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HPV Vaccines: 15 Physicians Report Risk of Conflict of Interest



Fifteen health professionals oppose the recent campaign to vaccinate girls and boys against HPV. Denouncing the influence of the pharmaceutical industry on the promotion of HPV vaccines, they urge governments to resist and demand a moratorium.

On March 20, the "call of 50" was very difficult. Academies, colleges, medical societies and trade unions, medical personalities and patient organizations have come together to urge governments to increase vaccination against human papillomavirus (HPV) and to extend it to boys. The statement of 50 found a resounding echo in the press. "More than 20 media outlets treated the issue," he congratulated LJCom on Twitter five days later. Specialized in communication and influence in the field of health, the agency that passed the call in the media counts among its clients the laboratories that produce vaccines against HPV.

Why such a coalition to ask for the vaccination of girls and boys? "We are doctors, each in different specialties, more or less involved in cancer and vaccination against HPV." In France, one of the main developed countries, the situation is the most catastrophic in terms of vaccination coverage and recommendation. United States, Australia, England, the Scandinavian countries … vaccines and children are vaccinated, "explains pediatrician François Vié Le Sage, coordinator of the vaccinology group at AFPA and specialist at Infovac.

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More than 1,000 women die each year from cervical cancer

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Considering it is a public health priority, while "over a thousand women die each year from cervical cancer," the pediatrician recalls that vaccination is "true prevention." And the smear test, "a worse yet essential, unfortunately insufficiently applied in France," but that one could "perhaps give up in a few years if it reaches 90% of vaccination coverage." HPV is the cause of various types of cancer: cervix, pharynx (tonsils), anus, vulva, vagina, penis. "Of the 6,300 cases a year, half concern women and the other, men and women," said the doctor.

While only 20% of French girls are involved in this vaccination, the learned societies want to "restore scientific truth" and "rely on these active and very well tolerated vaccines." "Gardasil and Cervarix prevent 70% of cancers infections due to HPV, and Gardasil 9, 90%. Tolerance studies worldwide show that the benefit is clearly favorable to the vaccine," says Dr. I saw Le Sage. "In Australia, with a massive vaccine coverage of girls and boys and a 12-year decline, the number of virus carriers in the cervix and anus and precancerous cervical lesions has collapsed. There is also an indirect effect in unvaccinated boys who have fewer lesions due to these sexually transmitted viruses, because many girls and more and more boys are vaccinated, which plans to eradicate cervical cancer virus in 20 years.

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It is necessary to vaccinate more girls and start vaccinating boys, under the same conditions of reimbursement

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Fearing that France is "against the grain" in "this vaccine that prevents preventable cancer," the 50 scientific societies call for mobilization to make possible a "tremendous and historic victory against cancer." And support the Minister Agnès Buzyn in her decision to refer to Haute Autorité de Santé (SAH) on the relevance of a universal vaccination recommendation. "It is necessary to vaccinate more girls until the age of 19 and to start vaccinating the children, under the same conditions of care by the social security and the mutual," adds the doctor. With 40% of hesitant vaccines in France, can the obligation be considered for these vaccines? "It is difficult to stop a pupil's schooling because he is not vaccinated against the vaccine," he said. the HPV. Regarding the imposition of fines, the minister is not in that respect. "

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I attend industrial meetings because they produce the product

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Asked about the weight of conflicts of interest in the health field, the pediatrician responds: "I have links with the industry, necessary to my expertise, but without personal enrichment.You would have your car repaired by a mechanic who has no connection with Renault or Peugeot, and who does not know what they do? Sometimes congresses are paid for by the laboratories. I go there, especially in Europe, because it is essential to see what is done elsewhere. they are making the product.I want to know what they do and how they do it.But the main source for me is scientific studies.Meanwhile, my office is closed and I am with zero income.The industry has been clearly undermined, among other things, the lack of transparency at the time of the controversy over hepatitis B and that based on the mediator.But since the 1990s, there is such a control that industrialists can not write a li or take action without the approval of the ministry. You do not see commercial radio or TV spots for a vaccine. All amounts paid to physicians must be reported on the Transparency Health Foundation website. Conflicts of interest, that is, when a physician personally enrich himself by promoting an industrial product, are clearly out of the question. "

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Uncertainties weigh on the efficacy and safety of these vaccines

