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Are microtaggants the key to making medicines smarter?

Pharmaceutical companies are accountable for ensuring that their medicine is safe when it comes into the hands of
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Pharmaceutical companies are accountable for ensuring that their medicine is safe when it comes into the hands of patients. The dramatic rise in online drug sales during the COVID-19 pandemic has increased the supply of counterfeit drugs, and many companies are now considering the addition of on-dose authentication for high-risk or high-value products.

To implement on-dose authentication, microtaggants are incorporated into coatings or inks used on each tablet or capsule; these can then be verified using desk-top readers or handheld devices, such as smartphones. This innovative solution doesn’t just provide the most robust method currently available for verifying drugs. Proof of concept shows that it is possible to identify microtaggants using smartphone apps, leading the way to software development kits (SDKs) which can be customised for individual companies and products.

For example, an app could remind a patient to take their medication, scan the tablet product to verify that the right medicine is being taken at the right time, deliver alerts and patient information, and indicate when repeat prescriptions are needed. Specific apps could also alert healthcare providers if vulnerable patients are failing to scan their medicine. This technology can also play an important role in supporting virtual clinical trials.

The threat of illegal online pharmacies

Globalisation and outsourcing have led to complex supply chains for many pharmaceutical products. This increases the risk of counterfeiting and diversion, which can result in health risks and loss of trust for the consumer, and loss of revenue and reputational damage to the brand owner.

Many countries have introduced serialisation legislation which requires product identifiers to be affixed to each package to provide traceability throughout the distribution supply chain. However, traceability and security measures focused on the packaging level may not be enough to protect patients. Even if a package is authentic, it may be impossible to determine whether the medicine inside is real or fake and whether it has been diverted.

It is estimated that the incidence of counterfeiting, illegal diversion and theft in the US increased by almost 70% between 2015 and 2019 driven mainly by a rise in internet sales. According to the Alliance for Safe Online Pharmacies, 100% of online searches to buy medicine return links for illegal pharmacies, and in 2018 the US Food and Drug Administration estimated that only 3% of online pharmacies complied with US pharmacy laws and practice standards.

Since the start of the COVID-19 pandemic, there has been a significant increase in online drug sales, and 1 in 4 American consumers now buy their medicines online. This had led to a corresponding rise in the supply of counterfeit drugs. The widespread use of pill presses by criminal gangs means that they can change production and ingredients rapidly to satisfy market demand. While counterfeiters often target lifestyle drugs, every medicine is vulnerable to counterfeiting and life-saving medicines are the fastest-growing category.

In 2020, the World Health Organization reported that over half of all drugs purchased from online pharmacies are suspected counterfeit, and identified the issue of counterfeit drugs as one of the urgent health challenges for the next decade. Writing in the American Journal of Tropical Medicine and Hygiene in 2019, doctors from the US government, universities, hospitals and the pharmaceutical company Pfizer warned that the rise in “falsified and substandard medicines” has become a “public health emergency” and that poor quality drugs exact an annual economic toll of up to US$200 billion. In addition to the direct harm that they cause, the supply of counterfeit antibiotics is a major driver of antimicrobial resistance.

There is growing recognition that serialisation alone will not solve the problem of counterfeit medicines. As serialisation matures it will provide a valuable tool for track and trace, but for the highest risk products, on-dose microtaggants provide a much higher level of security as each tablet or capsule can be authenticated. Instant verification at the dosage level reduces the risk of counterfeiting and product diversion while facilitating quality control and returns monitoring.

Microtaggants are uniquely encoded materials that are virtually impossible to replicate or reverse engineer. They can be incorporated into tablet coatings, or into the inks used on tablets or capsules, and detected using either field or lab-based equipment.

The technology requires no additional manufacturing equipment or processes, which makes it cost-effective and easy to implement. The FDA has stated that when microtaggants are pharmaceutically inactive and incorporated into new or existing drugs, they can be treated as excipients without the need for further clinical trials. Therefore, manufacturers of an approved product in the US would only need to incorporate the microtaggants as a Level 1 post-approval change  in the Annual Report.

