Apr 19 WHO summary of H5N1 treatment recommendations A study of the feasibility of an intravenous formulation “Today we can satisfy significant additional orders from governments and corporations, and unless demand picks up, Roche will be tailoring its production schedule accordingly,” said William M. Burns, chief executive officer of Roche’s pharma division, in a press release. Plans to cut productionDespite the continuing pandemic threat, demand for Tamiflu seems to be dropping off, Roche executives said at a press briefing today. Eugene Tierney, global head of virology and transplantation for Roche, told reporters the company has so far this year received orders for only 215 million doses, most of which have already been produced. However, he lauded governments that are encouraging businesses to prepare their own pandemic plans. He said corporate Tamifu programs for employees can help ensure that critical goods and services are delivered during a pandemic. Roche said it has received Tamiflu orders from more than 250 corporations, accounting for about 5 million doses. The company said it would maintain stocks of the ingredients it uses to make Tamiflu throughout its supply chain and would maintain close contact with its manufacturing partners so that it could respond quickly to surges in demand. Jan van Koeveringe, head of Roche’s pharma global technical operations, told reporters it would take 4 months to restore production to its current output level. Current and future research activities and collaborations, he said, also include: Apr 26 Roche press release Citing mathematical models that appeared in the medical literature in 2005 and 2006, Reddy said countries could decrease the clinical attack rate of a circulating pandemic virus by boosting their stockpiles to levels that would allow not just treatment of sick patients but also preventive use (postexposure prophylaxis) for their household and other contacts. Government antiviral stockpiles that cover only 20% to 25% of a population may not be enough to mitigate the impact of an influenza pandemic, Reddy said. Reddy said Roche is concerned that many government Tamiflu stockpile programs lack important details such as priority lists of groups to receive the drug, detailed logistical plans for distribution, and clarifications on treatment versus prevention. In response to stockpile demands and the desire of some businesses to supply their employees with Tamiflu, Roche geared up its manufacturing capacity to more than 400 million doses per year. The company, at the request of the US Department of Health and Human Services (HHS), upgraded its US supply chain to utilize US sources for all phases of Tamiflu production and can now produce 80 million doses a year in the United States. “We’ve taken capacity constraints out of the equation now,” said David Reddy, leader of Roche’s pandemic taskforce, at today’s press conference. “The question now is how much do governments want to be prepared for wave one of a pandemic?” Apr 26, 2007 (CIDRAP News) – The Swiss pharmaceutical company Roche announced today it is scaling back production of oseltamivir (Tamiflu) because of waning demand, and simultaneously questioned whether countries stockpiling the drug are buying enough to protect their citizens in the event of an influenza pandemic. According to the modeling studies, Reddy said, stockpiling enough Tamiflu for 57% of a country’s population would allow it to provide enough treatment and postexposure prophylaxis, including family contacts, to lower its clinical attack rate during a pandemic to 22%. Stockpiling enough for 102% of the population would enable a country to expand prophylaxis to other contacts and reduce the clinical attack rate to 13%, he said. Postexposure prophylaxis case studies See also: Preclinical virology studies to characterize how different H5N1 strains respond to Tamiflu Reddy said the same research group, known as the Southeast Asia Influenza Clinical Research Network, also has plans to study long-term prophylaxis for healthcare workers. A 6-week course has already been studied and approved, he said, but the researchers will explore whether 20 weeks of preventive treatment for healthcare workers is safe and effective. Roche questions stockpiling goalsTierney said that among the more than 80 countries stockpiling Tamiflu, coverage plans vary widely. For example, Greece and Brazil plan to buy enough to treat about 5% of their populations, whereas Switzerland, Kuwait, Luxemborg, Australia, and France aim to have enough to treat more than 40% of their populations. The US stockpile plan would cover 25% of the population. Research directionsIn other comments, the company said several studies are under way to clarify how to make optimal use of Tamiflu. For example researchers from Southeast Asia and the United States will soon test whether doubling the standard dosage of Tamiflu will improve patients’ chances of overcoming either the often-deadly H5N1 virus or severe seasonal flu. Monitoring of H5N1 virus resistance to Tamiflu Two events would prompt Roche to restore production to full capacity, van Koevering said: if inventories of key Tamiflu ingredients drop below target levels, or if the WHO raises the pandemic alert level from 3 to 4 (signaling increased human-to-human transmission). Safety profile studies for Tamiflu use in children younger than 1 year. The World Health Organization (WHO) recommends the antiviral drug as the first-line treatment for patients who have H5N1 avian influenza and has advised countries to stockpile it. In its most recent H5N1 treatment update, released last week, the WHO reaffirmed its Tamiflu recommendations. An avian flu registry to collect clinical data on the virus and use of Tamiflu Mar 29 CIDRAP News article “International network to study high-dose Tamiflu”
Nevada state governor Brian Sandoval has signed a bill, dubbed Senate Bill 240, amending the pari-mutuel wagering rules and thus paving the way for esports wagering to be legal in Nevada. The bill is sponsored by Clark County Republican Sen. Becky Harris and has been signed into law by the governor, Sandoval, over the weekend. The Bill, which becomes effective on July 1st, will see pari-mutuel betting systems include competitive gaming. The bill sees “sporting events or other events” added to the “off-track pari-mutuel system” section of the Bill, which thus allows wagers. “Other events” has been added throughout to add to the likes of horse and dog races and general sporting events. Esports remains a buzz word in Las Vegas, with recent plans for the Luxor to house a multi-tiered dedicated esports arena, and Millennial having already opened a 15,000 square foot space in Vegas. The Nevada Gaming Control Board has already allowed esports wagers to be taken – but this bill effectively adopts the approach into legislation. William Hill has previously taken bets on events that have taken place in Vegas, including IEM and DreamHack and it looks as if the trend is set to continue. Nevada, of course, remains tightly regulated and whilst esports wagering may now be in the legislation those wishing to take wager on esports must still adhere to the strict guidelines outlined by the Nevada regulators. The Nevada Gaming Control Board has recently signed a Memorandum of Understanding (“MOU”) with the Esports Integrity Coalition and this is another step that may assist Las Vegas in becoming an “esports hub”. Esports Insider says: The latest move from Nevada goes further to foster a safe environment for legal esports betting. As we, as an industry, still try to leave behind the dark past of skin betting it is vitally important that bodies such as the NGCB, the UKGC and ESIC continue their vigilant work against potential match-fixing and corruption. Esports in its current state arguably still resembles a target but creating a well regulated environment for those who wish to bet is undeniably integral.