Medical Writers' Right to Earn is Under Attack
In January 2009, the North American Association of Medical Education and Communications Companies (NAAMECC) published a draft Code of Conduct for Commercially Supported Continuing Medical Education (CME). Certainly, the lack of boundaries in the past is justification for increased oversight of the CME process. But this latest foray into increasing accountability by the NAAMECC goes too far.
The NAAMECC Draft Code of Conduct proposes that “Staff and/or freelancers who control content for promotional education should wait an appropriate length of time (eg, a “wash-out” period of 6 to 12 months) before working on educational content in the same therapeutic area. Accredited providers should verify this “wash-out” for staff who control content. No such “wash-out” period is needed for staff moving from educational to promotional work.” If adopted, this Code would effectively impose a restriction of trade on medical writers that could negatively impact our ability to earn a living. What the Code does, like so many discussions in the media recently about the role of medical writers have done, is make the assumption that medical writers are inherently unethical. This assumption is simply false.
The recommendation by the NAAMECC to restrict medical writers’ freedom to practice their profession also has the potential to make us unable to feed our families and put roofs over our heads. I, and many freelance medical writers like me, write a variety of medical communications materials for a wide range of audiences, in a wide range of media. This diversification provides us a degree of protection against the ebb and flow of the business environment. For example, when pharmaceutical companies pare down their sales forces, the need for sales training materials declines and emphasis shifts to another communications area to take up the slack, such as CME. The NAMMECC recommendation would inhibit the flexibility of freelance medical writers to follow the flow of these business opportunities, which could have dire economic consequences. Likewise, a medical writer who is employed by a company that produces promotional materials would be restricted from advancing his or her career, and from regaining employment in the event of a layoff, if this recommendation is adopted.
The NAAMECC Draft Code of Conduct is currently accepting comments. Medical writers should consider the implication of this document on our lives and livelihood, and add our comments to the discussion.
It’s the freelance circle of life—you pitch the job, you get the job, you do the job, you bill the job, and you get paid for the job. Right? If only it worked that easily. When any one piece of the circle comes apart, everything after it suffers. But when the last part of the circle, getting paid, comes apart, the rest of your life suffers.
So how do you collect from a slow-paying client? According to a January 22, 2009 article in the Wall Street Journal, some companies are using a sweet-talk approach, which ranges from personal phone calls to gift baskets. When things get really bad, some companies turn to a strong-arm approach. But hiring a collection company or an attorney can backfire by alienating them and destroying the relationship.
In The Accidental Medical Writer’s opinion, the best defense against slow-paying clients begins with a good offense. Start by developing a solid relationship with your client built on mutual trust, respect, and understanding. Send progress invoices for larger projects to limit your financial exposure. Invoice promptly, and follow up quickly if payment becomes overdue. Avoid the temptation to drag your clients through the mud. It may feel good at the time, but vengeance is a bitter pill. Besides, it’s even less likely to get you paid. Quite often, slow payment is the result of an unintentional loss of paperwork, and your client will be happy to expedite the process to keep your relationship on track.
Hefty Fines for Off-label Promotion: Should Medical Writers be Concerned?
In the prescription-drug industry, off-label use of prescription drugs is not that unusual. Health care providers are permitted to use a drug or device off label, that is, in an unapproved manner. Pharmaceutical companies, however, are not allowed to market of promote their priducts for any uses other than those approved by the US FDA, and the penalities can be severe.
Eli Lilly and Company
recently agreed to pay $1.415 billion to resolve allegations that it promoted
its antipsychotic product, Zyprexa, for off-label conditions. You can read the
Department of Justice press release about the case and its resolution here. This huge fine
includes a criminal
fine of $515 million and an additional $800 million in a civil settlement with
the federal government and the states. Among health care cases, this is the
largest fine on record, and the largest criminal fine for an individual
corporation ever imposed in a
If you’re a medical
writer who writes content for pharmaceutical sales and marketing materials,
should you be concerned? In our opinion, medical writers need to be aware of
the regulations surrounding the promotion of off-label uses, and help our
clients by avoiding writing about off-label uses when we know that content will
appear in promotional materials, since we know that is illegal. About the only
places where writing about off-label uses may be acceptable is in continuing
medical education (CME) programs, textbooks, and clinical study reports (CSRs).
When we are hired by our clients, we are expected to create content that is
accurate and well referenced. That means that we need to be acutely aware of a
product’s approved uses. If we include information about off-label use in
something we are writing, we need to state that this is an unapproved use. Once the content we create is out
of our hands, however, we have no control over how that content is ultimately
used. It is incumbent on the company marketing and promoting the product to
ensure that all materials comply with government regulations.
Still, we don’t know what kinds of repercussions might
follow a medical writer who creates content for materials that are later used
illegally to promote prescription drugs. The ongoing investigation into the
influence the pharmaceutical industry has on physicians has already resulted in
the public naming of a reputable medical communications firm and several of the
medical writers it hired. A year ago we would have thought this impossible, but
now it's apparent that it is not. The best strategy in the current environment
is to write accurately, site your sources, and keep copies of the final drafts
as they leave your computer, just in case.