Category Archives: Global Health

Compassionate Use: Experimental Drug Access from the Ebola Crisis to #Save[Patient]

During his visit to the U.S. Centers for Disease and Control today in Atlanta, President Barack Obama announced a major expansion of military and medical resources to combat the spread of the Ebola virus, including the development of 17 treatment centers, training for thousands of healthcare workers and the creation of a military control center for coordination.

Considering short- and long-term treatment options, $58 million will be allocated to speed the production of antibody-based ZMapp, as well as two Ebola vaccine candidates.

ZMapp, founded by Mapp Biopharmaceutical, Inc., was first in the spotlight when two American aid workers who had been based in Liberia received the experimental drug under the FDA’s “compassionate use” regulation, which provides access to experimental drugs outside clinical trials. Of the seven people who have now been treated with the drug, two have died.

Though the Ebola virus is rare among rare diseases, since the AIDS epidemic in the 1980s, patients with terminal and hard-to-treat illnesses have sought access to drugs in development. But the decision to grant this access is far from simple.

To receive a drug through compassionate use, a patient must have support from a physician, FDA consent and a pharmaceutical company willing to provide the treatment – a step where many patients run into roadblocks.

If a request is turned down by drugmakers, the companies are seen as heartless. But several issues must be considered: a poor outcome under compassionate use could put a hold on the approval process for the broader population; a limited supply of the experimental medication; and a lack of data on its safety and efficacy.

Considering ZMapp, Forbes columnist David Kroll raises this question: “Out of thousands infected, how did the company decide which six or seven patients would receive their medicine?”

Chimerix, a small, biopharmaceutical company, based in Durham, North Carolina, faced intense scrutiny in April when it initially refused an experimental medicine to and eight-year-old pediatric cancer patient who developed a viral infection following a bone marrow transplant, and due to kidney complications from the standard course of therapy, the family sought access to brincidofovir, Chimerix’s anti-viral drug still in development.

The family amassed a substantial social media following that led to national coverage and death threats to company leadership. Though the eight-year-old did not receive the medication through compassionate use, Chimerix worked with the FDA to immediately approve a clinical trial for pediatric patients, in which the boy was the first to enroll.

The public relations crisis led to CEO Kenneth Moch’s resignation and questions raised around the concept of crowdsourcing medical decisions. In the era of social media, should patients with more compelling stories or the ability to gain social media traction receive a life-saving treatment over those with the same or greater needs?

In his first public essay since he left Chimerix, Moch, along with NYU ethicist Arthur Caplan, reflect on these challenges in a Health Affairs editorial: “Without a new system and clarity within the regulatory process, medical decision-making will be left to those individuals and mechanisms — to social media, newscasters and print reporters, and politicians — least appropriate to decide complex medical facts.”

Families no longer need to host a community walk to raise funds and awareness for their loved one. Movements now begin with a compelling photo and #Save[PatientName] Twitter hashtag. As healthcare communicators, our role is not only to bring visibility to these untold patient stories, but also to share the perspective of the companies who must make these difficult access decisions.

Drugmakers need strategic guidance to communicate the complexities of the process and limitations, with a greater sense of transparency and understanding. Regulatory agencies need support addressing concerns and risks, and patient advocacy organizations will continue to need their voices amplified.

As Forbes’ Kroll puts it, we are not yet there in finding a middle ground on compassionate use that does not favor those who mount a social media following. But to reach this greater sense of transparency and collaboration, all parties will need cross-channel communications counsel – from combatting the Ebola virus to navigating the difficult challenge of providing a drug to one patient over another.

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Communicating the role of sugar in the obesity epidemic

Obesity is a global epidemic that impacts all people—either directly or indirectly—regardless of race, gender or nationality. Through the lens of a health care communications pro in the UK, TogoRun UK’s Jessica Greenman weighs in with her perspective.

With an impending obesity epidemic casting a dark cloud of financial doom over Europe, new figures report that by 2050, the obesity problem could cost the UK approximately £50 billion a year. The epidemic is becoming a regular feature in the tabloids, and more recently, sugar has been targeted as one of the main contributors to our overweight nation. So in the midst of the crisis, what measures can be put in place to avert such a catastrophe?

