Florida Health News

Pharmacist slams OxyContin 2 at FDA hearing

By Carol Gentry
5/6/2008 © Florida Health News

In the belief that one person can make a difference, Clearwater pharmacist Larry Golbom paid his own way to appear before an FDA advisory panel in Maryland on Monday to warn against approval of a new form of OxyContin. By the time he got home late Monday night, he had reason to hope he’d had an impact.

While no vote was taken, a majority of panel members expressed concerns about the product and suggested that Purdue Pharma, the manufacturer, make changes. Dow Jones newswire’s account quoted panel member Jeffrey R. Kirsch as saying the company’s data had “poor scientific rigor.” Kirsch reportedly added, “It’s almost insulting.”

Golbom said it was ludicrous for FDA to even consider approving a new form of painkiller made with oxycodone, an opium-derived compound that constitutes the active ingredient in OxyContin.

“Every narcotics officer…every addict knows oxycodone and heroin are interchangeable,” Golbom testified, according to the Dow Jones account. “The FDA has, for 12 years, ignored that fact.”

FDA urged companies to come up with a safer form of OxyContin after it became clear that drug addicts were crushing it to get a heroin-like high by injecting or snorting it. Purdue Pharma’s application for approval of the new formula said the pills now were coated in a way that made them break into chunks rather than powder when crushed. When wet, the company says, the new formula is too gooey to draw into a syringe.

But Golbom told the panel that the vast majority of deaths from OxyContin were from accidental overdoses in those who swallowed the pill whole, so the new formula probably would not save many lives. He also suggested it’s likely that addicts will find some way to thwart the new tamper-resistant features.

He was followed by Ellen and Peter Jackson of Arlington Heights, IL., whose daughter Emily died in 2006 after swallowing an OxyContin pill that a relative had given her. Golbom said that between his comments and the Jacksons’, “it was an emotional and passionate 25 minutes that the FDA needed to hear.”

“The FDA is finally acknowledging that the opioids (opium-derived drugs) are creating way too many negative outcomes,” he said in an e-mail message Tuesday morning to Florida Health News. “The academics and doctors who are involved with the FDA are finally coming out of their ‘bubble.’ They don’t have a clue what to do next. But their refute of Purdue yesterday is clearly an indication that it is no longer business as usual.”

Golbom said the trip cost about $500 and 10 hours of lost work at his job with a chain pharmacy. But that’s nothing compared to what it has cost him to finance a one-hour radio show, “Prescription Addiction – Breaking the Silence” each Sunday night for nearly two years. His archived shows are at http://www.prescriptionaddictionradio.com.

Carol Gentry, editor, can be reached at 727-410-3266 or Carol.Gentry@FloridaHealthNews.org.