South Korea sticks to flu vaccine plan despite safety fears after 13 deaths

South Korean health authorities said they found no direct links between the recent deaths and the flu vaccines administered as part of an inoculation effort in the country. (Kim Hong-Ji/Reuters) South Korean officials refused to suspend a seasonal influenza inoculation effort on Thursday, despite growing calls for a halt, including an appeal from a key group of doctors, after the deaths of at least 13 of those vaccinated. Health authorities said they found no direct links between the deaths and the vaccines. At least 11 of the 13 dead, including a 17-year-old boy, were part of a campaign to inoculate 19 million teenagers and senior citizens for free, the Korea Disease Control and Prevention Agency (KDCA) said. "The number of deaths has increased, but our team sees low possibility that the deaths resulted from the shots," the agency's director, Jeong Eun-kyeong, told Parliament. South Korea ordered a fifth more flu vaccines this year to ward off what it calls a "twindemic," or the prospect that people with flu develop coronavirus complications and overburden hospitals in winter. "I understand and regret that people are concerned about the vaccine," said Health Minister Park Neung-hoo said, who confirmed the free program would go ahead. "We're looking into the causes but will again thoroughly examine the entire process in which various government agencies are involved, from production to distribution." Vaccine providers include domestic firms such as GC Pharma, SK Bioscience, Korea Vaccine and Boryung Biopharma, a unit of Boryung Pharm, along with France's Sanofi. They supply both the free program and paid services that together aim to vaccinate about 30 million of a population of 52 million. Of the 13 who died, five received products from SK Bioscience, three from Boryung, two each from GC Pharma and Korea Vaccine and one from Sanofi. All four domestic firms declined to comment, while Sanofi did not immediately reply to requests for comment. It was not immediately clear if any of the vaccines made in South Korea were exported, or if those supplied by Sanofi were also being used elsewhere. Medical association calls for pause The Korean Medical Association, an influential grouping of doctors, urged the government to halt all inoculation programs for now, to allay public concerns and ensure the vaccines were safe. Kim Chong-in, leader of the main opposition People Power party, wanted the program halted until the causes of the deaths were verified. But health authorities have said a preliminary investigation into six deaths found no direct link to the vaccines, with no toxic substances uncovered. KDCA data on Thursday showed at least seven of the nine people it investigated had underlying conditions. The free program has proved controversial since it began last month. The launch had been suspended for three weeks after the discovery that about five million doses were kept at room temperature rather than being refrigerated, as required. Officials said 8.3 million people had been inoculated since the program resumed on Oct. 13, with about 350 cases of adverse reactions reported. A separate paid program allows buyers to pick from a larger pool of firms that make free vaccines and others. The most deaths in South Korea linked to seasonal flu vaccinations was six in 2005, the Yonhap news agency said. Officials have said comparisons to previous years are tough, since more people are taking the vaccine this year. Kim Myung-suk, 65, is among a growing number of South Koreans who decided to pay for a vaccine of their choice, despite being eligible for a free dose. "Though just a few people died so far, the number is growing and that makes me uneasy," she told Reuters in the capital, Seoul. "So I'm getting a shot somewhere else and will pay for it."

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Lack of antidotes called 'serious ethical dilemma' for COVID-19 vaccine challenge trial

