State Attorneys General to FDA: What Were You Thinking When You Approved Powerful New Painkiller?

<a href="http://en.wikipedia.org/wiki/File:Ritalin-SR-20mg-1000x1000.jpg">Wikimedia</a>

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Last month, Mother Jones reported that the Food and Drug Administration had approved a powerful new painkiller called Zohydro over the objections of its advisory board, which voted 11-2 against approving the drug. Now Attorneys General from 28 states (and the US territory of Guam) have asked the FDA to reconsider its approval of Zohydro. In a letter to the agency, the AGs raise many of the same concerns that the advisory panel did, noting that the drug lacks adequate safeguards to prevent it from being abused and could exacerbate America’s epidemic of painkiller deaths. Here’s an excerpt from the AGs letter, which was dated December 10:

State Attorneys General do not want a repeat of the recent past when potent prescription painkilling drugs entered the market without abuse-deterrent qualities and without clear guidance on how they were to be prescribed. This created an environment whereby our nation witnessed a vicious cycle of overzealous pharmaceutical sales, doctors over-prescribing the narcotics, and patients tampering with these drugs, ultimately resulting in a nationwide prescription drug epidemic claiming thousands of lives.

Zohydro, which is made by a company called Zogenix, is five to ten times stronger than Vicodin, making it very similar in potency to OxyContin, a widely abused prescription drug that has contributed to the tens of thousands of painkiller-related deaths in the United States. OxyContin, however, now includes a gel that prevents the drug from being crushed and snorted. Zohydro was approved without that measure. Zogenix has entered into a $750,000 agreement with a Montreal-based company, Altus Formulation Inc, to help make the drug abuse-deterrent, but it’s unclear whether the formula will be ready by the time Zohydro hits the market in a few months.

The Attorneys General don’t think that’s sufficient. “We hope that the FDA either reconsiders its approval of Zohydro ER, or sets a rigorous timeline for Zohydro ER to be reformulated to be abuse-deterrent while working with other federal agencies to impose restrictions on how Zohydro ER can be marketed and prescribed,” they wrote in their letter.

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WHO DOESN’T LOVE A POSITIVE STORY—OR TWO?

“Great journalism really does make a difference in this world: it can even save kids.”

That’s what a civil rights lawyer wrote to Julia Lurie, the day after her major investigation into a psychiatric hospital chain that uses foster children as “cash cows” published, letting her know he was using her findings that same day in a hearing to keep a child out of one of the facilities we investigated.

That’s awesome. As is the fact that Julia, who spent a full year reporting this challenging story, promptly heard from a Senate committee that will use her work in their own investigation of Universal Health Services. There’s no doubt her revelations will continue to have a big impact in the months and years to come.

Like another story about Mother Jones’ real-world impact.

This one, a multiyear investigation, published in 2021, exposed conditions in sugar work camps in the Dominican Republic owned by Central Romana—the conglomerate behind brands like C&H and Domino, whose product ends up in our Hershey bars and other sweets. A year ago, the Biden administration banned sugar imports from Central Romana. And just recently, we learned of a previously undisclosed investigation from the Department of Homeland Security, looking into working conditions at Central Romana. How big of a deal is this?

“This could be the first time a corporation would be held criminally liable for forced labor in their own supply chains,” according to a retired special agent we talked to.

Wow.

And it is only because Mother Jones is funded primarily by donations from readers that we can mount ambitious, yearlong—or more—investigations like these two stories that are making waves.

About that: It’s unfathomably hard in the news business right now, and we came up about $28,000 short during our recent fall fundraising campaign. We simply have to make that up soon to avoid falling further behind than can be made up for, or needing to somehow trim $1 million from our budget, like happened last year.

If you can, please support the reporting you get from Mother Jones—that exists to make a difference, not a profit—with a donation of any amount today. We need more donations than normal to come in from this specific blurb to help close our funding gap before it gets any bigger.

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