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Drug companies shouldn’t play favorites in granting access to experimental covid-19 treatments

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In the past month, US President Donald Trump and former New Jersey governor Chris Christie were diagnosed with covid-19 and spent time in the hospital, just like tens of thousands of other Americans nearly every day since the pandemic began.

But Trump and Christie were special cases. They received experimental covid-19 treatments that are not readily available to the general public. They have both since recovered and publicly acknowledged that US companies granted them access to drugs still off-limits to the vast majority of Americans with the disease.

Their treatment has generated a lot of conversation about the perception that the rich and famous have priority access to health care. What has received much less attention is whether these two men circumvented the rules to get access to experimental drugs outside clinical trials, and if so, how their actions could affect drug development.

Seriously ill patients with no other options are permitted by law to receive drugs in development before the drugs have been approved by the US Food and Drug Administration. Regulations governing this access are necessarily strict, to protect not just the parties involved but the clinical development process itself.

Allowing people to skirt these regulations could delay or derail that process. Even the perception that rules are being bent this way could raise public doubts about participating in clinical trials. This is problematic in any case, but especially so when the drugs in question are being developed to help stem a pandemic.

What is expanded access?

For decades, drug companies have granted some patients access to investigational products outside clinical trials via a pathway known as expanded access. Historically referred to as “compassionate use,” expanded access permits a patient with a serious or life-threatening condition to try such products as a last-ditch move.

Patients must meet several criteria to qualify for expanded access. There must be no FDA-approved therapies available to the patient; the request for access must be made by a physician, who has determined that the possible benefits outweigh potential risks; the patient must be unable to enroll in a clinical trial; and the company must believe that granting access will not interfere with clinical trials of the product.

Those last two requirements are especially important because the FDA evaluates safety and efficacy data collected during clinical trials to determine whether to approve new treatments, thus making them available to many more patients. It’s already difficult to get enough people to participate in clinical trials. If patients can access experimental drugs without enrolling in one, it will become even harder to collect that critical data. Flouting the letter or spirit of the expanded-access law could seriously harm not only the drug development system, but the public’s trust in it and the public’s health at large.

Trump tested positive for covid-19 on or around September 30. After being discharged from the hospital, he boasted repeatedly that he’d gotten “Regeneron”—that is, he received Regeneron Pharmaceuticals’ investigational antibody cocktail called REGN-COV2 via expanded access. He even said that it cured him.

Christie more recently received an Eli Lilly covid-19 drug via expanded access. It too was a monoclonal antibody cocktail.

We haven’t seen either man’s private medical information, and Trump’s physician has been accused of obfuscating the details of his patient’s covid-19 experience. However, based on what we do know, we doubt that one or both fully met the criteria for expanded access.

We acknowledge that covid-19 was a serious diagnosis for Trump and Christie; as older, obese men, they are among the population for whom the infection has been most lethal. And we presume that the men’s physicians believed the potential benefits of the investigational drugs outweighed the risks for their patients.

We’ll also grant there were no suitable alternative treatments. Dexamethasone, a commonly available steroid, has been shown to lessen some symptoms of the virus, but it’s not a cure-all for covid-19. And despite Trump’s claim earlier this year that hydroxychloroquine, an older drug used to treat malaria, lupus, and rheumatoid arthritis, was a miracle cure, clinical trials have not borne this out.

Of course, there are some clear differences between these two covid-19 patients. Trump is a sitting president while Christie, the former governor of New Jersey, does not currently hold political office, though remains active in politics (Christie helped Trump prepare for the recent presidential debates). However, both VIPs appear to have sidestepped the FDA’s clinical trial requirements. This point bears closer scrutiny than it has received.

Special treatment

Many patients cannot participate in clinical trials for many different reasons. They may not meet a trial’s inclusion criteria—they may be too old or too young, or have comorbidities such as high blood pressure that make them ineligible. Or they may be unable to travel to the trial site.

Trump was treated at Walter Reed National Military Medical Center, which is not listed as a trial site for REGN-COV2. That would have rendered him ineligible for a clinical trial and therefore a suitable candidate for expanded access, as he also met the criterion of having no approved treatment option. Without transparency into his medical condition, we can’t know if he met the Regeneron trial’s criteria regarding illness and hospitalization status.

Christie’s case is much more concerning. He was in a hospital that was participating in the Regeneron trial. According to a report by the trade publication BioCentury that cited an anonymous source, Regeneron, in accordance with FDA regulations, declined Christie’s request for expanded access to REGN-COV2, the product used by Trump, and instead offered Christie a spot in the randomized controlled trial. BioCentury reports that Christie did not want to participate for fear that he might receive a placebo treatment.

