Senior figures in the French medical sector sat on regulatory bodies that approved the use of new medicines while secretly advising the drugs companies who made them on how best to present their products, Mediapart can reveal. The affair involves a tight-knot circle of friends who, for 20 years, presided over key committees that advised not just on the safety of medicines but, crucially, also on whether their use should be subsidised by France's state-backed health insurance system. For the drugs companies the financial stakes were huge, and Mediapart has learnt that the senior officials were paid in cash for their secret consultancy role. The pharmaceutical firms are said to have paid out up to 60,000 euros for each clandestine meeting. The affair raises serious issues about the ethics of the senior medical personnel involved and their potential conflicts of interest. It also raises wider questions about the financial probity of France's health system itself.
After details of Mediapart's investigation emerged, France's health minister Marisol Touraine ordered an immediate inquiry. “If the facts as reported are correct, they are unacceptable and even of extreme gravity,” said the minister, adding that “transparency is an essential condition for trust in our health system”. The National Security Agency for Medicines and Health Products (ANSM) and the French National Authority for Health (HAS) have been instructed to look into the claims.
The HAS has now referred the issue to France's prosecution services, asking them to carry out the “investigations necessary to establish the truth of the reported facts, some of which pre-date the creation of the HAS in 2005”. The authority has also launched an internal audit into the procedures used to evaluate the products cited in Mediapart's article, in particular Seroplex, made by Danish pharmaceutical firm Lundbeck, and Cymbalta, produced by American company Lilly.
Enlargement : Illustration 1
After months of investigation Mediapart has established the names of some of the medical experts who effectively operated as paid consultants to drugs companies without ever declaring their work. They include Gilles Bouvenot, who from 2003 to 2014 was president of the Commission de la Transparence or transparency committee, a key commission of France's state health authority which evaluates the usefulness of each new medicine brought to the market. Other figures involved include Bernard Avouac, president of the Commission de la Transparence from 1989 to 1998, Jean-Pierre Reynier, vice-president of the French committee that approves medicines for use, the Commission d’Autorisation de Mise sur le Marché (AMM), from 1994 to 2002 and a member of the management board of the European Medicines Agency (EMA), Christian Jacquot, a member of the AMM from 1996 to 2012, and Renée-Liliane Dreiser, a former expert advisor on the transparency committee.
Several members of the group have admitted the facts behind the claims, which are based on the statements of numerous officials plus former executives at drugs companies, though they dispute that there was a conflict of interest. Others have sought to play down the details or claim that there are mistakes in the dates cited in the allegations.
There is no dispute, however, about the importance of the watchdog bodies on which these senior figures have sat. Approval by the Commission d’Autorisation de Mise sur le Marché (AMM) means a medicine can be sold on French territory, even if since 1998 most such authorisations have been made at European level.
The Commission de la Transparence or transparency committee, meanwhile, plays a crucial role on behalf of the French National Authority for Health (HAS). This committee evaluates the usefulness of a new medicine – known in the jargon as a drug's 'service médical rendu' (SMR) – as well as assessing the new benefits that this drug will bring in relation to medicines that are already available, known as a drug's 'amélioration du service médical rendu' (ASMR). Importantly, the committee gives its opinion – nearly always accepted by the ministry of health – on whether the cost of the new drug to patients should be picked up by the state health and social security system, the Sécurité Sociale. And if so, just how much of that cost should be refunded to the patient. Its official advice has a direct impact on the medicine's future price.
For the French public the advice handed down by these committees has two major effects. One is on health safety. The other, which has an even more direct impact, is on the Sécurité Sociale's budget deficit, which could reach 15 billion euros in 2015. The more the system pays back to patients the greater, potentially, its deficit.
As far as the drugs firms are concerned, hundreds of millions of euros can hinge on the committee's official advice. For if the committee deems that the cost of a particular drug should not be reimbursed by the state then it has no commercial future in France.
