Talking to… Dr. Aaron Milstone

Aaron Milstone

Dr. Aaron Milstone is a pulmonologist in Franklin, Tennessee and has been in practice for more than 20 years, 15 of them as an Associate Professor in Medicine at the Vanderbilt University Medical Center. In this interview to the M3 blog, the doctor shares the novelties in the treatment of COPD and asthma, his main areas of interest, and his opinions on e-cigarettes and home-test for sleep disorders.

Data from the United Network for Organ Sharing shows a 3% increase in organ donation in the US since 2016, and a 27% increase over the last ten years. What’s your opinion on new techniques which are helping to facilitate that?

I was at Vanderbilt University Medical Center in Nashville, Tennessee, where I directed a lung transplant program for 15 years, so obviously was involved in a great deal of critical research into transplantation. In terms of lung transplants, there are many aspects contributing to the increase in organ donation, including educating the public, and expanding the donor pool to include older patients, and the preservative solution used has improved so an organ can last longer outside the donor body than ever before.

Another one of your areas of expertise is the management of COPD. What are the hottest news in this field?

Yes, my main areas of interest are COPD and asthma. I have a large clinical research program conducting phase 3 and 4 studies in both asthma and COPD. COPD is a real hot topic now as we get ready to have biologic options for patients with the condition. COPD is an enormous problem in the US, especially in the South-East of the US where smoking rates are particularly high – the highest in the US. Just in my own state of Tennessee, the incidence is very high compared to the US in general. In turn COPD rates are very high here as well. My opinion is that we are in the era of Columbus in terms of COPD treatment.

By that I mean that historically we’ve used inhalers, but now we have drugs with new mechanisms of action and new delivery systems. Now a fixed dose, triple drug therapy has come to the US market, within the last year, and there are also multiple LABA/LAMA combinations and many more therapies to come. Triple drug therapy is going to have a significant impact – patients can now use a single device rather than three inhalers, so adherence improves.

Historically we’ve relied on patients to tell us whether they’re taking their medications, but now we’re doing a lot of research looking at new ways to improve compliance, and many of those involve smart electronic devices and smart phones. In the future, your inhaler will be able to report how frequently it’s been utilized, whether the correct dose has been administered and, most importantly, give feedback to the HCP. There’s lots and lots of knowledge on the horizon that will revolutionize the use of inhalers at minimal cost to the patient and HCP.

We’re also doing a lot of work with biologic therapy. Recently one of the larger drug companies published data on biologics and exacerbations of COPD. The impressive feature of biologics is that they have the ability to improve lung function but also may have the potential to reduce flare ups. So, I think there’s going to be a change worldwide in how we treat COPD and asthma in the near future. There are currently four different biologics treatments already on the market for asthma, and many more in the pipeline, and I’d expect to see biologics treatments for COPD coming soon. It’s an exciting and unique time to be in pulmonary medicine. I believe that soon there are going to have to be niche sub-specialists who are very familiar with immunology and biologic drug classes.

Data on smoking in the US shows that the percentage of people smoking has declined from almost 21% in 2005 to 15.5% in 2015, but cigarette smoking is still the leading cause of preventable deaths in the country. In other countries there have been initiatives to reduce smoking via taxation etc, how do you think the US should approach this?

The data in the US is very similar – there is a linear correlation between smoking tobacco and higher taxation. The states that have the highest taxation on tobacco tend to be in the east. The states that have the lowest taxation tend to be in the south-east, and there is a very clear correlation between taxation and prevalence. Taxation on tobacco products can be very effective at keeping prevalence down.

Another strong approach that I’m an advocate for is improved pharmacologic coverage by insurers. Unfortunately, most insurance companies do not cover the cost of smoking cessation products such as nicotine replacement patches. I think that insurance companies should be lobbied to cover the cost of treatments for smoking cessation. At the moment if a patient can’t afford nicotine replacement patches or other treatments they have a much lower likelihood of stopping smoking. Some insurance companies now are giving discounts on premiums to patients enrolled in tobacco cessation courses or if the patient makes a ‘valiant attempt’ at cessation, and I think that’s a really good way to increase quit-rates. I think that counselling combined with pharmacologies is the best approach.

