Big Pharma Firm Fined $471 Million over Deadly Weight Loss Drug
Yet another "safe and effective" weight loss drug craze ends in a train wreck, with up to 2,000 dead.
Pharma giant Servier must pay more than 430 million euros ($471 million) in connection with its now-banned weight-loss pill Mediator (benfluorex), a French court ruled last week. The court said the company was guilty of fraud and other charges because it knew the drug was potentially harmful when selling it.
French health experts believe the drug killed between 500 and 2,000 people before it was finally banned. Mediator stayed on the market despite a succession of warnings over its side effects, which include heart valve disease and pulmonary hypertension.
Originally intended for diabetics, it was "hugely misprescribed," with doctors routinely handing out Mediator as an appetite suppressant for people seeking weight loss - a scenario remarkably similar to that seen with the current generation of toxic weight loss drugs such as Ozempic, Wegovy and Mounjaro.
The court found the company concealed the risk of harm and heart problems from patients and doctors, and ruled the initial 1974 approval and subsequent renewals until 2007 were all obtained illegally.
The company knew the drug was cardio-toxic, but colluded with regulators to keep pushing the time-honoured Safe & Effective™ lie.
The fines imposed Wednesday are on top of compensation the company has already paid victims.
The ruling, which came after both the company and some victims of the faulty drug had lodged an appeal, partially overruled a verdict by a lower court from 2021.
Mediator's Troubled History
Benfluorex hit the market in 1976. Originally developed as a drug to lower lipid levels in the blood, it was subsequently prescribed to diabetics to help them lose weight. As its appetite-suppressant properties were recognised, family doctors began widely offering Mediator to regular folks seeking weight loss. The drug was never approved for this purpose.
France pulled the drug from the market in 2009, around a decade after Spain, Italy and the United States halted sales.
The 2009 withdrawal of Mediator — it was then available in France, Luxembourg and Portugal — caused little stir. Only the following year, with the publication of a book titled Mediator 150 mg: How Many Dead? did the news media and government officials take serious note.
“I realized they were withdrawing the drug on the sly,” said the book’s author, Dr. Irène Frachon, a pulmonologist. Servier and health authorities made little effort to alert former patients, she said, like “a car manufacturer who sees there’s a defect in the brakes of its car, and who corrects the defect in its production line but doesn’t warn the people who have the car.”
In 2007, Dr. Frachon was among the first to identify the risks of Mediator, and published a number of papers on the topic. Her book prompted lawsuits, public outcry and a government inquiry.
In January 2011, the interministerial commission leading the inquiry charged that Servier had deceived health authorities and patients in order to keep Mediator on the market.
Investigators also found health officials ignored a series of warning signs beginning a decade before. They additionally found regulatory decisions taken by Afssaps, the French drug licensing agency, were in fact a “co-production” reached in “cooperation” with drug makers.
In a blatant conflict of interest seen all around the world, voting members of the Afssaps approval committee have long served simultaneously as consultants or employees of the pharmaceutical firms they are meant to regulate, officials acknowledge. And while members are expected to declare conflicts of interest, there are no penalties for not doing so. Consultants or employees from various companies, including Servier, remained active participants after the 2011 charges were laid, according to then-Servier spokeswoman Lucy Vincent.
Another Miscarriage of Justice
The two buck-stops-here Servier figures in this story are the company's founder, Jacques Servier, and former Chief Executive Jean-Philippe Seta.
The late Servier had close links to politicians including former French President Nicolas Sarkozy, who awarded Dr. Servier the Legion of Honor’s Grand Cross in 2009, describing him as “an entrepreneur the likes of which few are to be found in France.”
That's probably true. Apart from weapons manufacturers, there are few other entrepreneurs in France who have presided over the kind of death toll Mediator caused.
Sarkozy had been Servier’s lawyer before taking office.
Servier soon became the object of severe criticism when the concerns about Mediator became public, but he died not long after in 2014 at the age of 92, with a personal fortune of $7.6 billion.
Crime does pay, at least when your buddies are running the country.
And Seta? Despite also presiding over a death toll that would make any serial killer jealous, in 2021 he was awarded a suspended jail sentence of four years, including one year to be served with an electronic bracelet, and a €90,000 fine.
This was far lower than the five years (three behind bars) and €200,000 fine demanded by the prosecution.
France's medicines agency was fined a mere €303,000 for its role in the scandal. The money for this fine will come from taxpayers, of course, not the grubs at the agency who colluded with Servier.
A total of 7,650 people filed civil claims in the trial – most of them in the "deception" case.
A further 5,000 cases of manslaughter or unintentional injury are still being investigated by the Paris public prosecutor's office, paving the way for a second Mediator trial within the next few years.
Among those who found the sentencing far too light was GP Dominique Dupagne. "This guy [Seta] deliberately fooled ill people, 2,000 of whom died because of his drug, and he gets a suspended sentence? This needs an explanation," he wrote on Twitter.
