HIV Gilead Kivexz Trial 2016 Unanswered Queries

Response to this request is long overdue. By law, under all circumstances, Barts Health NHS Trust should have responded by now (details). You can complain by requesting an internal review.

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

BARTSHEALTH, Foi (BARTS HEALTH NHS TRUST), Barts Health NHS Trust

Dear Mr Courtney

Your Request for Information: FOI-0630-19

Thank you for your recent request for information. This will be processed in accordance with the requirements of the Freedom of Information Act and you will receive a response within the stipulated timescale.

The FOI Act defines a number of exemptions which may prevent the release of the information you have requested. We will assess the material and if any of the exemption categories apply, then the information may not be released. We will tell you if that is so. If the information you request refers to a third party then they may be consulted prior to a decision being taken on whether or not to release the information to you. We will let you know if that is the case and give you an indication of the timescale for providing the information. There may be a fee payable for the information you have requested. The fee must be paid before the information is released. We will inform you if this is the case.

Information that we may provide in response to the Freedom of Information Act request will be subject to copyright protection. You may ask if you can re-use the information, perhaps for commercial purposes. Without the necessary permission you can breach our copyright. To enquire about re-using Trust information, please write to us at the above address or e-mail [Barts Health NHS Trust request email]

If you have any queries then please contact us at [Barts Health NHS Trust request email]

If you are dissatisfied on how your request has been handled, you can complain in writing to The Information Governance Manager, Barts Health NHS Trust: E-mail [Barts Health NHS Trust request email]

Postal address:
The Information Governance Manager,
c/o Archives and Records Centre,
Barts Health NHS Trust,
Lower Ground Floor,
9 Prescot Street,
Aldgate, London E1 8PR

If, after we have addressed your complaint, you remain dissatisfied with how we have responded, you are entitled to appeal to the Information Commissioner (Tel: 01625 545 745). Details are shown at www.ico.org.uk.

Yours faithfully,

Maria Björklund
Freedom of Information Co-ordinator
Barts Health NHS Trust
9 Prescot Street
London, E1 8PR

T: 020 7480 4866
Website: www.bartshealth.nhs.uk
[Barts Health NHS Trust request email]

show quoted sections

BARTSHEALTH, Foi (BARTS HEALTH NHS TRUST), Barts Health NHS Trust

Dear Mr Courtney

It would be very helpful for us if you could provide any unique clinical trial reference numbers (if you have this) which will help us locate the correct trial documents.

In accordance with the FOI Act and the FOI Code of Practice, your request will be put on hold while we wait your clarification and the clock restarted once sufficient clarification has been received. If we do not receive a clarification from you within 2 months of this email we will consider the request closed.

If you wish to make a complaint, we ask you to make this directly to the Complaints team. I have included the details below:

https://bartshealth.nhs.uk/complaints

How to make a complaint

•Speak to the staff at your clinic/department
•Call the complaints team (weekdays 9am - 4pm) 020 7480 4776 or 020 7480 4719 or email the central complaints team with your name and the details of your concerns including the hospital you attended, and the service and staff involved.
•Tell us what you think about our services [pdf] 953KB

Please note that the FOI Act provides access to information only, we will not be able to offer any redress through this route.

Yours sincerely

Maria Björklund
Freedom of Information Co-ordinator
Barts Health NHS Trust
9 Prescot Street
London, E1 8PR

T: 020 7480 4866
Website: www.bartshealth.nhs.uk
[Barts Health NHS Trust request email]

Please note our new Freedom of Information email address – [Barts Health NHS Trust request email]

show quoted sections

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

BARTSHEALTH, Foi (BARTS HEALTH NHS TRUST), Barts Health NHS Trust

Dear Mr Courtney

Thank you for your prompt clarification. Your request will now be processed in accordance with the requirements of the Freedom of Information Act and you will receive a response within the stipulated timescale.

The FOI Act defines a number of exemptions which may prevent the release of the information you have requested. We will assess the material and if any of the exemption categories apply, then the information may not be released. We will tell you if that is so. If the information you request refers to a third party then they may be consulted prior to a decision being taken on whether or not to release the information to you. We will let you know if that is the case and give you an indication of the timescale for providing the information. There may be a fee payable for the information you have requested. The fee must be paid before the information is released. We will inform you if this is the case.

Information that we may provide in response to the Freedom of Information Act request will be subject to copyright protection. You may ask if you can re-use the information, perhaps for commercial purposes. Without the necessary permission you can breach our copyright. To enquire about re-using Trust information, please write to us at the above address or e-mail [Barts Health NHS Trust request email]

If you have any queries then please contact us at [Barts Health NHS Trust request email]

If you are dissatisfied on how your request has been handled, you can complain in writing to The Information Governance Manager, Barts Health NHS Trust: E-mail [Barts Health NHS Trust request email]

Postal address:
The Information Governance Manager,
c/o Archives and Records Centre,
Barts Health NHS Trust,
Lower Ground Floor,
9 Prescot Street,
Aldgate, London E1 8PR

If, after we have addressed your complaint, you remain dissatisfied with how we have responded, you are entitled to appeal to the Information Commissioner (Tel: 01625 545 745). Details are shown at www.ico.org.uk.

