Up at 5AM: The 5AM Solutions Blog

With the death toll topping 3000 in West Africa, health agencies around the world are working to speed the development of treatments and vaccines against Ebola. According to the UN Security Council, the epidemic is "...a threat to international peace and security." Normally, taking medical treatments and vaccines from laboratories to patients is a lengthy process that can go on for years. Ebola is different. 

It is a gloomy, rainy day here in the Washington, DC area. It's the kind of weather that, when it goes on too long, can cause one's mood to swing to the decidedly negative side of the pendulum. As it turns out, two factors in the opening sentences of this post - cynicism and low levels of vitamin D - may play a role in developing Alzheimer's and dementia according to two recent studies. 

The National Institutes of Health announced today that it will provide $10.1 million in supplemental funding to 82 grantees so that they can include more female subjects in preclinical and clinical trials. Currently, the overwhelming number of subjects in research are males. Including male lab animals and male cell lines.  

On September 26, 1983, three weeks after the Soviet Union shot down a Korean Airlines passenger jet carrying a US congressman and raising Cold War tensions to new heights, Lt.  Col. Stanislav Petrov was quietly sitting at his desk in a bunker near Moscow when he received some bad news.  Satellites had detected five ICBMs coming from the United States and they were headed his way.  

If you're a parent you know this scenario well: your child is miserable with an earache, soar throat, and an endlessly running nose. You take her to the pediatrician who tells you that the sickness is probably not bacterial, but you are desperate to get relief for your little one. Against your better judgement, you ask for an antibiotic because the thought of one more moment of this illness is too much. And then, voila. After a couple of days, your child is back to herserlf, and even though you suspect that the placebo effect is in play, you're still kind of grateful for the meds. 

 According to the Personalized Medicine Coalition (PMC), personalized medicine is "... the tailoring of medical treatment to the individual characteristics of each patient…to classify individuals into subpopulations that differ in their susceptibility to a particular disease or their response to a specific treatment..." [emphasis ours]. It's an exciting proposition that could -- in the long run -- reduce health care costs overall, and offer individuals the best available treatments for them as people instead of the best available treaments for a disease.

So what's stopping us? There are lots of reasons that a personalized approach to medicine isn't yet part of the mainstream, but here is a roundup of 3 things standing between you and customized medical treatments.

Twenty human subjects became participants in clinical trials for an Ebola vaccine. Almost 2300 people have died from the disease since January 2014 when an outbreak of the disease began and spread through western Africa. In an animal study, four crab eating macaques showed immunity to lethal doses of the virus when they were inoculated with a vaccine.

For years, the placebo effect was the bane of clinical trials. The most revolutionary therapies have to prove themselves to be more efficacious than a placebo, an inert substance or procedure. Often a sugar pill. But what if that spoonful of sugar is the medicine? For the past few years, researchers have been investigating the up side of the placebo effect. Among their questions: can placebos be valid therapies for real illnesses? Could it change the way that subjects are selected to participate in clinical trials? If placebos work, is it ethical to administer them to patients expecting an acutal drug? And finally, are people genetically predisposed to responding to placebos?

The Sixth Annual Next Generation Dx Summit (NGDx) was the first conference I have attended in quite a few years. I was drawn to it by its emphasis on new research areas in clinical assay development and how the biomedical industry can bring these potentially life-saving diagnostics to market to fight diseases and benefit personalized medicine (PM). I decided to focus on two tracks for the conference. Companion Diagnostics: Strategy & Partnerships appealed to my personalized medicine interests and Clinical Application of Cell-Free DNA allowed me to see new research on a specific application of a potentially game-changing diagnostic approach.