[L]ast night’s ‘State of the Union’ speech contained loads of platitudes, congratulatory back-pats, and perhaps a few misleading statements (jobs numbers, for one—and the implication that Americans are better off now for another), but that’s not what I intend to write about this morning. Instead, I’d like to take a long at a little bomb our President dropped that may indicate the direction healthcare is heading in the near future.
Here’s the quote:
21st century businesses will rely on American science, technology, research and development. I want the country that eliminated polio and mapped the human genome to lead a new era of medicine — one that delivers the right treatment at the right time. In some patients with cystic fibrosis, this approach has reversed a disease once thought unstoppable. Tonight, I’m launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes — and to give all of us access to the personalized information we need to keep ourselves and our families healthier.
The President loves doing as much as he can to circumvent Congress, so he’s signed memoranda, letters, and executive orders on an almost daily basis. Now, the ‘Precision Medicine Initiative’ has not yet been signed (or at least, it is not showing up as such on the Internet—the only references are to last night’s speech), but if it is signed, then we can probably see how it might be structured by looking at the current budget requests from the National Institutes of Health.
According to their official budget for Fiscal Year 2015, Precision Medical Care is one of their Four Primary Areas of Research. PMC essentially means custom-tailored meds for each individual’s genome, which implies a need for individual genetic testing:
For example, NIH’s National Center for Advancing Translational Sciences (NCATS) works with the pharmaceutical industry, academia, and the U.S. Food and Drug Administration (FDA) to look for new uses of drugs that have been found to be safe in humans. And an exciting new venture between NIH and ten biopharmaceutical companies and several non-profit organizations aims to transform the current model for developing new diagnostics and treatments by working together to identify and validate biological targets of disease. Focusing first on pilot projects in the areas of Alzheimer’s disease, type 2 diabetes, and the autoimmune disorders of rheumatoid arthritis and lupus, the ultimate goal of the Accelerating Medicines Partnership is to increase the number of new diagnostics and therapies for patients and to reduce the time and cost of their development. [emphasis added]
Alzheimer’s, diabetes, arthritis, and lupus are four major sources of pharmaceutical revenue. It’s logical to assume that pharmaceutical companies would love to continue making money on patented formulas rather than allow them to enter generic status, and it only makes sense that ‘tailored’ formulas would never lose patent status, especially if changing conditions required regular adjustments (see the microbiome notes down the page).
Tissue on a chip model. Growing human and animal tissues on ‘chips’ is a new concept that’s catching on. The backlash against animal testing coupled with the realization in research circles that animal models do not always translate into human solutions has led to the development of this interesting solution. According to the NIH doc:
To help streamline therapeutic development, NIH along with its partners, the Defense Advanced Research Projects Agency (DARPA) and FDA, embarked in 2012 on a bold, technology-driven initiative to improve the process for predicting whether drugs will be safe in humans. This tissue-on-a-chip research initiative is aimed at developing 3-D human tissue chips that accurately model the structure and function of human organs, such as the lung, liver, and heart.
Currently, investigators are making great strides both in the reliable differentiation and maturation of induced pluripotent stem (iPS) cells into the desired cell types and in combining those cells into cellular microsystems. [This means the patients’ skin cells would be grown into a whatever tissue is needed, which would then be used to test the proposed drug – skg] NIH and DARPA investigators are also beginning to integrate individual tissues (e.g., heart, lung, or nervous system) onto miniaturized platforms that combine 2-4 systems together. The goal of the project is to have a commercially viable prototype chip available at the end of the five-year award period.
Oh, but it gets better:
[…] One project under consideration, Bioelectronic Medicines, would seek to establish methods to stimulate the peripheral, autonomic, and enteric nervous systems and thereby control the function of physiologic systems. This could lead to proof of concept for an entirely new class of neural control devices that have the potential to precisely treat a wide variety of diseases and conditions. [emphasis added]
Neural control devices can include optigenetics, a growing field of study that inserts light-reactive genes into neural cells, effectively allowing these nerve cells to be switched on or off via a light beam of the correct wavelength. Bioelectric Medicine may also include implants like those now used in researching Alzheimer’s and neurological disorders.
The National Institutes of Health also wants to know more about how the human body functions regarding what scientists call ‘the microbiome’:
The first phase of the HMP [Human Microbiome Project], involving the sequencing of microbial reference genomes from five areas of the body – the digestive tract, mouth, skin, nose and vagina – determined that more than 10,000 microbial species occupy the human body and that the microbiome provides more genes that contribute to human survival than the human genome itself (8 million vs. 22,000). [emphasis added]
This is an astonishing statement–that more of what constitutes ‘humans’ is provided by symbiotic organisms. Scientists would love to believe this, because it diminishes the contribution of our God-created genes. However, I do find it remarkable that human health appears to depend on this symbiosis. With genetically modified food and an altered environment all around us (thank you, chemtrails, nuclear testing, etc.) this microbiome is under attack. The twisted logic of pharmaceutical companies is to medicate the symptoms, and then medicate the side effects. One might hope that further study into said ‘microbiome’ might put a stop to some of this craziness, but it’s likely to be cumulative. The more science discovers, the more meds we’ll have to take!
There are other clues to our medical future in the NIH budget request. Goals include finding a ‘universal influenza vaccine’, effectively one that assaults and disarms all types. And the NIH would like to find a way to scrape, collate, and utilize all the mounds of data being produced by researchers, physicians, hospitals, and even ourselves via biotracking ‘wearables’. The Internet is alive with all our Big DATA, but most of it is not yet connected. The NIH wants to change that:
In 2012, NIH established an overarching initiative–termed Big Data to Knowledge (BD2K)–to accelerate the pace of discovery through the use of biomedical Big Data, to be led by the new NIH Associate Director for Data Science, Dr. Philip Bourne. By the end of this decade, the goal of BD2K is to enable a quantum leap in the ability of the biomedical research enterprise to maximize the value of the growing volume and complexity of biomedical data. BD2K also issued a Request for Information (RFI) for public input on developing a biomedical Data Catalogue that would enable researchers to easily find, share, and cite biomedical research data In FY 2015, the total NIH investment in BD2K is estimated at $88 million, or roughly double the FY 2014 level.
And to illustrate this point, the NIH mention this ‘success’ story:
In response to the President’s Alzheimer’s Initiative, NIH established the AD Genetics Data Warehouse–a collaborative effort between geneticists and the National Human Genome Research Institute (NHGRI) Large-Scale sequencing program to identify further genetic risk and protective factors. Now in its third phase, scientists supported by the Alzheimer’s Disease Neuroimaging Initiative (ADNI) have gathered and analyzed thousands of human brain scans, genetic profiles, and biomarkers and are continually refining ways of detecting AD at the earliest stage possible. [emphasis added]
How will this massive data collation and scraping take place? How can our government make use of the vast amount of medical statistics, test results, doctors’ notes, scans, blood screenings, and genetic tests now taking place across the country? Well, to begin with they’d need legal access to all of it, wouldn’t they? HIPPA laws generally preclude that, BUT if the government becomes the insurance provider for all its citizens, then that same government would have legal access to anything and everything.
Of course, they could always ‘cheat’ and just spy on us, but that is crazy, right?
Right. Say hello to Dr. Big Brother, folks. We will soon be genetically tested, labeled, spindled, and possibly mutilated (at least financially). Welcome to the Brave New World.