Semeglutide injection has a precise effect and relatively high safety, so it is not difficult to understand why it has become a new target for criminals. The company was qualified to produce facial masks, but found that the weight loss industry was more profitable, and began to illegally produce semeglutide.
Written by | Ling Jun
In March this year, the Food and Drug Huanzhisen Brigade of the Zhejiang Zhuji Municipal Public Security Bureau detected the first case of illegal development, production and sales of the drug simeglutide for the treatment of type 2 diabetes in China. Such "three no" counterfeit drug products have flowed into more than 20 provinces across the country, with a sales amount of more than 100 million yuan.
According to the "Rule of Law Daily", this batch of slimming counterfeit drugs is called "AB Light Combination", and the manufacturer first dissolves the powdered semeglutide and then freeze-dried, and sells it to beauty salons and agents under the name of cosmetics. Recently, the "medical community" contacted a merchant who sells "light hormone", and the other party said, "You can get injections at home, and there are many beauty salons that use it." Lose up to 30 pounds a month, which is very safe. ”
The first "semeglutide counterfeit drug case"
The illegal company, which has sixty or seventy employees, "has formal qualifications to mainly produce facial masks, but then they realized that the weight loss industry was more profitable and began to engage in this illegal production." The police officer in charge of the counterfeit drug case told the "Rule of Law Daily". In 2018, the gang was caught by the Jiangsu police for illegal trading of botulinum toxin, and the relevant responsible person was sentenced to 1~2 years in prison, suspended for 2~3 years.
This time the crime was committed again, and the gang's means of generating wealth were also upgraded with the development of medical technology. As a new generation of glucagon-like peptide 1 (GLP-1) receptor agonist, semeglutide was originally used to treat type 2 diabetes, but because of excellent clinical data on weight loss, it was further approved by the US FDA as a diet drug in June 2021. In China, in the past two years, it has become a "weight loss miracle medicine" that has become popular all over the Internet.
According to reports, the gang re-recruited professionals, set up a laboratory in the company, created a gang linked by family relationships, including "raw material research and development + manufacturing + packaging sales + brand building", produced counterfeit drugs containing semeglutide at a low cost, and then set up a special publicity team to carry out false publicity on social platforms and e-commerce platforms.
At present, the formal prescription of semeglutide is divided into 1.5ml and 3ml dosage forms, the price is about 700 yuan and 1100 yuan respectively. However, in the seized batch of illegal products, the content of semeglutide was minimal, and agents at all levels sold them at a markup, and the price increased by 50 times to consumers.
"We have been paying attention to the popular products of Internet celebrities and cracking down on the arrogance of criminals using the Internet to sell counterfeit products." Zhao Zhen, captain of the Food and Drug Huanzhisen Brigade of the Zhuji Municipal Public Security Bureau, said that the police first arrested the operator of the online store, and then followed the vine to collect counterfeiting dens in other provinces, and seized more than 16,000 bottles of "light and easy" products.
The "medical community" searched e-commerce platforms with "light light" and found that similar goods were still sold, including the so-called "AB light element" imported from South Korea, according to the "Rule of Law Daily", the packaging was exactly the same as the seized batch of illegal products.
The other is the "Diamond Lightweight" produced by a company in Guangzhou. The "medical community" contacted the store as a consumer, the other party said "one injection thin", a set of 580 yuan, when using the powder dissolved into a liquid and then injected by itself, a month can lose up to 30 pounds, "many beauty salons are using, very safe." ”
When asked about the active ingredient, the other party denied that it was semeglutide, saying that it was "smeglutide". However, it was not possible to see similar substances from any medical search engine.
"Even if you use genuine meglutide according to the doctor's advice, even if the effect is good to lose about 10 pounds a month, it is still for patients with a high BMI index itself." Bi Hui, deputy chief physician of the Department of Internal Medicine of the Plastic Surgery Hospital of the Chinese Academy of Medical Sciences, said to the "medical community".
