Pharma Execs Guilty of Misleading Public

The maker of the powerful painkiller OxyContin and three of its current and former executives pleaded guilty Thursday to misleading the public about the drug's risk of addiction, a federal prosecutor and the company said.

Purdue Pharma LP, its president, top lawyer and former chief medical officer will pay US$634.5 million in fines for claiming the drug was less addictive and less subject to abuse than other pain medications, U.S. Attorney John Brownlee said.

The plea agreement settled a national case and came two days after the Stamford, Conn.-based company agreed to pay $19.5 million to 26 states and the District of Columbia to settle complaints that it encouraged physicians to overprescribe OxyContin.

"With its OxyContin, Purdue unleashed a highly abusable, addictive, and potentially dangerous drug on an unsuspecting and unknowing public," Brownlee said. "For these misrepresentations and crimes, Purdue and its executives have been brought to justice."

Privately held Purdue learned from focus groups with physicians in 1995 that doctors were worried about the abuse potential of OxyContin. The company then gave false information to its sales representatives that the drug had less potential for addiction and abuse than other painkillers, the U.S. attorney said.

Ken Jost of the Justice Department's Office of Consumer Litigation said this case should put pharmaceutical companies on notice that they won't be able to get away with breaking the law to make a profit.

"The things that they plot in their boardrooms, the things that they do behind closed doors will not stay behind closed doors," Jost said. "We have the people, we have the resources. We'll take the time and we'll take the effort to find out what they did and how they did it."

Purdue Pharma said it accepted responsibility for its employees' actions.

"During the past six years, we have implemented changes to our internal training, compliance and monitoring systems that seek to assure that similar events do not occur again," the company said in a news release.

OxyContin, a trade name for oxycodone, is a time-release painkiller that can be highly addictive. Designed to be swallowed whole and digested over 12 hours, the pills can produce a heroin-like high if crushed and then swallowed, snorted or injected.

From 1996 to 2001, the number of oxycodone-related deaths nationwide increased fivefold while the annual number of OxyContin prescriptions increased nearly 20-fold, according to a report by the U.S. Drug Enforcement Administration. In 2002, the DEA said the drug caused 146 deaths and contributed to another 318.

The U.S. attorney said the guilty pleas were entered Thursday morning in U.S. District Court in Abingdon, southwest of Roanoke. In an unusual move, Brownlee said, company chief executive officer Michael Friedman, general counsel Howard Udell and former chief medical officer Paul Goldenheim each pleaded guilty to a misdemeanour count of misbranding the drug. Of the total fine, $34.5 million was levied on those three.

The fines will be distributed to state and federal law enforcement agencies, the federal government, federal and state Medicaid programs, a Virginia prescription monitoring program and individuals who had sued the company. About $5 million will go toward a six-year company program to monitor compliance with the agreement.

When he took office in 2001, Brownlee said, his office was handling a number of cases related to OxyContin abuse, including crimes by addicts seeking to support their habits and arrests of street dealers and even pharmacists and physicians.

"But it always seemed, I think to me and to the investigators, that there was more," he told a news conference.

Investigators from a number of state and federal agencies worked together on an investigation of Purdue Pharma and began to subpoena company records in 2002, Brownlee said.

"From these millions of records, they picked out probably 300 to 500 documents and pieced together a case," he said.

The Food and Drug Administration was part of the investigation. A spokesman for Connecticut Attorney General Richard Blumenthal said the agency had not acted on a citizen petition Blumenthal's office filed more than three years ago. The petition raised concerns about misbranding and called for stronger warnings and fuller disclosure about OxyContin's dangers.

Kim Rice of the FDA told the news conference that over time the agency has mandated increasingly stronger warnings on labels about OxyContin's abuse potential.

Source: CBC.ca

Drug Regulation Transparency??

Health Canada proposes progressive drug licensing

Health Canada is considering changing its system of licensing prescription drugs, moving to one in which the safety and effectiveness of medicines would be more closely monitored after products are approved for sale.

A discussion paper proposes progressive licensing for drugs to allow follow-up once they are being taken by large numbers of people.

'Drug companies do have to report to Health Canada around spontaneously reported events, but those are under-reported.'— Dr. Andreas Laupacis comments on current system

Clinical trials done before drugs are brought to market are typically small; rare side-effects generally only come to light when medications are taken by many thousands of people.

The aim is to improve the ability of the regulatory system to monitor the safety of medication during the entire life cycle of a drug.

The importance of this has been underscored in recent years by the revelation that popular painkillers from the COX-2 inhibitor family raised risks of heart attack and stroke.

Ongoing surveillance

"A progressive, life-cycle approach to the regulation of drugs is meant to recognize that valuable information continues to grow over time, and that this information should be captured and incorporated into decision-making in a well-planned and transparent manner," said the discussion paper, dated Feb. 21 and posted on the department's website.

"For example, a new use may be discovered for a drug, and this is a potential benefit. Conversely, an interaction with another drug may be uncovered that could be a potential risk in some situations."

The former head of the Canadian Expert Drug Advisory Committee said he believes the proposal is probably "a step in the right direction.

"What I think they are proposing … is a more systematic approach to pharmaco-surveillance or post-marketing studies," said Dr. Andreas Laupacis of St. Michael's Hospital in Toronto.

"Drug companies do have to report to Health Canada around spontaneously reported events, but those are under-reported. It's not the drug companies' fault, but they just are, and there's no systematic look at this."

Success depends on regulatory powers

The discussion document said that a modern regulatory regime should "allow for the initial and ongoing collection, evaluation, and communication about drug information throughout the product life cycle," based on the latest knowledge on the risks and benefits of a drug.

While Laupacis thinks there is a need to follow drug safety in a more organized way, how effective the proposal will be depends on the powers given the regulatory agency, he said.

"What if, when you do one of these post-marketing surveillance, you find that a drug does has unexpected side-effects … Is Health Canada going to respond to that?"

Source: CBC.ca