A sales rep for a Virginia-based contract research company offered a nurse at a Pennsylvania clinic $50 for each patient who signed a consent form and gave a cheek swab to enroll in “research” involving genetic tests, a whistleblower suit alleged.
The consent form, filed as evidence with the complaint, gave the company permission to test for genetic variants that might indicate a patient’s drug sensitivity or risk of experiencing side effects. Such tests are used in the field of pharmacogenomics, the study of genetics to inform choices about pharmaceuticals or dosing.
Healthcare insurers, including the federal government’s Medicare program, paid at least $4,000 per patient for the “unnecessary” tests, according to the suit initially filed by the clinic’s parent company, Greentree Medical Center, a suit later joined by the United States, against American International Biotechnology (AIB), LLC. A bill submitted to Medicare for one patient totaled $11,119.85 and the government paid $4,141.86, according to the complaint.
The company is described on its website as a combination of a diagnostic laboratory and contract research organization that can provide services that “support product development from discovery to market.”
According to a press release issued by the US Attorney’s Office for the Western District of Pennsylvania, “The United States alleged that AIB, acting through a contract sales agent, falsely marketed its genetic tests to a Pennsylvania medical practice as part of a free clinical research study for which patients and insurers would not be billed, and later billed those tests to Medicare.” According to the release, the Office of Inspector General of the Department of Health and Human Services and the Federal Bureau of Investigation also joined the investigation.
In late July the lawsuit was settled in the US District Court for the Western District of Pennsylvania with AIB agreeing to pay the US government $343,739. The settlement does not imply admission of wrongdoing, and the court did not make a finding of liability. The story never even made the news.
Yet if the allegations are true, the case offers an uncomfortable snapshot from the world of human research and informed consent, which requires that research participants should know about and consent to what is happening. The suit does not address the issues concerning informed consent, but if true, then patients signed consent forms under false pretenses.
The issue of informed consent to genetic research is hotly contested. One question is whether it is possible to give informed consent to an indefinite future, such as in biobanking. Biobanks, which aggregate biomaterials from large numbers of individuals, are at the heart of a bourgeoning industry to mine data derived from genetic materials for genetic test development. I told the story of one biobank community in an Investigative Fund article which appeared in the July/August issue of Pacific Standard magazine.
Other questions address what kinds of tests are created from genetic materials and data obtained through informed consent processes and, broadly, how to determine the reliability and safety of genetic tests. The FDA announced at the end of July that it plans to begin regulating laboratory-developed tests (LDTs), diagnostic tests developed in-house by laboratories and sometime referred to as “home-brew tests,” which thus far have gone to market largely without the same reviews the FDA requires for drugs.
When I contacted AIB for comment, they referred me to an official statement that denies wrongdoing and says the company chose to settle the matter to avoid the delay, uncertainty, inconvenience, and expense of litigation. “AIBioTech had no knowledge of the alleged actions of the contract sales agent, and only learned of the action on receipt of the complaint; it did not approve or sanctions the actions of the sales agent.”