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State, drug maker settle

Firm that made bad batch of colchicine will pay at least $100,000
by: L.E. BASKOW, ApothéCure, the Dallas, Texas, compounding pharmacy that mixed a batch of colchicine that was too potent and is thought to have killed three people, will pay $100,000 to the state as part of a settlement.

The Dallas, Texas, drug supplier that last year sent a Portland clinic a bad batch of medicine thought to have caused three area deaths reached a settlement with Oregon Attorney General Hardy Myers this week — a settlement that immediately came under some criticism. The attorney general’s stipulated judgment requires ApothéCure Inc. to pay $100,000 to the state of Oregon, $60,000 of which will go to the Department of Justice’s consumer education and protection fund, and $40,000 of which will go to the Board of Pharmacy. The agreement also requires ApothéCure to pay a $500,000 civil penalty if it wants to sell products in Oregon again. ApothéCure, which sells most of its products through a Web site, currently does not hold a license to sell drugs in Oregon. In fact, according to the Oregon Board of Pharmacy, ApothéCure never has held a license to distribute in Oregon. The lack of a license came to light only after the deaths of two Portland residents and one resident of Yakima, Wash., last spring. All three were found to have died after receiving intravenous colchicine from the now-closed Center for Integrative Medicine in Southwest Portland. Public health officials eventually connected the deaths to a single, 31-vial batch of colchicine from ApothéCure that tested at eight times its labeled potency, strong enough for one intravenous dose to kill, authorities said. Colchicine is highly toxic and not approved for any use by the federal Food and Drug Administration, but is sometimes used orally to treat gout. The Oregon and Washington victims had been administered colchicine intravenously for chronic back pain. Portland Tribune stories after the deaths detailed how ApothéCure, by holding a Texas license as a compounding pharmacy, was able to escape FDA oversight of drug manufacturers. A 2003 FDA analysis of drugs supplied by compounding pharmacies that sell on the Internet found that one in three did not contain what their labels advertised. In addition, the Oregon attorney general’s lawsuit that led to Monday’s judgment alleged that ApothéCure used low-quality water for its products, which could increase the possibility of contamination, and did not properly test its products for contamination or potency. The attorney general revealed this week that ApothéCure had made 44 total sales of injectable colchicine to Oregon health professionals over a period of about a year and a half before the three deaths. Nevertheless, no deaths or injuries have been reported in connection with ApothéCure’s 43 other Oregon colchicine sales. Two of the families of the colchicine victims filed wrongful death lawsuits against ApothéCure, and both have reached confidential settlements with the drug supplier. The third family is in negotiation with the the company over a settlement. As an additional part of the settlement, ApothéCure must refund money from all of its 222 sales to Oregon consumers from 2004 through 2007. Oregonians who purchased ApothéCure products will be notified of their right to a refund by mail. Jan Margosian, spokeswoman for the attorney general’s office, said that Oregon was the first state to reach a judgment against ApothéCure, and that it was sharing its agreement with attorneys general in other states that might want to pursue similar agreements. Margosian explained that the $500,000 penalty would have to be paid only if ApothéCure sought to do business in Oregon again. Still, Margosian said, the penalty served its purpose. “We use it as a deterrent,” Margosian said. “We don’t want them operating here. If they really want to operate here, they have to pay that. We accomplished what we wanted to, and we didn’t have to litigate.” But one longtime watchdog of companies like ApothéCure questioned the settlement. “This is not sufficient to protect Oregonians,” said Larry Sasich, chairman of the department of pharmacy practice at the Lake Erie College of Osteopathic Medicine in Pennsylvania. “The state of Oregon is going to charge ApothéCure $500,000 to sell substandard drugs in Oregon. That doesn’t protect the public from anything. It seems to me there should be a criminal case.” An ApothéCure official, contacted this week, said he had no comment about the agreement. The attorney general’s office has estimated that ApothéCure’s annual sales are roughly $6 million, with Oregon representing only a fraction of that. Drugs still are available for purchase through ApothéCure’s Web site. This email address is being protected from spambots. You need JavaScript enabled to view it.