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Mediator® (Servier) Scandal in France
Mediator® (Servier) Scandal in France Part I
The French privately owned pharmaceutical company Servier invented two of the drugs implicated in the US Fen-Phen scandal of the 1997. The amphetamine derivatives Fenfluramine and Dexfenfluramine were licensed to the US companies and were marketed by Wyeth. The drug combo for weight loss caused heart valve defects, hospitalizations and several deaths. Wyeth had to spend 21 billion dollars for class action and product injury related l litigation. Servier escaped any punitive damages payouts and failed to learn any lessons and was able to market another amphetamine derivatives in the French market.
A diabetes drug Mediator® (benfluorex, Servier) was launched in 1976 for overweight diabetes patients. The company Servier deftly turned its use for the unapproved indication of weight loss and appetite suppression. Isomeride a related derivative marketed by Servier was banned in 1997 in France. Benfluorex is an amphetamine derivative which is widely used as an appetite suppressant. The drug was approved in several countries under the mutual approval or under national registration schemes. The drug was banned in the US, and rest of EU in 1999. Spain and Italy banned the drug in 2004, Switzerland in 1997. Another appetite suppressant of the same class developed by Servier and marketed by Wyeth was banned in the US in 1997. Mediator® was allowed to remain in the market in France due to high level political connection, political contributions and kickbacks. A study by French Agency for health products (AFSSAPS) showed that the drug was taken by 5 million persons and probably linked to heart valve defects and may have caused between 500-2000 deaths in France during 33 years of marketing.
The drug was banned in France in November 2009, almost 10-12 years after it was withdrawn from the rest of the world. To add fuel to the fire, Jacques Servier has dismissed the 500 deaths as minor issue and not linked to Mediator® use. The company has rejected the drug safety body estimate as theories based on extrapolations and stated that millions have benefited from its use. Company estimate say that 2.5% of the French population has heart valve defects and the risk increase with age and diabetes.
How Fen-Phen, A Diet 'Miracle,' Rose and Fell
by G Kolata - https://docs.google.com/viewer?url=http://www.dartmouth.edu/~chance/course/Syllabi/97Dartmouth/day-2/fen-phen-1.pdf
The French privately owned pharmaceutical company Servier invented two of the drugs implicated in the US Fen-Phen scandal of the 1997. The amphetamine derivatives Fenfluramine and Dexfenfluramine were licensed to the US companies and were marketed by Wyeth. The drug combo for weight loss caused heart valve defects, hospitalizations and several deaths. Wyeth had to spend 21 billion dollars for class action and product injury related l litigation. Servier escaped any punitive damages payouts and failed to learn any lessons and was able to market another amphetamine derivatives in the French market.
A diabetes drug Mediator® (benfluorex, Servier) was launched in 1976 for overweight diabetes patients. The company Servier deftly turned its use for the unapproved indication of weight loss and appetite suppression. Isomeride a related derivative marketed by Servier was banned in 1997 in France. Benfluorex is an amphetamine derivative which is widely used as an appetite suppressant. The drug was approved in several countries under the mutual approval or under national registration schemes. The drug was banned in the US, and rest of EU in 1999. Spain and Italy banned the drug in 2004, Switzerland in 1997. Another appetite suppressant of the same class developed by Servier and marketed by Wyeth was banned in the US in 1997. Mediator® was allowed to remain in the market in France due to high level political connection, political contributions and kickbacks. A study by French Agency for health products (AFSSAPS) showed that the drug was taken by 5 million persons and probably linked to heart valve defects and may have caused between 500-2000 deaths in France during 33 years of marketing.
The drug was banned in France in November 2009, almost 10-12 years after it was withdrawn from the rest of the world. To add fuel to the fire, Jacques Servier has dismissed the 500 deaths as minor issue and not linked to Mediator® use. The company has rejected the drug safety body estimate as theories based on extrapolations and stated that millions have benefited from its use. Company estimate say that 2.5% of the French population has heart valve defects and the risk increase with age and diabetes.
