Opioid abuse in America is a well-documented and tragic epidemic. While the FDA has intervened to add abuse deterrents to some narcotic pain relievers, it’s also approved a new drug that lacks such deterrents and could be much more lethal if abused.
Medical practitioners, addiction specialists and others gathered in Washington over the weekend to offer even starker criticism, suggesting that recent actions by the federal government will further fuel this problem. The Centers for Disease Control and Prevention has dubbed the current wave of painkiller abuse an epidemic, which others have characterized as the worst drug-addition problem the country has ever faced.
“Over the past decade more than 150,000 Americans have died from painkiller overdoses,” Dr. Andrew Kolodny, the president of Physicians for Responsible Opioid Prescribing, an advocacy group, said Sunday in a statement. “The Obama Administration’s response to this severe epidemic has been slow and tragically ineffective.”
Opioid prescriptions have grown by almost 200 percent in the past two decades, according to widely cited figures. In the United States today, more people die from drug overdoses than any other type of injury, the Food and Drug Administration says, and 40 percent of these deaths are from narcotic painkillers. In a 2008 study, the United Nations found that the U.S. was consuming some 99 percent of the world’s hydrocodone, an addictive narcotic.
On Sunday, Kolodny and others took part in a demonstration here, including outside of the White House, that organizers estimate drew some 2,000 people – twice their initial goal. The protests were led by an umbrella group called the Fed Up! Coalition, which is comprised of medical personnel, addiction treatment experts, consumer groups and those who have lost family members to a painkiller overdose.
Sunday’s protest, the second of its kind, had a powerful new focus. Since last year’s demonstration, the federal government has approved Zohydro, a powerful and controversial new narcotic painkiller. While the opioid compounds in the drug are not necessarily higher than other high-end painkillers on the market, this new pill is a long-release formulation.
That means that it remains active for around 12 hours, and thus includes a hydrocodone dose 10 times higher than “immediate dose” painkillers like Vicodin, according to the drug’s maker, Zogenix. (Zohydro is also unique in that unlike many other narcotic painkillers, it doesn’t contain acetaminophen.)
More controversially, the pills do not include new safeguards aimed at making narcotic painkillers harder to use for recreational purposes. For instance, Oxycontin, a narcotic painkiller that was blamed for fuelling an outbreak of painkiller abuse in recent years, has now been re-engineered to include a hard outer shell. The new shell makes it far more difficult to crush the pill with the intent of snorting it.
Without such safeguards, critics worry that the far more potent Zohydro could now lead to a whole new rash of abuse among recreational users as well as overdoses by those legitimately suffering from pain. Indeed, a scientific committee advising the FDA on Zohydro’s regulatory application felt the same, last year voting 11-2 against approving the drug’s release.
But the committee’s recommendations are not binding, and FDA Commissioner Margaret Hamburg allowed for the approval to go forward. In response, the Fed Up! Coalition sent a letter to Health and Human Services Secretary Sylvia Mathews Burwell last week, calling for Hamburg to be replaced.
“We are especially frustrated by the [FDA’s] continued approval of new, dangerous, high-dose opioid analgesics that are fueling high rates of addiction and overdose deaths,” the letter states. “After careful consideration we have come to believe that without new leadership at FDA the opioid crisis will continue unabated.”
60 percent of fundingThe letter also speaks to potentially troubling concerns around conflicts of interest between the FDA and the pharmaceutical industry. Instead, it urges new leadership at the agency that will “consistently put the public’s health ahead of industry interests.”
“We’ve worked so hard to get changes at FDA and that change just is not taking place. There really seems to be some hesitation on the part of FDA to harm the pharmaceutical industry, so we’re grown particularly concerned about the connections between the agency and the industry,” Judy Rummler, the chair of the Fed Up! Rally, told MintPress.
“Sixty percent of the FDA’s [drug-review costs] comes from the pharmaceutical industry – through fees, of course, but in my opinion that’s a clear conflict of interest. Instead, the agency’s work should simply be funded through general funds rather than from industry fees.”
Rummler’s son, Steve, died of an Oxycontin overdose in 2011, following a back injury and a subsequent addiction to the painkiller. She now runs a Minneapolis-based foundation that pushes for greater public understanding around “the dilemma of chronic pain and the disease of addiction.” Rummler says the public stigma toward addiction continues to make it particularly difficult to get people to take substantive action around the current addition outbreak.