Taking these factors into account, the 'system' uncovered by Mediapart is an ingenious one. The close-knit group of friends and colleagues involved – who often met pharmaceutical company representatives in Marseille - could use their positions on key committees for their own personal benefit without, on the face of it, putting public health in danger. For simply paying this group of consultants did not guarantee that the drugs firms would get a favourable verdict on their medicine. And the drugs companies knew this. The laboratories simply hoped that the transparency committee might look on them more favourably, with no guarantee as to the outcome.
Contacted by Mediapart, Christian Jacquot played down the importance of what this group of experts did. A former specialist in pharmaceutical toxicology, he does not dispute either the existence or the nature of consultancy meetings with drugs firms, in which he often took part. These gatherings were frequently held in Marseille where Gilles Bouvenot and Jean-Pierre Reynier live. But, he explains, “...above all I went to these meetings for a bite to eat. I was there more than anything as 'Mr Common Sense' because of my experience. I no longer remember the payment exactly. It was very modest.”
But if these meetings were so routine, why did they take place discreetly in Marseille, and not in the official setting of the French National Authority for Health (HAS)? “It's better to go to Marseille than to Saint-Denis [editor's note, a town just north of Paris which has a bad reputation in France for its crime levels, and where the HAS is based] where you risk your car getting damaged,” says Christian Jacquot, who is now retired. He does not see how the advice he gave to drugs laboratories on different products while carrying out his own responsibilities on the AMM committee could have posed any problems. “You know, for me the AMM took up 2 hours or 2 hours 30 minutes a week. No more.”
Enlargement : Illustration 2
Another member of this discreet consultancy 'group', who sat on the transparency committee in the 2000s, agreed to speak to Mediapart about how the system operated on condition that he could remain anonymous. This doctor told Mediapart: “There were two types of meetings. One at a very early stage when a laboratory wanted to know how to develop a product to get an SMR or an ASMR five or six years down the line. And another type, which would take place just before an application was made to the transparency committee. We met in Marseille, at the Sofitel [hotel] or at the pharmaceutical faculty. And sometimes in Paris at hotels such as the Méridien Montparnasse [editor’s note, now the Pullman Paris Montparnasse Hotel]. On the laboratories' side there was often someone in charge of market access, a medical director and possibly a head scientist.”
The doctor continued: “I wasn't called to all the meetings. There were some regulars and then the invitations depended on the nature of the product and the competences of the various people. I was asked to come perhaps once a quarter. We advised on what should be highlighted, on how to present things.”
The doctor cited many French and foreign drugs firms who were advised in this way. But while numerous executives from the firms themselves told Mediapart that sums of around 60,000 euros were spent on such consultancy services at one go, the doctor said that he received 'only' 1,000 euros to 1,500 euros per meeting. “It was always in cash,” he said. “I would either find an envelope in the dossier that was sent to me or an envelope in my hotel room, on my bed.” He said he never declared these payments to anyone. The medical expert said that as soon as he left the transparency commission he stopped being invited to the meetings – which he thought was quite understandable.
When contacted by Mediapart, Jean-Pierre Reynier, the former vice-president of the AMM, former member of the management board at the European Medicines Agency and, in common with Gilles Bouvenot, Bernard Avouac and Christian Jacquot, recipient of the Légion d'honneur, was much more embarrassed and more cautious in his responses. Did he take part in meetings with Gilles Bouvenot, Bernard Avouac, Renée-Liliane Dreiser and Christian Jacquot? “It's possible,” he said at first. Then he noted: “Most of these meetings on the strategy for developing a product were held in hotels but there was nothing clandestine about it.” When asked about the details of the meetings Reynier responded: “It's all very hazy.” His payments? “I asked for the money to be paid as an apprenticeship tax [editor's note, in France companies, including drugs firms, pay an apprenticeship tax, which can be allocated directly to particular training or educational bodies] to the faculties,” he said. When questioned, the university faculty at Marseille declined to respond directly to Mediapart's questions. Instead it merely stated the obvious: “The faculty has received payments in the form of apprenticeship taxes from pharmaceutical laboratories.”