How Fen-Phen, A Diet 'Miracle,' Rose and Fell
by G Kolata - https://docs.google.com/viewer?url=http://www.dartmouth.edu/~chance/course/Syllabi/97Dartmouth/day-2/fen-phen-1.pdf
asked Jan 22, 2011 at 09:13AM in Cardiology/Heart Disease
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The FDA open and transparent model of functioning with its panel of expert advisory committee and its own analysis ensures proper evaluation of new drugs, devices and diagnostic procedures. Closed, secret and opaque systems of drug regulations, approvals and pharmacovigilance are often open to corruption, bribes, kickbacks, political interference and high level connections. Such systems are not in the interest of public health, fail to protect patients and are detrimental to the healthcare industry. Please comment on how to prevent such incidences in future.Krishan Maggon PhD commented Jan 22, 2011 at 09:28AM
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1Votes
answered Jan 22, 2011 at 03:32PMThanks for the information, which is highly important and timely. It is unfortunate that Servier and such pharmaceuticals negatively affect public perception of the whole industry.
Much needs to be done to clean up the approval process and prevent patient deaths.... -
2Votes
answered Jan 22, 2011 at 07:03PMI pose an interesting approach to Krishan's request. Members of the pharmaceutical company, drug regulators and the politicians who are ill with the studied disease should be assigned to take themselves the drug which is under consideration for general approval in a Phase 3 1/2 study. They may be the only ones who can best evaluate the benefit vs risk of the drug in this very personal way in which "corruption, bribes, kickbacks" and the other secondary gains are less likely to be influential. It's easy to sit across a conference table and give approval when you have money and influence to gain and nothing related to personal health and life to lose. My Phase 3 1/2 study would tend to diminish this type of decision-making and make it more personally realistic. What do you think? ..Maurice.
p.s.- for those Medpedia readers not knowledgeable regarding the classic research phases in drug development and approval:
Phase 1- Safety and pharmacokinetics of the drug.
Phase 2- Short term therapeutic effects on small number of patients who suffer from the target disease.
Phase 3-Prior to consideration for approval, demonstrate the potential advantages of the new therapy over other therapies already on the market; safety and efficacy of the new therapy are studied over a longer period of time and in many more patients enrolled into the study with less restrictive eligibility criteria. Phase 3 studies are intended to help scientists identify rarer side effects of treatment and prepare for a broader application of the product;
Phase 4- Post marketing survey with thousands of patients to establish long term efficacy and safety issues. -
1Votesanswered Jan 22, 2011 at 11:00PMMediator® (Servier) Scandal in France Part II
The founder and owner Jacques Servier (88 year old) has an estimated fortune of $ 5 billion and has close ties with the French president Nicolas Sarkozy and remains a major contributor to his election and the ruling Gaullist political party UMP. In the past he has funded the French ruling party irrespective of the ideology of the left or right from the early 1970. In 2009 Mr. J Servier was decorated with the French Legion of Honor by the French president. Mr Jacques Servier and his company were major clients of the law firm of the young advocate Mr Sarkozy for over a decade. Mr. Servier shifted his residence to the Neuilly sur Seine, a chic suburb of Paris and home of several other French billionaires where Mr. Sarkozy was mayor for several years. Several ministers or close collaborators of the health minister in the French governments were former employees of Servier. The company Servier had sales of $ 3.6 billion in 2009 and $ 4 billion in 2010. The company Servier, because of high level connections may get close to a billion of dollars of R&D funds, tax credit, grants, funds and exclusive supply orders from the local, regional, state, national and European governments, armies, hospitals and agencies.
In his 2011 new year message to his company staff, Mr. Servier stated that Mediator is only 3 deaths, 500 deaths is a good marketing trick and the rest had preexisting heart valve defect. About 100 patients have filed drug injury lawsuits against the company. The police last week raided and seized millions of documents related to the manufacture, quality control, batch records, regulatory approvals and marketing and sales record from the company. Mr. Jacques Servier for the first time in his life is to appear before a criminal court in Paris on 11 February for causing drug related deaths. The company and its founder have taken shelter under the position that the government is responsible for all drug related injuries for approved drugs. The company denies any wrongdoing and says it is not liable in drug related deaths or injuries.
