The early days of Apple's ResearchKit software seem set to revolutionize clinical research recruitment, with one Parkinson's study enrolling thousands of people in just a few hours. Apple's new ResearchKit: 'Ethics quagmire' or medical research aid?, from The Verge, discusses some of the ethical quandaries surrounding recruitment for medical studies via mobile app. A follow-up article discusses some changes already made to the developer guidelines to address some of these concerns about informed consent and data sharing. Ars Technica covers the Food and Drug Administration's regulatory requirements for medical devices and how they may apply to mobile apps, including those using ResearchKit.
Widespread fraud has been discovered in the case of an Indian generic drug manufacturer that makes generic Lipitor (atorvastatin calcium) and many other drugs. Ranbaxy has "pleaded guilty to seven federal criminal counts of selling adulterated drugs with intent to defraud." [more inside]
"Especially with the country in great need of donation, science should speak louder than stigma in determining who can help."
Tainted: Why Gay Men Still Can't Donate Blood - "Since 1983, Food and Drug Administration (FDA) guidelines have disqualified men who have ever had sex with men (MSM) from donating blood... Uneven application of exclusion to at-risk individuals suggests that risk aversion disproportionately impacts MSMs. For example, a non-MSM individual who has had sexual contact with a commercial sex worker or HIV-positive partner is deferred for only twelve months... The fact that the U.S. upholds a lifetime ban on MSM donation while Australian policy allows MSM individuals to donate a year or less after contact reveals a glaring discrepancy. Both ethics and science point to a flaw in FDA policy. That I could have had sex with 365 partners this year and be a perfectly fine candidate for donating blood, while the MSM next to me wouldn't qualify, betrays a faulty line of logic." [more inside]
Are the Rules That Determine Who Can Donate Blood Discriminatory? Canadian AIDS researchers Dr. Mark Wainberg and Dr. Norbert Gilmore say that while the ban on blood donation from men who have sex with other men may have been ethically and scientifically justified in the 1980's, it no longer makes sense. (CMAJ.) Even though the US FDA reaffirmed their long-standing ban in 2007, they plan to revisit the policy in June. [more inside]
Towards responsible use of cognitive-enhancing drugs by the healthy - a commentary in Nature that says, "we call for a presumption that mentally competent adults should be able to engage in cognitive enhancement using drugs". Farkesque debate here. [more inside]
The blood substitute PolyHeme has been previously discussed on MetaFilter, but new evidence shows that PolyHeme actually raises the chances of death by nearly 30%. PolyHeme was notable mostly for the reaction to its clinical trials, which, controversially, did not require patient consent.