Christie certainly was under no obligation to join the trial. But if he was eligible for a trial of an investigational drug, he should not have been able to obtain that drug via expanded access. Regeneron, to its credit, appears to have appropriately refused this.

When Ajay Nirula, VP of Immunology for Eli Lilly, was asked earlier this week at the EmTech MIT conference about how Christie gained access to his own company’s medicine, he said Lilly’s expanded-access program was “generally the path that was pursued here,” but he did not provide further details.

Christie’s fears of receiving a placebo reflect a common but mistaken belief: that trial participants who receive placebos are worse off than patients who get the investigational product. If a trial has a placebo arm, it’s because the safety and efficacy of the drug being tested are unknown. The vast majority of investigational medical products are rejected for FDA approval because they either don’t work or are unsafe. Patients in placebo arms receive the standard medical care for their disease. In a trial testing a drug against a placebo, then, it may be safer for a participant not to receive the drug, which could in fact cause harm.

Christie’s actions as they have been reported imply that anyone who can avoid clinical trials—particularly trials involving a placebo—should do so, and should try to get the investigational drug through expanded access. Such actions stoke public distrust of drug development at a time when clinical trials are crucial to mounting an effective pandemic response. They could also lead to a spike in the number of requests for expanded access, thus increasing the burden on physicians, drug companies, the FDA, and hospitals—all of which may be equipped to handle such requests occasionally but not in volume.

This is about more than just powerful politicians receiving unapproved drugs that are not available to others. It’s also about whether rich, famous people may have worked around a system that exists both to help patients in devastating circumstances and to preserve the system’s ability to help future patients.

Our colleagues have warned about the dangers of “pandemic research exceptionalism” in the context of clinical trials for covid-19 agents. They argue that during desperate times, scientists and regulators shouldn’t relax regulations governing trials but should follow them all the more closely, because trustworthy data is especially important when no treatments are available and there’s intense pressure to develop one. For the same reason, there should be no expanded-access exceptionalism. Regulations should be applied consistently and fairly, no matter who the patient is.

Lisa Kearns is a senior researcher in the Division of Medical Ethics at the NY Grossman School of Medicine and a member of the division’s Working Group on Compassionate Use and Preapproval Access (CUPA). Alison Bateman-House is an assistant professor at the division and a cochair of CUPA.

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What about $30 billion under 30

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Hello and welcome back to Equity, TechCrunch’s venture capital-focused podcast (now on Twitter!), where we unpack the numbers behind the headlines.

We’re back with not an Equity Shot or Dive of Monday, this is just the regular show! So, we got back to our roots by looking at a huge number of early stage rounds. And a few other things that we were just too excited about to not mention.

So from Chris and Danny and Natasha and I, here’s the rundown:

That was a lot, but how could we leave any of it out? We’re back Monday with more!

Equity drops every Monday at 7:00 a.m. PDT and Thursday afternoon as fast as we can get it out, so subscribe to us on Apple PodcastsOvercastSpotify and all the casts.

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Henry picks up cash to be a Lambda School for Latin America

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Latin America’s startup scene has attracted troves of venture investment, lifting highly-valued companies such as Rappi and NuBank into behemoth businesses. Now that the spotlight has arrived, those same startups need more talent than ever before to meet demand.

That’s where one seed-stage Buenos Aires startup wants to help. Henry has created an online computer science school that trains software developers from low-income backgrounds to understand technical skills and get employed. The company was founded by brother-sister duo Luz and Martin Borchardt, as well as Manuel Barna Ferrés, Antonio Tralice and Leonardo Maglia.

The Henry team.

The company claims that there’s an estimated 1 million software engineering job openings in Latin America, but fewer than 100,000 professionals that have training suitable for those roles.

“Higher education is only for 13% of the population in Latin America,” says Martin Borchardt, CEO and co-founder of Henry . “It’s very exclusive, very expensive, and has very low impact skills. So we’re giving these people an opportunity.”

With 90% of graduates coming from no formal higher education background, Henry seeks to help bring more back-end junior developers and full-stack developers into startups. Henry offers a five-month course that goes from Monday to Friday, 9 a.m. to 6 p.m., which focuses on software developer skills. Beyond technical training, Henry gives participants job coaching, resume workshops and up-skilling opportunities post-graduation.

To make the school more affordable, Henry looks to take on the same strategy used by Lambda School, a YC-graduate that has raised over $122 million in known funding: income-share agreements. The set-up would allow for boot camp participants to join the program at zero upfront costs, and then only pay once they get hired at a job.

