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Illinois set to approve insulin price cap of $100 for month supply
The move reflects a broader nationwide effort to lower prices of the life-saving drug.
- Some 30 million Americans have diabetes and must take insulin, but about 25 percent of them can't routinely afford the drug.
- In recent decades, the cost of insulin has skyrocketed, partly because only three companies make insulin in the U.S.
- There's some indication that recent efforts to make insulin more affordable are picking up steam.
Illinois is set to pass a measure to cap out-of-pocket insulin costs at $100 for a 30-day supply, a move that reflects a broader effort to lower costs of the hormone across the nation.
The bill is currently in the hands of Illinois Gov. J.B. Pritzker, who has expressed support for capping insulin prices, saying the rising costs are "an enormous burden for too many Illinois families," and that Illinois sees health care as "a right and not a privilege," according to the Chicago Tribune.
The cap applies only to commercial insurance plans, and it was modeled after a bill in Colorado, which became the first state to cap insulin prices earlier this year. If passed, the Illinois bill would take effect Jan. 1, 2021.
"For over a million Illinois residents, insulin is an absolute necessity," said State Sen. Andy Manar (D-Bunker Hill), who sponsored the bill. "Without it, they will die. Pharmaceutical companies are leveraging that fact in order to maximize profits. It's time we hold them accountable."
"Insulin belongs to the world, not to me"
Insulin is an essential and naturally occurring hormone that regulates blood sugar. About 30 million Americans have diabetes and must take insulin because they either don't produce enough of the hormone or don't respond to its effects. Before the discovery of insulin in the 1920s, a diagnosis for Type 1 diabetes was often considered a death sentence.
In 1923, Frederick Banting, James Collip, and Charles Best sold the first insulin patent to the University of Toronto for $1 each. They believed the drug — which meant Type 1 diabetes was no longer a death sentence — shouldn't be kept from the public for the sake of profit.
"Insulin belongs to the world, not to me," Banting reportedly said at the time.
But a century after their discovery, insulin is one of the most expensive liquids in the world, and it remains prohibitively expensive for millions of diabetes patients worldwide, many of whom risk facing blindness, strokes, foot amputations or premature death without access to the drug.
"You don't know if you will have enough of a freaking liquid that your whole life depends on," Marina Tsaplina, who has diabetes, told Business Insider. "You don't know if you have enough life. That's what being not sure if you can afford your insulin means."
The sixth most expensive liquid in the world? Insulin in the US.— Andy Slavitt (@Andy Slavitt)1566761450.0
The insulin crisis
The soaring prices of insulin have sparked outrage. In 2016, the average monthly cost of insulin was about $450, but nearly 25 percent of Americans with diabetes are unable to routinely afford these prices, and so they resort to rationing, skipping doses or even obtaining insulin illegally.
What's driving up prices? One explanation lies in the fact that there are only three major insulin makers in the U.S.: Eli Lilly, Novo Nordisk and Sanofi, each of which is able to negotiate drug prices with private insurers. These "big three" insulin makers have also been accused of price fixing in several lawsuits.
Typically, competing drug companies would be able to make generic versions of insulin, which would help lower prices. But no such generic insulin currently exists. That's in part because insulin makers have made incremental changes to insulin drugs over the decades, which allow them to keep their designs protected by patent laws. Some of these changes have resulted in improved diabetes care. But others seem designed to extend patent protection.
The result is that it's hardly profitable for alternative manufacturers to produce older versions of insulin.
"Older insulins have been successively replaced with newer, incrementally improved products covered by numerous additional patents," states a 2017 Lancet paper on insulin price increases.
What's more, navigating the patent laws is difficult and potentially dangerous for competing companies, as David Gaugh, senior vice president of sciences and regulatory affairs for the Association for Accessible Medicines, told STAT.
"There's all types of patents that are involved," Gaugh said. "Whether it be process patents, manufacturing patents, device patents É packaging patents, labeling patents and trademarks, all those are different methods used to prevent [competition]."
Patents aren't the only factor preventing a generic insulin from entering the market. In fact, a true generic — or even biosimilar — insulin is impossible to create, according to U.S. law. That's because generic drugs are derived from chemical-based medications, whereas insulin is a biologic-based drug. As such, any "generic" insulin is more complicated to manufacture and more difficult to get approved by the Food and Drug Administration.
More affordable insulin
In 2018, the American Diabetes Association recommended several steps U.S. lawmakers can take to make insulin more affordable:
- Streamlining the biosimilar process
- Increasing pricing transparency throughout the insulin supply chain
- Lowering or removing patient cost-sharing for insulin
- Increasing access to healthcare coverage
Earlier this year, members of Congress pressured the "big three" insulin makers, along with pharmacy benefit managers, to start lowering the costs of insulin. In November, the World Health Organization announced it would begin testing and approving generic versions of insulin, a process designed to make it easier for United Nations agencies and organizations like Doctors Without Borders to bring the drug to developing countries where it's in short supply.
"Four hundred million people are living with diabetes, the amount of insulin available is too low and the price is too high, so we really need to do something," Emer Cooke, the W.H.O.'s head of regulation of medicines and health technologies, said.
