美国默克自砍摇钱树(Merck shakes Qian Shu)
美国默克自砍摇钱树(Merck shakes Qian Shu)
Since 2001, Wan began selling in China, and by the end of 2003, more than 84 million prescriptions had been issued worldwide.
In October 9th, Merck & Co. launched its flagship drug in China, officially launched. Specific information is available on the drug withdrawal of Merck (Merck & Co. Chinese subsidiary) Chinese website, at the same time, free hotline 8008200188 has been opened.
Vioxx (VIOXX, rofecoxib), is the ace of drugs by one of the world's top 500 American Merck Co's treatment of arthritis and acute pain, since listing in 1999, the drug sales of more than 80 countries in the world, to the end of 2003, has opened more than 84 million global office, 2003 global sales of 2 billion 500 million dollars. Since 2001, Wan began to sell in China, and the retail price in China is about 50.8 yuan per box.
Why did Merck suddenly have to cut down such a Qian Shu herself?
In August 25th this year, the U.S. Food and Drug Administration (FDA) drug safety department DavidGraham held in Bordeaux the twentieth drug epidemiology and treatment of risk management international conference, announced a surprising result: the 1 million 400 thousand medical records research, high-dose Vioxx users compared with no Vioxx, the risk of myocardial infarction and sudden cardiac death has increased 3 times; and the study of Celebrex and Pfizer Inc were compared, found that myocardial infarction and sudden cardiac death risk taking Vioxx exceeds the standard dosage is 50% higher than that of taking any dose of celebrex. More than 27 thousand heart attacks
and sudden cardiac death have been caused by the use of the blood vessel. However, the researchers also acknowledge that the results are limited because the absolute number of cases is very small.
In the early part of September, Merck made a strong protest about the findings. Merck believes the study is unscientific and adopts a retrospective approach rather than a world - known, rigorous, randomized, double-blind clinical trial. Moreover, in the 1 million 400 thousand medical records of the study, there were 10 patients with a total risk of 8 cases in the WAN Luo group, compared with the control group, which was statistically meaningless.
In September 30th, the situation suddenly U.S. Merck headquarters announced a sudden turn for the worse, active recovery of Vioxx, in the global scope and said: recovery of Vioxx's decision is Merck voluntary action, a company to carry out the "Vioxx adenomatous polyp prevention on tumor". The research purpose is to observe Vioxx is also suitable for the prevention of colorectal adenoma recurrence, but found in the 3 year of the new course of the study, patients taking Vioxx after 18 months, the cardiovascular risk increases, including heart disease and stroke and other serious diseases. However, there is no risk of taking drugs for less than 18 months.
The Merck Co said it had considered whether to give more warnings about its potential heart risk on the drug label to continue selling the drug, but later decided not to do so.
"Given the availability of alternative therapies, as well as
problems revealed by the data we conclude that the active withdrawal (Vioxx) is irresponsible, Merck Co chairman and chief executive Raymond Gilmartin said.
The global Merck Co withdraw Vioxx behavior recognition of FDA, served as U.S. Commissioner FDA agent Leicester, Dr. Crawford said: "the United States Merck is taking the right approach, it immediately to the United States FDA reported their discovery, and spontaneously withdraw the product from the market."
September 30th, the global withdrawal of Wan net statement released the same day, the United States Merck shares immediately fell sharply, beating more than 25%. Data show that in the withdrawal of Vioxx before the announcement, the U.S. Merck Co for 2004 year earnings per share of $3.11 to $3.17, the index still hold, expects the product withdrawal will bring negative impact on earnings per share of $0.5 to $0.6,
So the company's fourth quarter sales wiped out as much as $750 million. These include sales losses, the destruction of Merck's existing inventory, customers' return to sold products, and the cost of recycling.
Merck public affairs and internal communication manager Zhou Jie told reporters that by the end of 2003, the world has prescribed 84 million Vioxx prescription, the company estimates that there are currently 2 million patients worldwide are taking Vioxx, but there is no specific statistics on the data China.
The U.S. Food and Drug Administration (FDA) released a report last year, surprising news: the use of well-known rheumatoid arthritis analgesic "10000 collaterals" more than 18 months of patients, the probability of sudden heart attack or stroke will double. The sudden death of the drug has risen to 60 thousand worldwide, the British Sunday times reported. At the end of last year, the drug maker, the American pharmaceutical tycoon Merck Co, was forced to recall "Wan Fu" around the world.
However, things did not end. A few days ago, a law firm in Beijing convened 200 thousand people in China, hoping to help them claim lawsuits in the United states.
Consumers do not have to pay court fees
In charge of this transnational lawsuit is Hao Junbo, a lawyer at Beijing Li Yuan Law firm.