I do agree that the Australian approach to taxation is helpful, but I also think that you need to look at secondary intervention in terms of helping people to quit and giving them affordable ways to quit. This has been a real focus for me as I live in the South, and Tennessee has one of the lowest rates of taxation, and hence is a state with very high tobacco use prevalence. The reality is that I see so many complications of tobacco in terms of stroke, myocardial infarction, and lung cancer, that this area of medicine is very important to me.

The UK has reached a record low in terms of smoking rate, with over a million people reporting using e-cigarettes, which can be somewhat controversial. What are you take on them?

I think the main problem with e-cigarettes is that the long-term health effects of these cigarettes remain unknown. There’s a multi-center study looking at the long-term impact of their consumption, and until the effects are known I strongly advocate against using them to quit smoking. Yes, there are less carcinogens, but many still include high levels of nicotine. The way I see it, is that you’re just switching out one addiction (ie. cigarettes), for another (ie. e-cigarette). I believe that when we see long term data we may find that e-cigarettes are no safer than regular cigarettes, but we don’t know that at this time.

Regarding sleep disorders, another area of concern in Pulmonology, what’s your evaluation on the recent practice of home tests for the diagnosis of sleep disorders?

Definitely a hot topic. Any physician, such as a primary care physician, for example, can now order a home sleep test for a patient. However, I think the patient really loses out on some of the analysis and expertise when they’re not seeing someone who is board-certified in sleep medicine. The reason I say that is that many of the home sleep tests lack data on aspects like leg movement, so you may not be able to make a diagnosis of periodic limb movement disorder with a home sleep test.

In addition, there’s a very crude analysis of REM and non-REM.  So, many times the home sleep study may not be adequate for a diagnosis of, for instance, narcolepsy or idiopathic hypersomnia. At the end of the day, home sleep tests are best when the health care provider is looking specifically for sleep apnoea. However, a home study can lack sensitivity for patients with mild sleep apnoea. Unfortunately, if you haven’t seen a board-certified physician for the analysis you may not have been fully assessed for other diagnoses like idiopathic hypersomnia, and most importantly, may not get the degree of follow-up after starting CPAP if you have been diagnosed using a home sleep study.

That being said, home studies are a trend that’s not going away. Physicians have to be very selective about who gets a home sleep study. The health care provider has to be purely thinking about sleep apnoea and ensure that the patient is safe to be assessed in the home environment. If someone has significant heart or lung disease or underlying seizure disorder, those patients should all be assessed in a monitored sleep lab setting. Also, if you do a home study you want to make sure adequate follow-up is in place when the patient initiates therapy with positive pressure (ie CPAP or BPAP).

Talking to… Dr. An Pham

Dr. An Pham, a pulmonologist from Pennsylvania, USA, shares his opinion on stress and quality of sleep, tobacco taxation, and advancements in procedures and drugs in the treatment of pulmonary conditions.

M3 Global Research is currently conducting studies on various pulmonology-related topics. If you are a pulmonologist or internal medicine physician specialising in pulmonology and practising in the US, please contact M3_US_support@eu.m3.com. If you are not a member of our panel already and are interested in participating in healthcare market research, you can register here.

What inspired you to specialise in pulmonology and what is the most interesting aspect of working in this area?

I did a rotation with a wonderful pulmonologist who became my mentor and made me want to follow in his footsteps.

You are certified in sleep medicine. What are your thoughts on new trends like home sleep tests, for example? Currently, the American Academy of Sleep Medicine recommends home sleep tests should be used in conjunction with a comprehensive sleep evaluation to diagnose obstructive sleep apnoea (OSA).

Mixed feelings. Most of the time this works out, but a lot of times the results come back inconclusive and have to be repeated. Additionally, the Apnoea Hypopnea Index (AHI) is frequently underestimated, which impacts treatment decisions, especially for borderline cases.

