During The Outbreak: All Sports Are eSports Now

from the vroom-vroom dept

The COVID-19 pandemic sweeping the world, and in many cases shutting it down, has become so pervasive so as to even dominate the headlines here at Techdirt. To say the outbreak has altered our way of life would be a massive understatement. Social distancing, shutdown states, stuck in our homes, jobs reduced and gone; this whole thing has become a nightmare.

And it impacts even areas of our life that we enjoy, but are less important than others, such as sports. Professional and college sports have basically taken an unwanted holiday, shutting down in an effort to partake in killing this virus off. It's been strange for fans like me, who wake up on Saturdays and have to find legit ways to watch sporting events that took place years and years ago as a substitute for live broadcasts. And if you think there aren't a great many people who are starved for live sporting content, you need only look to what is going on in the autoracing world, where it's basically all become eSports now.

We'll start with Formula 1 Racing, which pivoted from its canceled live races into using video games as a substitute, using current and former drivers behind the virtual wheels.

Interestingly, because some drivers are pretty good behind a virtual wheel and others aren’t, the competition will “be configured in such a way to encourage competitive and entertaining racing,” which is a gentle way of leading into the fact rubbish drivers will be given advantages like “reduced vehicle damage, and optional anti-lock brakes and traction control for those less familiar with the game.”

The races are going to be held on the same days as actual races were supposed to go down, which means the first one should be running any minute now (at time of posting), since the Bahrain Grand Prix was meant to be held today.

These races are being broadcast over the internet and a whole bunch of people are watching them. It's somewhat gratifying to see that real drivers driving virtual cars in a game realistic enough to get people to suspend the notion that they're watching video games somewhat has become a thing. All the more cool is how this is helping fans of the sport limp along through this epidemic while still being able to watch a version of the races and racers they love.

But that pales in comparison to what NASCAR is about to pull off. Having created its own ad-hoc race using NASCAR video games and, again, real drivers, the whole thing was watched by enough people that the broadcast channels are going to pick it up and televise the next races.

The first eNASCAR iRacing Pro invitational Series event, held on Sunday, was—like Formula 1's move to video game competition—a chance for both drivers and fans to get some kind of racing fix in these weird and challenging times. In first place was three-time Daytona 500 winner Denny Hamlin, and nearly one million people watched it on Fox, so now a whole season of it, called FOX NASCAR iRACING, is going to take place.

And just to drive the point home that this is all about giving people a sense or simulacrum of their normal Sunday experience, Fox is bringing in the normal television commentators into the virtual "booth", including Jeff Gordon.

To say that this whole episode the past several weeks has been surreal seems like it lacks punch. Still, it's been interesting to watch eSports fill the void for us, helping us try to pantomime normalcy in a world gone mad.

Filed Under: covid-19, esports, pandemic, sports

Public Pressure Works: Gilead Asks FDA To Rescind Orphan Drugs Designation For Possible COVID-19 Treatment

from the good-to-see dept

Earlier this week, we wrote about the sham orphan drug designation that the FDA gave to Gilead Sciences for remdesivir. As we explained, remdesivir was developed with mostly public funds, and Gilead Sciences already held three patents on it, with a fourth one pending. Orphan drugs designations are supposed to be extra incentives for drug makers to target rare diseases. The issue here was that part of the definition of a rare disease under the Orphan Drugs Act is that it has to affect fewer than 200,000 people in the United States. Ridiculously, the law does not take into account the rate at which the disease spreads -- just how many people have it at the time a drug maker requests the designation. Even worse, the law explicitly says that the FDA cannot remove the designation if the affected group later grows to over 200,000.

Over the last few days, anger continued to grow at Gilead and the FDA -- including with the news that the FDA won't even say when Gilead applied for Orphan Drug status, because that's apparently "a commercial secret." Either way, this morning a ton of public interest groups, organized by Public Citizen, sent a letter to Gilead asking it to renounce its claim for orphan drug status:

We were shocked to learn that your company sought a lucrative orphan drug designation from the Food & Drug Administration for remdesivir, one of relatively few medicines being explored as a possible treatment for COVID-19 this year.

This is an unconscionable abuse of a program designed to incentivize research and development for treatments for rare diseases. COVID-19 is anything but a rare disease. Some estimates suggest that half or more of all Americans may ultimately contract the disease.

We are writing to demand you reverse course and renounce your claim to orphan drug designation privileges for remdesivir.

As you know, Gilead was able receive an orphan drug designation only by rushing to file its application while there were fewer than 200,000 COVID-19 U.S. cases.

The United States most likely will surpass 200,000 COVID-19 reported cases in a matter of days. The real number of people suffering with the new coronavirus likely already has passed this mark. Calling COVID-19 a rare disease mocks people’s suffering and exploits a loophole in the law to profiteer off a deadly pandemic.

And here's the crazy thing. It worked!

Almost immediately after that letter was sent, Gilead announced that it has asked the FDA to rescind the designation:

Gilead has submitted a request to the U.S. Food and Drug Administration to rescind the orphan drug designation it was granted for the investigational antiviral remdesivir for the treatment of COVID-19 and is waiving all benefits that accompany the designation. Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation. Recent engagement with regulatory agencies has demonstrated that submissions and review relating to remdesivir for the treatment of COVID-19 are being expedited.

In early March, Gilead sought and was subsequently granted an orphan drug designation for the remdesivir as a potential treatment for COVID-19. Orphan drug designation is granted by the FDA in situations where the disease affects fewer than 200,000 patients in the United States.

