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The most important news in healthcare: Friday, May 1st
Happy Friday. On the docket today: a coronavirus drug for faster recovery, a new blood test helps diagnose cancer earlier, and we answer a reader question on vaccine timelines.
Rapid Start
The NIH has launched a $1.5 billion “Shark-Tank” like initiative to raise money for Covid-19 testing, through which researchers can appeal for funding and be matched with business experts who can bring the product to fruition. If anyone was wondering, Barbara Corcoran loves the idea, and for that reason, she’s out.
For the first time since 1998, global poverty is on the rise. The long-term impacts of financial destitution could leave hundreds of millions of people at risk for serious health conditions long after Covid-19 passes.
Trikafta, the cystic fibrosis drug made by Vertex pharmaceuticals, generated $895 million in its first full quarter on the market. The drug can be used for up to 90% of patients with the otherwise lethal congenital disease, but only if they can find a way to pay its $311,503 annual price.
Coronavirus drug improves recovery time for patients
The pulse:
Remdesivir, a medication for the treatment of COVID-19, improved recovery time for hospitalized patients by 31% in a recent trial conducted by the National Institutes of Health.
Remind me what remdesivir is.
Remdesivir is an antiviral drug produced by Gilead, a company well-known for making drugs for viruses like HIV and Hepatitis C. Remdesivir failed to have an impact on its initial target, the Ebola outbreak, in the mid-2010s, but was revived after showing promise in lab tests against the coronavirus.
Importantly, remdesivir is an intravenously administered drug, meaning that its use is largely limited to the hospital setting.
How well does it work?
Remdesivir fights the virus and helps hospitalized patients recover faster, but it’s not a cure. The drug was able to reduce recovery time for hospitalized patients from 15 days to 11 days.
The public has been on a remdesivir rollercoaster for weeks now. Conflicting and incomplete data readouts have vacillated experts between “it works great!” to “it has no impact.” The latest study, however, is thorough in a way that others have not been: it reaches the gold standard of being a randomized, placebo-controlled trial.
Beyond recovery rate, the study suggests that remdesivir can reduce death rates. 8.0% of patients receiving remdesivir died, compared to 11.6% of patients receiving placebo. This result, however, did not reach the cutoff for statistical significance.
Why does this matter?
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has said that remdesivir “doesn’t seem like a knockout 100 percent,” but that “it is a very important proof of concept, because what it has proven is that a drug can block this virus.”
What comes next?
The FDA will grant remdesivir an emergency authorization for distribution in the U.S. Gilead CEO Daniel O’Day has said the company is rushing to increase manufacturing, with 140,000 treatment courses expected by the end of July, and “several million” expected by the end of the year. Gilead has decided to donate its entire existing supply of the drug and has promised that price will not be an issue for patients.
Bottom line it for me.
This is promising news: a drug can work against the coronavirus. Remdesivir alone is not going to end the pandemic, but it is going to help make the burden more manageable, and it provides a scientific template for other manufacturers to use when fighting the virus.
Source: McGill University
Blood test promises earlier cancer detection
The pulse:
Researchers have announced positive results for CancerSEEK, a technology that screens blood tests to detect early-stage cancer.
How does the test work?
Cancerous tumors shed small amounts of unique DNA and proteins into the bloodstream. CancerSEEK, manufactured by Thrive Earlier Detection, screens patient blood tests to detect these molecules and drive earlier cancer diagnosis. The life-saving potential of early diagnosis can not be overstated. In lung cancer, for example, 80% of patients will survive for at least a year if diagnosed at the earliest stage compared to around 15% of people diagnosed with the most advanced stage of disease.
I’ve heard about miracle blood tests before...
We’re all a bit wary of Theranos-like claims, but Thrive has been forthright in admitting their test is by no means perfect. CancerSEEK on its own has a sensitivity of 27.1%, which is pretty low.
Sensitivity?
Here’s your annual Sensitivity Training: a test’s sensitivity is its ability to correctly identify patients with the disease. CancerSEEK was able to correctly identify 26 of 96 women with cancer in a large screening study of 10,000 patients.
How does that compare to other established screening tests?
Mammograms have a sensitivity of about 87% for detecting breast cancer while colonoscopy has a sensitivity of around 90% for detecting colorectal cancer. In comparison, CancerSEEK doesn’t look so hot. However, in 65% of cases, CancerSEEK detected tumors at an early stage -- before the disease had spread. Further, adding on CancerSEEK to standard clinical assessment (including consideration of clinical symptoms) doubled overall cancer detection rates from 25% to 52%.
Bottom line it for me.
Blood tests are exciting, but data show that CancerSEEK is not quite up to the mark yet in terms of reliable cancer screening. As the technology improves, CancerSEEK could provide a valuable supplement to standard clinical practice.
Reader question
Jon from Stamford asks:
On Tuesday, you mentioned that the Oxford vaccine makers think they may have a million doses ready by September. That would be a record for vaccine manufacture speed -- by years! Why is everyone so optimistic about how quickly they can make this vaccine?
It’s a great point: typical vaccine development and manufacture can take more than a decade, and our record for building a vaccine from scratch is roughly four years. The timelines involved with the coronavirus incorporate what the National Academy of Sciences called ‘pandemic speed:’ the fast-tracking, and sometimes skipping, of scientific protocols to move things along quicker.
Most vaccines are tested in phases, starting with a Phase 1 on just a few patients and moving up to a Phase 3 that may include thousands of patients. Coronavirus manufacturers are combining these phases: teams like the Oxford group are moving to Phase 3 without waiting on results in smaller-scale tests. Manufacturers are also working to speed up the production of vaccine factories, which usually take five years to build, by repurposing old facilities even before trial results are released. It also helps that we have a scientific head start: research on the SARS and MERS epidemics gave us an understanding of other coronaviruses that are up to 80% identical to SARS-Cov-2, the virus that causes Covid-19.
Still, September is really soon. Even if a million vaccines are ready by then, they’ll likely be distributed to healthcare workers and other essential workers first. There’s a long queue for the vaccine, and the general population should not expect it to receive it any time in 2020.
The downside of all this speed is that there are fewer of the normal checks to ensure a vaccine is safe and working properly. There’s a fine line to balance between rigorous safety and ‘pandemic speed.’
Thanks for reading, and enjoy the weekend. Share and subscribe to Morning Pulse below!