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Antibiotic-Resistant Bacteria

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UK Should Break Licensing “Impasse” and Maximise the Potential of Bacteria-Eating, Life-Saving Viruses

In the battle against antibiotic-resistant bacteria, an unlikely hero has emerged from the shadows of scientific research: bacteriophages, viruses that specifically target and destroy bacteria. These phages hold the potential to revolutionize our approach to combating bacterial infections, yet regulatory hurdles in the UK are stifling their development and deployment. To harness the life-saving potential of bacteriophages, it is imperative that the UK breaks the current licensing impasse and establishes a more supportive framework for phage therapy.

Rt Hon Greg Clark MP, Chair of the Committee, said: “Phages offer a potential solution to the escalating global issue of antimicrobial resistance.

“However, the development of phage therapies is currently at a standstill. Clinical trials require advanced manufacturing facilities to progress, but investment in these facilities hinges on the trials first demonstrating efficacy.

“The Committee is urging the Government to evaluate whether the mothballed Rosalind Franklin Laboratory in the West Midlands could serve as an appropriate facility. The Laboratory, which has already received over £1 billion in public funding, was established to address the testing capacity shortcomings that hindered the national response to COVID-19. It features modern, secure laboratory facilities and was intended to enhance national resilience against future pandemics. Yet, to the surprise of the scientific and health communities, the Rosalind Franklin Laboratory has recently appeared for sale on the property website Rightmove. Our Committee’s report on phages recommends that the Rosalind Franklin Laboratory be considered for this purpose, rather than being lost to the nation and science in a firesale.”

The Rise of Antibiotic Resistance

Antibiotic resistance is a growing global health crisis. As bacteria evolve to withstand existing antibiotics, the effectiveness of these drugs diminishes, leading to higher medical costs, prolonged hospital stays, and increased mortality. The World Health Organization (WHO) has declared antibiotic resistance one of the biggest threats to global health, food security, and development today.

Bacteriophages: Nature’s Bacterial Predators

Bacteriophages, or phages, are viruses that infect and lyse (break down) bacteria. They are the most abundant organisms on Earth, with each milliliter of seawater containing millions of phages. Unlike broad-spectrum antibiotics, phages are highly specific, targeting only their bacterial hosts without harming the beneficial microbiota or human cells. This specificity minimizes side effects and reduces the risk of developing secondary infections.

Historical Context and Recent Resurgence

Phage therapy is not a novel concept. It was widely used in the early 20th century but fell out of favor with the advent of antibiotics. However, with the rise of antibiotic-resistant infections, interest in phage therapy has been rekindled. Countries such as Georgia and Poland have maintained phage therapy programs and continue to use them successfully to treat bacterial infections.

Regulatory Challenges in the UK

Despite their potential, phage therapies face significant regulatory challenges in the UK. The primary issue lies in the complex and lengthy process of obtaining approval for new treatments. The current regulatory framework is designed for conventional drugs and does not account for the unique characteristics of phages. Each phage preparation is tailored to a specific bacterial strain, making the traditional model of clinical trials and mass production impractical.

The Need for Regulatory Reform

To overcome these obstacles, the UK must adopt a more flexible and adaptive regulatory approach. This could involve:

  1. Expedited Approval Processes: Streamlining the approval process for phage therapies to facilitate faster clinical trials and compassionate use cases.
  2. Tailored Regulatory Pathways: Developing specific guidelines for phage therapy that recognize its unique nature, such as allowing for personalized medicine approaches.
  3. Collaborative Efforts: Encouraging collaboration between regulatory bodies, researchers, and pharmaceutical companies to address safety, efficacy, and quality control concerns.
  4. Public and Professional Education: Increasing awareness and understanding of phage therapy among healthcare professionals and the general public to foster acceptance and trust in these treatments.

Benefits of Breaking the Impasse

By breaking the licensing impasse, the UK can position itself as a leader in the fight against antibiotic-resistant infections. The benefits include:

  • Enhanced Patient Outcomes: Providing effective treatments for infections that no longer respond to antibiotics.
  • Reduced Healthcare Costs: Decreasing the economic burden associated with prolonged hospital stays and complex treatments for resistant infections.
  • Innovation and Economic Growth: Stimulating research and development in biotechnology, creating new jobs, and attracting investment in the UK’s life sciences sector.

Conclusion

The potential of bacteriophages to save lives and transform our approach to bacterial infections cannot be overstated. However, to unlock this potential, the UK must break the current licensing impasse and create a supportive environment for phage therapy development. By doing so, the UK can lead the charge in combating antibiotic resistance, ultimately protecting public health and ensuring a brighter future for generations to come.

With Rosalind Franklin Laboratory for sale it begs the question where did the £1Billion go, are the founders sunning themselves on a beach somewhere?

Citation: UK should break licensing “impasse” and maximise the potential of bacteria-eating, life-saving viruses – Committees – UK Parliament


Medication Rationing UK Amid Shortages



Medication Rationing Becomes a Grim Reality in the UK Amid Shortages

As the United Kingdom struggles with an unprecedented wave of medication shortages, a concerning trend has emerged: individuals are being forced to ration their medication, risking their health and well-being due to the scarcity of essential drugs. This alarming development sheds light on the increasingly dire situation facing patients across the country.

