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. 

2014 Nobel Prizes Awarded!

The 2014 Nobel Prizes were recently awarded.  Annual Nobel Prizes are awarded for achievement in Physics, Chemistry, Physiology/Medicine, Economics, Literature, and Peace.

The Nobel Prize in Physics was awarded jointly to Isamu Akasaki, Hiroshi Amano and Shuji Nakamura "for the invention of efficient blue light-emitting diodes (LEDs) which has enabled bright and energy-saving white light sources".  While LEDs have existed for half a century, the creation of the blue-emitting LED when combined with either existing red and green LEDs or phosphor excitement allows the production of bright white light that is far brighter and more efficient than previous lighting technology. The development of blue LEDs was a long process, and the laureates’ updated work was presented through a series of publications over the course of 5-10 years. Both a general and a more scientific overview of the technology and its creation can be found at the Nobel Prize website. 

         
                                                                                                                  

The Nobel Prize in Chemistry was given to Eric Betzig, Stefan W. Hell and William E. Moerner for improving optical microscopy beyond the previously believed limit to the nanometer scale.  This feat was achieved by two independent methods, stimulated emission depletion (STED) microscopy by Stefan W. Hall, and single-electron microscopy by Eric Betzig and William E Moerner. STED creates high-resolution images by detecting fluorescent light with a nanoscale-width laser as all surrounding area is quenched.  Single-electron microscopy works differently, by weakly activating fluorescence randomly throughout the sample, repeating several times and then combining the images to obtain a high-resolution final processed image.  These two methods allow fluorescent visualization of structures such as viruses and individual proteins that were previously too small to resolve.  The physics behind these breakthroughs will surely revolutionize biological microscopy.

The Nobel Prize in Medicine was awarded 50% to John O’Keefe and 25% each to May-Britt Moser and Edvard I. Moser for discovering how our brain is able to orient ourselves and properly position ourselves within the environment.  O’Keefe identified hippocampal “place cells” that provide positional and spacial memory information while the Mosers discovered “grid cells” within the etorhinal cortex that offer directional coordination.  Each of these cells were found to be activated in particular locations and sequences of their respective brain regions and have important roles in understanding spacial memory and navigation.

Since this is a science blog I will not delve deeply into the other prizes, but just to summarize: the Nobel Prize for Economics was awarded to Jean Tirole for describing the framework for proper regulation of financial institutions, the Nobel Prize for Literature went to French author Patrick Modiano "for the art of memory with which he has evoked the most ungraspable human destinies and uncovered the life-world of the occupation", and the Nobel Prize for Peace was given to Kailash Satyarthi and Malala Yousafzai for fighting for children’s rights.  Satyarthi protested against child labor while Yousafzai risked her own life to fight for girls’ right to an education.

The (Radioactive) Decay of Western Civilization: Nuclear Physics and the Safety of Nuclear Power

          Nuclear physics and radioactive decay are probably among the most misunderstood scientific topics by the general public.  People have been terrified of nuclear energy since the creation of the nuclear bomb, fear which has only been enhanced both by legitimate disasters such as Chernobyl and the Fukishima Power Plant along with a 60+ year history of films that exaggerate the dangers and misrepresent the science.  Nuclear power plants have a better safety record than the fossil fuel plants that most of our energy currently comes from, while also being more environmentally-friendly.  Many scientists believe that worldwide energy problems could be improved by nuclear power, without the need for investing in newer less efficient technologies, if only they would be accepted by the public.  This post will explain the science behind nuclear power, atomic bombs and radioactive decay, including how they are so often misunderstood by society and the media.

Radioactive Decay

          Radioactive decay is the random breakdown of an atom with an unstable nucleus into a more stable form, releasing energy in the process.  Every radioactive substance has a predictable rate of decay, known as a half life.  The half-life of a radioactive substance is the time that it will take for half of its atoms to decay.  Radioactive decay releases energy, and it is the released energy that is known as radiation.  There are three major types of radiation released from decay: alpha decay, beta decay and gamma decay.  Alpha decay releases an alpha particle, which is essentially a Helium nucleus containing 2 protons and 2 neutrons.  It cannot penetrate materials very deep but is extremely damaging.  Beta decay releases an electron and in contrast to alpha decay, it has greater penetrance but is less harmful.  Gamma decay expels a high-energy photon, which is extremely penetrating while also able to cause DNA damage.  Radioactive decay occurs in all elements of atomic number (number of protons) 83 (bismuth) or greater.  Additionally, radioactive isotopes (varying number of neutrons) naturally exist for many elements under atomic number 83 at a specified ratio in nature.  By utilizing knowledge of the known ratio of these isotopes in nature and their half-life, they are useful for a multitude of processes including archaeological dating, medical imaging, and tracing of biological processes.

Nuclear Fission

          Nuclear fission is very often confused with radioactive decay.  While both involve the release of energy due to nuclear degradation, the two processes are unrelated.  Nuclear fission is usually instigated by bombardment with neutrons and results in the release of two large fragments of somewhat unpredictable size along with neutrons and massive amounts of energy. Unlike radioactive decay which is a controlled spontaneous process occurring at regular intervals that releases defined smaller particles (alpha, beta), nuclear fission only occurs spontaneously at extremely low rates in certain heavy elements (can theoretically occur in elements above atomic number 92, but only realistically observed above atomic number 231), and is typically induced through man-made reactions in only a select group of isotopes.  Isotopes that are able to undergo fission upon bombardment with a high energy neutron (even at low probability) are fissionable, while isotopes that can easily fission with lower-energy neutrons are fissile.  Nuclear fuel for energy reactors or bombs typically utilizes Uranium (U)-235, U-233, Plutonium (Pu)-239 and Pu-241.  These nuclides are all fissile isotopes that are capable of sustaining a chain reaction of neutron release and capture, are relatively abundant and are radioactively stable.

The Importance of Fixing Science Education

I have a guest post that I wrote for Scouse Science Alliance, an excellent blog run by PhD students at the University of Liverpool in the UK.

My post talks about the future of science education, primarily in the USA but also its impact internationally.  Improving science education and literacy is something I care greatly about (hence this blog), so please check it out here.

While you are over there, check out the rest of their blog, they have some great features aimed at a non-academic audience including opinion pieces, featured scientist of the month and highlighted recent scientific discoveries of interest.

Don’t STAP Believing: When Scientific Breathroughs Really Are Too Good To Be True

    I was recently asked to write a guest post for The Biology Blog about the recent STAP stem cell controversy.  The Biology Blog has over 3700 likes on Facebook and over 6600 followers on Twitter.  It features commentary on a regular basis about recent research papers, general scientific discussion and more.  I recommend checking it out!

    To learn about the saga of the recent publications on Stimulus-Triggered Acquisition of Pluripotency (STAP) cells and my personal view on the situation, check out my post here.