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    Japan’s PM pushes his country’s Avigan drug as treatment for coronavirus despite no evidence it works and admitting it has side effects ‘the same as thalidomide’

    • Shinzo Abe said he wants drug approved for use against COVID-19 by end of May
    • Avigan (favipiravir) and has been used in flu outbreaks and against Ebola
    • Approved in 2014, favipiravir blocks the ability of a virus to replicate inside a cell
    • However, it has been shown in animal studies to affect foetal development   
    • Here’s how to help people impacted by Covid-19

    Japan‘s Prime Minister is pushing his country’s Avigan drug as a treatment for coronavirus despite no evidence it works and admitting it has side effects ‘the same as thalidomide.’

    Shinzo Abe said on Monday he wanted the drug approved for use against COVID-19 by the end of the month despite conceding it had side effects which caused birth defects.

    Avigan is the brand name for favipiravir and has been used in flu outbreaks and the treatment of Ebola. Approved for use in Japan in 2014, favipiravir works by blocking the ability of a virus to replicate inside a cell. 

    However, it has been shown in animal studies to affect foetal development, meaning it is not given to pregnant women, and some doctors say they would not recommend it for children or adolescents.

    Shinzo Abe said on Monday he wanted the drug approved for use against COVID-19 by the end of the month despite conceding it had side effects which caused birth defects.

    Avigan is the brand name for favipiravir and has been used in flu outbreaks and the treatment of Ebola. Approved for use in Japan in 2014, favipiravir works by blocking the ability of a virus to replicate inside a cell

    Avigan is the brand name for favipiravir and has been used in flu outbreaks and the treatment of Ebola. Approved for use in Japan in 2014, favipiravir works by blocking the ability of a virus to replicate inside a cell

    And experts are increasingly concerned by Abe’s promotion of the drug. He has backed the drug to the tune of $130million to treble an existing stockpile and has even offered to provide it to other countries for free.

    THE THALIDOMIDE DISASTER

    Thalidomide was once a household name, but in the 1950s and 1960s, many women lost their pregnancies or gave birth to babies with missing or malformed limbs after taking the drug.

    Thalidomide first appeared in west Germany in 1957 where it was prescribed as a sort of cure-all for anxiety, insomnia, upset stomach and ‘tension.’   

    It soon found its niche in the treatment of morning sickness, especially nausea. It quickly became an over-the-counter staple. 

    But it took hardly any time at all for its dangers to become clear.  

    Almost as soon as the drug became widespread in West Germany, between 5,000 and 7,000 babies were born with malformed legs and arms, a condition called phocomelia.

    Some had no arms or legs at all. Others had extremely shortened limbs, with misshapen hands or feet, or under-developed body parts that looked more like flippers. 

    Another 100,000 babies were born with the same condition around the world. Just 40 percent of the West German babies and 50 percent of those born in other countries survived. 

    In the UK, 2,000 so-called thalidomide babies were born between 1957 and the early 1960s.  

    Thousands of women lost their pregnancies in the late 1950s and early 1960s, a phenomenon also attributed to the drug.  

    On April 7 the PM told a news conference: ‘Avigan has already been administered in more than 120 cases and we are receiving reports that it is effective in alleviating symptoms of the novel coronavirus.

    ‘We intend to expand to the greatest possible extent its administration to patients wishing to take it. … To make that possible, we will increase our stockpile of Avigan to three times the current level, enough to treat two million people.’ 

    However, without studies to corroborate Abe’s hopes, there is only anecdotal evidence to support his claims it can be used to treat the coronavirus. 

    Masaya Yamato, chief of infectious diseases at Rinku General Medical Center in Osaka, told The New York Times: ‘I’m not saying this medicine doesn’t work. I’m saying there’s still no proof that it works.’ 

    It is not apparent why Abe is such a vocal proponent of Avigan, although some Japanese newspapers have noted his friendship with the drug manufacturer’s CEO.