A nurse prepares to administer a COVID-19 vaccine candidate to a volunteer at a clinic in London in August. Medical ethics question whether having an effective treatment at the ready after deliberately infecting volunteers is a must in human challenge trials. (Kirsty Wigglesworth/AP Photo) UK scientists seeking approval to deliberately infect healthy people with COVID-19 in trials must first convince ethics specialists that, among other things, they have potential "rescue therapies" or antidotes to halt the disease. The problem is that, for the novel coronavirus, there is still no effective treatment or cure. That means, for now, that the best scientists planning the so-called human challenge studies can offer is Gilead's remdesivir — an antiviral drug that was found in a large trial to have no impact on COVID-19 death rates. Chris Chiu, a scientist at Imperial College London co-leading the COVID-19 challenge experiments, said the plan was to give remdesivir to infected volunteers based on a "strong belief" it will be effective if given in the very earliest stages of disease. Some ethics and medicine experts said that posed problems. "As an effective rescue therapy does not yet exist for SARS-CoV2, there is a serious ethical dilemma ... to address here," said Stephen Griffin, an associate professor in the school of medicine at Britain's Leeds University. WATCH | The challenges of vaccine challenge trials: Human challenge trials could make finding a COVID-19 vaccine faster, but the controversial approach involves exposing volunteers to the virus to see if a potential vaccine works. The National’s Andrew Chang finds out more about this process and the people volunteering to be test subjects. 9:01 Other specialists said the lack of antidotes or rescue therapies was only one of several risks the research team would have to minimize, and trial volunteers would have to accept, if the studies are to gain ethical approval. Plans to reduce those risks include picking the most robust, healthy, young volunteers to be infected, and using the bare minimum amount of the coronavirus to infect them with COVID-19. Second Opinion Could risky human challenge studies help find a vaccine sooner? Dominic Wilkinson, a professor of medical ethics at Oxford university, said that, while desirable, having an effective treatment at the ready after deliberately infecting volunteers was "not essential for the ethics of such a trial." "The ethical necessity of these trials, and of any trial, is that you assess the risks, you minimize the risks, and you communicate the risks," he told Reuters. "It's not the case that you have a situation where there are no risks."  Risk to public trust in medicine? Human challenge trials are not new. Scientists have used them for decades to learn more detail about — and develop treatments and vaccines against — several other diseases such as malaria, flu, typhoid and cholera. "Generally with such trials in the past, they were done when you had a specific treatment," said Margaret Harris, a spokeswoman for the World Health Organization (WHO), when asked about the planned UK trials using the novel coronavirus. "You must ensure that everybody involved understands exactly what is at stake ... and ensure informed consent is rigorous — that they really do understand all the risks," she said. Interactive How close are we to a vaccine for COVID-19? Ohid Yaqub, a science policy expert at Britain's University of Sussex, pointed to WHO guidelines on the issue, which among other things say human challenge trials "might be considered when the disease an organism causes has an acute onset, can be readily and objectively detected, and existing efficacious treatments ... can be administered ... to prevent significant morbidity, and eliminate mortality." Yaqub warned of a risk to public trust in science and medicine if these criteria are ignored or skimmed over, adding: "There needs to be wider consultation about undertaking such studies." He noted that selecting a small number of low-risk participants would mean "fatality, hospitalization or long-term symptoms are extremely unlikely scenarios," but added: "Even their remote possibility threatens trust in research and vaccines more than necessary, because public engagement on this issue has been limited." 

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OxyContin maker Purdue reaches plea deal in opioid probe