The director of the Affordable Insulin Now campaign, Rosemary Enobakhare, said in November that the W.H.O. move is "a good first step toward affordable insulin for all around the world," but that it wouldn't help diabetes patients in the U.S. To make a difference in the U.S., she said, would require "Congress to grant Medicare the power to negotiate drug prices" instead of leaving it up to insulin makers.
Inventions with revolutionary potential made by a mysterious aerospace engineer for the U.S. Navy come to light.
- U.S. Navy holds patents for enigmatic inventions by aerospace engineer Dr. Salvatore Pais.
- Pais came up with technology that can "engineer" reality, devising an ultrafast craft, a fusion reactor, and more.
- While mostly theoretical at this point, the inventions could transform energy, space, and military sectors.
The U.S. Navy controls patents for some futuristic and outlandish technologies, some of which, dubbed "the UFO patents," came to light recently. Of particular note are inventions by the somewhat mysterious Dr. Salvatore Cezar Pais, whose tech claims to be able to "engineer reality." His slate of highly-ambitious, borderline sci-fi designs meant for use by the U.S. government range from gravitational wave generators and compact fusion reactors to next-gen hybrid aerospace-underwater crafts with revolutionary propulsion systems, and beyond.
Of course, the existence of patents does not mean these technologies have actually been created, but there is evidence that some demonstrations of operability have been successfully carried out. As investigated and reported by The War Zone, a possible reason why some of the patents may have been taken on by the Navy is that the Chinese military may also be developing similar advanced gadgets.
Among Dr. Pais's patents are designs, approved in 2018, for an aerospace-underwater craft of incredible speed and maneuverability. This cone-shaped vehicle can potentially fly just as well anywhere it may be, whether air, water or space, without leaving any heat signatures. It can achieve this by creating a quantum vacuum around itself with a very dense polarized energy field. This vacuum would allow it to repel any molecule the craft comes in contact with, no matter the medium. Manipulating "quantum field fluctuations in the local vacuum energy state," would help reduce the craft's inertia. The polarized vacuum would dramatically decrease any elemental resistance and lead to "extreme speeds," claims the paper.
Not only that, if the vacuum-creating technology can be engineered, we'd also be able to "engineer the fabric of our reality at the most fundamental level," states the patent. This would lead to major advancements in aerospace propulsion and generating power. Not to mention other reality-changing outcomes that come to mind.
Among Pais's other patents are inventions that stem from similar thinking, outlining pieces of technology necessary to make his creations come to fruition. His paper presented in 2019, titled "Room Temperature Superconducting System for Use on a Hybrid Aerospace Undersea Craft," proposes a system that can achieve superconductivity at room temperatures. This would become "a highly disruptive technology, capable of a total paradigm change in Science and Technology," conveys Pais.
High frequency gravitational wave generator.
Credit: Dr. Salvatore Pais
Another invention devised by Pais is an electromagnetic field generator that could generate "an impenetrable defensive shield to sea and land as well as space-based military and civilian assets." This shield could protect from threats like anti-ship ballistic missiles, cruise missiles that evade radar, coronal mass ejections, military satellites, and even asteroids.
Dr. Pais's ideas center around the phenomenon he dubbed "The Pais Effect". He referred to it in his writings as the "controlled motion of electrically charged matter (from solid to plasma) via accelerated spin and/or accelerated vibration under rapid (yet smooth) acceleration-deceleration-acceleration transients." In less jargon-heavy terms, Pais claims to have figured out how to spin electromagnetic fields in order to contain a fusion reaction – an accomplishment that would lead to a tremendous change in power consumption and an abundance of energy.
According to his bio in a recently published paper on a new Plasma Compression Fusion Device, which could transform energy production, Dr. Pais is a mechanical and aerospace engineer working at the Naval Air Warfare Center Aircraft Division (NAWCAD), which is headquartered in Patuxent River, Maryland. Holding a Ph.D. from Case Western Reserve University in Cleveland, Ohio, Pais was a NASA Research Fellow and worked with Northrop Grumman Aerospace Systems. His current Department of Defense work involves his "advanced knowledge of theory, analysis, and modern experimental and computational methods in aerodynamics, along with an understanding of air-vehicle and missile design, especially in the domain of hypersonic power plant and vehicle design." He also has expert knowledge of electrooptics, emerging quantum technologies (laser power generation in particular), high-energy electromagnetic field generation, and the "breakthrough field of room temperature superconductivity, as related to advanced field propulsion."
Suffice it to say, with such a list of research credentials that would make Nikola Tesla proud, Dr. Pais seems well-positioned to carry out groundbreaking work.
A craft using an inertial mass reduction device.
Credit: Salvatore Pais
The patents won't necessarily lead to these technologies ever seeing the light of day. The research has its share of detractors and nonbelievers among other scientists, who think the amount of energy required for the fields described by Pais and his ideas on electromagnetic propulsions are well beyond the scope of current tech and are nearly impossible. Yet investigators at The War Zone found comments from Navy officials that indicate the inventions are being looked at seriously enough, and some tests are taking place.
If you'd like to read through Pais's patents yourself, check them out here.