Short sleep duration has been associated with a variety of adverse cardiovascular outcomes in cross-sectional and small prospective studies. As someone with more than 20 years of medical practice, during your career have you noticed much indication of lifestyle directly influencing quality of sleep and resulting in other health issues? 

That varies from individual to individual. In general, yes, to some degree, but many patients don’t even realise that.

The percentage of the population in the United States that smoke has declined from 20.9% in 2005 to 15.5% in 2016. However, cigarette smoking remains the leading cause of preventable disease and death in the country. Do you agree with measures trying to address this? The Australian government, for example, has announced it will raise tax on tobacco by 12.5% every year from 2017-2020. Would you agree with something similar being put in place in the US?

Mixed feelings. The effect of cigarettes on health is no longer a secret, so if someone chooses to smoke he or she is willing to take that risk. It’s the same with alcohol. I’m not sure where to draw the line as far as controlling what people do with their lives.

In your opinion, how has technology improved the treatment of pulmonary diseases in the last decade?

 Lung transplants and interventional pulmonology have advanced significantly. Older patients can now be candidates for lung transplants. Many patients can now avoid surgery given new intervention bronchoscopy procedures. Also, new drugs, especially the biologic agents, have improved patient outcomes significantly.

 

Parkinson’s Awareness Month

M3 Global Research is currently recruiting patients with Parkinson’s to participate in usability testing for a new device used in conjunction with a smart phone (both provided) in the United States and in Germany. We’re offering generous compensation to the patients taking part and also the physicians referring them. If you are a member of the M3 Global Research panel, contact M3_US_support@eu.m3.com to find out if you qualify. If you are a patient who is not a member and wish to participate, please register by clicking here if you are in the USA and here if you are in Germany. You will then receive an invite by email.

Around seven to 10 million people worldwide live with Parkinson’s disease, a condition that currently has no cure. For this year’s WordParkinson’s Day, Parkinson’s UK, a charity that works towards finding a cure and improving life for everyone affected by the condition, has launched the campaign #UniteForParkinsons. It aims to give voice and platform to the Parkinson’s community by featuring their experiences in a world-wide campaign video and encouraging others to do the same. Watch it here:


Complexity of Parkinson’s ‘massively underestimated’ in the UK

In a survey to mark World Parkinson’s Day (Wednesday 11 April), Parkinson’s UK has discovered that 78% of the public massively underestimate how many symptoms of Parkinson’s there are. Although most people are aware of visible symptoms like tremor, Parkinson’s can also come with more than 40 less well-known symptoms such as sleep issues, anxiety and hallucinations. Shockingly, more than a third (37%) thought there were fewer than ten symptoms of Parkinson’s and more than 41% thought there were fewer than 30.

The charity is warning that this lack of awareness means that people with Parkinson’s often feel they need to hide their symptoms in public, or don’t want to go out at all due to being incorrectly judged or mocked. Previous findings from the charity have uncovered:

  • A quarter (25%) have had symptoms mistaken for drunkenness
  • 11% have been laughed at because of their symptoms
  • More than a third (34%) feel they would be judged if they were out in public
  • Almost a third (32%) don’t feel like their symptoms are socially acceptable

These symptoms are merely the tip of the iceberg, it warns, and do not reflect what people with Parkinson’s most want addressing. In a recent project carried out by the charity to identify priorities to focus on for improving everyday life, tremor came 26th on a list of what people with Parkinson’s want research to tackle.

Artificial intelligence to help develop new Parkinson’s treatments

Parkinson’s UK is actively involved in research, and recently one of its research proposals has won the BenevolentAI Award. The project demonstrated how AI technology could solve specific research challenges in Parkinson’s.

There have been no major breakthroughs in Parkinson’s treatments in the last 50 years. Current treatments revolve around medication that works by restoring the level of dopamine in the brain or mimicking its actions; deep brain stimulation (DBS), a type of surgery where electrodes are implanted deep inside specific parts of the brain, but which is not suitable for every patient; and physical therapies such as physiotherapy, speech and language therapy and occupational therapy, that are important in the management of the condition.

