A two-year investigation conducted by ‘The Lever and the McGraw Centre for Business Journalism‘ uncovered a disturbing pattern within the FDA: In nearly a decade, the agency approved hundreds of prescription drugs without requiring substantial and robust proof of their effectiveness.¹ These findings were based on various evidence, including “government reports, internal FDA documents, investigators’ notes, congressional testimony, court records and more than 100 interviews with researchers, federal officials and patients,” the Children’s Health Defence (“CHD”) reports.² The FDA relied on four essential standards to assess a drug’s effectiveness and safety.  While these criteria don’t confirm “sound scientific evidence,” they do provide the minimum standard that determines drug manufacturers have given “substantial” evidence to back up their claims. These include:

• Control group.  Patients were tested versus a control group that received a placebo treatment or a comparator drug.
• Replication. There must be at least two “well-controlled” trials that also prove the drugs work as they should.
• Blinding.  The subjects and their physicians must not be aware which among the participants are receiving the drug and which ones are in the control group.
• Clinical endpoint.  Instead of relying on surrogate markers like lab results, the studies must show a significant effect on the patients’ survival or function.

However, after an intensive analysis, the reporters found that the majority of the FDA-approved medications failed to meet these basic criteria.

This Searchable Database Allows You to Check if Your Drugs Work: https://www.levernews.com/do-your-drugs-work-a-searchable-database/

As part of the joint investigative report, The Lever and the McGraw Centre created a searchable database¹¹ including all 429 drugs approved by the FDA from January 2013 to December 2022.³ They also provided evidence from the manufacturers on the drugs’ safety and effectiveness, and gave each drug a rating using the basic criteria:¹²

1. https://www.levernews.com/fda-approved-and-ineffective/ ↩︎
2. https://childrenshealthdefense.org/defender/fda-approved-hundreds-drugs-no-evidence-they-work/ ↩︎
3.  The Lever, Do Your Drugs Work? A Searchable Database ↩︎