CardioExchange Archive

CardioExchange is pleased to reprint selections from Dr. Richard Lehman’s weekly journal review blog at BMJ.com. Selected summaries are relevant to our audience, but we encourage members to engage with the entire blog.

NEJM  20 Sep 2012  Vol 367

Punishing Health Care Fraud? (pg. 1082): In the next few weeks, we can look forward to dignified murmurs of offended innocence from the pharmaceutical industry in response to Ben Goldacre’s brilliant and damning new book, Bad Pharma. But it is difficult to maintain dignity when caught with your pants down, as GlaxoSmithKline has been over the mis-selling of Paxil and Wellbutrin, and the hiding of safety data relating to Avandia. However, all that’s needed is to pay up $3BN and your pants can quickly be raised and adjusted. Nobody need be called to account, and business can go on as usual: after all, $3bn is about half the profit that these three drugs produced every year while they were being mis-marketed. Here’s a swingeing perspective piece titled Punishing Health Care Fraud—Is the GSK Settlement Sufficient? The answer of course is no. There is nothing to stop fraud continuing as a lucrative business plan, and nothing to bring those responsible to court. And is GSK just a bad apple? No way—there are 25 others who are under special measures, including most of the big names in US pharma.

How Physicians Interpret Research Funding Disclosures (pg. 1119):  Take a look at this study of how US medical interns rate hypothetical studies of new drugs: it’s free to everybody courtesy of Jeff Drazen, who also produces an editorial that you can read in full. Lampytinib, bondaglutaraz, provasinab: what fun to make up drug names like that, and trial designs that varied from a proper large RCT to a footling open-label study with no safety data. Not surprisingly, the interns had little difficulty in grading the quality of these mock-ups. But now comes the interesting bit: they were much less inclined to believe the results if the studies were marked as industry funded. This earns them a lofty reproof from headmaster Drazen: “Patients who put themselves at risk to provide these data earn our respect for their participation; we owe them the courtesy of believing the data produced from their efforts and acting on the findings so as to benefit other patients.” Amen to that—but that’s exactly why we mistrust data that have been gathered and interpreted by people with billions of dollars riding on the result—and who have a track record of deceit. If Drazen wants to show true courtesy to the trial participants, he needs to insist that for every trial published in the NEJM there is a full database of raw, de-identified patient-specific data, with the trial protocol and any variations from it, and all other meta-data required to interpret the study, open to all bona-fide investigators. And let’s not forget that the NEJM itself has a vested interest in putting a positive spin on industry-funded trials, as it gets a substantial (undisclosed) proportion of its income from the sale of reprints to pharma companies. There have been some terrific responses to this editorial, especially from Harlan Krumholz and Joe Ross.

BMJ  22 Sep 2012  Vol 345

Systolic and Diastolic BP and All-Cause Mortality in Those Newly Diagnosed with Type-2 Diabetes: “It is refreshing to read an article highlighting the risks of tighter blood pressure control in diabetic patients. But we have to remember that it is a retrospective study, so we don’t know when a patient’s glycaemic index breached the diabetes threshold and when patients were diagnosed. Furthermore, who measured patients’ blood pressures and by what method?” It’s really weird that the BMJ flagged up and printed this rapid response because it is mistaken on almost every count. This is a database study of the blood pressure as measured by UK general practitioners in the first year of diagnosis of type 2 diabetes (from 1990 to 2005), and how it relates to mortality over that period. It tells us nothing about treatment effects. The reason that the glycaemic index of the patients is not reported is presumably because nobody wanted to eat them.