PLOS Correction removes (then reinstates) previously available anonymised patient clinical trial data

Researchers have removed the previously openly available anonymised patient data of the clinical trial FINE from their publication in PLOS One. The correction, issued on May 18th 2016 states:

S1 Dataset was published in error. The error was corrected in the XML and PDF versions of this article on May 9, 2016. Please download this article again to view the correct version”.

The now removed S1 dataset was previously described by the authors around Alison Wearden, professor of Health Psychology at the University of Manchester, in their Data Availability statement:

“The authors have prepared a dataset that fulfills requirements in terms of anonymity and confidentiality of trial participants, and which contains only those variables which are relevant to the present study. Data are available as Supplementary Information”.

FINE was a “randomised controlled trial of a nurse-led self-help treatment, versus supportive listening, versus treatment as usual for patients in primary care with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)”, performed at the University of Manchester. It was funded by the British Medical Research Council (MRC) and the UK Department of Health.

These new restrictive developments are very important. FINE is considered as a sister CFS/ME therapy trial of the PACE trial (on which I previously reported), where the sharing of anonymised patient data to non-collaborators was repeatedly denied by the King’s College London and Queen Mary University London, with the consequence that now the courts are expected to decide upon this issue of clinical data sharing. A judge has already decreed that certain documents associated with PACE trial are to be released (information and list with links are available from the website by the lawyer and CFS/ME activist Valerie Eliot Smith). Continue reading “PLOS Correction removes (then reinstates) previously available anonymised patient clinical trial data”

PACE trial and other clinical data sharing: patient privacy concerns and parasite paranoia

PACE trial and other clinical data sharing: patient privacy concerns and parasite paranoia

Data sharing is all over academic news now. We had Research Parasites, a noxious species of scientists who want to analyse others’ published data without granting its “owners” co-authorships and a certain control over the interpretations. Then there is a major battle between patients and clinicians about the release of the original data from the so-called PACE trial, originally published in The Lancet, which analysed medical efficiency and economic costs of different therapies for chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME). Since the PACE study came out in 2011, the patients, but also a number of academic scientists, remained unconvinced of the published therapy recommendations and suspected a misinterpretation of data. The authors felt harassed and even threatened by the patients’ incessant demands. The relevant research institutions, the Queen Mary University London and the King’s College London, took the side of their clinicians and refused the release of data, using as argument the allegedly inappropriate nature of such requests and the privacy rights of trial participants.

Importantly, the data sharing requests always concerned anonymised patient data, where names and any other personal information of the trial participants was specifically deleted, to avoid any even approximate identification and breach of privacy. Yet even then, several attempts of patients as well as academics, to obtain the anonymised PACE trial data were converted by the universities from academic inquiries into the bureaucratic Freedom of Information Act (FOIA) requests, which were then repeatedly rejected. At the same time, some of the original PACE authors have been apparently somewhat critical of their original interpretations. Continue reading “PACE trial and other clinical data sharing: patient privacy concerns and parasite paranoia”

Do nanoparticles deliver? Merck’s Smart Flares and other controversies

Do nanoparticles deliver? Merck’s Smart Flares and other controversies

A large body of scientific nanotechnology literature is dedicated to the biomedical aspect of nanoparticle delivery into cells and tissues. The functionalization of the nanoparticle surface is designed to insure their specificity at targeting only a certain type of cells, such as cancers cells. Other technological approaches aim at the cargo design, in order to ensure the targeted release of various biologically active agents: small pharmacological substances, peptides or entire enzymes, or nucleotides such as regulatory small RNAs or even genes. There is however a main limitation to this approach: though cells do readily take up nanoparticles through specific membrane-bound receptor interaction (endocytosis) or randomly (pinocytosis), these nanoparticles hardly ever truly reach the inside of the cell, namely its nucleocytoplasmic space. Solid nanoparticles are namely continuously surrounded by the very same membrane barrier they first interacted with when entering the cell. These outer-cell membrane compartments mature into endosomal and then lysosomal vesicles, where their cargo is subjected to low pH and enzymatic digestion. The nanoparticles, though seemingly inside the cell, remain actually outside. How so? Continue reading “Do nanoparticles deliver? Merck’s Smart Flares and other controversies”