FDA Reviewer Speaks Out
- Created: 20 August 2014
A drug reviewer Ronald Kavanagh was employed by the FDA as a drug reviewer from1998 to 2008. In a recent interview he discussed how the FDA bypassed or ignored safety issues on a number of major drugs that were approved during his employment.
He pointed out that he felt the safety data was very malleable and the human trails and studies were typically too short and contain too few subjects to get a clear picture of what potential risks they may have. He said he had even seen drugs reviews where the medical safety reviewer completely failed to make evaluation prior to the drugs approval.
The reviewers were told not to question the drug companies and that it was their job to approve drugs. If they wanted to present findings then they would be reprimanded and reassigned.
Scientists have expressed concern over the approval of medical imaging devices such as mammograms and colonscopies which are believed to have high very high levels of radiation.
Other factors highlighted by Mr Kavanagh are the fact that drug companies are not required to include adverse effects if the adverse reaction is
- Below a certain percentage
- Or below the double the rate of the adverse event found in the placebo!! (factor that!)
Another revealed piece of information was that drug companies would provide pieces of information from different sources and at different times, this prevented the reviewer from having all the information together at one time. Kavanagh also said that on another occasion a company clearly stated in a meeting that they had ‘paid for an approval.’
As reviewers they were overloaded with material that could not possible be read in the time frame that they were given. If you did find issues that could turn down a drug, you would be pressured to reverse the decision or the review would be handed to some else.
Drug concerns he had during this time frame were with
Nerve gas—pyridostigmine , this drug was approved by animal studies ONLY.
Paediatric drugs as dosages were only based on adult dosages or sometimes the studies are carried out by overweight children or the trails included too few children to adequately evaluate the risks.
It is known that FDA funding comes from the very drug companies that it evaluates and monitors.
What is being protected here, industry or people?