Skip to main content

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recalled in 1961 after being linked to severe birth defects, or Fen-Phen, the "Miracle" weight loss drug that was withdrawn in 1997 for causing pulmonary hypertension, history has shown us that regulatory approval does not mean that a drug or intervention is truly safe.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

Comments

Post a Comment

Popular posts from this blog

Fauci Files Reveal Pfizer Helped Biden Rig 2020 Election

 Pfizer secretly colluded with Joe Biden's team to help him rig the 2020 election against Trump, according to new Fauci documents. In his new book, "On Call," Fauci admits that Albert Bourla, the CEO of Pfizer, called him the night after Biden was declared the winner of the election, to inform him of Pfizer's "Game-changing results" from the rigged mRNA trial. "On November 7, after the absentee ballots were counted, Joe Biden was declared the winner of the presidential election. It was the very next night that Albert Bourla, Pfizer's CEO, called me away from my neighbors' fire pit to inform me about the game-changing results from the Pfizer mRNA vaccine trial. I finally thought we had truly turned a corner in defeating this terrible disease." Today reports: In another interesting tidbit, Fauci discusses Trump's FDA Commissioner Stephen Hahn declaring that he would not go along with the Trump Administration's plan to roll out the vac...
Post a Comment
Read more

Republicans Withdraw $1 Billion From BlackRock Due To Its ESG Policies

  Multiple U.S. states governed by Republicans are withdrawing state funds from BlackRock's management, as they disapprove of the ESG investment policies of the world's top asset manager, the Financial Times reports. In recent weeks, Louisiana, South Carolina, Utah, and Arkansas have announced they would divest funds from... For months now, Republican states have said they would not do business anymore with asset managers who have ESG-aligned investment policies, which, the states say, show that those financial firms are boycotting the oil and gas industry. Texas is leading the campaign against this movement The Lone Star State published a list of financial firms that could be banned from doing business with Texas, its state pension funds, and local governments. https://oilprice.com/Latest-Energy-News/World-News/Republicans-Withdraw-1-Billion-From-BlackRock-Due-To-Its-ESG-Policies.html
Post a Comment
Read more

EU Ambassador & Munich Security Conference Chair Headline Chinese Communist Party Influence Event.

  The Vice Chairman of the Munich Security Conference and a former Ambassador of the European Union to the U.S. headlined an event sponsored by a leading Chinese Communist Party influence group The China-United States Exchange Foundation (CUSEF) CUSEF has been identified by the US government as part of China’s “United Front” which works “to co-opt and neutralize sources of potential opposition to the policies and authority of its ruling Communist Party.” O’Sullivan Director General of the Institute of International and European Affairs Has held a variety of influential positions within the European Union including Chief Operating Officer of the European External Action Service (EEAS) Ruge also has ties to the EU’s military infrastructure Vice Chairman of the Munich Security Conference https://thenationalpulse.com/2022/10/20/eu-amb-and-munich-chair-headline-cusef-webinar/
Post a Comment
Read more