Written by Poppy Smith, CNN
For one man, as he waited for his turn in the Neurorenal Dose Therapy area, there was hope. But for the other, there was only fear.
Then suddenly the room erupted in cheers.
A few hands went up from inside the room, as people cheered and clapped, clapped more, and then the crowd quieted down.
Standing on the square before the private audience had been a panel of expert panel members, members of the FDA’s Committee for Drugs for Therapeutic Development. More than a dozen of the 12 panel members had just given their thoughts about their panel’s recommendation to the FDA for the drug Ketek, developed by Pfizer (a pharma company), to be approved for the treatment of low back pain in adults.
Purdue Pharma, the company behind OxyContin, and its manufacturer, Purdue Pharma ( the US subsidiary of EUT ), Inc., have found themselves in a tizzy following an addiction crisis that has seen opioid overdoses take the lives of more than 142,000 people in the United States.
So far, it is drug manufacturers like Purdue that have faced much of the backlash. But after a panel of experts (a.k.a. the FDA’s panels) voted overwhelmingly Thursday in favor of Ketek’s use for adults, opiate manufacturers are being asked by an “advisory committee” to lower the price of their drugs or exit the opioid market.
The drug industry insists that these drugs — which generate billions of dollars in annual revenues for pharmaceutical companies — are essential to combat opioid abuse.
“Ketek is an important advance for adults with moderate to severe lower back pain,” Purdue Pharma said in a statement to CNN after the panel’s vote. “This is an important condition with an estimated 2.6 million patients on three to six months of opioid therapy.”
But the US Centers for Disease Control and Prevention has come to the conclusion that these drugs do not help reduce long-term use of painkillers. And in February, the FDA announced that it was going to take steps to strengthen its opioid standards for prescription drugs, including updating its labels and increasing the rate of reviews, and prompted the FDA to begin reviewing addiction and opioid policy.
“The biggest factor in this review process is the FDA recognition of the opioid abuse crisis that is plaguing our nation,” said Dr. Paul Brown, vice chair of the FDA’s committee for drugs for therapeutic development.
Drugs of this type should only be used for moderate to severe pain in adults, Brown said.
The FDA currently lists Ketek as the only drug in the United States that combines oxycodone and ketoprofen, which, he said, will decrease the risk of narcotic abuse. And yet in the main or street drug market, Ketek is priced at $30,000 for five daily pills.
At the start of the panel’s discussion Thursday, another expert panel member wondered if Ketek is too expensive — especially considering that people continue to take other opioid drugs that have more pronounced effects than Ketek, and also carry more of an underlying risk of addiction.
“The issue that I have with this drug is that there’s this inherent unknown risk,” said Dr. Rob Julian, president of the UK Pain Society. But Julian said that he will not be withdrawing his endorsement of Ketek.
“It’s perfectly reasonable for the community to ask for some cost saving,” Julian said.
Some panel members and others gave an example of such a cost-saving move: rolling back ketoprofen’s part of the ketogenic diet — or the infamous diet known as the paleo diet — to children or allowing adults to use the drug for a limited period of time without the ketogenic diet. The ketogenic diet requires foods to be rich in fat, such as chia seeds and liver.
“Why are they treating a known population with a bad treatment?,” asked panel member Dr. Isaac Paz.
Brown responded by saying that, as of right now, ketogenic diets are “less effective than Ketek” for those who are on stable doses. Ketek has been shown to help decrease the amount of opioids used in patients taking opioids, he said.
As for pricing, Brown didn’t want to speculate on price.
“What I can assure you is that we will take into account what they told us we can do,” he said.