The Cures Act 2.0, Build Back Better & Genomic Surveillance
By: Aly Alexandra & Sebs Solomon
You can find this article at Sebs Solomon’s Medium page as well - give her a follow!
With all of the buzz about the abysmal Infrastructure Bill and the Build Back Better Agenda, there are a few things that have fallen through the cracks. One of those things is the current Cures 2.0 Act being drafted by the same representatives who spearheaded the 21st Century Cures Act that passed in 2016 — the two representatives being Diana DeGette (D-CO) and Fred Upton (R-MI). It is obvious from the “D” (democrat) and “R” (republican) next to each of their names that the current bill they are working on and the past Cures Act that they got passed in 2016, are “bipartisan” — supported by both sides of the aisle; thus, do not receive very much attention from the media (since no one is squabbling about them in Congress). Because of its popularity, the bill received little attention when it passed in the House and Senate with an overwhelming majority. This was one of the last acts signed under Barack Obama and with all of the faux hysteria over “Trump stealing the election from Hillary,” there was little talk about this vital piece of legislation.
Two people who took vocal stances and voted against this bill (in the Senate) were Elizabeth Warren and Bernie Sanders — this is not to give them credit, but it’s interesting to take a look back and note who voted for and against it — note to the Tulsicrats, the Aloha Queen voted in favor of this abomination. Regarding the bill, Cures Act, Elizabeth Warren said “pushing treatments without scientific evidence that they work is fraud — fraud that can hurt people.” She’s right on this; however, in 2020, she changed her tune when she declared that it was imperative Operation Warp Speed succeed — knowing full well that Operation Warp Speed would not have even been possible without the 2016 Cures Act that she was, supposedly, vehemently against — as expected, inconsistency from members of Congress. Bernie, along with Warren and Gabbard, has since pivoted from his original position. Most of these people are either spineless, corrupt, or completely incompetent. Anyway, congress may “write” the legislation, but that does not mean they dictate what actually gets written down, they are merely glorified scribes. Anyway, let’s keep it moving; there is much to cover.
21st Century Cures Act of 2016
Before getting into the details of the Cures 2.0 Act, let’s discuss where it came from, the 21st Century Cures Act. As stated above, this bill had support from representatives on both side of the political spectrum (and yes, of course it’s two sides of the same bird, but there is a point to this, promise). What was in the Cures Act, you ask? Well, to summarize it in one sentence, one could say: The Cures Act of 2016 contained all of the mechanisms that made Operation Warp Speed and the Cares Act of 2020 possible and, more importantly, legal. That probably sounds like an over exaggeration, but as you’ll soon be able to tell, that statement is completely accurate. Several sections of significance have been highlighted — in an attempt at capturing the true dark essence of this reckless legal document that was signed into law on December 13, 2016.
Yes, discussing legislation is super boring, but this will tie into something broader than the theater that is the United States Congress.
Section 1001: Beau Biden Cancer Moonshot and NIH Innovation Projects — This section allocated money toward the Precision Medicine Initiative, BRAIN Research (also known as the Neurotechnological Initiative), cancer vaccines, and regenerative medicine.
According to the FDA, regenerative therapies include: cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination using such therapies. Furthermore, there was a provision that said if a drug can treat, modify, reverse, or has potential to cure a serious disease or condition and addresses “unmet” medical needs, then it can be classified as a regenerative medicine advanced therapy. This is extremely problematic because how can drugs be classified under a certain category (regenerative medicine) — which is eligible for “accelerated approval” as you’ll see in the next section — when they may or may not be effective? Solely based on their “potential” to treat something that doesn’t have a cure at the time — how does this make sense? Just because drugs “might” work on medical needs that are unmet, should they get a green light to be experimented on the population? That can’t possibly have horrific consequences, right? Wrong. Furthermore, Sec.3031 allows the FDA to rely upon a summary of clinical data in order to approve a supplemental application (or booster) for a medication instead of a full clinical trial. Let that sink in.
Having launched in 2019, Project Orbis (funded by the 21st Century Cures Act) is a collaboration among international regulators to allow cancer patients to get early access to treatments in other countries that may have delays in regulatory submissions (regardless of the FDA’s approval). The countries involved, in addition to the US, are Australia, Canada (and as of recently) the United Kingdom, and Israel. Project Orbis is sold to the public as an international collaboration among governments to fight a “common enemy.” Perhaps, if the world had regulators devoid of corruption then the thought of international institutions coming together as one to create a framework to “fit and fix” every nation in the same way — would not be such a terrifying thought, but that is not the case; so, this is concerning.
