Statutory restrictions on the commercial use of prescriber-identifiable (PI) medical data could have the knock-on effect of pushing up the time and costs involved in designing and developing clinical trials, warns the US-based Association of Clinical Research Organizations (ACRO).
ACRO has filed an amicus curiae (friend of court) brief with the Supreme Court of the United States in support of the respondents in Sorrell v. IMS Health, Inc, a case in which a challenge to provisions in Vermont state’s Confidentiality of Prescription Information law was rebuffed by the US District Court for the District of Vermont but subsequently upheld last November by the US Court of Appeals for the Second Circuit.
Oral arguments in Sorrell v. IMS Health, Inc, which revolves around First Amendment free speech protections and whether these apply to so-called ‘commercial speech’, are due to be heard in the Supreme Court on 26 April, with a decision likely by the end of June, ACRO notes.
Adopted in 2007, the Vermont statute prohibits the sale, transmission or use of PI data for marketing or promotional purposes, unless the prescriber opts to lift the restriction. The legal challenge to the law comes from data miners such as IMS Health and Verispan as well as the US industry association Pharmaceutical Research and Manufacturers of America.
While the statute makes an exception for data to be used for research purposes, ACRO “is concerned that without a broader market for the data there would not be an adequate economic incentive for the data to be gathered for commercial or research purposes”, the Association says.
Highlighting a “disturbing” trend towards “unnecessary” restrictions on the use of medical data, ACRO executive director Doug Peddicord warns that these constraints could limit the ability of clinical researchers to “appropriately identify physicians for participation in clinical trials, target patient populations, or measure drug safety and effectiveness”.
As Peddicord stresses, the data in question in Sorell vs IMS Health, Inc meet the standards of the 1996 Health Insurance Portability and Accountability Act – whose Administration Simplification provisions address the security and privacy of health data – and are not ‘personally identifiable health information’.
As such, “privacy is not the issue here”, Peddicord comments. “ACRO wanted to weigh in on this case to prevent further restrictions on access to de-identified data that is important to medical research”.
While it would be possible to design and develop clinical trial programmes without recourse to PI and other de-identified health data, says the amicus brief prepared by lawyers at Cleary Gottlieb Steen & Hamilton LLP, researchers would “find the process more expensive and subject to delay, which, in some cases, could compromise the sustainability of the research project altogether”.
More efficient trials
PI data enable contract research organisations and other stakeholders to run clinical trials more efficiently because the data “accelerate finding patients with the disease that a given medicine or treatment is designed to address and the physicians who treat them”, the brief argues.
Researchers can then approach these targeted physicians “to learn more about the efficacy of existing therapies and, if appropriate, invite their patients to participate in clinical trials”, it adds.
“The more quickly researchers can locate clinically appropriate subjects, the more quickly the safety and efficacy of a new compound can be determined, the more quickly the FDA can approve a new drug application, and the medicine can be available to the public.”