"The cause of the case was a coincidence. It was a by-product of another lawsuit." A few months ago, Beijing Li Min law firm took the "11. 21 Baotou crash" transnational litigation, and the United States Leaf law firm to cooperate. A casual chat with a reference to a case in the United States that raises claims and lawsuits.
"We feel that we can help Chinese patients deal with the personal injuries caused by those transnational corporations in china." Hao Junbo said they would take the action in the form of risk agents in cooperation with American lawyers. That is to say, consumers who appeal for litigation only need to sign the power of attorney, provide relevant information, and do not
personally go to the United States to prosecute. "If the case is lost, the consumer will not have to pay any fees."
Drug abuse triggered a wave of claims
What kind of medicine is "Wan Yu"? According to reports, this arthritis analgesic "10000 collaterals" (English name Vioxx, rofecoxib) is the world's fourth largest pharmaceutical giant Merck (MERCK) company's flagship product. Since its appearance in 1999, "Wan Luo" has brought 2 billion 500 million dollars of profits to Merck Co every year, and a total of 20 million patients in the world have taken "Wan Luo"". The drug has long dominated the drug of its kind.
August 25, 2004 was a black day for the Merck Co. On that day, the U.S. Food and Drug Administration announced a surprising result: compared to high-dose Vioxx users and do not use the "Vioxx", the risk of myocardial infarction and sudden cardiac death increased 3 times. 5 days later, Merck Co announced plans to launch a global network of 10000 recalls.
To add insult to injury, the pharmaceutical company is now facing a wave of lawsuits involving damages of up to $55 billion. It is reported that, as of now, in the United States, there have been more than 4200 cases relating to "Wan Luo". Similar cases have also been reported in Canada, Europe, Brazil, Australia and israel. The families of the 2000 British dead are also considering suing the Merck Co in the US court. According to the British Sunday times, the death toll could have killed 60 thousand people worldwide.
Our country takes more than 2 million people
Hao Junbo said, because the case is more special, firm plans to convene nationwide Vioxx users: "want" was due to the use of Vioxx "harm China patients aware of the matter, then contact us and provide the corresponding material, transnational litigation assistance by us."
He also said that since the end of the month launched convened after the event, the firm has received dozens of phone calls and e-mails with,
And most people are still in wait-and-see state of consultation. For litigation prospects, Hao Junbo said, according to the current data show that as one of the latest drugs in this field, "Wan Luo" has been widely used in clinical medicine in our country. China has more than one hundred million arthritis patients, and more than 2 million have taken it since 2001.
Hao Junbo hope that every filed of consumers can prepare the relevant evidence to prove the use of Vioxx prescription and purchase vouchers, before and after taking the health report and adverse symptoms, relevant certificates issued by the medical institution. "The more detailed the evidence, the greater the odds."!"
In the United States, a greater chance of prosecution
The United States of Dezhou Carol Nys, "Vioxx" is undoubtedly a "executioner" in May 2001, she has always been in good health that marathon athlete husband Robert Ernst heart attack, died
in his sleep, only 59 years old. And before, in order to ease hand pain, he had 8 consecutive months to take "Wan Luo"".
At the end of last year, Merck Co was quoted as saying "Wan Wan" may lead to sudden cardiac death. Nys filed a petition against the Merck Co court. In August, the court finally ordered the Merck Co to pay the plaintiff $253 million 400 thousand in damages.
Carol's win brought a glimmer of hope to people all over the world who had taken "ten thousand collaterals". "That's why we chose to litigate in the United states." Hao Junbo told reporters, although according to the "product quality law", China consumers can choose to sue the dealer, but in the United States sued the manufacturer to win greater grasp, because "the United States is a case law country, this case will affect the judgment of similar cases."
Without recall system, it will be difficult to collect evidence
Hao Junbo believes that the importance of drug safety in China is far from enough. In China, lawsuits are much more complicated and victims are more difficult to obtain evidence."
According to the analysis, the most difficult thing in the collection of evidence is the qualitative evaluation of the toxicity of drugs. According to China's "who advocates, who proof" litigation principle, consumers first need to prove the drug defects. Although American research institutions have confirmed that the continuous use of "ten thousand collaterals" may increase the risk of cardiovascular disease. However, since
the evidence of China and the United States is not mutually acceptable, it must be verified by relevant Chinese organizations before it can serve as legal evidence.
More importantly, there is no drug recall system in our country.
Experts believe that, because China does not have a formal drug recall system, leading to Chinese enterprises have problems, to conceal the possibility of increasing the problem. According to statistics, of the about 50000000 inpatients per year in China, about 2500000 were associated with adverse drug reactions, of which nearly 200 thousand died from adverse drug reactions. However, the list of drugs listed in the adverse drug reactions bulletin has never been banned from production or use. In September 30, 2004, the Merck Co recalled the "Wan Wan" operation on a global scale. It was the first domestic drug recall.
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