Mar11

SXSW 2014: Technology and Health

SXSW_Logo_2013_BlackBG_CS

In Part 1 of his SXSW blog series, Robert Egert recaps some of the SXSW themes that are transforming the way the world looks at healthcare.

Massive—that’s the first thing you need to understand about the SXSW experience. At any given time, there are 30 to 50 events to choose from taking place in multiple locations throughout downtown Austin. This means that, unlike conventional conferences, each individual attendee cuts his or her own path through the events by selecting and reselecting from the nearly unmanageable array of keynotes, panel discussions, presentations, and workshops.

Events that feature celebrity speakers or that focus on hot topics can fill up quickly. Dashing from event to event, waiting in long lines, and striking up random conversations en route is part of the experience. Many events include audience QA, so if it suits your fancy you can become part of the public conversation, even if you aren’t an official presenter.

Here’s a highly personal recap of the themes, issues, and events that impressed, stimulated, and/or frightened me:

BIOMETRICS

The Idea: The pervasive collection of quantified biometric data will transform healthcare.

Wearable, implanted, and otherwise applied technologies will collect vast amounts of data on each of us throughout the day and night regardless of where we are or what we are doing. The collected data won’t only be sent to our phones—it will also be shared with physicians and aggregated into an ever-expanding library of health data.

This library can be used to evaluate the impacts of lifestyle choices on health and longevity (how much of what kinds of exercise must you do to reduce hypertension?). They can also measure the impact of pharmacologic therapies (which drug was more effective?), they can help identify disease patterns (what patterns around comorbidity should be looked at?), and they can provide real-time reports on just about anything you want to know about human behavior and health.

Why this is important:

If we combine biometrics with the predictive capabilities of DNA analysis, we’ll be able to obtain a detailed image of our individual health within the larger social context.

CROWD-SOURCED DRUG DISCOVERY

The Idea: Crowd-sourcing health studies and clinical trials.

Current approaches to drug testing and conducting health studies are expensive, slow, and cumbersome. What if we used crowd-sourcing to answer quantifiable health questions?

Jessica Richman, who is the founder of uBiome, a start-up that uses a crowd-sourced approach to collecting scientific health data, proposes that we dramatically change our approach to scientific inquiry. She suggests that with the right protocols and infrastructure in place, crowd-sourcing will be used to speed the evaluation of new products, measure the effectiveness and safety of products already in-market, and obtain quantifiable data on the health impacts of lifestyle choices.

This approach promises to allow us to quickly and efficiently collect larger data sets than ever before. But with this comes the responsibility to maintain processes and checks to maintain scientific integrity.

Why this is important:

It can dramatically reduce the cost of conducting health and drug studies, and it can generate libraries of data for ad hoc inquiry and analysis.

SXSW Series:

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Mar15

Expanding Universe: Centers of Excellence

Expanding UniverseThe success of most pharmaceutical products and medical devices is in part based on the expertise of learned physicians in designing and conducting clinical trials, interpretation of data from these trials, and eventually in educating healthcare providers. Historically, these esteemed physicians are the most recognized names at the highest-ranked medical schools and affiliated teaching hospitals. More recently, a new trend has begun to emerge: the rise and expansion of private research centers that are quickly rivaling their traditional academic counterparts. This phenomenon is a consequence of two significant developments over the past few decades.

Since the 1980s, industry funding for biomedical research by pharmaceutical and medical device manufacturers has surpassed the investment by the federal government. PhRMA estimates that member companies in 2011 invested $50 billion in the discovery and development of drugs. This amount, even without counting the investment by medical device manufacturers, is significantly higher than the $31 billion spent by the National Institutes of Health.

A second development is an increase in media and legislative scrutiny of relationships between industry and physicians. Many media stories brought questionable interactions into the spotlight, and legislators at state and federal levels began to put rules in place to increase transparency and minimize perceived undue influence of industry on healthcare providers. As the industry developed guidelines for interactions with healthcare providers, academic institutions began implementing their own rules limiting interactions.