The French press has started exposing the reaches of the company Servier at all levels of government and talked about the Fall of Mr. Servier and end of his empire! The French Drug Industry association LEEM has excluded Servier from its list of member companies. The current Mediator® drug by a private company Servier is the butt of jokes and is a rich source material for the French humorists and talk shows TV hosts. This may emerge as the biggest health scandal in France after the AIDS tainted blood scandal.
Minister is linked to diet drug scandal
Telegraph.co.uk - Henry Samuel - Jan 13, 2011
http://www.telegraph.co.uk/health/healthnews/8257923/Minister-is-linked-to-diet-drug-scandal.html
Healthcare scandal surrounds Sarkozy
http://www.presstv.ir/detail/157129.html
Servier a développé des relations à tous les étages du système de ...
Le Monde - Il y a 1 heure
http://www.lemonde.fr/societe/article/2011/01/17/servier-a-developpe-des-relations-a-tous-les-etages-du-systeme-de-sante_1466890_3224.html -
1Votesanswered Jan 22, 2011 at 11:21PMMaurice,
This is a very interesting idea but may pose practical problems and how to implement it? Who monitors the study, ensures quality control, compliance with ethical, GCP and regulations, responsibility in case of drug injury. In the old USSR, industry was told to give the study drug, protocol and money to the MOH and come back after 2-3 years for approval or rejection. Were any actual studies done or published ? In the US, NIH and its institutes are frequently criticized for selection of drugs for government sponsored landmark studies. Drugs (marginal market share) donated by companies are often included at the cost of market leading brands. Drug companies are prohibited from giving free drug supplies and samples to investigators to test in their patients.
For breakthrough innovative drugs, everyone wants to study the drug. For a new ACE inhibitor or NSAID, very few investigators may show any interest. PHRMA and NIH are good candidates for setting up such studies?
Kim thanks for your comments. Similar scandals in the UK and Italy have resulted in regulatory reforms and we hope that the French system is reformed.-
The new NIH institute may be a good choice for new drug studies
http://www.nytimes.com/2011/01/23/health/policy/23drug.html?hpwKrishan Maggon PhD commented Jan 23, 2011 at 12:56AM
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1Votesanswered Jan 23, 2011 at 09:45AMConsidering the side effects of standard chemotherapies for cancer, including some which are deadly or at least greatly compromise quality of life, I would be in favor of your suggestion, Maurice. Also for heart medications. I knew someone who took a heart medication once that had to go to the emergency room because it caused a heart attack, rather than helping him. It caused such a rapid heart beat, that the "help" of the drug nearly killed him. He subsequently went on appropriate drugs that did help stabilize the heart condition. At the time, I wondered how many others had experienced the same thing, especially as a heart attack is one of the side effects.
My sister, who died of aggressive MS in 2007, was on an anti-smoking drug which has "heart attack" as a potential side effect. She died of a heart attack, despite having no history of heart problems, even according to the coroner report. How many others are there like that?
Thanks for the case study of Servier, Krishan. It sounds extremely corrupt, but I am not surprised. Corruption seems epidemic in our world, and is responsible for many deaths in many areas in which corruption occurs. I believe there should be criminal prosecution for pharma drug deaths, as there sometimes is, as well as of government officials who feed the corruption.
Is there any global convention that addresses accountability in drug deaths? If not, maybe it is time for one, which standardizes quality and holds country governments accountable for obvious breaches of patient safety in drug development and administration. I worked for the UN in the past, know the UN can develop this, but then it too is rife with corruption, so there you go.