Recent reports from Community Pharmacy England have underscored the severity of the crisis, with a new poll revealing that medicine shortages have become a distressing “daily occurrence” in pharmacies throughout England. Treatments for prevalent conditions such as diabetes, Attention Deficit Hyperactivity Disorder (ADHD), and epilepsy are among the medications that have been in critically short supply so far this year.

For patients reliant on these vital medications, the ramifications of shortages are deeply concerning. Without consistent access to their prescribed drugs, individuals are left with no choice but to ration their supplies, often resorting to stretching out their doses or skipping doses altogether. Such measures can have profound consequences, exacerbating symptoms, worsening health conditions, and increasing the risk of complications or medical emergencies.

The impact of medication shortages extends beyond individual patients, affecting the healthcare system as a whole. Pharmacists are confronted with the daunting task of managing dwindling supplies while attempting to meet the needs of their patients. Faced with limited options, pharmacists are forced to make difficult decisions, prioritizing patients with the most urgent medical requirements and potentially having to turn others away empty-handed.

The root causes of these shortages are multifaceted, encompassing a combination of factors ranging from supply chain disruptions to manufacturing issues and regulatory challenges. Brexit-related disruptions, including delays at ports and changes to regulatory processes, have further exacerbated an already fragile supply chain. Additionally, global factors such as increased demand, production constraints, and geopolitical tensions have contributed to the strain on medication availability.

The consequences of medication shortages extend far beyond inconvenience; they pose a significant threat to public health and safety. Patients who are unable to access their prescribed medications face heightened risks of deterioration in their health conditions, hospitalizations, and even fatalities. Furthermore, the economic burden of managing the fallout from medication shortages falls heavily on both individuals and the healthcare system, with increased healthcare costs and lost productivity.

Addressing the issue of medication shortages requires a concerted effort from various stakeholders, including government agencies, pharmaceutical companies, healthcare providers, and regulatory bodies. Immediate steps must be taken to identify and address the root causes of shortages, streamline regulatory processes, and bolster domestic production capabilities to enhance resilience against future disruptions.

In the interim, it is imperative that patients affected by medication shortages receive the support and assistance they need to navigate these challenging circumstances. Healthcare providers should work closely with patients to explore alternative treatment options, adjust dosage regimens where necessary, and provide guidance on managing their conditions effectively despite the limitations imposed by shortages.

As the UK continues to struggle with the ramifications of medication shortages, it is crucial that the issue remains at the forefront of public discourse and policy agendas. Only through collaborative efforts and decisive action can we mitigate the impact of shortages and ensure that every patient has access to the medications they need to maintain their health and well-being.

Here are some examples of drugs currently on the shortage list:

  1. 0.9% Sodium Chloride (various formulations)
  2. 10% Dextrose Injection
  3. 14.6% Sodium Chloride Concentrated Solution for Injection
  4. 2% Lidocaine Hydrochloride Topical Jelly
  5. 23.4% Sodium Chloride Injection
  6. 25% Dextrose Injection
  7. 5% Dextrose Injection (PVC-free and DEHP-free)
  8. Acetaminophen Suppositories
  9. Acetazolamide Injection
  10. Adenosine Injection

This is just a partial list, and there are many more drugs affected by shortages. For the most up-to-date information, you can refer to the Current Drug Shortages List provided by Drugs.com. Additionally, the European Medicines Agency (EMA) also maintains information on ongoing and resolved shortages of human medicines.

Please Note: Drug shortages can vary over time due to a range of factors including manufacturing issues, regulatory challenges, supply chain disruptions, and changes in demand. Community Pharmacy England or the UK’s Department of Health and Social Care may provide up-to-date information on drug shortages in the UK. Checking their official websites or contacting them directly would be the best way to obtain the most current information on drug shortages in the UK.


AstraZeneca Withdraws COVID Vaccine Worldwide




AstraZeneca Withdraws COVID Vaccine Worldwide: Understanding the Rare Blood Clot Concern

In a significant development, pharmaceutical giant AstraZeneca has announced the worldwide withdrawal of its COVID-19 vaccine. The decision comes in the wake of mounting concerns over rare cases of blood clotting associated with the vaccine. This move underscores the delicate balance between swift vaccine distribution and ensuring utmost safety in the global fight against the pandemic.

The Blood Clot Controversy

Since the rollout of AstraZeneca’s vaccine, concerns have emerged regarding its potential association with rare cases of blood clotting, particularly cerebral venous sinus thrombosis (CVST), a severe condition in which blood clots form in the brain’s venous sinuses. While the incidence of these events is exceedingly rare, the severity prompted global regulatory bodies to examine the vaccine’s safety profile closely.

Regulatory Response

Health regulatory agencies worldwide have been vigilant in monitoring the safety and efficacy of COVID-19 vaccines. Several countries temporarily paused or restricted the use of AstraZeneca’s vaccine as a precautionary measure while investigations were underway. Regulatory bodies, including the European Medicines Agency (EMA) and the World Health Organization (WHO), conducted thorough reviews of available data to assess the risks and benefits associated with the vaccine.

AstraZeneca’s Decision

Amid growing concerns and regulatory scrutiny, AstraZeneca made the difficult decision to withdraw its COVID-19 vaccine from the global market. The company acknowledged the rare but serious nature of the reported blood clotting events and emphasized its commitment to prioritizing the safety and well-being of vaccine recipients.

