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Drug Safety Whistleblower Wants to Fix FDA. GTO Says, Good Luck!

The International Herald Tribune profiles Steven Nissen, the Cleveland Clinic scientist best known for his early warnings about the safety of Vioxx, long before the drug was taken off the market. Just a few months ago he sounded the alert about diabetes drug Avandia, and he is now rumored to be eyeing a post at FDA. (In an interview, Nissen recently said, "I want to fix the FDA.") According to the article, "By digging deeply into companies' own clinical trial data information that used to be available only to U.S. drug regulators who did not always mine it as aggressively Nissen is among a new cadre of activist scientists demanding greater vigilance on drug safety."

Which leaves us at GTO wondering, if Nissen can track this information to come up with safety warnings for these drugs, why isn't everyone doing the same thing?

 

The Scan

Tens of Millions Saved

The Associated Press writes that vaccines against COVID-19 saved an estimated 20 million lives in their first year.

Supersized Bacterium

NPR reports that researchers have found and characterized a bacterium that is visible to the naked eye.

Also Subvariants

Moderna says its bivalent SARS-CoV-2 vaccine leads to a strong immune response against Omicron subvariants, the Wall Street Journal reports.

Science Papers Present Gene-Edited Mouse Models of Liver Cancer, Hürthle Cell Carcinoma Analysis

In Science this week: a collection of mouse models of primary liver cancer, and more.