I submit a good part of the explanation is that France's government and judiciary - just like Australia's - are corrupt as all get out.
Hefty but in no way crippling fines are part of doing business for large Pharma companies. The fines are a fraction of the profits they make from the drugs in question. Meanwhile, the company staff and regulators responsible almost never spend a day behind bars.
“Despite the severity of the verdict, the group is able to cope with this disappointing decision,” the company said in a statement.
Of course it is. Servier's friends in high places wouldn't have it any other way. Publicly, French courts must be seen to be doing something for victims (in reality, most of the 430 million euros will go to the government), but what I'll politely describe as "political considerations" would have ensured the company's future was not placed in jeopardy and that no-one went to jail.
By the time it was taken off the market in late 2009, an estimated five million people had taken Mediator in France alone, making it among the 50 most-prescribed drugs in the country. More than 80 million boxes were sold over its last 10 years, at a cost of 423 million euros (US $550 m) to the national health insurance fund (CNAM).
Most of that was unauthorized use, as Mediator was legally authorised for diabetics alone.
This means Servier's penalty doesn't even recoup the 1999-2009 cost to France's national health insurance fund incurred by mostly unauthorized Mediator prescriptions.
Not happy with this slap on the wrist, Servier plans to appeal to the Court of Cassation, France’s top court. After all, Servier is undergoing a "transformation" to even further maximize profits, which means reducing the size of the penalty would come in real handy for inflating that EBITDA figure.
Critics of the French system told BBC in 2011 that regulatory authorities are so in thrall to drug manufacturers like Servier, especially if they are French, that they find it almost impossible to withdraw treatments from the market.
"We have flooded the market without [sic] about 800 products - probably twice that if you ask me - which have absolutely no usefulness at all for the consumer," said Professor Philippe Even, president of the Necker Institute, the esteemed international biomedical research center based in Paris.
"They eat up half of our health budget solely for the benefit of shareholders in pharmaceutical companies and with no positive effects at all for the sick."
For Bruno Toussaint, editor of the independent medical magazine Prescrire, "About three-quarters of the drugs on the market have little or no health benefit and are utterly redundant."
"Mediator is not an isolated instance," he said.
What is Benfluorex?
Mediator's active ingredient, benfluorex, is an amphetamine derivative that belongs to a group of compounds known as "substituted amphetamines."
Another member of this drug class is fenfluramine, also introduced to the market in the early 1970s by none other than Laboratoires Servier.
Those on the wise and distinguished side of 50 will probably remember fenfluramine for its role in the fen-phen craze of the mid-late 1990s. Fen-phen, a combination of fenfluramine and fellow substituted amphetamine phentermine, was aggressively hyped and advertised to any and all seeking weight loss. That craze also ended in a train wreck, when in 1997 a Mayo Clinic researcher detected a link between the drug combo and heart valve disease. Wyeth, which held the American license for fen-phen, set aside $21 billion to settle subsequent lawsuits.
Other Toxic Junk Made by Servier
Another of Servier's ill-fated drugs was the TCA antidepressant mineptine. Released in 1978, the drug soon gained a reputation for abuse due to its short-lived but pleasant stimulant effect experienced by some patients. After its release into the European market, it gained a further reputation for liver toxicity, in some cases serious. These problems led to Servier's 'voluntary' suspension of the French marketing authorization for Survector, as it was marketed, in 1999.
Servier's current star antidepressant is agomelatine, marketed under the brand names Valdoxan and Thymanax as a gentler and more "tolerable" mood enhancer.
Like most antidepressant drugs, agomelatine is predicated upon the nonsensical, simple-minded and thoroughly unproven "chemical imbalance" hypothesis which claims depression and anxiety are caused by a "serotonin deficiency."
As SSRI drugs were found to cause everything from suicidal behaviour to sexual dysfunction, and as their patent protections wore off, the pharma cartel began developing 'new, improved' versions.
Agomelatine is supposedly a serotonin receptor antagonist and a melatonin receptor agonist that falls under the classification of "atypical antidepressant."
This is something of a misnomer, because agomelatine is entirely typical for this class of drugs: It is toxic and ineffective.
In 2014, a group of UK researchers from the South London and Maudsley NHS Foundation Trust (which specialises in mental health) published a review of the drug’s efficacy. As well as searching the literature for relevant trials, they asked the European Medicines Agency (EMA) for details of all studies submitted in support of regulatory approval for agomelatine. They also contacted the European manufacturer of agomelatine, Servier, and requested details of published and unpublished studies.
They ended up with twenty trials involving 7,460 participants, meeting the inclusion criteria. Eleven of these had been published; 4 unpublished trials were obtained from the EMA, and 5 from the manufacturer (1 of which was subsequently published). Almost all studies used the 17-item Hamilton Depression Scale. I could write an entire article about what a largely useless, irrelevant wank the HAM-D is, but let's stick to one enemy-creating controversy at a time.
