An Important Message from Dr. Ray Baker, ISIS President, on the Meningitis Outbreak
Tuesday, October 16, 2012
As I write this, there have
been a total of 247 confirmed fungal infections in 15 states, resulting in 19
deaths. This is a horrible tragedy for all involved. At ISIS, we are most
concerned with the patients and their families, and we want to offer our
sincere condolences during this difficult time to all those who have been
affected. We are also concerned about the treating physicians who assumed and
expected that they were obtaining safe medications from a reputable, national
compounding pharmacy. Patients and physicians alike may have been unwitting
victims of poor oversight and under-regulation of compounding pharmacies. This
letter is to update you on some information related to the fungal outbreak, and
to keep you abreast of what ISIS is doing on your behalf.
After being alerted by the
Centers for Disease Control (CDC) of the outbreak, we assisted in contacting stakeholder
societies by providing the CDC with names and contact information. We
immediately began informational posts on the ISIS website, with daily updates
and have issued multiple e-blasts to the membership. These have contained the
most up-to-date information available regarding the outbreak, as well as links
to the CDC and Food and Drug Administration (FDA).
Having worked with the CDC
since last April on safe injection practice policies, including the single dose
vial policy, ISIS appointed a Patient Safety Task Force in July, composed of
members from the Standards, Education, Research, and Socioeconomic Committees.
This task force just published the first in a series of ‘FactFinder’ statements
aimed at increasing member awareness of safe injection practices, and
dispelling myths around single dose vials and repackaging of medications (ISIS SDV/Repackaging FactFinder).
Predictably, as soon as the
outbreak became public, numerous media outlets contacted ISIS for statements
and content expertise. Having been alerted by the CDC, ISIS had ‘talking
points’ already prepared. We distributed these to other stakeholder societies,
and worked collectively with them to assure that accurate information was
transmitted to the media, and focus remained on the primary issue associated
with this outbreak: the contamination of medication by a compounding pharmacy.
Indeed, ISIS’ emphasis has
remained consistent over time: properly
performed interventions - interventions performed by skilled physicians who are
appropriately trained and are performing the right procedure on the right
patient for the right indications - are safe and effective.
Although not quoted often,
ISIS representatives have spent countless hours on the phone and on email with
reporters over the past two weeks providing content expertise and answering
questions. We have provided media representatives with scientific data refuting
claims of treatment ineffectiveness and injections abuse, and supporting the
efficacy of our interventions. We have facilitated patient interviews with
reporters to help balance some of the stories of alleged harm from injections
that have been highlighted in the media. Indeed, positive stories are getting
out, but not as often as we would like. Unfortunately, as is often the case, some
in the media seem most interested in sensational stories and allegations.
We have countered claims of
physician ‘profit motive’ as the rationale for using compounding pharmacies,
and have made the media aware that the primary reason physicians use
compounding pharmacies for methylprednisolone is not a result of the CDC SDV
policy or any profit motive; it is to obtain a preservative-free preparation
that is commercially unavailable, and may be safer for patients. We also reminded
reporters of ISIS’ strong stance on scope of practice, and of the fact that
ISIS only teaches specialty boarded physicians who are qualified to undertake
the complex practice of medicine required to diagnose and treat these complicated
We continue to stress that
the overall number of severe complications with interventional pain procedures is
very small, and that sensationalizing these complications might actually lead
to greater numbers of patients being harmed as they opt for other, riskier
treatments. As issues of increased utilization are raised, while not condoning
the abuse of injections, we note that the vast number of Interventional Pain
Medicine (IPM) physicians are conscientious and are earnestly trying to provide
the best care for their patients.
This weekend, I traveled to
Washington, DC and attended the American Society for Anesthesiologists (ASA)
Pain Committee Meeting and a meeting of the "Council of Pain Physician
Societies” where representatives from ISIS, ASA, American Academy of Pain Medicine,
American Society for Interventional Pain Physicians, and North American
Neuromodulation Society spent a great deal of time discussing issues related to
the outbreak, and developing a common response.
At ISIS, we realize that
this is a very difficult time for all of you. We want to assure you that we
will continue to work ceaselessly to provide you with timely, accurate
information during this crisis; to provide you with the education you need
moving forward; to work on solutions to reduce the need for reliance on compounding
pharmacies; to advocate for strict and appropriate regulation of compounding
pharmacies; and to safeguard the reputation of Interventional Pain Medicine.
I want to especially thank the
ISIS staff, who have worked tirelessly keeping the board and committees updated
on breaking events, gathering the latest media releases, obtaining background
information, and preparing web posts and various responses. Suffice it to say
that all of the staff have done a tremendous job during this difficult time.
Please continue to monitor
our e-news, website and social media as we continue to bring you breaking news
and up-to-date information on this issue.