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Millennium Labs Leads Effort to Establish Industrywide Code of Ethics

MILLENNIUM LABORATORIES INC.

CEO: James Slattery.

Financial information: Not disclosed.

No. of local employees: 400.

Headquarters: Rancho Bernardo.

Year founded: 2007.

Company description: A clinical diagnostic company that provides health care professionals with services, clinical tools, scientific data and education to personalize pain-treatment plans to improve clinical outcomes and patient safety.

Key factors for success: Focus on providing dependable lab test results. Company is leading efforts to establish industrywide ethical standards for clinical labs providing drug-testing services.

It’s like the Wild, Wild West in the pain-medication monitoring industry, say leaders at San Diego-based Millennium Laboratories Inc.

The 700-person company, which sells its drug-testing services to doctors and other health care professionals, is taking a very public stand against competitors that it says are disregarding ethical standards and putting patients at risk. Kickbacks to doctors are among the many unsavory practices in play, said Millennium President Howard Appel.

Appel didn’t provide names of companies he believes are the biggest offenders, but said that the problem is widespread due to a low barrier to entry for lab startups and the prospect of fast profits.

“It becomes harder to compete when no one is following the rules,” Appel said. “We think there’s a need for this industry to self-regulate, just like Pharma did. We don’t wait for the government to take action.”

Appel compares Millennium’s efforts to the successful push by the Pharmaceutical Research and Manufacturers of America to regulate how drug marketers interact with health care professionals.

The trade association’s ethics code went into effect in 2002, prohibiting pharmaceutical companies from offering perks like restaurant meals and theater tickets to doctors.

The drug industry’s rules are meant to ensure the focus of marketing interactions is on “the exchange of medical or scientific information that will benefit patient care,” according to the code. “An important part of achieving this mission is ensuring that health care professionals have the latest, most accurate information available regarding prescription medicines.”

Appel said similar guidelines should apply to lab companies like Millennium, through which doctors order tests that detect the presence of pain medications in their patients. Health care professionals should choose a vendor based on factors such as how accurate the tests are and how quickly the lab can return a result — not on financial kickbacks, Appel said.

Taking the Pledge

Privately held Millennium in March announced it had adopted a “Clinical Laboratory Responsibility Pledge,” with the goal of setting the course for more and ethical business practices in the medication monitoring industry.

The pledge builds on the U.S. Office of Inspector General’s Compliance Program for Clinical Laboratories. The company calls upon all other medication monitoring laboratories to take the pledge, too.

Bioethics expert Richard Payne, professor of medicine and divinity at Duke University, will be chairing a “stakeholder” summit of various physician and pain-management associations to consider the ethics issues facing the industry.

The summit, details for which have not yet been announced, will help raise awareness of expected laboratory conduct among physicians and other prescribers, and reduce unethical practices by “those companies seeking an unfair advantage,” Payne said.

He said Millennium’s pledge could help “lead the medication monitoring industry to a higher level of integrity in business practices and patient care.” Millennium is providing a grant for the summit.

Millennium, whose founder and CEO James Slattery once worked as a Massachusetts police officer, is also advocating regulation of other areas of the pain management industry that don’t directly involve lab-testing practices.

At the American Academy of Pain Medicine annual meeting in March, Millennium sponsored a two-day seminar on safe opioid prescribing practices and a symposium on the medication-taking behaviors of pain patients and ways to minimize adverse events caused by misuse and abuse. Appel said the events are timely “given the state of drug misuse and abuse in society.”

According to the most recent data from the Substance Abuse and Mental Health Services Administration, a government agency based in Rockville, Md., an estimated 5.2 million people reported recently using prescription pain relievers such as Vicodin or OxyContin for nonmedical reasons.

Millennium in 2010 launched a nonprofit research center, the Millennium Research Institute, housed at the company’s headquarters and labs, which encompass more than 100,000 square feet in Rancho Bernardo. The institute focuses on research and education that helps doctors better identify and prevent prescription drug abuse, among other things, Appel said.

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