Coming Soon to your local physicians office may be sales reps from the Federal Government.
Senator Kohl, of Wisconsin and Congressman Henry Waxman today announced their plan to shortly introduce “The Independent Drug Education and Outreach Act of 2008”(Draft Bill)”.
The bill is to set up a pilot project at the Agency for Healthcare Quality Research (AHRQ), ten grants to develop, and educate physicians on the relative safety, effectiveness and cost of prescription medications (Academic Detailing).
The bill provides a list of eligible recipients including medical schools, academic medical centers, school of pharmacy, medical societies, pharmacist societies, research institutes and any other entity determined appropriate by the secretary then section b qualifies this in that these entities “receive no support from any entity that manufactures products used to treat the medical conditions discussed, or any organization funded by such entities, during the period beginning 1 year prior to submission of an application.
This section basically disqualifies the previous list of entities because most if not all of these entities receive support for research, sponsorship and education from manufactures.
By and large the bill is a reasonable approach to test if “Academic Detailing” (sending doctors in to offices to discuss generic drugs) works on a National scale.
Thus far in over thirty years of development it is only used on a limited small scale by one state (Pennsylvania) and several countries and provinces including: Nova Scotia, Australia and Israel.
The most notable published research on this topic was by Jerry Avorn, MD in the New England Journal of Medicine published in 1983 (that’s right 25 years ago). Jerry has a small business the Independent Drug Information Service providing “Academic Detailing” Services to the state of Pennsylvania and he is hoping through this and measures in Massachusetts to increase his business, which also includes all the staff of his department at Harvard.
Jerry helped coordinate the speakers at the hearing on this issue to ensure that his clients (the State of Pennsylvania and Kaiser Permanente where also speakers espousing the benefits of Academic Detailing by the Independent Drug Information Service)
It is interesting to note that the supporters of the bill include all the usual suspects (NLARX, Prescription Project, American Medical Students Association, Gray Panthers, PIRG).
Plus UMASS (which is also doing this with Avorn), The Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital / Harvard Medical School (If you look at the listing of staff for Independent Drug Information Service and the Staff at the Division of Pharmacoepidemiology and Pharmacoeconomics at Harvard they are all the same people – please click on the links you will get a good laugh)
In CME we would consider this an undisclosed conflict of interest. To put your academic center supporting a bill that benefits your personal income…
On another a friend pointed out is that: All communications to physicians via pharmaceutical and device sales reps has to be approved by the FDA and can only discuss on-label information. The concern is that the bi-annual review of material by HHS may not be nearly as rigorous as an FDA review and the playing field for accurate information may not be level.
In the end, a pilot project is a good idea as long as it is not limited to Jerry Avorn’s company as the current language currently has in it. I am sure that the level headed people on capitol hill will address this issue.
Key Documents
Draft Version of Bill:The Independent Drug Education and Outreach Act of 2008
Bill Summary: ideoa_bill_summary.pdf
Press Release: ideoa_press_release.doc
Prescription Project Press Release
Jerry Avorn Medscape Interview