BRAIN Initiative (Funded by 21st Century Cures Act in 2016)
The BRAIN Initiative website is quite interesting if anyone wishes to take a gander at some of the recent studies researchers from Harvard, MIT, Massachusetts General Hospital, and other hospitals and institutions alike are working on. For example, through the BRAIN Initiative, Mass. General Hospital is currently working on the ethical issues raised by research on next-generation neurotechnologies to detect consciousness in patients with DoC (disorders of consciousness) — basically, in a coma. They will be taking input from the stakeholders, of course, because who is more familiar with ethics than the business community. The Connectome Project in particular, is interested in observing the brain at different developmental stages. There’s quite a bit of data on the Amish because they have large nuclear families; therefore, are the ideal population to study if the goal is to track different stages of development. Frankly, this is kind of creepy because most of this information goes to a central database at NIH — which has data going back fourteen generations on the Old Order Amish in Maryland.
Section 3033: Accelerated Approval for Regenerative Advanced Therapies — As already stated earlier, this section makes it legal to approve drugs at an accelerated pace if they fall under “regenerative advanced therapies.” Also, certain human gene therapies and xenogeneic cell products — using animal cells other than human for medicinal purposes — also meet the definition of a regenerative medicine therapy. Furthermore, through Sec. 3012, the FDA established a process to expedite the development of drugs that target genes or variant proteins to treat rare or serious conditions. These specific drugs can be approved if they rely upon already submitted information that uses the same technology — without having to do traditional clinical trials.
Interestingly, Sec.3016 gives HHS authority to award grants to institutions and nonprofits to study and make improvements in the process of continuous manufacturing of medications (instead of just making them in batches). Fast forward to 2020 and this is related to Operation Warp Speed — pharmaceutical companies were given the legal authority to continuously produce (in mass) the drugs they were still testing — before they were even approved. In Sec.3023, there was a provision about reducing regulatory duplication and unnecessary delays in order to “protect” vulnerable populations. Obviously, this is being sold as a way to quickly get drugs to people who need them; however, how can this not be misused to approve drugs that pharmaceutical companies want to make profit from when the drugs have not proven to be safe? Sure, this may help some people, but how about the people it could hurt? Why aren’t all of these angles taken into consideration?
BARDA — Biomedical Advanced Research and Development Authority
Similarly, Sec.3084 made it so BARDA could enter into an agreement with non government entities to foster and accelerate the development of qualified pandemic or epidemic products through the use of strategic venture capital methods — to address unmet public health needs. Sound familiar? It should. Right below that, in Sec.3085, it states that BARDA’s procurement of medical countermeasures no longer requires Presidential approval or an agreement between HHS and Homeland Security. This is quite substantial, the Cures Act, more or less, turned BARDA into an independent entity — to whom do they answer? As many have pointed out, BARDA was the financial interface between the US federal government and the biomedical industry for Operation Warp Speed — but what many may not know is that the 21st Century Cures Act is what gave BARDA the power to facilitate these business deals with private companies (public-private partnership) under the guise of a “public health” emergency.
Section 3024: Informed Consent Waiver for Alterations for Clinical Investigations — if accelerating the approval of drugs which have not gone through a full clinical trial wasn’t enough, the Cures Act also waived “informed consent” for alterations made during the trials (if those changes posed “minimal risk” and “safeguards” were present). Who decides what is a minimal risk or what safeguards are appropriate? This is not to discount the many well-meaning researchers and scientists who are in those fields in order to help people, but this is quite dangerous — it is a moral (not just legal) imperative that the subjects — in any clinical trial — be updated with what changes are being made to studies in which they are participating.
Section 3022: Real World Evidence — Since regulations for clinical trials were loosened, the Cures Act had a section dedicated to “real world evidence” — which allows for data, regarding the use, potential benefit, or risk of drugs, to be derived from sources other than clinical trials. This basically allows for drugs to be approved by the FDA, without going through the usual steps, and then studying “post approval” by seeing how it helped (or hurt) the people who were administered the drug. There is a section (Sec.2036) about the NIH supporting more “high risk, high reward” research; will those trials also utilize “real world evidence” or informed consent waivers?
Section 3091 and Section 3093: Predictable Review Timelines for Vaccines & Encouraging Vaccine Innovation — In May of 2020, Moderna received the FDA Fast Track Designation for their mRNA vaccine. The fast track designation is for a drug that treats a life-threatening condition and clinical or nonclinical data show the potential to address an unmet medical need. This is similar to Breakthrough Therapy Designation, which requires clinical evidence to indicate the drug may demonstrate improvement on a clinically significant endpoint(s). In Sec.3092, it indicates that vaccine stakeholders can legally give input during the process of making immunization and vaccine recommendations. What do the stakeholders know about making drug recommendations if they work in the business sector? This is absurd, how can stakeholders have a say in medical decisions? Conflict of interest, much? This is dangerous, to say the least.
