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[ Opinion ] [ Science and Tech ]

Naloxone: life saver? or money maker?

By Jason Smith

At the mouth of the Black River in northeastern Ohio, Reverend Tim Williams and his wife, co-pastor Deena Williams, prepare their 11 a.m. sermon, like they do every Sunday.

Greater Victory Christian Ministries, a staple of Lorain, Ohio, begins with worship music. They always begin with worship music, allowing, as they put it, “the spirit of God to flow through the music into the parishioners.”

Music is followed by prayer. Followed by music. Followed by more prayer. Finally, it’s time for the sermon. For the message. Divinely inspired, from God’s lips to our ears.

Today’s message: How to administer Naloxone to reverse the effects of an opiate overdose.

“At the end of the service, people will get a hands-on demonstration on how to assemble their Narcan kits,” Williams told The Morning Journal. “They will leave here with everything they need to respond in case an overdose occurs. Within their kit, there is information that will tell them how they can get a refill.”

Did you catch that? A refill. Administering to one overdose may not be enough.

A nation-wide debate over the use of Naloxone has emerged as opiate addiction, according to the Centers for Disease Control (CDC), reached epidemic proportions. According to a CDC report from June, 2014, there were 259 million prescriptions written for opioid medications in 2012.

In some states, there were more opiate prescriptions than there were people.

The government’s solution to this drug epidemic — a drug called Naloxone.

With one opioid-related death occurring every half-hour in the United States, the FDA is making it easier to get these delivery systems of Naloxone into the hands of as many as people as possible.

You know. Just in case.

Available since 1971, Naloxone is the drug administered for overdoses of heroin or prescription drugs like hydrocodone, oxycodone, fentanyl, and morphine. When taken in excess, these drugs relax the body to the point of respiratory failure. The body is so relaxed that it forgets to breathe. Naloxone reverses the binding of the opiate receptors in the brain, immediately reversing the effects of the drug.

Kaléo Pharma submitted application for approval of its auto-injector and received it in only four months, signaling that the FDA is serious about public health and safety and is fully aware of the public health crisis on its hands.

Which would be great, if only it were true.

———————

A few months prior to fast-tracking Evzio, the FDA approved Zohydro Extended Release (ER), a powerful, synthetic opiate, whose time-release formula is similar to that of OxyContin. What OxyContin was to oxycodone, Zohydro is to hydrocodone. Addiction professionals throughout the country begged the FDA to reject the drug, predicting it would bring on a new wave of opiate abuse similar to what the US saw with OxyContin prior to its formulation change in 2010, with abusers able to crush the drug to snort, smoke, or inject. The FDA’s own scientific advisory board voted 12–2 to reject the drug’s application, citing its danger to the public. Attorney Generals from 28 states petitioned FDA Commissioner Margaret Hamburg, MD, to prevent Zohydro from coming on the market. A Milwaukee-Wisconsin Journal Sentinel investigation found a November 2012 memo from the FDA’s own staff warning that the drug will be abused more than traditional hydrocodone products.

Massachusetts governor Deval Patrick ordered a ban in his state, arguing that more needed to be done to make the capsule tamper-resistant before he’d allow doctors in Massachusetts to prescribe the drug. Zohydro’s manufacturer sued Massachusetts and a federal judge sided with the drug company, arguing that because the drug was approved at the federal level, Massachusetts had no right to block it at the state level.

Like it or not, Zohydro is coming, even if its maker has to sue its way into your state.

The same year the FDA approved Zohydro, with addiction experts predicting large-scale abuse and overdose, it fast-tracked Evzio, to treat the large-scale abuse and overdose. The poison and the antidote, within a few months of each other, approved for public consumption.

In 2008, the pharmaceutical company Hospira found itself with a monopoly on injectable Naloxone. As other manufacturers either folded or discontinued the drug, Hospira was the last man standing, becoming the sole producer of the drug when officials declared a prescription drug epidemic in 2008.

Hospira decided it would help the crisis, but at a cost. Raising the price of Naloxone from $3.00 per-dose to $33.00 per-dose, Hospira upped the price of the life-saving drug by a staggering 1100% at the time the public needed it most.

Amphastar Pharmaceutical, makers of the Naloxone nasal-spray, raised the price from $22.00 to $42.00.

As Rita Nieves of the Boston Public Health Commission told NPR in February, 2014, “[The manufacturer] doubled the price because they know what they have in their hands — a life-saving tool that everybody wants to use now.”

Hospira, makers of Naloxone in injectable form, is also one of the leading producers of injectable morphine, meaning it will sell you the powerful opiate and then sell you the antidote for an overdose, profiting on both ends.

It’s both the genius and tragedy of capitalism.

In the past year, 17 states have passed laws increasing access to Naloxone, bringing the total to 22. In the town of Revere, Massachusettes, Fire Chief Michael Viviano swears by the drug. “It’s just incredible, it’s like magic,” Viviano told NPR. “There’s somebody who’s on the ground who’s literally dead. They have no pulse. Sometimes they’re blue, sometimes they’re black. And you administer this stuff and sometimes, in a minute or two or three, they’re actually up and talking to you.”

Hospitals and clinics are able to pay for the drug, despite its rising cost. Naloxone makes up such a tiny portion of a hospital or clinic budget, an 1100% price increase can go unnoticed. Many addicts, however, will not ask their doctor to prescribe it, out of fear that they’ll be cut off from receiving their prescriptions.

According to Pastor Tim Williams of Greater Victory Christian Ministries, the success of his program can be attributed to the trust his church has built up in the community.

“When the county held a clinic on (Naloxone) administration, six people showed up,” said Williams. “They went through the Department of Health and our community didn’t trust it. They didn’t want to go on some government list as a ‘drug addict,’ or maybe they had warrants. People refused the service.”

Running the Naloxone program through his church, Pastor Williams says about 120 people showed up for the training. “Thanks to this program,” says Williams, “we’ve had 60 reversals of opiate overdoses. In one weekend we had 22 overdoses, with 18 reversals.”

It’s programs like Williams’ that suffer from the Naloxone price increases. Small organizations that are too small to collectively bargain for lower costs; Community-based programs that are more trusted by the public than hospitals and the doctors through which many of these addicts got hooked in the first place.

As for the future, according to Williams it looks bleak. “In our community we’ve had a 150% increase in opiate overdoses. These people are getting hooked on prescription drugs and then moving to heroin.”

When churches are giving sermons on how to counter a drug overdose, there’s a pretty good chance opiates have permeated a never-before reached level of our social fabric.

There’s an inherently tragic irony in all of this. According to The National Institute of Health, the heavy marketing and over-prescribing of prescription drugs is what’s fed the resurgence of heroin in the US. Now, the government is turning to those same drug companies to help save the lives they are destroying.

And those drug companies are agreeing to do so.

At a price.