As for Renée-Liliane Dreiser, her role as part of the 'group' was said to have been to canvass likely pharmaceutical firms and send them offers. She has not responded to Mediapart's various requests for a comment.
'I didn't ask for money as that was taxable'
The revelation of this secret, paid consultancy work is, of course, most embarrassing of all for those experts who presided over the transparency committee. How can one simultaneously head an authoritative committee and receive favours from drugs companies to help them present a better case?
Bernard Avouac was chairman of the transparency committee from 1989 to 1998 before officially moving to the other side of the fence and setting up his own consultancy firm. Both legally and ethically that move is questionable. But what happened before then is even more so. For Bernard Avouac was advising the pharmaceutical industry while he was still head of the commission. This was only implied by his declaration of interests at the time, in which he mentioned that he worked with PR International. This company was run by Daniel Vial, a leading figure in the pharmaceutical industry who at one time also employed Jérôme Cahuzac, the disgraced former budget minister. However, Avouac was careful not to mention the laboratories he advised. Though he was asked many times by Mediapart to respond to questions, Bernard Avouac simply replied: “I neither confirm nor deny anything.”
In reality the small group of friends, of whom Avouac was one of the mainstays, was already at work during the 1990s. Gilles Bouvenot, who took over as chairman of the transparency committee in 2003, confirmed as much to Mediapart, knowing that his comments were being recorded. “We had a lot of meetings in the 1990s,” he revealed. Then, noting Mediapart's surprise at the admission, and realising the disastrous consequences of his blunder for his friend Bernard Avouac, he at first declared: “It's up to him to respond to you.” Then a few days later he retracted his initial comments, saying he had been mistaken about the dates.
Gilles Bouvenot also gave different explanations regarding his own career. First of all he explained that he had stopped his activities as a consultant as soon as he had become chairman of the transparency committee in 2003. Then, once again, he realised that his comment did not clear everything up. For from 1997 right up to 2003 Bouvenot had already occupied a number of key positions in the world of health regulation and supervision. From 1999 to 2003 he had been been vice-president of the Commission d’Autorisation de Mise sur le Marché des Médicaments (AMM), which approves the use of medicines in the French market, from 2002 he had been the scientific advisor on medicines to the director general of health at the ministry of health, and from 1997 to 2000 he had been president of the National Observatory for Drug Prescription and Use for the outpatient and hospital sectors. Bouvenot had also been president of the Commission de contrôle de la publicité et de la diffusion de recommandations sur le bon usage du médicament, a body which produces recommendation on the use of medicines, from 1994 to 1997, and was president of a working group on the correct use of medicines at the medicine and medical product health watchdog AFSSAPS (now the National Security Agency for Medicines and Health Products (ANSM) ) from 1997 to 2000. Finally, he was also president of the AFSSAPS committee on good medical practice from 1997 to 2005.
On December 19th, 2014, and in the presence of his lawyer Léon-Lef Forster, Bouvenot did not deny having advised the pharmaceutical industry at the same time as his held those positions until 2003. When Mediapart expressed surprised at these consultancy activities in view of the positions he occupied, notably as vice president of the AMM, he explained that it was an “honorific position. I worked in a hospital. I didn't want to lose ground and I wanted to stay in touch with the pharmaceutical industry”. However, his declarations of interests for 1997 to 2003 made no mention of his activities as a consultant, apart from attending a conference for which he said he was not paid.
When asked how much he was paid for his advice, Gilles Bouvenot replied: “I didn't ask for money as that was taxable. I asked for the firms to invite me to some conferences. The tax authorities were not particularly interested in benefits in kind.”
When Bouvenot became chairman of the transparency committee – the time that he says he gave up all consultancy work - he also neglected to declare his past activities. This was despite the fact that he was getting ready as chairman to evaluate products whose development he could have advised on several years earlier. “At the time you had to declare your future links. I did not take into account the preceding months but [worked from] the day of my arrival at the HAS,” he replied.
A few days later, perhaps after reflecting on the implications of what he had said, Gilles Bouvenot corrected himself. Once again, he said he had mixed up the dates. He said he “thinks” he stopped his activities as a consultant in 2000.