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Unlike the appeal of the 50s, doctors and pharmacists are opposed to the generalization of papillomavirus vaccination and consider that a moratorium on these vaccines is "necessary." All of them are very committed to their independence from the pharmaceutical industry and sign a well-documented right of reply that "great uncertainties weigh the efficacy and safety" of HPV vaccines. Considering that the influence of the industry has been ubiquitous on these products since their introduction on the market, these doctors denounce the convening of the 50 whose signatories did not respect the obligation to declare personally and individually their links and conflicts of interest. This law of the Public Health Code, little respected, was born after the Mediator case. The 15 signatories of the right of reply expect the Minister of Health "to withstand pressure from the media that is not spontaneous."

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We are in the magical thought of a revolutionary product that is not

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General practitioner and university professor in Lyon, Rémy Boussageon is a member of the scientific committee of the National Council of Medical Practices of Teaching (CNGE). One of the few scientific societies that refused to sign the 50's call, considering it was "a lobbying operation," explains the doctor, who in his own name signs the right of reply. "We are in the magical thinking of a revolutionary product that is not," react Dr. Armel Sevestre in Rennes. Health blogger and general practitioner at Mantes-la-Jolie, Jean-Claude Grange says "terrified that in presumptions of efficiency, we involve the whole population." For him, the message of the 50s betrays "an authoritarian and paternalistic approach, where we do the good of people in spite of themselves."

Pharmacist and hospital doctor in Cholet (Maine et Loire), Amine Umlil recalls Gardasil's arrival in France in 2007: "I was surprised that in February Minister Xavier Bertrand announced the reimbursement of this vaccine that the HAS transparency committee was still evaluating the benefit-risk ratio and had not voiced her opinion. "" This miracle vaccine is not yet reimbursed by social security, "was then the main female press. The minister was reported to have succumbed to media pressure following a major media campaign launched by Sanofi Pasteur MSD at the end of 2006. On the island of Réunion, where Gardasil was released on a preview, Dr. Philippe de Chazournes thinks he is the first French to "raise the hare". President of an independent medical training association, he presents himself as a field doctor "specialist in doubts".

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Why a vaccine when cervical cancer is not a public health problem?

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When, in November 2006, a medical professor who "participated in the development of Gardasil" came to the island to present the vaccine as a "revolution" for Réunion, Dr. de Chazournes did not understand. "Why a vaccine when cervical cancer is not a public health problem?" Brochures in newspapers, on TV and in all pharmacies … Gardasil is boosted as a great innovation against cancer. "This is not a vaccine against cervical cancer, but a vaccine against some HPV-related viruses," the doctor says. Under his leadership, the Réunion Regional Physicians Union funded a quarter of the page in "Le Monde" on September 8, 2008 to publish a counter-advertisement.

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His activism earned him several phone calls from one of the vaccine manufacturers: "The turnover in Reunion does not take off!" And a call from the departmental council of the College of Physicians on "the campaign of orchestrated denigration around Gardasil" that causes "discontent of many confreres." A recognized specialist, president of a learned society, made the trip to the island to defend the virtues of the cervical cancer vaccine and put an end to the controversy. "In 2006, I was an easy prey because I was very isolated, we are more numerous nowadays, we are embarrassed because we are credible," says the doctor. Former High Health Authority correspondent Philippe de Chazournes explains that the independent institution "has never been very supportive of HPV vaccines."

At Cholet Hospital, Amine Umlil organizes public meetings on the drug. When he discovers the 50's call in the press, he decides to balance the information on these vaccines to his readers. "I published some data before our meeting on Gardasil because the issue was urgent. I felt that the disclosure of the appeal was neither objective nor misleading, that it did not present the prospective risk of the expected benefit and did not identify any uncertainties, such as" require the Code of Public Health and the rules of communication recalled in 2018 by the Agence du médicament.

The efficacy of the cancer vaccine has not been demonstrated by clinical trials

"Uncertainties" is the central problem pointed out by these 15 professionals: while the vaccine prevents certain precancerous lesions, its effectiveness against cancer has not been demonstrated by clinical studies. "Prescrire," the independent review that allowed the pneumologist Irène Frachon to blow up the scandal of the mediator, recalled in March that the evolution of a precancerous lesion to cervical cancer is rare (0.3% of infections) and occurs after an average of 30 years (most infections are transient). The efficacy of the vaccine is now "hypothetical." In addition, it claims that the benefit of the vaccine "in vulvar, vaginal and anus cancers (rare cancers)" is not established by clinical data, "and that its ability to reduce the risk of serious injury in men is not demonstrated.

