BMJ finds inaccuracies in key studies for AstraZeneca’s blockbuster heart drug ticagrelor

Investigation finds evidence of serious misreporting, raising fresh doubts over the approval and decade long use of ticagrelor

2025-06-19

(Press-News.org) In a follow up investigation into the multibillion dollar drug ticagrelor, The BMJ has uncovered fresh concerns, this time in key platelet studies used in its FDA approval.

For more than a decade, ticagrelor (Brilinta in the US and Brilique in Europe) has been recommended for patients with acute coronary syndrome - a range of conditions related to sudden reduced blood flow to the heart.

Last December, an investigation by The BMJ found serious data integrity problems in the landmark clinical trial (PLATO) that was used to gain worldwide approval for ticagrelor, calling into question the drug’s advantage over cheaper rivals.

Now, as generic versions of the drug prepare to launch this year, The BMJ has expanded its investigation, looking at two key platelet studies that AstraZeneca claimed explained ticagrelor’s ability to treat acute coronary syndrome successfully.

It finds that the “primary endpoint” results (the trial’s key measurement) for both clinical trials were inaccurately reported in the leading cardiology journal Circulation, and reveals that more than 60 of 282 readings from platelet machines used in the trials were not present in US Food and Drug Administration (FDA) datasets.

What’s more, one active trial investigator never became a study author, while one author told The BMJ he was not involved in the trial, and most investigators, including the principal investigator, were unreachable or declined to be interviewed.

Victor Serebruany, an adjunct faculty member at Johns Hopkins University and ticagrelor’s most renowned critic, told The BMJ that “there are episodes of skyrocketing rebound and profound platelet inhibition after ticagrelor making patients prone to thrombosis or bleeding. If doctors had known what happened in these trials, they would never have started using ticagrelor.”

Circulation and AstraZeneca did not respond to a request for comment.

Serebruany added: “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—on top of the many problems their own reviewers identified and are now being discovered by The BMJ—is unconscionable. We all need to know how and why that happened.”

[Ends]

END

ELSE PRESS RELEASES FROM THIS DATE:

Paper outlines more efficient organic photoredox catalysis system inspired by photosynthesis

2025-06-19

EMBARGO: THIST CONTENT IS UNDER EMBARGO UNTIL 2 P.M. U.S. EASTERN STANDARD TIME ON JUNE 19, 2025. INTERESTED MEDIA MAY RECIVE A PREVIEW COPY OF THE JOURNAL ARTICLE IN ADVANCE OF THAT DATE OR CONDUCT INTERVIEWS, BUT THE INFORMATION MAY NOT BE PUBLISHED, BROADCAST, OR POSTED ONLINE UNTIL AFTER THE RELEASE WINDOW. Colorado State University researchers have published a paper in Science that describes a new and more efficient light-based process for transforming fossil fuels into useful modern chemicals. In it, they report that their organic ...

Plastic bag bans: Study finds up to 47% drop in shoreline bag litter

2025-06-19

Among the biggest culprits of plastic pollution in the ocean and along shorelines are thin plastic shopping bags, which have low recycling rates and often become litter when they blow away in the wind. Once there, they can entangle animals and break down into harmful microplastics. As awareness of this problem has grown, more than 100 countries have instituted bans or fees on plastic bags. But what effect those policies are having on the amount of plastic litter in the marine environment had not been systematically evaluated until now. A new study ...

Plastic bag policies are effective in reducing shoreline litter in the US

2025-06-19

Plastic bag regulations – bans and consumer fees – have led to meaningful reductions in plastic litter on U.S. shorelines, according to a new study. Plastic pollution has become a pervasive environmental issue; plastic debris comprises most of the marine litter worldwide and has been shown to pose serious threats to ocean life, ecosystems, and coastal economies. Much of this pollution originates from land and enters the ocean via rivers, wastewater, or wind. Among the most problematic ...

Current chemical monitoring data hinders global water risk evaluations

2025-06-19

A large-scale analysis of U.S. water quality data reveals that most toxic chemicals remain poorly characterized or undetected in routine monitoring. This is largely due to sparse risk assessment data, as well as detection limits that are too high to capture ecologically relevant concentrations, researchers report. The findings suggest that the true scale of chemical risk to biodiversity and ecosystems may be significantly underestimated. Chemical pollution is widely recognized as a major threat to biodiversity, human health, and the stability of ecosystems worldwide. However, the accelerating rate at which new chemicals are introduced into the environment outpaces the current ability ...

New method enables in vivo generation of CAR T cells to treat cancer and autoimmune disease

2025-06-19

Researchers present a new method to safely and preferentially generate CAR T cells directly inside the body using targeted lipid nanoparticles that deliver mRNA directly to T cells. The approach showed rapid and sustained immune reprogramming in preclinical models, highlighting its promise for treating cancer and autoimmune diseases. Adoptive immunotherapy, which harnesses a patient’s own immune cells to treat disease, holds immense therapeutic potential. Among its most prominent forms is CAR T cell therapy, in ...

Decline in population data collection threatens global public policy

2025-06-19

In a Policy Forum, Jessica Espey and colleagues argue that waning support for accurate collection and curation of population data worldwide threatens to compromise crucial evidence-based government planning. “We live in an era of seemingly unlimited data, where our digital activities may generate nearly constant information streams, yet some of our most essential infrastructure – demographic information – is deteriorating, introducing known and unknown bias into decision-making,” write the authors. ...

Ocean ‘greening’ at poles could spell changes for fisheries

2025-06-19

DURHAM, N.C. -- Ocean waters are getting greener at the poles and bluer toward the equator, according to an analysis of satellite data published in Science on June 19. The change reflects shifting concentrations of a green pigment called chlorophyll made by phytoplankton, photosynthetic marine organisms at the base of the ocean food chain. If the trend continues, marine food webs could be affected, with potential repercussions for global fisheries. “In the ocean, what we see based on satellite measurements is that the tropics and the subtropics are generally losing chlorophyll, whereas ...

No data, no risk? How the monitoring of chemicals in the environment shapes the perception of risks

2025-06-19

Several hundred thousand chemicals are considered as potentially environmentally relevant. Scientists from the RPTU Kaiserslautern-Landau in Germany show that monitoring data for surface waters are only available for a very small fraction of these chemicals. In their article, published in the latest issue of Science, the authors also demonstrate that the environmental risks of highly toxic chemicals might be overlooked, because these chemicals affect ecosystems at concentrations that cannot be detected on a regular basis. “We analyzed a very extensive US database for the presence of chemicals in the US surface waters ...

More and more people missing from official data

2025-06-19

Researchers are warning that millions of people around the world aren’t being counted in census and survey data, leaving policymakers in the dark about the populations they govern. They say a ‘quiet crisis’ is unfolding with census data due to declining response rates and concerns about the accuracy of the data. In a paper published in Science, researchers from the University of Southampton and Columbia University point to a ‘perfect storm’ of disruptions from the COVID-19 pandemic, declining confidence in institutions, ...

Two transparent worms shed light on evolution

2025-06-19

Two species of worms have retained remarkably similar patterns in the way they switch their genes on and off despite having split from a common ancestor 20 million years ago, a new study finds. The findings appear in the June 19 issue of the journal Science “It was just remarkable, with this evolutionary distance, that we should see such coherence in gene expression patterns,” said Dr. Robert Waterston, professor of genome sciences at the University of Washington School of Medicine in Seattle and a co-senior author of the paper. “I was surprised how well everything lined ...