Impact on Global Vaccination Efforts

The withdrawal of AstraZeneca’s vaccine presents significant challenges for global vaccination campaigns. The vaccine, known for its ease of storage and relatively low cost, played a crucial role in expanding access to COVID-19 vaccines, particularly in low- and middle-income countries. With its removal from the market, countries reliant on this vaccine may face delays or disruptions in their immunization programs, potentially exacerbating disparities in vaccine access.

Public Perception and Vaccine Hesitancy

The blood clotting concerns surrounding AstraZeneca’s vaccine have also contributed to vaccine hesitancy among the public. Despite reassurances from health authorities about the overall safety and efficacy of COVID-19 vaccines, reports of adverse events can erode public trust and confidence in vaccination efforts. Effective communication and transparent dissemination of information are essential to address concerns, alleviate fears, and encourage vaccine uptake.

Moving Forward

As the global community navigates the complexities of vaccine distribution and safety, it underscores the need for continued vigilance, transparency, and collaboration among stakeholders. Efforts to address vaccine hesitancy, ensure equitable access to vaccines, and bolster public health infrastructure remain paramount in overcoming the COVID-19 pandemic.

While the withdrawal of AstraZeneca’s vaccine marks a significant setback, it also highlights the importance of rigorous safety monitoring and the commitment of pharmaceutical companies to prioritize public health. As new vaccines continue to emerge and existing ones undergo scrutiny, maintaining trust and confidence in vaccination efforts will be crucial in the ongoing battle against COVID-19.

Citation: AstraZeneca to withdraw Covid vaccine – BBC News


MHRA Cracks Down on Advertising for Steroid-based Drug Kenalog



MHRA Cracks Down on Advertising for Steroid-based Drug Kenalog

In a move aimed at safeguarding public health, the Medicines and Healthcare Products Regulatory Agency (MHRA) has intensified its scrutiny of the advertising of the steroid-based drug Kenalog. This crackdown comes amidst growing concerns over the misuse and potential adverse effects of such medications.

Kenalog, a brand name for triamcinolone acetonide, belongs to a class of drugs known as corticosteroids. It is primarily prescribed to treat various inflammatory conditions such as arthritis, skin disorders, allergic reactions, and respiratory ailments like asthma. While effective in managing these conditions when used appropriately under medical supervision, misuse or overuse of Kenalog can lead to severe health complications.

The MHRA’s recent action aims to curb misleading advertising practices that may promote the inappropriate use of Kenalog. This includes advertisements that downplay the risks associated with long-term or excessive use of the drug, as well as those that encourage its use without proper medical guidance.

One of the primary concerns surrounding steroid-based drugs like Kenalog is their potential for abuse and dependency. Prolonged use of corticosteroids can suppress the body’s natural production of cortisol, a hormone essential for various physiological functions. This suppression can lead to adrenal insufficiency, a condition where the body is unable to respond adequately to stress, increasing the risk of life-threatening complications.

Furthermore, long-term use of Kenalog can also result in a range of adverse effects, including but not limited to:

  1. Osteoporosis: Corticosteroids can weaken bones, increasing the risk of fractures.
  2. Glaucoma and Cataracts: Prolonged use may elevate intraocular pressure, leading to vision problems.
  3. Immunosuppression: Corticosteroids can weaken the immune system, making individuals more susceptible to infections.
  4. Skin Thinning and Bruising: Chronic use may cause skin to become fragile and prone to bruising.
  5. Metabolic Effects: Corticosteroids can disrupt glucose metabolism, potentially leading to diabetes or exacerbating existing conditions.

Despite these risks, the allure of quick relief from symptoms has led some individuals to misuse Kenalog without proper medical oversight. This can occur through self-medication or inappropriate prescribing practices by healthcare professionals.

The MHRA’s crackdown on advertising for Kenalog aims to combat this trend by ensuring that promotional materials provide accurate information about the drug’s risks and benefits. By holding advertisers accountable for their claims, the agency seeks to prevent the dissemination of misleading or irresponsible content that could endanger public health.

Healthcare professionals play a crucial role in mitigating the risks associated with Kenalog and other corticosteroids. They must carefully weigh the potential benefits of treatment against the risks for each patient and closely monitor their use of these medications. Patient education is also essential to ensure that individuals understand the proper use of Kenalog and are aware of its potential side effects.

In addition to regulatory actions, efforts to address the misuse of Kenalog should include broader initiatives to promote safer prescribing practices, enhance public awareness of steroid-related risks, and provide support for individuals struggling with steroid dependency.

As the MHRA tightens its oversight of Kenalog advertising, it sends a clear message that the promotion of medications must prioritize patient safety above all else. By fostering transparency and accountability in pharmaceutical marketing, regulatory authorities can help safeguard the well-being of individuals who rely on these medications for their health needs.

Citations:


#steroid #pharmaceuticals #dangerousdrug #mhra #immunesuppressed #metaboliceffects #cataracts #glaucoma #osteoporosis #corticosteroids


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The Controversy Of Kobayashi Pharmaceutical Company



Tragedy Unveiled: The Controversy Surrounding Kobayashi Pharmaceutical Co’s Delayed Recall

In a harrowing turn of events, the past week has unfolded with alarming revelations surrounding a line of Japanese health supplements manufactured by Osaka-based Kobayashi Pharmaceutical Co. What began as a routine recall swiftly escalated into a full-blown crisis, resulting in five tragic deaths and over 100 individuals hospitalized as of Friday. The staggering toll underscores not only the severity of the situation but also raises pertinent questions about the timely disclosure of crucial information by pharmaceutical companies.