"If the vaccine is effective in precancerous lesions, it would not be illogical for it to have a benefit on cancer," said Pr Boussageon. But the formal evidence is not there yet, contrary to what everyone says. "What about the Australian data?" These are statistical modeling. This study, like the one recently launched in Scotland, does not have a good level of proof. Relying on observational data to claim victory is not consistent with evidence-based medicine when it comes to proving the effectiveness of a treatment. It is not because the "Lancet" or "British Medical Journal" publishes those studies that are good. These are authorized arguments. "The professor emphasizes that the global prevention of cervical cancer is not just the vaccine:" It would reduce the cancer to the virus. But if it is necessary, it is not enough. Tobacco, the age of the first sexual intercourse, the number of partners, socioeconomic precariousness, and triage are all elements that play. We also forget to promote the use of condoms while it is essential to protect against sexually transmitted diseases. These elements should be discussed in consultation with the patient whose choice is most enlightened. It is even more important to take advantage of this time because the benefit and risk of these vaccines are uncertain. "

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If the vaccine is 30% effective, 100,000 women will need to be vaccinated to save one life per year

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To evaluate preventive therapy, the doctor defends the "population approach": "Consider that of 30 million women, 1,000 die each year from cervical cancer. If the vaccine is 30% effective, 300 lives are saved. This means that 100,000 women need to be vaccinated to save a life a year! So you have to ask yourself how you justify it from an economic point of view. On the other hand, if the vaccine benefit is low, the risk of a serious adverse effect even though rare, may counterbalance the benefit. "Although among the observed adverse effects (many are not reported), most are relatively mild and transient, it is plausible that this vaccine exposes to an increase in Guillain-Barré syndrome in particular. "A rare but serious and potentially fatal risk," says the hospital pharmacist who refers to the CNAMTS independent study and the ANSM technical committee's pharmacovigilance report of 2015. If the 400,000 girls in question chose to be vaccinated, there would be 4 to 8 more girls each year with Guillain-Barré syndrome because of the vaccine, with one death every 2 years to 3 years. Every year, 1 or 2 women will be permanently disabled. "

On the "Prescribing" side, Gardasil's replacement by Gardasil 9 raises a critical point. Firstly, because the new generation vaccine does not bring additional benefits, but also because the dose of adjuvant (aluminum) it contains doubles the risk of a serious reaction at the injection site. In a context of "reluctance to vaccinate for fear of serious side effects," the medical journal concluded last year: "Instead of accepting painful teenage vaccination, it is far more helpful to focus on a public health measure that can reduce severity of cervical cancer: organized screening among adult women ".

The vaccine was twelve years before the launch of the organized screening

Organized screening for cervical cancer has been in demand for 30 years by health professionals. Cervical smear examination is the main factor in the rapid decline since the 1980s in the incidence and mortality of the disease. Today relegated to 12and classification of cancer deaths in women. A few weeks before Gardasil was marketed in 2007, a cost-effectiveness analysis by the Technical Committee on Immunization (CTV) recommended that organized screening be introduced prior to the introduction of vaccination. Thought of desire. Once marketed, the vaccine will be twelve years before the launch of the organized screening, announced in January by Agnès Buzyn.

Although recommended in combination with the screening swab, HPV vaccination appears to have had a real route since its approval. Despite the doubts, the reluctance and the cost that this will bring to the community, if the government starts the routine vaccination of girls and boys. The 15 signatories to the right of reply made the calculation: "The only tax-free cost of vaccines would amount to € 1.9 billion over the first two years and € 180 million in annual cruise speed." The generalization of vaccination would also be a good operation, especially for the Merck laboratory, which since the end of 2018 has become profitable again, mainly thanks to sales of an anti-cancer and Gardasil. HPV vaccines are a vein to the American giant, who is recovering from the loss of Vioxx, its "blockbuster king" drug, whose withdrawal in 2004 and compensation for the victims cost him billions.

