February 10, 2016

Manchin: Culture change needed in FDA | Times West Virginian

FAIRMONT — There isn't a day that goes by when Kylie doesn't think about her father.

At the end of the month, it will be nine years since she last saw her father. Kylie was a junior in high school at the time in Clarksburg, but she stayed home from school that day. Her father had been going through drug withdrawals, and when she woke up at about 10 a.m. that morning, Kylie found him dead.

“He’d found drugs and overdosed while I was asleep, leaving me there to find him,” Kylie wrote in a letter to U.S. Joe Manchin, D-W.Va. “It’s something I carry with me everyday. I don’t have many memories of my father interacting with us kids as a father should. I only have the bad memories of him going above and beyond for drugs.

“Even back then, if the prescription drug problem wouldn’t have been so bad, I feel like he’d still be here today,” Kylie wrote. “I remember exactly how he was laying when I found him. I remember everything. It’s my first thought in the mornings and my last thought at night. It changed my life, taught me a lot of life lessons but it also left me with a lot of heartache.”

Kylie’s story was shared with Manchin on the floor of the Senate Tuesday afternoon as he continues to oppose President Barrack Obama’s nominee, Dr. Robert Califf, to lead the Food and Drug Administration.

“If you look at West Virginia, we have more people dying of legal prescription drugs, that have been produced legally, they were approved by the FDA legally, they were prescribed by doctors legally,” Manchin said minutes before taking Senate floor in an exclusive interview with the Times West Virginian. “Basically, they have killed people legally.

“There are 50 prescription drug deaths a day. When you have this kind of an epidemic, you ought to be able to do something about it,” Manchin said.

On a recent trip through West Virginia, the senator asked those he came in contact with to share their stories of loss and pain at the hands of prescription drug abuse. Those letters are now coming into his office by the hundreds, he said, as so many have been affected by what he calls an opioid epidemic. It's not a problem contained to West Virginian or Appalachia, Manchin said, but one that affects American families across the country.

“We shouldn’t have the government signing off and allowing these addictive drugs to come on the market in more lethal forms every year when there are other ways to treat chronic pain without using an addictive opiate,” Manchin said.

This isn’t about Dr. Califf, Manchin said, whom he describes as “very honorable with a good reputation,” but about the system that’s in place now and Califf’s background as a researcher for large pharmaceutical companies.

“There’s no way he’s going to be able to step into that position and shake it up and change it,” the senator said.

Pharmaceutical companies have to stop putting out stronger and stronger opioid drugs on the market, Manchin said, and they have to be challenged to to create effective alternatives that are less addictive.

“There has to be someone in this government who is determined that they’re not going to let a business model destroy America. It’s a very profitable industry with all these pills. You be dispensing as many addictive opiates as we do in this country without thinking that's not a business model.”

It’s a fight that Manchin says he knows too well from the legislative side. After three years of fighting to get painkillers like Vicodin and Lortab reclassified as Schedule II narcotics so there are more rules that govern how they are prescribed by doctors, there was an immediate 22 percent decline in the number of pills being distributed. But then shortly after that, the FDA approved zohydro for market, which Manchin says is 10 times more addictive than Vicodin and Lortab.

That shows Manchin there needs to be a cultural change in the FDA, and he says that won’t happen with Califf leading the organization.

Manchin’s concerns about Califf are echoed by other senators, including Lisa Murkowski, R-Alaska, Ed Markey, D-Massachusetts, and Bernie Sanders, D-Vermont.

“We’re going to continue to put this out there. This is not going to be out of sight because we're going to keep it front and center,” Manchin said.

By:  Misty Poe