Two different types of microtaggants are now available, one produced from non-biologic DNA and the other from silica:

DNA microtaggants

DNA is robust and easy to detect and because it is possible to produce different versions of the same DNA molecule, it can be made regional, product, or company-specific. The microtaggants are simply added to the standard tablet film coating or capsule printing process and can then be detected using appropriate reagents (like lock and key). The microtaggants are not damaged by exposure to heat and pressure during manufacturing, and the integrity of the DNA remains consistent throughout the shelf life of the product.

Silica microtaggants

Spectrally encoded silica microtaggants can be detected by how they reflect light and can be customised with unique information for product verification and traceability. Like DNA, the microtaggants are incorporated into the film coating or printing ink and applied during the manufacturing process. Silica is already present in virtually all tablet and capsule formulations, making it an easy material to include.

Recent work has concentrated on developing convenient readers to scan information carried on the microtaggants. Proof of concept demonstrates that tablets or capsules with silica microtaggants can be identified using smartphone apps, providing instant verification by law enforcement and border agencies.

The introduction of smartphone apps means that patients could play a part in verifying their medication, and that interaction could be leveraged to add value through patient engagement and brand loyalty. Through software development kits (SDKs) this type of app can easily be customised for individual companies and specific medications to help:

  • Improve adherence and achieve better outcomes for patients

It is easy for someone who is sick or confused to take the wrong drugs or miss doses. The app can remind patients when it is time to take their medication and which tablets to take. For many conditions, for example following an organ transplant or for the treatment of certain cancers, adherence to the correct medication regime is vital. Scanning each tablet before it is taken would reassure the patient, and results could also be relayed to a caregiver or medical team, alerting them if the patient has failed to scan the medication at the correct time. This could also be helpful in the case of people living with early-stage dementia.

  • Promote patient trust and brand loyalty

Cases have been reported of patients with extremely serious conditions failing to take their medication due to concerns over side effects. The app could remind and actively assist patients to recognise certain side effects, provide reassurance that they are not unusual, and help manage these initial challenges to ensure they stay compliant with their regimen. There could also be reminders for repeat prescriptions, and updates as new information becomes available. This type of engagement could give the patient a sense that the drug manufacturer is doing all it can to support them.

  • Make virtual clinical trials more robust and reduce costs

Virtual clinical trials could help to recruit more patients and greatly reduce R&D costs. The COVID pandemic has brought this a step closer but trials must be robust. It may be soon possible for patients to film themselves scanning and taking a drug as required for the trial, thus improving visibility and compliance, and providing real-time patient support.

  •  Reduce wastage

Medicine waste can occur due to patients over-ordering medicines on repeat prescriptions or continuing to order medicines which they no longer take. In 2010 a report from the Department of Health estimated that unused medicine costs the NHS in England around £300 million each year. These figures don’t take account of the impact on patients’ health if medicines are not being correctly taken, which could lead to worsening symptoms and further treatments that could have been avoided.

Choosing the best solution

It is important to understand how effective and reliable an authentication process will be, and the benefits that may be gained as a trade-off for the time and resources required to implement advanced technology.

This technology equips product quality teams with a faster way to identify rogue batches and make more informed decisions as to whether a batch needs to be held pending further investigation or immediately recalled. The cost per tablet of incorporating microtaggants is negligible relative to other manufacturing costs and the overall cost to the producer of the finished dosage form. The quantities of microtaggants that are added to the film coatings or inks are small, and their use has no impact on how coatings are applied, and will not affect the product’s stability, disintegration or dissolution. Machine-reading of security features is faster and more reliable than manual inspections and will be suitable for high-volume applications.

Through real-time data collection and analysis, patient-focused product teams will be able to provide more personalised support resources at the right time. Incorporating microtaggants directly into the product and associating the smartphone app provides a unique opportunity for brands to interact with patients as they are taking their medication to ensure the best possible outcomes. The app could be used to offer patients improved regimen support with personalised dosing schedule reminders, regimen/therapy/condition education, copay program availability, and refill reminders.

As we look to the future, smart medicines are becoming a reality.  Innovative technology can ensure digital authentication of patient’s medicine using their smartphone and a secure cloud application to provide real-time support.

About the author 

Colorcon designs and develops specialty excipients for solid oral dosages for the pharmaceutical and nutritional industries.

The post Are microtaggants the key to making medicines smarter? appeared first on .

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Are Voters Recoiling Against Disorder?

Are Voters Recoiling Against Disorder?

