NARCOTIC ACTIQ'S USE AND ABUSE RAISE CONCERN

In the wake of the controversy over the prescription narcotic Oxycontin, health experts and insurers are raising concerns about the increasing use - -- and abuse -- of Actiq, a newer and faster-acting prescription painkiller.

Actiq, derived from opium, comes in the form of a berry-flavored lollipop or lozenge that takes seven to 15 minutes to hit the bloodstream after a patient places it in the mouth.  The drug, sold by Cephalon Inc.  of West Chester, Pa., was approved by the Food and Drug Administration in 1998 for severe spikes in pain.  It is so powerful and potentially addictive that its label says Actiq "is intended to be used only by oncologists and pain specialists" knowledgeable in using opioids to treat cancer patients who are already tolerant to opioid therapy for their underlying chronic pain.

But use of Actiq appears to have grown far beyond cancer treatment.  Among the 321,463 U.S.  prescriptions written for Actiq last year -- up from 77,478 in 2001 -- 26% were written by family-practice doctors or internists, five times the number in 2001, according to data from NDCHealth, a health-care information company.

Workers compensation programs usually handle relatively few cases of cancer.  Yet in 2003, as more doctors prescribed the drug to patients, Actiq shot up to 15th on the list of total medication costs in worker's comp claims at The Hartford Financial Services Group.  It had ranked 66th two years before.

In many cases, patients with back or neck pain or other ailments are taking the drug four or more times a day, racking up annual bills of $12,000 to $18,000 for Actiq alone, says George Furlong, vice president of provider and payment services for CHOICE Medical Management Services, a Tampa, Fla., workers-compensation managed care company.  Those big bills have prompted many health plans to keep Actiq off their formularies for covered drugs or to require special authorization for its use.  As of May 1, Medi-Cal, California's Medicaid program, will cover Actiq only after a doctor shows that it is for cancer-related pain.  But provisions in many states prevent workers-comp administrators from restricting coverage of painkillers like Actiq, even for nonapproved use.

Off-label drug use, that is, administering a drug for an illness the drug wasn't specifically approved to treat, isn't illegal and is common in medical fields in which doctors tend to experiment with the latest advances in therapy.  Some pain specialists report small doses of Actiq successfully treats sources of severe chronic pain such as migraines.

But some addiction specialists say the drug's growing use has coincided with an increase in its abuse and illegal trade.  In recent months, police in Philadelphia made several arrests of people who allegedly sold Actiq on the street for $20 a dose under the name "perc-a-pop."

Jake Epperly, president and clinical director of Midwest Rapid Opiate Detoxification Specialists and New Hope Recovery Center in Chicago, says his staff treated their first cases of Actiq addiction about three years ago.  In most of those early cases, patients originally had been prescribed the painkiller for a legitimate injury.  In the past 18 months, Mr.  Epperly has started seeing people who got Actiq illegally or by doctor shopping.

So far, no one is calling Actiq the next Oxycontin, which became a widely abused street drug.  Actiq may not have as much street appeal because it isn't as cheap and its effects aren't as long-lasting.

But some addiction specialists and pharmacists say Actiq's powerful, sudden relief makes it particularly enticing for some drug abusers.  Unlike Oxycontin, "Actiq is designed to deliver a quick effect in the first place," says Robert Bonner, vice president of medical claims and medical director at The Hartford.  "It is ripe for misdirection."

In a survey of some 200 law enforcement agencies, diversions of Actiq to street sales were reported seven times in 2002, while diversions of Duragesic, a patch with the same pain-killing ingredient as Actiq, were reported 159 times, says James Inciardi, director of the Center of Drug and Alcohol Studies at the University of Delaware.

Doctors disagree on whether use of Actiq should be strictly limited to prevent abuse.  "People start feeling the withdrawal and that makes them think they actually need more," says Clifford Bernstein, an anesthesiologist and medical director of the Waismann Institute in Beverly Hills, Calif.  Dr.  Bernstein says he uses a fraction of the opioids to treat patients' pain that many other pain specialists do.

Carl Hess, medical director of the Anaheim Memorial Pain Management Center, says the drug can bring long-sought relief to certain patients dealing with excruciating pain.  However, he concedes that for some chronic-pain patients "it can almost work too well."

Actiq still accounts for a very small piece of the multibillion-dollar market for opioid pain medications.  But sales have taken off since Cephalon inherited the drug in October 2000 after taking over Salt Lake City biotech firm Anesta Corp.  Actiq sales have more than quadrupled since 2001 to $237 million last year, and Cephalon is predicting a 37% to 58% increase this year.  Sheryl Williams, a Cephalon spokeswoman, attributes the growth to more recognition among physicians that pain remains an undertreated, widespread problem.

Nevertheless, some of the robust growth is being driven by increased visits by the company's 450 sales representatives to noncancer specialists.  The reps now pitch the product to pain specialists and even some primary-care doctors who treat pain.  Ms.  Williams says the company calls on noncancer specialists because many of them also treat cancer patients suffering from pain.

- --Theo Francis contributed to this article.

Write to Vanessa Fuhrmans at vanessa.fuhrmans@wsj.com and Leila Abboud at leila.abboud@wsj.com

GOING UP

Sidebar U.S.  prescriptions of Actiq, in thousands

2001 2003

Total                          77         321

DOCTOR*                  2001   2003

Oncologists                5          7

Primary Care             16       83

Anesthesiologists      27       110