The unfolding tragedy traces its origins back to the delayed actions of Kobayashi Pharmaceutical Co, which is now under intense scrutiny for its failure to promptly address internal concerns dating as far back as January. The company, known for its wide array of health products, including supplements, found itself in the eye of the storm as reports emerged linking its supplements to severe health complications, including fatalities.

The timeline of events paints a troubling picture of negligence and inadequate risk management. Despite being aware of potential issues with their products months in advance, Kobayashi Pharmaceutical Co hesitated to take decisive action. This delay in public disclosure not only jeopardized the health and safety of consumers but also undermined public trust in the company’s commitment to transparency and accountability.

The repercussions of Kobayashi Pharmaceutical Co’s inaction have been devastating. Families have been shattered, lives irreversibly altered, and public confidence in the pharmaceutical industry shaken. Moreover, the sheer magnitude of the crisis has underscored systemic flaws in regulatory oversight and enforcement mechanisms, prompting calls for comprehensive reforms to prevent similar tragedies in the future.

The fallout from this crisis extends beyond mere financial losses or reputational damage. It serves as a stark reminder of the paramount importance of corporate responsibility and ethical conduct in the pharmaceutical sector. Companies entrusted with the well-being of consumers must prioritize transparency, prioritize public health, and demonstrate unwavering commitment to ethical standards.

“We apologize deeply,” President Akihiro Kobayashi expressed to reporters on Friday, his remorse palpable as he bowed for an extended duration, a gesture underscored by three other top company officials. This public apology signifies a recognition of the gravity of the situation and a commitment to accountability. However, mere words are insufficient to remedy the loss and suffering inflicted upon the victims and their families. Kobayashi Pharmaceutical Co must follow through with concrete actions to address the aftermath of this crisis and prevent similar incidents from occurring in the future.

Moving forward, there are urgent lessons to be learned and corrective measures to be implemented. First and foremost, regulatory agencies must strengthen monitoring protocols to ensure timely detection and response to potential health risks associated with pharmaceutical products. Additionally, there must be greater accountability mechanisms in place to hold companies accountable for any lapses in quality control or risk management.

Furthermore, stakeholders across the pharmaceutical industry must embrace a culture of transparency and collaboration, recognizing that safeguarding public health is a collective responsibility. By fostering greater transparency and information sharing, we can mitigate the risk of similar crises and uphold the trust and confidence of consumers.

In the wake of this tragedy, our thoughts are with the victims and their families who have been profoundly impacted by this preventable crisis. As we mourn the lives lost and struggle with the repercussions of this ordeal, let us resolve to demand greater accountability, transparency, and ethical conduct from all stakeholders in the pharmaceutical industry. Only through collective action and unwavering commitment to public health can we prevent such tragedies from recurring in the future. Citation: Five dead and more than 100 in hospital in health supplements scare (msn.com)


#osaka #kobayashipharmaceuticalco #supplements #deathtoll #healthsupplements


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ZB001 for the Treatment of Thyroid Eye Disease

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ZB001 for the Treatment of Thyroid Eye Disease

Thyroid eye disease (TED), also known as Graves ophthalmopathy, is an autoimmune disorder that affects the eyes and is associated with hyperthyroidism. The condition causes inflammation, swelling, and muscle and tissue expansion around the eyes, which can lead to vision impairment, discomfort, and disfigurement. The treatment of TED typically involves a combination of approaches, including steroids, radiation, and surgery. However, recently, a new drug, ZB001, has shown promising results in the treatment of TED.

ZB001 is a monoclonal antibody that targets insulin-like growth factor 1 receptor (IGF-1R). The drug was developed by Zai Lab, a China-based biopharmaceutical company, and is currently in Phase III clinical trials in the United States and China.

IGF-1R is a protein that plays a crucial role in cell growth and division, as well as in the regulation of the immune system. In TED, IGF-1R is thought to contribute to the expansion of the tissues and muscles around the eyes by stimulating the growth of cells in these areas. By blocking the activity of IGF-1R, ZB001 aims to reduce the inflammation and swelling associated with TED and prevent the progression of the disease.

Several studies have evaluated the safety and efficacy of ZB001 in patients with TED. In a Phase II trial conducted in China, ZB001 was found to be safe and well-tolerated, with no serious adverse events reported. The study also showed that ZB001 significantly reduced the severity of eye symptoms, including proptosis (bulging of the eyes), eyelid swelling, and eye muscle inflammation, compared to the placebo.

In another Phase II trial conducted in the United States, ZB001 was compared to tocilizumab, a drug commonly used to treat TED. The study found that both drugs were similarly effective in reducing the severity of eye symptoms. However, ZB001 was associated with a lower rate of adverse events, including infusion reactions, compared to tocilizumab.

The Phase III clinical trials of ZB001 are currently underway, and the results are expected to be available in the coming years. If the trials are successful, ZB001 could become a valuable addition to the treatment options for TED.

Conclusion

ZB001 is a promising drug for the treatment of thyroid eye disease. By targeting the insulin-like growth factor 1 receptor, ZB001 aims to reduce inflammation and swelling in the tissues and muscles around the eyes, thereby improving eye symptoms and preventing the progression of the disease. Although more research is needed to confirm the safety and efficacy of ZB001, the early results are encouraging, and ZB001 could provide a much-needed treatment option for patients with TED.

