2015 Nobel Prizes!

The 2015 Nobel Prizes were recently awarded.  Annual Nobel Prizes are awarded for achievement in Physics, Chemistry, Physiology/Medicine, Economics, Literature, and Peace.

The 21st Century Cures Act: Is it an overall positive?

The below article is published in the Fall 2015 issue of the National Institutes of Health -NIDDK newsletter "The Informer"

In a rare showing of bipartisan collaboration, on July 10th the U.S. House of Representatives passed the 21st Century Cures Act by the substantial margin of 344-77. The 21st Century Cures Act is a large bill that is subtitled as “an act to accelerate the discovery, development, and delivery of 21st century cures, and for other purposes.” According to the U.S. House of Representatives Energy and Commerce committee where the bill was drafted, the goal of the Cures Act is to streamline the process from drug discovery to development and ultimately delivery to patients. The Act promotes scientific research on deadly diseases and attempts to reduce regulatory hurdles in bringing new drugs to market.

In an era of ever-decreasing federal research funding, the bill offers a welcome boost to the research community, allocating $8.75 billion in research funds to the NIH over 5 years and an additional $550 million to the FDA. Not all scientists are in favor of the bill, however. The Cures Act aims to expedite the regulatory approval process for drugs by the FDA. As a means to this end, the bill promotes drug approval based on less rigorous clinical trials, biomarker readouts as opposed to clinical end points, and even non-quantitative anecdotal evidence in some cases. It also further reduces the rigor and objectiveness of medical device approval, which is already more lenient than the drug approval process. In the name of accelerating innovation, the bill attempts to streamline existing bureaucratic barriers to drug development and public release. However, while the bill does contain a section dedicated to “reducing administrative burdens of researchers”, it also adds additional unnecessary bureaucracy by requiring individual review by NIH institute directors of all awarded R-series grants and creating several instances of redundancy with programs or directives already in place at the NIH.  

While there are some potentially troubling issues with this bill, it is refreshing to see Congress finally recognizing the need for additional biomedical research funding. The Senate is now debating the bill and drafting their own version, but the upcoming budget debate may define whether the Cures Act is even passed this year. Assuming the 21st Century Cures Act becomes law, it will be several years before its full effects will be known. In the meantime, it is important to continue evaluating the potential long-term outcomes of this bill for everyone affected.

My Chemical Romance: Natural Is Not Always Better

The Free Dictionary defines ‘chemical’ as “a substance with a distinct molecular composition that is produced by or used in a chemical process”. However, based on the word’s usage by many people such as health bloggers and environmentalists, it has become synonymous with “unnatural”, “additive”, “unhealthy” and most simply, “bad”.

The food industry today loves to advertise products as being “natural” with “no added chemicals”. This is especially true for the organic food industry, whose fearmongering about toxins in everything has eeven expanded to non-edible products! There is no clear standard for what constitutes a toxin however, and any molecular compound whether naturally-existing or artificial is by definition a chemical. The ambiguity of terms such as “natural” and “toxins” allows health food peddlers to define these words as best promotes their products.  The organic and homeopathic industries vilify scientifically-validated biomedical achievements such as vaccines and GMOs (genetically-modified foods, see my blog post on GMOs for more details) for containing potentially dangerous “toxins”. Ironically, organic food often contains higher incidences of ACTUAL biological toxins and pathogens from increased bacterial and fungal load due to their proudly-advertised natural farming practices. Additionally, organic farming produces substantial environmental pollution that can be more damaging than traditional means.

The Star"buck"s Stops Here: What is the Role of Coffee/Caffeine on Long-Term Health?

            The market for coffee sales in the United States alone is $18 billion, owing to the fact that over 50% of Americans drink coffee daily, and the average coffee drinker consumes 3.1 cups of coffee per day.  Coffee consumption has sharply increased worldwide over the past several decades (Figure 1), although it has surprisingly decreased dramatically in the United States (Figure 2). 

Figure 1: Worldwide coffee consumption in weight by decade (www.unctad.info) .

Figure 2: Volume of coffee consumption in the United States by year www.marketwatch.com) .

            With so much recent focus on trendy nutritional regimens and the popularity of “chemical”-free diets such as gluten-free and organic, it is surprising that there has not been a greater public interest in the health effects of coffee.  Should we be drinking more, or drinking less? Fortunately, several studies have been performed assessing the association between coffee consumption and mortality.  While all of these studies exhibit the caveat of only evaluating correlations and not causal relationships, meaning that some other associated variable may actually be responsible for the observed effects (known as a cofactor), they can still provide useful information.