However, Christian Jacquot, who was a member of the group of friends while carrying out his activities at the AMM, is not bothered about the dates. For he does not perceive Gilles Bouvenot's work as a consultant in parallel with his functions as head of the transparency commission as a concern. “It's his problem. I have absolutely no idea what he might have earned. I never saw him take money in front of me. I don’t want to say anything against him. He is from the Jura [editor's note, a département or county in the east of France on the border with Switzerland], he's from my area, and you know, with men from you own area you are partisan,” he said.
Christian Jacquot continued: “What I can tell you is that conflicts of interest, that means nothing. One is never in conflict with one's interests. And there were no consequences for the advice given by the transparency commission. Why would I be shocked? Someone who works, works. There is nothing normal or abnormal in that. There are no rules, there are human relationships.”
Another doctor in the 'group', who was quoted anonymously earlier, also confirms that he advised drugs companies in the presence of Gilles Bouvenot when the latter was chairman of the transparency committee. “Even though it's true he wasn’t always there. It depended on the manufacturer. I think that he only came for those with whom he was on good terms, when he felt at ease. At Marseille he was often there. In Paris, sometimes. Sometimes he only came the following day, for a kind of debriefing of the meeting with us. He then gave his opinion. Gilles was very critical and very demanding. I don't think that these pre-committee [meetings] gave [the drugs firms] an extra chance when it came to the official stage. You can't invent data that doesn't exist,” said the doctor.
Gilles Bouvenot denied his former colleague's claims. “It's true that, as their meetings were held in Marseille, we sometimes met the following day, but as friends. Ok, perhaps sometimes they spoke about their meeting the previous day, but that was not what our meetings were about,” he said.
'Are there any microphones here?'
In addition to obtaining evidence from members of Gilles Bouvenot's own consultancy 'group', Mediapart has also spoken to current or former senior figures at drugs firms whose accounts undermine his version of events.
At the Danish pharmaceutical company Lundbeck, for example, a former executive told Mediapart he had taken part in a meeting about the antidepressant drug Seroplex at the Sofitel hotel in Marseille at which Gilles Bouvenot was present. This meeting had, he said, been at the instigation of Renée-Liliane Dreiser, who was apparently been sent a payment. The company itself neither confirms nor denies this claim. Another executive from Lundbeck told Mediapart that Gilles Bouvenot had received money from the Danish company in relation to this drug. A third different source inside the company has meanwhile described how, at the time, he was asked to remove from his computer all traces of documents that had been used for the secret meetings.
Bouvenot himself only recalls an official meeting with a Lundbeck representative at the HAS health authority, and no other meeting. The chief executive of the Danish firm at the time, Jacques Bedoret, said he was not aware of any consultancy meetings. But he added: “You have to put yourself in the mindset of the people in the industry. I think that people who provide a sum as low as 60,000 euros don't feel they are corrupting. You don't feel you are corrupting by offering a 5,000-euro trip. What you're buying is discussion time.”
Two senior executives from American pharmaceutical firm Lilly, who were met separately, told Mediapart a story about one of their products that had been due to go before the transparency committee in the near future. One executive said that first of all they had met Renée-Liliane Dreiser. “At the beginning it was business as usual,” said the executive. “And then in my office Dreiser asked me: 'Are there any microphones here?' And then suggested that I buy the committee's decision. As I recall, she was asking for 100,000 euros and suggested a meeting with Bouvenot, in Marseille, several days before the committee [meeting]. It was unthinkable. I protested. [Bernard] Avouac replied: 'Your colleagues do it.' When I said no, they replied: 'You won't be able to do it without us.'”
In fact Lilly did manage to get the product classified as a refundable medicine as they had hoped. But this was as a result of unusual circumstances. For when another Lilly executive learnt about the proposed deal he decided to get involved himself. “They wanted to organise a meeting at Marseille about our [antidepressant] medicine Cymbalta,” said the second Lilly executive. “They said that 7,500 euros had to be given to each participant. Ten thousand euros for Bouvenot. And to organise two meetings. They wanted us to pay in cash. We were being taken hostage. Bouvenot thought he was untouchable.
