Tastes like candy, packs a wallop
Small package, big problem
Actiq, a Utah-made painkiller, is called a blessing by many, but police and regulators warn of a possible darker side
- Salt Lake City Tribune
12/24/2006 - For those in the throes of the searing pain of late-stage cancer, Actiq, a Utah-made painkiller on a stick, brings quick, euphoric relief.
But for the very reason the fruit-flavored, lollipop-like narcotic is acclaimed - it is 80 times more potent than morphine - Actiq has come under scrutiny by law enforcement and the medical profession because of its addictive nature and un prescribed, or even illicit, use.
Steve Shoemaker oversaw clinical trials for the solid, orally dissolved form of the opioid fentanyl at what was then Anesta Corp. in the late 1990s - and he still remembers the payoff. The tearful gratitude of agonized patients relieved by just a few sucks on the painkiller.
"We called it the 'Actiq Hug,' " says Shoemaker, who works for a small Florida medical consulting firm. "Doctors, even [drug] sales representatives, were getting hugged by cancer patients.
"One told me, 'My pain used to control me, now I can control my pain.' For severe chronic pain, that is a matter of quality of life."
Anesta was acquired by pharmaceutical giant Cephalon in 2000, and in the years since, Actiq has become a huge profit center, while also becoming a leading "off-label" prescription, or a drug prescribed for other than its government-designated use. An estimated 80 percent of users of the extremely potent narcotic suffer from maladies other than cancer, the only usage approved by the Food and Drug Administration in 1998.
In fact, in the battle to get the drug approved, the FDA required that Actiq be marketed only to oncologist's and their associates, and it mandates that Cephalon report quarterly whether there is potential for off-label usage greater than 15 percent. In a recent report in The Wall Street Journal, Cephalon officials argued that it is difficult to prove a prescription is inappropriate because cancer patients may visit many types of doctors to treat their pain and ailments.
Although the FDA's restrictions on Actiq remain in force, they amount to little more than a prohibition on actively marketing products for off-label use.
Otherwise, they are advisory in nature. Doctors can legally prescribe Actiq for other types of pain and regularly do, with severe backaches and migraines favorite targets.
In The Wall Street Journal report, Verispan, whose surveys of prescription-drug sales are widely used in the industry, data for the first half of 2006 show that two specialties exceed 15 percent of Actiq prescriptions - anesthesiologists at 29.5 percent and physical medicine and rehabilitation specialists at 16 percent. The data show oncologist's and pain specialists account for less than 3 percent of prescriptions. Cephalon doesn't dispute the data.
The FDA won't comment on the issue beyond promising enforcement actions against companies that cross the off-label promotional line. But within the medical community, the practice of off-label drug prescription is cause for debate.
"It's important to remember that despite the FDA indication [for use], Actiq was intended for chronic pain, cancer-caused or not," Shoemaker says. "Misunderstanding this is a frustration I have. Actiq has since been used in millions and millions of doses without a serious safety issue."
Salt Lake lab: Cephalon, which is based in Frazer, Pa., but continues to operate a Salt Lake City laboratory, has reported 129 deaths associated with Actiq since it debuted in 1999. The company says 36 were tied to overdoses or other misuse. The remaining 91 deaths, which the company says occurred in clinical studies prior to the drug's launch, were primarily because of cancer.
Still, Connecticut state and Philadelphia federal investigators are looking into Cephalon's alleged off-label marketing of Actiq and other drugs. Company spokeswoman Sheryl Williams says Cephalon is cooperating with investigators, but insists the company's representatives stress appropriate use for Actiq. No charges have been filed.
"Our sales force is focused on visiting physicians who are experienced in treatment of cancer pain - and that group is broader than" cancer specialists, adds Williams, whose company has seen sales of Actiq grow from $15 million in 2000 to more than $400 million today, according to The Journal report. Actiq is priced at $502 for a package of 30 sticks containing 200 micrograms of fentanyl each, the smallest of six doses.
The report in The Journal pointed to a survey by research firm ImpactRx, showing that visits by Cephalon sales representatives to noncancer doctors to pitch Actiq increased sixfold from 2002 to 2005. These doctors reported more than 300 visits in 2004 and 2005. Cephalon says it can't confirm the numbers but it doesn't dispute that it has stepped up its marketing of Actiq to various types of doctors, ranging from sports-medicine specialists to family practitioners.
Prescribing off-label is a common practice, leaving physicians the final authorities on whether certain drugs intended for specific ailments also can benefit patients diagnosed with other problems. A recent Archives of Internal Medicine study estimates that 20 percent of prescriptions are for off-label uses.
"You don't want to get to where these drugs are so tightly controlled that physicians are afraid to use them. Then, people who need it most will suffer," says Mark Fotheringham, spokesman for the Utah Medical Association.
When it comes to Actiq, Bradford Hare, a pharmacologist and senior member of the University of Utah Pain Management Center, agrees - to a point.
"There are very few valid applications" for off-label use of Actiq, he says. "There may be certain clinical situations, for short intense periods of pain, but [Actiq's] effects are too intense and too short-lived to really be of use for long-term, chronic pain."
Patients have been referred to Hare who are taking several Actiq doses a day, but he immediately stops that. "It can put patients on a roller coaster," he says, expressing preference for more conventional, longer-lasting pain medications.
About Actiq
Actiq is made by Cephalon's Salt Lake City facility.
Fashioned as a fruit-flavored sucker, it contains the ultra-potent painkiller fentanyl.
The compound is estimated to be 80 times more powerful than morphine.
Although approved by the FDA only for cancer patients, it is not illegal for doctors to prescribe the drug for other ailments.
If you or a loved one have been injured by Actiq side effects, Actiq addiction, Actiq overdose, or Actiq related death you may be entitled to compensation. For information regarding your legal rights, or the possibility of a Actiq class action lawsuit contact our actiq lawyers for a free, confidential, case evaluation today. Fill out our online case evaluation form or call us toll free at 1-800-856-6405. |
