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Vaccines: "European slowness owes more to its bureaucracy than to its prudence"

2020-12-18T19:19:47.906Z


FIGAROVOX / TRIBUNE - Greater decentralization of the precautionary principle would allow vaccines to be disseminated more quickly, analyze Fergane Azihari and Laurent Pahpy. According to the general delegate of the Free Academy of Human Sciences and the entrepreneur, as soon as a ...


Ferghane Azihari is general delegate of the Free Academy of Human Sciences (ALSH) and is preparing an essay on the ecological question.

Laurent Pahpy is an entrepreneur and coordinator for the Students for Liberty network in Paris.

He is also an analyst for IREF.

"The prophecy of doom must always prevail over the prophecy of happiness

."

It is on this enlightened catastrophism that the philosopher Hans Jonas, anxious to domesticate the unleashed Prometheus, proposed to build the principle of precaution which would serve as a compass for our civilization.

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Along with the growing ability of man to modify his environment, there has been a growing distrust of his freedom.

This precautiousness effectively establishes a form of preventive repression.

The precautionary principle weakens the rule of law

The burden of proof is reversed.

Human action is subject to a presumption of guilt and malice.

It is only when the "

certainty

" of its harmlessness is established that it is freed from all harassment.

The precautionary principle operates a spectacular ideological reversal in a civilization that had become accustomed to freedom being the rule, and punishment the exception.

Precautionism was originally limited to environmental issues.

But now he overflows them.

He makes his bed in the penal field and interferes in our daily life.

We owe him the suspension of social life decreed since the start of the pandemic.

Those who implement it swear that they are only seeking to protect us from ourselves.

However, their precaution is variable geometry.

The millions of people plunged into misery due to the cessation of social life, however, deserved that we exercise caution before ruining their existence

Seeing only the risks of the free course of life, the prophecy of doom omits those of its suspension.

The millions of people plunged into misery due to the cessation of social life, however, deserved that we exercise caution before ruining their existence.

But it is clear that these evils are hardly mentioned by decision-makers.

They are made invisible by the dominant health discourse.

This omission is easily explained.

In the event of laxity, the additional victims of the pandemic would have been visible, immediate, concentrated and directly attributable to the decision of the governors not to confine.

Conversely, the lives shattered by the authoritarian suspension of the economy are struck in a much more diffuse manner in space and time, so that they arouse indifference, even if they are more numerous. .

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Decision-makers therefore have every incentive to ignore these collateral victims.

It is in this sense that Gérald Bronner and Étienne Géhin said in 2010 of precautionism that the evil it produces does not inspire fear "

because it is, in a certain way, indirect and socially invisible

".

This observation applies to another determining aspect in the crisis we are experiencing: the certification of vaccines.

What is the correct level of hindsight for vaccines?

Vaccination seems to be the most credible solution to end the covid-19 pandemic.

Since the beginning of the year, many pharmaceutical companies around the world have focused their efforts on developing the safest and most effective vaccines possible.

However, there is the question of the level of hindsight to adopt to know how satisfactory the risk-benefit balance is.

On August 11, 2020, Vladimir Putin declared that the Sputnik V vaccine had been approved before the Russian regulator announced that phase 3 of the evaluation still had to be validated beforehand.

This haste had aroused the concern of several experts who found this declaration premature.

Earlier still, on June 25, China issued an exceptional authorization for the CanSino vaccine for its armed forces.

Centralized administration of an excessive level of prudence can be detrimental to society

In the West, the British regulator approved the Pfizer / BioNTech vaccine on December 2.

His American counterpart (FDA) followed suit nine days later.

While it was due to deliberate on December 29 on the Pfizer / BioNTech vaccine, the European Medicines Agency (EMA) moved its meeting to the 21st. The Moderna vaccine, for which the logistical constraints are lighter, should be authorized this Friday December 18 by the FDA, but not before January 6 in Europe.

The EMA is under pressure from some leaders, including Angela Merkel's government, who accuse it of being too slow.

Without an emergency procedure, the Swiss authorities say they want to wait several months before a possible marketing authorization for the Pfizer / BioNTech and Moderna vaccines.

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This scattered campaign is not surprising.

