All you need to read in the other general journalsBMJ 2011; 342 doi: http://dx.doi.org/10.1136/bmj.d2755 (Published 04 May 2011) Cite this as: BMJ 2011;342:d2755
FDA’s approval of depot naltrexone undermines scientific, regulatory, and ethical standards, say critics
A group of international experts has criticised the US Food and Drug Administration (FDA) for approving a depot form of naltrexone for heroin addiction after a single placebo controlled trial conducted in Russia. The new formulation worked, but a linked comment (doi:10.1016/S0140-6736(10)62056-9) charges the FDA with undermining scientific and ethical standards by accepting evidence from a placebo controlled trial that denied participants an active comparator, such as methadone maintenance. Accepted comparator treatments are available in the US (where depot naltrexone is now licensed) but not in Russia, where the new drug’s manufacturers chose to conduct their trial. “The testing of depot naltrexone in Russia is akin to finding a location with no access to antiretrovirals and then testing a new HIV drug against placebo,” they write.
Questions are already being asked about the safety of depot naltrexone as a treatment for addiction. Dozens of deaths associated with depot naltrexone for alcohol addiction were reported to the FDA between 2006 and 2010. Fatal overdose is a well documented risk associated with oral naltrexone for heroin addiction. The new trial failed to assess or report this risk adequately, says the comment, particularly among the many participants who dropped out before completing the protocol (136/250).
Experts want to know why the FDA approved XR-NTX in the US when it might endanger the lives of heroin users. By doing so the regulator has set a precedent that “degrades standards for all treatment of opioid dependence.”
Wild armadillos implicated in mystery leprosy in southern US
Citizens of the southern US may be catching leprosy from wild armadillos, say researchers, who found a previously unknown and matching genotype of Mycobacterium leprae in people and armadillos⇓.
Leprosy is prevalent in armadillos ranging through Alabama, Arkansas, Louisiana, Mississippi, and Texas. Human leprosy remains rare, here and elsewhere, and most people become infected after living or working in endemic areas outside the US. In a few people, the source of the infection remains a mystery—and these cases tend to cluster in Louisiana and Texas, say the researchers
To explore the possibility of a zoonotic link, they compared the genome sequence of M leprae strains from 50 patients seen over some years in a Louisiana clinic, 33 wild armadillos, 64 Venezuelan patients, and four other foreign control strains. They found a brand new genotype in 28 of the armadillos and 25 of the 39 US patients who lived within the known range of infected animals. Eight patients with the matching genotype remembered having contact with armadillos, including one who reported hunting the animals for meat.
This isn’t the first time that armadillos have been implicated in human leprosy, say the researchers. They are clearly a natural reservoir, and occasionally the infection may jump between species. We shouldn’t blame the armadillos, who must have caught leprosy originally from early European settlers.
Tai chi improves quality of life for people with heart failure
Tai chi gently exercises both mind and body, and it is gaining ground as an option for older adults with heart failure who may struggle with more vigorous forms of exercise. In one trial, a 12 week programme of classes improved quality of life significantly for adults with mild to moderate symptoms and a mean left ventricular ejection fraction of 29%. The 50 controls attended education sessions over the same period. Tai chi also seemed to improve mood and confidence but had no effect on physical measures, including peak oxygen capacity or walking distance. Participants were US outpatients with a mean age of 67. More than half had an implantable cardioverter defibrillator or a pacemaker.
Tai chi and other treatments aimed at both mind and body deserve more attention from researchers, says a linked comment (p 758). Tai chi has a good safety record and the potential to give people with heart failure what they really want—a better quality of life. This relatively small trial hints at the possibilities—bigger and better trials should be done, along with cost effectiveness studies and some basic science exploring how the slow meditative movements characteristic of Tai chi might work
Observational analysis suggests no harm from ovarian removal at hysterectomy
Women who need a hysterectomy must decide, along with their surgeon, whether to conserve or remove their ovaries. Conclusive evidence favouring one option or the other is hard to find, and in the absence of head to trials, researchers continue to dissect data from large cohort studies. The Women’s Health Initiative included more than 25 000 postmenopausal women with a history of hysterectomy. The 14 254 women who had both ovaries removed during surgery were no more likely than the rest (11 194) to develop coronary heart disease, other cardiovascular diseases, or hip fracture. They were also no more likely to die, during an average follow-up of just under eight years. They were, however, much less likely to develop ovarian cancer, a rare event in both groups (0.02% v 0.33%; number needed to treat 323).
These findings were fully adjusted for a wide range of confounding factors, including use of hormone therapies. The authors and a linked editorial (p768) note that these findings are more reassuring (for women without ovaries) than those of a similarly large observational study in nurses, which reported a link between oophorectomy and deaths from heart disease and cancer. The Nurses’ Health Study had a longer follow-up and participants were younger than in the latest analysis from the Women’s Health Initiative.
Cite this as: BMJ 2011;342:d2755