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In recent months, efforts have been initiated to curb the sugar problemincluding Action on Sugar, a new group lobbying the government and food industry to reduce the hidden or “unnecessary” sugars found in processed foods. The group is calling for food and drink manufacturers to re-size their products, offering smaller portions of foods that contain high levels of sugar. Activists believe that these suggested cuts could halt or reverse the growing obesity epidemic in less than five years and reduce the risk of patients developing type 2 diabetes; a common comorbidity of obesity and a substantial drain on National Health Service (NHS) funds.

Campaigners have also made claims that sugar is even more of an issue than another health care crisis: smoking. However, unlike sugar, tobacco is not added into processed foods and consumed by the overwhelming majority of the population. Smoking is a choice, whilst many people are unaware of the level of added sugar in the foods they are eating.

In March, the World Health Organization (WHO) announced new sugar intake recommendations. The guidance indicated that sugar should make up no more than 10 percent of our total daily calorie intake, and limiting sugar intake further (to 5 percent) could offer additional health benefits. To give some perspective, drinking one can of full calorie soda would exceed this 10 percent daily limit.

Even if measures are taken to reduce the levels of hidden sugars, foods such as cakes and chocolate candy still contain very obvious, unhidden sugars. So, how do we encourage people to stop eating these sorts of snacks? Or rather, is promoting moderation the key? With whatever direction we choose, it is imperative that communications professionals partner with policy makers to combat this rising epidemic.

As in the case of smoking, public health campaigns played a key role in educating the public about the dangers of tobacco. In 2012, the NHS launched the Stoptober campaign, which encouraged smokers to go smoke free for 28 days throughout October. Participants were provided with a ‘quit kit,’ as well as encouraging text messages each day. The campaign was so successful that it continued through 2013, where a quarter of a million people in England and Wales registered to take part in the challenge. In parallel, the NHS also launched Mutation, a more hard-hitting campaign in 2012.  The campaign dramatised the harms of smoking by making the invisible visible, showing a tumour growing from a cigarette. The advertising achieved awareness of 92 percentthe highest for any smoke free campaign in five years and the commercial was viewed more than four million times on YouTube. It was also recorded that:

  • 41 percent of people that saw the commercial were more likely to quit smoking
  • 61 percent agreed that the commercials made them realize that every cigarette is harmful

Clearly high levels of sugar in foods are posing a significant risk to our health, but can we really talk about sugar the same way we talk about tobacco? Critics argue that we should not draw comparisons because in moderation, sugar makes up part of a healthy and balanced diet, whilst tobacco is a proven poison that offers no health or dietary benefits. If consumed as part of a healthy and informed diet, then sugar should not pose any problems to our health.

Currently, action groups, such as the Children’s Food Campaign are lobbying for a tax on sugar found in food and drink, and England’s chief medical officer, Sally Davies, has shown her support for the campaign, suggesting it would help to combat obesity. That said, the government seems disinclined to use food taxes as a way to combat unhealthy eating habits.

Whatever the direction, we must address the rising number of people that are not making informed decisions about their diets. Changing policy and taxing sugar like tobacco seems like an extreme measure that doesn’t necessarily halt or reverse the impending epidemic. In order to create true behavior change, we must couple any changes in policy with a well-constructed, public campaign that highlights the underlying damage being caused by sugar, and encourages individuals to make informed decisions about the foods they decide to eat.

From a communications perspective, it is imperative that the government and advocacy communities’ work together to form a public/private partnership that communicates the merits of the policy and provides education and awareness around this important health issue.

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To Tweet or not to Tweet: Europe’s digital conundrum

Twitter-BirdFor most pharmaceutical companies in Europe, the use of Twitter verges on an existential crisis. With social media regulations that vary from country to country and language barriers to overcome, companies often find themselves asking, ‘Why do I need Twitter and what value can Tweeting bring?’

Why do I need Twitter?