The dwindling federal research dollars and ever stricter institutional rules are beginning to drive some investigators to switch their affiliations to private health organizations or start their own research centers. Early indications are that the quality of research at these nontraditional research centers is likely to be as good as that performed at major medical centers. In fact, a 2012 article by researchers from Harvard Medical School reported that “academic and nonacademic sites are equally effective in their ability to identify and retain appropriate study participants.” If the current trends continue, we can expect more industry-funded clinical research to be conducted at these private research facilities.

Many of the physicians at these centers are already well-known in their respective therapeutic areas due to their prior research and publications. Their personal reputations may translate into their new centers’ prestige, as they continue their contributions through congress presentations and peer-reviewed publications. In time, younger researchers from these centers may indeed grow into future thought leaders, just as those from academic research centers have done historically.

Emergence of these potential new “centers of excellence” presents opportunities and challenges for the manufacturers and for communication agencies. As the nonacademic research centers are managed by investigators who have expertise and interest in working with industry in various capacities as investigators, advisors, and educators, they may be more open to collaboration than the experts at academic institutions. They will also continue to maintain high ethical standards to protect their own reputations among their peers. However, there may be a need for the industry to educate them regarding the latest guidelines issued by PhRMA or AdvaMed, and the constantly evolving regulations at the federal and state levels, since these centers may lack the compliance infrastructure of the major academic centers. As communicators who facilitate interactions among industry, researchers, practitioners, and patients, it behooves us to keep an eye on this trend to better serve our clients.

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Dec4

Fighting the Stigma of Mental Illness

Even with our medical knowledge of the neurobiologic causes of mental illness, prejudice and discrimination against people with mental illness is not decreasing (according to a study published by Indiana University and Columbia University).

The World Health Organization (WHO) reports that there are 450 million people worldwide who suffer with mental illness but fewer than half receive care (caused by limited resources and stigma). While the WHO is taking action, by assisting governments with better access to healthcare and training healthcare workers to recognize the signs of mental illness, the WHO cannot fight stigma alone.

Many people with mental health concerns hide their illness or decide not to seek help because of what others “think.” They are often plagued with shame and agonize over with whom to share (family, friends, colleagues) their diagnosis. Worst of all (in my opinion), people with mental illness often “self-stigmatize” (internalize the public’s perception) and limit the amount of success they think they can attain or deserve.

Could you imagine how different our lives and nations would be if society knew that Abraham Lincoln or Winston Churchill had a mental illness? Or worse, if these two men held themselves back because they felt they didn’t deserve to succeed?

Mental illness is no different than any other illness, but because it manifests in the characteristics that make us human, it is more difficult to understand and often feared. In some cultures, superstition also contributes to how people are treated or viewed among a productive society.

So what is the tie-in with why I picked this blog topic and Fast4wD Ogilvy? Fast4wD has been at the center of global communications for clinical research for the past 10 years. While our therapeutic area of expertise is broad, the majority of our business has fallen under CNS. In addition, since 2003, my career has coincidentally focused on mental health research. I say coincidental because several of my immediate family members and very close friends have struggled with these concerns. I’ve learned a lot through my personal and professional experiences, but the most heartbreaking learning I’ve had is that a double standard exists. From a scientific and medical professional perspective, the “support” is there (just look at the list below of common or well known disorders currently open on ClinicalTrials.gov), but the dialogue behind the scenes isn’t always very nice or compassionate when it affects the immediate business.

ClincalTrials.gov lists the following open clinical trials:

  • 2005 depression trials
  • 1505 anxiety disorder trials
  • 594 schizophrenia trials
  • 475 ADD and ADHD trials
  • 472 eating disorder trials
  • 351 post-traumatic stress disorder (PTSD) trials
  • 296 bipolar trials
  • 158 trials listed collectively for obsessive compulsive disorder (OCD), panic disorder and Tourette’s syndrome

As the National Alliance on Mental Illness (NAMI) says, “Stigma erodes confidence that mental disorders are real, treatable health conditions. We have allowed stigma and a now unwarranted sense of hopelessness to erect attitudinal, structural and financial barriers to effective treatment and recovery. It is time to take these barriers down.”

We can start by looking for ways to help make a change.

