Thursday, August 21, 2014

VaccineLike many of you, over the past several months, I have watched the tragedy of the Ebola outbreak in West Africa unfold. Given my past training and career experiences, I felt a chill reading the headlines, developing a deep concern about those individuals and groups affected, as well as a growing interest as to how the resulting global dialogue would develop.

In particular, and very personally, my heart ached when I read the headline that the physician in charge of treating patients with Ebola at the Kenema General Hospital in Sierra Leone died from Ebola hemorrhagic fever. While I never met Dr. Sheik Umar Khan directly, in the past year, I had worked with this physician and his team in a very peripheral role, quite safe and insulated from the emerging dangers. I was working in my Washington, DC, office overseeing a project designed to have experts in Kenema, Sierra Leone, teach scientists and medical professionals from Nigeria to identify and control similar, deadly viral hemorrhagic fever disorders such as Lassa fever. I was never on the front lines of the effort, nor was I in the same position as several of my very dear friends and colleagues who had just returned in July from West Africa, direct from the epicenter of the outbreak, the very location where this brave soul lost his life caring for those in the throes of the devastating disease caused by the Ebola virus.

Were my friends safe? Did they come in contact with virus directly while on travel to provide consultation to the local teams? Are they now on 21-day fever watch? How terrified are they?

As terrified as they may be, are they comforted to know that that they are now back in the United States with access to potentially life-saving measures—things we might consider a standard of care or a “right,” such as access to highly controlled infection control suites in pristine hospitals, IV fluids and other supportive measures given by skilled nurses and other health care professionals, and access to promising experimental treatments to combat this deadly disease?

Throughout the past few months, I have continued to ponder the myriad of complex considerations, including global health, politics, economics, fairness, access, research ethics, and numerous other concerns that could decide the fate of individuals and groups most deeply affected while voraciously reading all related coverage in order to understand the direction the dialogue would be heading. You need go no further than the weekly headlines page on Global Biodefense to find that despite prior challenges to obtain funding to develop therapeutics and vaccines for Ebola, there is now full attention on the matter. You will also see that this topic is rife with controversy where acceleration of therapeutic development and funding from both local and global priority perspectives are concerned.

I joined Altarum Institute and KAI Research, Inc. just after the Ebola outbreak began, having just come from a company that was and still is deeply immersed in Ebola outbreak response support activities, to a company with intent to become more deeply immersed in clinical research activities by supporting clinical trials, both domestically and internationally. I am thrilled to support the clinical research pipeline of therapeutics and vaccines that will mitigate diseases and outbreaks that typically affect very few directly, as well as many other promising products that will benefit very large groups of people, such as those with chronic or acute pain, addiction, neurological issues, or a number of other indications. I did not anticipate how quickly all my past training and interests would collide in my new roles (e.g., medical ethics, information systems and technology, clinical research, biotechnology, biosecurity, international medical diplomacy).

As I now sit with a team of exceptionally dedicated and talented professionals who manage clinical trials and other clinical research with such quality and rigor, I continue to consider how we will apply this same approach to the pending clinical trials and to considerations of “compassionate use“ principles for access to therapeutics and vaccines that are still in early-stage development and may not be quite ready for prime time. How will we rigorously collect the data and information necessary to support the validation of new medical products, especially if such studies would need to be conducted in areas where no clinical trials have ever been introduced? How will we determine access to trial participation when so many are dying and it could be argued that all should be granted compassionate us to available, unproven treatments? How will we maintain the trust gathered over many years of building programs and supporting local efforts, especially if that trust is still tenuous at best in some regions or only through individual, very personal connections?

Throughout this global dialogue of research ethics and access to therapeutics and vaccines in the midst of a devastating outbreak, there is an imperative to ensure that those most vulnerable will be provided access and opportunity, while appropriately acknowledging, managing, and mitigating the associated risks. In this case, an experimental drug was made available, and those risks were weighed.

Ultimately, the decision was made not to provide an experimental drug to Dr. Khan, and he perished a few days after that decision. This drug was then sent to Liberia and given to two Americans, while some cried foul over U.S. preferential treatment. What if the drug had been given to Dr. Khan and he perished anyway? Would it have been the fault of the disease or of the drug, or could we possibly know under these circumstances? These are not easy questions, and only through rigorous clinical trials that take time could we uncover the coveted answer to such questions—time that slips away far too quickly in the midst of an outbreak.

The debate about the use of experimental drugs is complex and evolving, very much like the unanticipated twists and turns in this current Ebola outbreak. Although several weeks ago the World Health Organization indicated that it would be unlikely that experimental drugs to combat Ebola would be used in this current fight, the newest consensus from a special United Nations panel indicates that it is in fact ethical to consider such use in the current circumstances. Additionally, the President commented that “we have to let science guide us” in the decisionmaking about what treatments should move forward and how they should be accessed.

As we let science and ethics guide us, it is my hope that we do so with the utmost compassion, common sense, and clearest possible intent to develop and maintain trust with the global community.

For more information about Ebola hemorrhagic fever (also known as Ebola virus disease) from the U.S. Centers for Disease Control and the World Health Organization: and

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