Parkinson’s UK’s proposal will use BenevolentAI platform’s capabilities to reason, deduce and suggest entirely new treatments for Parkinson’s. The aim is to identify at least three currently available medicines that can be repurposed to address Parkinson’s, and two brand-new ways to treat the condition with new drugs. Read more about the project: Artificial intelligence to help develop new Parkinson’s treatments.

*All rights belong to Parkinson’s UK. We would like to thank the charity for sharing this content with us.

Understanding healthcare market research

Working in the pharmaceutical industry includes frequent use of market research and collaboration with fieldwork agencies like M3 Global Research. The M3 blog spoke to someone working regularly at that interface about how healthcare market research affects their decision making. Read the full interview:


How does market research support the development of a new therapy at each stage (of its development and trials)?

In the pre-launch phase we use market research (MR) to understand the needs of HCPs and patients, and which of those are currently unmet. We then consider whether we can monitor these gaps as part of our clinical trial data collection programme. Additionally, we research patients and allied HCPs to understand if there is an opportunity to build a support programme to better help those living with, caring for those living with, or treating those living with the illnesses we’re researching.

After a new therapy is launched, the need for market research changes. How does it continue to play a role in ensuring the best possible outcomes for patients?

Clearly, we use MR to assess the markets, and then track our penetration, so we can better understand prescribing, patient numbers, effectiveness of advertising and communications and patient types and characteristics. These activities help us see how our medicines are being used outside a trial setting. MR can tell us if there are anomalies in patient characteristics in greater numbers, as individual cases may not look unusual to a busy HCP. It is important to note we are required to report any adverse events (AEs) or product quality complaints (PQCs) through MR, which provides another layer of patient safety.

In addition, we have our own sets of goals and objectives that can only be measured using MR. One important factor in doing this is to anticipate usage so that we can forecast demand and make sure we never run out of medicine, but also whilst considering their “shelf lives” so this process needs to be carefully managed.

As the pharma industry continues to evolve and guidelines in how we interact and promote our medicines become ever more stringent, we use MR to better inform our touchpoints with customers, so that we don’t bombard them with un-necessary promotion. We are not there yet, but we hope to move more towards constructive discussions around meeting customer needs and away from “please use my product” discussions. Also, in this modern age, we are aware that different customers like to interact using different channels and media, therefore we use MR to understand which channels we should maximise use of, so the HCP does not have a waiting room full of reps!

We also use MR to understand the educational needs of HCPs, in order to build our medical education programs to deliver meaningful and useful disease area education. Finally, we use MR to understand potential opportunities to buy new medicines, or licence in from other manufacturers (some companies don’t have a commercial presence). MR will tell us if this is an investment worth making – will it address an unmet need or is it just another “me too”?

A cynic may argue that market research only exists to help pharmaceutical companies make money and it has little to do with promoting the best patient outcomes. How would you counter this argument?

I won’t pretend that market research does not help us commercially. Unfortunately, there are some companies who do not have resources to be able to run multiple projects, so will try and capture as much as they can in one survey. Our clinical trial data helps us understand where our medicines are optimal and therefore set expectations on usage – we use MR to see what is happening in the real-world, where these patients are not in a clinical trial setting and are instead impacted by the reality of their day to day lives. We use MR to ask the HCPs (and patients) about their experiences of these real-world settings and we use these outputs to help tailor our communications to identify the most relevant patients and help the HCP identify those who will best benefit from our medicines. An example might be patient adherence to medication – this could be identified as an issue during MR, where usage may differ from clinical trials and therefore may put the patient at risk from sub-optimal self-management. MR will help us send focused communication on these findings to HCPs and potentially deliver better patient support solutions.

Patient centricity has become increasingly important for pharmaceutical companies over recent years. What is it and how does market research with patients and doctors support it?

