Connect with us
We’re experimenting with AI-generated content to help deliver information faster and more efficiently.
While we try to keep things accurate, this content is part of an ongoing experiment and may not always be reliable.
Please double-check important details — we’re not responsible for how the information is used.

Blood Clots

“Flaws in AstraZeneca’s Research Exposed: FDA Approval for Ticagrelor Called into Question”

Fresh concerns have emerged about the platelet studies underpinning the FDA approval of ticagrelor, AstraZeneca’s multibillion-dollar heart drug. A new BMJ investigation reveals data discrepancies, missing lab readings, and questions about the integrity of the trial process. Notably, key results reported in a major cardiology journal were inaccurately presented, and some study contributors were omitted or denied involvement. With generics on the horizon, critics say these revelations highlight potential dangers, including severe rebound effects and bleeding risks, that were never properly disclosed.

Avatar photo

Published

on

The FDA has faced criticism over its handling of the approval process for AstraZeneca’s ticagrelor, a multibillion-dollar medication used to treat acute coronary syndrome. The concerns were raised by an investigation conducted by The BMJ, which found serious issues with key platelet studies that supported the drug’s approval.

For over a decade, ticagrelor has been recommended for patients suffering from sudden reduced blood flow to the heart. However, in December last year, The BMJ uncovered data integrity problems in the landmark clinical trial (PLATO) used to gain worldwide approval for the medication. This led to questions about the drug’s advantage over cheaper rivals.

The latest investigation by The BMJ delves deeper into two crucial platelet studies that AstraZeneca claimed explained ticagrelor’s effectiveness in treating acute coronary syndrome. Unfortunately, it has been discovered that the primary endpoint results for both trials were inaccurately reported in the leading cardiology journal, Circulation.

What’s more, an analysis of data from platelet machines used in these trials revealed that over 60 out of 282 readings were missing from FDA datasets. This raises serious concerns about the reliability and accuracy of the research conducted on ticagrelor.

Victor Serebruany, an adjunct faculty member at Johns Hopkins University and a prominent critic of ticagrelor, expressed his shock and disappointment in an interview with The BMJ. He stated that “there are episodes of skyrocketing rebound and profound platelet inhibition after ticagrelor making patients prone to thrombosis or bleeding.” If doctors had known about these issues during the trials, they would have never started using ticagrelor.

The lack of transparency in AstraZeneca’s research is concerning, especially when coupled with the FDA’s failure to address the problems. The need for accurate and reliable data in healthcare cannot be overstated, as it directly impacts patient care and treatment outcomes. As Serebruany aptly put it, “It’s been obvious for years that there is something wrong with the data. That the FDA’s leadership could look past all these problems…is unconscionable.”

Anemia

Hidden Risk: Three Genetic Variants That Raise Clot Risk by 180%

Genetic research in Sweden has unveiled three new gene variants that dramatically increase the risk of venous blood clots, sometimes by up to 180%. These discoveries build on existing knowledge of Factor V Leiden and suggest that genetics plays a bigger role than previously thought, especially for clots in the legs that can lead to life-threatening pulmonary embolisms.

Avatar photo

Published

on

The risk of blood clots is a serious concern worldwide, with venous thrombosis being one of the most common causes of death globally. A recent study from Lund University in Sweden has shed light on three genetic variants that significantly increase the risk of blood clots in the leg by up to 180%.

While arterial and venous blood clots have different causes and consequences, understanding the risk factors is crucial for prevention and treatment. In Sweden, over 10,000 people suffer from venous thromboembolism each year, with age being a strong risk factor.

“Venous thrombosis is a common disease that has always been somewhat overshadowed by arterial blood clots,” says Bengt Zöller, a specialist in general medicine at Skåne University Hospital and professor of general medicine at Lund University. “However, it’s essential to acknowledge its significance and take steps to prevent it.”
The risk factors for venous thrombosis include age, being overweight or tall, and lack of physical activity. Smoking is considered only a weak to moderate risk factor, while high blood pressure and high levels of blood lipids are associated with arterial clots, not venous ones.

Research suggests that commercial fishermen have a lower risk due to their diet rich in omega-3 fatty acids. Additionally, ultra-processed foods have been linked to an increased risk of blood clots, whereas plant-based diets may reduce this risk.
“Prophylaxis in the form of blood thinners may be particularly important if other risk factors are also present,” advises Zöller.