Laser Augmented Turbojet Propulsion System
Credit: Dr. Salvatore Pais
The symbol for love is the heart, but the brain may be more accurate.
- How love makes us feel can only be defined on an individual basis, but what it does to the body, specifically the brain, is now less abstract thanks to science.
- One of the problems with early-stage attraction, according to anthropologist Helen Fisher, is that it activates parts of the brain that are linked to drive, craving, obsession, and motivation, while other regions that deal with decision-making shut down.
- Dr. Fisher, professor Ted Fischer, and psychiatrist Gail Saltz explain the different types of love, explore the neuroscience of love and attraction, and share tips for sustaining relationships that are healthy and mutually beneficial.
A new study suggests that reports of the impending infertility of the human male are greatly exaggerated.
- A new review of a famous study on declining sperm counts finds several flaws.
- The old report makes unfounded assumptions, has faulty data, and tends toward panic.
- The new report does not rule out that sperm counts are going down, only that this could be quite normal.
Several years ago, a meta-analysis of studies on human fertility came out warning us about the declining sperm counts of Western men. It was widely shared, and its findings were featured on the covers of popular magazines. Indeed, its findings were alarming: a nearly 60 percent decline in sperm per milliliter since 1973 with no end in sight. It was only a matter of time, the authors argued, until men were firing blanks, literally.
Well… never mind.
It turns out that the impending demise of humanity was greatly exaggerated. As the predicted infertility wave crashed upon us, there was neither a great rush of men to fertility clinics nor a sudden dearth of new babies. The only discussions about population decline focus on urbanization and the fact that people choose not to have kids rather than not being able to have them.
Now, a new analysis of the 2017 study says that lower sperm counts is nothing to be surprised by. Published in Human Fertility, its authors point to flaws in the original paper's data and interpretation. They suggest a better and smarter reanalysis.
Counting tiny things is difficult
The original 2017 report analyzed 185 studies on 43,000 men and their reproductive health. Its findings were clear: "a significant decline in sperm counts… between 1973 and 2011, driven by a 50-60 percent decline among men unselected by fertility from North America, Europe, Australia and New Zealand."
However, the new analysis points out flaws in the data. As many as a third of the men in the studies were of unknown age, an important factor in reproductive health. In 45 percent of cases, the year of the sample collection was unknown- a big detail to miss in a study measuring change over time. The quality controls and conditions for sample collection and analysis vary widely from study to study, which likely influenced the measured sperm counts in the samples.
Another study from 2013 also points out that the methods for determining sperm count were only standardized in the 1980s, which occurred after some of the data points were collected for the original study. It is entirely possible that the early studies gave inaccurately high sperm counts.
This is not to say that the 2017 paper is entirely useless; it had a much more rigorous methodology than previous studies on the subject, which also claimed to identify a decline in sperm counts. However, the original study had more problems.
Garbage in, garbage out
Predictable as always, the media went crazy. Discussions of the decline of masculinity took off, both in mainstream and less-than-reputable forums; concerns about the imagined feminizing traits of soy products continued to increase; and the authors of the original study were called upon to discuss the findings themselves in a number of articles.
However, as this new review points out, some of the findings of that meta-analysis are debatable at best. For example, the 2017 report suggests that "declining mean [sperm count] implies that an increasing proportion of men have sperm counts below any given threshold for sub-fertility or infertility," despite little empirical evidence that this is the case.
The WHO offers a large range for what it considers to be a healthy sperm count, from 15 to 250 million sperm per milliliter. The benefits to fertility above a count of 40 million are seen as minimal, and the original study found a mean sperm concentration of 47 million sperm per milliliter.
Healthy sperm, healthy man?
The claim that sperm count is evidence of larger health problems is also scrutinized in this new article. While it is true that many major health problems can impact reproductive health, there is little evidence that it is the "canary in the coal mine" for overall well-being. A number of studies suggest that any relation between lifestyle choices and this part of reproductive health is limited at best.
Lastly, ideas that environmental factors could be at play have been debunked since 2017. While the original paper considered the idea that pollutants, especially from plastics, could be at fault, it is now known that this kind of pollution is worse in the parts of the world that the original paper observed higher sperm counts in (i.e., non-Western nations).
There never was a male fertility crisis
The authors of the new review do not deny that some measurements are showing lower sperm counts, but they do question the claim that this is catastrophic or part of a larger pathological issue. They propose a new interpretation of the data. Dubbed the "Sperm Count Biovariability hypothesis," it is summarized as:
"Sperm count varies within a wide range, much of which can be considered non-pathological and species-typical. Above a critical threshold, more is not necessarily an indicator of better health or higher probability of fertility relative to less. Sperm count varies across bodies, ecologies, and time periods. Knowledge about the relationship between individual and population sperm count and life-historical and ecological factors is critical to interpreting trends in average sperm counts and their relationships to human health and fertility."
Still, the authors note that lower sperm counts "could decline due to negative environmental exposures, or that this may carry implications for men's health and fertility."
However, they disagree that the decline in absolute sperm count is necessarily a bad sign for men's health and fertility. We aren't at civilization ending catastrophe just yet.