    Abe and Fujifilm’s chief executive, Shigetaka Komori, have often played rounds of golf and dined together. 

    In February, Fujifilm was the only company invited to attend a government meeting on an international response to the contagion, the NYT reported. 

    In a presentation, the company noted the Chinese government was preparing to approve their drug for emergency use. The Chinese patent on Avigan expired in 2019 and if Japan was not fast enough they could lose a lucrative market. 

    In early March, chief cabinet secretary, Yoshihide Suga, told reporters that Abe’s relationship with Komori had ‘ absolutely no connection’ to the PM’s hopes for the medicine. 

    Some doctors began trying favipiravir to treat coronavirus patients early on, reasoning that its anti-viral properties would be applicable.

    Tablets of Avigan, a drug approved as an anti-influenza drug in Japan, developed and manufactured by Japanese drug maker Fujifilm Toyama Chemical

    Tablets of Avigan, a drug approved as an anti-influenza drug in Japan, developed and manufactured by Japanese drug maker Fujifilm Toyama Chemical

    Some initial results suggested the drug could help shorten recovery time for patients, with China’s ministry of science and technology hailing it as yielding ‘very good clinical results’.

    There are currently around five clinical trials ongoing in countries including the US, Italy and Japan, where Fujifilm announced it would be testing the drug’s efficacy on a group of 100 patients through until the end of June.

    The Japan study will involve administering the drug for up to 14 days to patients between 20 and 74 with mild pneumonia.

    Gaetan Burgio, a geneticist at Australian National University’s College of Health and Medicine, said the trials would be looking at a variety of factors.

    They include clinical outcomes – meaning effects on fever, cough, oxygenation, recovery time and time spent in hospital – as well as how quickly the virus clears the system, along with x-rays or CT scans for pneumonia.

    ‘If we see a significant reduction in clinical outcome and lower viral load from the favipiravir group, this would be a good sign for a larger-scale clinical trial,’ he told AFP. 

    While doctors have already been experimenting with favipiravir for treating coronavirus patients, these trials will be conducted according to rigorous guidelines intended to ensure the drug is safe and effective across a broad range of patients.

    Japanese bar workers watch a public TV showing Abe speaking at a televised news conference on Monday at Kabukicho, Tokyo's popular entertainment district

    Japanese bar workers watch a public TV showing Abe speaking at a televised news conference on Monday at Kabukicho, Tokyo’s popular entertainment district

    ‘Smaller studies have been reported but it’s hard to draw conclusions from these as patient numbers are small and the trials often don’t compare versus (a regime of) best supportive care and placebo, more often to another drug,’ said Stephen Griffin, a virologist at the University of Leeds.

    ‘The big trials should be segregated according to disease severity and will compare to placebo.’ 

    Scientists are studying a wide variety of drugs for possible treatment of coronavirus patients, including remdesivir, another antiviral.

    One study of the two drugs as a treatment for coronavirus found favipiravir was only effective at relatively high concentrations, with remdesivir considered a better option, possibly in part due to the way coronaviruses replicate compared to other viruses, said Griffin.

    But remdesivir is not yet licenced anywhere in the world and has to be administered intravenously via a drip, whereas favipiravir is approved in several countries and can be taken orally as a pill.

    Japan has heavily backed the drug, asking Fujifilm to ramp up production for use at home and offering to supply it for free to dozens of countries that have put in requests. 

    Fujifilm’s Japan and US trials will run until the end of June, with other data coming in from trials in Italy and elsewhere. Additional information will also be available from so-called compassionate use of the drug by doctors offering it to patients in non-study settings where other medication is not working.

    But Burgio cautioned against high hopes.

    ‘There are to date over 300 clinical trials underway for COVID-19. The expectations are very high for a miracle drug!’

    ‘Let’s wait and see. However, rather than drugs, the best treatment against COVID-19 for now is social isolation, wash our hands and stay at home.’ 

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