The national public debate over the misuse and abuse of opioid pain medicines has been in the news long enough now for state and federal lawmakers and regulators at the Food and Drug Administration to focus on the real issues rather than the tabloid headlines.
That’s why the latest story on the subject from Consumers Report is so puzzling. Not only is it a day late and a dollar short, but it reaches all the wrong conclusions – providing a distinct disservice to its readers.
Specifically, CR has the pain medicine Zohydro ER in its crosshairs. The article calls on the FDA to reconsider its 2013 approval of Zohydro ER and to make acetaminophen standards consistent.
Strangely the piece fails to mention that one of the benefits of Zohydro ER is that it is acetaminophen-free. It also neglects to mention that this very concern was specifically addressed by FDA Commissioner Margaret Hamburg who testified before Congress that, “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.”
The investigative tigers at CR call for the FDA to approve only opioids that are “abuse deterrent.” Well, here’s what the FDA commissioner had to say on that subject (also in open public testimony that the CR story either missed or chose to ignore), “It doesn’t do any good to label something as abuse deterrent if it isn’t actually abuse deterrent, and right now, unfortunately, the technology is poor.”
Surprisingly absent from the CR story was any mention of the most promising of the FDA’s initiatives on abuse deterrence; a study (to be conducted by the National Institute for Pharmaceutical Technology and Education) to evaluate opioid product formulations and performance characteristics for solid and oral dosages.
Unfortunately complex systems make for bad media coverage, while simplistic, dramatic demagoguing makes for sexier headlines.
CR also believes another reason Zohydro ER should be recalled by the FDA is that it was approved, “against the recommendation of its own panel of expert advisers.” That’s true – but it’s not the whole truth. What the CR authors left out is that, by a vote of 11-2, the experts affirmed that there was no evidence to suggest Zohydro had greater abuse or addiction potential than any other opioid.
“Facts,” as John Adams said, “are pesky things.”
What the newshounds at CR missed completely are the issues surrounding opioid misuse – at present the poor public health stepchild of abuse. In the United States, the use of opioids as first-line treatment for chronic pain conditions doesn’t follow either label indications or guideline recommendations.
In fact, 52 percent of patients diagnosed with osteoarthritis receive an opioid pain medicine from their doctors as first-line treatment as do 43 percent of patients diagnosed with Fibromyalgia and 42 percent of patients with diabetic peripheral neuropathy.
Payers in the healthcare system often impose barriers to the use of branded, on-label non-opioid pain medicines, relegating these treatments to second line options. The result is a gateway to abuse and addiction with opioids.
Another fact conveniently missed in the CR story is that the vast majority of people who use opioids do so legally and safely. A subset, approximately four percent of patients, use these medications illegally. In fact, from 2010 to 2011, the number of Americans misusing and abusing opioid medications declined from 4.6 to 4.2 percent.
How strange that Consumer Reports missed so many facts after all this time.
Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest and author of the new paper, “Who Lost Opioids” (Journal of Commercial Biotechnology).