Ethics: July 2010 Archives
The original source of Baxter's contaminated heparin, which killed scores of Americans in 2007 and 2008, has still not been identified, according to letters sent between the FDA and Congressmen Joe Barton (R-TX), who is investigating the matter. The heparin, which was intentionally spiked with oversulfated chondroitin sulfate (
According to the agency's response letter of June 16, officials of China's State Food and Drug Administration (SFDA) have stifled the FDA's investigation beyond Changzhou SPL, and "repeated" follow-up requests to the SFDA have yielded only "general information." The latest from Chinese officials to the agency: There have been no breakthroughs in the case. However, Congressman Barton, in his latest volley with the FDA, suggests that the US agency has been lax in its follow-up and specifically in its investigation of several suspect Chinese firms, including transparently bogus "front companies." (For more on these suspect firms, read the letter.)
In its efforts to protect the American public, the FDA posted testing methods for OSCS and initiated a "sampling program" to examine products on entry to the country. In addition, specific Chinese firms, like Changzhou, have been given an "import alert" status, in which products can be confiscated without inspection.
Leading the search for a synthetic version of heparin, which would entirely circumvent any reliance on the crude harvesting process (in China or elsewhere), are investigators at Rensselaer.
SPL = Scientific Protein Labs.
Just as an astronomical white count is not an entity unto itself but a marker of a serious underlying disorder, like leukemia, so a big lie on a CV is an indicator of a grave underlying problem, like sociopathy.
Faculty members at the Duke Institute for Genome Sciences and Policy are learning this lesson the hard way thanks to the failure of someone at Duke to perform the basic HR duty of vetting Anil Potti's curriculum vitae 7 years ago. Potti, who was hired in 2003 as a physician-researcher by Duke, falsely claimed that he was a Rhodes Scholar on scientific grant proposals, according to a recent expose by Paul Goldberg in The Cancer Letter. That's a big lie and one suggesting that other big lies are possible, if not probable. Taking this very cue, Goldberg then questioned the integrity of Potti's research at Duke and found that 2 biostatisticians at M. D. Anderson discovered "a series of errors," including mislabeling errors, in a seminal article by Potti and others.
Consequently the biggest victim of Duke's remote HR lapse: cancer patients who enrolled in clinical trials, which were based on Potti's questionable work. According to the NYT, these trials have now been suspended (after stuttering efforts by Duke officials to reopen them, reported Goldberg). News coverage can also be found at NPR's Shots blog.
For yucks or groans, I performed a quick PubMed search: "A Potti" is the coauthor of 48 articles that were published within the last 5 years. Potti's articles appeared in, for example, PNAS, JAMA, JCO, PLoS One, Lancet Oncology, Nature Medicine, and the NEJM.
Photo of Anil Potti from Duke Institute for Genome Sciences and Policy.
10/24/10 addendum: As the AP reported yesterday, Lancet Oncology editor David Collingridge relayed an "expression of concern" from 15 European investigators who were coauthors with Potti and 3 other Duke researchers on a 2007 article in the journal. (The article validated the use of gene signatures to predict the response of breast cancers to neoadjuvant [perioperative] chemotherapy.) After the damning report from biostatisticians at M. D. Anderson about Potti's alleged errors in another article, the Lancet Oncology coauthors repeatedly attempted to contact their Duke colleagues, but they were ignored, wrote Collingridge.
The editor also revealed that "a large group of scientists" wrote to NCI director Harold Varmus on July 19th, expressing their concerns about the validity of a) Potti's cancer-treatment prediction models and b) 3 clinical trials that were based on these prediction models. Collingridge expressed his own concerns about the Lancet Oncology article given recent developments surrounding Potti. The journal has contacted the Duke coauthors—Anil Potti, Chaitanya Acharya, Sayan Mukherjee, and Joseph Nevins—and awaits their responses.
Two studies* have now documented that Medicare spending per beneficiary varies widely on the basis of geographic location. The latest study, published in today's NEJM, indicates a difference of up to 52% between the highest- and lowest-spending areas in the United States. But reasons for a big portion of this spending difference remain a mystery.
While the authors conclude that some regionally based differences in Medicare spending per beneficiary can be explained by baseline health and demographic characteristics (like age, sex, and race), explanations for 60% of the spending difference are unknown. The researchers speculate that differences in Medicare spending might be influenced by a number of factors, including what boils down to fraudulent Medicare billing (eg, "providers' profit-seeking behavior" and "rates of inappropriate Medicare payment").
My own view, given a recent hospitalization, is that rampant billing fraud by in-hospital physicians (whether targeting Medicare, insurance companies, or patients) plays a substantial role. If my experience is any indication, it seems the rule,** rather than the exception, for physicians to greatly exaggerate their services—both in terms of level of care provided and time spent. Unfortunately this type of billing fraud is difficult, if not impossible, to detect, unless a very granular survey of physician billing can be compared with a reliable account of services actually rendered. And a reliable account probably requires the input of an unusually savvy patient—like a hospitalized physician.
* The first is Sutherland et al. NEJM. 2009;361:1227-1230.
** At least in my neck of the woods.