There is, after all, no objective and universal standard for defining the right level of risk and certainty.

The interpretation of this notion varies from person to person.

We observe it for various issues.

After a terrorist attack, there is always someone to play it down by reminding people that the average person is more likely to die in a car accident when leaving home than to be murdered, while the majority frightened, who does not bear the slightest criminal risk, is ready to make many concessions in terms of police surveillance.

The right cursor in terms of risk and certainty is a matter of subjective judgment.

The fact remains that centralized administration of an excessive level of prudence can be detrimental to society.

Let's go back to vaccines by taking a strong hypothesis.

Suppose for a moment that we find out tomorrow that most of the vaccines under review give excellent results with negligible side effects.

It will then be legitimate to deplore the countless lives that could have been saved if these vaccines had been available earlier.

On the grounds of preventing a hypothetical health risk, the precautionists will have unnecessarily prolonged unacceptable suffering.

The decision whether or not to use these drugs is ultimately up to the patient, regardless of the level of risk and certainty.

To this, the latter will respond that their arbitration involves necessary sacrifices.

What would have been said on the contrary if the consumption of these drugs had worsened the health of the population?

Haunted by the tainted blood or PIP prosthesis scandal, executives and regulators would rather be accused of over-caution than negligence.

These charges do not, it is true, have the same media, political and criminal repercussions.

However, there would be a way to free decision-makers from their burden.

It would be to recognize that the decision to use or not to use these drugs rests, whatever the level of risk and certainty, ultimately with the patient.

This would obviously not be left to itself.

He would be assisted by a multitude of trusted third parties: doctors, pharmacists or scientists who collaborate with certification bodies and whose job is to communicate the potential risks and benefits of new products by constantly updating knowledge.

For a more decentralized approach to the precautionary principle

Thus, some elderly patients or patients with strong comorbidities will tolerate the risks of the virus less than those of a vaccine for which the traditional evaluation procedure has not yet been finalized.

Others, worried about the consequences of the virus, will nevertheless wait until the end of phase 3 to be vaccinated.

Those who know they are allergic to the components of the first vaccines will wait until a more suitable product is developed.

Skeptics will delay even after phase 3 to ensure that no serious side effects are observed in the population.

The conspirators and those who do not fear the virus will refuse, whatever happens, the vaccination.

Getting the vaccine to market as soon as possible - while keeping vaccination optional - would satisfy all of these profiles and achieve what economist Milton Friedman calls "

unanimity without uniformity

."

The evaluating organizations would continue their work by accumulating data as time passes, to dispel - as much as possible - the fog of uncertainty, in order to rally more and more people to vaccination.

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Accelerating time to market would therefore not mean abandoning all safety standards.

Any approved drug is subject to interrupted surveillance in the name of pharmacovigilance.

Getting it to market as soon as possible can save precious time - and save more lives - in the event that no major side effects are to be deplored afterwards, while leaving the most worried free not to expose themselves or wait for the subsequent certification of a more cautious agency.

This criticism of the centralized application of the precautionary principle does not prevent us from recognizing that regulators have been pragmatic.

We salute the approach of those who have been able to initiate essential emergency procedures in this race against time.

Our proposal emphasizes the existence of more optimal mechanisms that respect the health needs of populations.

Once a drug is accepted in a country with reliable standards, it could automatically be marketed in all countries that recognize its standards.

If it may seem radical, an intermediate solution would consist in applying a principle of recognition of marketing authorizations between developed countries.

Once a drug is accepted in a country with reliable standards, it could automatically be marketed in all countries that recognize its standards.

Thus, the French or the Swiss most in a hurry to be vaccinated would not be impatient for many weeks to see the images of the first American or English vaccination campaigns.

Some will argue that our proposal will only save a few weeks and that the distribution of the vaccine is in any case limited by logistical constraints.

While governments have demanded heavy sacrifices from their citizens to flatten the contaminations curve and deaths continue to count in the hundreds daily, it would be surprising if we minimize even a second lost against this virus due to a vaccination campaign slowed down by bureaucracy.

To save as many lives as possible, let's save as much time as possible.

Source: lefigaro

All news articles on 2020-12-18

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