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I have exposed so many horrific scandals within the FDA that even I thought the agency can't get any worse. I thought wrong!
At the heart of the FDA's rationale for existence is its supposed ability to evaluate findings from human clinical drug trials. The FDA's ultimate decision to approve or reject a new drug is based on how the drug performs in human trials.
If you ever wonder why a drug works so well in clinical trials, but then inflicts lethal side effects (and only mediocre efficacy) after FDA approval, one part of the answer is that the clinical trials themselves are often fraudulent.1-9
In a revelation widely reported by the news media, a crooked clinic helped conduct 170 drug studies for nearly every major pharmaceutical company and routinely falsified data and patient records. The clinic's criminal conduct rendered the findings from the human trials they conducted meaningless. The FDA relied on these fraudulent findings, however, to approve drugs used by tens of millions of Americans.10
FDA Lets Criminals Oversee Clinical Trials
The shocker is that after federal agents raided this clinic and those who perpetrated these illegal acts pleaded guilty to fraud, the FDA did not ban them from participating in additional human clinical drug trials!11
According to federal law, the FDA had five years from the criminal conviction to ban the perpetrators from conducting further drug research. In this case, the FDA did nothing for over four years, and then sent the revocation notice to the wrong address. The result is that those involved in these criminal acts are free to continue conducting human clinical trials.12
When Congress learned of the FDA's gross incompetence, they conducted their usual hearings where FDA officials are subpoenaed to appear before a Congressional oversight committee to explain how such a blatant error could occur.
Congressional investigators found the FDA pays little attention to its responsibilities to ban researchers convicted of fraud and is totally disorganized about carrying out revocation procedures.13
The General Accounting Office reviewed 18 instances of research fraud and found the FDA took between one and 11 years to ban these criminals. FDA negligence enabled those convicted of fraud to conduct human experimentation for years.12,14 Is it any wonder why so many FDA-approved drugs kill their users either from side effects or lack of efficacy?
The Urgent Need for Radical FDA Reform
If radical FDA reform is not enacted, most people reading this article will suffer premature aging and death.
This book Pharmocracy provides a plethora of irrefutable facts that provide Congress with a basis to redically reform the FDA so as to remove its compulsory and incompetent dictatorial power to prevent Americans from accessing safe medications.
References
1. Available at: http://firstclinical.com/journal/2007/0701_Fraud.pdf. Accessed April 8, 2011.
2. Available at: http://www.naturalnews.com/001298.html. Accessed April 8, 2011.
3. Available at: http://www.drugsettlement.com/articles/ketek-linked-liver-failure-drug-company-doctor-convicted-fraud. Accessed April 8, 2011
4. Available at: http://oig.hhs.gov/publications/docs/press/2007/FDAClinicalTrials3.pdf. Accessed April 8, 2011
5. Available at: http://pn.psychiatryonline.org/content/39/13/1.1.full. Accessed April 8, 2011
6. Available at: http://www.biospace.com/news_story.aspx?NewsEntityId=130116. Accessed April 8, 2011
7. Available at: http://blogs.wsj.com/health/2010/01/15/feds-accuse-doc-of-faking-research-on-pfizer-merck-drugs/. Accessed April 8, 2011
8. Available at: http://www.guardian.co.uk/business/2004/jun/03/mentalhealth.medicineandhealth. Accessed April 8, 2011
9. Available at: http://online.wsj.com/article/SB123672510903888207.html?mod=googlenews_wsj. Accessed April 8, 2011
10. Available at: http://www.nytimes.com/1999/05/17/businesss/a-doctor-s-drug-trials-turn-into-fraud.html. Accessed April 8, 2011
11. Available at: http://www.nytimes.com/2009/10/22/health/policy/22fda.html?_r=1. Accessed April 8, 2011
12. Available at: http://www.naturalnews.com/027536_criminals_doctors.html. Accessed April 8, 2011
13. Available at: http://www.nytimes.com/2006/04/24/washington/24fda.html?fta=y. Accessed April 8, 2011
14. Available at: http://online.wsj.com/article/SB125622345164801405.html. Accessed April 8, 2011 |