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Healthcare organizations around the world depend on US FDA decisions, however, profit, rather than safety, seems to be the primary motivation.
Keywords: healthcare, health, obamacare, donald, trump, fda, fraud, kickback
Date Created/Edited: March 26, 2017
It appears as though our new president is not quite sure how to deal with the United States Food and Drug Administration. Media reports that he has considered many candidates as the new US FDA Commissioner. At one point, he stated he'd shut it down - which is likely a very good idea when we take a look at the effectiveness of this government agency.
Our current United States Food and Drug Administration Commissioner, Dr. Robert Califf, had a career as not much more than a killer drug pusher and mouthpiece for Johnson & Johnson. Obviously more concerned with fat checks from Johnson & Johnson, Dr. Califf pushed Xarelto, a blood thinner with missing safety data and no antidote - the source of over 15,000 lawsuits against Johnson & Johnson.
Dr. Califf replaced Margaret Hamburg who is under investigation for using her position as the United States Food and Drug Administration Commissioner to ignore scientists and put harmful drugs on the market so her husband could make billions of dollars on pharma stock. She's currently under investigation for her role in misapproval of Levaquin and, not surprisingly, was FDA Commissioner when killer Xarelto was approved and put on the market with MISSING SAFETY DATE, a high drop-out rate AND no proof that it actually worked as claimed - not to mention the massively higher price, eh?
Prior to Hamburg we had Dr. Andrew C. von Eschenbach. It seems that, with help of New Jersey Senators Robert Menendex and Frank R. Lautenberg and New Jersey Representatives Frank Pallone, Jr. and Steven R. Rothman, pressure was put on US FDA scientists to approve MenaFlex against the unanimous voice by scientists NOT to approve the knee implant over safety concerns. The FDA did finally pressure Regen Biologics to pull the product, and the ruling was upheld during appeal, but not before an unknown number of people were injured, and Regen Biologics bankrupt - oh, and all those guys made millions on 'large donations' ;o)
Prior to Dr. Andrew C. von Eschenbach we had Lester Mills Crawford who also used his position at the United States Food and Drug Anministration to fill his bank accounts with increased stock value with approvals of products that were potentially harmful and resign, keeping all that money...
In an effort to protect the lives of Americans from a flood of harmful products due to corruption, nine United States Food and Drug Administration scientists joined together and crafted a letter to President Obama in 2009. The letter very clearly stated that management at the United States Food and Drug Administration are corrupt. The letter explained that pressure to approve products scientists deemed unsafe included intimidation, threats, bullying, etc. In closing the letter clearly states: "The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk."
When we look at the flood of lawsuits against Johnson & Johnson for a large variety of products, it's painfully clear the scientists were correct with their warning.
Lawsuits against Johnson & Johnson for products with overstated benefits and understated and/or undisclosed risks have skyrocketed from 20,400 in 2012 when I started this project to over 100,000 today. That number is from their shareholder report, but only lists a few of the products. The shareholder report includes: 2,900 with respect to DePuy ASR™ hips; 9,300 with respect to PINNACLE® hips; 53,400 with respect to pelvic meshes; 15,400 with respect to RISPERDAL®; 15,600 with respect to XARELTO®; 2,400 with respect to JOHNSON'S® Baby Powder. The number of lawsuits against Johnson & Johnson for numerous other products, such as Baby Tylenol, morcellators, knees, spine parts, bone cement, diabetes devices, surgical tools, etc. are NOT included in the shareholder report.
A fact many seem to miss is that decisions by the United States Food and Drug Administration are used by countries other than the United States when considering new healthcare products to be sold in the respective country. This fact is becoming painfully clear as the flood of lawsuits against Johnson & Johnson for numerous products flood in from: the United Kingdom, Canada, Australia, Ireland, Germany, Italy, Belgium, England, Israel, the Netherlands, Scotland and Venezuela.
The warning by nine United States Food and Drug Administration scientists "...the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk." was obviously a gross understatement. This is more accurate:
"The scientific review process at the United States Food and Drug Administration has been corrupted and distorted by FDA managers, placing every person on the planet at risk of harm, disability and/or early, long, slow, painful death."
Considering the incredible number of victims from such a wide variety of products, it may actually be in the best interest of the American people, as well as people around the world, to shut down the United States Food and Drug Administration and supply the nine honest, brave scientists with the resources they need to conduct a consultant-based review of safety and effectiveness of all products by all pharmaceutical companies. They can keep the most effective, least harmful for use; remove the most harmful, least effective and build new products based on the harm/risk ratio set for treatment of disorders.
And provide those results in an ongoing basis to the folks in other countries who might be interested in reducing the flood of victims from known harmful products in their country.
The companies can pay for the service with the money they had previously been spending on kickbacks, bribes, gifts and excessive donations ;o)
Then you can return the $4.5 billion used to support the corrupt and useless United States Food and Drug Administration back to taxpayers, eh? Don't worry, I won't hold my breath on that one...
1. Emily Patterson (2016, March 2). New United States Food and Drug Commissioner Dr. Robert Califf Responsible for KILLER Xarelto. Johnson And Toxin. Retrieved from http://www.johnsonandtoxin.com/califf_fda_commissioner.shtml
2. Emily Patterson (ongoing). Xarelto Files. Johnson And Toxin. Retrieved from http://www.johnsonandtoxin.com/xarelto_files.shtml
3. (20, ). Larry Klayman files lawsuit against Former FDA commissioner Hamburg, Johnson & Johnson and others sued for alleged racketeering and other claims over dangerous drug Levaquin. PRNewsWire. Retrieved from http://www.prnewswire.com/news-releases/larry-klayman-files-lawsuit-against-former-fda-commissioner-hamburg-johnson--johnson-and-others-sued-for-alleged-racketeering-and-other-claims-over-dangerous-drug-levaquin-300206300.html
4. Emily Patterson (2012, May 23). Xarelto by Johnson & Johnson is Likely Another OverHyped Dud. Johnson And Toxin. Retrieved from http://www.johnsonandtoxin.com/xarelto.shtml
5. (20, ). FDA: NJ Politicians Pressured Them Into Approving Unsafe Medical Device - After They Received Large Donations. Crooks and Liars. Retrieved from http://crooksandliars.com/susie-madrak/fda-nj-politicians-pressured-them-app
6. (20, ). FDA Rescinds Approval of Menaflex Knee Replacement Device. About.com. Retrieved from http://www.aboutlawsuits.com/menaflex-knee-implant-approval-revoked-13493/
7. (20, ). Court Upholds FDA in Menaflex Case. MDDI Online. Retrieved from http://www.mddionline.com/article/court-upholds-fda-menaflex-case
8. (20, ). Regen Biologics files for bankruptcy. Mass Device. Retrieved from http://www.massdevice.com/regen-biologics-files-bankruptcy/
9. (20, ). Ex-F.D.A. Chief Pleads Guilty in Stock Case. Mass Device. Retrieved from http://www.nytimes.com/2006/10/18/washington/18fda.html
10. (20, ). Embattled Food and Drug Administration Commissioner Lester Crawford Resigns. Mass Device. Retrieved from http://www.nbcnews.com/id/9455426/ns/health-health_care/t/embattled-fda-chief-lester-crawford-resigns/#.WNgeWn95XIU
11. (20, ). . Mass Device. Retrieved from http://www.johnsonandtoxin.com/data/cert-fda-letter-to-the-president-4-2-09-and-trans-team-1-7-09.pdf
12. (20, ). . Mass Device. Retrieved from http://www.johnsonandtoxin.com/2016_third_quarter_lawsuit_leap.shtml