  • Be compassionate and be careful of what you say:
    • “Tard”
    • “Psycho”
    • “Did you take your meds today?”
    • “Just snap out of it!”
  • Participate in a nonprofit like NAMI at some level:
    • Memberships
    • Volunteering your time
    • Join fundraisers (walks, runs, etc.)

My challenge to you is to add to my list above of how we can help make a change. I want to hear from you.

 

 

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Aug30

A Common Goal for Clinical Trial Participants

The Olympics opening and closing ceremonies allowed us to reflect upon and appreciate the diverse world we live in. Watching the procession of athletes was proof to us all that Olympians come from all corners of the world, in very many different shapes and sizes!

The same can also be said for clinical trial participants.

By their nature, global clinical trials can be considered an oxymoron. From a patient perspective, their participation in a clinical trial is a very personal decision. Many patients choose to enroll in a clinical trial for access to a medication that might give them a few more weeks or months to live, or the possibility of improved quality of life. Other patients may choose to participate as they want future generations to have the opportunity to live life to the fullest, something that might have eluded them. The list can go on.

As an agency when we look at patient participation, we need to remember that the probability of two patients on the same study knowing each other is very slim, so there will never be the coming together of a group of likeminded individuals on a given clinical trial. Likewise, we want to avoid the possibility of patients discussing their study experiences for fear of un-blinding themselves, but we want them to embrace the fact that they are not alone.

There are many different tactics we can use to bring a sense of community, or belonging, to patients in clinical trials. The biggest hurdle to overcome is creating a program that can be inclusive to all patients. Of course, the answer here is that a) that’s impossible, and b) that’s not a smart solution.

Thinking back to the Olympic athlete procession, the mix of cultures and values on show reflected the diversity of a group, but together with a common goal, to win gold.

In clinical trials, we want patients to have that same sense of a common goal, of purpose. However, the way we share that message is very different. For some patients, they just require clear instruction from their study team and feel confident that they know their commitment to the study. For others, they want to receive regular bites of information, telling them how many patients have been recruited, which countries are taking part, etc.

The tactics that we implement to inform patients about a clinical trial and then to keep them motivated to continue in the trial are not off-the-shelf ticket items. We know that each patient recruited will bring his or her own set of beliefs and information needs. In business, we often use Myers-Briggs as a way to build teams and recognize the differences among us. We embrace those differences and slowly learn how to work within our structure. We must do the same when communicating with patients globally about their health and their decision to volunteer to be a research study participant.

Crafting solutions can be challenging. In these cost-conscious times, sponsors are looking for the most cost-effective way to get their message across. As an agency working in these lean times, we are moving forward with new technologies and communication channels to reach all patients. London 2012 showed what can be achieved in tough economic times. The athletes have proved that regardless of ethnic background or values, there was a common goal and everyone has been part of the greatest sports day the world will see for another four years.

The same sense of belonging can be achieved for clinical trial participants; you just need to know what makes them tick….

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Jul31

Affordability of Medicines—the New Kid on the Block

You know the feeling: you pop into the shop and see something you want to buy, but times are tight and you simply can’t afford it. You want the best, but you feel compelled to consider all your spending priorities and choose to go for the less expensive brand—it’s a question of affordability.

In today’s environment, this is a challenge facing healthcare systems throughout the world. Coupled with this, more healthcare resources are being consumed as people are living longer with increasingly complex health problems. Add to this the increased complexity of how national health systems are assessing a medicine’s value, and you have the perfect storm.

Indeed, just as you weigh up whether you can afford to pay for something, those who pay for medicines (termed “payers”) all have affordability at the forefront of their minds. Governments are addressing the issue by driving further healthcare reforms, while payers are aggressively managing costs, limiting therapy choice, and shifting more of the cost burden to consumers.

However, if industry is to effectively support payers in their informed decision-making, it is important that they are viewed as investors in their community’s health and not simply gatekeepers of the budget.

As investors in health, payers deploy a variety of instruments to support medicines’ cost control. These can be broadly divided into supply-side and demand-side approaches.

