Hooked on heroin: Did the FDA enable the epidemic?

RICHMOND, Va. (WRIC) — Heroin use and overdoses are skyrocketing across the country. Some say the federal agency that’s supposed to protect the public’s health may be to blame for America’s addiction.

It’s estimated four out of five heroin users started out misusing prescription pain pills or opioids. Virginia is not immune to the problem. In fact, Andrew Barnes, Ph.D.,Assistant Professor for Healthcare and Policy Research at VCU, says overdoses are very prevalent in Virginia.

“You’re more likely to die of an overdose in this state than a car crash,”  Barnes said.

E6872F83434E43E8A6F582E6713764B6VCU researchers recently found that overdoses from heroin and pain pills kill at least two Virginians every day.

“Of the approximately 1000 overdoses a year in Virginia, 80 percent have to do with prescription opioids or heroin,” Banes said.

Some lawmakers, like Senator Edward Markey of Massachusetts, point the finger of blame at the Food and Drug Administration. He says the FDA, the very agency in charge of protecting our health, enabled the epidemic.

“Yes the FDA stands for Food and Drug Administration, but over the last 20 years it really stands for fostering drug addiction,” Markey said. “It has to end.”

Dr. Andrew Kolodny, one of the nation’s leading experts on prescription opioids and the heroin crisis, agrees.

“They allow these drugs to be promoted as safe and effective for conditions that are not safe or effective,” he said.

Kolodny is also the Chief Medical Officer for Phoenix House, a drug treatment center with locations across the country. He questions the decisions of former FDA Commissioner, Dr. Margaret Hamburg, who resigned last year.

“While commissioner of FDA, Dr. Hamburg did nothing to appropriately address the opioid crisis,” Kolodny said.

Under her leadership, he believes there was a lack of oversight causing the heroin epidemic to escalate.

“It was during her tenure that a steady stream of new opioids were approved, ” Kolodny said.

48D474D128CD4301B4620338B3E2A969Kolodny and Senator Markey are both concerned about a highly addictive and potentially deadly painkiller called Zohydro. The drug was approved while Dr. Hamburg was commissioner.

“What is different about Zohydro is it has a very large dose of Hydrocodone in it, meant to be delivered slowly over a long period of time,” Kolodny said.

Yet, the drug was being marketed to ease chronic pain like every day back aches and migraines.

Kolodny was very vocal about his concerns. During the time Hamburg was commissioner, Kolodny, along with dozens of other treatment centers and 29 state attorney generals, urged her not to approve Zohydro.

In addition, an FDA advisory panel overwhelmingly voted 11 to 2 against the drug. Despite all the critics, the FDA the approved it.

“I was shocked that the FDA approved the drug over the objection of its scientific advisors.” Kolodny said. “It is very unusual for the FDA to go against its advisory group.”

Larry Klayman, attorney and government watchdog, wasn’t shocked. He recently filed a lawsuit against Hamburg regarding her approval of another drug. In that complaint, Klayman claims at the time of Zohydro’s approval, the commissioner’s husband held stock with the makers of the drug.

“Her husband’s company, Renaissance Technologies, owned $20 million in shares of the company that manufactures Zohydro,”  Klayman said.

8News obtained copies of Hamburg’s financial disclosure forms through the U.S. Office of Government Ethics. She did properly note Renaissance Technologies as a source of income. Still, Klayman and Kolodny see it as a conflict of interest.

“I think it was a mistake to appoint Hamburg commissioner considering her financial relationships with pharmaceutical companies,” Kolodny said.

Hamburg’s attorneys tell 8News that for nearly six years, their client served to protect the safety of the American public’s health. They call the accusations against her “reckless, offensive and without basis.”

Responding to the critics, the FDA has recently announced it is rethinking its approach to opioids. The new FDA Commissioner has announced a plan that includes more public and expert input, toughening warning labels and improving treatment.

Still, some say it still doesn’t go far enough.They want the FDA to consult with outside experts before approving any prescription pain killers.

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