October 30, the State Food and Drug Administration issued an emergency notice, announced the official stopped the 15 kinds of diet pills, and made it clear that their total drug ingredient sibutramine is the "culprit" and its style of weight loss treatment
Risks than benefits, easily lead to cardiovascular disease and other adverse reactions.
Drug recalls are not uncommon, however, this "recall order" has caused a great disturbance, consumers do not understand, "stop list", a song on the United States, Australia music light, music ting so up to 15 drugs, weight loss market
Why are there so many "dangerous" product? Sibutramine in the United States in 1997, allowed the Chinese market in 2000, up to ten years, why now face a red card?
Taiji Group play "Tai Chi"
Song on the list stop the United States, "China 500" Taiji Group (600129.SH) of competitive products, once the weight loss market "champion." "Recall order" after the release of the United States bear the brunt of being a music consumer
Questioned.
In 2002, the United States with annual sales of 400 million yuan Qu sit tight in the domestic market, half of the weight loss. According to promotional information Taiji Group, 10 years, the song brings the U.S. total of Taiji Group of 50 billion yuan of sales revenue.
However, trimetazidine is not easy. In 2008, the song of beauty sibutramine pharmaceutical composition caused controversy in the international arena, the United States as a prescription drug song has also been the impact of strict management during the Olympic Games, sales fell
Less than 1 million. If the United States at this time but suffered a hit song, then shortly before the "recall order" is undoubtedly a fatal blow. Trimetazidine was ordered to stop selling and recall products sold.
"Recall order" a few days after the release, Taiji Group, in its official website posted eight consecutive statements, repeatedly stressed that Taiji Group is a "socially responsible business", "the United States are taking the music is safe and effective," "Song
U.S. production quality of full compliance with national standards "and so on.
Taiji Group's "Eight Man responded," not only failed to cause controversy, but also led to a "question bickering" - no problem since the product recalls that why?
Quality problems in the war of words at the same time, Taiji Group, "play ball" attitude also led to strong resentment among consumers. Taiji Group, said the notice, whether or shopping vouchers can be returned. However, in practice,
Taiji Group staff explained that "consumers are not shopping vouchers can only be registered, and can not return money back."
On the issue of compensation, Taiji Group's attitude is often "fade."
November 1, Taiji Group spokesman position, "Qu U.S. products meet national standards, so long-term use of trimetazidine had no compensation plans to consumers." For a time, accused of cries.
"People's Daily" published in the Nov. 4 commentary, "" national standard "is not" safe harbor shields "," in which the sharp rhetoric that the quality of products Taiji Group neglect and disregard of the interests of consumers, "not qualified
Talk about social responsibility. "
Day, Taiji Group immediately, "Song of the mouth", that "the company is not reluctant to claim, but the current main task is to recall song beautiful."
November 5, Taiji Group has a new response: "not reluctant to claim the work as long as the claim is reasonable, the company will be held accountable in the legal context."
What is "reasonable claims," what will be the extent to which Taiji Group "responsible" remains to be further development of the incident.
"Sibutramine 'Happy' years of normal"
Taiji Group production of music, including the United States, including, this time ranked "stop list" of 15 weight-loss drugs have a common element - sibutramine. Sibutramine is an internationally renowned research and development by pharmaceutical company Abbott Laboratories, Abbott was
1997 successfully developed composition containing sibutramine slimming Connaught Mei Ting, six months after listing swept the world, had become a highly acclaimed weight loss "medicine." This was stopped in China, 15 kinds of diet pills, almost all of Connaught
Mei Ting generic drugs.
In 2002, the Connaught side effects of US-ting gradually emerging, but only gradually increased consumer complaints in connection with the case of death, the U.S. Food and Drug Administration (FDA) have considered the "halt" Snow Mei Ting.
But Abbott took out "from the card clean" of data: 8.5 million of those who took the world because of adverse reactions reported 32 cases of death, the ratio was less than the normal mortality of obesity at 1 / 200.
Ultimately, the U.S. FDA and Abbott agreed to carry out "sibutramine cardiovascular end point studies" took 6 years of the study by the European Medicines Agency to appoint independent expert group to evaluate the experimental results.
End of 2009, experimental results show promise Mei Ting taking resulting in death and serious cardiovascular events than not taking the higher the probability of 16%. Meanwhile, the European Union, Canada and other countries also permit Ming Xibu experiments will lead to serious heart sibutramine
Vascular disease risk, including non-fatal myocardial infarction, nonfatal stroke, can be resuscitated cardiac arrest, and cardiovascular death.
This year in January, the European Union to stop the Drug Administration Department of sibutramine in European sales. October, Abbott take the initiative to withdraw from the U.S. market, China suspends composition containing the drug sibutramine.
Ministry of Health, Malaysian national rational drug monitoring network of experts in the "China Economic Weekly" interview, said: "The results made clear the harmful sibutramine achieved a 16% chance, while less than 5% weight loss, which is the 'rule
Treatment risks outweigh benefits' explanation. "
So, why sibutramine be able to "Happy" years it?
MCA said that, first of all, sibutramine cardiovascular damage is not caused by dominant, usually difficult to detect medication.