When you look at what pharmaceutical companies have flocked to Twitter, the majority of the tweets are coming out of the United States. As one of only two countries (the other being New Zealand) that is allowed to advertise directly to the consumer, the U.S. tends to throw caution to the wind when considering the use of social media channels such as Twitter. Whilst the tweets tend to be quite corporate in nature – covering items such as press releases, company overviews and CEO blog posts – the appeal of this format is obvious. It gives companies the opportunity to control their message and disseminate news directly to their followers for a fairly nominal cost.

On the flip side, if European pharma should try this tactic, the price could be much more significant.  Individual countries in Europe have restrictions in place to stop direct-to-consumer advertising. That, combined with the threat of considerable fines, may be more risk that companies are willing absorb. A well-known global pharmaceutical company found this out the hard way when it was reprimanded for tweeting about two medications in 2011. Though the company escaped without a fine, the decision in the UK by the Prescription Medicines Code of Practice Authority (PMCPA) set a cautious tone, instilling fear that even the slightest mention of a drug can result in a public rebuke.

Companies are now bound by the following PMCPA guidance on digital communications:

“If a company wanted to promote a medicine via Twitter it would have to ensure that if the medicine was prescription only, the audience was restricted to health professionals only.”

In a medium like Twitter, this is simply not possible.

What value can Tweeting bring?

Pharmaceutical companies have a lot to gain by using a channel like Twitter.  The apparent limitation of being unable to advertise could slipstream the companies into a more concise role. Rather than delivering details of their corporate environment, they stand to help patients better manage their disease and improve their profile by becoming thought leaders within a disease area. By improving the dissemination of information in the health environment, pharmaceutical companies stand to gain from an educated audience who are able to more easily recognize their symptoms.

‘To be or not to be’ – this is an allusion of a choice. With the equivalent of 8,123 copies of War and Peace tweeted every day, Twitter has become one of the most valuable business resources available today. The pharma industry has a lot to lose by sitting on the sidelines.

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The continuing challenges of pharma’s new-found transparency

You can’t please everyone!…so goes the idiom.

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It’s an age-old problem, and one that has for a long time been a sticking point for pharma in the push towards payment transparency. But it seems there’s finally light at the end of the tunnel.

On both sides of the Atlantic, regulation is now in-place that will finally help silence long-standing criticism of the opaque nature of the payments made between pharma and the medical community, whilst balancing the associated issues of privacy law and anti-bribery legislation.

Whilst the United States was seen to lead the way with the introduction of the Sunshine Act in 2010, the implementation has been relatively slow-paced, and it will only be in September of this year that the first data on payments and gifts made to physicians and teaching hospitals, must be made publicly available on a searchable federal database.

This delay has given Europe the opportunity to catch-up. In its updated code of practice, which came into force on 1st January of this year, EFPIA (European Federation of Pharmaceutical Industries and Associations) has set-out the requirement for all members to disclose all ‘transfers of value’ in 2016, starting with transfers made in the prior year.

The UK is spearheading this initiative, with the publication of aggregate numbers for payments made by member companies to healthcare professionals in 2012, for activities including attendance at medical education events, speaker engagements and participation in advisory boards. The next stage will be a move to the publication of far more detailed data, declaring individually-named healthcare professionals on a single, publicly searchable, central database.

This move towards greater payment transparency has been a truly gargantuan task, and has taken many years to take its final form. The question is, despite all the good intentions on which these regulations have been built, will this prove to be a turning point for pharma that helps repair a damaged reputation and build trust with the public? Or will the scale and scope of collaboration and the associated payments, just serve to stoke the fire? TogoRun will be keeping a close eye on the situation as it unfolds!

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Thoughts on Politico’s ‘Health Care of the Future’

At a recent event sponsored by Politico and Microsoft, an interesting mix of innovators and policymakers gathered to discuss how modern health technologies, such as mobile apps and clinical support tools, are changing the future of health care as well as the role that policy plays – or should play –  in the advancement of such technologies.