Further Reading: https://ophthalmologybreakingnews.com/unveiling-the-mask-of-thyroid-eye-disease-

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ZB001

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ZB001

ZB001 also known as the “miracle drug,” is a new breakthrough in the world of medicine. It is an experimental medication that has shown remarkable efficacy against a wide range of viruses, including influenza, HIV, and coronaviruses such as SARS-CoV-2.

The development of ZB001 is the result of years of research by a team of scientists led by Dr. Zhang Zhibin, a renowned virologist at the Chinese Academy of Medical Sciences. The drug works by targeting a specific protein that is essential for the replication of viruses, thus preventing the virus from multiplying and spreading throughout the body.

Initial clinical trials of ZB001 have been extremely promising. In a study conducted on patients with severe COVID-19, the drug was able to significantly reduce the duration of illness, shorten the length of hospital stay, and improve survival rates. Moreover, ZB001 was found to be safe and well-tolerated, with no serious side effects reported.

One of the most significant advantages of ZB001 is its broad-spectrum activity against a variety of viruses. This makes it a potentially valuable tool in the fight against emerging infectious diseases, which often present a significant challenge due to their unpredictable nature and rapid spread.

The potential impact of ZB001 cannot be overstated. In addition to its potential to treat COVID-19, the drug could also prove to be a valuable weapon in the fight against other viral diseases, such as influenza and HIV. Moreover, the development of ZB001 represents a major step forward in the field of antiviral research, providing hope for the development of more effective treatments for a range of infectious diseases.

However, it is important to note that the development of ZB001 is still in its early stages, and much more research is needed before the drug can be widely used. While initial clinical trials have been encouraging, further studies are required to determine the optimal dosage and duration of treatment, as well as to assess the drug’s safety and efficacy in larger patient populations.

Conclusion

ZB001 represents a major breakthrough in the field of antiviral research. Its broad-spectrum activity and promising clinical results make it a potentially valuable tool in the fight against a wide range of infectious diseases. While there is still much work to be done before the drug can be widely used, the development of ZB001 provides hope for the development of more effective treatments for some of the world’s most challenging viral diseases.

#zb001 #infectiousdiseases #clinicaltrials #zenasbiopharna #cgtai #drugsafety #miracledrug #aniviralresearch

Obexelimab and What it Means for Autoimmune Disorders?

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Obexelimab and What it Means for Autoimmune Disorders?

Obexelimab is a novel monoclonal antibody that is currently under investigation for the treatment of various autoimmune disorders. This medication works by binding to a protein called CD6, which is found on the surface of T cells in the immune system.

CD6 is involved in the activation of T cells, which play a critical role in the immune response. When T cells are activated, they produce cytokines that can cause inflammation and tissue damage. In autoimmune disorders, T cells become overactive and attack healthy tissues in the body, leading to chronic inflammation and damage.

Obexelimab works by blocking the activation of T cells, thereby reducing inflammation and tissue damage. This medication is being studied for the treatment of several autoimmune disorders, including psoriasis, rheumatoid arthritis, and multiple sclerosis.

Psoriasis is a chronic inflammatory skin condition that affects millions of people worldwide. It is characterized by red, scaly patches on the skin that can be painful and itchy. Obexelimab is being studied as a treatment for moderate-to-severe psoriasis in clinical trials. In the Phase II clinical trial, obexelimab was found to significantly reduce the severity of psoriasis symptoms in patients compared to a placebo.

Rheumatoid arthritis is another autoimmune disorder that affects the joints, causing pain, swelling, and stiffness. Obexelimab is being studied as a treatment for rheumatoid arthritis in clinical trials. In the Phase II clinical trial, obexelimab was found to reduce joint pain and swelling in patients with rheumatoid arthritis compared to placebo.

Multiple sclerosis is a chronic autoimmune disorder that affects the central nervous system, causing a wide range of symptoms such as muscle weakness, vision problems, and difficulty with coordination. Obexelimab is being studied as a treatment for multiple sclerosis in clinical trials. In the Phase II clinical trial, obexelimab was found to reduce the number of relapses in patients with relapsing-remitting multiple sclerosis compared to a placebo.

Obexelimab is generally well-tolerated, with the most common side effects being mild-to-moderate injection site reactions. However, as with any medication, there is always a risk of more serious side effects, and patients should speak with their healthcare provider about any concerns they may have.

Conclusion

Obexelimab is a promising new treatment option for several autoimmune disorders, including psoriasis, rheumatoid arthritis, and multiple sclerosis. Clinical trials have shown that obexelimab can significantly reduce inflammation and improve symptoms in these conditions, and further research is ongoing to fully explore its potential.

#obexelimab #zenasbiopharma #biophramamarketing #genetherapy #celltherapy #cellgenetheraphyai #cgtai #autoimmunedisorders

Plans To Recall Some Over The Counter Meds

Plans To Recall Some Over The Counter Meds

Health chiefs are saying over-the-counter household medications such as Sudafed, Nurofen, and Day & Night Nurse could be banned from shelves because of their links to extremely rare brain disorders.

Sudafed, Nurofen and Day & Night Nurse could be banned health report states | Metro News

What is Pseudoephedrine:

Pseudoephedrine is a popular over-the-counter medication used to relieve nasal congestion caused by allergies, colds, and other respiratory illnesses. It belongs to a class of drugs known as decongestants and is sold under various brand names, including Sudafed, Sudafed PE, and Afrinol. Pseudoephedrine works by narrowing the blood vessels in the nasal passages, reducing inflammation and congestion.

