Friday, March 23, 2018

Florida could see abuse rise with super potent painkiller Zohydro (w/video)

As 2012 neared its end, those on the front line of Florida's battle against a ferocious, decade-long prescription drug epidemic finally glimpsed hope. Though the progress came with a caveat — overdose deaths were still claiming an average of nearly six lives a day — the numbers had dropped for a second straight year and reached their lowest totals since 2007.

Around the same time, those same people — drug abuse experts, law enforcement officials, pharmacists, doctors and families of the dead — directed their focus to a conference center in Maryland where a U.S. Food and Drug Administration advisory committee had gathered to discuss the future of Zohydro, a potent capsule of pure hydrocodone designed to release its pain-deadening ingredient over 12 hours rather than all at once.

The committee noted Zohydro's obvious dangers: The drug holds up to 10 times more hydrocodone than Vicodin and is not tamper resistant, meaning someone could easily crack the casing and swallow, snort or inject the entire dose in an instant. A single pill could kill a child. Two could kill an adult.

By a count of 11-2, they voted against approval.

And yet, in October, the FDA rebuffed that advice and approved Zohydro, prompting a national backlash. A U.S. senator from West Virginia introduced legislation to prohibit the drug. Separately, a coalition of medical experts, attorneys general in 28 states and a group of eight U.S. congressmen wrote letters asking the FDA to reconsider.

That hasn't happened, and with Zohydro's commercial release this month, medical and law enforcement officials in Florida fear that this highly publicized, easy-to-abuse drug could exacerbate an epidemic that remains far from over.

Adding to their concern is the fact that use of the state's most powerful tool to prevent the abuse of such a narcotic — the Prescription Drug Monitoring Program, which allows doctors and pharmacists to check their patients' prescription histories — remains dismal, according to a recent review by the Tampa Bay Times.

Since the program's inception on Sept. 1, 2011, more than 98 million prescriptions have been written in Florida for controlled substances — about five for every Floridian. Prescribers, however, checked the database before writing just 3.5 percent of them.

Among Tampa Bay physicians allowed to prescribe opioids, just one in seven has ever used the database.

The database, often called the PDMP, is set up to help prevent doctor shopping, a practice in which people illegally get multiple prescriptions from different physicians. Officials with the Drug Enforcement Administration vowed to monitor Zohydro's use as many expect it to inspire a new wave of opportunists.

"How are they most readily going to get this stuff? It's going to be through doctor shopping," said Pinellas Sheriff Bob Gualtieri. "This is where the PDMP becomes even more important."

• • •

A potent, slow-release painkiller vulnerable to tampering and rampant abuse.

That description matches not just Zohydro, but also the original OxyContin, FDA-approved in 1995. Not until 2010 did Purdue Pharma produce a safer, tamper-resistant version. For 15 years, as OxyContin earned the company more than $10 billion, thousands overdosed in part because of how easy the drug was to crush.

The two drugs' similarities did not escape the FDA advisory committee 15 months ago.

"It's likely to be the choice of illegal use," said Dr. James G. Ramsay, of Emory University Hospital.

"This drug will almost certainly cause dependence in the people that are intended to take it," said Dr. Judith Kramer, of Duke University Medical Center.

"I don't believe that one can conclude the drug is safe," said James H. Ware of the Harvard School of Public Health.

In their decision to ignore those assertions, FDA officials argued that the drug didn't pose a higher risk than other available narcotics.

The Washington Post reported last year that pharmaceutical companies had paid six-figure sums to attend private meetings with FDA officials overseeing painkiller safety. Two U.S. senators have suggested those gatherings may have played a part in Zohydro's clearance.

"It made absolutely no sense for the FDA to approve this drug," said Dr. Andrew Kolodny, one of the nation's leading experts in opioid addiction.

He compared the capsule's design to "filling up a gelatin cap with heroin." Inevitably, he said, patients without experience or a drug tolerance will mistakenly take two pills.

Also, children frequently find and eat medications.