Authored by Michael Barone via The Epoch Times (emphasis ours),

The headlines coming out of the Super…

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Are Voters Recoiling Against Disorder?

Authored by Michael Barone via The Epoch Times (emphasis ours),

The headlines coming out of the Super Tuesday primaries have got it right. Barring cataclysmic changes, Donald Trump and Joe Biden will be the Republican and Democratic nominees for president in 2024.

(Left) President Joe Biden delivers remarks on canceling student debt at Culver City Julian Dixon Library in Culver City, Calif., on Feb. 21, 2024. (Right) Republican presidential candidate and former U.S. President Donald Trump stands on stage during a campaign event at Big League Dreams Las Vegas in Las Vegas, Nev., on Jan. 27, 2024. (Mario Tama/Getty Images; David Becker/Getty Images)

With Nikki Haley’s withdrawal, there will be no more significantly contested primaries or caucuses—the earliest both parties’ races have been over since something like the current primary-dominated system was put in place in 1972.

The primary results have spotlighted some of both nominees’ weaknesses.

Donald Trump lost high-income, high-educated constituencies, including the entire metro area—aka the Swamp. Many but by no means all Haley votes there were cast by Biden Democrats. Mr. Trump can’t afford to lose too many of the others in target states like Pennsylvania and Michigan.

Majorities and large minorities of voters in overwhelmingly Latino counties in Texas’s Rio Grande Valley and some in Houston voted against Joe Biden, and even more against Senate nominee Rep. Colin Allred (D-Texas).

Returns from Hispanic precincts in New Hampshire and Massachusetts show the same thing. Mr. Biden can’t afford to lose too many Latino votes in target states like Arizona and Georgia.

When Mr. Trump rode down that escalator in 2015, commentators assumed he’d repel Latinos. Instead, Latino voters nationally, and especially the closest eyewitnesses of Biden’s open-border policy, have been trending heavily Republican.

High-income liberal Democrats may sport lawn signs proclaiming, “In this house, we believe ... no human is illegal.” The logical consequence of that belief is an open border. But modest-income folks in border counties know that flows of illegal immigrants result in disorder, disease, and crime.

There is plenty of impatience with increased disorder in election returns below the presidential level. Consider Los Angeles County, America’s largest county, with nearly 10 million people, more people than 40 of the 50 states. It voted 71 percent for Mr. Biden in 2020.

Current returns show county District Attorney George Gascon winning only 21 percent of the vote in the nonpartisan primary. He’ll apparently face Republican Nathan Hochman, a critic of his liberal policies, in November.

Gascon, elected after the May 2020 death of counterfeit-passing suspect George Floyd in Minneapolis, is one of many county prosecutors supported by billionaire George Soros. His policies include not charging juveniles as adults, not seeking higher penalties for gang membership or use of firearms, and bringing fewer misdemeanor cases.

The predictable result has been increased car thefts, burglaries, and personal robberies. Some 120 assistant district attorneys have left the office, and there’s a backlog of 10,000 unprosecuted cases.

More than a dozen other Soros-backed and similarly liberal prosecutors have faced strong opposition or have left office.

St. Louis prosecutor Kim Gardner resigned last May amid lawsuits seeking her removal, Milwaukee’s John Chisholm retired in January, and Baltimore’s Marilyn Mosby was defeated in July 2022 and convicted of perjury in September 2023. Last November, Loudoun County, Virginia, voters (62 percent Biden) ousted liberal Buta Biberaj, who declined to prosecute a transgender student for assault, and in June 2022 voters in San Francisco (85 percent Biden) recalled famed radical Chesa Boudin.

Similarly, this Tuesday, voters in San Francisco passed ballot measures strengthening police powers and requiring treatment of drug-addicted welfare recipients.

In retrospect, it appears the Floyd video, appearing after three months of COVID-19 confinement, sparked a frenzied, even crazed reaction, especially among the highly educated and articulate. One fatal incident was seen as proof that America’s “systemic racism” was worse than ever and that police forces should be defunded and perhaps abolished.

2020 was “the year America went crazy,” I wrote in January 2021, a year in which police funding was actually cut by Democrats in New York, Los Angeles, San Francisco, Seattle, and Denver. A year in which young New York Times (NYT) staffers claimed they were endangered by the publication of Sen. Tom Cotton’s (R-Ark.) opinion article advocating calling in military forces if necessary to stop rioting, as had been done in Detroit in 1967 and Los Angeles in 1992. A craven NYT publisher even fired the editorial page editor for running the article.

