Feds Resist Control for 2nd Most-abused Pain Drug

NEW YORK

It is the nation's second-most abused medicine, linked to murders, celebrity overdoses and a rising tide of violent pharmacy robberies. But since 1999 federal regulators have put off deciding whether to tighten controls over hydrocodone, the addictive narcotic that is the key ingredient in Vicodin and other medicines.

The Drug Enforcement Administration and Food and Drug Administration insist they are still actively studying whether to move hydrocodone-containing medicines from the Schedule III category of medicines to the more restrictive Schedule II. But the 12-year delay is frustrating drug treatment counselors, lawmakers and relatives of overdose victims.

"They're not doing a darn thing," said Robert DuPont, president of the Institute for Behavior and Health, a Rockville, Md.-based think tank. "There's no study that takes 12 years. When you think how many people have died of hydrocodone overdoses, it's inexcusable."

Nationally, emergency room visits related to non-medical hydrocodone use have quadrupled since 2000 - from 19,221 to 86,258 in 2009. In Florida alone, hydrocodone caused 910 deaths and contributed to 1,803 others between 2003 and 2007. Actors Heath Ledger, Brittany Murphy and Corey Haim all died from drug cocktails containing it.

A DEA review of police drug labs shows seizures of hydrocodone-containing pills number second only to those of oxycodone, the narcotic used in drugs like OxyContin and Percocet. Hydrocodone seizures have soared from 13,659 in 2001 to 44,815 in 2010.

In March, alarmed by the rising rates of abuse, 58 members of Congress filed a bill that would bypass the DEA and FDA's rulemaking process and tighten controls on hydrocodone.

"The FDA is about controlling dangerous drugs, and they're just not doing their job here," said Rep. Mary Bono Mack, R-Calif., one of the bill's sponsors.

Legitimate pain patients, meanwhile, are worried that such a move could jack up their medical expenses by forcing them to repeatedly return to their doctors for refills. They also worry doctors will be afraid to prescribe needed medicines for fear of attracting FDA scrutiny.

The DEA and FDA have refused to release any documents from the 12 years of study. But an Associated Press review of hundreds of pages of other regulatory documents and court filings mentioning the study show it has been repeatedly passed back and forth between the two agencies, with no final decision taken. In fact, it took weeks for each agency to pin down the status of the review after repeated AP requests.

Hydrocodone is a painkiller that is chemically similar and almost as strong as oxycodone, the active ingredient in the drug OxyContin.

Pills that combine oxycodone with another painkiller like acetaminophen or aspirin are strictly controlled as Schedule II drugs. The category includes products like Percocet and Percodan.

But their hydrocodone equivalents like Vicodin, Norco and Lortab fall under the less-restrictive Schedule III.

The legal difference dates from 1970, when hydrocodone was mainly used as a cough suppressant instead of a painkiller and scientists knew less about how narcotics work on the human body. But the classification has led to dramatic differences in the way the drugs are regulated.

"There was a misunderstanding about hydrocodone's potency," said Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, an advocacy group that wants controls on the drug increased. "They made a terrible mistake."

Schedule II drugs must be kept under lock and key at pharmacies, doctors can only prescribe one bottle at a time, and patients must have an original prescription slip with them. State punishments for abusers are severe, and traffickers can face up to 20 years in prison for the first offense under federal law.

In contrast, prescriptions for Schedule III medications can be refilled up to six times without a doctor visit, and doctors can renew prescriptions by phone or fax. And the penalties for abusing Schedule III drugs are lighter: a maximum 10 years for first-time traffickers under federal law.

States have their own drug schedules for punishing abusers and lower-level drug dealers, but they usually mirror the federal categories.

Drug treatment clinics have been warning about the dangers of easier access to hydrocodone since the early 1990s, and in 1999 the DEA agreed to review whether combination products containing it should be rescheduled.

Twelve years later, the DEA and FDA say they are still in the preliminary stages of that review.

"DEA is following the process outlined in the (Controlled Substances Act), and we will act as that process unfolds," spokeswoman Barbara Carreno said.

"It's the nature of the process; it takes time," said Shelly Burgess, an FDA spokeswoman.

Meanwhile, addicts are increasingly turning to hydrocodone as states crack down on sales of oxycodone products, Kolodny said.

The boom was underscored in June, when a man walked into a pharmacy on New York's Long Island and gunned down four people before leaving with 11,000 hydrocodone pills.