I put up several links on the CLL community in a document about TRND, which is a new (2009) initiative in the US NIH that is seeking to develop new drugs for "rare and neglected diseases" (RND) like CLL (Chronic Lymphocytic Leukemia). RND often have insufficient or non existent drug development due to the relatively small patient population and lack of profit incentive to private industry pharmaceuticals. It also probably takes out at least some of the corruption. At least the TRND is an initiative recognizing that drug development often depends on size of patient population. Unfortunately, considering the US Federal Government has a 14 trillion dollar debt at this time, I would be surprised if the pilot projects receive funding, especially all the way to fruitiion. When I clicked on the CLL project, it linked back to the Leukemia and Lymphoma Foundation, suggesting that the initiative hasn't actually gotten off the ground yet. Maybe it has, I don't know. I tried another RND project link, and it worked. So we'll see. The best ideas can die with fiscal crisis.-
Regarding MS, it is always a "crap shoot" as to whether it is the primary disease, or a secondary condition or event that is a cause of death. I suppose one can have a serious condition like aggressive MS, but still have a healthy heart. So it begs the question, is the drug still responsible if heart attack is a side effect, or is it the primary disease?Kim M Robinson commented Jan 23, 2011 at 09:50AM
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0Votesanswered Jan 23, 2011 at 12:24PMAll of the major innovative new drugs were developed by the Industry. All over the world government agencies or Public private partnerships have failed to develop new drugs over the past 5 decades. Setting up another national or international body to collect, monitor and analyze all the drug, vaccine, device, diagnostic or medical intervention related adverse events is a gigantic task and requires substantial resources with uncertain outcome.
What comes out of the Servier scandal is the attitude of its owner towards its victims and his mafia style operations in keeping the tainted drug on the market in France. Servier has a poor reputation in France/Europe and it has never represented the mainstream ethical pharma industry.
In India, a few years ago a drug was banned due to ADR but the ban was effective 3 months later to allow the companies to sell their stock and cause more adverse reactions? France has modern drug regulation in place but lacks in implementation and enforcement of its rules. There are plans to compensate victims from a government fund, which will allow once again Servier to escape its civil and criminal liabilities. -
1Votesanswered Jan 23, 2011 at 01:31PMSo what can be done about "the bad apples", when there is failure of will to prosecute or even adequately regulate? Certainly the cost in lives is not worth doing nothing. If an individual kills, he/she often is prosecuted and jailed, preferably for a long time if guilty. If it is a corporation (as in Bhopal, India, or with some of the "bad apple" pharma), it is attributed to the "cost of doing business" and "free will" of the consumer to consume the product. I guess.....
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0Votesanswered Jan 24, 2011 at 12:22PMKim,
There is no perfect regulatory system for drug approvals and ADR monitoring which works. Maybe the EMA system just like the ICH can evolve into a global regulatory system. Health rules and regulations, all over the world, evolved in gradual way in a patch work fashion, to deal with specific health crisis. or drug related tragedies like the Thalidomide, LSD, Benoxaprofen or Fen-Phen. The outbreak of AIDS, SARS, Avian H1N1 resulted in lot of crisis management teams, fast track, priority review and solutions, resource mobilization at the national and international levels, which were wasted by the WHO during the 2009 H1N1 pandemic. The performance of UNAIDS, TDR, GAVI, MMV, several other PPPs and Global Fund ATM has been termed lackluster and charges of corruption, wastage on luxury, meetings, travel, self glorification and favoritism often get media coverage. Any system without its own checks, balances, oversight, public access, transparency and media scrutiny is bound to fail.
