There Are No Free Meals
There Are No Free Meals
By Jason J. Nichols, OD, MPH, PHD, FAAO
Two years ago (December 2008), I wrote an Editor's Perspective that addressed forthcoming changes in the regulatory aspects of the way in which for-profit companies interact with practitioners. The title of that editorial was “The Cost of a Free Meal?” Those changes are upon us now, and it has become obvious that there are no longer any free meals, or at least they are becoming quite difficult to come by.
Late this summer (2010), the Department of Health and Human Services published a draft proposal of new rules that relate to financial conflicts of interest. Specifically, the dollar threshold that relates to a “significant” conflict of interest will be substantially reduced (from $10,000 to $5,000, in addition to changes that relate to definitions in conflicts associated with equity interests). Likewise, the exact nature of the relationship of the individual and for-profit companies must be disclosed (e.g., consulting, advisory board membership, sponsored lectures, research activities). There will be reporting time-line requirements. And lastly, all information must be publicly disclosed, either by the company or by the institution. That is, companies will be required to report the amount of money paid to individuals (or their institutions). Although this is still in draft form, it is expected that a version of these rules will be enacted into United States federal law. Aside from federal laws or regulations, most major companies have also adopted guidelines (e.g., AdvaMed, Phrma) that relate to managing conflicts and healthcare compliance.
Although many in the field have strong opinions (often negative) about these changes, they appear to be inevitable. That being said, clinical journals such as Contact Lens Spectrum need to be observant of these changes. It is important that both our contributors and our leadership are aware of these issues. The editorial team of Contact Lens Spectrum diligently reviews all materials that we publish to try to ensure that we print accurate, reliable, and non-biased information. We observe guidance from the Department of Health and Human Services about conflicts of interest as well as other regulations regarding ethical standards associated with research involving human subjects. We ask all authors to disclose any relationships with industry, and we then disclose those relationships to our readership. As I said in December 2008 and emphasize even more so today, “it is critical that I emphasize that the industry is and will always be vital to our publication. We will to continue to work together with industry in light of any new regulations to preserve our strong relationship. This will ultimately allow us to continue to provide you with the clinical information needed to practice to your very high clinical standards.”
Contact Lens Spectrum, Issue: December 2010