Has the push for transparency gone too far? (Part 1)

Darshan Kulkarni

Kulkarni law firm

Background

There has been a recent surge in requests for disclosures of relationships between individuals and pharmaceutical, biopharmaceutical, and medical device companies (collectively, “Industry”). These calls for transparency are often from individuals who believe that healthcare providers, who have typically completed 6-10 years of college level courses and experience, may be easily influenced by a pen and a pretty pharmaceutical sales representative. They effectively assert that these high-achieving, over-performing individuals who routinely make life and death decisions cannot be trusted to understand the difference between marketing and education. They have hence convinced the government to require that some healthcare providers be forced to disclose their private and personal information for the “crime” of being a healthcare provider. This article questions if the push for transparency has gone too far.

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“They have hence convinced the government to require that some healthcare providers be forced to disclose their private and personal information for the “crime” of being a healthcare provider.”

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Introduction

The push for transparency has gone too far if this push:

1. Erodes trust in existing relationships which rely on trust, or

2. The rules being created are unique to the Industry, or

3. If the transparency is demanded when a requester doesn’t actually have a right to know such information, or

4. The cost of compliance outweighs potential benefits.

Analysis

Erosion of trust: Physician payment Sunshine Act

Like the attorney-client relationship, the physician-patient relationship is considered sacrosanct not only by affected physicians and patients but also by courts. Courts make exceptions to the rules of evidence in order to promote an open and honest relationship between the parties for the simple reason that these relationships are based on trust. Disclosing personal and private information of not only physicians but also their loved ones, with no evidence that it enhances the physician-patient relationship, for the mere paranoid “crime” of being a physician is inappropriate. Such paranoia breeds a destruction of trust between patients and physicians.

The Federal Physician Payment Sunshine Act (“Sunshine Act”) requires sponsors to collect all payments made to physicians (over a certain amount) and then publicize these payments via centralized websites. The Sunshine Act requires physicians to disclose any paid relationship that they may have with life sciences companies even if such a relationship is not only appropriate but also enhances patient care. This environment of required disclosure seemingly presumes that physicians have acted inappropriately and have somehow put their interests above the interests of their patients. There is, however, insufficient evidence to suggest that: (1) physicians put their own interests above the interests of their patients, and (2) a significant number of their relationships with pharmaceutical companies are, or have been, inappropriate.

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“…these physicians are also often providing or being provided with life-saving advice that furthers science.”

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Physicians work with members of the Life Sciences Industry (“Industry”) to address multiple needs of both the Industry and patients. While they are also admittedly marketed to via drug dinners where they may be educated on the latest treatment options, these physicians are also often providing or being provided with life-saving advice that furthers science. While this advice may include marketing and positioning information from the Industry, it also includes discussions on a treatment’s place in therapy, appropriate use of a therapy, conducting ethical clinical trials for on-label conditions of a product, and sometimes to evaluate treatment options in untreated / under treated conditions. These physicians may also be asked to teach other healthcare providers about disease state management via continuing medical education programs. Unfortunately, despite the variety of legitimate services that these healthcare providers may provide, the Sunshine Act lumps all of these actiand / vities together and effectively classifies them as payments to physicians with an implied connotation that these payments may be inappropriate. This atmosphere of distrust does nothing to enhance the physician- patient relationship and unfairly diminishes the trust that patients have in their physicians.

Part 2 of this article can be viewed here.

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DISCLAIMER: The opinions stated in this blog are the sole and present opinions of Dr. Kulkarni as of the time of writing of the blog in question and do not necessarily represent the legal or medical opinions of Kulkarni, LLC and / or its other attorneys. Such opinion(s) may change over time. These blog postings do not constitute legal advice, and do not create an attorney-client relationship and should not be construed as such. These blog postings also do not constitute medical advice. Please contact your physician for medical advice, and your attorney for legal advice, that is appropriate for you.

About the author:

Dr. Kulkarni holds a Doctor of Pharmacy degree, a Master of Science in Quality Assurance / Regulatory Affairs, and a Juris Doctorate degree. He works with and / or for research sites, clinical research organizations and a variety of small and large pharmaceutical and biopharmaceutical companies to assist them in meeting their clinical, legal, regulatory and / or compliance needs.

Dr. Kulkarni has worked, and continues to work, as a pharmacist for more than 10 years He currently serves as Adjunct Associate Professor in the Biomedical Writing Program at the University of the Sciences and has taught courses in Regulatory Documentation Processes, Ethical and Legal Issues in Biomedical Communication, Research in Biomedical Communication, and the Promotion of Biomedical Products- Regulatory Considerations.

You can follow him on twitter at @FDALawyers or visit him at the Kulkarni Law Firm.

Has the push for transparency gone too far?