DID the manufacturer of OxyContin, a controversial painkiller to which many have become addicted, withhold crucial information from regulators? That’s what a former employee of Purdue Pharma of Connecticut claims in new details added to a lawsuit filed earlier this year. The company denies the allegations.
The drug’s active ingredient is oxycodone, an opiate found in more than 50 painkillers whose effects are similar to morphine. A patented mechanism is supposed to release the drug slowly over a 12-hour period. But since the drug went on sale in the US in 1996, numerous people claim to have become addicted after using it as prescribed by their doctors, though most abuse relates to illegal use of the drug, sold as “hillbilly heroin” or “oxy”.
OxyContin is now also sold in the UK, France, Germany, Australia and Canada. In the US, however, more than 300 lawsuits have been filed against Purdue by people claiming the drug harmed them or destroyed their lives. But the company says its investigations show the plaintiffs were either not addicted, not taking the drug for pain, or abused other substances before taking OxyContin. The package insert says addiction is rare in properly managed pain patients.
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But a former assistant director at the company, Marek Zakrzewsky, is claiming that he warned Purdue that the extended release mechanism in OxyContin pills might be faulty, which could increase the chances of patients becoming addicted or accidentally overdosing.
“We’ve heard story after story that the extended release doesn’t work, but there’s been no way to really prove that,” says lawyer Jeffrey Cooper of the Simmons Firm in Illinois, which is overseeing several OxyContin-related lawsuits. “If the allegations are proven correct it will explain why so many people have become addicted to this drug,” he claims.
In the lawsuit, for example, Zakrzewsky claims that he discovered more than one crystalline form of oxycodone in the pills and that these forms dissolved at different rates. The findings were described in several documents – whose titles are named in the lawsuit – which Zakrzewsky says he showed to his superiors.
In addition, Zakrzewsky claims he also discovered that stearyl alcohol – a component involved in controlling the release of the drug – was present in different forms and that he told the firm’s management that this could affect the way the drug dissolved in the body. In November 2001, the US Food and Drug Administration sent a warning letter to Purdue that highlighted similar concerns about the presence of different forms of stearyl alcohol. But Zakrzewsky says the company rejected his earlier report and ordered another, issued in January 2002, stating that only one form of the alcohol was present.
“We cannot comment on the allegations other than to say that they are baseless and we expect to prove this if and when the case goes to trial,” says Purdue spokesman Jim Heins. FDA spokeswoman Kathleen Kolar said the agency could not comment on pending litigation.