Evidence of visible and tangible discontent with increasing violence and its consequences—barren and locked shelves in Manhattan chain drugstores, skyrocketing carjackings in Washington, D.C.—is as unmistakable in polls and election results as it is in daily life in large metropolitan areas. Maybe 2024 will turn out to be the year even liberal America stopped acting crazy.

Chaos and disorder work against incumbents, as they did in 1968 when Democrats saw their party’s popular vote fall from 61 percent to 43 percent.

Views expressed in this article are opinions of the author and do not necessarily reflect the views of The Epoch Times or ZeroHedge.

Tyler Durden Sat, 03/09/2024 - 23:20

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Veterans Affairs Kept COVID-19 Vaccine Mandate In Place Without Evidence

Veterans Affairs Kept COVID-19 Vaccine Mandate In Place Without Evidence

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

The…

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Veterans Affairs Kept COVID-19 Vaccine Mandate In Place Without Evidence

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

The U.S. Department of Veterans Affairs (VA) reviewed no data when deciding in 2023 to keep its COVID-19 vaccine mandate in place.

Doses of a COVID-19 vaccine in Washington in a file image. (Jacquelyn Martin/Pool/AFP via Getty Images)

VA Secretary Denis McDonough said on May 1, 2023, that the end of many other federal mandates “will not impact current policies at the Department of Veterans Affairs.”

He said the mandate was remaining for VA health care personnel “to ensure the safety of veterans and our colleagues.”

Mr. McDonough did not cite any studies or other data. A VA spokesperson declined to provide any data that was reviewed when deciding not to rescind the mandate. The Epoch Times submitted a Freedom of Information Act for “all documents outlining which data was relied upon when establishing the mandate when deciding to keep the mandate in place.”

The agency searched for such data and did not find any.

The VA does not even attempt to justify its policies with science, because it can’t,” Leslie Manookian, president and founder of the Health Freedom Defense Fund, told The Epoch Times.

“The VA just trusts that the process and cost of challenging its unfounded policies is so onerous, most people are dissuaded from even trying,” she added.

The VA’s mandate remains in place to this day.

The VA’s website claims that vaccines “help protect you from getting severe illness” and “offer good protection against most COVID-19 variants,” pointing in part to observational data from the U.S. Centers for Disease Control and Prevention (CDC) that estimate the vaccines provide poor protection against symptomatic infection and transient shielding against hospitalization.

There have also been increasing concerns among outside scientists about confirmed side effects like heart inflammation—the VA hid a safety signal it detected for the inflammation—and possible side effects such as tinnitus, which shift the benefit-risk calculus.

President Joe Biden imposed a slate of COVID-19 vaccine mandates in 2021. The VA was the first federal agency to implement a mandate.

President Biden rescinded the mandates in May 2023, citing a drop in COVID-19 cases and hospitalizations. His administration maintains the choice to require vaccines was the right one and saved lives.

“Our administration’s vaccination requirements helped ensure the safety of workers in critical workforces including those in the healthcare and education sectors, protecting themselves and the populations they serve, and strengthening their ability to provide services without disruptions to operations,” the White House said.

Some experts said requiring vaccination meant many younger people were forced to get a vaccine despite the risks potentially outweighing the benefits, leaving fewer doses for older adults.

By mandating the vaccines to younger people and those with natural immunity from having had COVID, older people in the U.S. and other countries did not have access to them, and many people might have died because of that,” Martin Kulldorff, a professor of medicine on leave from Harvard Medical School, told The Epoch Times previously.

The VA was one of just a handful of agencies to keep its mandate in place following the removal of many federal mandates.

“At this time, the vaccine requirement will remain in effect for VA health care personnel, including VA psychologists, pharmacists, social workers, nursing assistants, physical therapists, respiratory therapists, peer specialists, medical support assistants, engineers, housekeepers, and other clinical, administrative, and infrastructure support employees,” Mr. McDonough wrote to VA employees at the time.