Wednesday's settlement in the U.S. is the highest-profile display yet of the federal government seeking to hold a major drugmaker responsible for an opioid addiction and overdose crisis linked to more than 400,000 deaths in the U.S. country since 1999. (Toby Talbot/The Associated Press) Purdue Pharma LP agreed to plead guilty to criminal charges over the handling of its prescription opioid OxyContin in a deal with U.S. prosecutors that effectively sidestepped paying billions of dollars in penalties and stopped short of criminally charging its executives or wealthy Sackler family owners. In a far-reaching agreement unveiled on Wednesday, Purdue formally admitted to criminal conduct related to distribution of its painkillers and agreed to pay $225 million US to resolve U.S. Justice Department investigations. Prosecutors imposed significant penalties exceeding $8 billion against Purdue though the lion's share will go largely unpaid. Purdue agreed to pay $225 million toward a $2 billion criminal forfeiture, with the Justice Department foregoing the rest if the company completes a bankruptcy reorganization dissolving itself and shifting assets to a "public benefit company" or similar entity that steers the unpaid portion to thousands of U.S. communities suing it over the opioid crisis. A $3.54 billion criminal fine and $2.8 billion civil penalty are likely to receive cents on the dollar as they compete with trillions of dollars of other claims from those communities and other creditors in Purdue's bankruptcy proceedings, according to court documents and people familiar with the matter. Sacklers pay civil penalty over false claims Members of the billionaire Sackler family who own Purdue agreed to pay a separate $225 million civil penalty for allegedly causing false claims for OxyContin to be made to government healthcare programs such as Medicare, according to court records. Neither the Sacklers nor any Purdue executives were criminally charged. The agreement does not release any individuals associated with Purdue from potential criminal liability. A separate Justice Department criminal investigation scrutinizing individuals is ongoing, according to a person familiar with the matter. Purdue conspired to engage in criminal conduct over the years that kept medically questionable prescriptions of its opioids flowing, prosecutors said. The Stamford, Conn.-based company has agreed to plead guilty to three felonies, two of them violations of a federal anti-kickback law and another charge of defrauding the U.S. and violating the Food, Drug and Cosmetic Act. Representatives for Purdue, its Sackler family owners and the Justice Department had no immediate comment or did not immediately respond to requests. Opposition from lawmakers The settlement had already come under fire before its unveiling from Democrats on Capitol Hill, who called for Purdue and its owners to face more severe consequences for their alleged roles in the opioid crisis, criticism that followed Reuters reporting details of the looming agreement. Dozens of state attorneys general, meanwhile, oppose a plan that would essentially put government litigants in charge of a restructured company continuing to sell OxyContin. Purdue reaped more than $30 billion from sales of OxyContin over the years, enriching Sackler family members while funnelling illegal kickbacks to doctors and pharmacies, U.S. and state officials have alleged. The cases against Purdue and the Sacklers reflect an attempt by officials to hold accountable alleged perpetrators of an epidemic that has claimed the lives of more than 400,000 people since 1999, prompting the Trump administration to declare it a public health emergency. Purdue's misconduct included paying illegal kickbacks to doctors and to a vendor called Practice Fusion that created a software alert designed to push the drugmaker's opioids on physicians, prosecutors said. Practice Fusion earlier this year entered a deferred prosecution agreement and admitted that it received kickbacks from an opioid company, which Reuters reported was Purdue. Restructuring into public benefit company not certain Purdue also ignored doctors suspected of improperly prescribing opioids that were flagged by its internal controls and failed to report OxyContin prescriptions from these physicians to the Drug Enforcement Administration as legally required, officials said. Purdue, which filed for bankruptcy protection last year under an onslaught of litigation, has proposed settling thousands of lawsuits in a deal it values at more than $10 billion. That is contingent on donations of opioid reversal and addiction treatment medications it has under development and a $3 billion cash contribution from the Sacklers. The Sacklers would cede control of Purdue. The part of that plan reshaping Purdue as a public benefit company is no longer assured, said people familiar with the matter. Attorneys general from two dozen states and Washington, D.C., last week said it would improperly entangle them with a restructured Purdue's continued OxyContin sales while they attempt to hold alleged perpetrators of the opioid crisis accountable. Purdue asked its bankruptcy judge on Wednesday to approve the plea agreement, including the $225 million payment it owes.

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Remdesivir has little effect on hospital stay or mortality in COVID-19 patients, WHO study finds

Gilead Sciences Inc.'s remdesivir had little or no effect on COVID-19 patients' length of hospital stay or chances of survival, a clinical trial by the World Health Organization (WHO) has found. The antiviral medication, among the first to be used as a treatment for COVID-19, was one of the drugs recently used to treat U.S. President Donald Trump's coronavirus infection. The results are from WHO's "solidarity" trial, which evaluated the effects of four potential drug regimens, including remdesivir, hydroxychloroquine, anti-HIV drug combination lopinavir/ritonavir and interferon, in 11,266 adult patients across more than 30 countries. The study found the regimens appeared to have little or no effect on 28-day mortality or the length of the in-hospital course among patients hospitalized with COVID-19, the WHO said on Thursday. The results of the trial are yet to be reviewed and were uploaded on the preprint server medRxiv.  Earlier this month, data from a U.S. study of remdesivir by Gilead, the company that developed the drug, showed the treatment cut COVID-19 recovery time by five days compared with patients who got a placebo in a trial that involved 1,062 patients. "The emerging [WHO] data appears inconsistent, with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of remdesivir," Gilead told Reuters. "We are concerned the data from this open-label global trial has not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design." Second Opinion Drug strategies to fight COVID-19 move beyond guesses WHO chief scientist Soumya Swaminathan said on Wednesday that during the study, hydroxychloroquine and lopinavir/ritonavir were stopped in June after they proved ineffective, but other trials continued in more than 500 hospitals and 30 countries. "We're looking at what's next. We're looking at monoclonal antibodies, we're looking at immunomodulators and some of the newer anti-viral drugs that have been developed in the last few months," Swaminathan said. Remdesivir received emergency use authorization from the U.S. Food and Drug Administration on May 1, and has been authorized for use in several countries.

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