STLR Link Roundup – October 27, 2017

Listeria-Based Recall In US and Canada

California-based vegetable supplier Mann Packing has issued a voluntary recall of certain “minimally processed” vegetable and vegetable-containing products from its customers across the US and Canada. According to the company announcement posted on the FDA’s website, the distributor made the decision after the Canadian Food Inspection Agency found “a single positive result” of Listeria monocytogenes in one of their products. All products covered in the recall carried “best if used by” dates of October 11th-20th, and thus far, no cases of illness linked to Mann Packing’s products have been reported.

In 2011, Canada Health, Canadian Food Inspection Agency, and Public Health Agency of Canada jointly published a finalized update to the nation’s 2004 industry guidance, dubbed Policy on Listeria monocytogenes in Ready-to-Eat Foods.  By contrast, in January of this year, the US Food & Drug Administration published an updated version of earlier draft guidance it had published in 2008, but had never finalized.  Whether the Mann Packing recall, which affects familiar national chains like Wal-Mart and Trader Joe’s, encourages the FDA to finalize its update remains to be seen–the deadline for comments on the updated draft was July 17 of this year.  Ultimately, any guidance is just that, as legal obligations for operators of food facilities come from the Food, Drug, and Cosmetic Act and the Food Safety Modernization Act.

California Court Finds Talc-Cancer Link Lacking

Pharmaceutical giant Johnson & Johnson won its appeal of a $417 million jury verdict awarded to a woman who claimed that routine use of J&J’s talc-containing Baby Powder caused her ovarian cancer. The award had been the largest yet against J&J in its ongoing defense of hundreds of lawsuits involving thousands of plaintiffs in state and federal courts.

California Superior Court Judge Maren Nelson reversed the jury’s verdict on multiple grounds, including that the plaintiff had failed to demonstrate by clear and convincing evidence that J&J acted with malice in selling their product despite evidence that regular, prolonged use causes ovarian cancer. Judge Nelson held the evidence shows, at most, that there is “an ongoing debate in the scientific and medical community about whether talc more probably than not causes ovarian cancer and thus [gives] rise to a duty to warn.”

Even if state and federal appeals courts take a different view of the causation issue, there may be a jurisdictional hurdle to clear as well for talc plaintiffs.  J&J had won another talc appeal from a $72 million verdict just days earlier in Missouri.  The Missouri appellate court followed the US Supreme Court’s recent Bristol-Myers Squibb decision, ruling that Missouri courts did not have specific jurisdiction to hear the case, owing to an insufficient connection between the forum and the events underlying the plaintiff’s individual claim.  In both cases, the plaintiff was from out-of-state, and the connection alleged was primarily that the company sold the product in that state, even if not to the plaintiff in the present suit.

The Expanding CRISPR/Cas Toolkit: Base-Editing

The journals Nature and Science published papers this week detailing new variations of the CRISPR/Cas family of gene-editing techniques with significant therapeutic potential.

In the Nature study, researchers from Harvard demonstrated the ability to change the chemical identity of individual DNA base pairs without cutting the DNA strand, like replacing rungs on a ladder without breaking the sides of it. Specifically, their technique converts A-T pairs into G-C pairs, which is significant for two reasons, according to the paper: 1) The opposite mutation—conversion of a G-C pair into an A-T pair—accounts for approximately half of the disease-causing, single-base mutations that have been identified; and 2) while previous studies have demonstrated this technique in RNA, as did the Science study, none had done it with DNA.

That distinction is important for their potential therapeutic applications, as RNA molecules are created from the cell’s DNA. Thus, edits to RNA molecules could eliminate their proximate disease-causing effects, but it wouldn’t prevent the cell’s DNA from continuing to produce the defective version of the RNA.  As a result, for many applications, DNA edits would aim to cure a condition, while RNA edits would function more as treatment.

Base-editing techniques that do not require any slicing and dicing of DNA might be among the most likely candidates to be used first in humans. Proving safety will be an enormous hurdle in gaining FDA approval for use of CRISPR-based gene-editing techniques in humans, and these studies indicate that base-editing is potentially far more reliable, at least for undoing this type of mutation.

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