Clinical Research

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Let’s Talk About Poop

The ups and downs of the first two keynotes at the 2016 Mayo Transform Conference were mirrored in the session The Challenges of Change which highlighted the story of Cologuard. Cologuard is a joint venture between Mayo Clinic and Exact Sciences whose sole goal for the venture was to create a less invasive way for early detection of colon cancer. They succeeded in this goal and were also the first product to receive FDA clearance and CMS reimbursement on the first day. Cologuard launched to much fanfare on national news.

Did they knock it out of the park? Yes. Are they wildly successful today? No. Why? Keep reading and I’ll tell you.

First let’s start with the problem. Colonoscopies, while effective, are not favored by most people. The preparation is extremely uncomfortable, they require general or partial anesthesia, and people need to take time off work. In addition, in some remote communities, it is difficult to get access to care from specialists. As a result, people put off or skip getting colonoscopies and by the time cancer is detected it is often too late. A clinical challenge with colonoscopies is that they are good at detecting left-side tumors but not right side tumors, the incidence of which has been increasing since the 1980s.

CologuardCologuard solves all of these problems. The test is designed to be used at home and is basically a nicely-packaged stool collection kit combined with specialized testing at Cologuard’s lab. No time, and no procedure required for an individual. As well, Cologuard is more effective than colonoscopy at detecting right side tumors, and comparably effective at left-side tumors. Since it’s a home collection, and all tests are processed at Cologuard, access to care is not an issue either and it’s widely used in the Alaska Native Tribal Health Consortium, which was presented as a success story.

Sounds great, yes? Everyone (aka people who at some point will need a colonoscopy or have already had one) I talked to about it thought so. So what’s the problem? As usual, what’s preventing this innovation is an issue of reimbursement. Colonoscopies are a profit center for healthcare organizations, and they are effective, so this isn’t necessarily a case of a better technology losing. It’s the case of a more patient-friendly technology losing, except in Alaska where there really isn’t a viable option for delivering colonoscopies. As well in violation of CMS, some payers are refusing to cover Cologuard.

Cologuard CEO Kevin Conroy was evasive when asked about pricing, which is more expensive than other screenings but pales in comparison to the coimg_0060sts of a procedure that requires booking an operating room and an anesthesiologist.

Let’s hope that a shift to value-based care changes this. From a patient’s perspective it can’t come soon enough.

PS Apparently a lot of single Cologuard kits are being ordered by cardiologists and other specialists. Conroy thinks they’ve recognized the value and are using the kits on themselves. Harrumph.

Posted in: Clinical Research, Health Regulations, Healthcare Disruption, Healthcare Legislation, Outcomes, Patient Advocacy, patient engagement, Patient Satisfaction

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LAM Conference – A patient’s perspective

Dr. George Pappas, LAM Regional Clinic Director

Last weekend, my husband and I attended the Regional TSC and LAM Conference at Swedish Medical Center in Seattle, WA. This conference covered current research developments, treatment options, and patient education. I attended because I wanted my husband to learn more about Lymphangioleiomyomatosis (LAM), because I am a patient. The LAM Foundation defines LAM as “a rare lung disease that usually strikes women during the prime of their lives… this disease is characterized by an abnormal growth of smooth muscle cells, especially in the lungs, lymphatic system, and kidneys.” LAM occurs almost exclusively in women, and it is usually misdiagnosed for years, often as asthma, emphysema, and/or bronchitis. LAM is considered a progressive disease, which can lead to lung transplantation 10 years post diagnosis or for some, like me, it progresses slower. Treatment with a mTOR inhibitor, Rapamune, may improve lung function, which was all the buzz at this conference, but unfortunately there is no cure.

This conference was coordinated by the patient advocacy networks, The LAM Foundation and TS Alliance, and was designed to provide patients with the opportunity to interact with the LAM scientific community, physicians, and patients. I have to be honest, I was surprised to see a packed room because there are only 3-5 LAM patients per million women in the world. I later learned that newly diagnosed patients traveled from as far as Alaska with their loved ones for the same reasons as I: to learn more about clinical drug trials, to ask questions, and meet other ‘Lammies’. This mutual interest was palpable during the presentation by Dr. Ray Yeung, a surgeon and renowned LAM expert. Hands were flying up with questions. Dr. Yeung spoke about the pros and cons of clinical trials, and the pathogenesis of Angiomyolipomas (AML) and LAM. Dr. Yueng had a great amount of positive energy for what he has learned about LAM through his research and it was awesome to hear from a scientist about the importance of patients getting involved in clinical trials.

After the session with Dr. Yeung, we had lunch and I got to talk to a very lovely woman that worked as a Patient Relations Advocate for Lundbeck, a pharmaceutical company that sponsored the conference. Her role was to bring the face of the company to the patient advocacy foundations and their patients, and in return be the voice of patients in order to always keep us in the forefront of the company’s mission. I was particularly impressed with this, especially coming from the pharmaceutical industry, which tends to get a bad rap as being money centric. I continue to be awestruck with her grace, attitude, and lovely disposition, and how she didn’t once talk about her company, but wanted to know more about ME, not my disease. I really hope that our talk (and the fact that I thanked her repetitively) and the other conversations she had with patients that gathered around us, made her journey worth it.

On the drive home, she really got me thinking about how important her role is, and how the information she gathered will be priceless to both Lundbeck and to the LAM community; what she learned cannot be found in any search engine or book. I believe there is a huge disconnect between patients and some of the key players in making us… well, not patients anymore. The folks that advocate for us are so important because not only do they form an overarching understanding of disease, research treatments, help us keep symptoms under control, argue with the insurance companies, help us manage setbacks, etc., they also help us realize there is meaning to getting up in the morning and living life knowing we are not alone. It’s like having a big mama bear always looking out for you, so you can focus on you and not your disease.

Upcoming events…
The International Rare Diseases Research Conference & LAMposium, Cincinnati, OH, Sept 22-25, 2016
LAM Regional Conference, Cleveland Clinic, November 5, 2016.

Posted in: chronic disease, Clinical Research, Managing Chronic Disease, Patient Advocacy, patient engagement, Rare disease, Research, Seattle

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