Influence of medical writers

Darshan Kulkarni

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Kulkarni law firm

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Medical writers write, edit, or develop materials about medicine and health. They do this by gathering, organizing, interpreting and presenting information in a manner appropriate for the target audience.

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Who is worried about influence and why?

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Government

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The government is often the largest payor for pharmaceuticals, biopharmaceuticals and devices. Resultantly, the influence on prescribing often results in a cost to government. The government has an interest in lowering cost, and hence intends to minimize the cost by lowering the influence.

“…last year pharmaceutical companies paid up to five billion dollars in fines.”

Companies

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Causing the government to overpay may result in companies facing legal actions by the state, local and federal governments. Under the False Claims Act, for example, the submission of false claims may result in criminal, civil and / or administrative penalties against companies or individuals working with the companies. In fact last year pharmaceutical companies paid up to five billion dollars in fines. Additionally, between October and November of 2011, the pharmaceutical industry paid over $4.5 Billion dollars in fines.

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Patients

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Patients may be paying for certain medications, partly or wholly, out of pocket. Additionally, if a prescriber was inappropriately influenced, she / he may prescribe a drug that is not in the best interest of the patient. I believe that this is a weaker argument since, in my experience, prescribers look at the best interests of a patient, and do not simply prescribe a drug inappropriate for their patients.

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What would be considered to be influencing?

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Final Review Rights

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Depending on the type of medical writer, and the type of agreement the pharmaceutical company has with the medical writer, the pharmaceutical company may have what is referred to as “final review rights”. Once an entire write-up has been provided by a medical writer, the company may want to look at it and they may want to insert certain promotional language into it. This is considered to be influencing.

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Ghost Writing

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Additionally, medical writers may be asked to attribute their writing to other providers irrespective of the contributions of these providers. This issue of ghost writing has been in the forefront of the media recently and inappropriate influencing of who should be listed as an author could be considered influencing.

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Study Burying

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If the sponsor doesn’t like the results of the study and they want to “bury” the final writeup by choosing to publish the writeup in a less renowned journal, and / or in a country where the results of the study would not be noticed. This would be considered influencing since negative data is not brought to the notice of Prescribers.

“…medical writers may be asked to attribute their writing to other providers irrespective of the contributions of these providers.”

Individually, these actions may not, necessarily, be illegal. However, collectively, in whole or in part, they may constitute the “influence” of prescribers, and may violate some laws.

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What steps can be taken to prevent the influence?

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Disclosures of Conflicts of Interest

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A separation between Pharma advertising and continuing medical education writers is becoming more and more important. Corporate Integrity Agreements (CIAs) often discuss the creation of firewalls. However, if a company outsources its promotional and scientific writing, the same medical writer may theoretically be simultaneously working on advertising and scientific writing for the same company. This could, hence constitute a conflict of interest.

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Medical writers will often freelance or work for multiple vendors at the same time. One vender may be a scientific writing agency and another vendor may be a promotional agency. The promotional agency and the scientific agency may each be working for the same pharmaceutical / biopharmaceutical / medical device company. Resultantly, theoretically, the same medical writer could be working through two different companies in two different capacities for the same client. These actions may hence result in an inappropriate influence on the medical writer. It is hence, critical, that there be appropriate disclosures by medical writers.

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Publication Rights

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Another critical decision that must be made by a bio / pharmaceutical / device company includes choosing to give up control on the publication of a writeup. If study data is given to a medical writer to publish, does that medical writer have to provide drafts to the Sponsor? A decision regarding the point at which a Sponsor gives up control of the drafted medical writing may be indicative of whether a written piece has been influenced.

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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.

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About the author:

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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.

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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.

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

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What concerns do you have about the influence of medical writers?