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By Rady Ananda
To clean up its drugs that are contaminated with genotoxic ingredients (which are also carcinogenic), Big Pharma may deploy lab-created, nanosized, polymer-based scavengers.
But is the cure any safer?
New research explains that:
A variety of chemical compounds, intermediates, and reagents are used during the process of synthesizing active pharmaceutical ingredients (APIs). Some of these chemicals, intermediates, and reagents, as well as byproducts of synthetic processes, can have toxic properties and be present as impurities at low levels in the API or final drug formulation....
The kinetics of acrolein scavenging in the presence of the API iodixanol and the scavenging capacity of resins were demonstrated in this paper.
They found a nanopolymer so efficient it cleans up 97.8% of acrolein without eating the active pharmaceutical components.
Yum… drugs with nanobots.
“Pharmaceutical genotoxic impurities may induce genetic mutations, chromosomal breaks, or chromosomal rearrangements, and have the potential to cause cancer in human,” lead researcher Ecevit Yilmaz told In-PharmaTechnologist. “Therefore, exposure to even low levels of such impurities present in the final API may be of significant toxicological concern.”
Research began in earnest after the European Medicines Agency issued its Guideline on the Limits of Genotoxic Impurities in 2006, which set the limit at 1.5 microgram/day under the Threshold of Toxicological Concern (TTC):
A TTC value of 1.5 μg/day intake of a genotoxic impurity is considered to be associated with an acceptable risk (excess cancer risk of <1 in 100,000 over a lifetime) for most pharmaceuticals.
The US Food and Drug Administration followed suit in 2008.
Some nanopolymer scavengers are more or less selective in their activity, the team discovered, based on polymer structure. “Less cross-linked ones showed an ‘undesired high level of nonspecific binding to the API’,” meaning they readily eat the good properties of the drugs, and who knows what else.
In a 2008 study, mesoporous silica nanoparticles (MSNs) were also found to “restore damaged cell membranes and ameilorate abnormal mitochondrial behavior induced by” genotoxins (like acrolein). “MSNs modified with drug/polymer constructs provide significant neuroprotection to cells damaged by a usually lethal exposure to acrolein.”
Safety questions for nano-agents remain, however. Because of the size, a whole new set of health hazards are raised. Does this technology trade one set of hazards for another?
Last December, a group led by the International Center for Technology Assessment filed suit against the FDA over untested, unlabeled nanomaterials added to our food, cosmetics and drug supplies. Represented by the Center for Food Safety (CFS), the litigation forced the FDA into making some changes to its nanotech policy.
CFS explained that under the new policy, “FDA acknowledged that there are differences between nanomaterials and their bulk counterparts, and that nanomaterials have potential new risks and may require new testing. However, the agency declined to enact mandatory regulations at this time.”
George Kimbrell, CFS Attorney, provides this background:
Nanotechnology is a powerful new set of technologies for observing, taking apart and reconstructing nature at the atomic and molecular level. Despite already being commercially available, nanomaterials in sunscreens, cosmetics, foods and food contact substances are unlabeled and largely untested for their human health effects. Existing research raises red flags, indicating that nanomaterials have the ability to enter the bloodstream through contact with the skin, ingestion and inhalation, as well as move in the natural environment once discarded.
Not only that, nanosize particles easily cross the blood-brain barrier and placental walls. From my January piece:
Though the ICTA lawsuit demanded a recall until nanomaterials are labeled and their effects tested for safety, the only real change the six-year fight made is that the FDA now admits that size matters. After pushing the issue this long, perhaps a different legal strategy is now needed to protect the public from dangerous substances the FDA is not willing to control.
We can expect some industry-sponsored toxicity studies on lab-created, nanosized, polymer-based scavengers used to clean up genotoxins in pharmaceuticals that we will ingest.
We can also expect, like with genetic engineering and nanofoods, no US federal agency will require labeling.
Meanwhile, you can support the movement to “Label GMOs” by wearing the slogan. Shirt sales also support my work.
Until April 5, 2013 the 1984 American science fiction-horror film, directed by John Carpenter could be streamed or downloaded from a number of websites. They Live (Full movie) was in the playlist below created by Buddy Huggins.
These days you can’t swing a cat or open your mailbox without being hit by a flood of emails about the memorials, tributes, condolences, and donation sites for the victims of these tragedies that the conspiracy theorists say were created -- not right after the event, but right before the event.
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