The leader of the U.S. Food and Drug Administration, whose agency is responsible for what drugs hit the market, heard state leaders' frustrations Tuesday with the amount of addictive painkillers that have been shipped to West Virginia, fueling a wave of abuse and overdoses in the Mountain State.
Dr. Robert Califf, who took over the FDA in February, was in Charleston on Tuesday for a discussion on opioids, drug abuse and recovery, during which time he also heard about some of the steps West Virginia has taken to fight the opioid epidemic.
West Virginia, which leads the nation in overdose deaths, had 730 people die of overdoses in 2015, Dr. Rahul Gupta, state public health commissioner said.
That's one person every 12 hours.
"We're a country of 3 to 4 percent of the world's population, we consume 80 to 90 percent of the world's opioids," said Sen. Joe Manchin, D-W.Va. "Something's wrong. Something's wrong."
Manchin, who was one of only four senators to oppose Califf's appointment, nonetheless had praise for some of the changes he has made in his short time in office and said he is hopeful Califf can lead the agency toward a greater consideration of opioid abuse as it considers new drugs.
Manchin had opposed Califf's appointment because of his ties to the pharmaceutical industry - Califf has consulted for drug companies and ran a Duke University research institute that got much of its funding from drug companies.
"Anybody that comes from the industry, I believe, has a hard time transitioning to a watchdog for the consumer," Manchin said.
"How do we stop pharmaceuticals from putting all this stuff on the market?" Manchin asked Califf. "What authority do you have to say, 'We don't need any more product ... don't bring it to me, because we're not going to approve it?' "
Gov. Earl Ray Tomblin urged Califf to read news accounts chronicling the hundreds of millions of pills that drug companies shipped to West Virginia pharmacies in the mid-2000s, figures that have come out because of the state's lawsuit against drug distributors.
"There's no doubt, the American pharmaceutical industry is a driver," Califf said.
"It's a business model," Manchin cut in.
"It's a business model, doctors have been prescribing it," Califf agreed. "There's no question, doctors have been influenced by the pharmaceutical industry; a lot of money has been made."
Manchin talked about his frustration that it took three years to get the Drug Enforcement Administration to reclassify hydrocodone, the active ingredient in Vicodin and Lortab, as a drug with high potential for abuse, so that it is more difficult to get refills.
Compounding his frustration, soon after the DEA reclassified hydrocodone, the FDA approved a powerful new opioid, Zohydro.
"I just went crazy, I went completely insane. I said, 'How can you do that to us?' " Manchin said. "It's too potent, too dangerous."
While the FDA approves new drugs, the DEA regulates them and is in charge of approving how many pills can be manufactured per year.
Califf, who will travel to Mingo County Wednesday to hear from first responders about their experience with the opioid epidemic, also heard about some of the steps West Virginia has taken to respond to the epidemic.
Dr. Carl Sullivan, head of the addiction program at West Virginia University Medicine, talked about the increase in the availability of treatment, specifically medically assisted treatment, but how much more is still needed.
Sullivan, an advocate for Suboxone, said his clinic in Morgantown serves 450 patients but has 600 on the wait list.
The Obama administration recently announced a rule change that will allow doctors like Sullivan to prescribe Suboxone, and other buprenorphine-based drugs, to more patients.
Califf called addiction a "chronic, lifelong issue," in praising medically assisted treatment, in comparing it to other diseases.
"If your blood pressure's high, you take the pills for life," he said. "Nobody says after two years, you should stop taking your pills."
Drug treatment counselors talked about the difficulty of finding jobs for their patients, well over half of whom tend to have drug-related felonies in their past.
Others talked about the importance of training doctors to cut down on unnecessary prescriptions.
"Doctors are prescribing, in my opinion, a lot more responsibly than they were five years ago," Tomblin said, adding that that had helped cause an increase in street drugs, like heroin and fentanyl.
Gupta talked about the state's success in making naloxone, which can reverse the effects of an opioid overdose, more available - both over the counter and in the hands of first responders.
EMS agencies statewide have administered nearly 10,000 doses of the life-saving drug since 2013.
"It seems like you're on a good path, Califf said. "With a long way to go."
Reach David Gutman at david.gutman@wvgazettemail.com, 304-348-5119 or follow @davidlgutman on Twitter.