Author's posts
Does Medicare Draft Decision To Restrict Coverage Of Aduhelm Hold Lessons For Future Launches Of Drugs With No Proven Clinical Benefit?
Despite the decision to restrict coverage of Aduhelm, the Centers for Medicare and Medicaid Services (CMS) is not taking over FDA’s job as arbiter of which drugs ought to be licensed. It is simply doing a different job.
Medicare Proposes Restricting Coverage Of Aduhelm To Alzheimer’s Patients Who Enroll In Clinical Trials
On January 11, Medicare issued a draft memorandum that it will only pay for Aduhelm under the so-called coverage with evidence development (CED) pathway. On one hand, proponents say Medicare can learn whether the drug works in the context of a CED stud…
Pfizer-BioNTech And Moderna mRNA Vaccines Are Not Gene Therapies
Vaccines have saved lives and prevented severe disease, with comparatively few adverse events. But, anti-vaccine groups persistently refer to mRNA vaccines as “experimental gene therapies.” Vaccines that use mRNA technology, however, aren’t gene therap…
Predictions 2022: Covid-19 And Public Health
Covid-19 is not going away any time soon. Even in its aftermath, the U.S. isn’t fully committed to essential building blocks of public health. Yet the public-private partnership has been revived. Perhaps this will form a foundation for future collabora…
Predictions 2022: The Economy, Politics, And Drug Pricing Reform
I predict a sustained economic recovery with diminishing inflation (from its peak), along with midterm results in which Democrats maintain a slim majority in the House and a 50-50 Senate. On drug pricing, a combination of market-driven moves and legisl…
Touting Anti-Parasitics For Covid-19: A Curious Obsession Among Vaccine-Skeptics
It’s problematic when people – often politicians, celebrities, and media folks with no scientific expertise – promote treatments that have no evidence as Covid-19 remedies. It’s especially harmful when juxtaposed with adamant rejection of vaccines, whi…
The Omicron Variant May Be Less Severe, But Higher Transmissibility May Cancel Out The Effect, Especially In The U.S.
Preliminary data suggest that the Omicron variant is less severe than its predecessor, Delta. But, Omicron’s much higher transmissibility may cancel out the effect. Furthermore, the U.S. will likely suffer more from the Omicron wave than other wealthy,…
In The Face Of An Imminent Omicron Wave, Public Health Officials Seek To Optimize Timing Of Covid-19 Vaccine Boosters
Public health officials are seeking to optimize timing of a Covid-19 vaccine boosters. Specifically, they’re trying to figure out what’s optimal in terms of spacing between the second and third doses of vaccine. Differences in scheduling across countri…
Senator Ron Johnson Now Peddles Mouthwash As A Covid-19 Treatment: His Advice Exemplifies The Rising Tide Of Anti-Science
Ron Johnson promotes Covid-19 conspiracy theories and the use of drugs that have shown no evidence that they are effective. His latest foray into quackery – promotion of Listerine as a Covid-19 treatment – encapsulates the rising tide of anti-science t…
As Medicare Decides Whether To Pay For Aduhelm To Treat Alzheimer’s Disease, Its Future Is Uncertain
CMS has embarked on a national coverage determination process, in which it’s examining the clinical safety and benefit profile of Aduhelm and other anti beta amyloid monoclonal antibodies in Alzheimer’s patients. As CMS decides whether to pay for Aduhe…