Lambda School’s ISA terms ask students to pay 17% of their monthly salary for 24 months once they earn $4,167 monthly. The students pay a maximum of $30,000. Henry takes a much smaller slice of the pie, partly because salaries are lower in Latin American than in the United States. Henry asks students to pay 15% of their monthly salary for 24 months once students earn $500 a month.

If a Henry student doesn’t get employed in a job that allows them to make $500 a month within five years after the program completes, they are off the hook for paying back the boot camp.

Henry is also focused on helping more women get into the field of software development. Internally, Henry’s remote team is 20% women, 64% men. The current students reflect the same breakdown.

One issue with coding boot camps is that while it might help a student go from unemployed to employed, the lack of credential and degree might limit career mobility past that first job. For that reason, Henry has created a database of alumni resources, including up-skilling and reskilling opportunities in the latest skill, which will be free of charge for graduates.

Henry needs to execute on job placement to be successful in its field. Currently, more than 80% of students in Henry’s first cohort have found jobs, but it’s too soon in the startups’ trajectory to get a stronger metric on that front. About four Henry graduates have been employed by the startup.

The need for more talent in emerging countries has not gone unnoticed. Microverse, also funded by Y Combinator, is similarly using income-sharing agreements to bring education to the masses in developing countries, including spaces in Latin America. Henry thinks the competitor is approaching the dynamic too broadly.

“They’re focusing on all emerging markets and don’t teach to Spanish speakers,” Borchardt said. Henry, alternatively, focuses on Spanish speakers, over 60% of its market in Latin America.

What if Lambda School, the source of Henry’s inspiration, was to break into Latin America? The founder added that the richly funded company has tried, and failed, to expand into international geographies, including China and Europe, due to fragmentation.

Currently, Henry has graduated 200 students and is working with 600 students across Colombia, Chile, Uruguay and Argentina. It plans to expand into Mexico and to bring on Portuguese instruction.

Now, VCs are giving Henry some cash to do so. After going through Y Combinator’s Summer batch, Henry announced today that it has raised $1.5 million in seed funding in a round led by Accion Venture Lab, Emles Venture Partners and Noveus VC. There were also a number of edtech angel investors from Latin American that participated in the round.

“I love the human interaction within instructors and our staff and students,” Borchardt said. “That is something very powerful of Henry compared to a MOOC. The biggest challenge is how do you scale maintaining those assets that bring you that?”

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Fantasy startup Esports One raises $4M more

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Esports One, a startup bringing the fantasy approach to esports, is announcing that it has raised an additional $4 million in funding.

When I first wrote about Esports One in April, co-founder and COO Sharon Winter described it as the first “all-in-one fantasy platform” in the esports world, allowing you to research players, create fantasy teams and watch games, with an initial focus on the North American and European divisions of League of Legends.

According to the Esports One team, creating this platform required building out a set of data and analytics products, as well as using computer vision technology that can track game activity (and update player stats) without relying on a publisher’s API.

The startup says its user base has been growing by more than 25% month-over-month. It may also have benefited from the pause in professional sports earlier this year, while CEO and co-founder Matt Gunnin told me recently that he also sees fantasy as a way to make video games accessible to a broader audience — he recalled one Esports One user who introduce his sister to League of Legends using the fantasy platform.

“I use the example of growing up and sitting there with my dad, watching a baseball game, he’s telling me everything that’s happening,” Gunnin said. “Now it’s the opposite — parents are sitting and watching their kids.”

Many parents, he suggested, are “never going to pick up a mouse and keyboard and play League of Legends,” but they might play the fantasy version: “That’s an entry point … if we can make it easily accessible to individuals both that are hardcore gamers playing video games and watching League of Legends their entire life, as well as someone who has no idea what’s going on.”

The new funding was led led by XSeed Capital, Eniac Ventures, and Chestnut Street Ventures, bringing Esports One to a total of $7.3 million raised. The company also recently signed a partnership deal with lifestyle company ESL Gaming.

Gunin said the money will allow the company to grow its Bytes virtual currency, which players use to enter contests and buy customizations — starting next year, players will be able to spend real money to purchase Bytes. In addition, it’s working on native iOS and Android apps (Esports One is currently accessible via desktop and mobile web).

Gunnin and his team also plan to develop fantasy competitions for Rainbow Six: Siege, Rocket League, Valorant and Fortnite.

“As a fairly new player in the esports world, we’ve seen immense determination and grit from Matt, Sharon, and the whole Esports One team to grow into a household name, ” said XSeed’s Damon Cronkey in a statement. “I’m excited to be partnering with a company that will deliver new perspectives and features to an evolving industry. We’re eager to see how Esports One grows in 2021.”

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