Tamiflu 2? Vaccines, science and shady business
By Sergio Minué: “We need the commitment of organizations and pharmaceutical companies so that all data is available even if it means that we have to go back 20 years. Otherwise we run the risk of another knee-jerk reaction to a possible pandemic. And can we really afford it?
" This was written by Fiona Godlee, director of the BMJ more than 6 years ago. It was clear that we could not afford it but it has happened again: knee-jerk reactions to the worst pandemic in a century. This week Godlee returns to writing an editorial in the BMJ under the title "The Lost Lessons of Tamiflu," in which she laments how little we learn from the mistakes we make. For those who did not experience it or have decided to forget it, the management of the H1N1 “pandemic” was one of the biggest disasters and recent public health scandals, although it must be recognized that it was widely surpassed by the grotesque management of COVID-19. The list of blunders committed was endless: global hysteria epidemic not justified by infection and death data, extremely shady behavior by the WHO (which modified its own pandemic criteria to justify its decisions, while hiding the obvious conflicts of interest of his advisers linked to Roche and Glaxo, the two companies producing Tamiflu and Ralenza), disproportionate purchase of both drugs and vaccines by governments around the world, misrepresentation of information ... It is advisable to read the best summary of what what happened then, written by Juan Gervas, to see to what extent we do not learn. At that time, the Spanish Government bought about 13 million vaccines, of which only 2 were used. Like the rest of the countries that got their fingers caught, Spain had to look for places to put the surplus, from auctioning them to donating them to other countries. “Low income” or wait until they expire to throw them away.
As Godlee well describes, the same strategy of indiscriminate sale and use of drugs of unproven effectiveness and insufficient information on their safety, based on propaganda studies by pharmaceutical laboratories, has been repeated with COVID-19. Knowing the truth about Tamiflu (oseltamivir) took more than five years. During that time, the two pharmaceutical companies refused to share their databases with independent researchers, which they only ended up doing due to continued pressure from the BMJ and the Cochrane Collaboration, whose work confirmed that oseltamivir (Tamiflu) was not effective in treatment. nor did it reduce its transmission, while producing significant adverse effects.
Spain then spent 333 million on the treatment of the H1N1 flu. Now it could spend around 1,200 million, extendable to just over 2,000, if it signs the six contracts that the European Union has signed or is going to sign with the respective manufacturers (Pfizer / BioNtech, Astra Zeneca, CureVac, Sanofi / GSJ, Janssen and Moderna). Based on this, it would receive 10.5% of the product and the corresponding 10.5% of the total bill, between 137 and 206 million vials, according to Five Days.
For the Spanish minister, Mr. Illa, this would mean "a stab of death" for the virus. Very expressive bullfighting term that I do not know if the most appropriate to refer to something as little tangible as a virus. It is true that from the moment in which Pfizer published its press release where it guaranteed 95% of the efficacy of its vaccine, there has not been a politician, talkative, paid epidemiologist, or television expert who has even timidly questioned said data, taking for granted that the announced death of the damn coronavirus is a matter of days. However, the real data is far from it.
Two essential reading articles are enough to confirm this: the first is the work of Sussane Hodgson et al. in the Lancet on what defines the efficacy of a COVID-19 vaccine. A vaccine can act against infection, transmission or disease, but what is really important is to know its effect against severe disease and death. And it is not possible to demonstrate these last two aspects in phase 3 of its development; in fact, "any proof of efficacy regarding severe disease or mortality in populations at risk will only be achieved after their leave through large epidemiological studies."
The second is the magnificent work of Peter Doshi, associate director of the BMJ in this journal (and one of the authors of that historic Cochrane review) whose title already makes it very clear: “Will COVID-19 vaccines save lives? The current trials are not designed to tell us. " Doshi notes that neither vaccine is designed to detect reductions in some of the severe outcomes, such as reduced hospitalizations, ICU admissions, or deaths. Nor on whether they interrupt the transmission of the virus. The required number of cases may partially explain the fact: "COVID-19 hospital admissions and death from it are too rare in studies of the use of a vaccine in populations of 30,000 people to demonstrate statistically significant differences." The same is true for reducing mortality or transmission of infection: the trials are not designed for this. Even so, they are sold as if such a thing were happening and are accepted without proof by political leaders, communicators and experts. None of these trials include children or adolescents (except partially for Astra Zeneca), immunocompromised patients, or pregnant or lactating women. And although some include the elderly, their number is not relevant enough to draw clear conclusions about their efficacy in this group. The consequence of this is brutal: as Paul Offit points out, "if we do not have adequate data on people over 65 years of age, they should not receive the vaccine, and it would not cease to be shameful that those who need it most do not receive it." A similar situation happens with minorities.
Another important issue is safety: the number of participants in all the trials conducted to date is insufficient to guarantee it. As Eric Topol writes, quoted by Dashi: “… you are talking about giving a vaccine to tens of millions of people; And you are going to rely on only 100 events?
There is an extremely dangerous argument in many of those who cling like a burning key to the supposed efficacy of vaccines: the responsible agencies will only authorize safe and effective vaccines. Hard to believe when that demonstration is made through press releases and not scientific publications. Difficult to trust when contracts with companies are confidential. This aspect hardly worries those who occupy various press, radio and television pages every day. According to Cinco Días, all "these contracts will have a return clause, whereby Spain must pay the cost of the order made to the manufacturer if the vaccine does not finally receive authorization, according to Health sources, although the exact terms of the penalty they are not known for the confidentiality of the agreements ”. What would happen then if hypothetically a vaccine does not receive authorization? Another Tamiflu 2 but in a big way?
According to the Chilean newspaper La Tercera in this country, pharmaceutical companies will not respond in case of damage or death of the inoculated, having to be the State solely responsible for adverse effects of vaccines. The Chilean government responded that there was no other option when negotiating with the pharmaceutical companies. Chile does not seem to be an exception in the negotiation of COVID 19 vaccines. What will happen in Spain when adverse effects appear? Will the State also pay, Mr. Illa?
In summary, we do not have reliable information (published in serious journals) on the efficacy of vaccines, the measurement of their supposed efficacy does not include their possible effect in severe disease or mortality, nor would it be very representative in the elderly. And to top it all off, the companies that market them seem to obtain incalculable benefits by bearing the risks on governments.
With the H1N1 pandemic, a group of blogs warned about the nonsense of what was happening (Flu and calm). Today is unthinkable. The silence of the lambs is thunderous. Sergio Minué, doctor, specialist in Family and Community Medicine, professor at the Andalusian School of Public Health of Granada Source: https://gerentedemediado.blogspot.com/2020/12/tamiflu-2-vacunas-ciencia-y-negocios.html?
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