Overall, agomelatine returned a statistically significant but clinically insignificant effect size of 0.24 when compared to placebo. Many of the trials also compared agomelatine with other antidepressants and, overall, found no difference in efficacy.
Predictably, a separate comparison of the published and unpublished studies yielded contrasting results. Unpublished studies suggested no advantage for agomelatine over placebo. In comparisons with other antidepressants, published studies favoured agomelatine while unpublished studies tended to favour the comparison drug. As the reviewers noted, "Overall, there is a strong impression of publication of trials whose results favoured agomelatine and the non-publication of less favourable trials."
Hmm, Big Pharma hiding non-supportive evidence. Who would’ve thought?
Unfazed by the fact unpublished trials showed agomelatine no better than placebo and inferior to other antidepressants, the EMA approved the drug in February 2009, as did Australia’s Therapeutic Goods Administration in August 2010. The TGA are the corrupt, industry-funded liars who approved the toxic Pfizer COVID gene therapy in 2020 without even looking at the actual data.
The European and Australian authorities green-lighted agomelatine, and have allowed it to remain on the market, despite knowing full well the drug increases the risk of liver damage. As a cover-your-butt measure, these agencies admonished periodic liver testing before and after commencement of agomelatine therapy.
In 2014, the European agency issued a press release with the upbeat title, "EMA confirms positive benefit-risk for antidepressant Valdoxan/Thymanax (agomelatine)." Four paragraphs in, however, the real reason for the press release became apparent. "[S]ide effects on the liver have continued to be reported," admitted the EMA, "and an observational study has shown a considerable level of non-compliance with the recommended liver monitoring programme." The EMA, continued the release, “has therefore concluded that there is a need to reiterate the importance of liver monitoring.”
Agomelatine’s lack of efficacy and its liver-unfriendly nature are likely reasons the drug never made it onto the US market. Back in 2006, the Swiss-based pharma giant Novartis purchased the US development and marketing rights for agomelatine from Servier.
Novartis then commissioned several phase III clinical trials with the goal of gaining FDA approval for agomelatine by 2013. Unfortunately for Novartis, these studies failed to deliver the much hoped-for results. Stuck with a drug that tested poorly in RCTs and whose hepatic side effects were now well-established, Novartis stopped pursuing FDA approval for the drug in 2011.
Never Mind the Deaths and Corruption, We're ESG-Friendly!
Servier clearly has a problem in its ethics department, but not to worry, at least it pays lip service to all this woke "environmental, social, and governance" bollocks. And in today's superficial, emperor-has-no-clothes world, that's what really matters, right?
The company’s website boasts about its reduced carbon footprint, and proudly declares that by 2024 at least 40% of senior management positions at Servier will be held by women.
I'm sure that will come as a great relief to all the women injured and killed by Servier's dodgey drugs.
Many of the victims who testified in court about the impact of Mediator on their lives were women. Exhausted and out of breath, they recounted their stories sitting down.
"It was said that the drug was extraordinary. I lost ten kilos the first month," said one plaintiff, Stephanie, who took the drug for three years before being diagnosed with heart disease in 2009.
Muriel Rousset, 45, began taking Mediator to lose weight shortly after the birth of her second son, in 1998. In 2006, she underwent open-heart surgery to replace two damaged heart valves; she continued to take Mediator, not knowing the drug may have caused her heart problem.
When Will People Ever Learn?
Weight loss pharmaceuticals have a habit of being hailed as wonder drugs, before inevitably ending in a multi-carriage collision of injury, death and controversy.
We saw this with fen-phen, we've just seen it with Mediator, and we're going to see it again with the current crop of gastro-toxic junk being sold under names like Ozempic, Wegovy and Mounjaro.
Meanwhile, there's a safe and effective method for weight loss known as the diet-ex combo. The diet portion involves eating no more than your daily caloric needs, while the (ex)ercise portion involves moving your butt around to create an increased calorie burn. Side effects include looking and feeling healthy, and improved longevity.
A great exercise to start with is the seated push-up, which is where you eat your sensible fill and no more, then - in a controlled, deliberate fashion (no cheating) - push yourself away from the dinner table. Heck, I hear they even make chairs with rollers on them to make this exercise easier, so there really is no excuse for lack of adherence.
Anthony's new book, Not So Fast: The Truth About Intermittent Fasting & Time-Restricted Eating is now available at at Amazon and Lulu.
Yes, and I used to go to Weight Watchers (when they were mostly food-based and some emotional eating training) and never will again as they are partially responsible for them buying the drug. Oprah owns 8% of WW! Hopefully, she will get her due but not in money Many people who take Ozempic, wake up in the middle of the night with a pant load of SH_T and it is very bad for the digestion!