Monday, August 29, 2011

To Those With Congressional Concerns

As predicted, the whole Pump Hacking issue in the news has led to some of those unintended consequences we in the diabetes community feared.

Word came recently that two influential and high-ranking Congress members have taken an interest in this "pump hacking" issue and requested that the Government Accountability Office conduct a review of the Federal Communications Commission's (FCC) actions in regard to wireless medical devices. Both Democratic Reps. Anna G. Eshoo from California and Edward Markey from Massachusetts pushed this after reading about this "pump hacking" issue in the media.

So unfortunately, now comes the necessary response to not only these particular elected individuals but also to others who have a Congressional-voice and may be brought into all of this. I am sending the below letter to my own House and Senate leaders from Indiana, those who are on this committee, and to the FDA that is concerned with these issues. I encourage others to do the same to get the word out.

Also, what do you think of my letter? What needs to be addressed that isn't currently included, or re-phrased? Do you think that this kind of advocacy can make a difference? Thanks in advance for any feedback.

Dear Reps. Eshoo and Markey:

I’m writing to you both in regard to your recent letter to the U.S. Government Accountability Office on Aug. 15, which relates to your concern about wireless health technology security in response to recent media coverage.

As someone who’s been living with Type 1 diabetes for most of my life and has been using an insulin pump for a decade, this is an issue I have a personal interest in and believe warrants my writing to you both about this. I’m a patient-advocate who writes a personal diabetes blog and uses social media to share my story, and with that I wanted to take a moment to write to you about this topic.
First, thank you both for what you do generally and for specifically taking an interest in this important issue. I share your concern that wireless security be protected and these medical devices be secure, and that device makers and those in regulatory roles should ensure this happens.

However, I believe that currently happens and this “hacking” issue should not take away from those real-world concerns that already present a true danger. As you move forward, I hope that you ensure the focus of this review does not take away from the regulatory process that's already burdened by delays at the FDA level and puts the United States behind others worldwide in offering these types of medical device innovations.

While these “hacking” possibilities do theoretically exist in this 21st Century, I’m personally not concerned and have faith in the process we have reviewing these issues. I continue to trust that the medical device manufacturers are aware of these possibilities and address them accordingly, and that the FDA already addresses them thoroughly with existing regulatory procedures in place. Although a threat may exist in theory, the practical risk is non-existent and shouldn't be blown out of proportion. Please don’t let these far-fetched, unlikely scenarios hold up these valuable life-saving tools for those of us Living with Diabetes and facing these concerns every day. It’s so important for the FDA to prioritize these risk and evaluate them objectively, based on what the real concerns are.

For example, hypoglycemia is currently costing the lives of American children and adults – those high stakes mean that this guidance is incredibly important and must be done adequately as soon as possible, in order to not remain behind the rest of the world in providing innovative technology to protect lives. The FDA is studying something called Low Glucose Suspend, which is offered outside the U.S. and is proven to save lives. But that innovation is not offered here and the FDA has only recently started seriously exploring this issue; we need this option in our country because people are dying as a result of low blood sugars too often and this could help prevent that.

Even as that serious issue exists, few Congress members use their voice and influence to discuss it. Instead, you are focused on a matter that’s essentially next-to-impossible chance these devices will be hacked. That comes as many of your constituents struggle to get your attention on an even-broader matter that is incredibly important and time-sensitive.

Not only can the U.S. move forward on that technology aspect, we can also be a part of a bigger conversation worldwide about improving health and lives. The first-ever United Nations (UN) High-Level Summit on Non-Communicable Diseases (NCDs) happens Sept. 19-20, 2011, and heads of state from across the globe will meet in New York City to discuss important health issues such as diabetes, cancer, cardiovascular disease, and chronic respiratory diseases. A similar event in 2001 raised the profile of AIDS/HIV internationally, and the same must be done now. More can be found online here: http://www.ncdalliance.org. Unfortunately, neither President Barack Obama nor our country’s top leaders have expressed an interest in attending – even to just have a seat at the table to listen and learn, symbolizing to the world that we care about these issues even if we can’t officially support or commit to anything specific. That is a travesty that politics can trump over some so universally significant.

As a voter who observes all of this from the patient perspective, I am disappointed that members of my Congress are focusing so much energy and resources to these less-significant issues – even as higher-priority matters demand attention in the U.S. and abroad. I’d hope that senior members of the House Energy and Commerce Committee such as yourselves could help spread more awareness about this necessary balance and where our country’s attention should be focused.

I appreciate your consideration, and again for what you do overall. I’m also forwarding this letter on to other members of your committee and my own representatives in the House and Senate. I look forward to observing your reflection and support on these matters.

Most gratefully,
Michael Hoskins
Greenwood, IN

2 comments:

Meagan said...

Great letter Mike, such an important subject! I don't have a pump yet, but am worried right along with you all since I plan to get one as soon as I am able.

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