Kelly Close: State Of Diabetes Treatment, Companies In The Sector And Challenges Patients Face

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.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. (More...)

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Study highlights challenges of predicting disease outcomes in a warming world

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Public Health;  Tropical Diseases
Article Date: 14 Aug 2013 - 1:00 PDT Current ratings for:
Study highlights challenges of predicting disease outcomes in a warming world

Climate change is already affecting the spread of infectious diseases--and human health and biodiversity worldwid - according to disease ecologists reporting research results in this week's issue of the journal Science.

Modeling disease outcomes from host and parasite responses to climate variables, they say, could help public health officials and environmental managers address the challenges posed by the changing landscape of infectious disease.

"Earth's changing climate and the global spread of infectious diseases are threatening human health, agriculture and wildlife," said Sam Scheiner, National Science Foundation (NSF) program director for the joint NSF-National Institutes of Health Ecology and Evolution of Infectious Diseases Program, which funded the research.

"Solving these problems requires a comprehensive approach that unites scientists from biology, the geosciences and the social sciences."

According to lead author Sonia Altizer of the University of Georgia, the issue of climate change and disease has provoked intense debate over the last decade, particularly in the case of diseases that affect humans.

In the Science paper, Altizer and her colleagues - Richard Ostfeld of the Cary Institute of Ecosystem Studies; Pieter Johnson of the University of Colorado; Susan Kutz of the University of Calgary and Canadian Cooperative Wildlife Health Centre; and Drew Harvell of Cornell University - laid out an agenda for future research and action.

"For a lot of human diseases, responses to climate change depend on the wealth of nations, healthcare infrastructure, and the ability to take mitigating measures," Altizer said.

"The climate signal, in many cases, is hard to tease apart from other factors like vector control, and vaccine and drug availability."

In diseases affecting wildlife and agricultural ecosystems, however, findings show that climate warming is already causing changes.

"In many cases, we're seeing an increase in disease and parasitism," Altizer said. "But the effect of climate change on these disease relationships depends on the physiology of the organisms and on the structure of natural communities."

At the organism level, climate change can alter the physiology of parasites. Some of the clearest examples are found in the Arctic, where temperatures are rising rapidly. Parasites are developing faster as a result. A lungworm that affects muskoxen, for instance, may be transmitted over a longer period each summer, making it a more serious problem for the populations it infects.

Climate change is also affecting entire plant and animal communities.

Community-level responses to rising temperatures are evident in tropical marine environments such as the coral reef ecosystems of the Caribbean. Warmer water temperatures have directly stressed corals and facilitated infections by pathogenic fungi and bacteria. When corals succumb, other species that depend on them are affected.

The potential consequences of these changes are serious. The combination of warmer temperatures and altered disease patterns is placing growing numbers of species at risk of extinction, the scientists say.

In human health, there is a direct risk from pathogens like dengue, malaria and cholera. All are linked to warmer temperatures.

Indirect risks also exist in threats to agricultural systems and game species that are crucial for subsistence and cultural activities.

The scientists recommend building on and expanding data on the physiological responses of hosts and parasites to temperature change. Those mechanisms may offer clues to how a system will respond to climate warming.

"We'd like to be able to predict, for example, that if the climate warms by a certain amount, then in a particular host-parasite system we might see an increase from one to two disease transmission cycles each year," Altizer said.

"But we'd also like to try to tie these predictions to actions that might be taken."

Some of those actions might involve more monitoring and surveillance, adjusting the timing of vector control measures and adopting new management measures.

These could include, for instance, closing coral reefs to human activity if a disease outbreak is predicted, or changing the planting strategy for crops to compensate for unusually high risks of certain diseases.

The researchers also point out that certain local human communities, such as those of indigenous peoples in the Arctic, could be disproportionately affected by climate-disease interactions.

Predicting where these local-scale effects might be most intense would allow societies to take measures to address issues such as health and food security.

"Involving local communities in disease surveillance," said Altizer, "could become essential."

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our infectious diseases / bacteria / viruses section for the latest news on this subject.

Climate Change and Infectious Diseases: From Evidence to a Predictive Framework

Sonia Altizer, Richard S. Ostfeld, Pieter T. J. Johnson, Susan Kutz, and C. Drew Harvell. Science 2 August 2013: 514-519. [DOI:10.1126/science.1239401]

National Science Foundation

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Liverpool care pathway review shows challenges in palliative care

The Liverpool care pathway has been encouraged to avoid unnecessary interventions in the care of people who are dying. Photograph: Voisin/Phanie/Rex Features

The law of unintended consequences can be insidious. The Liverpool care pathway (LCP) has been encouraged over the last decade with the express objective of avoiding unnecessary interventions in the care of people who are clearly dying, and ensuring they achieve a good death. However, it should now be phased out and replaced by an individual end-of-life care plan, according to the findings of the independent review led by Lady Julia Neuberger.

Almost a decade ago, the House of Commons health select committee conducted an inquiry into palliative care and while it supported the take up of tools such as the Gold Standards Framework and the LCP, the committee cautioned "that there are significant challenges in raising the skills and awareness of all healthcare staff in palliative care." The findings of the independent review provide testimony to the continued failures of training around the LCP, with the result that far from providing a model of good practice in palliative care, the LCP too often leads to poor practice – "uncaring, rushed and ignorant".

This is a shocking indictment of the care of people in their final days of life, often very elderly people whose relatives were left with the impression that their life was no longer valued. Withholding food and drink has caused the greatest concern and distress with staff apparently on occasion refusing to allow liquids for people who were thirsty and dehydrated. The review is in no doubt that the failure to provide oral hydration and nutrition "when still possible and desired should be regarded as professional misconduct."

Poor communication with patients and relatives is at the root of many of the failures and criticisms of the LCP, and evidence to the review found significant numbers did not feel involved in discussions about the care plan, or were not given the chance to be involved. People are sometimes not told that a loved one is dying or what they can expect to happen.

Inappropriate use of opiate pain killers and tranquillisers was also the focus of criticism, particularly when this led to a patient becoming drowsy, and relatives left wondering if the use of drugs had hastened death.

The review has recommended that the LCP should be phased out, and this has been accepted by health minister Norman Lamb. However, it is vital not to abandon the core principles which underpin the model. The failure of the LCP has been in its application and poor support; the review found that when used appropriately "patients die a peaceful and dignified death", but that implementation is sometimes associated with poor care.

The clear thinking and pithy recommendations of this review will be welcomed, so too will the speed of response from government. It is clear that when the LCP is operated "by well trained, well-resourced and sensitive clinical teams, it works well." The reverse is also true and the need for new guidance and training for all staff is evident. Nonetheless, existing guidance is not being adequately followed or understood and major cultural change is needed at all levels of health and care to prioritise good quality end-of-life care. The review identifies the need for a strategic approach from NHS England down to clinical commissioning groups, and with the Care Quality Commission taking a lead in reviewing how well dying patients are treated.

It is distressing that what began as a model to raise the quality of care for the dying has too often been reduced to a tick box procedure which takes insufficient account of individual needs or wishes, and where vital care and compassion are absent. It is a tragedy however for families and carers who have lost relatives who have been cared for under the LCP, and for whom there will remain considerable distress and unanswered questions. Did their relative die a hastened death? Did they suffer unnecessarily because of the interpretation of the LCP? And would they actually have been able to live longer and die better without the involvement of the LCP?

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