Dear Barts Health NHS Trust,

As a brief patient of the Gilead Kivexa Trial in 2016 (January to March), left due to HSR and poor clinical treatment and bizarrely left on Kivexa post trial, I am raising GENERAL queries that may be relevant to other trial users who suffered adverse reactions. Although, oddly from my limited research (96 individual who experienced HSR like symptoms whilst taking Kivexa), I seem to be almost unique in remaining on the drug where others had it stopped immediately. That concern was highlighted on transfer to the Royal Free ICDC unit by its former much respected and missed consultant (and further confirmed by recent private medical review of treatment).

The British HIV Association (professional body of HIV Professionals in the UK) now headed by the former head of these trials at the Royal London, doesn't want to speak to me. The understanding I now have of my health experiences in 2016 and 2017, has been realized by a clinical error in April 2019 - the re introduction of Kivexa. BHIVA do have a published Standard of Care for HIV Professionals - but in true British fashion - it's mere words sadly not put into practice. Somewhat similar to the NHS Constitution Duty of Care and the Duty of Candour.

1. What is the start date of the clinical Kivexa Trial at the Grahame Hayton Unit?
2. January 2016 - number of participants solely under the GHU?
3. March 2016 - number of participants solely under the GHU?
4. Provide quarterly thereafter for 2016 and 2017 number of participants?
5. Number of participants that withdrew from the trial in 2016 after 1 month?
6. Number of participants that withdrew from the trial in 2016 after 2 months?
7. Number of participants that withdrew from the trial in 2016 after 3 months?
8. Number of participants that withdrew from the trial in 2016 after 6 months?
9. What financial provisions were provided to the Trust by trial sponsors for the administration costs in 2016 for the trial?
10 Number of staff directly employed by NHS Barts for this clinical trail in 2016, stating number of nurses, specialist nurses, doctors and consultants?
11. State name of treating doctors providing clinical care in 2016 on this trial to patients at the GHU.
12. State name of registered nurses solely providing care/observation in 2016 for this trial to patients.
13. Confirm if Gilead employed or contracted directly any members of medical, administrative or care team in 2016 for this clinical trial - confirm involvement role with patient if applicable.
14. Confirm status of Research Co-ordinator if registered nurse or associated with any other professional UK accredited/licensing body.
15. Please confirm any incentives financial or otherwise directly provided to clinical and administrative staff both involved in this trial and clinical referrals to this trial at the GHU in 2016? Confirm source and nature of incentive as appropriate.
16. Please confirm whether patient data was shared with Gilead and/or trial once patient had withdrawn? If so, on what basis?
17. Please state how monitoring of BHIVA Standards (2015 - amended 2018) of Clinical Care is undertaken at the GHU?
18. Please state the preferred method of recourse for issues regarding standard of care provided whilst on the trial?
19. Please confirm liability for Duty of Care for patients whilst under this clinical trial?
20. Please provide the Clinical Guidelines for selection of patients for the Kivexa Trial in 2016?
21. Please provide the Clinician Guidelines provided in 2016 in event of management of side effect and associated medical issues for patients whilst on this trial? Also, state reporting framework for side effect/drug reactions.

I look forward to receiving your public reply and kindly request that you state the provision appropriate that permits the withholding of any part of this FOI request.

Yours sincerely,

Philip Courtney

Dear Ms Björklund (BARTS HEALTH NHS TRUST),

Thank you for your reply.

The Trial Reference information requested is as follows:

EuduraCT#: 2015-00871-28
Short Title: 1717 - Phase 3b switch study with F/TAF in HIV-1 infected subjects.
Full Title: A Phase 3b, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 infected subjects who are Virologically Suppressed on Regimes containing ABC/3TC.

As stated, the FOI I have raised is for generalized information and not subject specific.

I am aware of the complaints process as a long-standing welfare advocate, and in respect of my own personal experiences briefly on this study have now raised formal complaints.

I hope I have provided adequate clarification in order to proceed further in providing the data requested in this FOI.

Yours sincerely,

philip courtney

Dear BARTSHEALTH, Foi (BARTS HEALTH NHS TRUST),

Yours sincerely,

philip courtney

Dear Simon Rackstraw and [abusive material removed] colleagues,

No hidden surprises there - you are a [abusive material removed]

I will challenge this vehemently..... re read - some parts of the FOI you could answer - that research co-ordinator!

All that time and that is the best you can come up with - Duty of Candour ...heard of that?

[extraneous material removed]

Yours sincerely,

philip courtney

Dear Maria,

Don't patronise me - given my personal situation and the conduct of Dr. Rackstraw and colleagues, words on a website are the last of your worries.

I want accountability.

The unnecessary delay and sheer dribble offered as a response is worthy of formal challenge . I will address the matter through Governance Procedure (another meaningless joke) and the ICO. ...and more than happy to pursue judicial review.

Odd that I am the only one (to my knowledge) that was maintained on Kivexa despite having experiencing HSR within the first two months of your dubious trial. Out of 96 people canvassed on an open HIV forum who experienced side effects /HSR symptoms within the 30 days had there medication changed, irrespective of protein presence.

How honoured I am for Dr. Rackstraw to keep me on Kivexa 18 further months, with meagre attempts to managed the side effects. Thankfully on transfer to Dr. Mervyn Tyrer (at the gay ghetto ICDC - although he vanished conveniently) immediately changed my medication and made various unapproving comments of Dr. Rackstraw's treatment (do email if anyone wants to see the notes - I am dead confused - as Dr. Ainsworth oddly re-prescribed Kivexa in a rather underhand way in April 2019).

