Another FDA Failure
By de Andréa
Opinion Editorialist for
‘THE BOTTOM LINE’
Posted October 22, 2019
If you would like to write me direct with a question or a
comment on this or other articles, you can email me at writedeandrea@hotmail.com
Does Ranitidine or the commercial brand Zantac break down
into a human cancer causing carcinogen? YES, but the FDA defended their position
of “it is not a contamination,” but the fundamental problem is that it's an
unstable molecule. Again the FDA has been caught with its pants down.
Zantac, and the generic Ranitidine,
that's now being shelved across the country as I write this article, isn't
necessarily "contaminated" with nitrosodimethylamine (NDMA); rather,
the carcinogen stems from a breakdown of the ranitidine molecule. According to online
pharmacy Valisure. Have you ever noticed that pharmaceuticals advertised on TV this year, are being sued next year, because people are dying from the drug that was previously approved by the FDA?
Those of you that are my regular readers, are likely familiar with my complaint against the criminal organizations of the FDA and the CDC. Touted as pharmaceutical safety oversight departments, they are not only unconstitutional, illegal Federal organizations, but they are next to useless and sometimes dangerous government agencies, especially when they judge a drug to be safe - when it is not.
This particular drug may not be important to you, but it is to me, because I have been taking the drug Ranitidine for the past three years. This, by the way is when it was discovered by a Stanford doctor, and found to cause more than 3,000 times the level of NDMA (a human cancer causing carcinogen) that the FDA set when it had to decide how much NDMA could be tolerated in angiotensin receptor blockers (ARBs).
Note: To date, my doctor at the VA hasn’t
contacted me about the alert.
Recently a company, which performs its own testing on drugs that it carries, alerted the FDA to the ranitidine issues in June of 2019. It then filed a Citizen Petition again in September urging the FDA to pull all ranitidine from the market. That was in June and September, today it’s the end of October and the FDA still’, not only ignores the alert, but defends its previous findings. The problem here, as I see it is a faulty test by the FDA. Read, then you decide.
"The fundamental problem is that it's an unstable molecule," David Light, CEO of Valisure, told MedPage Today. "The drug itself can directly degrade and form, very high levels of nitrosodimethylamine or NDMA a human Cancer causing carcinogen."
The FDA response was: “A protocol that doesn't use elevated temperatures should be deployed instead, and this has revealed lower levels of NDMA in ranitidine” -- although the agency still called those levels "unacceptable."
Again I am not exactly ignorant about what is going on here. It is quite obvious that the FDA has just created multiple conditions until they find one that fits the results they are looking for, in order to approve the drug for use.
Light argued that other studies using other conditions also showed NDMA as a ranitidine breakdown product, including exposure to chlorine (particularly in wastewater treatment plants) and ozone.
"These are conditions that could cause NDMA to form during the standard transit of ranitidine products both by suppliers and individual patients -- a hot car, for example," Light said.
While a "body-temperature" model used in Valisure's ranitidine testing didn't turn up NDMA, another test mimicking the stomach environment yielded 300,000 ng of NDMA from a 150-mg tablet.
That's more than 3,000 times the level the FDA set when it had to decide how much NDMA could be tolerated in angiotensin receptor blockers (ARBs).
William Mitch, PhD, of Stanford University, co-authored a 2016 paper that found an average of 48,000 nanograms of NDMA in 24-hour urinary excretion after participants took a 150-mg ranitidine dose, a 400-fold spike from baseline.
"We don't know if the ranitidine was converted to NDMA in the stomach or in the body (e.g., liver), because we only measured the urine," Mitch said in an email to MedPage Today. "But we suspect some conversion in the body since the levels we were seeing were higher than previous measurements of NDMA in human gastric juice after ranitidine consumption."
Despite the findings of more than three independent studies, the FDA hasn't ordered a recall of ranitidine products. However, other countries -- including Canada, Germany, France, Italy, Switzerland, and Austria -- have done so, and major U.S. retailers including CVS, Walmart, Walgreens, and Rite-Aid have pulled all ranitidine including the commercial brand Zantac from store shelves. Sandoz and Apotex have voluntarily recalled their versions.
"Unfortunately, there's a misunderstanding with some regulatory agencies thinking about this as just contamination, and that does appear to have been the position of the FDA," Light said. "Contamination is almost irrelevant compared with the fundamental instability of this drug."
Valisure launched about a year ago, positioning itself as a pharmacy, a lab, and a wholesaler. Now licensed in 38 states and with a staff of 12 in Yale University's Science Park in New Haven, Connecticut, it analyzes some 2,000 compounds -- mainly generics, and now some brands -- to introduce a level of quality control into the system that Light says hasn’t exist before.
"This is a largely self-reported industry, with very little chemical analysis of products," Light said, noting that many manufacturers are in China and India. "We thought, wouldn't it be great to have chemical analysis at the end of the supply chain where it matters the most, when patients are going to get the drug?"
The carcinogenic breakdown doesn't appear to be a class effect for H2 antagonists, and it doesn't seem to extend to proton pump inhibitors (PPIs), the other major heartburn drug class, Light said.
Valisure tested 10 major H2 antagonists and PPIs, and found only one other drug, nizatidine (Axid), which is less commonly used in the U.S., turned up some NDMA, at levels 70-fold lower than those seen with ranitidine.
Other drugs in the same class, famotidine or cimetidine, didn't generate any NDMA under the high-heat test; nor did the PPIs Omeprazole which is what I now take. (Prilosec) or esomeprazole (Nexium).
Given ranitidine's popularity, physicians are facing questions from patients about whether they should be tossing it from their medicine cabinets. Yeah ya think?
While the FDA hasn't called for patients to stop taking the medication, Joshua Gagne, PharmD, ScD, noted on a Harvard Medical School blog that ranitidine "is only recommended for short-term use."
For patients who have been "using ranitidine for a while, now would be a good time" to determine whether they still need it or if they might switch to another drug, "including other drug classes or a different H2 blocker."
THE BOTTOM LINE: It
is still my opinion based on several studies and an enormous amount of research
that the FDA is more interested in its residual under the table kickbacks
otherwise known as financial incentives or bribes than it is in the safety of
prescription drugs.
This my friend, is your government
protecting you while you sleep your apathetic life away.
Think about it…
Thanks for listening my friend. Now
go do the right thing, pray and fight for truth and freedom.
-
de Andréa
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pass on this article to everyone on your email list. It may be the only chance for your family and
or friends to hear the truth.
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