It's Deja Vu all over again

Wednesday, March 12, 2014 | 0

Zohydro is in the news yet again. This month the new medication will become available. Its manufacturer says it will market this only to a select few physicians whose experience with pain will assure their discretion and restraint in distributing this strong painkiller.

In November, I noted the approval of this new opioid formulation, and in December, I wrote when more than half the nation’s attorneys general wrote to the U.S. Food and Drug Administration urging that the approval receive greater scrutiny and perhaps reconsideration (Zohydro in the News Again).

Well, as Yogi Berra once said, “its déjà vu all over again.” Zohydro is back in the news at the end of February. Now, an “activist” group is questioning the Food and Drug Administration and has released a letter it sent to the FDA in late February. The group is called “Fed Up!” and their points are interesting.

They note that Zohydro is being marketed in the “midst of a severe drug addiction epidemic.” They note that Zohydro “will kill people as soon as it is released.” Dr. Andrew Kolodny calls it “a whopping dose of hydrocodone packed in an easy-to-crush capsule.” Drug overdoses killed 38,329 Americans in 2010, the 11th straight year in which a new record was set. People are dying; more each year.

Other Zohydro criticisms are focused on the strength of the new formulation. They note that it is about 10 times stronger than Vicodin. They note that a two-capsule Zohydro overdose may be fatal, and that one pill could be fatal to a child.

The manufacturer claims that Zohydro is safer than other opioids because it does not contain the acetaminophen (commonly referred to as Tylenol) that has been linked to liver damage. Some opium painkillers (Vicodin, Vicodin ES, Vicodin HP, Anexsia, Lortab, Lorcet, Lorcet Plus, Norco, Zydone) are composites that include Tylenol. The Zohydro pill that is 10 times stronger than Vicodin, easily crushed to speed absorption, and free of any anti-addictive precautions is safer for the public because it does not contain Tylenol? The Zohydro, which could be fatal to a child in a single dose, is safer for the public because it does not contain Tylenol?

The manufacturer, Zogenix, disputes the contention that Zohydro is up to 10 times more powerful than existing formulations of opium. They also contend that within three years, a version of Zohydro will be available with the "abuse-deterrent formulation," that is the anti-addictive efforts common today in other opioids. With anti-addictive measures and anti-abuse measures on existing opioids, people are dying. For three years, Zohydro will be on the market without such precautions. Will drug deaths continue?

Medpagetoday.com recently ran an online survey asking if "Zohydro approval (was) the most dangerous decision the FDA has ever made." On Tuesday, the response was about 60% "yes."

"Fed Up" is not alone. On March 3, 2014, Senator Charles Schumer joined the chorus. "It is baffling that at the same time policymakers and law enforcement officials are waging a war on the growing prescription drug crisis, we are essentially rolling out the welcome mat to a new, more powerful, and easily abused super-drug," Schumer said in a statement, according to medpagetoday.

He is the third U.S. Senator in a week to weigh-in against the approval of Zohydro. In February, Senators Joe Manchin (D-W.Va.) and David Vitter (R-La.) voiced concerns in a letter to a medical school that is tied to the approval process.

So, to recap, the Food and Drug Administration had Zohydro evaluated by its own team of experts. That team recommended against approval. The FDA overruled its own team and approved the drug. It will enter the market without anti-addictive and anti-abuse precautions common to other opioids.

Deaths from opioids have increased dramatically in the first decade of the 21st century. Opioids are a problem in this country. They are destroying and ending lives. The government that is supposed to protect people has overruled its own team of experts and approved Zohydro. Unless the calls of "Fed Up," various states' attorneys general, these Senators and a variety of news outlets are answered, Zohydro becomes a reality in the marketplace in March.

Time will tell if it is as dangerous as critics assert.

David Langham is deputy chief judge of the Florida Office of Judges of Workers' Compensation Claims. This column was reprinted with his permission from his Florida Workers' Comp Adjudication blog.