Text/Lv Ping, Contributing Writer of CC Intelligence Bureau, Phoenix.com
Key Takeaways:
1. On December 20, the French pharmaceutical giant Servier was fined 430 million euros for the death of more than 500 people due to the drug Metito. Metito has been used to treat diabetes and obesity and has been used by 300,000 people in total. Its main ingredient is fflurazol, which carries a fatal risk of thickening the patient's heart valves. As early as 1997, the United States and most European countries banned the sale of drugs containing fflurales, but it was not until 2009 that France explicitly banned the sale of such drugs.
2. In addition to Metito, there are also some diabetes drugs that are also used for weight loss, such as semaglutide, the "miracle drug" for weight loss. It is reported that Musk and former British Prime Minister Johnson have both used semaglutide to lose weight successfully, but then also announced that they would stop taking the drug. The reason is that semaglutide may cause symptoms such as nausea, vomiting, diarrhea, and even cancer, and the drug is only used to treat diabetes in China. At present, only orlistat has been approved by the State Food and Drug Administration of China and can be used as a weight loss drug.
3. All weight-loss drugs may have side effects, such as GLP-1 receptor agonists may cause gastrointestinal and gallbladder related diseases. Relying solely on drug injections cannot "lie thin", but also have to cooperate with a certain amount of exercise, both to "control the mouth" and "open the legs". In fact, most people are in the normal range, and the drugs used to treat obese people may not be effective for others. Blindly taking diet pills may not have more benefits than harms.
A diabetes drug called Mediator was used as a diet pill to kill 500 people!
On December 20, the Court of Appeal in Paris, France, upheld the verdict of "serious fraud" and "manslaughter" against the French pharmaceutical giant Servier, and imposed a total fine of more than 430 million euros, or about 3.36 billion yuan. It is reported that one of the pharmaceutical company's diabetes drugs was once abused as a diet drug, and in the 34 years it was sold, it caused at least 500 deaths.
The case began 13 years ago.
November 16, 2010. The French Agency for the Health and Safety of Health Products (AFSSAPS) disclosed that Mediator, a weight loss drug for diabetics manufactured by the French Servier group of companies, has used the drug by about 300,000 people in the 34 years from its launch in 1975 to November 2009, resulting in 500 deaths, and some experts believe that the actual death toll is 2,100. Another 3,500 people have suffered serious heart disease as a result of taking this medicine.
The problem drug "Mediator", whose main ingredient is fflurex, was introduced to the market in 1976 and is not only used as a primary drug for obese diabetic patients, but also as an effective appetite suppressant for the treatment of obese patients without diabetes. According to expert analysis, the main ingredient of the drug, benzflurazol (benfluorex), can cause heart valve thickening and cause death of patients.
Some survivors said they were forced to undergo heart transplants after taking the drug as a diet pill. In the complaint, the plaintiff, Stephani, said: "Some people say that this drug is very good, and I lost 10 kilograms in the first month of taking it. She took Mediator for 3 years and was diagnosed with a heart attack in 2009.
Since 1997, the United States and most countries in Europe have banned the sale of the drug Benflorex, but France did not finally ban the sale of its substitutes for Metito and Benflurax until November 2009.
The drug has been found to cause heart problems and lead to death. A doctor named Frachon at the Brewster Hospital in France has been studying the dangers of Metito to the human body since 2007. In early 2010, she warned the French Agency for the Health and Safety of Health Products about the dangers of the drug. She then completed a monograph titled "Mediator 150 mg, How Many People Die from It?", detailing the harm that Medito can do to patients taking the drug. However, the drugmaker took her to court for this. Eventually, she was forced to remove the title of her book, "How Many People Have Died Because of This?" before her book could be published. The case has sparked huge controversy in the European Union. The French film "150 Mg", released in 2016, tells the story of the doctor who exposes the fatal risks of the Mediator.
The case of Metito's death caused by the use of weight loss drugs in diabetes has detonated people's doubts about the safety of diabetes drugs for weight loss. Servier, the company involved in the case, said that any drug will have side effects. The so-called number of deaths from taking Metito diet pills is just an exaggerated inference and cannot be verified.
Servier Group of Companies is the largest pharmaceutical laboratory in France and the second largest pharmaceutical group with a turnover of 3.6 billion euros. According to statistics, the company sold 145 million boxes of Metito to nearly 3 million people in France. In 2010, sales of the drug amounted to 30 million euros. In the case of Metito, the French Ministry of Health recommends that all people who have taken Metito, especially those who have been taking it for more than 3 months, see a doctor.
The Mediator case was heard over 10 months from 2019 to 2020, with nearly 400 lawyers involved. Agence France-Presse reported that more than 6,500 plaintiffs, including several French health insurance funds, have claimed a total of about 1 billion euros from Servier.
On March 29, 2021, a court in Paris, the capital of France, convicted Servier of manslaughter, aggravated deception, and involuntary injury, fined 2.7 million euros, and ordered compensation to the defendant. Jean Philip, the former vice president of the company, was given a four-year suspended sentence and fined on the same day. He was the last surviving defendant in Servier's leadership. AFP called it one of the worst medical scandals in French history.
On December 20 this year, the Court of Appeal in Paris, France, upheld the appeal and increased the fine to 430 million euros.
Is Musk and Johnson's "miracle drug for weight loss" safe? Why has it not been approved for weight loss treatment in China?
The case of 500 deaths caused by the use of diabetes pills to treat diabetes drugs has sounded the alarm for the current hot diabetes drug weight loss tide. It is understood that there are currently a total of diabetes drugs such as semaglutide, tirzepatide (Tirzepatide), and liraglutide, which have been approved by the US FDA for weight loss.
