Drug Approvals By Regulators Are Often Based On Poor Clinical Data, Researchers Find

Drug approvals by regulators are often based on poor clinical data, researchers find.

Whether it's thalidomide, recalled in 1961 after being linked to severe birth defects, or Fen-Phen, the "Miracle" weight loss drug that was withdrawn in 1997 for causing pulmonary hypertension, history has shown us that regulatory approval does not mean that a drug or intervention is truly safe.

In that study, which was published in the journal BMJ Open, researchers concluded that most of the decisions to approve new drugs, medical devices and procedures are not based on solid clinical data - and it has been that way for at least two decades.

The researchers based this assessment on 400 appraisals made by the U.K. drug regulator the National Institute of Health and Care Excellence, although the Food and Drug Administration in the U.S. does not have the best track record, either, recalling 14,000 drugs in the last 10 years.

Their appraisal involved 384 drugs, along with 14 medical devices, 25 non-pharmaceutical products, five surgical procedures and six other types of therapy.

Speaking on the "Trials with Maya Z" podcast recently, she said that a lot of "Sub-optimal clinical trials providing sub-optimal data" are used to help new treatments and drugs get reviewed by regulators.

Everyone is looking for the next blockbuster drug, and quality can be sacrificed along the way. 

https://www.naturalnews.com/2024-02-27-drug-approvals-regulators-poor-clinical-data.html