This also includes VA volunteers and contractors. Effectively, this means that any Veterans Health Administration (VHA) employee, volunteer, or contractor who works in VHA facilities, visits VHA facilities, or provides direct care to those we serve will still be subject to the vaccine requirement at this time,” he said. “We continue to monitor and discuss this requirement, and we will provide more information about the vaccination requirements for VA health care employees soon. As always, we will process requests for vaccination exceptions in accordance with applicable laws, regulations, and policies.”

The version of the shots cleared in the fall of 2022, and available through the fall of 2023, did not have any clinical trial data supporting them.

A new version was approved in the fall of 2023 because there were indications that the shots not only offered temporary protection but also that the level of protection was lower than what was observed during earlier stages of the pandemic.

Ms. Manookian, whose group has challenged several of the federal mandates, said that the mandate “illustrates the dangers of the administrative state and how these federal agencies have become a law unto themselves.”

Tyler Durden Sat, 03/09/2024 - 22:10

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Low Iron Levels In Blood Could Trigger Long COVID: Study

Low Iron Levels In Blood Could Trigger Long COVID: Study

Authored by Amie Dahnke via The Epoch Times (emphasis ours),

People with inadequate…

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Low Iron Levels In Blood Could Trigger Long COVID: Study

Authored by Amie Dahnke via The Epoch Times (emphasis ours),

People with inadequate iron levels in their blood due to a COVID-19 infection could be at greater risk of long COVID.

(Shutterstock)

A new study indicates that problems with iron levels in the bloodstream likely trigger chronic inflammation and other conditions associated with the post-COVID phenomenon. The findings, published on March 1 in Nature Immunology, could offer new ways to treat or prevent the condition.

Long COVID Patients Have Low Iron Levels

Researchers at the University of Cambridge pinpointed low iron as a potential link to long-COVID symptoms thanks to a study they initiated shortly after the start of the pandemic. They recruited people who tested positive for the virus to provide blood samples for analysis over a year, which allowed the researchers to look for post-infection changes in the blood. The researchers looked at 214 samples and found that 45 percent of patients reported symptoms of long COVID that lasted between three and 10 months.

In analyzing the blood samples, the research team noticed that people experiencing long COVID had low iron levels, contributing to anemia and low red blood cell production, just two weeks after they were diagnosed with COVID-19. This was true for patients regardless of age, sex, or the initial severity of their infection.

According to one of the study co-authors, the removal of iron from the bloodstream is a natural process and defense mechanism of the body.

But it can jeopardize a person’s recovery.

When the body has an infection, it responds by removing iron from the bloodstream. This protects us from potentially lethal bacteria that capture the iron in the bloodstream and grow rapidly. It’s an evolutionary response that redistributes iron in the body, and the blood plasma becomes an iron desert,” University of Oxford professor Hal Drakesmith said in a press release. “However, if this goes on for a long time, there is less iron for red blood cells, so oxygen is transported less efficiently affecting metabolism and energy production, and for white blood cells, which need iron to work properly. The protective mechanism ends up becoming a problem.”

The research team believes that consistently low iron levels could explain why individuals with long COVID continue to experience fatigue and difficulty exercising. As such, the researchers suggested iron supplementation to help regulate and prevent the often debilitating symptoms associated with long COVID.

It isn’t necessarily the case that individuals don’t have enough iron in their body, it’s just that it’s trapped in the wrong place,” Aimee Hanson, a postdoctoral researcher at the University of Cambridge who worked on the study, said in the press release. “What we need is a way to remobilize the iron and pull it back into the bloodstream, where it becomes more useful to the red blood cells.”

The research team pointed out that iron supplementation isn’t always straightforward. Achieving the right level of iron varies from person to person. Too much iron can cause stomach issues, ranging from constipation, nausea, and abdominal pain to gastritis and gastric lesions.

1 in 5 Still Affected by Long COVID

COVID-19 has affected nearly 40 percent of Americans, with one in five of those still suffering from symptoms of long COVID, according to the U.S. Centers for Disease Control and Prevention (CDC). Long COVID is marked by health issues that continue at least four weeks after an individual was initially diagnosed with COVID-19. Symptoms can last for days, weeks, months, or years and may include fatigue, cough or chest pain, headache, brain fog, depression or anxiety, digestive issues, and joint or muscle pain.

Tyler Durden Sat, 03/09/2024 - 12:50

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