction” but points out three challenges that lay ahead for the reviewers.
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.
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