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Clinical Trials in China fabricate 80 Percent Data, says Chinese Government Investigation

China's food and drug regulator recently carried out a one-year review of clinical trials, concluding that more than 80 percent of clinical data is fabricated

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October 3, 2016: A recent survey of clinical trials in China has revealed fraudulent practice on a massive scale, according to a government investigation.

China’s food and drug regulator recently carried out a one-year review of clinical trials, concluding that more than 80 percent of clinical data is “fabricated,” state media reported.

The scandal is the result of “breach of duty by supervision departments and malpractice by pharmaceutical companies, intermediary agents and medical staff,” the State Food and Drug Administration (SFDA) said in its report.

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The review looked at data from 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass production, according to an expose in the Economic Information Daily newspaper.

More than 80 percent of applications for mass production of new drugs have been canceled in the light of the findings, with officials warning that further evidence malpractice could still emerge in the scandal.

According to the SFDA report, much of the data gathered during clinical trials were incomplete, failed to meet analysis requirements or were untraceable, the paper cited a source in the agency as saying.

It said some companies were suspected of deliberately hiding or deleting records of adverse effects, and tampering with data that did not meet expectations.

Fakery China’s open secret

The scandal came as no surprise to industry insiders, however.

“Clinical data fabrication was an open secret even before the inspection,” the paper quoted an unnamed hospital chief as saying.

It said China’s generic drug industry is plagued with quality problems, hence the need for the manipulation of clinical trials data to meet standards that are high on paper.

Many “new” drugs are simply combinations of existing drugs, while clinical trial outcomes are written beforehand, with the data massaged to fit in with it, the report said.

It singled out third party inspection agencies known as contract research organizations, saying they have become “accomplices in data fabrication due to cutthroat competition and economic motivation.”

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Healthcare professional Luo Liang told RFA that the domestic pharmaceutical industry struggles to turn a profit under current conditions.

“The domestic market for Western pharmaceuticals in China is either confined to very straightforward generic products that have been around for a long time … or revolves around joint-venture pharmaceutical manufacture with foreign companies,” Luo said.

“Either that, or Chinese pharmaceutical factories get hold of the formula for certain drugs whose patents have expired,” he said. “There are no new drugs in development in the same way that there are overseas.”

Poor implementation

A doctor surnamed Zhang at a top hospital in the northern city of Xian said the problem doesn’t lie with insufficient regulations governing clinical trials data, but with the failure to implement them.

“There are national standards for clinical trials in the development of Western pharmaceuticals,” he said.

“Clinical trials must be carried out in three phases, and they must be assessed at the very least for safety,” Zhang said. “But I don’t know what happened here.”

Public safety problems in China aren’t limited to the pharmaceutical industry and the figure of 80 percent is unlikely to surprise many in a country where citizens routinely engage in the bulk-buying of overseas-made goods like infant formula powder.

Guangdong-based rights activist Mai Ke said there is an all-pervasive culture of fakery across all products made in the country.

“It’s not just the medicines,” Mai said. “In China, everything is fake, and if there’s a profit in pharmaceuticals, then someone’s going to fake them too.”

He said the problem also extends to traditional Chinese medicines, which are widely used in conjunction with Western pharmaceuticals across the healthcare system.

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“It’s just harder to regulate the fakes with traditional medicines than it is with Western pharmaceuticals, which have strict manufacturing guidelines,” he said.

According to Luo, academic ethics is also an underdeveloped field in China, leading to an academic culture that is accepting of manipulation of data.

“I don’t think that the 80 percent figure is overstated,” Luo said. “If you compare Western pharmaceuticals manufactured overseas with those manufactured in China, there is a huge difference in the ingredients; the quality of the China-made drugs is appalling.” (BBG)

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FIFA World Cup 2018: Indian Cuisine becomes the most sought after in Moscow

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Indian cuisine in FIFA World cup
Indian dishes available in Moscow during FIFA World Cup 2018, representational image, wikimedia commons

June 17, 2018:

Restaurateurs Prodyut and Sumana Mukherjee have not only brought Indian cuisine to the ongoing FIFA World Cup 2018 here but also plan to dish out free dinner to countrymen if Argentina wins the trophy on July 15.

Based in Moscow for the last 27 years, Prodyut and Sumana run two Indian eateries, “Talk Of The Town” and “Fusion Plaza”.

You may like to read more on Indian cuisine: Indian ‘masala’, among other condiments spicing up global food palate.

Both restaurants serve popular Indian dishes like butter chicken, kebabs and a varied vegetarian spread.

During the ongoing FIFA World Cup 2018, there will be 25 per cent discount for those who will possess a Fan ID (required to watch World Cup games).

There will also be gifts and contests on offers during matches in both the restaurants to celebrate the event.

The Mukherjees, hailing from Kolkata, are die-hard fans of Argentina. Despite Albiceleste drawing 1-1 with Iceland in their group opener with Lionel Messi failing to sparkle, they believe Jorge Sampaoli’s team can go the distance.

“I am an Argentina fan. I have booked tickets for a quarterfinal match, a semifinal and of course the final. If Argentina goes on to lift

During the World Cup, there will be 25 per cent discount for those who will possess a Fan ID (required to watch World Cup games).

There will also be gifts and contests on offers during matches in both the restaurants to celebrate the event.

FIFA World Cup 2018 Russia
FIFA World Cup 2018, Wikimedia Commons.

“We have been waiting for this World Cup. Indians come in large numbers during the World Cup and we wanted these eateries to be a melting point,” he added.

According to Cutting Edge Events, FIFA’s official sales agency in India for the 2018 World Cup, India is amongst the top 10 countries in terms of number of match tickets bought.

Read more about Indian cuisine abroad: Hindoostane Coffee House: London’s First Indian Restaurant.

Prodyut came to Moscow to study engineering and later started working for a pharmaceutical company here before trying his hand in business. Besides running the two restaurants with the help of his wife, he was into the distribution of pharmaceutical products.

“After Russia won the first match of the World Cup, the footfall has gone up considerably. The Indians are also flooding in after the 6-9 p.m. game. That is the time both my restaurants remain full,” Prodyut said.

There are also plans to rope in registered fan clubs of Latin American countries, who will throng the restaurants during matches and then follow it up with after-game parties till the wee hours.

“I did get in touch with some of the fan clubs I had prior idea about. They agreed to come over and celebrate the games at our joints. Those will be gala nights when both eateries will remain open all night for them to enjoy,” Prodyut said.

Watching the World Cup is a dream come true for the couple, Sumana said.

“We want to make the Indians who have come here to witness the spectacle and feel at home too. We always extend a helping hand and since we are from West Bengal, we make special dishes for those who come from Bengal,” she added. (IANS)