That’s not to say that regulators and lawmakers have taken no action. In December, four Democratic senators called the FDA’s approval of Zohydro “irresponsible,” and urged the agency to immediately begin work with the drug’s manufacturer to incorporate abuse-deterrence features. Massachusetts attempted to ban the drug out of hand (though a federal judge later ruled the move unlawful), while state legislators and attorneys general have likewise expressed concern.
In mid-September, legislation was proposed in the Senate that would, among other things, fund a strengthening of state-level monitoring programs for the prescriptions of narcotic painkillers. Right now, Rummler says, such monitoring is “haphazard” at best.
Perhaps most importantly thus far, the U.S. Drug Enforcement Agency, at the FDA’s behest, in August reclassified painkillers containing hydrocodone from Schedule III to Schedule II drugs. The up-scheduling ensures tighter controls around these drugs, including requiring a doctor’s visit prior to prescription refills. Previously, no such formal check-in was necessary.
Still, it was just a day after the FDA announced its support for this rescheduling that the agency approved Zohydro. And a similarly controversial approval took place earlier this year around another high-dose extended-release narcotic painkiller, called Targiniq. Although this drug comes with naloxone, a new “anti-opioid” compound, the mitigating effects of naloxone kick in only if the drug is injected or snorted – not if it is taken orally.
Critics of the approval acknowledge that this approach will help keep Targiniq out of the hands of recreational users. Yet because the drug, again, comes without a hard shell, there will be nothing to stop a user from chewing up a pill and receiving a full dose all at once, either on purpose or by accident.
Further, “FDA approved Targiniq without convening a scientific advisory committee meeting,” the Fed Up! letter notes. “The decision by FDA to bypass the advisory committee violated its own policy.”
No ‘particular position’Rummler and others say they feel momentum is picking up around critique of U.S. opioid approvals, both among policymakers and the broader public. To date, however, the Obama administration has publicly resisted calls for change.
“Secretary Burwell appreciates hearing from stakeholders on the important issue of prescription opioid abuse, and looks forward to responding to [the Fed Up!] letter,” a spokesperson for the Department of Health and Human Services told MintPress in a statement. “Prescription opioid abuse is a serious issue and one that the Secretary is focused on.”
Jeff Ventura, a spokesperson for the FDA, told MintPress that Commissioner Hamburg “has been a tireless public health advocate for more than 20 years and is committed to continuing to champion the rights of patients as Commissioner of the FDA.”
Next month, Ventura noted, the FDA will be hosting a public meeting to collect public input on the development, assessment and regulation of opioids with abuse-deterrent properties.
On Monday, Hamburg continued to defend the Zohydro approval in an article published by USA Today. (That same day, the newspaper’s editorial department ran a strongly worded warning that the FDA was “undermining” the fight against painkiller addiction.)
“Singling out any individual opioid diverts the nation’s focus from interventions that can make a real difference,” Hamburg wrote. “The problem of opioid overdose is largely driven by inappropriate prescribing, use and diversion of these drugs.”
Hamburg and others maintain that Zohydro fills an important need for certain sufferers of chronic pain. And indeed, anecdotal accounts suggest that the drug has been welcomed by certain users.
Yet the controversy around the drug’s approval – particularly in the context of the broader problems around narcotic painkillers – appears to have unsettled prominent medical associations, including those that advocate nationally for pain sufferers and doctors. Many are taking no public stance on the issue, a reticence that could further strengthen the lobbying influence of the drugs industry.
MintPress contacted more than a half-dozen such groups for this story, requesting analysis on the importance of Zohydro for pain management and the FDA’s related approvals process. Each of these organizations either failed to respond or declined to comment, including the American Medical Association.
Even the American Pain Society, a prominent multidisciplinary group, “is not commenting on the issue,” a spokesperson said. In a brief video posted in April, the group’s then-president, Roger Fillingim, clearly did not want to answer a question on the issue.
“The American Pain Society doesn’t have a particular position on that. I’m sure we have members on many sides of the issue,” Fillingim said.
“We’re very concerned that policy decisions that are made … be based on evidence and be carried out in the best interest of the public and of patients suffering from chronic pain, rather than being driven by other concerns or other agendas. So to the extent that that relates to the Zohydro issue, people can draw their own conclusions.”