PACE trial a Trojan horse for Dept. of Work and Pensions?

[Merry]

Dr. Speedy posts at his blog, The NICE Guidelines, more information, written by Margaret Williams, on the lack of guarantees of confidentiality for PACE trial participants:

http://niceguidelines.blogspot.com/2015/12/just-when-you-think-it-cant-get-worse.html

. . . one of the organisations funding the study was the UK Department for Work and Pensions (DWP). How many participants looked at the funding bodies before signing the consent forms and realising to what they were giving their consent?

Quite how “confidentiality” could be guaranteed if the DWP had access to the data has never been explained, especially as ME/CFS is known to be a targeted disorder for the withdrawal of state benefits, with patients being harassed by the DWP who required a 60-page form to be completed because the DWP menacingly informed such patients: “We have reason to believe that you are capable of work”.

If the PACE trial therapists and Investigators deemed a participant “recovered” enough to resume work, then might that participant quickly discover that the DWP stopped paying benefit? The PACE Trial has been described as a “Trojan horse” for the DWP.

 

[Merry]

Although participants were promised that their data would be secure, the staff failed to follow through.

Regarding the secure storage of data, the Full Protocol is unambiguous:

“Will you keep my details confidential?”

“Yes. All your details and all recordings will be kept strictly confidential and held in a locked filing cabinet or on a secure computer. People on our research team will only see your records if they need to for the research”.

The DWP was not involved in research but still had participants’ signed permission to access their records/data.

From the outset, recordings were not kept in a locked filing cabinet: some were stolen and thus lost to review (see previous post on 19th December 2015

 

[Merry]

Researchers asked participants for information that was irrelevant to the research but might have been useful to those investigators who had worked, or were working at the time of the trial (Peter White?), as consultants to insurance companies.

In relation to the PIs’ undeclared conflict of interest, one of the pre-trial assessments was at Baseline Visit 1; this set out to collect personal data that seems to have little bearing on a clinical trial but could be of value to the DWP and the permanent health insurance industry because the collected data included not only the customary demographic details, date of birth, age, sex, ethnicity, marital or partner status, years of education, occupation (the latter would obviously afford information about a participant’s earnings) but also very detailed questions about participants’ permanent health insurance payments, for example, questions on page 172 ff of the Full Protocol included the following:

“Do you currently receive income protection benefit (income protection or total and permanent disability)?”

“ If yes, how much annually do you receive? £”

“If the participant chooses not to give an answer, please use the prompt card to show income brackets, and record the letter [an alphabetical letter designating an income bracket] that corresponds to the participant's income”.