The three genetic variants identified by Bengt Zöller and his fellow researchers are ABO, F8, and VWF. These variants increase the risk of venous blood clots by 10-30% each, with an individual having five of these gene variants having a 180% higher risk.
“These genetic variants are present in all populations, making it essential to investigate how the number of risk genes affects the duration of treatment with anticoagulants after a blood clot,” concludes Zöller.

To prevent blood clots, one can take steps such as maintaining physical activity, monitoring blood pressure and lipid levels, quitting smoking, and eating a balanced diet rich in omega-3 fatty acids. Tailoring treatment based on risk assessment will become increasingly important in the future.
“Tailoring treatment based on risk assessment will become increasingly important,” concludes Bengt Zöller.

In summary, understanding the three genetic variants that increase the risk of blood clots by up to 180% is crucial for prevention and treatment. By acknowledging these risk factors, individuals can take steps to reduce their likelihood of developing venous thrombosis.
“Blood clot prevention is a vital aspect of healthcare, and awareness about the risks is essential,” emphasizes Zöller.

Continue Reading

Anemia

Groundbreaking Discovery in Chronic Renal Failure: A Promising Biomarker for Early Diagnosis and Prevention

Scientists have identified microRNA able to protect small blood vessels and support kidney function after severe injury.

Avatar photo

Published

on

Chronic renal failure affects millions worldwide, including four million Canadians. Researchers at the Canadian hospital research centre, CRCHUM, have made a world-first breakthrough by identifying microRNA that can protect small blood vessels and support kidney function after severe injury. This advancement has significant implications for early diagnosis and prevention of the disease.

Previously, there was no reliable biomarker to evaluate the health of tiny capillaries in the kidneys or develop targeted approaches to preserve kidney function. A study published in JCI Insight reveals that miR-423-5p microRNA is a promising marker in the blood for predicting the microvascular health of the kidneys.

Researchers Marie-Josée Hébert and Héloïse Cardinal, along with Francis Migneault, have been studying the loss of peritubular capillaries, a conclusive indicator of chronic renal failure. These tiny blood vessels filter waste products out of the blood and transport oxygen and nutrients necessary for the organ’s functions.

Kidney injuries can lead to a decrease in small blood vessels, seriously disrupting kidney function. In people who have received a transplant, if kidney function is severely altered, the kidney’s survival is threatened. Using this biomarker, a test could be developed to evaluate the status of small blood vessels much earlier. Doctors could then better assess microvascular health in higher-risk patients.

This breakthrough has been confirmed in 51 transplant recipients and has shown potential for preventing further damage to kidneys. The researchers are now focused on alternative techniques to transport microRNA or a cocktail to the kidney, which may be useful for other patients with cardiac failure, pulmonary failure, or certain neurodegenerative diseases.

The discovery of miR-423-5p microRNA could have a significant impact on the health of Canadians and potentially lead to new treatments for various medical conditions. Researchers are currently exploring its potential in other areas, such as determining if existing medications impact small blood vessel health in kidney transplant patients.

Continue Reading

Agriculture and Food

“Uncovering Hidden Habits: Molecules in Blood and Urine Reveal Ultra-Processed Food Intake”

Sets of metabolites found in blood and urine reliably correspond with how much energy from ultra-processed food a person consumes, according to a new study.

Avatar photo

Published

on

A groundbreaking study published in PLOS Medicine has shed new light on the relationship between ultra-processed food (UPF) consumption and human health. Researchers from the National Cancer Institute analyzed blood and urine samples from 718 older adults to identify chemical fingerprints, or poly-metabolite scores, linked to UPF intake.

The findings revealed that hundreds of metabolites in blood and urine were associated with the percentage of energy someone consumes from UPFs. By using 28 blood metabolites or 33 urine metabolites, a poly-metabolite score could be created that accurately predicted UPF intake among participants. This score was then validated in a controlled feeding study, confirming its ability to distinguish between high-UPF and no-UPF diets.

The researchers emphasize the potential of these poly-metabolite scores as objective measures of UPF intake in large population studies. By reducing reliance on self-reported dietary data, which can be prone to errors and biases, this approach could provide more accurate insights into the relationship between UPFs and human health.

The implications of this study are significant, given that ultra-processed foods account for over half of calories consumed in the average American diet. As the researchers note, their findings could serve as a starting point for further research into the role of UPFs in human health, potentially leading to more targeted and effective public health interventions.

Continue Reading

Trending