“I didn't sleep at all for days. The stakes were enormous for us. If we didn't get the reimbursement [status] we were not going to launch the product. We let Gilles Bouvenot know that we would make this malpractice public, that corruption was unacceptable for obtaining the reimbursement [status]. Was Gilles Bouvenot scared? In any case, several weeks later we won approval.”
When questioned about this episode Gilles Bouvenot denied any conversations of this nature and urged Mediapart to be wary about Lilly and its executives, with whom he had been on poor terms, he said. Bernard Avouac meanwhile said: “I have never met a Lilly executive in these circumstances.”
Mediapart has also been told stories suggesting a slightly dubious closeness between the group of friends and pharmaceutical firms outside working hours. The claims involve an invitation from an Italian drugs group to the opera in Verona; truffle dinners in the Vaucluse in the south of France laid on by a German company; and a weekend with a representative from the French firm Servier in Bernard Avouac's house near Orange in the south of France. Gilles Bouvenot disputed, played down or denied the claims, depending on the different versions of events he gave over the space of several days.
After the scandal involving Servier's weight-loss drug Mediator, Gilles Bouvenot seems to have become more cautious. An executive from the American pharmaceutical firm Amgen recalls a different tack from the French medical expert at the end of 2010. “Bouvenot said to me 'I can no longer speak to manufacturers' and asked me 'how do we do it?' without giving any answer himself. And at that time we were approached by Bernard Avouac and Renée-Liliane Dreiser, who suggested a meeting in Marseille, explaining that Bouvenot would perhaps turn up. We paid a lot, 60,000 euros. He didn't come. Several months later I spoke again with Bouvenot who told me: 'I learnt that your positioning [of the product] had changed. I would be ready to accept it.' But I will never know exactly what happened between them.”
Gilles Bouvenot explained that lots of intermediaries in general boasted – wrongly – that they had his ear. “I have always said to manufacturers that no one could speak in my name.” However, when it comes to his circle of close friends he adopted a slightly different tone. “They know me well, know my way of looking at things and can prejudge my point of view.”
Whether it was before, during or after his chairmanship of the transparency committee, Gilles Bouvenot has certainly taken care to leave as little trace as possible of his activities as a consultant. In relation to the outside world, he has been at pains to construct an image of a tough, ruthless man, like former Elysée advisor Aquilino Morelle or Jérôme Cahuzac in the very same world of pharmaceuticals.
Putting to one side Gilles Bouvenot's multiple versions of events and contradictions, if one follows his final line of reasoning, another question still arises. Once he had become chairman of the transparency committee how could he tolerate his friends being paid by drugs companies on cases that they would have to examine in their official capacity some months later? “I didn't judge,” he says. “They do what they want.” Nonetheless, how could he accept them not declaring their meetings with the firms in their declarations of interests? “I didn't pounce on everyone’s declarations of interests. I wasn't keeping watch. Everyone is supposed to leave the room if they have an interest and not take part in the vote. And in that case, there's nothing shocking about it.”
In his comments to Mediapart Gilles Bouvenot, who publicly portrayed himself as the “last line of defence” against the drugs companies, always returned to the same two points. “You'll find nothing compromising in my assets, which consist of a 100m2 flat in Marseille and a Peugeot 308,” he maintained. He also insisted: “We were very tough with the companies. Today some are taking their revenge.”
The problem with this reasoning is that, when they were questioned, executives from different drugs firms spontaneously gave the same story, describing the same group, roughly the same sums, the same practices, the same places. And even if they were all in it together, joined in some improbable conspiracy with an aim that would not make much sense (Bouvenot left the chairmanship of the committee in 2014), there remains a key question. Why did his own friends, inside his own group, confirm that he did indeed take part in these consultancy activities?
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- The French version of this article can be found here.
English version by Michael Streeter