In connection with the investigation of the same type of counterfeit drug sales case, the police said that the reason why criminals take risks to sell counterfeit drugs is not only driven by huge profits, but also because many counterfeit drugs do not cause death, in practice, light sentences, suspended sentences or even only fines and other additional punishments are applied, which is difficult to play a punitive deterrent effect.
Semeglutide has a precise effect and relatively high safety, so it is not difficult to understand why it has become a new target for criminals. The aforementioned merchants said that the "protein light hormone" they sell is contraindicated in patients with hypoglycemia, pancreatitis, ketoacidosis, and pregnant women. The "medical community" comparison found that this is completely consistent with the contraindications to semeglutide.
The popular celebrity diet pill on the whole network
The industry describes semeglutide as a "game changer" for weight loss. In the "weight loss section" of social platforms, the long-term hegemony version of semeglutide, and the overseas version of TikTok, the views of related tags have exceeded 600 million. "You can lose weight after beating", attracting countless people with weight loss needs to rush to buy, and it is difficult to find a medicine in some places.
Zhai Xiaobo, chief pharmacist of Shanghai Dongfang Hospital, told the "medical community" that it became a star product as soon as it was admitted, and in just one year, its sales ranked among the top drugs in the hospital.
By mimicking the effects of a hormone called glucagon-like peptide 1 (GLP-1), semeglutide can make users feel full. According to the results of a clinical trial published in February 2021 by the New England Journal of Medicine, the average weight loss in the group with subcutaneous injection of 2.4 mg of semeglutide per week was 15.3 kg, and more than three-quarters of people lost more than 10% of their body weight.
Health media STAT reported that as a diabetes treatment drug, the annual sales of GLP-1 drugs worldwide is $23 billion. As a drug to treat obesity, one of the multinational companies alone has an estimated market revenue of nearly $100 billion in the next 10 years, making it the largest drug market ever.
However, at present, China has not approved the indications of semeglutide for weight loss. The Jiangsu Provincial Food and Drug Administration said in an April 1 statement that "this is because there is still a lack of data on the safety and effectiveness of Chinese groups using it to lose weight." Caught between "regulations" and "needs," doctors are caught in a dilemma.
Bi Hui told the "medical community" that in her endocrinology clinic, there has been an endless stream of patients who have consulted smegglutide in the past two years, "Among the 'drug seekers' who do not meet the diabetes indications, there are mostly women, almost every day, the peak is before the summer, everyone wants to lose weight." ”
This medicine has some gastrointestinal side effects. For those patients who are difficult to lose weight by diet and exercise, including 'prediabetes', obese patients with metabolic diseases such as hyperlipidemia may also cause a series of complications such as cardiovascular and cerebrovascular diseases. For the sake of benefit/risk ratio, I think it can be used. Bi will say, but she can't prescribe this drug, it is an off-label use, and the prescription cannot pass the review of the hospital system.
However, prescribing this drug online is extremely simple. The "medical community" search e-commerce platform found that although it is a prescription drug, in many online stores, consumers only need to simply confirm that they know the risk, and claim that they are diabetic, and they do not need to upload medical records, and they can enter the payment interface after one minute.
In this regard, Bi Hui said, "There are still risks in how to inject this drug, which parts to inject, how many doses to use, and how to gradually adjust it." For weight loss and hypoglycemia, are two completely different doses, excessive will make digestive tract symptoms more obvious, but also may cause 'hypoglycemia-like reactions', palpitation, hand tremors, etc. ”
"Even for overweight people, this drug is not effective for everyone, but on e-commerce platforms, it is difficult for consumers to get detailed medication guidance." Bi will say. For simple "beauty seekers", the risk will be further intensified. In the outpatient clinic, Bi will observe that nearly 80% of the "drug seekers" have no underlying disease, and the BMI value is also in the normal range.
