Gardasil: Emmanuel Macron’s (very) expensive back-to-school vaccination has arrived, what do we think of its effectiveness?

by time news

2023-09-08 18:00:00

HEALTH – It is for the President of the Republic a surprising hobbyhorse. Last March, Emmanuel Macron announced that he wanted “generalize” vaccination of 5th grade students aged 11 to 13. Putting on his doctor’s costume, according to him, it is necessary “go fast” and realize “from school onwards, an enormous amount of information work”even “do not exclude that we will move towards compulsory vaccination when all this is installed and we have the right recommendations”. But at what cost and for what result? The safety of the product also raises questions as a trial in the United States opened this year because of the side effects and an alleged lack of effectiveness of Gardasil, according to the plaintiffs.

For the moment, the Gardasil vaccine (from the Merck laboratory, in a quasi-monopoly situation) is not yet imposed on young adolescents. The injection remains subject to parental consent. But the 2023 school year is indeed that of an all-out vaccination campaign. Nearly 800,000 students are affected. According to government communication, this is“improve vaccination coverage to prevent the 6,000 new cases of cancer and the 30,000 precancerous lesions of the cervix caused each year by this infection.”

Flattering communication

The Minister of Health Aurélien Rousseau even delivered a very impactful interview to the media on September 1 Brut to detail the operation: “The first vaccinations begin from October 2, in colleges. A communication campaign to give you all the information begins on September 4. A vaccine is available to help eradicate cervical cancer but also breast cancer. vagina, vulva, anus, this concerns everyone. (…) There are countries which have succeeded in eradicating these diseases. It is in your hands (…) There are health personnel who are there to answer you, we have a chance to protect ourselves collectively.”

In short, one month is devoted to “information work”, promised by the head of state. Then the doses are offered to the parents of students whom Aurélien Rousseau hopes to persuade of the merits of the operation. Their offspring then receives two doses, the main one and a booster a few months later.

Specified as “free”, however, this has a hefty cost for the taxpayer. The price of one dose of the Gardasil 9 vaccine is 115.84 euros. It is therefore necessary to count 231.68 euros for the complete vaccination schedule, in the majority of cases (1). For comparison, this represents around 2.5% of the expenditure per student per year granted by the State within national education (2018 figures) for middle school students.

The human papillomavirus (HPV) vaccine is the most expensive of the vaccines covered by Health Insurance. The total could reach a sum exceeding 150 million euros. A sum to which must be added the organization of this public health campaign, the mobilization of health personnel who take care of consultations, etc.

Exorbitant price for the taxpayer, super margin for the manufacturer

But how much does the production of the vaccine cost for the laboratory? We can estimate the production cost at a few tens of cents, around 50 cents. How can we explain such a difference with the “sale price”? Research and development of the product, like what happened for example recently in the development of the Pfizer/BioNTech anti-Covid-10 vaccine, is largely supported by public money. And we cannot say that advertising the product costs the manufacturer dearly: the government takes care of everything with a President of the Republic ready to get involved personally, like a luxury sales representative. After all, the latter has already collaborated with Pfizer.

Gardasil is a real cash machine. Between 2006 and 2015, Merck raked in nearly $14 billion from its sales of Gardsil. In November 2022, Merck announces a publication on its vaccine in the journal Expert Review Of Vaccine. According to her, “Use of Gardasil has been observed to result in reductions in the rates of high-grade (precancerous) and low-grade cervical lesions, as well as reductions in certain non-human papillomavirus diseases and papillomavirus infection. HPV in women and men. Ravinder Dhawan, vice-president at Merck Research Laboratories then indicated, very enthusiastically, that it was necessary “do more to expand vaccinations to men and women as part of the global fight to reduce the incidence of certain HPV-related diseases and cancers.”

In the third quarter of 2022, Merck presents sales of pharmaceutical products increasing by 13%, which reach 13 billion dollars. The targeted turnover objective exceeds 60 billion dollars. And the commercial success of the Gardasil vaccine is one of the key elements of this performance. From this angle, the French vaccination campaign looks like a nice jackpot for Merck.

Effectiveness, to say the least, debated through scientific studies

Given this incredible price, is the product effective? What is it used for exactly? Is it without side effects? Vaccination against HPV infections should, generally speaking, prevent the occurrence of genital precancerous lesions in women. The objective sought – and praised by the Minister of Health – whose training is that of a professor of history geography, this former ENA does not have a medical background – is therefore “eradication” cancers of the cervix, vulva and vaccine, such as the anus in men.