So I suspect your internal review will be as meaningless and patronising avoidance dribble so common of the NHS (and trusts beleaguered by endless civil litigation claims!).

I make no apology for the language - you should hear what I say about the disgusting immoral commercial care home sector ([potentially defamatory material removed]) and their low life pathetic managers. I want accountability there to - especially CCG Herts Valley.

We have legislation (NHS Constitution, Duty of Care, Duty of Candour and piles of other meaningless process and regulations) essentially to ensure accountability and transparency - as of yet I have no seen one state organisation act accordingly.

Want better …. so take it - the message is mild compared the to level of contempt and sheer disgust I feel.

Any further clarification required - re read!!!!! You're being paid for it.

Philip Courtney

Let me help you.

With exceptions to questions 11, 12 your response is entirely errant - presents no conflict of interest or trial data compromise - so your blanket response is unlawful.

Perhaps I should take counsels advice and pursue this litigation in the US against Gilead - where disclosure of information is enforced by its judiciary promptly. That option would avoid waiting for delayed complaints replied, failed statutory disclosures (including withholding medical profession details) and the token meaningless complaint process so specialised in the UK.

Nothing in the FOI compromises the trial as the questions relate to financial matters, employment and those not continuing the trial. No medical or clinical data has been requested ... yet.

[potentially defamatory material removed]

Any other suggestions given that the Royal London is doing its best to avoid explaining my dubious treatment and unlawful post trial practices .... Norman Fowler next stop.

PHILIP COURTNEY

Dodgy [profanity removed] and desperate

I will get this information ...form you ... its personal too"

Yours sincerely,

philip courtney

Matter submitted to Information Commission
Complaint to GMC - Simon Rackstraw / Chloe Orkin
Complaint to NMC - Anne Marie Waters (Nurse)
Complaint raised to UKRI - Chloe Orkin / Simon Rackstraw

Still no clinical explanation for use of Kivexa despite contraindications, clinically unsuitable and better treatment available. - but incentivized by GiLead Sciences Inc. Issue starts in 2010 - Royal London refuses any to provide any valid clinical explanation or reply.

Repeatedly refuse Guidance to Clinical for selection of patient for this trial - has provided nothing to support any reason why I was on this trial.

REASON FOR DENIAL UNLAWFUL -see below including link to information already published.!!!! JUNE 2018

Thank you for the offer of another complaint (I don't know whether to piss myself laughing or cry) .., but as of this evening it is confirmed the issues regarding missing PIIC Form (UK) pages has been obtained! No personal exemptions are printed within that document.

The issue regarding a denied FOI re this clinical trial and the criteria for selection repeatedly requested has taken a more serious turn given that the refusal to provide or guide access to published data (See link) has been unlawful.  Your colleagues in various departments have deliberately attempted to hinder and frustrate access.

This is the link to the trial information that was first posted in June 2018 - considerably predating a FOI request and Subject Access Request (May 2019 onwards).

THEREFORE, it is not a matter for complaints, but as a varying ray of breaches (HR / GDPR. PHSSO Good Practice Complaints, Duty of Candour, Access to date for participants post trial as stated in PIIIC Form ) is clearly a GOVERNANCE issue (for more feeble excuses! - misguided interpretation of the role, common across the NHS).

The only issue for Complaints would be [potentially defamatory material removed - removed material expressed general concern that access to information law has not been complied with].

. Experience so far shows that any reply, likely [unpleasant material removed] and inadequate, would require further external referral  .... That would push an already intensely personal frustration where levels of tolerance border the rational solutions.

THE LINK to all that requested information!!!!!!!

https://www.clinicaltrials.gov/ct2/show/...

Your colleagues could have provided that over 6 months ago ..... such unnecessary furry and discourse. I was supposed to be the patient ... not a sodding investigator.

Philip Courtney

Disturbing - published June 2018

Period Title: Double-Blind Phase
Arm/Group Title F/TAF ABC/3TC
Started 285 / 282
Completed 218 / 226
Not Completed 67 / 56

Reason Not Completed
Randomized and Never Treated 5 / 6
Adverse Event 12 / 9
Death 2 / 0
Lack of Efficacy 2 / 1
Investigator's Discretion 8 / 8
Non-Compliance with Study Drug 3 / 1
Protocol Violation 1 / 1
Withdrew Consent 25 / 25
Lost to Follow-up 9 / 5

Dear Barts Health NHS Trust,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of Barts Health NHS Trust's handling of my FOI request 'HIV Gilead Kivexz Trial 2016 Unanswered Queries'.

You unlawfully withheld the requested information!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/h...

philip courtney

Dear BARTSHEALTH, Foi (BARTS HEALTH NHS TRUST),

Yes I am aware - and as stated it is unlawfully and errant!

Given that fact, I was giving the Trust the opportunity to correct those "errors". Two state salaried NHS staff deliberately withholding information [names removed]

I emphasize the oxymoron known as "governance". If you wish to stand by the unlawful dribble provided by [name removed], I will of course raise it further - and expect the Trust to undertake a formal complaint.

Can you explain why you are being so obstructive and obtuse? Can you explain how that is acceptable and under what proviso .... I strongly suggest you re-think your errant and unlawful "Internal review" - its meaningless and not factually based.

Yours sincerely,

philip courtney

Conveniently - they won’t explain the interpersonal employee salaried unlawful obstruction ass.isted by [personal information removed]

Oddly every time I come across "Governance", especially in the NHS and commercial care sector, its an overpaid post, usually the incumbent is [abusive material removed].

Is the Duty of Candour a myth?