Drug maker paid doctors millions to promote off-label use of Actiq

posted on:
February 24, 2010

author:
JENNIFER WALKER-JOURNEY

Biopharmaceutical company Cephalon paid more than $9.1 million in 2009 to health care professionals for speaking fees and consulting services. Cephalon was required to disclose the information, available on the company’s Web site, along with paying $425 million in settlement charges, after the Department of Health and Human Services charged that the company illegally marketed three of its drugs, including Actiq, a drug approved by the Food and Drug Administration for very limited use to treat breakthrough pain in cancer patients who have built up a tolerance to opioids.

Actiq is a form of fentanyl citrate, an opioid narcotic more powerful than morphine. Administered as a lollipop lozenge, the drug was promoted off-label by Cephalon to treat migraines and backaches. But the powerful painkiller is not intended for use in patients who are not opioid tolerant, and many people prescribed the drug for pain who did not have cancer suffered serious consequences. Actiq has since been linked to 127 deaths and 91 incidents of severe side effects.

While doctors are free to prescribe medicines for any condition they believe is appropriate, drug makers can only promote their drugs for uses that have been approved by the FDA. Lawmakers and health-policy experts say that Cephalon blurred the lines when it paid health care professionals, mostly doctors, between $63 and $149,900 to educate other doctors about Actiq, including its off-label uses.

Cephalon denies any wrongdoing, saying that its payments to doctors were “not intended to influence their prescribing activity in any way,” but to educate other healthcare professionals “about the appropriate and safe use” of its drugs, according to the Philadelphia Daily News

The Frazer, Penn.-based drug company made nearly $2.2 billion in 2009. As part of the settlement agreement, Cephalon will not be banned from participation in Medicare, Medicaid and other federal health care programs.

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