It's just urine. But for a Baltimore company and a rival, it's liquid gold worth bruising legal battles.
When a patient is prescribed a powerful painkiller like Vicodin or OxyContin, many doctors require periodic urine tests to check dosage levels as part of safeguards to ensure the drug isn't being abused. Some states are making the practice law, and that means a big opportunity for Baltimore-based Ameritox Ltd. and other companies that have rushed to meet the demand.
The competition has spawned no fewer than a half-dozen lawsuits in recent years and what one judge called an "advertising war" between Ameritox and San Diego-based rival Millennium Laboratories. The companies have traded accusations that include false advertising, patent infringement and kickbacks to physicians.
Ameritox, facing allegations of kickbacks, settled with federal authorities for $16.3 million in 2010. The company said cash payments to doctors were to cover "specimen processing" and that it ended the practice in 2005, before a federal investigation. Meanwhile, a federal grand jury investigation into Millennium is continuing, and company officials said they are cooperating.
In a new lawsuit filed last month, Millennium accuses Ameritox of using kickbacks to drum up business, along with taking efforts to publicly disparage Millennium in news releases as a way to take back market share. Ameritox denies the claims, calling it "more of the same" from Millennium and similar to a lawsuit already dismissed in another court.
Such legal maneuvering can be common in industries where there are few differences among competitors' products, said William Hubbard, an assistant professor at the University of Baltimore School of Law. Sometimes, a cycle of litigation can develop, with new lawsuits filed as a way to resolve older ones, he said.
"There's always uncertainty in litigation, and litigation is expensive," Hubbard said. "As the potential of benefit grows rapidly, it becomes worth that risk to take."
The market for drug screenings — for patient monitoring as well as other purposes such as employee vetting — grew to $2 billion last year, according to market research firm IBIS. There are no dominant companies in the market, as most of them are regionally focused, according to IBIS.
Both Ameritox and Millennium have a significant footprint around their respective headquarters, with salespeople and other employees scattered across the country. Ameritox employs about 800, one-fourth of them in Baltimore and Columbia. Millennium employs about 1,200.
About 40 million people across the country take powerful drugs such as OxyContin on a regular basis to deal with pain, said Bob Twillman, director of advocacy and policy for the American Academy of Pain Management. As that number rose over the past decade, competition between Ameritox, Millennium and others became fierce.
"You go to meetings of the big pain management organizations, and you go into the exhibit area, and it would not be uncommon to find five or six different companies advertising there" for screening services, Twillman said. "It's really come along with more attention to the prescription drug abuse problem."
A sustained surge in prescription drug abuse has prompted doctors to be more vigilant and has led to efforts by some states — though not Maryland — to require more frequent monitoring of patients. That, in turn, stoked demand for companies such as Ameritox and Millennium.
In California, a study using data from that state's workers' compensation program found that drug-testing doctor visits for those on painkillers ballooned from about 4,000 in 2004 to more than 186,000 in 2011, and the total cost jumped from less than $200,000 to more than $27 million. Extrapolating to the entire state, researchers estimate nearly $100 million was spent on drug testing in California in 2011.
No similar study of Maryland data has been made, but the state has shown a spike in the prescription drug abuse and overdoses that the urine screenings seek to prevent.
The number of those seeking treatment for addiction to prescription drugs in the state jumped from more than 3,400 in 2007 to more than 7,000 in 2010, according to a state health department report. Since then, the rate of abuse has declined somewhat. A 2012 report found prescription opioid overdose deaths fell 15 percent, while heroin overdose deaths rebounded, rising 41 percent.
Doctors have made it standard practice to periodically screen patients who are prescribed opioid painkillers. The frequency depends on a patient's risk of dependence or addiction, something that doctors evaluate carefully, said Dr. Paul J. Christo, an associate professor of pain management at the Johns Hopkins University who hosts a weekly radio show on Sirius XM Radio – Family talk 131 called "Aches and Gains." Patients are mostly understanding of the need for monitoring, he said, given the risk of using the drugs.
"This is the standard of care," Christo said. "Things can get out of control. We're human and we make mistakes and we all understand that, and I think most of my patients do, too."
As competition in the drug screening industry has intensified, so have the legal battles.
For Millennium and Ameritox, the first clash came in November 2010, weeks after Ameritox agreed to the settlement with the federal government over allegations of kickbacks to doctors.
In a lawsuit, Millennium accused Ameritox of false advertising for marketing claims that its key product could not only detect the presence of a given prescription, but whether a patient was taking it at prescribed levels.