Critics Question FDA's Approval Of Zohydro

Prominent universities and drug addiction organizations are asking the FDA to reconsider its approval of a controversial painkiller called Zohydro. It's 10 times more powerful than OxyContin.

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The Food and Drug Administration is under enormous pressure to change its mind about a powerful new prescription painkiller. Forty-two public health groups are urging the FDA to withdraw its support of Zohydro. The drug is similar to Oxycontin, except it comes in significantly higher doses. The FDA approved Zohydro last year, despite its own advisory panel voting against it. And critics are, among other things, raising questions about that approval process.

NPR's Laura Sullivan reports.

LAURA SULLIVAN, BYLINE: When Zohydro is released next month, it will be one of the most powerful prescription painkillers on the market. It's highest dosage will contain five to 10 times as much hydrocodone as the widely used Vicodin. The drug company's literature says an adult could overdose on two capsules. A child could die from swallowing just one pill.

DR. MICHAEL CAROME: People are going to die from this drug.

SULLIVAN: Dr. Michael Carome is the director of Health Research for Public Citizen.

CAROME: We are in the midst of a public health crisis. There is an epidemic of opioid addiction resulting in thousands of deaths. And the last thing we need now is another high-potent, high-dose, long-acting opioid drug, Zohydro, that will simply feed the epidemic.

SULLIVAN: Overdose deaths and addiction rates from prescription painkillers similar to Zohydro have grown dramatically in recent years. Carome and 41 other health care advocates are asking the FDA to remove its approval of the drug. Zohydro is a crushable pill. That means it's snortable and, some experts say, more prone to abuse than other drugs like the new versions of Oxycontin, which are no longer crushable. The drug company Zogenix is marketing the drug.

DR. BRAD GALER: There's a lot of misinformation being put out there by people who don't have all the facts.

SULLIVAN: Dr. Brad Galer is the company's chief medical officer. He says they will introduce a non-crushable version of Zohydro in three years. And the company will closely monitor prescription transfer abuse. But he says millions legitimately need this drug.

GALER: We're talking about patients that are in bed, depressed, can't sleep, can't work, can't interact with their loved ones. It's a very significant medical health problem that is being ignored.

SULLIVAN: That argument isn't sitting will with public health advocates. Dr. Andrew Kolodny is chief medical officer at the Phoenix House Foundation.

DR. ANDREW KOLODNY: We have many opioid formulations on the market. There's absolutely no need for a new opioid formulation.

SULLIVAN: FDA's own advisory panel seem to agree. The panel voted 11-to-2 not to approve the drug. Then in November, top FDA officials overruled that panel. And that's where things get complicated. Last fall, a series of emails were made public from a Freedom of Information Act request. They were emails between two professors who had, for a decade, organized private meetings between FDA officials and drug companies who make pain medicine. The drug companies pay the professors thousands of dollars to attend.

And here's what has critics concerned. One of those companies was Zohydro's original manufacturer, Elan Corp. Zogenix wasn't in the picture yet but went on to partner with Elan.

Dr. Kolodny, of Phoenix House Foundation.

KOLODNY: When those emails surfaced, I think for many of us there was a sense of ah-ha.

SULLIVAN: Elan has a new owner, and the company did not respond to requests for comment. In a statement, the FDA said the meetings did not address specific drugs and that the FDA took part to develop better research methods. The statement says those research methods may have benefitted companies making pain drugs but that they also benefitted patients.

Zohydro's Dr. Galer attended the meetings when he worked for another drug company.

GALER: Those actually were looking at old studies to improve patient care.

SULLIVAN: So I asked him...

But if the drug manufacturers are sitting in a room with FDA officials, talking about pain drugs, and they're there because they spent 20- to $30,000 to be in the room, and some of these other advocates aren't allowed in that room at the same time, does that raise any concerns for you that that could be a conflict of interest?

GALER: Well, again, I'm here as chief medical officer for Zogenix. Zogenix was not involved whatsoever. All I can say is that this medication, Zohydro E.R., will benefit many patients.

SULLIVAN: But police agencies are worried.

MAJOR JASON BOGUE: It's a problem we're trying to get ahead of because we know it's coming.

SULLIVAN: Maj. Jason Bogue runs the narcotics division of the Prince George's County Police Department, in Maryland. He's been battling prescription drug abuse and its crime, violence and addiction. He doesn't want to battle Zohydro.

BOGUE: The impact that that has on society, the impact that it has on families, it's catastrophic. I can see this compounding that problem.

SULLIVAN: Attorneys general from 28 states have already asked the FDA to reconsider its approval. But in its statement, the agency said, the data shows the drug is safe, effective and needed.

Laura Sullivan, NPR News, Washington.

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