What is it? The first Cures Act changed the way drug treatments were researched and the new Cures 2.0 Act seeks to “improve” how those new treatments and therapies are delivered to the patients. It is marketed as the “fight to cure cancer” bill, but it is much bigger than that and it has nothing to do with “curing” anything, the bill is about “managing” sickness. There is no cure coming, only deregulation for risky research through ARPA-H, funding pandemic-related impact, expanding genetic testing, financing cell and gene therapy research, and investment in digital health technologies — such as: wearables sensors, virtual reality headsets, AI, digitally-enabled drug drug delivery devices, advanced analytics, and cloud services.
ARPA-H (in the same family as DARPA) is described as being able to bridge the public/private divide in order to more efficiently do “risky” research that would take too long for the NIH — because of the regulations to which they have to adhere (to which ARPA-H research is not subject). The two representatives in Congress spearheading this bill, Upton and DeGette, believe ARPA-H can be good for research that is too risky for the private sector and would move too slowly through the government institutions. ARPA-H is designed to get around the problems with regulations and allow for very “nimble” research — and even though there may be a high failure rate, the “experts” in the scientific community believe it is worth the risk (not risking their own lives, of course, but other people).
Genetic testing: In addition to the Build Back Better Act — which lays out increased funding for genomic surveillance — Cures 2.0 Act also places emphasis on and expands access to genetic testing in order to preemptively determine whether any disease-causing genetic variants are present in the genome of individuals. This is sold as preventative care and precision medicine to reduce “health disparities’’ in marginalized communities. The Cures 2.0 Act seeks to do this by advising the government to encourage genetic testing in order to “help” diagnose people who may be “susceptible” to illness “because” of their genes—in addition to encouraging insurance companies to expand coverage for genetic testing. Mind you, environmental factors are never a part of these types of discussions about illness because many of the “experts’’ never stop to think that if sickness befalls a large population, it could be due to the toxic environment in which those people are forced to live and not necessarily because of their genes.
It’s important to understand how much of what we’ve come to understand as modern day “genomics” has a long and intertwined history with the federal government, universities, and medical research groups. The excerpt below is from 1978 — Jon Beckwith’s concerns, unfortunately, ring quite true in the current context in terms of how this massive surveillance state is expanding on a level not seen before. Jon Beckwith wrote about the inherent risks that come with anything related to genomic studies and how the findings are applied on a global scale. Rightfully so, his assertion that many of the social problems of the world have become “medicalized,”—but not necessarily in the ways we might think.
Interestingly enough, the Build Back Better Act lays out funding mechanisms; or, in this case, is just reauthorizing what was already laid out in previous legislation—genomic surveillance.
The idea that addressing a presupposed condition, before it’s become evident (or, appears at all), is highly problematic. Sure, if there are developments in medical tech and science that can help people manage their lives better within the framework of their specific genomic sequencing, there’s no problems with that. Unfortunately, as with any other technological and scientific progressions, we have to examine what it is we’re actually doing and why. Will the data collected on patients ultimately be used against them? We know they do this in the insurance industry—and we know this is what’s coming with Medicare in the years ahead as interoperability becomes the norm and “information blocking” becomes illegal—this will crush any semblance of privacy that exist under the protection of HIPAA laws. In other words, why are we using “precision medicine” based on the demographics of an entire group, to determine what is right for each individual? Are we doomed for certain outcomes, based solely on our genes? Many in the scientific community would argue yes—and that is a chilling thought. More importantly, within the current economic and social framework, the fate of the general population seem to be in the hands of a select few. Because we understand that patient’s are valued on a quality-of-life scale that they’ve created based on aggregate data fields without taking the INDIVIDUAL into account—how, then, are we being PRECISE with our medicine? It doesn’t make sense—unless you understand their interpretation of what “precision” actually means.
It doesn’t require much effort to understand the potential implications of what is happening—we have seen the vaccine passports and digital ID discussions in the news and the reactions of societies around the world. With all of the funding towards genomic surveillance, what would be the reason for collecting even more data? Could it be to continue the study of genes to understand what makes the “ideal” human? What happens, ultimately, when some genomic patterns are deemed to be invaluable and some are considered inferior to our society? Concerns that were expressed about the he Human Genome Project—a GLOBAL endeavor that launched in 2000—were generally dismissed, but those qualms never went awat. CRISPR and others alike are focused on “editing” human beings and some of their goals are problematic when the ethics aspects are only discussed in a limited and narrow manner. Is it up to human beings to cross those lines, regardless of how one may feel about “innovation and growth.”
