Someone sent me an article published in 2016 about ghost writing where at the end, a scientist stated the following: “I think major journals should discourage and eventually prevent the use of professional medical writers, and I think investigators should be required to write their own papers.
My response: Dr. Tannock’s quote reflects a common lack of understanding about the role of medical writers in scientific publication writing. Medical writers are to scientific publications as accountants are to taxes. No aspersions are cast simply because an accountant works on someone’s taxes. In fact, it means the taxes are more likely to be done correctly. The same is true when medical writers work on journal articles.
The problem arises when transparency is lacking. If medical writing assistance is used, it’s best practice to acknowledge that at the end of the manuscript. It’s up to medical writers to make sure that happens. And most of us do.
Medical writers perform a much needed function. Just because a doctor made it through medical school doesn’t mean they have the writing ability to describe their findings. After all, writing skills are rarely taught in medical school–doctors have enough to learn as it is.
Medical writers (many of whom have an advanced science degree themselves) bring expertise to publication writing. We are distinct from ghost writers in that we write things only when our work is reviewed by the contributing scientists whose papers we are writing. It’s a red flag to us when a scientific expert is not involved in approving the outline and reviewing the final manuscript.
In summary, medical writers are a group of highly educated professionals who provide an important service. We are committed to ensuring accuracy and maintaining integrity in medical communications. Dr. Tannock is simply misinformed about that issue.
Today the FDA made an announcement. This commenced before the new administration takes office, the FDA released a “memorandum” taking positions on the First Amendment of truthful off-label speech. However with no particular regulatory significance it may be an attempt to put agency views on record before the change in administration.
Understanding the healthcare value dossier. How to accelerate revenues and expand markets. Virtual or corporate onsite training for MSLs, MA professionals and Medical Writers. Nascent Medical LLC to offer a Six-week Course on Health Economics and the Health Outcome Liaisons on April 20th. The course will be led by Jennifer Williams PhD, JD, MBA, RN, MS a veteran leader in the field of Medical Science Liaison and Market Access. Corporate onsite training available.
In my role of reviewing the work of multiple medical writers on a daily basis, I see the complete variety of what’s possible in medical writing. Here are 5 mistakes in medical writing to avoid. I could probably include more than 5, but these are the most common.
Tuesday, Feb 23, 2016
How to grow your small medical writing business, what to do and not do
In this episode, Emma Hitt Nichols talks to her business partner Chrystie Leonard, co-owner of Nascent Medical. This is the second part of a three-part series. We talk about strategic planning, how to grow a business, and the key metrics that are needed to evaluate the growth of you medical writing business.
In the first part, aired a week ago, we talked about what to look for when buying a business. Next week, in the final third, we’ll talk about getting the business ready for sale.
A new survey of women executives in medtech reveals that while most feel they hold as much power as their male counterparts, they don’t see the same pay or opportunities for investment. Read more from the article, “Blue skies behind a glass ceiling for women execs in medtech.”
Tuesday, Feb 16, 2016
Discussion With Chrystie Leonard about the sale/purchase of Hitt Medical Writing and considerations when selling your medical writing business.
What is involved in selling your medical writing business and getting it ready for sale? What do buyers look for in a business?
Join me as I talk to my business partner Chrystie Leonard about what to look for in a business purchase and also what to consider if you ever want to sell your medical writing business. Maybe as a freelance medical writer, you have never thought about how your business is going to end, but end it must at some point!
Chrystie, who has formerly conducted several mergers and acquisitions transactions in corporate America, bought into Hitt Medical Writing, LLC, in August, 2015, and together we formed Nascent Medical, LLC.
Over the past several months I have encountered many questions relating to off-label data communication. In this article I am providing the three most asked questions on this topic and the summarized responses that I have provided.
In today’s medical environment there is a two-fold element of risk that affects a medical device company. It is comprised on the one hand by the risk of improper treatment through the agent’s lack of scientific disease state knowledge, and on the other by the medical device company’s fiduciary duty to ensure patient safety, including the facilitation of proper education to the physician of off-label indications. The body of law that regulates the marketing of medical device products in the United States is the Drug and Cosmetic Act, which places a restriction on off-label marketing and advertising. To date, proponents have argued that off-label utilization is a First Amendment right necessary to ensure that patients receive the most effective treatment. Read more about physician education using off-label indications.