A potent new painkiller hit the US market this week, despite warnings from top experts that the drug may deliver a deadly setback in the nation’s battle with opioid addiction.
Zohydro ER can contain 10 times more of the opioid hydrocodone than Vicodin — the most popular prescription painkiller in the US — and since it has none of the recent safeguards added to pills like OxyContin (hydrocodone’s fellow semi-synthetic opioid oxycodone) it can easily be crushed and snorted.
In a nation where about 15,000 people die annually from prescription painkiller use, the drug’s approval has raised alarm among doctors, lawmakers and relatives of those lost to overdose.
Two US senators have launched an investigation into practices by the US Food and Drug Administration (FDA), amid allegations that pharmaceutical companies eager for a chunk of the US$9 billion painkiller market may have paid to influence regulators’ decisions.
“It’s almost unheard of,” Physicians for Responsible Opioid Prescribing president Andrew Kolodny said. “For [the] FDA to approve a drug that is going to make a serious problem worse, it is pretty shocking.”
Zohydro was approved in October last year, even though a panel of FDA-convened experts voted against it 11-2. The administration is not obligated to follow the advice of its advisory committees, but typically does.
An FDA spokesman told reporters the decision was made “after careful consideration” and that “the product’s benefits outweigh its risks when used as intended.”
Zohydro contains pure hydrocodone in a range of doses, including time-release options that are much stronger than rival products. It does not contain acetaminophen, which can cause liver damage and death in high doses and is included in most other prescription opioids.
The drug’s maker, California-based Zogenix, said in a statement that the “acetaminophen-free formulation of extended release hydrocodone is an important therapeutic option for certain chronic pain patients.”
Musician and financial adviser Steve Rummler was one of the 100 million people in the US who suffer from chronic pain. He was prescribed narcotic painkillers in 2005 for a lingering back injury.
“The doctor kept increasing the amounts that he would give to Steve,” his mother, Judy Rummler, told reporters.
In 2009, Steve Rummler’s family learned that he was seeking painkillers from multiple sources. He tried to learn other ways of coping with the pain and tried rehab.
“He seemed great for a very short period of time, then he relapsed because of his pain,” his mother said.
When his last refills ran out, he scored some heroin and overdosed on July 1, 2011, at the age of 43.
“He was a totally different person the last few years of his life,” said his mother, who now chairs a coalition of activists called Fed Up.
The group has held rallies and met with lawmakers in an effort to curb the prescription painkiller epidemic, which public health experts say is also fueling a rise in heroin and street drug use — 100 people die in the US each day from drug overdose, according to the US Centers for Disease Control and Prevention.
Regulators have introduced some tighter rules as a countermeasure and drugs like Zohydro fall under Schedule II, which means they can only be dispensed with a written prescription.
Yet plenty of people, including kids as young as 10, find ways to get opioids, said Janina Kean, president and CEO of the High Watch Recovery Center in Connecticut.
“They are being overly prescribed. They end up in people’s medicine cabinets,” she said in an interview. “We have a huge crisis in our country.”
The Washington Post and Milwaukee Journal Sentinel reported in October last year that hundreds of e-mails released in a public records request showed pharmaceutical companies paid tens of thousands of US dollars to attend FDA advisory panel meetings.
The administration has denied any impropriety, but US lawmakers have launched a probe into whether the payments influenced regulators’ decisions to approve drugs like Zohydro.
“If these allegations are true, there is a clear, illegal conflict of interest between the FDA and these pharmaceutical companies that puts consumer safety at risk,” Louisianan Senator David Vitter said in a letter to the agency last week.
New York Senator Chuck Schumer has urged the US Department of Health and Human Services to override the FDA and remove Zohydro from the market until protections to prevent abuse are added, but that seems unlikely, as a Zogenix spokeswoman has said that the drug is already available in select US pharmacies.