When the CDC expanded into areas far removed from specific infectious disease management, the CDC subsequently gained a significant amount of power from the federal government. Under the guise of public health, the CDC’s rapid expansion provided the framework in terms of where we are today. The idea that public health is used as a weapon of compliance, while not surprising, is something that shouldn’t be ignored. When operating within the public health space, the focus is not so much on the individual health of the people who collectively make up the society.
In fact, public health is generally determined by, you guessed it, the health of the population in terms of the productivity and “outputs” per person. Society, as some of these people see it, is “burdened” with the costs of taking care of their fellow man—and, let’s be honest, it doesn’t have to be this way.
Health Equity and Social Determinants of Health
Equity in healthcare is NOT equality. This is fundamental when understanding the issue on a broader level. “Health equity” relies on data provided about groups of people based on their demographic information rather than individual aspects that may contribute to a person’s ability to receive healthcare. Equitable healthcare, then, means that a person should receive the best care possible in order to meet their individual needs. However, this is not determined by simply treating the patient when an issue arises. In fact, equitable healthcare actually relies on monitoring and surveillance in order to determine “effective interventions” when addressing healthcare on a population-level. Equity, then, means that your potential “best self” is determined not by you or the actions that you take, but rather on a set of data provided to healthcare providers and insurers, in order to define the extent to which a life will be improved.
One doesn’t have to look far to find the word “equity” across multiple industries and realms. Everyone from corporate America to the newest app on the market mentions equity, inclusion, and diversity. Again, these sound wonderful — but let’s refer to the graphic above. How does this fit into the realm of healthcare? Social determinants of health, which we’ll dive into a bit, are part of the larger framework in determining the groups of people who are more or less “in need” of social services, in conjunction with a “whole-of-society” approach to improving outcomes in healthcare and in society as a whole. It’s important to remember the notion of free will and self-determination. Do our genes define us above all else? What about our geographical location? The powers that be and the structures they’ve set up point to a resounding “yes” across the board. How did public health’s reach expand into the social problems of our time?
The domain of public health has expanded dramatically in the last 60 years. This expansion makes it clear why public health is now able to address problems as basic as the social determinants of health.
Dr. William H. Foege—The Gates Foundation (2010)
Sounds harmless, right? How far are we willing to let public health dictate areas of our lives that have nothing to do, traditionally, with our idea of what health actually is? Worse yet — what if these Social Determinants of Health, driven by AI-powered systems in healthcare, actually create problems that are far worse than the initial problems they were created to address?
Healthy People 2020/2030
The World Health Organization and the Commission on Social Determinants of Health created a working group in 2008—designed to “marshal the evidence on what can be done to promote health equity” in order to bridge the gap between the poorest and wealthiest citizens of the world from a “holistic” perspective, uniting political, academic, and advocacy groups in this effort. With over 200 pages of research, developmental goals, and agendas, this commission’s efforts were the foundations of what is now known as Healthy People 2030. Once again, while the efforts of these groups sound like admirable goals, we have to remember the actors involved and their global aspirations in terms of meeting the UN Sustainable Development Goals (Agenda 2030).
Healthy People 2030 is the United States’ framework for pushing this larger global health program with a whole-of-society approach embedded into the program. With more than a dozen working groups, these programs seek to facilitate action items that can be taken—with an emphasis on urban and poor areas, to improve conditions within the context of racism, education, pollution, job opportunities, and literacy skills. By citing these “social” factors as larger determinants of someone’s overall health, Healthy People 2030’s emphasis on bridging the gap between seemingly unrelated circumstances into the healthcare sphere, in this context, brings cause for concern when it comes to the issue of personal autonomy on a larger scale. More importantly, the data aggregated under these programs provides a baseline for future AI-powered healthcare systems. Given what we understand about the funding mechanisms used within the healthcare system, it’s clear that a profit-motive still exists within this structure—even if it’s focused on alleviating broader factors that contribute to someone’s overall heath. Proponents of utilizing social determinants of health, such as income-level or access to food, cite the need for an “outcome-based’ system, because the metrics for success can be easily tracked, measured, and ultimately, capitalized on by the same predators who, in large part, had no interest in improving the “social” aspects of health in years past. When the profit-incentive is outcomes-based and social determinants of health are considered as part of the larger picture, healthcare reimbursement models incentivize “improved” outcomes above the actual treatment itself.
