Brilinta, Big Pharma, Corporate Greed and the FDA

[SorellaLaBefana]

The British Medical Journal reports that Brilinta (ticagrelor)—a drug used to treat people having a heart attack—might have been approved for use over equally effective, cheaper and safer drugs because of data manipulation and flawed (yes, let’s just say *flawed*) FDA review. In the following excerpt, bolding has been added as well as comments [in brackets]

Fresh concerns have emerged about the platelet studies underpinning the FDA approval of ticagrelor, AstraZeneca's multibillion-dollar heart drug. A new BMJ investigation reveals data discrepancies, missing lab readings, and questions about the integrity of the trial process. Notably, key results reported in a major cardiology journal were inaccurately presented, and some study contributors were omitted or denied involvement. With generics on the horizon, critics say these revelations highlight potential dangers, including severe rebound effects and bleeding risks, that were never properly disclosed…

It finds that the "primary endpoint" results (the trial's key measurement) for both clinical trials were inaccurately reported in the leading cardiology journal Circulation, and reveals that more than 60 of 282 readings from platelet machines used in the trials were not present in US Food and Drug Administration (FDA) datasets.

What's more, one active trial investigator never became a study author, while one author told The BMJ he was not involved in the trial, and most investigators, including the principal investigator, were unreachable or declined to be interviewed.

Victor Serebruany, an adjunct faculty member at Johns Hopkins University and ticagrelor's most renowned critic, told The BMJ that "there are episodes of skyrocketing rebound and profound platelet inhibition after ticagrelor making patients prone to thrombosis or bleeding. If doctors had known what happened in these trials, they would never have started using ticagrelor."...

https://www.sciencedaily.com/releases/2025/06/250621233811.htm

This might remind you of the controversial approval of an Alzheimer’s Drug (Aduhelm) in 2021?

Three experts have now resigned from a Food and Drug Administration advisory committee after the agency approved an Alzheimer's drug called Aduhelm [monoclonal anti-beta-amyloid antibody] against the wishes of nearly every member on the panel [since Phase-3 trials gave conflicting and unclear results]…

"Accelerated Approval is not supposed to be the backup that you use when your clinical trial data are not good enough for regular approval," Kesselheim said via Twitter on Monday as the FDA issued its OK for Aduhelm…

The drug will be administered through infusions every four weeks, resulting in a yearly cost of about $56,000, the companies said. That's the list price, which doesn't necessarily reflect the out-of-pocket costs for someone who has insurance and/or Medicare. Preliminary estimates suggest patients' copayments for the drug could cost around $11,500 annually.,,,

https://www.npr.org/2021/06/11/1005567149/3-experts-have-resigned-from-an-fda-committee-over-alzheimers-drug-approval...

Subsequently, Aduhelm was withdrawn from the market in 2024. Apparently cost, unaddressed concerns about brain bleeding and the requirement that a confirmatory trial be undertaken to demonstrate effectiveness made it a poor seller—or, as Biogen put it, simply to "reprioritize its resources" to a newer Alzheimer's monoclonal antibody (Leqembi) that costs only about $26k/year.

Of course, then there is the whole issue of whether or not there is a causative relationship between amyloid plaques and Alzheimer's. That, however, is a story for another day.