Has the push for transparency gone too far? (Part 2)

Darshan Kulkarni

Kulkarni law firm

(Continued from “Has the push for transparency gone too far? (Part 1) ”)

Why the big deal

Without the appropriate connotations as to why these payments were made, the Sunshine Act seems to cast physicians in a bad light. Additionally, to avoid being cast in this bad light, physicians and thought leaders are hesitant to participate in any activities with pharmaceutical companies that may actually enhance the standard of care. This hurts the development of research and therefore erodes trust in existing relationships.

Drug approvals

In addition to the push for transparency with physicians, there has also been a push for transparency with drug approvals. In 2009, a report by USA Today indicated that about half the experts on FDA approval panels had a direct financial interest in the drug or topic that they were asked to evaluate. These conflicts included stock ownership and / or consulting fees. The report asserted that even though federal law restricted the use of experts with conflicts, the FDA had waived the requirement more than 800 times between 1998 and 2000.

Janet Woodcock, the Head of the Center for Drug Evaluation and Research (CDER), was quoted as saying that while she expected drug approvals to increase, the financial interest standards to advisory committee members had made recruitment difficult. She asserted that these issues are complex and the FDA wants people with expertise in clinical trials who understand all the issues involved. However, because these top experts were often the ones that pharma companies hired as paid speaker consultants, they were automatically excluded. She pointed to recent data that suggested that a significant number of vacancies existed in advisory committees and this was delaying drug approvals.

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“Without the appropriate connotations as to why these payments were made, the Sunshine Act seems to cast physicians in a bad light.”

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Additionally, a later formal study examined about 221 meetings held by 16 advisory committees. The study researchers concluded that only a weak relationship existed between the conflicts of interest and voting behaviors. The study concluded that excluding advisory committee members and voting consultants with conflicts would not have actually altered the overall vote outcome.

Critics do a disservice to healthcare providers and patients by creating bureaucratic hurdles that unnecessarily prolong the time to drug approval. This unnecessary delay in drug and device approvals not only hurts companies who have often spent billions of dollars and decades of research on a drug, but often, and more importantly, hurts patients. In light of these delays, congress has recognized this problem and has already submitted bills to combat these delays.

Despite the lessons to be learned, critics have raised the same or similar arguments about the latest version of the “bible” of psychiatry: The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders. Only time will tell if cooler heads will prevail.

No other industry is required to adhere to this

Some critics argue that even though the pharmaceutical and healthcare industries relate to health and saving lives, they are simply just another business and should be treated as such. However, it is important to recognize that these demands of accountability and transparency are requirements with which most other industries are not required to comply. Dr. Henry Black, a physician and Clinical Professor of Internal Medicine at the New York University School of Medicine who will be affected by the upcoming changes, recently said,

“I wish Charles Barkley would disclose how much he is getting from Weight Watchers or Paula Deen would disclose how much she is getting from a company that makes insulin while she is creating recipes that seem to make people more likely to get diabetes. That is not required right now. We don’t know how much Tom Hanks or Brad Pitt got paid for their movies unless they want to tell us and that doesn’t seem to bother us.”

I agree with Dr. Black. Somehow, we now hold physicians and healthcare providers to a higher standard. We somehow believe knowledge of not only a physician’s personal income, but also the personal income of their spouse, is now somehow relevant to feed this insatiable thirst for “transparency” that comes at the cost of privacy. This information will be collected, compiled, and published on a public website with minimal clarification. This selective targeting of physicians (and for some states, healthcare providers) is an aberration of disclosure requirements and is unfair.

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“…a significant number of vacancies existed in advisory committees and this was delaying drug approvals.”

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Individuals demanding this information do not have a right to know

There was a recent outcry over Paula Deen signing an agreement with Novo Nordisk when she disclosed that she had diabetes. Commentators were upset that Paula Deen had kept her diabetes private while she created recipes that, if followed and eaten, could exacerbate her viewers’ diabetes. Paula Deen has always been in the business of creating fatty, delicious food. She has never asserted that her foods were anything but tasty. She has never asserted that they were good for diabetics or good for diets. Nevertheless, individuals who have no right to know whether she had diabetes (her personal condition) assert and demand that she should have been forthright about this condition. I fail to see why she should have been and, in my personal opinion, these calls for forthrightness are misplaced.

Cost of compliance far outweighs potential benefits

There has been a misplaced claim that disclosures of income and transparency of relationships will reduce costs and somehow convert into savings for patients. There is, however, no evidence to suggest this. In fact, the Center for Medicare and Medicaid Services (CMS) projected that their

“total estimated burden for year one implementation is approximately 4.6 million hours, at a cost of $225 million.1 For year two and annually thereafter the total estimated burden reduces to approximately 3.4 million hours at a cost of approximately $163 million (based on assumption of 1,150 applicable manufacturers made up of 150 drug and biologics, 1,000 device and medical supply, and approximately 420 applicable GPO reports).

Smaller manufacturers are projected to dedicate 50% of a full time equivalent employee, whereas larger manufacturers are projected to dedicate 5 to 15 full time equivalent employees to comply with the reporting requirements (10 on average).”

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“…the extent of intrusion has reached a point where the burden of providing this transparency comes at the cost of the very drugs whose prices must be reduced…”

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On the other hand, there is limited, if any, data on what the savings would be. In fact, several life sciences companies who have actually been forced, because of the requirements of corporate integrity agreements, to disclose payments have not resulted in any cost savings and / or significant downward adjustments in pricing of medications and medical devices. Without a resultant cost benefit analysis, it seems apparent that such transparency initiatives would not result in beneficial savings and / or serve the interests of patients.

Conclusion

None of this is to say that healthcare providers cannot be biased or that they are immune to the lure of riches. However, the extent of intrusion has reached a point where the burden of providing this transparency comes at the cost of the very drugs whose prices must be reduced and whose availability must be increased and is now affecting the very lives of patients.

These demands actually propose rules to which no other industry is forced to adhere. And lastly, these transparency demands are actually often from individuals who have no right to know.

References:

1. PWC: CMS Proposed Rule for Implementing the Sunshine Act Introduces New Challenges and Opportunities, December 16, 2011.

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.

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