2010年10月28日星期四

Anhui dozens of elderly people into a drug test without the knowledge of local drug regulatory department said

Two years ago, is located in the remote villages of Anhui Nanshan ushered in a group of hypertensive patients, "hospital drug delivery" and "angels", which also opened the big screen for free medication. However, they do not know two years swallow their drugs are a "Clinical medicine", the so-called large hospital doctors are "deceptive."

So, in the end to the peasants who are "drug delivery"? Done without the knowledge of two years, "people try drugs," the old Dell Inspiron e1505 Battery, their interests and whether they can get the appropriate protection?

□ Special Investigation

Line, blood pressure, signature, dispensing ... ... starting from May 2008, every 3 months, a similar scene will be in Anhui Province, staged Wangjiang Nanshan Village Committee, which made drugs are claimed to be Anhui Medical University, Professor of experts who, during the so-called "for the rural elderly hypertensive patients free Songyisongyao the countryside." Queue up the natural medicine is the local old people suffering from high blood pressure.

From the first hundred people receive medication, to some people choose to give up some people continue to insist that more than two years later, this "charity" is still continuing. However, these simple people might not think of the old has been taking drugs for two years, turned out to be still in clinical trials of new drugs, and they became the first completely thorough, "reagent people."

Nanshan Village come out of the "free medicine"

Hefei, capital of Anhui Province in order to Wangjiang from Nanshan Village, the village must be more than a dozen kilometers from town, Nanshan get off, then go to car rental. Outside the village are the vast majority of young workers, leaving many empty nesters and the children left behind. The remote location, where medical conditions are not ideal, to the nearest county hospitals, there are 60 km away, if not seriously ill or pain, where most of the elderly in rural health department for a simple treatment.

In 2008, it was found Nanshan Village Committee, said a group of experts and professors of Anhui Medical University, elderly care in the country, ready to carry out the "drug delivery hospital to the countryside" activities.

"This is good to have experts and professors to a free Dell Inspiron 8200 Battery, free of drugs, I certainly would not refuse." A village officials said.

Starting from May 2008, "Songyisongyao" flash lasted for more than two years.

It is understood that provide free medicine to the Nanshan village called "enalapril folic acid tablets," the bottle's label is "prevention of cardiovascular medicine clinical observation of the event program," provides pharmaceutical unit is "Anhui Medical University Anhui Institute of Biomedical Sciences, "while the packaging is not marked" Zhunzi "word.

"My blood pressure is maintained at high pressure 120 over 80, the antihypertensive effect of this drug is very good, those experts I continue to eat, to eat 4 consecutive years." It is understood that there are still dozens of people in Nam Shan Estate medication , and are elderly, 67-year-old Zhang Xiaoguo is one, he also told the "Legal Daily" reporters, taking with him now generally believed that the elderly antihypertensive drug effectiveness.

Reporter learned from the Nanshan village health, activities carried out at the beginning, more than 100 people queue up drugs, to the way some people are not suited to give up drugs.

Nanshan village health doctors who declined to be named, told reporters after the drug received to indicate that the bottle is "Clinical medicine", he began to doubt the so-called "Songyisongyao" activities of authenticity.

"But to send medicine to people who claim to be the First Affiliated Hospital of Anhui Medical University and its professors and medical experts, we, the village health doctor even if it is a clinical trial of suspected drug use, nor would anything, after all, people are free of charge. "It is the name of Nanshan village health room doctor, in order to avoid unnecessary misunderstandings, they have not come to receive your medicine for old people any" warning. "

Food and Drug Administration "clinical medicine" Food and Drug Administration has no Dell Inspiron 9300 Battery

Holding the bottle to provide old people, "Legal Daily" reporters came to the Wangjiang Food and Drug Administration, identified by the council inspectors shares Xugu Zhang, Nanshan Village, the elderly are taking "enalapril folic acid tablets" Indeed drugs for clinical trials. But he said the matter Wangjiang Food and Drug Administration did not know.

According to statistics, an average of 370 new drugs come out every day, each of the new drugs on the market before, to go through clinical trials, drug trials in China in the total number of test drug were more than 50 million people.

"Republic of China on Medical Practitioners" Article 37, paragraph 8: without the patient or the family agreed that clinical trials of patients treated, according to the circumstances held liable.

In addition, according to Xu Guchang, China's September 2003 introduction of the "drug clinical trial quality management standards" clear that new drugs enter clinical trials before approval by the State Food and Drug Administration, and can only be confirmed after the national clinical examination pharmacological bases, specific clinical trials for new drugs the doctors must go through the state special professional training and pass examinations to obtain the relevant certificate to participate in this work.

"Meanwhile, the provisions of Chapter III in the subjects participated in standardized testing should be voluntary, the trial period, such as the occurrence of damage associated with the test, the subjects get treatment and the appropriate compensation, that is, clinical trials of new drugs, must sign a drug testing consent form. "Xugu Zhang said.

But when the "Legal Daily" Nanshan Village, a reporter asked the old people know that "folic acid tablets enalapril" clinical trials of new drugs, old people have no knowledge of that, it does not enter into any so-called informed consent.

"We are the leader in the village to the Ministry of medicine, to professors who are experts heard, which we the people know what the drug was not drug money is good medicine." Golden Bridge is still the elderly pay for medication, said.

"If you reflect the true situation, it is certainly not allowed, free delivery does not work, as long as the drugs are toxic and negative effects, especially at times of new drugs is the potential side effects must be informed to the parties." But at the same time Xugu Chang also expressed frustration that "since this drug is a clinical observation of marked drug, at an experimental stage, and no Dell Inspiron 9200 Battery, precisely, it can not be defined is the drugs, so the Food and Drug Administration has no jurisdiction, no punishment based. "

This drug delivery unit and journalists have anything to do

Nanshan Village to provide new drugs Wangjiang "enalapril folic acid tablets," the Anhui Medical University, Institute of Biomedical Sciences, Anhui Medical University, No. 4 in the sixth teaching building, the reporter found this unit.

Office of the Director Wu of the Institute admitted drug "enalapril folic acid tablets" is a project that studied.

When a reporter pointed out that clinical trials must be qualified in the hospital, and must sign a drug testing consent form, the Director Wu asked a reporter, "so you will not be tired? It have anything to do with you reporters? We have materials and approval of documents, but I just do not give you. "

Subsequently, a Professor Tang Xing of the Institute explained to reporters that they are doing "enalapril folic acid tablets," the four clinical trials, the drug has been the State Food and Drug Administration approval in 2008 of a class of drugs, currently Tasly Pharmaceutical Co., Ltd. production, do not need four clinical trials in hospitals designated by the State, they could do, "since countries have approved a new drug, and why can not we give people to eat? and we is free, and never received a penny. "

Office computer at the Institute, the reporter online query to the "drug clinical trial quality management standards", which expressly provides that the trial of new drugs must be qualified by the hospital.

Thus, the reporter pointed out that new drugs would like to see the pilot's qualifications and the subjects informed consent, Director Wu said the information center in Anqing, in Wangjiang and ZONGYANG have their pilot sites, but refused to provide Anqing Center address and contact Dell Inspiron 700m Battery.

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