Commentary by Michael Poles MD, Associate Editor, Clinical Correlations
Welcome back blogophiles to this week’s clinical correlations. Hope you all had a nice President’s Day weekend. Now, let’s move on to the discussion.
I was a bit disturbed last night, while watching 60 minutes on TV. Their first piece was an expose on Bayer’s drug Trasylol (aprotinin), which has been used for 14 years to control bleeding in the OR. This blockbuster drug resulted in earnings of hundreds of millions of dollars for the company, but in 2006, a study published in the New England Journal of Medicine revealed an increased risk of death and renal failure associated with its use. Upon hearing the evidence, the FDA failed to act aggressively, but what is most egregious is the fact that while the company refuted the results of the study at an FDA advisory meeting, they had, in their possession, a second study. This study, which they, themselves, had commissioned, was far more comprehensive, and supported the results of the original study. Thus, it appears that Bayer was guilty of suppressing data that could have saved up to 22,000 lives in order to keep their profit margins high and their stockholders content. While the medical and pharmaceutical industries are distinct, the public appears to associate the two, and thus another black eye for them (and there have been many recently), reflects poorly on us all.
On to more positive reporting. In this week’s New England Journal of Medicine, Stephen L Hauser and colleagues report their study showing that Rituximab, the anti-B cell antibody may have efficacy in the treatment of patients with multiple sclerosis. B cells are believed to play a pathophysiologic role in the causation of multiple sclerosis, so the authors performed a phase 2, double-blind, 48-week trial involving 104 patients with relapsing–remitting multiple sclerosis. Patients were assigned to receive 1000 mg of intravenous rituximab or placebo on days 1 and 15. They found that patients who received rituximab had reduced counts of total gadolinium-enhancing lesions and of new lesions at weeks 12, 16, 20, 24 and 48. Rituximab was also associated with decreased risk of relapse. Although rituximab was associated with an increased risk of adverse events after the first infusion, but not the second. The majority of these were mild to moderate in intensity.
In the current issue of JAMA, Brook I. Martin and colleagues report on expenditures and health status among adults with back and neck problems. Since back and neck problems are ubiquitous in clinical practice, they sought to estimate the medical expenditures related to back and neck problems in the United States from 1997 through 2005. A total of 23 045 respondents were sampled in 1997, of which 3139 reported spine problems. In 2005, they sampled 22 258 respondents, of whom 3187 reported spine problems. In 1997, the mean medical costs for respondents with spine problems was $4695, compared with $2731 among those without spine problems. In 2005, the mean medical expenditure among respondents with spine problems was $6096, compared with $3516 among those without spine problems. Thus, estimated expenditures among respondents with spine problems increased 65% (adjusted for inflation) from 1997 to 2005. They conclude that spine-related expenditures have increased substantially from 1997 to 2005, without evidence of corresponding improvement in self-assessed health status.
Finally, the current Annals of Internal Medicine provides us with updated guidelines on the Screening for Bacterial Vaginosis in Pregnancy to Prevent Preterm Delivery. In this update of a 2001 recommendation, the U.S. Preventive Services Task Force explains why it recommends against screening for bacterial vaginosis in pregnant women at low risk for preterm delivery.
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