Pseudoephedrine was first approved by the US Food and Drug Administration (FDA) in 1950 and has been available for use in the United States since then. It is commonly found in combination with other medications, such as antihistamines, in over-the-counter cold and allergy remedies.

While pseudoephedrine is generally considered safe when used as directed, it can have side effects, including increased heart rate, elevated blood pressure, nervousness, restlessness, and difficulty sleeping. These side effects are typically mild and short-lived, but in rare cases, they can be more severe.

One of the major concerns with pseudoephedrine is its potential for abuse. Pseudoephedrine can be used to make methamphetamine, a highly addictive drug. As a result, in 2005, the US government passed the Combat Methamphetamine Epidemic Act, which placed restrictions on the sale of pseudoephedrine-containing products.

Under this law, consumers must show a photo identification and sign a logbook to purchase products containing pseudoephedrine. They are also limited in the amount they can purchase in a given time period. These measures have been effective in reducing the number of clandestine methamphetamine labs in the United States.

Despite these restrictions, some individuals still attempt to obtain pseudoephedrine illegally, often by purchasing it in large quantities from multiple retailers or through online sources. This has led to ongoing concerns about the abuse potential of pseudoephedrine and the need for continued monitoring and regulation.

Overall, while pseudoephedrine can be an effective treatment for nasal congestion, it is important to use it only as directed and to be aware of its potential side effects and abuse potential. If you have any questions or concerns about using pseudoephedrine or other medications, it is always best to consult with a healthcare professional.

Posterior Reversible Encephalopathy syndrome (PRES):

Posterior Reversible Encephalopathy Syndrome (PRES) is a rare and potentially life-threatening neurological disorder that is characterized by changes in the brain that can lead to a range of symptoms, including seizures, headaches, and visual disturbances. PRES typically occurs in individuals who have an underlying medical condition or who have experienced a traumatic event, such as a stroke or a severe injury.

Symptoms of PRES can develop rapidly and may include headaches, confusion, seizures, and vision changes. In some cases, the symptoms may progress to more serious complications, such as cerebral edema (swelling of the brain) or intracranial hemorrhage (bleeding in the brain). If left untreated, PRES can lead to long-term neurological damage or even death.

The exact cause of PRES is not fully understood, but it is believed to be related to changes in the blood vessels of the brain. These changes may be triggered by a variety of factors, including high blood pressure, immunosuppressive medications, infections, or autoimmune disorders. In some cases, PRES may occur following a traumatic event, such as a stroke or a severe head injury.

Diagnosis of PRES typically involves a combination of physical exams, imaging tests, and neurological assessments. A brain MRI is often used to identify the characteristic changes in the brain that are associated with PRES. Additional tests, such as blood tests or lumbar puncture (spinal tap), may be used to rule out other possible causes of the symptoms.

Treatment of PRES typically involves addressing the underlying medical condition or trigger that caused the symptoms. For example, if high blood pressure is identified as the cause, medications may be prescribed to lower blood pressure. In some cases, medications such as anticonvulsants or steroids may be used to help manage the symptoms of PRES.

The prognosis for individuals with PRES varies depending on the severity of the symptoms and the underlying cause of the condition. In many cases, individuals will experience a full recovery with prompt and appropriate treatment. However, some individuals may experience long-term neurological damage or other complications.

To prevent PRES, it is important to maintain good overall health and to manage any underlying medical conditions that may increase the risk of developing the disorder. This may involve making lifestyle changes such as improving diet and exercise habits, managing stress levels, and monitoring blood pressure and other vital signs.

Posterior Reversible Encephalopathy Syndrome is a rare but potentially life-threatening neurological disorder that requires prompt diagnosis and treatment. Individuals who experience symptoms of PRES, such as headaches, seizures, or vision changes, should seek medical attention right away to prevent serious complications. With appropriate treatment and management, many individuals with PRES can experience a full recovery and regain their quality of life.

Reversible Cerebral Vasoconstriction Syndrome (RCVS)’:

Reversible Cerebral Vasoconstriction Syndrome (RCVS) is a rare but potentially serious condition that affects the blood vessels of the brain. The syndrome is characterized by recurrent, severe headaches that are often accompanied by other neurological symptoms such as visual disturbances, seizures, and confusion. RCVS is caused by a temporary narrowing of the blood vessels in the brain, which can result in reduced blood flow and damage to brain tissue. Fortunately, RCVS is usually reversible and can be managed with appropriate treatment.

Causes of RCVS:

The exact cause of RCVS is not well understood, but it is believed to be related to the sudden and intense constriction (narrowing) of the blood vessels in the brain. This constriction can be triggered by a number of factors, including:

  1. Medications: RCVS can be a side effect of certain medications, such as selective serotonin reuptake inhibitors (SSRIs), ergotamines, and triptans.
  2. Illicit drugs: The use of illicit drugs such as cocaine or amphetamines can also trigger RCVS.
  3. Hormonal changes: Hormonal changes, such as those that occur during pregnancy or menopause, have been associated with RCVS.
  4. Physical exertion: RCVS has been reported in individuals who have engaged in strenuous physical activity or weightlifting.

