Up at 5AM: The 5AM Solutions Blog

How Compassionate is Compassionate Use?

Posted on Thu, Jul 02, 2015 @ 03:00 PM

My last post talked about off-label use of drugs, which is one way that patients can get access to drugs that are not officially approved for their condition. There’s another way this can happen, and it’s called compassionate use.

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Tags: clinical trials, map of biomedicine, compassionate use

Should We, Maybe, Dial Back Personalized Medicine?

Posted on Thu, Jun 25, 2015 @ 03:00 PM

The short answer to our provocative headline is no. But two other recent headlines got us pondering the question. Yesterday, the New York Times, and on Monday, the Journal of the American Medical Association(JAMA) published, respectively,  a story and an opinion piece on the potential downsides to medicine that is aimed at specific genetic profiles.

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Tags: clinical trials, personalized medicine, genetic testing, precision medicine

How to Get Drugs That Haven't Been Approved

Posted on Thu, Jun 18, 2015 @ 03:30 PM

The last two Map of Biomedicine blog posts have introduced us to the clinical trial process. Clinical trials are the gold standard for determining whether a drug works, and are extremely important to make sure that drugs are only used in situations when they are known to help.

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Tags: clinical trials, map of biomedicine, drugs, off label

Faster, Cheaper TB Diagnostics?

Posted on Tue, Jun 16, 2015 @ 04:02 PM

Yesterday evening, the Wall Street Journalreported on its website that researchers at the Texas A&M Health Science Center are closing in on faster, more accurate diagnostics for tuberculosis. The infectious disease usually attacks the lungs, but it can spread to other parts of the body -- extrapulmonary tuberculosis in those cases -- through the air from person to person. Although it is relatively rare in the U.S. it is not unheard of; tuberculosis (TB) made headlines when a woman with extensively drug resistant TB (XDR TB) was admitted to NIH.

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Tags: clinical trials, diagnostics

Genes, Drugs, and Diagnostics: How Clinical Trials Work

Posted on Wed, May 27, 2015 @ 11:25 AM

In my last Map of Biomedicine blog post, I talked about the different phases of clinical trials and a little bit about how trials are structured. I mentioned that trial is really just an experiment designed to test a hypothesis. When you studied science in school you learned about the scientific method:

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Tags: clinical trials, personalized medicine, map of biomedicine, genes, drugs

New Studies Could Lead to New Diagnostics for Alzheimer's Disease

Posted on Thu, May 21, 2015 @ 03:30 PM

Two new studies published in JAMA this week confirm that amyloid plaques on the brain predict future Alzheimer's Disease (AD). What's more, there is evidence that the plaques appear decades before patients experience the cognitive declines associated with AD. Researchers have long suspected that amyloid plaques precede the disease, but according to an article in the New York Times, this new research is "[t]he largest analysis to date of amyloid plaques in people’s brains [and it] confirms that the presence of the substance can help predict who will develop Alzheimer’s and determine who has the disease."

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Tags: research, clinical trials, map of biomedicine, diagnostics, Alzheimer's Disease

Clinical Trial Basics on the Map of Biomedicine

Posted on Thu, May 07, 2015 @ 02:00 PM

As I said in my last post, one of the key components of the Map of Biomedicine is how new treatments get developed. That’s one of the parts of the map that is highlighted, as shown below.

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Tags: clinical trials, biomedicine, map of biomedicine, drug development, Vignette 2

Precision Medicine and the Placebo Effect

Posted on Fri, Apr 17, 2015 @ 12:00 PM

If you’ve been watching the AMC series “Better Call Saul” then you know that Chuck McGill — the older brother of protagonist Jimmy McGill — suffers from a mysterious, and little-understood collection of symptoms described as electromagnetic hypersensitivity (EHS). EHS sufferers report symptoms ranging from headaches to rashes to burning sensations when they are exposed to electromagnetic fields, such as those associated with cell phones. 

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Tags: clinical trials, precision medicine, placebo effect

Ebola: New Outbreaks Amid New Hope for Vaccines

Posted on Fri, Mar 27, 2015 @ 03:00 PM

Liberia was poised to be the first of the three hardest-hit countries stricken with the Ebola epidemic to declare itself free from the deadly virus that has ravaged the region for a year. The West African nation had gone two weeks without a new infection; and then a 44-year-old street vendor developed a fever. Her teenaged daughter, who'd tended to her sick mother developed a telltale headache.

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Tags: clinical trials, vaccines, ebola

5 Reasons Apple's ResearchKit Moves Us Forward

Posted on Tue, Mar 17, 2015 @ 03:00 PM

Last week, Apple announced that it had released the first generation of ResearchKit. For those of us working to bring the internet to healthcare, the Web blew up with strong opinions about it. Whether you are for or against the new platform, it has to be acknowledged that it is an important step toward further uncloaking the world of biomedicine and making it accessible to lay consumers in the healthcare marketplace.

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Tags: clinical trials, Research Kit, ResearchKit, Apple

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