One of the most famous weight loss "miracle drugs" is a diabetes drug called semaglutide, which was originally used to treat type 2 diabetes. In 2021, the U.S. FDA approved its weight loss indications. It works primarily by suppressing appetite and delaying gastric emptying, and clinical studies have shown that obese patients who continue to receive the drug can achieve an average weight loss of 17% to 18% after 68 weeks.
In October 2022, Musk said on social media that through dieting and semaglutide, he lost 18 pounds in a month. On June 16 this year, former British Prime Minister Johnson wrote an article in the "Daily Mail" revealing that he wanted to "lose weight into a well-defined whip", and successfully lost 19 pounds by taking semaglutide and fitness.
But what is surprising is that these two "big shots" announced that they would no longer take this Internet celebrity diet pill after taking it for a while. Johnson said he "had to give up the weight loss injections after a month of trying semaglutide because they made me feel uncomfortable." He said that due to the demands of his work, he constantly flew around the world and often had to adapt to different time zones, in which case the drug did not work for him, although it worked well for his colleagues. Johnson also revealed that he bravely stopped taking drugs to lose weight and returned to running and fitness, which he believes works better for him.
Musk, on the other hand, stopped taking it because of its nausea and other side effects, and switched to fitness.
According to an article published in the journal Nature, long-term dependence on drugs to lose weight can bring unexpected side effects. The most common adverse reactions reported for semaglutide were nausea, vomiting, diarrhoea, abdominal pain, and constipation. The FDA specifically warns that the use of this drug has been found to induce thyroid cancer in animal tests. Other, rarer side effects include pancreatitis, gallbladder disease, and diabetic retinopathy, among others.
Another diabetes drug, tirzepatide, which is said to surpass even semaglutide in weight loss in head-to-head clinical trials, was approved in May 2022 for blood sugar control in patients with type 2 diabetes, and the price is also relatively low. In July 2022, the New England Journal of Medicine (NEJM) released a phase 3 clinical trial of the drug, showing that it is very effective in treating obesity.
In clinical trials, tirzepatide is commonly associated with gastrointestinal adverse reactions, including nausea, diarrhea, and constipation. Cholecystitis and acute cholecystitis were reported more frequently in the tirzepatide group, although the overall incidence was lower (≤0.6%). In addition, if you want to maintain the effect of weight loss, you need to inject the drug all the time, otherwise the weight will regain.
In April 2021, semaglutide was approved as a diabetes drug in Chinese mainland and was able to enter medical insurance.
It is understood that the indication of semaglutide for weight loss in China is still in the phase III clinical stage, and the dosage form has been changed to an oral preparation, which has not yet been approved. The trial direction is the efficacy and safety of semaglutide oral formulation 50 mg once daily in overweight or obese adults in China.
Liraglutide injection was approved for blood sugar control in adults with type 2 diabetes in March this year, and was approved for obesity or overweight indications in July.
Tirzepatide is still not approved for marketing in China.
Are several diabetes drugs safe for weight loss and how to deal with side effects?
At present, there is only one weight loss drug orlistat approved by the State Food and Drug Administration in the domestic market, and there is no particularly clear cut-off value for drug application for other drugs that do not belong to this category. GLP-1 receptor agonists must be prescribed in obese patients with diabetes, in combination with other glucose-lowering drugs, and in accordance with a BMI of more than 28 kg/m2 (the Chinese standard for obesity). Because a large number of studies have proved that patients eat less and lose weight during the administration of the drug, it is also very beneficial for blood sugar control.
All weight-loss drugs can bring some side effects, among which GLP-1 receptor agonists are mainly gastrointestinal, nausea, vomiting, diarrhea, etc. Behind the weight loss, the side effects of the drug itself have not been taken seriously. From 2013 to 2019, the official website of the State Food and Drug Administration issued several pharmacological alerts about GLP-1 receptor agonists, and Canada warned of the risk of pancreatic cancer associated with exenatide. In its adverse event reports from July to September 2021, the US Food and Drug Administration (FDA) disclosed that GLP-1 receptor agonists such as liraglutide may cause gallbladder-related diseases.
So what do you think of the popular online use of semaglutide, orlistat and other diabetes drugs to lose weight, is it safe?
Zhuang Shilihe, a special expert of the "CC Intelligence Bureau" of Phoenix.com, believes that first of all, semaglutide is not the only way to intervene in weight loss. Lying flat injections cannot lose weight, and it needs to be accompanied by appropriate exercise. In the clinical trial published by NEJM, both the placebo group and the control group carried out lifestyle interventions, including daily calorie control and exercise for more than a year. Musk's weight loss relied on "regular fasting" and fitness training under the guidance of a personal trainer, and one shot of semaglutide a week to lose 20 pounds.
Second, clinical trials are for a specific population. "Fat people" who do not meet the criteria for obesity cannot be used. Nowadays, many friends who are clamoring for weight loss are actually within the normal range and have not reached obesity. The average weight of volunteers in the clinical trial is more than 200 pounds, and the BMI reaches 37, so you can compare your own data.
And, most of the volunteers were white women. For Chinese with normal weight or slightly overweight, there is no clinical trial data on semaglutide weight loss, we do not know what effect it can achieve, and whether these effects and its potential side effects far outweigh the disadvantages, there is not enough evidence to support it. (The phase 3 clinical trial in China enrolled 300 patients, hosted by 301 Hospital, and the results of the clinical trial have not yet been announced.) ）
Finally, semaglutide is a prescription drug, which is only approved for the treatment of type 2 diabetes in China, not as a substitute for insulin, and has not yet been approved for weight loss.