A powerful new opiate, approved by the FDA last year, hit the market early this month despite protests from groups of doctors, pharmacists, politicians, law enforcement officials, and addiction specialists. In spite of this, many are still appealing to those with FDA oversight, hoping to get the decision reversed and the drug pulled from shelves.
Zohydro-a pure hydrocodone pill, easily crushable and available in a dose 10 times more potent than a single Vicodin-hit shelves March 3, according to the Ohio Board of Pharmacy. The FDA approved the drug in October, despite a 11-2 vote against its approval by the FDA's own advisory board.
The drug, which time-releases the hydrocodone for extended pain management, provides an alternate option for patients who find other treatments ineffective, intolerable or inadequate, said the FDA in its press release announcing approval.
But those who have seen and battled the rise of opiate addiction are skeptical.
"From what I'm reading it's a lot more powerful than OxyContin. It causes us some concern because...there's always the potential for abuse out there," said Washington County Sheriff Larry Mincks.
Another issue raised by critics is that the new drug is designed without an abuse-deterrent, said Aaron Howell, a doctor of physical medicine and rehabilitation at the Memorial Health System's Pain Management Center in Belpre.
First single-ingredient hydrocodone drug ever cleared for U.S. patients.
Comes in 10 mg, 15 mg, 20 mg, 30 mg, 40 mg and 50 mg capsules.
The largest capsule is 10 times more potent than a 5 mg Vicodin.
The drug contains no abuse-deterrent, which would prevent it from being crushed and injected or snorted.
The drug's proposed use is "management of moderate to severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time."
The drug was approved by the FDA in October and went into the market March 3.
Source: Times research.
"One of the big concerns right now is it is easily crushable and similar to OxyContin," he said.
When OxyContin first hit the market, it was widely abused by addicts because it could be easily be crushed and administered more directly-albeit unsafely-through snorting or injection.
The current OxyContin formulation is made with an abuse-deterrent, as are many other drugs, which cause unwanted side effects when the drug is crushed and injected or snorted.
Howell noted the drug could be useful for a select group of patients, but added that determining who those patients are would be difficult. While such opiate treatments have proven useful for short-term acute pain and end of life care, long-term use is a different story.
"There's not a whole lot of evidence that shows these type of drug benefit folks with pain for months and years. But they're often used on these people because they do provide some relief," he said.
But long-term risks include an increased potential for drug tolerance, abuse and even hyperalgesia, which means the drugs actually make the pain worse, said Howell.
"There probably is a use for this medication in some patients. But there's already enough options for patients out there," he said.
A week before the drug hit shelves, the Fed Up! Coalition wrote a letter to FDA Commissioner Margaret Hamburg asking her to reverse the drug's approval.
The coalition consists of more than 40 people, mostly physicians and presidents of drug treatment or addiction awareness programs.
They cited the drug's high dosage rate as a main concern. In its highest dosage, a 50 milligram capsule, a single pill could prove fatal to a child and two pills could cause an adult to overdose, they wrote.
The FDA did not reverse its decision, but groups and individuals are still appealing to others with oversight in hopes of getting the drug's approval reversed.
The Ohio Board of Pharmacy is just one such group that has taken a stance against the drug, said Jesse Wimberly, an agent and spokesman for the board.
"As a matter of fact, our agency wrote a letter to the director with the Office of National Drug Control Policy for the White House, and it documented our concerns with regard to Zohydro and its abuse potential," he said.
The director, R. Gil Kerlikowske, has some oversight as to FDA decisions, he said.
Sen. Joe Manchin, D-W.Va, also urged an overturn of the drug's approval, sending a letter to U.S. Health and Human Services Secretary Kathleen Sebelius asking her to overrule the FDA decision.
Last Thursday Manchin stepped up his efforts, introducing a bill that would force the FDA to pull the drug and prevent them from approving drugs without abuse-deterrents.
Opiates continue to be the biggest drug of abuse locally, said Mincks.
That matches a national trend that saw opiate overdose deaths quadruple between 1999 and 2010, according to data from the Centers for Disease Control and Prevention.
Howell said he is confident that increased awareness and tools that help doctors monitor prescriptions have helped cause a downward trend in regard to doctors overprescribing and patients abusing opiates,
"People are aware it's a problem now. People before were more concerned with undertreating pain. Now we're asking ourselves if we're overtreating pain," he said.
But the addition of this new drug could have a detrimental affect on that progress, Howell said.
"This is adding another bullet to the gun, really. There's more potential for the bad things than there are for the good things," he concluded.