Blockbuster Anticlotting Drug Approved on Flawed Studies

• U.S. patients had worse outcomes — The FDA’s analysis revealed that patients in the U.S. had a 27% higher risk of major cardiovascular events when given ticagrelor, the exact opposite of what was seen in Europe and other regions. AstraZeneca argued that high aspirin doses in the U.S. explained this difference, but FDA scientists rejected that explanation as insufficient.

This matters to you because if you were prescribed ticagrelor in the U.S., the very population where the drug performed poorly, your risk of harm could be higher than your doctor realizes.

• Lead FDA reviewer sounded the alarm — Dr. Thomas Marciniak, a medical officer at the FDA known for his rigorous reviews, concluded in a 47-page memo that ticagrelor appeared inferior in both safety and efficacy. He described AstraZeneca’s submission as “the worst in my experience regarding completeness of the submissions and the sponsor responding completely and accurately to requests.”

His recommendation was to deny approval. Despite this, FDA leadership approved the drug. This means the green light came not from consensus among scientists but from administrative override.

• Data monitoring raised red flags — Another alarming detail from the investigation was that AstraZeneca monitored most trial sites themselves, except in four countries where independent organizations oversaw the process. In those four independently monitored countries — including the U.S. — ticagrelor performed worse than clopidogrel.

Where the sponsor oversaw data collection, ticagrelor appeared superior. This inconsistency suggests that oversight and data handling directly shaped the reported outcomes, which should concern you if you trust that “gold standard” trials are always impartial.

• Death records were altered — The BMJ uncovered that adjudicators — those tasked with classifying patient outcomes — added 45 heart attacks to the clopidogrel group and zero to the ticagrelor group. Furthermore, among disputed deaths, the final classifications disproportionately favored ticagrelor.

Even more troubling, The New England Journal of Medicine publication reported 905 deaths, while AstraZeneca’s internal records listed 983, leaving dozens unaccounted for.² If you rely on published medical journals to reflect reality, this discrepancy shows how data manipulation shaped the drug’s image.

• Mechanism of harm tied to bleeding and misclassified events — The trial design used a primary endpoint that combined death from vascular causes, heart attack, or stroke. This meant even small shifts in how events were classified could tip the scales.

When deaths or heart attacks were reclassified in ticagrelor’s favor, the appearance of benefit emerged. For you, this demonstrates how outcome definitions — not just biology — determine whether a drug is labeled a “life saver” or a “risky bet.”

What you take from this is not just about ticagrelor but about the system itself. If a multibillion-dollar drug could be approved over scientific objections, it shows how important it is for you to ask questions, look at alternatives, and demand transparency in how medical data is reported. Empowering yourself with this knowledge means you’re not blindly dependent on drugs that were fast-tracked through a flawed process.

• Studies were inaccurately reported, casting serious doubt on AstraZeneca’s claims — These trials were central to convincing regulators and doctors that ticagrelor worked better, yet the primary endpoint results were misstated in Circulation, a leading cardiology journal.^5,6 This means the very foundation used to justify the drug’s “superiority” over cheaper options was built on flaws.

• Participants faced extreme and unusual demands — Patients in these platelet studies, who had stable coronary artery disease, were required to give large amounts of blood — up to 604 milliliters across visits, which is more than a full unit donated at a blood bank. Typically, platelet studies involve just one or two blood draws, but AstraZeneca’s required six within a single eight-hour period.

As one trial investigator admitted, only the most committed participants could endure that burden. This unusual setup raises questions about whether the data reflected typical patients or only those willing to undergo intense procedures, which directly impacts whether the results apply to real life.

• Data gaps and missing records weakened credibility — The BMJ investigation found that more than 60 platelet readings were missing from the datasets submitted to the FDA. Even worse, some of the excluded results showed significantly higher platelet activity, suggesting ticagrelor did not inhibit clotting as strongly as advertised.

Implausible readings, such as platelet activity increasing after treatment, were included in final analyses, but instead of being flagged, they were hidden through unpublished “data adjustments.” If you trusted those published results to reflect reality, the findings show that key data was either mishandled or left out.

• Authorship was misrepresented — Several individuals listed as study authors later denied involvement, while others who actively recruited patients were excluded. For example, Tonny Nielsen, identified as a Danish investigator and author, stated outright, “I did not participate in the RESPOND study.” Conversely, a Baltimore physician who enrolled 12 patients wasn’t credited.

• Statistical tricks distorted outcomes — RESPOND originally showed non-significant results, meaning ticagrelor did not reliably outperform clopidogrel. But by changing the definition of the primary endpoint, the published paper reported it as significant. That single shift turned ticagrelor into a “winner.” If you were ever told this drug had clear advantages, the truth is those advantages were manufactured by re-writing the rules of analysis.

• What this means for your health decisions — Victor Serebruany, a Johns Hopkins pharmacologist and one of ticagrelor’s earliest critics, summarized it bluntly: “If doctors had known what happened in these trials, they would never have started using ticagrelor.”⁸

This means that the trust placed in ticagrelor’s science was misplaced, and drugs like clopidogrel were pushed aside based on faulty evidence. Armed with this knowledge, you can ask sharper questions about whether the medications you’re offered are backed by solid science — or by manipulated data.

1. Question the strength of the evidence — Before starting any drug, look into whether the key studies supporting it had problems with data accuracy, missing information, or conflicting results. In this case, ticagrelor’s studies were riddled with errors and misreporting. When you ask “What does the evidence actually show?” you set yourself up for better decisions.

2. Reduce your risk by addressing root causes — Anticlotting drugs are often prescribed because of lifestyle-driven heart disease. If you lower your risk through diet, movement, and reducing toxic exposures, you’ll rely less on drugs in the first place.

Cut vegetable oils from your diet, avoid ultraprocessed foods, increase your intake of whole-food carbohydrates, and build strength through daily walking and regular resistance training. This improves your circulation and lowers clotting risk naturally.

3. Track your progress with the right markers — Instead of relying on outdated measures like total cholesterol, focus on health tests that actually reflect your metabolic health. Monitor your HOMA-IR score to track insulin resistance, check fasting glucose, and keep an eye on your triglyceride-to-HDL ratio.

You can also use a simple blood pressure cuff at home to watch for improvements in circulation. Treat these numbers like checkpoints — every improvement is proof that your daily choices are moving you in the right direction and away from dependence on risky drugs.

4. Stay informed and proactive about drug safety — Don’t assume that just because a drug is FDA-approved, it’s the best choice. Ticagrelor proves that approvals often ignore serious flaws. Read investigations, follow updates from independent researchers, and ask yourself whether the benefits outweigh the risks. Knowledge puts you in charge, not the system.