Good morning. Today we’re covering intentional exposure to COVID, some dazzling lung cancer data, and the future of your office space.
Would you deliberately contract COVID – for science?
The pulse:
In a bid to accelerate COVID vaccine development, scientists are mulling the idea of using human challenge trials: vaccinating people and then deliberately infecting them with COVID to test whether the vaccine actually works.
Tell me more about “human challenge trials.”
In normal vaccine testing, a company vaccinates hundreds or thousands of people and then waits to see whether they contract disease less than the normal population does. It can, however, be quite time-consuming to wait and see how many people get sick – most experts expect this process to take a minimum of 12 – 18 months in the case of COVID.
In human challenge trials, scientists would intentionally infect a small number of vaccinated volunteers with COVID and then examine whether the vaccine offers protection. In theory, such a study could reduce the time it takes for a vaccine to reach the market.
Have human challenge trials been used before?
Human challenge trials have been used for hundreds of years. In fact, the world’s first recognized vaccine was tested when English physician Edward Jenner injected his 8-year old son with cowpox and then exposed him to smallpox to see if he was immune. More recently, challenge trials have been used to evaluate vaccines for the flu, malaria, cholera, and typhoid.
History of use, however, does not mean that human challenge trials are the right thing to do. Experts warn against the ethical concerns of exposing patients to disease, especially a disease like COVID, for which there is limited disease understanding and limited treatment options.
Are people actually willing to inject themselves with COVID?
A lot of people are –1DaySooner.org, a website advocating for the initiation of human challenge trials, has had close to 27,000 volunteers sign up to be part of any potential such trials.
How much will human challenge trials speed up vaccine development?
It’s unclear. 1Daysooner.org presents a graphical timeline in which they show a human challenge trial shaving a few months off the projected time to market. Other experts think that it would take so long to set up a challenge trial that we wouldn’t actually save much time – and we’d put a lot of people at risk in the process.
Bottom line it for me.
Willingly exposing yourself to COVID in the hope that it accelerates vaccine development: noble, foolish, or both?
Source: Stat News.
Lung cancer drug delivers “home run” results
The pulse:
A couple months ago, we reported that large pharma company AstraZeneca had cut short a trial of Tagrisso, their lung cancer drug for patients with a specific genetic mutation called EGFR, due to “overwhelming efficacy.” That efficacy was published today, and it’s really, really good: after a year of treatment, Tagrisso reduces the risk of cancer relapse in patients by 83% over placebo.
How good is 83%?
Numbers as big as 83% are usually not seen in large cancer trials. Roy Herbst, one of the lead physicians on the study, said:
“Results like this are so profound for patients. We set out to show a 30% improvement in disease recurrence. I would have been happy to have seen a 40% or even 60% improvement but to actually show 83% — I almost couldn’t believe it.”
Tell me more about Tagrisso.
Tagrisso is currently approved for patients with lung cancer that expresses a mutated version of a gene called EGFR. Somewhere between 40,000 – 60,000 patients are diagnosed with this type of lung cancer in the U.S. annually. Until now, Tagrisso has been used for patients with metastatic disease and for patients who have failed other therapies. Prior clinical trials have shown that for these patients, Tagrisso delays progression of lung cancer by about 7 months.
In this most recent trial, AstraZeneca was evaluating how effective Tagrisso would be as an add-on therapy for patients who have already had their tumors surgically removed. Notably, the study included patients with early stages of lung cancer that have not yet spread outside of the lungs. This data gives Tagrisso the potential to treat 60,000 more patients globally and expand its sales from an already sizable $3.1B in 2019.
What does this mean for patients?
Tagrisso’s data is fantastic, and is likely to drive more evaluation of EGFR mutations and better outcomes for these patients. That said, the fact that AstraZeneca cut the trial short means that data about overall survival benefit – how much the drug actually improves lifespan – is not available. And at $15,000 a month, Tagrisso is not going to be affordable for everyone.
Bottom line it for me.
This is some of the best data in lung cancer in years.
Rapidfire:
Larry Kramer, an author, essayist, and playwright whose work helped transform AIDS healthy policy in the 1980s and 1990s, died on Wednesday. You can read more about his life here.
A new poll found that 40% of Americans feel more positively about the pharma industry than they did before the pandemic began, mainly due to the industry’s efforts to produce vaccines, treatments, and diagnostic tests.
As Americans slowly return to work, the CDC has recommended a sweeping set of changes to office life that range from barring seating in common areas to discouraging mass transportation when commuting. Most upsettingly to us, they suggest abolishing communal latte makers. Starbucks Frap it is…