http://knol.google.com/k/global-health-public-private-partnerships-ppp?collectionId=3fy5eowy8suq3.54#
AP Enterprise: Fraud plagues global health fund The Associated Press
http://www.google.com/hostednews/ap/article/ALeqM5jBNgIu-Vg-_pAVtF6PcN9eSYPfiA?docId=eccd6da0cec34b489a67dfdf80cb933b -
0Votes
answered Sep 22 at 01:53AMI know that one of the persons employed by Servier, Marielle Scrive, was also a defendant in the Phen-Phen lawsuit here in the U.S. They lost the case. These people don't know what they are doing and have caused irreparable harm to women and their families. Dissolve Servier and punish those responsible. -
2Votesanswered Sep 22 at 02:05AMThe French media has widely covered Mediator scandal. Servier Legal troubles in France
Mr Jacques Servier and 5 other directors of Servier Labs were extensively questioned by 3 judges yesterday for selling the antidiabetic Mediator as appetite suppressing and anti obesity weight loss agent and not disclosing the adverse drug reactions. It causes heart valve defects and increases pulmonary arterial hypertension in some patients. These 6 persons were placed under judicial control and were ordered to provide bank guarantees worth $ 75 million euro to remain in liberty. Mediator was prescribed and used by 2 million persons in France and may have caused 500-2000 deaths. It was banned in November 2009 and had 300.000 persons using it at that time. French justice suspects Servier of cheating the French National Health Scheme and Social Security for overcharging for a drug for unapproved indications and not disclosing reported adverse events and deaths. These legal troubles may doom Xoma which licensed its Xoma 052 mab to Servier.
http://goo.gl/k4HrT.qr
http://www.ladepeche.fr/article/2011/09/22/1173392-mediator-jacques-servier-mis-en-examen.html -
2Votesanswered Sep 23 at 01:51AMCurrent status of Mediator related injuries and deaths
2226 claims filed in Paris/French courts
800 claims filed with the Mediator Fund (Oniam) which excludes cases currently in direct civil litigation with the company. The fund will pay compensation to all valid victims or families and later recharge Servier.
French justice has Mr J. Servier and 5 other defendants to deposit a caution of 35 million euro and provide an additional guarantee of 45 million euro. -
1Votesanswered Sep 24 at 11:21AMI subscribe to Medscape Medical News, and read this today. Glad to hear this guy has been charged with involuntary manslaughter. Wish it would be a precedent for other such cases.
From:
http://www.medscape.com/viewarticle/750218?sssdmh=dm1.720622&src=nldne
From Heartwire
French Judges Charge Servier Head in Mediator Scandal
Shelley Wood
Authors and Disclosures
September 22, 2011 (Paris, France) — In the latest twist in France's benfluorex (Mediator, Servier) scandal, magistrates there are charging the head of the country's second-largest drugmaker with involuntary manslaughter, aggravated deception, and fraud, according to media reports.
Judges allege that Jacques Servier engaged in dishonest practices and deception over the drug's quality and falsely obtained authorization to sell it, his lawyer, Herve Temime, told news outlets. -
2Votesanswered Sep 24 at 09:57PMThe other 5 defendants are current or former executives of the company Servier.
In the US, the FDA had banned all such products after the Fen-Phen scandal in the US and insider and political connections fail to get such drugs approved.
The French social security is claiming 225 million euro from the company and the national health scheme is claiming 100 million euro for past payments for Metdiator. -
1Votesanswered Sep 24 at 11:15PMSounds like some kind of a medical racket if there ever was one. I know a French woman who was one of the defendants in the Fen-Phen suit and she moved back to France and worked for Servier after they lost the case. I was just wondering if she was a defendant again but she is not an executive, but has a Ph.D. Thanks for the information!
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1Votesanswered Sep 25 at 12:05AMMarisa,
I checked, the case is against Mr. Jacques Servier and 5 associated companies. The 5 companies are SAS Servier, Laboratoire Servier industries, les laboratoires Servier, Oril industrie and Biopharma. Mr Jacques Servier has been ordered to pay 4 million euro in cash and provide a guarantee of 6 million to the court. The 5 companies were ordered to provide caution and guarantee of 100 million euro. The company is accused of transforming a Fen-Phen tainted weight loss drug into an antidiabetic with connections, influence, bribes and kickbacks and suppressing drug related adverse reactions. -
1Votesanswered Sep 25 at 06:55AMTerrible!!! The person I was interested in discovering about was Marielle Rebuffe-Scrive. She had been associated with Judith Rodin in the U.S. with the Fen-Phen suit and then moved to France and I saw her "employer" most recently was SERVIER. Doesn't surprise me. Some people are either unscrupulous or don't know what they are doing. Marielle Scrive would fall into the latter category I believe.