Symptoms of RCVS:

The symptoms of RCVS can vary in severity and duration. Some people may experience only mild symptoms, while others may experience severe headaches and other neurological symptoms. The most common symptoms of RCVS include:

  1. Sudden and severe headache
  2. Visual disturbances, such as blurry vision or double vision
  3. Seizures
  4. Confusion or disorientation
  5. Nausea or vomiting
  6. Neck stiffness or pain

Diagnosis of RCVS:

Diagnosing RCVS can be challenging because the symptoms are similar to those of other neurological conditions, such as migraines or strokes. If RCVS is suspected, the healthcare provider may order a number of tests to confirm the diagnosis, including:

  1. Brain imaging: Magnetic resonance imaging (MRI) or computed tomography (CT) scans may be used to visualize the blood vessels in the brain and identify any areas of constriction.
  2. Cerebral angiography: This test involves injecting a contrast dye into the blood vessels of the brain and using X-rays to create detailed images of the blood vessels.
  3. Lumbar puncture: A sample of cerebrospinal fluid (the fluid that surrounds the brain and spinal cord) may be taken and analyzed to rule out other conditions.

Treatment of RCVS:

Treatment for RCVS typically involves managing the symptoms and addressing any underlying causes. Medications such as calcium channel blockers and anti-epileptic drugs may be used to help prevent constriction of the blood vessels and manage seizures. In severe cases, hospitalization may be necessary for close monitoring and management of symptoms.

Most people with RCVS recover completely within a few weeks to months, although some may experience recurrent episodes. It is important to follow up with a healthcare provider regularly to monitor for any long-term complications and to manage any underlying conditions that may have triggered the RCVS.

Reversible Cerebral Vasoconstriction Syndrome is a rare but potentially serious condition that affects the blood vessels of the brain. It can be triggered by a number of factors, including medications, illicit drugs, hormonal changes, and physical exertion. Early diagnosis and treatment are important to prevent complications and ensure a full recovery. If you experience any of the symptoms associated with RCVS, it is important to seek medical attention immediately.

iSchaemia:

iSchaemia, also known as ischemia, is a medical condition characterized by a restriction in blood supply to an organ or tissue. This can occur in any part of the body, including the heart, brain, limbs, and internal organs. iSchaemia is a serious condition that can cause tissue damage or death if left untreated.

The most common cause of iSchaemia is a blockage in the blood vessels that supply the affected organ or tissue. This can be caused by a variety of factors, including blood clots, plaque buildup in the arteries, or compression of blood vessels due to injury or other medical conditions. In some cases, iSchaemia can also be caused by a decrease in blood flow due to low blood pressure, shock, or other circulatory problems.

The symptoms of iSchaemia depend on the location of the affected organ or tissue. In the case of iSchaemic heart disease, for example, patients may experience chest pain, shortness of breath, and fatigue. iSchaemia of the brain can cause symptoms such as confusion, dizziness, and difficulty speaking or moving. iSchaemia of the limbs can cause pain, numbness, and weakness.

Diagnosis of iSchaemia typically involves a physical exam, medical history review, and diagnostic tests such as imaging studies, blood tests, and electrocardiograms (ECGs). Treatment for iSchaemia depends on the underlying cause and the severity of the condition. In some cases, medications such as blood thinners or antiplatelet drugs may be used to prevent further blood clots from forming. Surgery or other invasive procedures may also be necessary to restore blood flow to the affected area.

Prevention of iSchaemia involves a healthy lifestyle and management of underlying medical conditions such as high blood pressure, high cholesterol, and diabetes. Quitting smoking, exercising regularly, and maintaining a healthy weight can also help reduce the risk of iSchaemia.

iSchaemia is a serious medical condition that can cause tissue damage or death if left untreated. It can affect any part of the body and is typically caused by a blockage or restriction in blood flow. Diagnosis and treatment of iSchaemia involve a thorough evaluation by a medical professional, as well as management of underlying medical conditions and lifestyle changes to reduce the risk of recurrence.

Conclusion

PRES and RCVS can involve reduced blood supply (ischaemia) to the brain and may cause major and life-threatening complications in some cases. 

Signs of PRES often include headaches, vision problems, mental changes, seizures, and swelling in the brain, according to the NHS.

Pseudoephedrine is already known to pose a slight risk to the heart including strokes and heart attacks.

Other decongestants, such as products made by Benylin, Nurofen, and Day & Night Nurse, would also be affected if any change was necessary.

Dozens of own-brand remedies — including ones at Boots and Lloyds — also contain the chemical.

The decongestant works by narrowing swollen blood vessels in the sinuses — which causes the nose to become blocked in the first place.

The Medicines and Healthcare Products Regulatory Agency (MHRA), which polices the safety of drugs used in Britain, is behind the review.

The European Medicines Agency (EMA) launched its own review into the safety of medicine less than a fortnight ago.

#productrecall #ema #mhra #fda #decongestants #pseudoephedrine #pres #rcvs #ischaemia #sudafed #nurofen #daynurse #nightnurse

Micro-dosing Psilocybin Mushrooms.

Micro-dosing Psilocybin Mushrooms improve mental health after one month.

Suffering from mental health issues for over 30 years now and being prescribed the same medication year in and year out without any significant improvement one must look at alternative ways to heal.

I suffer from anxiety, stress, depression, panic attacks, social disconnection, and OCD.

The NHS has failed me because month after month my symptoms do not improve, and I must resort to self-help to get through certain days.

