Harmonyx Releases New Tests for Gauging Painkillers

A Tennessee-based laboratory has brought to market a new assay its chief executive officer hopes will go a long way toward resolving the often thorny issues of pain medication management in the U.S.

Known as the Harmonyx Test for Pain, the assay will test genetic compatibility between the patient and 21 different painkillers, ranging from non-steroidal analgesics that are often obtained over-thecounter, to opioids such as oxycodone that require prescriptions and can sometimes lead to patient addiction and abuse issues.

"If you have a genetic makeup that allows you to take non-addictive pain medicine, then someone struggling with addiction, with a genotype favoring medicine that is non-addictive, can be moved off of an opioid," said Harmonyx Chief Executive Officer Bob Bean. Alternatively, Bean noted that such testing can also avoid issues where patients are taking massive doses of painkillers with little result because their bodies are genetically unable to metabolize the drug.

The buccal swab-based test focuses on eight genes specific to the metabolizing of painkillers. It will be available primarily through pharmacies for $99. Results are provided in a compact one-page report that lists the drugs and plugs them into three recommendations: Try as directed, try with caution, try an alternative.

"We believe that many people are taking medicines that are ineffective, or struggling with dosing that is ineffective, or starting with medicine that is ineffective," Bean said.

The issue of pain medication management has been inching toward a crisis for some years now. The aging population means that about one in three Americans uses some form of medication for pain management. But the use of opioids and their potential for abuse has grown into a significant public health issue. According to data from the Centers for Disease Control and Prevention, the number of prescriptions for painkillers has quadrupled since the late 1990s, and the agency estimates that about 2 million Americans are currently abusing such drugs. A total of 43,000 Americans die of drug overdoses every year, eclipsing the mortality rate from car crashes. Nearly a quarter of those die from prescription painkiller overdoses. The issue has led to huge increases in the number of lab tests performed for what is known as drug management, to determine whether patients are abusing drugs or not taking them and presumably selling them to other parties.

Some Obstacles
Despite Harmonyx providing a painkiller efficacy test at a relatively low price, the lab has some obstacles to overcome. Since it is a prognostic assay, the company has been unable to obtain clearances from the Food and Drug Administration to market the test directly to consumers, prompting it to try the pharmacist route (Harmonyx will provide a physician for interpreting the test). And while Bean noted that it is willing to work with any physician or pain management clinic to provide the tests for patients, the current reimbursement environment does not favor the assay (although Medicare, Medicaid and private payers cover drug monitoring assays).

"There is no financial incentive for physicians to do these tests. They cannot bill for them ... and doctors are choosing tests that will make them money," he said.

There is also some question in the pain management community whether an assay such as Harmonyx's would make a difference in prescribing habits of clinicians in the first place.

"My feeling is that, if a prescriber is appropriately conservative in prescribing and provides appropriately close follow-up, these tests may only be necessary if you see undesirable results from the medication trial," said Robert Twillman, executive director of the American Academy of Pain Management. And while Twillman acknowledged that assays along the lines of Harmonyx's have slowly gained traction, he observed that "given that it is a minority of patients who are not normal metabolizers, I'd expect that this testing would actually be useful in well under half of all cases."

Takeaway: A new test for predicting the efficacy of painkillers may have a tough battle in gaining widespread acceptance.