The notice tries to give some justification for the orphan designation, suggesting that it would have made approval easier:

Among the benefits of orphan drug designation, this status results in a waiver of the requirement to provide a pediatric study plan prior to the submission of a New Drug Application – a process that can to take up to 210 days to review.

Gilead recognizes the urgent public health needs posed by the COVID-19 pandemic. The company is working to advance the development of remdesivir as quickly as possible, and will provide updates as they become available

So, in the end, public pressure worked, and the right thing was done.

As a side note, I've seen some people point to this article to suggest that because the FDA had only designated remdesivir as an orphan drug for COVID-19, and not yet approved it, that this story was blown out of proportion. This is wrong. The designation almost certainly eventually leads to the approval, and the mere designation creates a massive chilling effect on others working in the space, as it effectively tells them not to go down that path at all. The designation was a big deal, and a terrible scam pulled off by the FDA and Gilead, and it's good to see that Gilead was realizing that it was being seen as a pandemic profiteer and has backed off.

Filed Under: covid-19, exclusivity, fda, greed, orphan drugs, pandemic, patents, public pressure, remdesivir
Companies: gilead sciences

FBI Says It Will Only Accept Snail Mail FOIA Requests Until Further Notice, Due To Coronavirus Concerns

from the and-it's-not-even-going-to-respond-to-those dept

With the Coronavirus grinding everything to a halt (except for stock market losses! [sobs in 401(k)]), it's understandable that public services would be affected as well. The unexpected shift to telecommuting means everything is going to slow down as public and private entities figure out how to still serve customers/citizens while still keeping the spread of the virus to a minimum.

But none of that explains this completely incomprehensible response from the FBI, which appears to be using the virus as a way to become even more tight-fisted with its stash of FOIA-able files. "FOIA terrorist" Jason Leopold reports the FBI is seeking to serve the public in the worst way possible during this national health crisis.

A message posted on the FBI's Freedom of Information Act website Tuesday says:

"Due to the emerging COVID-19 situation, the FBI is not accepting electronic Freedom of Information/Privacy Act requests or sending out electronic responses through the eFOIPA portal at this time. You may still submit a FOIPA request via standard mail. We apologize for this inconvenience and appreciate your understanding."

Left unexplained by the agency is how sending out snail mail -- which could conceivably carry a bit of COVID with it -- is preferable to email requests, which can only infect others if they insist on opening sketchy attachments.

This is also against the law, unless the administration decides it's going to suspend FOIA law until the it's declared safe to act sane again. The regulations governing FOIA responses say all federal agencies must have the capability to "receive requests electronically" either via email or their FOIA portals. It appears the FBI has simply chosen to ignore its online portal and its capability to receive emailed requests.

Even if lower staffing levels might result in slower responses, the agency's virus response shouldn't be to switch off the online portal and direct everyone to another government service that itself might be negatively affected by the virus in the near future.

But there's more to it than this inexplicable explanation for shutting down the internet-friendly side of its FOIA services. Those bothering to send snail mail shouldn't expect responses, either.

Katie Townsend, the legal director for the Reporters Committee for the Freedom of the Press, told BuzzFeed News that in a FOIA case she is litigating, an assistant US attorney filed court papers Tuesday saying the office that handles the FBI's FOIA requests is "closed at least until March 30, 2020 because of the current coronavirus outbreak."

This has been confirmed by other attorneys involved in FOIA litigation with the FBI. The regulation-dodging statement on the FBI's website doesn't inform requesters that the FBI won't be touching any requests for the rest of the month. The FBI -- through its lawyers -- insists this all very logical because FOIA response personnel can't work from home due to security issues. Even if so, encouraging people to climb into an FOIA time machine to take them back before the internet was a thing isn't helping anyone but an agency that would rather not answer FOIA requests at all.

Filed Under: coronavirus, covid-19, fbi, foia, pandemic, transparency

DailyDirt: Tis The Season To Catch The Flu

from the urls-we-dig-up dept

December is a time to celebrate the holidays with family and friends, but it's also when flu season starts ramping up. Several states have already reported an increase in flu activity, and it appears that the predominant strain of flu found in patients who have been hospitalized so far is H1N1 -- the "Swine Flu" that caused a global pandemic in 2009 but is now a human seasonal flu virus. Here are a few links about the flu season, pandemics, and vaccines.

• The flu pandemic of 1918 killed more than 50 million people worldwide. The virus was a bird virus that had, by chance, acquired the ability to travel via coughing and sneezing, which enabled it to infect a person who then spread it others, starting the pandemic. Could an outbreak of that scale and lethality happen again? Possibly, but there are many events that have to come together just the right way for that to occur, and there's no way to predict it.[url]
• Flu season in the Northern Hemisphere starts in October and ends in May, typically peaking in February. In the Southern Hemisphere, flu season goes from May to October and usually peaks in August. But thanks to modern air travel, these complementary flu seasons can easily feed each other.[url]
• Scientists are working towards developing a new kind of flu vaccine -- one that would provide lifetime protection against many flu strains, including ones that haven't even evolved yet. The key to developing such a universal vaccine is to target an area of the flu virus that doesn't change very much, such as the stems of the surface proteins. Trials in mice and other animals have shown promising results, but it could be several years or decades before an effective universal vaccine becomes available for people.[url]

If you'd like to read more awesome and interesting stuff, check out this unrelated (but not entirely random!) Techdirt post via StumbleUpon.

Filed Under: flu, flu season, health, pandemic, vaccine, virus