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1Votesanswered Sep 25 at 12:03PMI posted the news of the same French case and action on a bioethics listserv ending with my question:
"Would our U.S. judicial system take similar action to discovered similar alleged behavior of United States pharm executives? "
A lawyer-ethicist, from U.S.A. responded: "I wonder how others on the list feel about the use of the criminal law (and, especially, homicide law) as a remedy in a case like this one. The use of homicide law in such a case would be very rare in this country, although perhaps that is because our more robust tort law provides a better alternative. Should we be moving from tort law to criminal law to seek justice from those in medicine (or business) whose decisions arguably lead to death?"
Do you think the American legal system does not have the "guts" of that of the French or is making this a homicide case really totally inappropriate approach to justice? ..Maurice. -
1Votesanswered Sep 25 at 10:12PMThis should definitely be a homicide case. The same people seem to be involved in these cases. Take for instance one of the defendants in the Fen-Phen case of several years ago.... she still works for Servier and is likely again a defendant in THIS case, involving deaths. Either put individual people in jail or collectively punish those involved with HEAVY FINES and/or prison time.
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0Votesanswered Sep 25 at 10:19PMMaurice,
Thanks for listing it in your popular and highly rated Bioethics Forum. One of the objectives of the French judges and lawyers representing victims to provide speedy justice and compensation to victims. A class action lawsuit may take another decade or so with millions of documents, testimony and evidence from thousands of cases. A criminal case offers a relative fast track approach in France. It is likely to be followed in other countries.-
Marisa,
You are right. That person was the driving force and provided scientific rationale for the Fen-Phen weight loss drugs. Must be a top executive in the Servier labs or affiliated companies. Searches at the main Servier web site were negative.Krishan Maggon PhD commented Sep 25 at 10:24PM
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1Votesanswered Dec 12 at 05:03PMNew York Time covers Mediator scandal.
Scandal Widens Over French Weight-Loss Drug Mediator. NYTimes
17 hours ago ... Mediator and its enigmatic French manufacturer, Laboratoires Servier, a privately held company with a troubled past, find themselves at the ...
http://www.nytimes.com/2011/12/12/health/scandal-widens-over-french-weight-loss-drug-mediator.html?_r=1&scp=1&sq=Servier&st=cse -
0Votesanswered Jan 07 at 09:41AMThe case is now in courts which means slow moving and is no longer in the French media headlines.
The current French media interest is moved to faulty Brest Implant scandal where a now defunct company Poly Implant Prothese (PIP) and its billionaire owner Dr. Jean Claude Mas.
To increase profits, the company used a substandard type of cheap silicone (probably made in China?) which is more prone to rupture. The company falsified documents and failed to report cases of rupture as early as 2005. The product was banned only in 2010-2011. About 30,000 women in France had the PIP implant, out of which 1000 were ruptured and 8 cases of cancer were detected. PIP exported these faulty implants in 60 countries and about 300,000 women now carry these risky implants (42000 in the UK, 25000 in Brazil, 9000 in Australia).
Since the company is under court protected liquidation, PIP and its former directors and owners are unlikely to pay! Alliance which provided global insurance to PIP for product related damage can escape by citing false declaration by PIP in the contract. All the clinics and plastic surgeons can say they acted in good faith and were never informed by the PIP about the faulty silicone used.
http://abcnews.go.com/Health/Wellness/wireStory/uk-evidence-routine-removal-implants-15305890#.TwiAyjF8DTR
http://www.reuters.com/news/health
http://www.europe1.fr/France/PIP-quel-avenir-judiciaire-893445/-
And so the government, whose agency had responsibility to establish the safety of the products which are released for public use, should pay! After all, someone owes something now to the citizens who assumed the product was safe. ..Maurice.Maurice Bernstein MD commented Jan 07 at 10:00AM
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