This was on TLN
Changes to Human Medicine Regulations to support the rollout of COVID-19 vaccines
The public can submit but they are clearly marginalised, and weren’t told.
Govt says might consider later responses.
It’s like a sales team in full swing.
EDIT: More information here in this second TLN post from yesterday, including a link to make a response.
In the spirit of the rushed vaccine, I decided to do a rushed response. The numbers are the items in the proposals. I hope easy to follow, but it’s worth looking at the proposals to see how the laws are being bypassed using the pretense that this is the best way to deal with Covid-19.
At the outset it needs to be asked why, if it’s non-commercial, the public are not considered stakeholders?
The ‘need’ driving this politic is dressed up as “the biggest threat this country has faced in peacetime history”. Where is the science to support this claim?
If I may examine it…two or three months ago, when the virus fatalities were vastly more numerous, I calculated using Worldometer data that two thirds of the world’s Covid-19 deaths were in seven countries (including the UK) that between them totalled only 12% of the world population… In the UK we have one of the worst per population Covid-19 death rates in the world, 600+ per million even after ‘shuffling’. The world rate is about 140 per million. Therefore statistically (ie using science) the ‘country effect’ of living in the UK during the virus GREATLY exceeds the overall world ‘virus’ effect itself. If its about science, the clear scientific ‘need’ is for the government to examine its own initially leisurely reaction, and to act more like the vast majority of countries with smaller death rates. This might mean for example a proper testing programme that is planned and not for-profit. The reliance on the commercial instincts of the pharmaceutical industry has scuppered serious scrutiny of the most promising but unprofitable treatments (like Vitamin C, hydroxychloroquine+zinc and Vitamin D). The only serious scrutiny of HCQ has been with the purpose of suppressing it. There is not space here to point out the flaws in the allegedly ‘gold standard’ RCTs that claimed ‘No Effect’ but they aren’t hard to spot for a moderatly trained or critical eye, and if genuinely interested in ‘sound science’, feel free to contact me for these criticisms.
Nutrition is hugely relevant in fighting infection. Yet the prior nutritional status of neither the population nor covid-19 sufferers has had no serious attention, despite the known medical fact that vitamin D is a potent inhibitor of respiratory infections. It is most seriously negligent not to have issued vitamin D while FORCING people to stay indoors. Does the government need to be told that the elderly, and indeed those vulnerable through co-morbidities, are usually short of Vitamin D? This is the problem with commercializing science, you get a version of science that is unable to join up the dots.
Until the main factors are addressed without political and commercial prejudice, the justification for blind rush to vaccines can not be called ‘scientific’.
The first medical tenet of ‘First do no harm’ could have been practiced by supplement or even advice to supplement. It STILL could. Yet now the corporatized medicine wants to sell us invasive and rushed solutions to its own neglect.
Please see the response in the previous box, as it’s relevant to all of these.
Specifically, if the testing and efficacy are genuinely sufficient then there is no need to protect anyone in the chain of manufacture and supply from legal action. This in fact removes the standard protection the public (those missing stakeholders) have against medication being pushed onto them that has been over influenced by political or commercial agendas.
All part of the same unseemly rush. See previous responses.
The prohibitions and restrictions on “promoting an unlicensed medicine to healthcare professionals and the public” are there for good REASONS. It’s the government’s reasons for over-riding them that matter. As noted above, these reasons deliberately ignore the principles of science. Genuine science would seek to identify ALL the influences and effects on the crisis and effects first, and address the main ones as priority. As noted above, the government’s actions in ignoring nutritional and other medical evidence made the UK’s virus outcome greatly worse. Therefore the justification due to the ‘threat’ to the country is exaggerated as government policies have constituted the bigger part of this threat, as even the rough statistical explanation given in the first section indicates.
The rush to seize the opportunity provided by the virus to vaccinate also ignores the interests of the public, who it has marginalized in the consultation…
Again, as this is another part of the same rush, which as noted (by reference to the spurious justifications given), can not be claimed to be for the benefit of the public, the situation does not justify cutting such corners as proposed. The existing restrictions are there for a good reason and need a better reason to override them. The justifications are not good reasons and merely serve to further illustrate the previous neglect of the public good and herald its ongoing continuation.
The headings of these five areas (authorisation…of unlicensed…expansion…promotion…wholesale dealing) themselves suggest a rushed commercial operation.
*Not frame the critical issue as a vaccine-absence, like the government is a sales team for vaccines. This has meant depriving the population of independent medical advice on eg nutritional status. You also confined the most vulnerable people to their homes depriving them of vitamin D without EVEN telling them to top up, which would have undermined the ‘we must have a vaccine’ message.
*Required gathering of vitamin status on hospitalization, and conducted a study or two on the effect on Covid-severity.
*Rolled out a nutritional program to buffer the vulnerable people against respiratory infections. Factoring in influenza as will, this would have saved a great deal of money.
*Implemented test-and-trace using the NHS not entrepreneurs that didn’t know what they were doing and were only in it for the money.
*Consult more widely than only with politically compromised appointed that seem mainly to say yes.
*Ensure medical analysis is independent ie free from bias.
*I suggest a quick look at ALL the HCQ studies (maintained here, with knowledgeable commentary, https://c19study.com/) and bear in mind (this is SCIENCE after all) that (i) studies need to have the right kind of dose (some of these RCTs used a multiple of the maximum stipulated by NICE), (ii) Need to examine EARLY treatment not very sick people, (iii) Include zinc and or antibiotic, (iv) Check the study conclusion matches the data - non-significant improvement is not the same as demonstrating ‘no effect’. One RCT (Boulware) showed clearly a strong effect if given early but author didn’t report it. (v) Pay attention to the detail; several of thes RCTs stopped early deliberately, thus preventing statistical significance (which depends on size) from being reached. (vi) If serious, end austerity as poverty kills indirectly. The virus has shone a bright light on human catastrophes due to lack of political care, as is shown by the worst countries being the richest or most capitalist (France, Spain, UK, USA, Italy and now Brazil.
*Thank you for this opportunity but the public should have been consulted directly not allowed to squeeze in the back door.
This is a fantastic post, @Evvy_dense. Great info and lots to think about.
I’ll digest and maybe have something to add
Cheers!
PP
Thanks Aly! Look forward to your take on this, Cheers
Breath of fresh - honest - air, Walter! With added basic scientific/statistical intelligence. You should be the health minister; or better still you should take the - currently empty - post of PM. Then, we’d see a proper response to this slightly-more-severe-than-usual flu, with far fewer deaths from either covid or all the other health problems which have been so savagely exacerbated by the current NHS-paralysing uk-shambles.
Thanks v much Rhis - You’re too kind. I think I’d make too many gaffes in front of the camera - no ‘edit’ function! Cheers