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Between 2012 and 2018, the signatories of the 50 call received 1.6 million euros from vaccine manufacturers

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Should we see the industry hand behind the March 20 media campaign? "To clarify their fellow citizens," the 15 doctors linked to their right of reply an analysis of the links and conflicts of interest of the signatories of the appeal of the 50s. Transparency Health Base being uncomfortable and badly indexed, they used Euros for Docs, a tool that makes data reported by manufacturers much more exploitable. Knowing that "a significant proportion of the remuneration of the contracts declared in the database is kept secret" and that the payments are underreported due to lack of control. "Undervalued values," experts "without conflict of interest indirectly remunerated by the industry", patient associations that are "empty shells", "medical training under influence" … The research conducted by these doctors also reveals "a certain financial power" "Between 2012 and 2018, all signatories received € 1,611,066 from HPV vaccine manufacturers (Sanofi Pasteur MSD, MSD and GSK)." An amount divided between professionals (€ 223,765) and structures (1,387,301 euros) ".

The press and the media, the first target of the pharmaceutical industry

Very interesting, research reveals, in the same period, the values ​​allocated by these three laboratories to all health actors for the promotion of all their products: 420,041,772 euros. In the distribution of its investments, we see that the "press and media" goal occupies much ahead of the first place, with 113,124,317 euros. Academies, learned societies and foundations come in second place.

Quantities allocated by the 3 HPV vaccine manufacturers to all health workers.

Quantities allocated by the 3 HPV vaccine manufacturers to all health workers. © Euros For Docs

The call of the 50s: "A house of cards backed by strong connections and conflicts of interest"

"It's a huge lobbying campaign," says Dr. Sevestre, who compares the 1950s appeal to a "house of cards." "This is a large building whose structures are quite fragile but hold together through strong links and conflicts of interest. By failing to declare them, signatories to the 50 call do not allow message recipients to take a critical view of A person who does not have time to look or who is accustomed to trust will think that it is impossible for all these people to be mistaken, "the doctor says.

"The amazing thing is that labs do not have to show up," says Dr. Grange. "Before a product is launched, we have already assembled and convinced those who have been designated as the future world leaders in a pathology." These boards are created by the laboratories that bring together experts to reflect on the long-term strategy: what could be made in infectology, in antibiotic therapy, in AIDS research? Words are collected.Marketing people listen.In a second step, we try to infuse product marketing development ideas.These experts are then used as lecturers at post conferences -market to popularize articles that show the effectiveness of the product. "

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The 10 pharmaceutical giants invested 2.6 times more in marketing than in research

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A new pharmaceutical era in which marketing would be king? This was demonstrated in 2005 in a socioeconomic analysis of the University of Quebec in Montreal on a global level: "Between 1996 and 2005, the ten Big Pharma spent $ 739 billion on marketing and development costs. 288 billion in research and development costs. "

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What's happening with Gardasil is true for other health products

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Faced with such power of influence, drained by a very complex network of conflicts of interest, can critical thinking about a health product be stifled or discredited? "In France, where academic power is very strong, it is the absolute void," laments Jean-Claude Grange. "The international medical system has become frightening. "What's happening with Gardasil is true for other health products, what's dramatic is that people are losing faith in medicine and taking refuge in non-health care therapists." This is not good for the care of our patients "answers Dr. de Chazournes.

Read too.Cervical Cancer: How to Prevent It

Of the 15 signatories, bloggers are accustomed to reviewing scientific literature and discussing the relevance of public health policies. Perhaps there is no agency in France that, without resorting to experts with conflicts of interest, analyzes the scientific data according to a rigorous methodology inspired by medicine based in evidence, "notes Professor Boussageon. Believing that citizens are at the forefront of institutions, the professor adds, "We can have experience without a conflict of interest with industry. It was a weakness in the 1980s because we were not considered experts. Our word is even more credible because we have no interest in promoting or opposing treatment. "

Restoring public confidence in the word of health is also the will of our public authorities.

* Evidence-based medicine or evidence-based medicine.

The website of the 15 signatories' right of reply, accessible here: "In the face of uncertainty about efficiency and safety, independent doctors and pharmacists in the pharmaceutical industry are asking for a moratorium"

The statement of links and conflicts of interest of Dr. Vié Le Sage (website Infovac).
The 15 signatories to the right of reply declare that they do not receive the medical examination and have no conflict of interest with respect to HPV vaccines or any health business.

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