Thanks in part to their petition, the U.S. Food and Drug Administration is holding a public meeting May 27 and 28 about how to reduce accidental overdose deaths caused by prescription painkillers.
West Virginia has the nation’s worst death rate from drug overdoses, with the number of overdose deaths increasing five-fold since 1999.
On a recent day in the courthouse in Pineville, W.Va., clerk Michael Goode flips through a fat folder full of death certificates.
Each one represents someone who died of an accidental drug overdose – 20 total in Wyoming County last year, he says.
Goode, who’s also the town’s only funeral director, watched about ten years ago as drug abusers began to crush and snort prescription painkillers for a heroin-like high.
Some steal the prescription drugs, or buy them on the street. Others trick their doctors -- or find the physicians who don’t ask too many questions.
And now, prescription drug overdoses are killing more people here than car accidents, homicide and suicides combined.
“It’s amazing the things that cause the death of relatively young people, who should be contributing members of society for the next 20 years,” Goode said.
“If these people had died of the swine flu, we’d probably be making national headlines,” he said.
It’s become a national problem, fueled mainly by the misuse of prescription painkillers.
In recent years, the number of drug overdoses in the U.S. rose from about 11,000 in 1999 to almost 20,000 in 2004.
That’s the same year Barbara Van Rooyan’s son died of an accidental drug overdose – 3,000 miles away from Wyoming County in San Diego, California.
Patrick was 24, a personal trainer, and not a regular drug user.
But at a Fourth of July party in 2004, he made a terrible mistake – someone gave him a pill or two of OxyContin, and he took it. Later, he passed out and stopped breathing.
Hundreds of miles away, Barbara Van Rooyan received a phone call from an emergency room doctor.
“The doctor told me that if he were to survive, that he would most likely be seriously brain-damaged. And all of this I had to hear on the telephone,” she said.
“And we could not get a flight down there. It was the Fourth of July and we could not get a flight down there, and I had to wait until the next day to go and be with my son,” she said.
Patrick’s family friends gathered at the hospital for a several-day vigil.
“None of them believed he could die, because Patrick was not a drug user,” she said. “He’d probably done his share of experimenting in college, but you know, this wasn’t Patrick. They couldn’t believe this was happening to him.”
A toxicology report later revealed that when he died, Patrick had no other drugs in his system except OxyContin and the equivalent of two beers, his mother said.
After they buried Patrick, Barbara and her husband, Dr. Kirk Van Rooyan, filed a formal petition with the Food and Drug Administration, asking them to remove certain formulations of OxyContin from the market.
For years, they heard nothing. Then recently, she was at a meeting sponsored by the FDA, and met a woman in the elevator who said she had been put in charge of the Van Rooyan’s petition.
At first, FDA officials weren’t very receptive to Barbara’s message, she said. But then, the overdose deaths continued to mount.
According to Barbara, the woman said most of the people at the FDA “have done a 180-degree turnaround on your petition and they’re recognizing this is a very bad epidemic and something needs to be done.”
Indeed, the problem had become big enough to grab the attention of the FDA.
In February, the FDA sent letters to the makers of several opioid drugs.
FDA spokeswoman Judy Leon said oxycodone, methadone, hydrocodone, fentanyl and others will be required to have a Risk Evaluation and Mitigation Strategy, or REMS, to insure the benefits of the drugs continue to outweigh the risk.
It’s not like the FDA hasn’t done anything about these overdose deaths. They’ve added new warnings for fentanyl and methadone, and sent educational letters to doctors.
But FDA officials say these previous education efforts have largely failed.
In 2007, Congress passed a law giving the FDA new powers to oversee the safety of drugs that are already on the market. It’s used that power several times since then.
But this would be big – what one FDA official called it a “massive new program” affecting more than 21 million prescriptions.
In this new REMS plan, the agency could require patients to submit to drug testing, or, it could require a pill count, where patients must bring to their doctor unused pain medication.
It also could require doctors to attend special training – or even limit who can prescribe certain painkillers.
And if the drug companies don’t go along, the FDA could conceivably pull some of these painkillers off the market.
In fact, that’s exactly what the FDA threatened to do to several painkillers in March.
The agency had not formally approved these potent, highly-concentrated formulations of oxycodone and morphine, and threatened to halt production of them in 60 days.
Pain-specialist J.K. Lilly says the REMS and threat to pull certain drugs off the market has sent shockwaves through his profession. Lilly runs Appalachian Pain Clinic in Charleston.
“As far as I know, nobody expected it. The way it came, out of nowhere, was like a bomb, out of the blue, with a 60-day fuse,” Lilly said.
An outcry from pain specialists and hospice workers caused the FDA to back down and allow continued marketing of a high-concentration morphine solution that’s used largely to help terminally-ill patients.
But Lilly is worried the FDA’s more aggressive stance may make life harder for legitimate pain patients.
He says since many overdoses occur when the drugs are used illicitly, it’s the DEA, the Drug Enforcement Administration -- not the FDA that should be taking the lead.
“It’s not uncommon to see people come in the hospital overdosed with Grandma’s Xanax, brother-in-law’s hydrocodone, and a couple of methadone someone has bought off the street,” he said. “Those people can get dead real quick.
“Those drugs that they got were prescription drugs, but they were not provided for them,” Lilly said.
While pain doctors worry the FDA may go too far, relatives of overdose victims think the agency may not do enough.
Dr. Kirk Van Rooyan, a long-time plastic surgeon, plans to speak at a FDA-sponsored public meeting in Washington today.
He’s calling for an outright ban on certain extended-release painkillers -- such as OxyContin, which he says is too easily abused.
“From the very beginning, Purdue Pharma has promoted OxyContin as sort of an end-all, be-all kind of drug for pain relief of pretty much any situation.
“They’ve encouraged their prescribing physicians not to be selective. They’ve violated one of the basic principals of medical practice, which is, you don’t treat someone for something until you know what’s wrong with them,” Van Rooyan said.
Any effort to cut down on overdose victims leads to protests from pain patients and doctors about access to care.
Now, it’s up to the FDA to balance those interests and try to come up with some sort of solution.