However, a large proportion of papillomavirus infections, of which there are around forty strains, do not – fortunately – lead to a cancerous lesion. Nine times out of ten, the infection disappears naturally, without any treatment, according to a communication of the High Health Authority (HAS). Beyond one or two years, if the infection persists, dysplasia (precancerous lesions, editor’s note) can then appear, for example in the cervix. But again, three times out of four, these dysplasias disappear within a few months. HPV is ultimately very common: 80% of people are exposed to this virus. And the vast majority remain not serious: 0.7% of infections degenerate into cancer, after an average period of 30 years.

This makes it very difficult to prove with certainty the effectiveness of a vaccine against this type of disease. And which questions the budgets allocated in relation to other public health issues which concern children and young people.

In 2018, cancer doctor and health specialist Véronique Chabernaud recalled the lack of perspective on the effectiveness of these injections. According to her, the real results in this matter cannot be known only “in twenty years”. Car “cancers tend to develop between the ages of 40 and 60 and young girls aged 9 to 15 are vaccinated.” This is for a vaccination which, in any case, does not replace screening by cervical smear, which remains essential.

To convince of the effectiveness of its product, the Merck laboratory communicated in particular about a Swedish study published in October 2020. The analysis of its results would show that the number of cases of uterine cancer is decreasing significantly. in vaccinated women, particularly in the case of vaccination before 17 years of age. However, in an opinion delivered in September 2017the HAS specifies that “the data available to date do not allow us to answer questions concerning the effectiveness in terms of cancer prevention, as for the Gardasil or Cervarix vaccines (the anti-HPV vaccine from GSK, editor’s note)” This is surprising when this element is highlighted in the speeches of the Minister of Health.

According to Aurélien Rousseau, the promise to eradicate this type of cancer has already been kept in other countries. This statement does not stand the test of facts. In 2022, in Australia, which has seen general HPV vaccination campaigns, the estimated number of new cases of cervical cancer diagnosed is 942 among women. In Sweden, for the year 2019, the increase in these same cancers is noted in a study by researcher Lars Jorgensen. Other scientific studies show a similar trend: in 2020, he is shown what “among women correctly screened with normal results, there was a sharp increase in incidence in 2014-2015 compared to previous years” (Wang study).

Side effects and lawsuits in the United States

Finally, is the vaccine safe? The subject is cause for concern. There initially appears a risk of side effects of 1 to 2 cases per 100,000 young women vaccinated of developing Guillain-Barré syndrome (see a epidemiological study carried out by the National Medicines Safety Agency – ANSM).

And this very present and proven risk appears absent, surprisingly, from the communication supported by Emmanuel Macron around Gardasil. In a flyer developed by Santé Publique France, “The 5 good reasons to get vaccinated”it is presented that “reactions are uncommon and benign” and “In the vast majority of cases, there are no side effects after HPV vaccination. Among the most common side effects, we may observe pain or redness at the site of the injection. There is no scientifically demonstrated link between HPV vaccination and the occurrence of autoimmune diseases.” However, the French pharmaco-epidemiological study clearly indicates this. The oncologist Véronique Chabernaud described, 5 years ago, before the decision to lead such a generalized health campaign, a “vaccine [qui] is still not trivial.” with side effects like “tremors” or effects “rigidity”.

Other signals are concerning. Since February 2023, the United States has recorded the opening of a mega trial against the pharmaceutical laboratory Merck, under the principle of class action. The plaintiffs are suing because of serious and sometimes fatal side effects they say are attributed to Gardasil. Side effects such as premature ovarian failure (menopause) or postural orthostatic tachycardia syndrome (STOP), about which Merck would have forgotten to communicate, as well as the obvious limits of effectiveness in terms of protection against cancers linked to sexually transmitted infection of its product.

Across the Atlantic, at the end of August, a meeting between the lawyers and the judge in charge of the case prepares the progress of the first trial in a long series. Financial negotiations linked to compensation for alleged victims of the Gardasil vaccine have already been mentioned. It is at the same time that Emmanuel Macron and his government are plunging France and its youngest students into a vaccination frenzy. With a very particular application to resume the communication that the manufacturer Merck has developed about its product. In 2014, experts from Europe and France rushed the authorization of the first version of the Gardasil vaccine. Some had a conflict of interest with the pharmaceutical company. A scandal quickly forgotten.

Note :

(1) The European Medicines Agency recommended up to 3 doses. The age of first vaccination or the profile of the vaccine recipient may result in different recommendations.

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