Hydrocodone pills on the market today each contain no more than 10 mg of the drug, while some kinds of oxycodone pills contain up to 80 mg. But the lower content doesn't stop abusers.

"It doesn't make any difference - people will just take more of them," said Ronald Dougherty, the former director of the Pelion Inc. drug treatment center in Syracuse, N.Y.

Dougherty filed the original petition in 1999 requesting that hydrocodone combination products be changed to Schedule II. About 80 percent of patients to his clinic were on hydrocodone, and many had gotten addicted after being prescribed the drug for legitimate injuries or surgery, he said.

In April 2000 the head of the DEA's Drug and Chemical Evaluation Section confirmed the agency was looking into his petition.

Since then the study has been repeatedly passed back and forth between the two agencies, documents show.

In 2004, then-DEA chief Karen Tandy told reporters that Vicodin abuse was "staggering" and said the DEA was actively working on Dougherty's petition. In July 2004 she sent a letter to the FDA asking for its input.

The FDA responded in March 2008, Burgess said, but she would not disclose the content of the report. The next year the DEA asked for more information, she said.

"This process varies for different drugs," Burgess said. "Some are quick, some are one to two years, some are three to five. It's a long, laborious process."

Both agencies refused to release documents from their review, saying the information is not public until the DEA publishes a proposed rule change in the Federal Register. The DEA has previously refused to even release Dougherty's original petition, saying its release could disrupt the policymaking process.

Abbott Laboratories, which makes Vicodin, and Watson Pharmaceuticals, which makes Norco, said neither of the agencies has turned to them for input.

Watson said it's unconvinced that rescheduling would prevent violent crime linked to the drug.

"We want to make sure these drugs get to patients who need them," said Charles Mayr, a spokesman for Parsippany, N.J.-based Watson. "The situation on Long Island, that's a terrible situation, but I don't know if rescheduling addresses that."

Meanwhile, new experiments show hydrocodone is more seductive to the brain than once thought.

In two studies sponsored in 2008 and 2009 by the National Institutes of Health, volunteers were given roughly equal doses of pure hydrocodone and oxycodone. Scientists then tested the volunteers to measure their intoxication and hunger for more of the drug.

The results were nearly identical, researchers said.

"The Schedule III designation of these hydrocodone products does not necessarily indicate lower abuse potential," researchers wrote.

As concern has grown over hydrocodone, in March 58 members of the U.S. House of Representatives filed a bill aimed at cracking down on so-called "pill mills," in which unscrupulous doctors fill out dozens of painkiller prescriptions each day.

The same bill moves hydrocodone combination drugs into Schedule II, effectively bypassing the DEA and FDA rulemaking process.

"It's unusual, but given the intransigence of FDA to move on it, it was the only option left to us," said Rep. Hal Rogers, R-Ky.

Legitimate patients fear that rescheduling hydrocodone will make it harder for them to get much-needed pain relief.

Pattie Crossen, who has fibromyalgia and degenerative spinal disc disease, has to drive 65 miles and pay a $40 copayment every time she visits a pain specialist to renew her hydrocodone prescription.

"It's going to be another med that I have to travel 130 miles to get," said Crossen, 55, of Mount Shasta, Calif. "It's just a big, huge added expense."

Patricia O'Donnell, president of a support group for sufferers of neurological diseases in Allentown, Pa., said many of her group's members depend on hydrocodone to maintain normal lives.

Crackdowns on oxycodone abuse have already made doctors, pharmacies and hospitals wary of treating such people, she said.

"All of these doctors are so afraid that the FDA is going to come after them that they won't prescribe these Schedule II drugs," she said. "I know people are abusing hydrocodone, but if you reschedule it they'll just find other things to abuse."

Requiring more doctor visits could increase costs for insurance companies and Medicare, said Jessica Waltman, vice president of government affairs for the National Association of Health Underwriters, which represents health insurance brokers.

But in the long term there might be savings as well because there would be fewer addicts in rehab programs and emergency rooms, she said.

"I would think there would be some cost savings if you are preventing people from abusing drugs," Waltman said.

Advocates for tighter controls say the government has to act to save lives.

"It's a health care epidemic," said Cindy Harney, founder of a support group in Florida for families of people who have overdosed on prescription drugs.

"The government works for us and it's up to them to protect us. I don't understand how they can sit back with all this devastation going on all around us."