Fearing 'wave of addiction,' Hal Rogers hopes to overturn FDA approval of powerful painkiller

bestep@herald-leader.comMarch 16, 2014 

U.S. Rep. Hal Rogers spoke during a morning news conference held at the University of Kentucky Chandler Hospital in Lexington, Ky., Friday, July 12, 2013. UK announced it's Markey Cancer Center has received a Cancer Center designation from National Cancer Institute which brings it additional federal research money. Only 67 other hospitals have received this designation, with UK being the first in Kentucky. On the left is UK pres. Eli Capilouto and in the middle is Carl Nathe, with UK public relations. Photo by Charles Bertram | Staff


Federal lawmakers want to roll back approval for a powerful new painkiller that authorities in Kentucky and elsewhere worry could drive an increase in abuse and overdose deaths.

U.S. Rep. Hal Rogers, a Republican who represents Kentucky's 5th District in Eastern Kentucky, is among the sponsors of a bill that would cancel U.S. Food and Drug Administration approval to market a drug called Zohydro ER.

The pill is a formulation of pure hydrocodone with an extended-release function. Other painkillers that contain the drug, such as Vicodin and Lortab, are not 100 percent hydrocodone.

The concern is that Zohydro does not incorporate measures to deter drug abusers from crushing it up and snorting or injecting it for a high akin to heroin.

Kentucky faced a similar problem beginning in the late 1990s with OxyContin, a pill of pure oxycodone with a time-release function.

Abuse of OxyContin exploded after drug abusers figured out they could crush and ingest the pills, getting 12 hours worth of the drug in one shot. The drug helped drive a staggering 296 percent increase in overdose deaths in Kentucky from 2000 to 2010.

Lawmakers, police and some treatment providers fear a repeat with the current form of Zohydro.

"There's no way around this not being another OxyContin epidemic if it's released on us," said Dan Smoot, president of Operation UNITE, whose work includes drug investigations in Southern and Eastern Kentucky. "I'm just afraid it would be devastating, to our region in particular."

Eastern Kentucky was one of the original flashpoints for OxyContin abuse in the late 1990s, and abuse of prescription drugs remains a tremendous problem.

The maker of OxyContin later reformulated it to include measures aimed at deterring abuse.

That's one goal of the bill Rogers introduced Thursday with U.S. Rep. Stephen Lynch, D-Mass., and several co-sponsors.

In addition to withdrawing FDA approval for Zohydro, the bill would bar the agency from approving other pure, extended-release hydrocodone formulations that do not include features to deter abuse.

For example, the drug maker could include another drug that would blunt or eliminate the illicit high if someone crushes the pill.

Other companies are developing formulations of pure hydrocodone, but Zohydro won FDA approval first.

Rogers said it is imperative that painkillers like Zohydro include features to deter abuse.

"In Southern and Eastern Kentucky, we lost nearly an entire generation when crushable OxyContin was first prescribed, and I fear this crushable, pure hydrocodone pill will take us backward with a new wave of addiction and tragic, untimely deaths," Rogers said in a news release. "While there isn't a silver bullet, abuse-deterrent formulations offer common sense measures to curb the tide of overdose deaths in this country."

Rogers is chairman of the House Appropriations Committee and, with Lynch, co-chairs the Congressional Caucus on Prescription Drug Abuse.

U.S. Sen. Joe Manchin, a Democrat from West Virginia, introduced a companion "Act to Ban Zohydro" in the Senate.

Kentucky Attorney General Jack Conway said the FDA approval of Zohydro runs counter to other actions of the agency aimed at curbing prescription drug abuse.

For instance, the agency tightened prescribing restrictions on hydrocodone just before it OK'd Zohydro, he said.

"It's a step backward. It's wrong-headed," Conway said of allowing Zohydro on the market in its current form.

Conway and 27 other top state prosecutors wrote to the FDA in December to express concern that Zohydro has the potential to worsen a national epidemic of prescription drug abuse.

The new drug is hitting the market just as Kentucky is seeing encouraging signs in the effort to curb prescription abuse, said Van Ingram, head of the state Office of Drug Control Policy.

Tougher state rules have gotten rid of several unscrupulous pain clinics, and overdose deaths dropped from 1,023 in 2011 to 1,004 in 2012.

Final numbers are not yet available for 2013 because toxicology reports are not finished in every case, but the preliminary numbers indicate the leveling-off in overdose deaths in 2012 — after many years of increases — continued in 2013, Ingram said.

Zohydro raised concerns among drug-abuse prevention advocates and police even as it was still being developed, and an advisory panel of the FDA voted 11-2 against letting it onto the market without abuse-deterrent features, citing concerns over the potential for addiction.

However, the FDA approved the drug last October, saying the benefits to people suffering from chronic pain outweighed the risks. The agency said the safety of Zohydro had been demonstrated in clinical studies involving more than 1,100 people with chronic pain.

The same day lawmakers introduced the bill to overturn FDA approval of Zohydro, the agency's commissioner defended the decision to approve it, the Reuters news service reported.

"We recognize that this is a powerful drug, but we also believe that if appropriately used, it serves an important and unique niche with respect to pain medication and it meets the standards for safety and efficacy," Commissioner Margaret Hamburg told a Senate committee, according to the news service.

Zogenix, the San Diego company that makes Zohydro, did not respond to a request for comment Friday.

However, the company says on its website that one advantage of its product is that it does not pose the risk of liver damage because it does not contain acetaminophen, as other hydrocodone pills do.

"Zogenix recognizes and appreciates that prescription opioid misuse and abuse is a critical issue," company head Stephen Farr said in a statement posted on its website in December 2012. "However, it is also important to remember that there is a documented patient need for an extended-release hydrocodone medicine without acetaminophen."

Zogenix says it has taken steps to promote safe use of the drug and is committed to developing a version that includes features to deter abuse.

The FDA required further studies of Zohydro to measure the risks of abuse, addiction and death.

Bill Estep: (606) 678-4655. Twitter: @billestep1

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