"Some women have a BMI in their early 22s, and they feel that they are fat, have meat on their stomachs, and have thick arms, and they come to me to prescribe medicine to lose weight." According to the indications approved by the US FDA, if used for weight loss in non-type 2 diabetes, the scope of application of semeglutide is BMI ≥30kg/m2, or BMI ≥27kg/m2 but at least one weight-related comorbidity.
Bi Hui introduced, "Drugs will suppress appetite, for people in the normal weight range, gastrointestinal risk will double, may also cause malnutrition, and even hypoproteinemia, electrolyte imbalance and a series of other conditions, resulting in decreased immunity, increased risk of infection or allergies." I don't recommend using it. ”
On the e-commerce platform, there was a premium for semeglutide, and other media reported that some small hospitals with tight supply have difficulty finding a drug for diabetic patients. Another person left a message in the comment area, saying, "A batch just arrived at the hospital, and just entered the system and digested it internally." ”
Globally, this shortage is also widespread. In Australia, due to the continuous feedback of shortage information, the Medicines Administration issued a warning on February 16 this year that doctors should not use semeglutide to treat obesity until the supply is stable.
France's national drug safety agency stressed on March 1 that off-label prescriptions are crowding out diabetics who really need it. On March 13, the European Medicines Agency also released news that semeglutide injection will face a long-term shortage, which is expected to continue throughout 2023.
A new generation of weight-loss drugs has appeared
Bi Hui said that "diet drugs" have always existed, including liraglutide, dulaglutide, and SGLT-2 inhibitors, which are also GLP-1 agonists, and metformin also has weight loss effects, their effects are mixed, but they have not been approved in the mainland for weight loss alone. Orlistat, the only approved one, also has limited clinical effect and has been an embarrassing existence for many years.
In his more than ten years of clinical career, he has encountered patients with serious diseases caused by taking weight loss products every year. The deepest impression was a 31-year-old woman who visited the doctor for "edema, nausea and vomiting", and her blood creatinine was more than 900, diagnosed with uremia, and began dialysis since then. She doesn't have any underlying medical conditions, the only thing is to eat weight loss products. "Bi will say that kidney failure, high protein in the urine, diarrhea and dehydration, low blood pressure and so on are common." We also don't know what ingredients are in these products that cause them to have multi-organ damage. ”
Even if it seems to be safe, when semeglutide is made into a counterfeit drug, the quality of the drug may change during the transportation and storage of the drug. Zhejiang police told the "Rule of Law Daily" that illegal weight loss injections flowing into the market, if the storage conditions are not strict, will not only weaken the effect, but even aggravate the side effects.
It is reported that the phase III clinical trial of semeglutide injection for weight loss indications in China has been completed, and the clinical trial of the oral version is being carried out; The application for weight loss indications for liraglutide has been submitted, and relevant pharmaceutical companies said that it is expected to be approved this year; Another pharmaceutical company also announced in February this year that its phase III trial of telpotide in obese or overweight adults in China met the primary endpoint and all key secondary endpoints.
"It should be noted that after stopping the drug of this type of drug, there may be an appetite rebound, leading to weight regain. It is impossible to inject for a lifetime, and it is still necessary to emphasize cooperation with exercise and adjust the diet structure. Bi Hui said that up to now, the weight loss practice of semeglutide has only been in China for nearly two years.
"Strong efficacy drugs" can allow users to maintain their original living habits while getting weight loss effects, such weight loss is too easy, so it will lead to irregular use and addiction problems, which may exist for a long time in the future, and need to be regulated and supervised.
But in any case, the history of human weight loss may be ushering in a seismic change. STAT commented that history proves that blockbuster drugs will change people's perceptions of disease and health. In the 1960s, the emergence of stability changed society's perception of anxiety; Prozac in the 80s influenced people's perception of depression; When statins came out, people became concerned about their cholesterol. Now, a new generation of highly effective weight loss drugs is coming out one after another, which will continue to influence the public and medical community's perception of obesity.
Source: Medical community
Responsible editor: Wang Xiao
Editor: Zhao Jing
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