New Alzheimer drug

The Food and Drug Administration (FDA) recently approved use of a new drug -- Aduhelm or aducanumab developed by Biogen -- for treating Alzheimer’s disease. 

Three medical experts on an FDA advisory panel resigned from the panel after deciding the drug's effectiveness has not been sufficiently shown or that the drug will do more harm than good. Link.

The financial effect of the approval on Medicare and Medicare Advantage programs and beneficiaries will be huge. Only time will tell how huge. Medicare’s long-standing practice is to make coverage determinations without taking cost into consideration.  This article from the Kaiser Foundation puts an expected price tag on the drug of $56,000 per patient per year. Since the drug will be physician-administered, it will be covered by Medicare Part B, for which Medicare covers 80% of the cost and the patient 20% (up to the annual out-of-pocket maximum of $7,550 for in-network care and $11,300 for combined in-network and out-of-network care in 2021).

"[T]he drug’s approval could trigger hundreds of billions of dollars of new government spending, all without a vote in Congress or indeed any public debate over the drug’s value." "If even one-third of the estimated 6 million people with Alzheimer’s in the United States receives the new treatment, health-care spending could swell by $112 billion annually." (The Atlantic).

Social Security, Medicare, and Medicaid are sacred cows to politicians and more than half of federal government spending. 

Coronavirus – clinical trials #5 (& statistics)

The New York Post reports that a clinical trial has shown another repurposed drug, baricitinib (brand name Olumiant) is effective in reducing mortality rates of Covid patients.  Other sources, such as news-medical.net report the same. 

The articles say baricitinib reduces mortality by two-thirds or 71%. I don't understand how, because 1 - 17/35 = 0.514 is significantly less. Moreover, I have seen other cases where I didn't understand how the number was calculated. 

I have heard of other metrics used for clinical trials, such as odds-ratio and Cox Proportional Hazards-model but have been unable to replicate numbers the story claimed. I couldn't calculate an odds ratio for baricitinib because the news stories do not give all the numbers needed. Anyway, the alleged number in the news story has every time been higher than the number I got using the simple method shown above.

Coronavirus - remdesivir #2

 A Wall Street Journal article says that nearly three dozen attorneys general are attempting a legal act of theft of Gilead's patent on remdesivir. Since the article is behind a paywall, the following are some excerpts.

The attorneys general effectively assert that remdesivir belongs to the government because taxpayers helped fund its development. 

First, Gilead’s scientists are entirely responsible for the invention of remdesivir.

The government didn’t get involved until later, when it teamed up with Gilead to test whether the drug was effective against Ebola. 

Later, Gilead collaborated with academic and government institutions to test remdesivir against coronaviruses like SARS and MERS. But the total government expense for research adjacent to remdesivir, about $70 million, is a fraction of the more than $1 billion Gilead has committed to the drug.