Demand-side instruments include:

  • National-level price negotiations/price cuts
  • Reference pricing systems–using the cost of other similar drugs to set the price
  • Health technology assessments–assessing the value of a medicine using a range of tools including cost- and comparative-effectiveness
  • Promoting generic medicines and parallel imports–parallel imports refer to the practice of importing a medicine from another market where the medicine is cheaper

Supply-side instruments include:

  • Patient co-payments–this is the practice where patients will pay a certain percentage of the medicine’s cost
  • Reimbursement restrictions–restricting the money paid for a particular drug
  • Delisting–removing a product from a list of drugs that will be paid for
  • Prescribing budgets–setting financial budgets for the prescribing of medicines
  • Formularies and guidelines–a list of medicines that have been approved to be prescribed, or their incorporation within guidelines that should be adhered to

To date, the pharmaceutical industry has focused predominantly on communicating about cost and cost-effectiveness to secure optimal pricing and reimbursement for their brands at a market level. Arguably, more needs to be done to demonstrate the true benefit of treatment to patients, the communities in which they live, and society at large.

Some solutions to help demonstrate the true value of a treatment include:

  • Evaluating and demonstrating the longer-term patient outcomes
  • Demonstrating and communicating the economic value across all stages of a product lifecycle
  • Supporting payers to identify which patient segments would benefit most from treatment
  • Relating the outcomes demonstrated through clinical trials to local demographics

There is no doubt that the industry continues to go through a challenging time, while the economic crisis faced by many countries is only likely to get worse. In this environment, the issue of affordability is higher up on governments’ and payers’ agendas. However, by understanding and meeting the needs of payers and their communities, the industry will be better placed to ensure patient access to their medicines.

 

 

Also posted in Access, adherence, Clients, Efficacy, Health & Wellness, Healthcare Communications, Managed Care, Marketing, medical affairs, Reimbursement | Tagged , , , , , , , , | Leave a comment
Jun12

BATMAN, SIESTA and AWESOME

An apology to fans of Gotham as this blog post isn’t about the awesome Batman having a siesta prior to launching an attack on the Joker but on the (often somewhat fudged) acronym names given to clinical trials in the pursuit of creating a captivating trial identity.

So which clinical trials were betrothed with BATMAN, SIESTA and AWESOME?

BATMAN:  Bisphosphonate and Anastrozole Trial – Bone Maintenance Algorithm AssessmeNt

SIESTA:  Snooze-Induced Excitation of Sympathetic Triggered Activity

AWESOME:  Angina With Extremely Serious Operative Mortality Evaluation

I also have to mention other enchanting clinical trial name acronyms that caught my eye:  ASTRONAUT, CABG Patch Cardioplegia Substudy, EUROSTAR, REDHOT and BLIND-DATE.

A catchy identity based on an acronym of the title of the clinical trial is memorable. The acronym can resonate with both the clinical trial participant and the trial investigator. And an unforgettable acronym doesn’t need to be as complicated as a superhero.

I asked an oncologist friend for a memorable clinical trial name and their response was: SCOPE—Study of Chemoradiotherapy in Oesophageal cancer Plus or minus Erbitux. Their reasoning being that not only is SCOPE an acronym of the trial title but it is also strongly associated with using an endoSCOPE to examine the oesophagus.

It is proving increasingly difficult to come up with unique acronym-based clinical trial names for our clients as indicated by SMART (at least 25 trials lay claim to this name), HOPE (five trials) and CURE (six trials). To get around this, some clients opt to use a name that symbolizes the tone and goal of the research as opposed to an acronym. However, The New England Journal of Medicine reported that compared with clinical trials without acronym names, acronym-named trials enrolled five times as many patients (but were not more likely to report positive results).1

Either way, naming a clinical trial, whether using an acronym or otherwise, gives the trial an unforgettable identity and provides a creative platform for communications and messaging. The identity engages clinical trial participants and investigators, optimizing the recruitment and retention of participants in clinical trials.

 

1Acronym-Named Randomized Trials in Medicine — The ART in Medicine Study

N Engl J Med 2006; 355:101-102, July 6, 2006

 

 

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