Permit UK doctors to use their judgment about how to treat Covid patients.

Roland Gilmore made this Freedom of Information request to Medicines and Healthcare products Regulatory Agency

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Dear Medicines and Healthcare products Regulatory Agency,

In light of international studies and research that indicate positive outcomes, the American Medical Association has rescinded its statement that doctors should be prevented from prescribing Hydroxychloroquine (HCQ). The AMA’s new position is that doctors must be permitted to use their judgment about how to treat Covid patients.

In light of international studies and research, when will the MHRA review their policy and permit UK doctors to use their judgment about how to treat Covid patients?

Yours faithfully,

Roland Gilmore

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency


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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 20/575

Dear Roland Gilmore,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 18 December 2020.

I confirm that your request is now being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.

Kind Regards,


MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

FOI 20/275
 
Dear Mr Gilmore,
 
Thank you for your email.
 
A link to the current Summaries of Product Characteristics (SmPCs),
Patient Information Leaflets (PILs)  and Public Assessment Reports (PARs)
for hydroxychloroquine products is provided below:
[1]https://products.mhra.gov.uk/search/?sea...
 
Hydroxychloroquine is not currently authorised for use in treating
patients with COVID-19 infection. Any change to the indications for a
product must be submitted as a variation application by the marketing
authorisation holder before it can be assessed and approved by MHRA.
However, although a marketing authorisation defines a medicine’s terms of
use, there are clinical situations when the use of a medicine outside the
terms of the licence (i.e. ‘off-label’) may be judged by the prescriber to
be in the best interest of the patient on the basis of available evidence.
Further information on off-label use is published on the MHRA website:
 
[2]https://www.gov.uk/drug-safety-update/of...
 
If you are dissatisfied with the handling of your request, you have the
right to ask for an internal review. Internal review requests should be
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Yours sincerely
 
MHRA Customer Service Centre
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000
 

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Dear MHRA Customer Services,
Although not explicitly stated, your answer to my question appears to be no. The MHRA appears to be denying the application of treatments that can reduce the severity of infections, reduce the strains upon the NHS and reduce mortality.

It is evident that the UK has the highest case fatality rate (CFR) in the world and by refusing to allow doctors to treat patients as they see fit, I believe that the MHRA (as well as the DHSC and other agents of the UK government) are acting with restrictive complacency. This has the effect of demoralizing doctors and medical staff while causing consequential damage to mental health. Countries across the world (including developing/3rd world countries without the resources of the UK) have a significantly lower CFR than the UK yet the MHRA is not responding proactively enough to investigate what they are doing right then copying their protocols. This includes the use of Hydroxychloroquine (HCQ).

The Virology Journal, the official publication of America’s National Institutes of Health, published an article on August 22, 2005, under the heading “Chloroquine is a potent inhibitor of SARS coronavirus infection and spread.” The researchers wrote, “We report…that chloroquine has strong antiviral effects on SARS-CoV infection of primate cells. These inhibitory effects are observed when the cells are treated with the drug either before or after exposure to the virus, suggesting both prophylactic and therapeutic advantage.”

HCQ offers a safe, cheap and effective prophylaxis treatment when combined with zinc and an antibiotic to prevent co-infections and most importantly when prescribed early and at the correct dosage. HCQ acts as an ionophore, enabling zinc to enter cells of the alveoli where it disrupts or prevents attachment of virus protein spikes. The UK "Prevent" trial of HCQ (and CQ) prescribed toxic doses of HCQ (x4 the normal dose) and administered it to patients who were already at too advanced a stage of the disease to be of benefit. In other words, the UK Prevent trial of HCQ was designed to fail. This led to the WHO effectively banning what they designate a safe and essential medicine however; many countries recognized the deficiencies of the UK trials and have continued to use it.

There is an even more effective treatment than HCQ using another cheap, safe drug; Ivermectin. I have made a separate freedom of information request regarding this.

Another treatment that MHRA does not appear to have investigated or supported is ozone therapy. This treatment has been demonstrated to significantly improve the time to clinical improvement, reduce mortality, or time to clearance of virus in patients with mild to moderate COVID- 19, compared to patients who received only Standard of care (SOC).
https://reader.elsevier.com/reader/sd/pi...
https://www.sciencedirect.com/science/ar...

Anecdotally, I believe there are only four machines in the UK that take a patient’s own blood, oxygenates in then returns it to the patient. This treatment has a remarkable success rate compared to placing patients on ventilators that for the majority of patients equates to a death sentence.

Yet another effective protocol developed by the FLCCC Alliance is the I-MASK prophylactic and early outpatient combination treatment that was first developed in March 2020 and has subsequently been refined. Why has the MHRA not at least trialed it?
https://covid19criticalcare.com/i-mask-p...

It is unacceptable to instruct people who test positive for the SARS CoV-2 virus to isolate themselves with no treatment until they are so ill that they need admission to hospital when prophylaxis treatments are available. In a pandemic, every doctor knows that you should use what works until something better comes along. When thousands of lives are being lost every week, you simply cannot wait for double blind placebo controlled trial results before allowing doctors to use their judgement and skills to treat the patient presenting to them. It is immoral to insist that current protocols are correct.

In view of the above, I am requesting an internal review.

Yours sincerely,

Roland Gilmore

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Thank you for your email.  This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible. 

 

Please note that we may not respond if your query: 

 

• contains offensive language
• has already been answered in a previous reply to you
• is illegible
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Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
Stay connected 
 
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC. 

 

The UK has left the EU, and the transition period ends on 31 December
2020. Our [1]guidance and information can be accessed here. 

References

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Mr Gilmore,

Thank you for your email.

We confirm that an internal review is being carried out on FOI 20/275.

Please note the deadline for reply for Internal Reviews is 20 working days from our date of receipt and the date for this request is 12 February.

Kind Regards

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000

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Roland Gilmore left an annotation ()

"Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection" published by the American Medical Journal
https://www.amjmed.com/article/S0002-934...
This study found that immediate use of HCQ, while the patient was still at home, showed significant benefits. COVID-19 hospitalizations and death can be reduced with outpatient treatment. The Principles of COVID-19 outpatient care protocol include: -
1) reduction of re-inoculation,
2) combination antiviral therapy,
3) immunomodulation,
4) antiplatelet/antithrombotic therapy
5) administration of oxygen, monitoring, and telemedicine.
There have been 195 published trials of or including Hydroxychloroquine (in vivo and in vitro) involving 3,054 scientists and 166,999 patients. 25 early treatment trials returned a 67% improvement. 11 early treatment results indicated a 76% improvement in mortality rates. These are the protocols that that should be followed.
Ivermectin has produced even better results than HCQ. There have been 35 trials involving 228 scientists and 10,338 patients. Of 17 Randomised Controlled Trials, there was an average 71% improvement. 10 prophylaxis trials returned a 90% improvement. 10 Early treatment trials returned an 84% improvement. 14 showed a 78% improvement in mortality rates.
Other medications that show positive results are vitamin D and Zinc supplementation and Povidone-iodine.
It appears that the MHRA is locked into "silo thinking" rather than being proactive.