In this post I will take PhRMA at its word and offer my analysis of the code, assuming that it would be enthusiastically and fully implemented (a state of affairs seldom claimed by neutral observers for the previous PhRMA code). In a subsequent post I will look at the larger context within which this Code has been brought forward.
So--what is different here than in 2002? The previous code seemed designed to defend the industry marketing status quo, throwing to critics as few sops as possible just in order to clean up the most egregious bad-taste abuses--mainly, things like buying golf balls for docs and paying for docs' spouses also to attend gala dinners. The present code is a much more serious and sober affair. You can read between the lines here that PhRMA now admits a serious credibility and integrity problem. The goal now seems to be--let's figure out the line that we can defend with all of our firepower, based on an appeal to principle, and let's withdraw all our forces behind that line and dig in. Everything that we can't take with us as we retreat behind that line, we toss to the wolves--even if it's such a time-honored emblem of Pharma marketing as the Lipitor coffee mug or the Cialis pen.
The principle on which the new line is to be defended is clearly stated: provide scientific and educational information to physicians regarding company products, and receive scientifically useful information back from selected experts.
What does the industry think it can defend, with head held high, as part of those goals?
- Promotional materials
- Informational meetings and presentations
- Paying physicians as company speakers, and training them to do so
- Paying selected physicians as company consultants
- Providing "modest" meals for events held in medical or educational venues
- Patient-education items for offices such as anatomic models
- "Reminder items"--coffee mugs, pens, notepads, etc. emblazoned with drug logo, but not used directly for patient (or staff) education
- Lavish meals (or whatever is not "modest" according to local standards)
- Meetings held at resort venues
- Any events designed as entertainment or recreation rather than as education
- Paying docs as speakers or consultants when the real criterion for selection is amount of drug prescribed, rather than expertise
Continuing medical education (CME) is handled a bit differently, and in that section, the main agenda seems to be bringing industry practices strictly in line with the rulings of the Inspector General of DHHS in 2003 (see HOOKED). The industry sees an interest in continuing to fund CME programs. The code calls for such funding to be unrestricted and to be used at the discretion of the event sponsors. The division of the company that supports CME should be separated from the sales and marketing divisions. Payments directly to physicians to pay for their registration or expenses in attending a CME event is equivalent to a cash payment to those physicians and is prohibited; the company may instead give an unrestricted grant that the sponsor can use to decrease registration fees, for instance. The company cannot give funds to the CME sponsor that are specified for the purpose of paying for a meal or a reception. In essence, a clear line is drawn in this code between a CME event that adheres to official ACCME guidelines, and a company-sponsored event with a paid speaker in which CME credit is not given.
The code is not willing to forgo company approaches to docs who sit on formulary and guidelines committees. The claim is that such physicians "often have significant expeience in their fields" that "can be of great benefit to companies and ultimately to patients if these individuals choose to serve as speakers or commercial consultants". The only requirement is that the company should "require" the doc (just how is not specified) to disclose the financial relationship to the committee, and what happens then is their business.
What about compliance? PhRMA says it will post the names of companies who agree to follow the code on a website and require an annual cetification of compliance as a condition of the company being listed. It also "encourage[s]" companies "to seek external verification" at least once every three years that it is following the code, and promises later to prepare a specific set of guidances as to how that external verification might be conducted. You might say this is mostly toothless but it at least offers a few more appearances of teeth than was present in the old code.