The Ghosts in the Machine

In my opinion ghost writing is one of the most pressing issues that pharmaceutical and biotechnology firms face today. What better topic for Halloween….

What is ghost writing? According to CBC News: The practice of drug companies procuring professional medical writers to draft articles endorsing new medicines and presenting them to prominent doctors and scientists to put their names to, in exchange for financial (or other) compensation. So what? Who cares?

Let’s put this into context.

Fast forward…
Your father has severe plaque psoriasis and has had it for years. He faces issues with depression, discomfort and unsightly scaly skin. He’s taken every conventional therapy available. He’s sat under UV lights. He’s worn long sleeve shirts as long as you can remember. Essentially he has let psoriasis run his life and accepted there is not cure for the auto immune disease. Now imagine that there are 3 drugs at the disposal of your father’s dermatologist which could potentially help your father’s conditions. Your father’s dermatologist prescribes a biologic, “intolumab”, that has been proven to be very effective in treating psoriasis. The reason: Your father’s dermatologist read of the positive impact of intolumab in a prominent medical journal that was written by a prominent dermatological researcher Dr. Frankenstein. Your father begins treatment and finds out after 2 years of very costly treatment, his psoriasis is no better than it began. He’s had to pay approximately $4K out of his own pocket and his morale is lower than ever. I can hear him rumbling something about ghosts…

Rewind…
6-8 years where research is being conducted in phase II clinical trials for intolumab, the future biologic therapy that will be used to treat your father. intolumab is meeting all safety and efficacy endpoints. Intolumab evolves through the clinical development process and right around Phase III or Phase IV of the process, intolumab’s manufacturer “Bio Odyssey” begin dreaming of the impact their emerging product will have on psoriasis patients. Bio Odyssey begins a “publication planning” campaign; bringing together a cross-functional team consisting of medical affairs and marketing to prove to the world intolumab is the best therapy for treating psoriasis. A communication strategy is developed outlining how Bio Odyssey will promote the effectiveness of intolumab to the world. (Let’s face it everyone reading…the purpose of this “strategy” is to increase prescriptions. I hope we can all agree on this point)! As a part of the communication strategy the cross-functional team develops marketing messages or “key clinical findings” as some may refer to them.

The team hires a medical communications (aka ghost writing) firm to help them draft the publications. The accepted role of the firm is to do research, work with the authors in an iterative manner to more efficiently produce the article. By the way this is absolutely legal and practical to garner the assistance of a medical writing company to help craft a manuscript, review article etc since many researchers lack the ability to draft professionally written articles.
The breakdown…
Along the process, all parties realize the publication will have significant impact on the dermatology community and the positive impact for intoumab. Bio Odyssey asks the medical writing firm to identify a prominent dermatologist to include as an author in the late stages of developing a manuscript. You guessed it…Dr. Frankenstein. Dr. Frankenstein does contribute in periodic reviews and posting comments for the “ghosts” to incorporate, however Dr. Frankenstein has not analyzed any of the data. The medical writing firm has accidentally forgotten to include important subset of data that shows intolumab being not as effective in patients who are 50 and older. Uh Oh Casper, what’s that you say your father is 62?

Do you see the dilemma here? It’s not my intent to make you think that all pharma/biotech companies and medical communications firms are real monsters that don’t adhere to ethical publishing practices. It’s my intent for readers to recognize that this does occur. Even if the occurrence of inaccurate information posed by ghost writers is minimal, it should be none since the core publishing principal is “publish only your own work”.

I’m scared are you? Who’s to blame? It’s complicated since there are competing principles all which have merit. Many observers tend to point the finger at pharma/biotech and the medical writing firms. Regardless of where the blame falls, I think we can agree that a solution is needed so my hypothetical father can live a better life with psoriasis. I think the question we should all be asking is how do we solve this problem and make sure all the ghosts in the machine are friendly. Interested? Stay tuned.

Disclaimer on “intolumab” and “Bio Odyssey” are completely fictitious. Any accidental match of current drugs or organizations is simply coincidence.