Second, the weight loss drugs sibutramine content is not high, that normally does not take significant short-term expression, and for the purpose of weight loss medication is usually intermittent, so the symptoms much less show it.
In addition, cardiovascular disease is a common disease, obesity, so even if the disease appeared in medication, it is usually considered to be caused by long-term obesity, weight-loss drug suspects ignored.
So MCA that sibutramine is not slip through the net, it "Happy" Ten years is very normal. R & D stage, the nature of the clinical trial drugs is very limited and experimental drugs for the primary role
, Side effects can easily be overlooked. Only in a large number of potential side effects listed and only after years of accumulation can be found. "This is a modern manifestation of advanced medical technology is not enough to fully understand the drug properties, it is necessary
Pay the price. "MCA expressed frustration.
But he also said that the inappropriate choice of research and development stage and drug test sample tracking and monitoring system, after market imperfections also lead sibutramine "Happy" years of important reasons. Currently there is no perfect world of medicine
Listing track and monitor the system, which is a big loss.
Who is responsible for the bad weight-loss drug?
United States and other weight loss drugs hit song "recall order" is not by chance, over the years, the composition of weight loss drugs has been the often-criticized safe.
MCA said that weight loss drugs containing a diuretic, speed up the metabolism, suppress appetite and mind control The components are very common, and these components in the diet, while fewer side effects, from a scientific point of view for medication
, Method of weight loss drugs is not recommended, because almost all of the weight-loss drugs have a variety of risks and hazards.
Drugs are stopped, damage the interests of consumers, producers should take risks, how to be responsible for bad products?
In 1997, FDA ordered pharmaceutical company Wyeth's well-known weight-loss drug fenfluramine delisting, to 2005, the Wyeth litigation by victims of endless debt, 2009, the Wyeth pharmaceutical company Pfizer eventually Public
Division acquisition.
In view of this case, the United States, Japan, Germany, Sweden and other countries began to try to enterprises funded the establishment of pharmaceutical production and sales of insurance in the form of funds or adverse drug reactions to damage relief. This side
Type can not only effectively protect the interests of consumers, to achieve full compensation, but also reduce adverse reactions due to uncontrollable and the enormous risks and maintain business interests.
Law Lawyer Zhaozheng An Ping told the "China Economic Weekly", the international production and sales of many large pharmaceutical companies to spend 8% of annual profit compensation fund established adverse reactions, as respond to risks. In addition
Many companies have also established an internal risk assessment and drug testing system to ensure effective feedback of drug information, thereby reducing the scope of adverse effects of drugs. However, China's pharmaceutical companies related to this work is very small
The.
Hui Huang Zhibin City law firm recently because "the U.S. music event" fame, he is collecting a large number of patients with trimetazidine collective compensation suits, and he expressed the hope that through their own efforts to safeguard the interests of consumers,
Manufacturers to promote social responsibility, also contributed to the relevant national authorities to strengthen supervision of food and drugs.
But he also said, "This case is not good to do." First, the domestic legal system is not perfect. "As the quality of the main legal basis for the tort law and consumer protection laws are not on the recall caused by drugs
Against a clear point. "
In addition, the legal consciousness of consumers are generally weak, as long as no more incidents, it would not take the initiative to safeguard their rights.
Even a strong awareness of the law for some consumers, hard evidence of consumer rights has hampered the road. How to prove that their health is poor because of weight-loss drug after taking the damage it? If
Instructions are specified adverse events, then this "express" is able to exempt it? This topic is currently considerable debate, there is no consensus.
In addition, the high cost of claims has resulted in substantial consumers of the existing "know the bad luck" here. In accordance with existing law, if consumers do take legal means alone will cost a lot of energy rights and high litigation costs
. Costs relative to illegal consumers, "the high cost of rights", particularly when the defendant is a more powerful large-scale enterprises, consumer power is very weak. This is also a large number of consumers Huang Zhibin lawyer for collective collection
The main reason the proceedings for compensation.
Who have been delisting of the weight-loss drug
In the U.S. there are five FDA-approved weight loss drug market, namely: fenfluramine, dexfenfluramine, sibutramine, benzene Temin, orlistat. Currently, the first four have been stopped.
Fenfluramine
60's of last century was FDA approved its safety and effectiveness, followed by Jibei widely used to treat obesity and other diseases, but the obese patients treated with cardiac valve regurgitation may cause, withdraw from the market in 1997 Nianxia frame.
Dexfenfluramine
1996 was approved for marketing in 1997, simultaneously with fenfluramine FDA stopped.
Phentermine
Listed in 1970, due to lead thousands of people suffering from dangerous and even fatal heart and lung dysfunction, withdraw from the market in 1997 Nianxia frame. The compound with fenfluramine diet pills Fenfen also been stopped.
Sibutramine
Listed in 1997, in October 2010 by the State Food and Drug Administration halted.
Orlistat
In 2007 the low-dose drugs are FDA approved as non-prescription drugs sold in the U.S.. The domestic market with the drug orlistat ingredients are Xenical more famous, but now discontinued.
