Obama's Heroin Pledge Has A Huge Obstacle, Senator Says

Joe Manchin says the president's FDA nominee is too close to painkiller-pushing Big Pharma.

WASHINGTON -- President Barack Obama may have targeted opiate abuse in the second paragraph of his final State of the Union speech Tuesday, but Democratic Sen. Joe Manchin (W.Va.) thinks the president could do a better job fighting the epidemic if he'd pick a new FDA boss who was not tied to Big Pharma.

"I hope we can work together this year on some bipartisan priorities like criminal justice reform, and helping people who are battling prescription drug abuse and heroin abuse. So who knows?" Obama said just moments into his final annual address to Congress. "We might surprise the cynics again."

Manchin doesn't count himself a cynic, but he told HuffPost in an interview Tuesday night that the Obama administration needs to do more to battle the epidemic of heroin and prescription painkiller abuse that is ravaging states like his. And he wonders how an FDA nominee who received significant income from big drug companies is going to do a good job slowing down those companies' pushes to sell more -- and more powerful -- pain medications.

Last year, the president nominated Robert Califf, who is currently the No. 2 official at the FDA, to lead the agency. But Califf's ties to industry have raised questions among lawmakers.

"Get somebody in the FDA that’s basically conscious about what’s going on and not married up to large Pharma," Manchin said. "We’ve got more products coming onto the market than ever before, and they know that these opiates are addictive. And they’ve just ruined and destroyed lives."

The senator said he wants an FDA that is more in tune with encouraging doctors to prescribe fewer painkillers for shorter periods of time -- not one that is pushing new drugs into the market.

"I’m not saying anything personal about the person [Califf], but he comes from an establishment that’s basically [supported him] for over 20 years," Manchin said, arguing that it's difficult for most people to turn around and oppose the aims of their backers and colleagues.

Manchin singled out the FDA's recent overruling of its own advisory committee to approve one new addictive drug, and its decision to allow OxyContin for 11-year-olds as evidence of a failed mindset at the agency.

"None of this makes sense. Until that culture changes there, it’s going to be hard for us to have a real upper hand on this thing," said Manchin.

Manchin, the former governor of West Virginia, recounted how his eyes were opened to the prescription drug epidemic by visits to the coal-mining town of Oceana, a West Virginia community that was featured in a documentary and dubbed "Oxyana" because of its population's devastating struggles with addiction.

He went there five years ago, and again recently.

"A little girl, 12 years old, comes, she says, 'I watched my mother’s boyfriend shoot her up, shoot her up. Not only did he shoot her once ... he gave her three shots to make sure he killed her,'" Manchin recounted.

"When you have a 12-year-old girl that tells you they see this because of the rampant epidemic of drugs, and, 'Please, can you do something? Can you give me a better opportunity? Can you get me out of this?' And then they were afraid a little bit to even come talk to us," Manchin said.

Some of those children attended Obama's talk on addiction in Charleston, West Virginia, in October, when the president unveiled plans to better train doctors on prescribing pain medication and to remove barriers to the use of medications that can help those with addiction issues.

"I had those kids come, and I think it made a difference, and they were willing to speak up, they were willing to be brave, not afraid," said Manchin.

Obama may have called for bipartisan action to deal with the opioid abuse epidemic, but Manchin suggested the commander in chief shouldn't wait on Congress to act in his final year, and could do plenty by picking a different FDA boss.

"I think if we can find somebody solid, that doesn’t come from the culture of Pharma being supportive, of Pharma funding research and supplementing all their pay and compensation, I think we really could change," Manchin said.

Earlier on Tuesday, however, the Senate Health Committee voted to send Califf's nomination to the full Senate.

While the well-regarded doctor and researcher has bipartisan support, 2016 presidential candidate Sen. Bernie Sanders (I-Vt.) has threatened to block Califf over his Pharma ties. Sen. Lisa Murkowski (R-Alaska) also threatened to stall his nomination because of the FDA's approval of genetically modified salmon.

Update: 5:22 p.m. -- In a statement, the FDA said that Califf has already gone through a careful process to avoid any conflicts of interest with his past benefactors.

Prior to joining FDA, Dr. Califf went through a comprehensive screening process for conflicts of interest, working closely with HHS staff.  He believes that our best doctors and biomedical scientists should be sharing their insights and knowledge to help develop therapies that save lives and prevent suffering.  However, as we work together to improve human health, transparency and integrity are critical values that we must cherish because the U.S. – indeed the entire world – depends on a strong, unbiased FDA.

Specifically addressing Manchin's concerns about the opioid epidemic ravaging his state, the statement said that the FDA is pushing multiple approaches to battling the scourge. The agency added that not only did Califf never do corporate-backed work on opioids, he also led efforts to reduce their use.

Identifying solutions to prevent prescription opioid abuse is a top priority for the FDA. Our approach is multi-pronged, from encouraging scientific investigation to improving the training of practitioners who prescribe these powerful medicines. Our strong commitment is ongoing, as we work to support regulatory, educational, scientific, and other collaborative activities designed to curb abuse and misuse. Of note, Dr. Califf has never conducted pharmaceutically-funded research on opioids. However, in his public health role as Director of the Duke Clinical Research Institute, he had oversight of Coordinating Center activity for a major grant from the National Institute of Drug Abuse (a branch of NIH) to develop effective approaches to treating drug abuse. Duke remains a research node in the network.

Also as Principal Investigator of NIH’s Healthcare Systems Research Collaboratory, he led network administrative oversight of a major trial done by the Kaiser Permanente Center for Health Research with a primary goal of evaluating multidisciplinary methods of controlling chronic pain while reducing opioid prescriptions. And finally, Dr. Califf served as principal investigator of the Southeastern Diabetes Initiative (actually involved Mingo County W.Va.), receiving an add-on grant from the National Institute on Drug Abuse to work out screening and prevention of substance abuse.