Personally, I think this is a buzz word – patient centricity SHOULD be the focus of everyone in pharma, it’s what we get out of bed for – but patient research is often the first to be cut when budgets are restricted. I believe this is a reaction to needing to inform the financial side of the business and keeping shareholders up to date, as these are how we are measured externally. MR can help us understand more about the patient side and then use this data to communicate internally about patient needs and how well (or not) we are meeting those needs. Because we are not permitted to communicate directly with patients, HCPs are the gate keepers to contact with them, and therefore are perceived to be the most knowledgeable. However, patient research can turn our head towards the important topics that may not be picked up in HCP research. Patient associations and pharma work together to support their activities and help them raise a voice when Patient Association Groups don’t have the resources to do this alone. MR can help us understand more about the patient side and subsequently use this data to communicate internally about patient needs and how well (or not) we are meeting those needs.

Thinking of a typical market research project, what types of people have a role in developing and reviewing the questionnaire before it is presented to doctors or patients?

This is very dependent on who us asking the questions. If it is for a commercial research project it will be the MR manager, medical approver, compliance, marketer or pharmacovigilance. For health economics research, everyone from the commercial research team will also be involved, plus the people responsible for outcomes research and market access. In patient research we’ll also involve the communications manager and the patient liaison team.

Technology investment in the healthcare sector

Our first monthly Pulse of 2018 asked the M3 Global Research community their opinions on technology investment in healthcare. The healthcare sector has experienced dramatic changes over the last 25 years and will likely continue to change and evolve in the immediate future. Technology is already powering new models of care and disrupting traditional ideas about care provision. However, the level of investment will become a key driver in the speed of delivery. For this Pulse survey we asked healthcare professionals which areas of potential technology investment they think would have the most impact patients over the next five years. Participants could choose up to three of the following:

  1. Preventative medicine (home test kits, measures for disease prevention and identification of risk factors)
  2. Self-diagnosis (recognising or identifying medical conditions for oneself using online resources)
  3. Telemedicine (online or telephone consultations with HCPs without face-to-face contact)
  4. Social prescribing (a means of enabling primary care professionals to refer patients to a range of local, non-clinical services)
  5. Self-care (actions that individuals take for themselves in order to protect, maintain and improve their health or wellbeing)
  6. Care navigation (using signposting and information to help patients and their carers identify their treatment and care options)
  7. Patient access to online health records (patients can access, electronically, their own records from all primary and secondary care interactions)
  8. Other

January’s Pulse revealed that the majority of respondents in Europe, Canada, and the US believe that telemedicine, with 2,752 votes, is the area of technological investment that will most improve patient care over the next five years.  This might include Skype consultations, or digital clinics, and would be particularly useful in improving access to care in remote areas or for specialist treatment. Preventive medicine followed as the next most popular option, with 2,495 votes, and was particularly popular in the United States. Preventative medicine is seen to be a way of reducing healthcare costs, and also improve efficacy of treatments by early diagnosis, and so might include the  development of home testing kits, for example. Social prescribing was deemed to have the least potential impact, with only 485 votes, but this could be because its application is less well understood outside the UK, where it is quickly gaining traction. In the UK, primary care clinicians are able to refer patients to a range of local, non-clinical services, often provided by the voluntary and community sector, thus reducing costs for the NHS.

In Europe specifically, results broadly reflected the global findings, with 2,710 professionals surveyed in UK, Germany, France, Spain and Italy choosing telemedicine as the area of technological investment that they thought would most improve patient care over the next five years. Preventive medicine followed, with 2,436 votes. Social prescribing was the option with the least votes, with 485.

healthcare sector

Interestingly, in the USA results were different. Preventive medicine was chosen as the area of technological investment that will most improve patient care over the next five years, with 1,136. Telemedicine came in second, with 517 votes. Self-diagnosis apps were deemed to have the least potential impact, with only 86 votes.

Technology investment

By registering with M3 Global Research you will receive the monthly Pulse straight to your inbox so you can give your opinion about topical healthcare-related issues and compare your thoughts with those of your colleagues around the world.