Yours faithfully,

Maria Björklund
Freedom of Information Co-ordinator
Barts Health NHS Trust
9 Prescot Street
London, E1 8PR

T: 020 7480 4866
Website: www.bartshealth.nhs.uk
[Barts Health NHS Trust request email]

show quoted sections

Dear BARTSHEALTH, Foi (BARTS HEALTH NHS TRUST),

Yours sincerely,

philip courtney

BARTSHEALTH, Foi (BARTS HEALTH NHS TRUST), Barts Health NHS Trust

Dear Philip Courtney

Thank you for your email of 10 September 2019, which we received on 11 September 2019.

We understand that you not content that we have not provided you with a response to your request. As requested, we will therefore conduct an internal review of our handling of your request.

If, after we have addressed your complaint, you remain dissatisfied with how we have responded, you are entitled to appeal to the Information Commissioner (Tel: 01625 545 745). Details are shown at www.ico.org.uk.

Yours sincerely

Maria Björklund
Freedom of Information Co-ordinator
Barts Health NHS Trust
9 Prescot Street
London, E1 8PR

T: 020 7480 4866
Website: www.bartshealth.nhs.uk
[Barts Health NHS Trust request email]

Please note our new Freedom of Information email address – [Barts Health NHS Trust request email]

show quoted sections

BARTSHEALTH, Foi (BARTS HEALTH NHS TRUST), Barts Health NHS Trust

1 Attachment

Dear Mr Courtney

Please find attached the Trust's response to your request.

Yours sincerely

Maria Björklund
Freedom of Information Co-ordinator
Barts Health NHS Trust
9 Prescot Street
London, E1 8PR

T: 020 7480 4866
Website: www.bartshealth.nhs.uk
[Barts Health NHS Trust request email]

Please note our new Freedom of Information email address – [Barts Health NHS Trust request email]

show quoted sections

Dear Simon Rackstraw and sloppy back covering colleagues,

No hidden surprises there - you are a slimmy dishonest bunch of turds that stick together.

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?

Remind Rackstraw and the American they have a debt.

Yours sincerely,

philip courtney

BARTSHEALTH, Foi (BARTS HEALTH NHS TRUST), Barts Health NHS Trust

Dear Mr Courtney

We understand that you are disappointed in our response, however the language you have used in your email is not acceptable.

If you would like us to conduct an internal review of our response, please confirm this in writing.

Please be aware due to the language and tone of your email, your request may be considered vexatious.

Yours sincerely

Maria Björklund
Freedom of Information Co-ordinator
Barts Health NHS Trust
9 Prescot Street
London, E1 8PR

T: 020 7480 4866
Website: www.bartshealth.nhs.uk
[Barts Health NHS Trust request email]

Please note our new Freedom of Information email address – [Barts Health NHS Trust request email]

show quoted sections

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 (Azalea Court and TLC Group - Carlton Court) 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

BARTSHEALTH, Foi (BARTS HEALTH NHS TRUST), Barts Health NHS Trust

Dear Philip Courtney

Thank you for your email of 30 September 2019.

We understand that you are not content with our response to your request. As requested, we will therefore conduct an internal review of our handling of your request.

If, after we have addressed your complaint, you remain dissatisfied with how we have responded, you are entitled to appeal to the Information Commissioner (Tel: 01625 545 745). Details are shown at www.ico.org.uk.

Yours sincerely

Maria Björklund
Freedom of Information Co-ordinator
Barts Health NHS Trust
9 Prescot Street
London, E1 8PR

T: 020 7480 4866
Website: www.bartshealth.nhs.uk
[Barts Health NHS Trust request email]

Please note our new Freedom of Information email address – [Barts Health NHS Trust request email]

show quoted sections

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.

You are aware that the allegations against Rackstraw and sidekicks potentially involve prosecution.

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

BARTSHEALTH, Foi (BARTS HEALTH NHS TRUST), Barts Health NHS Trust

1 Attachment

Dear Mr Courtney,

 

Please find the response to your request for an internal review attached
to this email.

 

Kind regards,

 

Sarah Palmer-Edwards

Head of Information Governance

Barts Health NHS Trust

Email: [1][email address]

Tel: 07710064950

 

 

 

 

show quoted sections

Dodgy bastards! 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 why individual Trust colleagues deliberately undertook that hindrance in both FOI and SAR, and failed to carry out the remit of their state salaried role. Experience so far shows that any reply, likely patronising 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

BARTSHEALTH, Foi (BARTS HEALTH NHS TRUST), Barts Health NHS Trust

Dear Mr Courtney

The Trust has already conducted an internal review of your request and provided you with the outcome of this on 28 October 2019.

If you remain dissatisfied, you can make a complaint to the Information Commissioner's Office.

Yours sincerely

Freedom of Information Co-ordinator
Barts Health NHS Trust
9 Prescot Street
London, E1 8PR

T: 020 7480 4866
Website: www.bartshealth.nhs.uk
[Barts Health NHS Trust request email]

Please note our new Freedom of Information email address – [Barts Health NHS Trust request email]

show quoted sections

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 (Maria Bjorklund and Head of Governance - Sarah Palmer Edwards).

I emphasize the oxymoron known as "governance". If you wish to stand by the unlawful dribble provided by Ms. Palmer-Edwards, 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