As another likely corrupt FDA Commissioner, Dr. Margaret Hamburg, leaves, another likely corrupt FDA Commissioner, Dr. Robert Califf, appointed. Oh joy.
Keywords: xarelto, FDA, commissioner, risk, johnson & johnson, johnson and johnson, bayer, califf
Date Created/Edited: March 2, 2016
Here we go again. The project leader for Johnson & Johnson killer drug Xarelto is now the Commissioner of the United States Food and Drug Administration. Wonderful, eh? Dr. Robert Califf replaces likely corrupt Margaret Hamburg whose investment guru husband made billions when she pushed another killer drug, Levaquin, through the FDA without any concern for consumer safety.
'Doctor' Califf was project leader for Johnson & Johnson Xarelto. Somehow, with Dr. Hamburg as FDA Commissioner, Xarelto was pushed through the FDA with missing safety data, the trial had a 12% drop-out rate and three deaths. Wonder how much Dr. Hamburg's husband made on that deal? Obviously enough to retire on, since Dr. Hamburg publicized her resignation in February of 2015. Under her less-than-watchful eye, over 51 healthcare products were pushed through the FDA. Goodies such as Xarelto, Levaquin, transvaginal mesh, Essure and other, obviously harmful products to increase, I mean serve those with, 'unmet medical needs'. Sounds like a Johnson & Johnson CEO Gorsky slogan, eh? Obviously her comments come straight from a Johnson & Johnson marketing plan.
Back to Dr. Califf...
I noticed that the write-up regarding Dr. Califf posted on the National Institutes of Health web site makes no mention of any specific projects headed by Dr. Califf. It simply claims he's an expert in the field, went to school, yada-yada-yada. The write-up makes no mention of Dr. Califf's work with failed medicated heart stents or Xarelto. Hm. Wonder why? Oh, because both medicated stents and Xarelto are failed projects that killed people, have Johnson & Johnson facing numerous lawsuits from harm and death. Yeh, can see why that shouldn't be publicized, eh?
While the approval department of the United States Food and Drug Administration is obviously corrupt, at least the safety end of the organization appears minimally intact. The FDA did send out warning letters regarding flaws in Xarelto trials in 2005 and 2006, but Johnson & Johnson and Bayer simply ignored them. The drug was passed through in record time, the money was (and still is) pouring in like blood from the victims of the drug's main side effect, internal hemorrage. Xarelto is still on the market, increasing risk of the silent killer of internal hemorrhage.
Johnson & Johnson attempted to get Xarelto pushed through to treat stent thrombosis. They wanted to use the victims from Cypher stents to increase demand and profit from another product. While that sounds good in theory, it's probably best that people who will likely require surgery to remove or replace the defective device, don't take a drug that will make surgery impossible due to risk of hemorrage caused by Xarelto. Because, without any consideration for victims, I mean patients, Xarelto was passed through the FDA without an antidote, the blood-thinning effects of Xarelto cannot be turned off. Thankfully, the FDA panel said NO. Not once, but all three times Johnson & Johnson tried to push this garbage through.
So, we have an FDA Commissioner who obviously has no concern for the health, safety and well-being of patients replacing an FDA Commissioner who obviously had no concern for the health, safety and well-being of patients.
The most frightening part, the US Senate approved this killer drug project leader 89 to 4, with the rest abstaining or unable to vote. The four who voted against Califf as new FDA Commissioner were: Joe Manchin, III (D - WV), Edward J. Markey (D - MA), Richard Blumenthal (D - CT) and Kelly Ayotte (R - NH). Although on the US Senate HELP Committee, Senator Sanders did not vote due to his presidential campaign. Supposedly, he stated he would have voted against approving Dr. Robert Califf. The next act of this corrupt three ring circus, the New England Journal of Medicine is a bit pissed that they were mislead into supporting the approval of Dr. Robert Califf's Xarelto project. This could get interesting. Killing people, lying and withholding information from the FDA to get a drug approved is one thing. But it seems as though screwing with the reputation of the world's most prestigious medical journals may actually have more consequences than harming, and even killing, people around the world.
Hopefully, we will see an investigation into what Califf knew and when. Likely, we'll get nothing more than a lot of marketing baloney. But as head of US FDA with a reputation of hiding safety data, ignoring FDA warnings and promoting a drug to compensate for the harm caused by a device approved 89-4, it seems the health and safety of the American people, and people around the world, is the furthest thing from at least 89 of our senators minds, eh?
1. 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
2. Chris Newmarker (2016, February 8). Former FDA Commissioner, J&J Targeted in Federal Lawsuit. QMed. Retrieved from http://www.qmed.com/news/former-fda-commissioner-jj-targeted-federal-lawsuit?cid=sm.qmed.site.qmedsocial&hootPostID=274e0ae283f928abd7add1129a5a5ca9
3. Toni Clarke (2015, February 5). U.S. FDA Commissioner Margaret Hamburg to step down. Reuters. Retrieved from http://www.reuters.com/article/us-fda-hamburg-resignation-exclusive-idUSKBN0L90GT20150205
4. Staff Writer (2015, December 16). U.S. FDA Commissioner Margaret Hamburg to step down. National Institutes of Health. Retrieved from http://www.nih.gov/precision-medicine-initiative-cohort-program/robert-m-califf-md-macc
5. Ed Silverman (2015, December 7). J&J blood thinner under review for trial overseen by FDA nominee Califf Stat News. Retrieved from http://www.statnews.com/pharmalot/2015/12/07/fda-xarelto-robert-califf-drug/
6. Barbara J. Lassens (2005, October 4). WARNING LETTER United States Food and Drug Administration. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2005/ucm075594.htm
7. Barbara J. Cassens (2006, November 29). WARNING LETTER United States Food and Drug Administration. Retrieved from http://www.fda.gov/iceci/enforcementactions/warningletters/2006/ucm076188.htm
8. AA Bavry, DJ Kumbhani, TJ Helton, and DL Bhatt (2005). What is the risk of stent thrombosis associated with the use of paclitaxel-eluting stents for percutaneous coronary intervention: a meta-analysis National Institutes of Health. Retrieved from http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0022694/
9. Thomas F. Lüscher, MD; Jan Steffel, MD; Franz R. Eberli, MD; Michael Joner, MD; Gaku Nakazawa, MD; Felix C. Tanner, MD; Renu Virmani, MD (2007). Drug-Eluting Stent and Coronary Thrombosis American Heart Association. Retrieved from http://circ.ahajournals.org/content/115/8/1051.long
10. Emily Patterson (2014, September 14). Johnson & Johnson Xarelto, False Marketing, Lawsuits and FDA Says THREE TIMES, "NO EXPANDED USES!" Johnson and Toxin. Retrieved from http://www.johnsonandtoxin.com/xarelto_continued.shtml
11. Mary Clare Jalonick and Matthew Perrone (2016, March). Senate confirms Robert Califf as head of FDA NBC. Retrieved from http://www.nbc-2.com/story/31304240/senate-confirms-robert-califf-as-head-of-fda
12. Katie Thomas (2016, March 1). Document Claims Drug Makers Deceived a Top Medical Journal New York Times. Retrieved from http://www.nytimes.com/2016/03/02/business/document-claims-drug-makers-deceived-a-top-medical-journal.html?smid=tw-share&_r=0