Ghostwriting is a topic that plagues the pharmaceutical and biotech industries. See my previous post entitled “Ghosts in the Machine” (http://wekfiles.blogspot.com/2007/10/ghosts-in-machine.html). The ghost writing issue has been debated to death without firm resolution. I promised in a previous post that I had a solution to help with the ghost writing dilemma…well here is one solution. Sorry medical writing firms and publication planners, though many of you are good friends, I don’t believe a long-term solution can be developed with multiple competing interests.
In my opinion the issue really boils down to people. People can be influenced very easily, especially if there is $$$ in the mix. In contrast systems cannot.
I’ve spoken to many publication planners and medical writers about this very topic. Full disclosure, everyone I’ve spoken to, thinks its nuts and there is no way an automated system could ever replace a human being in such a complex set of processes. I think Larry Ellison said it best, “When you innovate, you've got to be prepared for everyone telling you you're nuts.” I’ll also cite the radiation technology industry. 10 years ago, aside from the visionaries no one thought that XRays could be read by a machine….well today they are. Not only are they screens read, they are analyzed and emailed to the physicians who can tend to patients while the processing is occurring. Nuts? Maybe, but who else is going to dream this stuff up?
The idea…
I’d hope Larry Ellison would endorse this one…
There are volumes of data and warehouses of publicly available data on the Internet (e.g. PubMed.com, ClinicalTrials.gov). What medical (ghost) writers will typically do in a nutshell is troll the online data stores, confirm citations, garner permissions from publishers, create an outline, and draft the paper, format it to guidelines - rinse, repeat. This process of back and forth typically takes 30 weeks.
Often times not only are the data freely available but are also consumable by XML technologies. Enter Web 2.0. These XML technologies are commonly used to distribute or get information from disparate sources (e.g. Froogle, weather and news updates). Imagine a tool that pulls information from online medical repositories, based on parameters (search criteria) a user enters through a website. The website in the backend compiles online data intelligently, rendering at the very least an automatically generated set of references and perhaps an outline for the publication. Let’s take it one step further and give the application the ability generate data that is deemed regulatory “safe” and within online and traditional publisher guidelines. Futuristic? Yes. Crazy ? - You decide, but the technology exists today to get what I just outlined done. Of course there are caveats and much alignment needs to be performed to make something like this happen…but wouldn’t information that is disseminated more quickly, more transparently and more completely from sources that cannot be influenced help an industry that is accused of hiring professional writing talent to spin a drug’s messages in the medical literature? I think so.
Who loses? Well of course the ghostwriters. But do they have to lose? Couldn’t they change their business to adapt? Publication planners don’t want to become the Polaroid of the pharmaceutical industry. Take a lesson from Kodak. Moving from traditional writing role to service oriented architecture may give medical writing firms the nimbleness to change with technology as opposed to change with the law.
Showing posts with label Ghost Writing. Show all posts
Showing posts with label Ghost Writing. Show all posts
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.
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.
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