As president and founder of Close Concerns, a healthcare information firm focused on diabetes and obesity, Kelly Close says her passion comes from her extensive professional work as well as her personal experience, contracting Type 1 diabetes 25 years ago. Prior to starting Close Concerns, she worked in the financial sector, including stints as an analyst at Goldman Sachs, as an equity research analyst covering medical technology at Merrill Lynch, and as a management consultant at McKinsey & Co., where a majority of her work focused on for-profit and nonprofit healthcare organizations. Ms. Close and her colleagues at Close Concerns attend more than 40 scientific, regulatory and economic conferences around the world focused on diabetes and obesity, analyze key medical literature, and cover more than 50 private and public companies and nonprofit organizations. Recognized as an expert on the diabetes and obesity markets, and as a frequent speaker on the public health implications of these conditions, Ms. Close is a tireless advocate for patients. In this interview Ms. Close discusses the state of the industry and challenges that patients face.
Can you describe your mission?
It's to make everyone - researchers, clinicians, scientists, companies, and patients - smarter about diabetes and obesity in order to improve patient outcomes. Our team studies new research, and we synthesize news and insights on therapies and technologies on diabetes and obesity.
Why diabetes and obesity?
I have a deep personal interest in diabetes, so my goal once on Wall Street was always to narrow my focus from writing about medical technology (and helping biotech and pharma analysts) to working on all parts of diabetes, in a way you can't do as an analyst. In other words, I wanted to work on medical devices, pharmaceuticals and biotech all at once. Then, there's obesity. Well, the association between obesity and Type 2 diabetes has long been recognized. You can't separate the two; they are inextricably linked. Cases of diabetes have risen nearly tenfold since I was diagnosed in 1986. There were about 30 million people globally with diabetes then. Today there are 30 million in the US alone, with nearly 400 million globally, with much of the trend due to the increasing prevalence of risk factors, including obesity. And around 80% of Type 2 diabetics are either overweight or obese.
Tell me a little about your information services.
Our first publication in 2003 was Diabetes Close Up, where we simply updated news about different companies and conferences that we attended. In 2007, we started Closer Look, which goes out several times a week - sometimes daily - and the two publications now keep researchers and members of the industry abreast of scientific breakthroughs. Our online newsletter, diaTribe, began in 2005 as a free service, with the goal of keeping patients up-to-date on the latest research, products, and advice from the diabetes scientific community. And through dQ&A, our sister company that we started in 2009, we offer corporate clients market research and consulting services.
When I began Close Concerns, 18 million Americans had diabetes, and the sector had $14-billion in revenue. Today, in 2013, the industry has expanded to more than $40-billion, and there's widespread agreement that diabetes and obesity have turned into global epidemics that cannot be sustained. We absolutely must change diabetes management to make sure patient treatment, therapy and advice are optimized from the time of diagnosis throughout the entire spectrum of the condition.
What are some of the challenges you see today?
It's never been a more challenging time in terms of reimbursement and patient access to medicines and healthcare professionals. In much of the world, patients still don't have access to insulin or other medications. On the other hand, extensive progress has been made on the actual tools that are available. Access is so much more challenging, however, regardless of whether we are talking first world or third world. Doctors, for example, may reach a common diagnosis of diabetes, but the pressure they face with patients is prescribing the correct treatment, determining what patients will adhere to, and what insurance will cover. And that is patients with insurance. Medicare is missing the forest for the trees on some of its new reimbursement decisions in the U.S., and globally, patients certainly are not getting the treatment, therapy and advice they need to keep them healthy. Finally, there are major issues with patient advocacy - it must be much stronger, but lingering stigmas about this disease continue.
What about treatment challenges today?
The positives are that medications have improved dramatically and the technology exists to see which medications work and don't work. Today, the emphasis is on early, optimized treatments, given that nearly 50% of Type 2 diabetics are not at their glycemic target even here in the U.S. Because there are many more oral medications available before a patient is moved to insulin, the best healthcare providers no longer take a wait-and-see approach if a patient can't control their HbA1c (a three-month average measurement of glucose in the blood); they prescribe a new medication, often a combination of drugs. Another bonus of having many more drugs available today is that treatments can be customized for a patient, which is the promise of personalized medicine - again, this varies with access. Adherence is such a challenge that it will be great to move several medications to one - one pill and one co-pay for patients in the U.S. and, ideally, better adherence. Adherence studies have been very hard to do historically, and this is one of the biggest challenges ever. Historically, taking insulin has also been very challenging. We hope this will become easier all over the globe and that the stigma of taking insulin will begin to dissipate.
Can you talk about emerging trends in technology?
Absolutely. One really dispiriting area is that in the U.S., we see pricing pressure and reduced access to good technology. This is driven by CMS wanting to save money, and while it may sound good for patients, we worry that it winds up resulting in less product innovation, fewer funds going to R&D, less customer education and customer service, etc. We're seeing better insulin pumps coming out all the time, combined with continuous glucose monitoring. Monitors used to be inaccurate and unreliable, but the technology is much improved and readings from meters are getting closer to readings from actual blood tests. The data we've seen on the Dexcom (NASDAQ:DXCM) G4 Platinum, for example, is better than some glucose monitors. But lots of people still dose their insulin based on counting carbohydrates, and there are lots of reasons why scores can be incorrect.
What's the status of oral insulin?
I thought we'd never see it because there are so many challenges associated with it. But I'm much more optimistic than ever before. It's still very early stage, but Novo Nordisk (NYSE:NVO) is working on it, and that's a very positive sign. We're beginning to see positive data come out, and the flat truth is just that we need more alternatives to injected insulin. MannKind (NASDAQ:MNKD) and its inhaled insulin therapy, AFREZZA, has driven our optimism. It has taken a long time to get to a second-generation inhaled insulin that is practical, easy to use and effective, but the data, especially that on hypoglycemia, look good.
What are your thoughts on the potential of GLP-1?
This is the first new class of therapeutics to come to market that doesn't cause hypoglycemia and doesn't cause weight gain. That's awesome because insulin has had all of those problems. Novo Nordisk's GLP-1 reached $1 billion in sales a year before the company expected - again, this has been easier for patients to take and provides a valuable step between traditional orals and insulin. What's really compelling in combination therapy is the potential for GLP-1 plus insulin. SGLT2 inhibitors are also interesting - we'll definitely see fixed-dose combinations here too, eventually. Earlier this year, the FDA approved Johnson & Johnson's (NYSE:JNJ) SGLT2 inhibitor, Invokana, which has efficacy closer to GLP-1 and, judging by the early data, a safety profile closer to DPP-4 inhibitors, which have the best side-effect profile of all. We'll see - we'll be eager to watch the emerging data.
Have you seen any interesting new data in GLP-1 research?
Transition Therapeutics (NASDAQ:TTHI; TSX:TTH) announced some really exciting data in the summer for TT401, which targets GLP-1 and glucagon receptors for obese diabetic patients and may provide clinical effects superior to those of GLP-1 agonists. (BT note: the proof-of-concept data prompted partner Eli Lilly (NYSE:LLY) to acquire an option on the drug candidate to complete clinical development.) We're also really looking forward to seeing more data on iDegLira, which is the combination of next-generation insulin degludec, which the FDA recently delayed, surprisingly, and on Victoza, from Novo Nordisk. BMS/AZ is also working on a Bydureon pen as well as a once-monthly formulation, and Intarcia is working on implantable GLP-1. There's no doubt this class will continue to grow as the applications become even easier and as the efficacy and safety data continue to grow.