Controversy Over ALS Drug
Read about the controversy over a new drug that is supposed to treat ALS and how retina scans can be used to predict risk of heart disease
FDA Approval of New ALS Drug is Not Without Controversy
On September 30, the U.S. FDA approved a new drug for the treatment of the fatal disease ALS. Early results show that the drug, which will be called Relyvrio, can extend the lifespan of ALS patients for up to six months. Relyvrio, a combination of two existing drugs, is manufactured by Amylyx Pharmaceuticals and will be available in the market as soon as the end of October.
Despite optimism about the drug from patients, the FDA decision to approve Relyvrio has been controversial. For approval, the FDA usually requires either two mid-size independent studies or one large study with outstandingly positive results. Relyvrio is backed by a single study of only 137 patients. For this reason, the FDA’s advisory committee, in March, concluded that the drug could not be approved based on the study. For most drugs, this type of FDA decision would require new studies before returning to ask for approval. Relyvrio was different. The ALS Association submitted a petition with over 50,000 signatures and 13,000 emails asking the organization to reconsider their decision. Dr. Billy Dunn, the director of the FDA’s Office of Neuroscience, encouraged the committee to exercise “flexibility”. In September, the panel reversed its decision and voted for approval, citing the drug’s minimal side effects and valuable benefits.
The exact mechanism for how Relyvrio works is still unknown. Scientists at Amylyx postulate that the drug protects the nerve cells that ALS damages, slowing the progression of the disease down. While extending life for only six months may not seem very long, most people don’t survive for more than 5 years after being diagnosed with ALS. A founder of Amylyx noted that, since Relyvrio is a combination of two drugs, many patients have already been self-medicating by buying the ingredients on their own, paying more than $11,000 a month for one of the ingredients. By making Relyvrio clinically available, these patients won’t have to take these steps. The results of a larger study, called the “PHOENIX” study, is set to be released in 2024.
Amylyx has set the list price of Relyvrio at $158,000 a year. While that price may seem high, Amylyx has indicated that they are ensuring the copay for the drug will be $0 for patients. So while the price is high, it won’t be borne by patients. There are two other FDA-approved ALS medications, Riluzole (<$10,000 a year) and Edavarone ($171,000 a year) which both slow down the progression of the disease. Amylyx officials expect patients to take Relyvrio with the other drugs.
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Retina Scans Might Help AI Predict Heart Disease
The eye is among the few parts of the human body that can be studied in a non-invasive way. The eyes have a rich bed of arteries and veins that maintain blood supply. These vessels can be studied to understand overall blood flow and risk of heart disease.
Researchers at the St George Medical Hospital which is a part of University of London recently published a study wherein 95000 retina scans were used to study risk of heart disease. The researchers used an AI program called Quartz which analyzes the twists and turns and the width of the blood vessels behind the retina to evaluate risk of heart disease.
Quartz was able to do so with about 70-80% accuracy and was comparable to the Framingham model which is a model commonly used to predict risk of heart disease. The model needs blood pressure and blood glucose values in addition to some lifestyle data to make a prediction. Quartz is a comparatively less invasive way to look for cardiac disease as it does not need blood glucose levels which often require a blood draw. Additionally, retina scans can be taken during routine eye exams and therefore Quartz can be used to reach more people.
Overall, AI driven imaging for predicting heart disease can become a useful tool to reach a large number of patients. It is a good way to understand the overall risk of a population to cardiac disease and can help inform patients that might need further investigation to evaluate risk of cardiac disease.
Featured Fake News
Graphic Warning***
So this post has been circulating among “pure bloods,” a term some unvaccinated people are using to refer to themselves. We can dig deeper into that at some other point but returning to the video in this tweet, this reaction is not from a COVID-19 vaccine!
Based on the comments to this tweet, it seems like many of these so called “pure bloods” have yet to realize that.
The woman in this video is Emily Herbert and she was diagnosed with Stevens-Johnson Syndrome (SJS). This is an extremely rare skin reaction to certain medications. She actually needs some support at this time and has a GoFund me running which explains her condition and her circumstances. You can check that out and contribute here!
Unfortunately, because this tweet is only heavily implying that the video is of a vaccine adverse reaction, it is unlikely to be labeled as fake news. This means it is even more important that if you know someone who may have watched this video and believed it, you forward them this fake news article!
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