"I'm really concerned with the potential for pediatric poisoning," said Alfred Aleguas Jr., director of Tampa General Hospital's poison information center. "Kids get into things all the time. It's not a matter of neglect. It's just a reality."

There were 15,071 reports of children under the age of 6 ingesting over-the-counter and prescription medications in Florida in 2013. Of those, 387 involved opioids.

Executives at the drug's manufacturer, Zogenix, have acknowledged its hazards but insist it fills a pressing need. They noted that, unlike Vicodin, it doesn't contain acetaminophen, which can cause liver damage.

But Tampa Bay area practitioners who regularly prescribe painkillers deny any such need exists.

"I seriously doubt that we would use it, mostly because of the potential for abuse," said Christopher Wittmann, a physician assistant at Trinity Pain Clinic.

At least four other safer, slow-release painkillers, including OxyContin and morphine, are available without acetaminophen, said David Craig, a clinical pharmacist specialist at Moffitt Cancer Center.

He thinks some have overstated Zohydro's danger, but he still doesn't recognize its usefulness, even for his patients, many of whom suffer from excruciating illness.

"I think probably this would be a fourth- or fifth-line option," Craig said.

And how often do sufferers of chronic pain not respond to three or four of the available drugs?

"It barely happens," Craig said. "At all."

• • •

In February, Zogenix described its intended audience in narrow terms: patients with "pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate."

Early last year, though, the company's target was much more ambitious, indicating in statements to shareholders that the drug was for "the management of moderate to severe chronic pain."

The market, they said back then, included an estimated 100 million Americans "burdened with chronic pain." They projected the "national economic cost" to be $560 billion to $635 billion.

In a conference call this month, company executives said nothing about 12-figure projections. They promised to introduce Zohydro with a responsible, measured approach. Among their plans: prescriber, pharmacist and patient education; an external system to surveil use of the drug; and an incentive structure for its 150 drug representatives not dependent on sales.

Zogenix's now-tempered message raises a big question: How will the company, which is publicly traded, turn a profit?

"Every time you get a new opioid released on the market, the sponsor has to make its enormous investment back," Kolodny said. "The only way they can do that is to get the medical community to prescribe the drug."

Zogenix officials didn't respond to interview requests, but the drug's price might be indicative of its financial strategy. Depending on dosage, a 30-day prescription of Zohydro will wholesale for between $351 and $429. OxyContin and Oxymorphone retail for about $95 and $110, respectively.

The issue may become moot. Earlier this month, Purdue announced it would submit a tamper-resistant version for FDA approval later this year. Though the drug likely wouldn't reach consumers for two or three more years, Zogenix stock plunged over 20 percent after the news.

• • •

Ask why more doctors don't check the state's database before prescribing drugs that routinely kill people and the answer is almost always the same: They don't have to.

Eighteen other states with databases recognized that problem and now mandate some level of use, but in Florida, even with Zohydro's introduction and as state and local leaders stress the database's importance, a mandate seems unlikely.

"I've always wished it would be mandatory," said Attorney General Pam Bondi. "I've always seen it as a great tool."

Instead, state Sens. Jeff Brandes and Aaron Bean are pushing a bill that would require law enforcement officers to get a court order before accessing the database, a change investigators say will make it harder for them to prevent doctor shopping. For now, they can retrieve data if it relates to an open investigation.

"What business is it of the government to be in our medicine cabinets?" Bean said. "We just want some types of checks and balances."

But what about mandated use?

Brandes seemed confused by the question, initially saying he would have "real concerns" if the law required Floridians' prescription histories to be kept in a statewide database — though the law has required exactly that since 2011.

Later, he said he didn't believe practitioners should be obligated to check the program.

"Look, I think doctors should check it," Brandes said. "I don't think it should be mandatory that they check it."

Bean said he had not considered the question.

"We're not there yet. I don't know," he said. "That's not the issue that I'm focused on."

Times researcher Natalie Watson contributed to this report.

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