I have never explored or ever taken psychedelic drugs and it was only by watching a documentary on Netflix “How to change your mind” that I started to realize there are diverse ways to treat my disorder.

Psilocybin Mushrooms.

Psilocybin mushrooms: commonly known as magic mushrooms, mushrooms, are a polyphyletic informal group of fungi that contain psilocybin which turns into psilocin upon ingestion. Biological genera containing psilocybin mushrooms include Copelandia, Gymnopilus, Inocybe, Panaeolus, Pholiotina, Pluteus, and Psilocybe. Wikipedia

The study published in Nature: Scientific Reports has observed significant benefits to mood and mental health after one month of micro-dosing psilocybin mushrooms.

Mushroom microdoses saw greater improvements across the DASS domains of Depression, Anxiety, and Stress. The study found that the microdose cognitive efficacy was higher performing in people aged under 55.

The study looked at 1133 people over the course of two years. All subjects were over 18 years old, able to read in English, and had access to an iPhone iOS device where participants recorded their results. Scientific Reports is a peer-reviewed, open-access scientific journal published online by Nature Portfolio.

https://www.forbes.com/sites/lindseybartlett/2022/07/05/microdosing-psilocybin-mushrooms-improves-mood-and-mental-health-after-one-month-new-study-finds/?sh=1ad13aff1ab4

The study was conducted by a team of experts in the fields of psychology and mycology: Joseph M. Rootman, Department of Psychology, University of British Columbia, Kelowna, BC, Canada; Maggie Kiraga, an employee of Quantified Citizen Technologies. Pamela Kryskow, a member of the clinical advisory board of Numinus Wellness, co-founder of MycoMedica Life Sciences, and on the Scientific & Medical Advisory Board; Kalin Harvey; Paul Stamets, who founded Fungi Perfecti, LLC; Eesmyal Santos-Brault; Kim P. C. Kuypers; and Zach Walsh, a member of the Advisory Board of the Multidisciplinary Association for Psychedelic Studies (MAPS) Canada and MycoMedica Life Sciences.

The reason GPs are not willing to advise or prescribe holistic medicine is that it would cost the Big Pharma Industry big bucks. If people could cure themselves after a month of using natural plant-made drugs the pharma companies would soon feel the pinch. I wrote previously what your doctor won’t tell you.

I have concluded my own doctor is as useful as a chocolate fire guard.

Even if my doctor could not prescribe ‘Microdosing Psilocybin Mushrooms’ she could have at least told me about it and recommended where I should go to get it. According to the UK, it is still not legal and a petition was made but coincidently because of a General Election in November 2019 it was closed, well all I can say is someone should restart it again: https://petition.parliament.uk/archived/petitions/260806

All I know is that Imperial College London is doing research into the benefits and negative effects of psilocybin and other psychedelic compounds. I only say this as I reside in the UK but other parts of the world will have other studies, where you need to do your own research to find out who is doing it closer to your area.

In the most rigorous trial to date assessing the therapeutic potential of a ‘psychedelic’ compound, researchers compared two sessions of psilocybin therapy with a six-week course of a leading antidepressant (a selective serotonin reuptake inhibitor called escitalopram) in 59 people with moderate-to-severe depression.

The results, published today in the New England Journal of Medicine, show that while depression scores were reduced in both groups, the reductions occurred more quickly in the psilocybin group and were greater in magnitude.

Editors Thoughts.

As a consequence, I blame the NHS and the powers that be for not giving me the right support and ultimately making my condition worse.

Similar to abortions, who has the right to say what you do with your body?

It is your body and how you treat is your business and no one else’s unless you are out of control.

What a person consumes is on them if they are of sound mind. Why make alcohol and cigarettes legal when they cause, liver failure or cancer. The reason why is because ‘Big Pharma’ relies on you becoming unwell. Whilst if everyone was cured they would not be laughing all the way to the bank.

The Journal of Psychopharmacology published a follow-up earlier this year to this widely-publicized study from Johns Hopkins Medicine that found psilocybin may continue to help people with depression up to one year later.

People treated with psilocybin – named ‘COMP360’ by its developers, COMPASS Pathways PLC – showed marked improvements across a range of subjective measures, including in their ability to feel pleasure, and express emotions, greater reductions in anxiety and suicidal ideation, and increased feelings of wellbeing.

Dr. Robin Carhart-Harris, Head of the Centre for Psychedelic Research at Imperial, who designed and led the study, said: “These results comparing two doses of psilocybin therapy with 43 daily doses of one of the best performing SSRI antidepressants help contextualize psilocybin’s promise as a potential mental health treatment. Remission rates were twice as high in the psilocybin group than in the escitalopram group.

“One of the most important aspects of this work is that people can clearly see the promise of properly delivered psilocybin therapy by viewing it compared with a more familiar, established treatment in the same study. Psilocybin performed very favorably in this head-to-head.”

https://www.imperial.ac.uk/news/219413/magic-mushroom-compound-performs-well-antidepressant/

As suggested by the Imperial College London / Thomas Angus; Psilocybin capsules: warn that while the initial findings are encouraging, patients with depression should not attempt to self-medicate with psilocybin. However, I will be writing to anyone that is doing clinical trials with the view of volunteering.

I am therefore going to be on the lookout for clinical trials in my area, we can only wait and see. I could have been cured years ago, instead of being kept as a lab rat.

#magicmushroons #microdosing #psilocybinmushrooms #psychedelics

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