Because of our value-based healthcare system, outcomes are of the highest priority when discussing reimbursement systems and quality-of-care. Let’s say someone has a certain genomic profile that is at higher-risk for diabetes. With the current structure, doctors can look at a profile and, based on data gathered on a specific demographic along with the individual’s social determinants of health, determine a potential outcome before any sign of disease. This might sounds great in theory, but what does that actually look like? Why are we treating people for diseases if they have zero symptoms and are taking the steps to ensure they maintain their healthy status? It’s as if we’re predetermining outcomes based on large-scale surveillance that is “patient-centered” — yet seems to focus specifically out the idea out “improved outcomes” that are not focused on the specific individual in question. It’s not to say that this can be effective in preventing some diseases, but if social determinants of health are a larger factor in these preventative diagnoses, why would we expect them to suddenly change their tune? We’re used to excessive treatments post-recovery — this seems like it’s just shifting the timeline without changing the financial incentive.
Here’s an example of how Social Determinants of Health are interwoven with the healthcare system on a broader level. Johns Hopkins Medicine hosted a panel recently and laid out a number of examples on SDOH’s. Notice the emphasis on the idea of “interventions” and “outcomes” as a way to “improve quality” of lives.
Aren’t These Good Things?
In a perfect world—sure. These programs would be fantastic. But given what we understand about the world today and the predatory investor class that is directly involved with many of these programs, we have to ask ourselves what the real goals are. Why are the patients themselves not involved in defining the metrics of success? When did we decide that “intervention” strategies, on behalf of society on a macro scale, actually improve the quality of life at the individual level? If we’re making decisions based on larger data sets about certain groups within our population, it’s hard to say that we are making any decisions that are truly “patient-centered.” Just take a look at the examples listed above in the slideshow from Johns Hopkins. The successful outcome metrics are intentionally vague, yet depending on the demographics of your specific social group, they might mean many things, depending on who you are. “Improved obesity,” for example. How are we measuring this?
Years ago, when Rahm Emanuel was mayor of Chicago, he was lauded by other city leaders for getting a Whole Foods opened in one of the poorer areas of the city—Englewood. While the man had no idea what a “food desert” was until asked by the press corps, he felt that a Whole Foods could fix the problems within a community ravaged by violence and poverty for decades—just like that. One can assume that this was part of a larger program designed to “improve outcomes” solely with the construction of this business. Years later, there’s no solid proof that Whole Foods has fixed the structural problems that led to Englewood’s conditions in the first place.
When the same groups of people who define the problem can also define the metrics of success within the outcomes, the question remains — what improves for the patient, on an individual level? Are they getting care designed to improve THEIR specific health based on their individual conditions or illness? Or are they only getting the care designed to meet the profile designed by an algorithm based on their social determinants of health, along with their “traditional health,” rather than the best care possible? For further context on this issue, please check out our recent article on “Value-Based Healthcare” and the larger implications of this global healthcare system.
Given what we understand about the funding mechanisms used within the healthcare system, it’s clear that a profit-motive still exists within this structure — even if it’s focused on alleviating broader factors that contribute to someone’s overall heath. Proponents of utilizing social determinants of health, such as income-level or access to food, cite the need for an ‘outcome-based’ system, because the metrics for success can be easily tracked, measured, and ultimately, capitalized on by the same predators who, in large part, had no interest in improving the “social” aspects of health in years past. When the profit-incentive is outcomes-based and social determinants of health are considered as part of the larger picture, healthcare reimbursement models incentivize “improved” outcomes above the actual treatment itself.
In an attempt to close this:
All of these pieces of legislation may seem insignificant, but we are essentially seeing the construction of a biosecurity state through the legal system — where the pharmaceutical companies, the military, domestic and international legacy institutions, and venture capitalists are collaborating to herd us into a frightening future. Not trying to be an alarmist, but this is where this specific trajectory seems to be headed. With the passage of 21st Century Cures Act in 2016 (which is what made Operation Warp Speed possible) and now with the emphasis on genomic surveillance in the Cures 2.0 Act and the Build Back Better Act—the future is looking mighty bleak. The point of writing this is not to make anyone feel helpless or depressed, it is simply to fill in some of the gaps that have been left out in understanding the bigger picture. This doesn’t mean all if this is a done deal, if these policies and laws are made by humans then they can be undone by humans, too. Not going to lie, this is quite frightening because the powers that be have dotted all of their i’s and crossed all of their t’s, legally.
Last thing, if you want to protest something—start with the closest biotech company near you. Joking…but seriously, a lot of those companies are conducting the research and development necessary to create this global biosecurity hell-hole.
Peace and blessings,
Aly and Sebs
contributing research: Shadowbanned Refugee & Jack Sith