The impressive list of participants in this informative discussion included Dr. Farzad Mostashari, National Coordinator for Health IT for the Department of Health and Human Services (HHS), Christy Foreman, Director of the Food and Drug Administration’s (FDA) Office of Device Evaluation, Dr. Joe Smith, FACC, Chief Medical and Science Officer of West Health, Dr. Jordan Shlain, Founder of HealthLoop, among others.

As an attendee of the event, I came away with the following key themes and issues:

–          There is a gap between health policy and health care technology innovation.

Although the FDA has developed rigorous testing to determine the safety and efficacy of medical devices and drugs, they have yet to establish standards for recent health care innovations such as mobile health apps. This poses a problem as there are thousands of apps used for health care purposes every day. According to Joel White, executive director of the Health IT Now Coalition, “technology is changing in such a rapid innovative pace, and the current [regulatory] structure doesn’t work.”  There seemed to be a consensus among the non-policymaking participants of the panel on White’s statement. Dr. Joe Smith stated that “the government is struggling at the moment, we’ve witnessed a technological impact in every other aspect of our lives, and healthcare has escaped from it.”

 In the defense of policymakers, Farzad Mostashari states that regulations are much more enablers of innovation than health care technology developers think, the issue is that “[developers] don’t understand the regulations and rules.”

Although steps have been taken by the government to develop standards on mobile health technology, such as draft guidance on mobile medical applications that FDA released in 2011, clear standards need to be defined in order for health care innovation to reach its full potential. One thing we can certainly look forward to is FDA’s final mobile medical app guidelines, which Christy Foreman said will be available by October of this year.

–          With the quantity of data and health care technology out there – developers must not lose focus on quality.  

According to Audie Atienza Ph.D., senior program director of the Science of Research and Technology Branch of the National Cancer Institute, there are currently between 20,000 to 40,000 apps that are used for health, wellness or fitness purposes. With this number of apps, how are they being tested for effectiveness and reliability? The simple answer is that they’re not. While the FDA has developed draft mobile medical guidelines, it has become the health technology developer’s prerogative to ensure that they’re not innovating for innovation’s sake – technology must be meaningful and centered on the patient to make a lasting difference.

Atienza provided one example of how using technology in the right way can lead to desired results – when the National Institute of Health (NIH) sought to reduce teenage smoking, they launched a campaign centered on text messaging called SmokefreeTXT. NIH found that a sizeable percentage of teens using the service were quitting smoking after using their text-messaging service over a length of time. Health technology developers should take a page from NIH’s book – the key to successful innovation is to make it meaningful to its users.

–          There needs to be a shift from the current reactive nature of our health care system to a proactive one.

Dr. Jordan Shlain used a great term to describe our current health care system, calling it a “reactive health care system”. I couldn’t agree more; our health care system focuses on treating patients’ illnesses, rather than providing patients with tools that help them to avoid illness in the first place. Although the health care reform law attempts to address this issue by punishing hospitals that have excessive hospital readmissions, Atienza took it one step further and says that we need to prevent admissions, not just readmissions.

What’s Dr. Shlain’s solution to making our health care system a more proactive one? Email.   He states that personal medical records (PMRs)/electronic medical records (EMRs)/electronic health records (EHRs) capture a fraction of a patient’s health history, but “we live 99 percent outside of the EHR.”  He believes that creating a system that allows doctors to regularly engage with patients by email will keep patients out of the hospital.  Although there are many obstacles to making email a widely adopted practice by doctors, such as fear of malpractice and privacy concerns, I believe that more people need to be thinking like Dr. Shlain. In order for the health care system to be proactive, its players – doctors and patients – need to be proactive.

We’re in an era in which innovations in health care are growing at an ever-increasing rate, but this seemingly boundless potential of health care technology brings its own set of problems. The key is to find the balance between advancement and the quality of the technology. The leaders that participated in this panel brought these issues to table, but there needs to be a systemic discussion among all leaders in the industry in order for health care technology to reach its full potential. This event may be one baby step, but as health care communicators we are uniquely situated to encourage our clients and colleagues to promote and advance key health care issues of our day – one thing I hope you take away from this is to encourage your clients to promote meaningful health care innovation.

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