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How Much Does It Hurt?

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The FDA staff may have sensed it, too. At one point during the afternoon session, Bob Rappaport, head of the FDA’s Anesthesia, Analgesia, and Addiction Products section, reminded the advisory committee that it had to consider the Zohydro application within the narrow regulatory framework that legally governed all FDA decisions: Was the drug safe and effective for the “intended population”—that is, for chronic-pain patients? Did the company satisfy the same requirements for effectiveness and safety that previous opioid manufacturers had satisfied when they had sought FDA approval? “To do other than what I’m asking you today,” Rappaport said, “while no doubt heartfelt and in the best interest of patients and the public health, may not provide us with a level of guidance that will be useful as we make our final decisions” about Zohydro.

Almost every time a panel member expressed concern about the societal danger Zohydro posed, Rappaport walked the discussion back to the narrow question of whether the drug was safe for intended patients. “This question, the last clause in there is ‘for the intended population,’ is it safe for the intended population. I just wanted to remind everybody of that.” A few moments later, Rappaport again redirected the committee’s focus to chronic-pain patients. If addicts diverted the drug and abused it, he said, “it’s really not a problem for the intended patient.”

“It seemed like Bob Rappaport was getting frustrated with the panel,” says Andrew Kolodny, chief medical officer of Phoenix House Foundation, the substance-abuse treatment center, who also testified at the meeting. “He actually started to scold the committee at one point.” By the time it came for the final vote, the exchanges between FDA staff and outside experts became, in Walsh’s view, “a little spicy.”

If there was a single voice politely insisting on arguing that the panel—and the FDA—had a greater societal responsibility, it was probably that of Judith Kramer, the doctor from Duke. Earlier in the day, she had questioned Zohydro’s effectiveness, predicting that the drug would cause harm because of its addictive potential; by late afternoon, she distilled the rising frustration of the committee when she explained why she didn’t think the drug was safe: “It’s striking me, as I’m listening to people give their reasons, that this drug is, in a way, held to a lower standard because of all the other drugs that we’ve accepted [with] this kind of profile … This drug will almost certainly cause dependence in the people that are intended to take it.” Summing up, she said, “I realize there has to be a level playing field in terms of business practice, but the primary thing has to be the public health.”

Ultimately, the advisory committee agreed with Kramer. “It started with more people surprisingly saying ‘No,’ and then there was quite a bit of momentum for ‘No,’ ” says Jeanmarie Perrone of the University of Pennsylvania, who was on the panel. When the votes were all counted, the FDA’s outside experts had not just rejected Zohydro by a lopsided 11-to-2 margin, as has been widely noted. In two votes leading up to the final judgment, the committee considered the drug barely effective as a treatment for chronic pain by a narrow seven-to-six vote; and even when forced to consider the drug’s safety in the context of its intended patients, as FDA officials had insisted all afternoon, a nine-to-five majority of the experts deemed the drug unsafe. Alan Kaye, a Louisiana State University School of Medicine anesthesiologist and pharmacologist, was proud of the vote.* “I was excited to vote ‘No,’ ” he recalls. “I was feeling I was there entrusted to make an educated decision that had a lot of implications for the people of the United States. And I know I made the right decision.”

Kaye left the meeting thinking Zohydro had been shot down, and he wasn’t alone. But Rappaport may have foreshadowed the agency’s thinking when he told the panel that day, “We may not be able to act on all of your recommendations because of our regulations and the law.”

On October 25, 2013, the FDA announced it had approved the drug. The agency gave its rationale later in a statement: “In the case of Zohydro ER [extended release], we determined that the benefits of the product outweigh its risks.” (The FDA has taken a public beating ever since; every time the FDA defends its decision, the makers of Zohydro post it on the company website like an endorsement.)

Before the sun came up the day after Zohydro’s approval, an opiophile had posted this reaction online: “When a 50 mg Zorro hits the block, it’s gonna fetch a big ol’ price, I betcha. And it’s anti-abuse-proof. Hell, yeah, I can see the Tweens lining up at my klinik already.”


*This article has been corrected to show that Alan Kaye is an anesthesiologist and pharmacologist, not a toxicologist.


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