Opinion: Why Zohydro Ban Is A Tough Call

Update 4/15:

The AP reports that a federal judge blocked Massachusetts from banning the powerful new painkiller Zohydro.

U.S. District Court Judge Rya Zobel on Tuesday issued the preliminary injunction after the maker of the drug, Zogenix, said in a lawsuit that the ban ordered by Gov. Deval Patrick was unconstitutional.

Zobel said in issuing the injunction that Massachusetts appears to have overstepped its authority in banning the drug, which had been approved by the U.S. Food and Drug Administration.

Patrick ordered the ban after declaring a public health emergency in light of widespread prescription drug abuse in the state.

The judge said federal law preempted the state’s order.

By Judy Foreman
Guest contributor

U.S. District Court Judge Rya W. Zobel today disappointed anyone who expected her to quickly strike down Gov. Deval Patrick’s ban on the sale of the new pain reliever Zohydro. She declined to rule on the drugmaker’s request to quickly but temporarily lift the ban, and is continuing to consider whether to lift the ban permanently.

Judge Zobel faces a difficult decision but not because Zohydro, as many media reports have said, is more potent than anything else on the market. It’s not, and we’ll get to that in a minute.

(wikimedia commons)

(Wikimedia Commons)

First, the legalities. It should be up to federal health officials, including the U.S. Food and Drug Administration, not governors, to make decisions about the safety (or lack thereof) of drugs. For better or worse, the FDA, after a long 2013 review, and against the vote of its own advisory committee, did approve Zohydro in October of last year.

Legally, and logically, it also made little sense in the first place – except politically — for a governor to focus on one particular drug when the whole class of drugs to which it belongs — opioids, also known as narcotics – is controversial precisely because that whole class of drugs has such a complex mix of risks and benefits.

In truth, Zohydro is probably not the wonder drug that its manufacturer, Zogenix, claims, nor is it the menace that critics assert. The furor over Zohydro is simply the latest example of how difficult it is to balance the legitimate needs of people in chronic pain who need long-acting opioids and the also-legitimate need to protect vulnerable people from getting their hands on drugs they might abuse.

The unique feature of extended-release Zohydro is that it contains the opioid hydrocodone, and only hydrocodone. Other hydrocodone-containing drugs such as Vicodin contain both hydrocodone and acetaminophen (the active ingredient in Tylenol.) Strange as it may seem, it’s the acetaminophen that is often the dose-limiting ingredient because it can cause serious liver toxicity. So, in that sense, a hydrocodone-only pill is a step forward.

Zohydro is likely to lose its unique status soon. Purdue Pharma has just finished Phase 3 trials on its own extended release hydrocodone-only product, which still has to go through the FDA approval process.

A major criticism of Zohydro is that it was approved without having tamper-resistant features built in. Zogenix spokeswoman Catherine O’Connor said in a telephone interview that the company is working on two approaches to tamper-resistance now.

Why the FDA would allow a non-abuse-deterrent form of Zohydro on the market is a mystery to many, among them pharmacologist and neuroscientist June Dahl of the University of Wisconsin.

Dahl, who has studied pain drugs for decades, said in a telephone interview that it’s a good thing to have a hydrocodone-only pain reliever on the market because it gives pain patients another option. But she asks, “Why in the devil did the FDA allow this formulation to get approval? It seems like a disaster waiting to happen.”

On the other hand, it’s not clear how helpful abuse-deterrent forms of opioid pain relievers actually are.

“I would love if we had abuse-deterrent formulations that were actually meaningful and effective at deterring abuse in all instances. We are moving in that direction,” Dr. Margaret Hamburg, the FDA Commissioner, told a senate panel in March. But, she added, “Right now, unfortunately, the technology is poor.”

One problem is that, even when pills are manufactured so that they are harder to chew or crush (which addicts do in order to snort or inject the drug), determined abusers can simply swallow handfuls of the pills to get the high they are looking for.

Another problem is that abuse-deterrent formulations can actually spur some abusers to turn to heroin. That’s what happened when Purdue began marketing an abuse-deterrent form of OxyContin in 2010. It worked — in the narrow sense that, because it turned to a mushy gel when chewed or ground up, it couldn’t be snorted or injected. But an unintended side effect was that frustrated abusers turned to heroin.

In a July, 2012 letter to the New England Journal of Medicine, for instance, researchers from Washington University reported that the percent of drug abusers who chose OxyContin as their primary drug of abuse dropped from 36 percent before the release of the abuse-deterrent form to 13 percent – and their use of heroin almost doubled.

So what are the real risks and benefits of Zohydro? Here’s what FDA spokeswoman Sandy Walsh wrote in answer to that question:

First of all, she stressed that the FDA approved Zohydro because it is a “new option for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatments…are inadequate.”

Unlike the combination hydrocodone products, Zohydro “can be taken without the threat of severe liver damage,” she noted. People who are prescribed Zohydro will probably be those pain patients who are already taking other opioids – in other words, they will be switched to Zohydro. Thus, Walsh wrote, the total number of pain patients taking opioids may not be increased: “We anticipate Zohydro will take a slice of the market away from other opioids, and not expand the opioid market in general.”

As Walsh went on to note in her email, “There are many misperceptions about the potency of Zohydro in the press.” The FDA has been trying to correct those.

In an April 3 interview with TIME magazine, FDA Commissioner Margaret Hamburg, said, “It’s been said that Zohydro is super-potent. That surprises me because the highest dosage unit of Zohydro extended release is lower than the highest dosage unit of all the other available extended release products on a milligram basis…No doubt it’s a powerful drug, and it needs to be used appropriately with the proper oversight. But it’s certainly not the most powerful drug on the marketplace.”

As FDA spokeswoman Walsh explained in her email, “The highest Zohydro strength is five times the highest combination immediate-release hydrocodone strength; whereas the media is reporting 10 times…[the] highest strength of Zohydro is roughly half that of the highest strength OxyContin and extended-release morphines. Media reports have said that hydrocodone is stronger than anything on the market.”

In its own press release, Zogenix notes that a patient taking the 10-milligram Vicodin every four hours will have the same total daily dose of hydrocodone as a person taking the 30-milligram Zohydro every 12 hours. (Zohydro comes in five different doses ranging from 10 to 50 milligrams.)

A bit complicated, isn’t it? But that very complexity is all the more reason to think drug policy questions through carefully and to not rush to panicky, band-aid solutions such as banning certain drugs and not others.

Zohydro is certainly not a perfect pain drug. But it’s probably not the menace it’s portrayed to be, either.

Longtime nationally syndicated health columnist Judy Foreman is the author of “A Nation in Pain — Healing Our Biggest Health Problem.”

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