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Big Pharma's Hidden Trials: The Drug Approvals That Should Never Have Happened

Internal documents from three pharmaceutical companies reveal a pattern of suppressed clinical trial data, regulatory capture, and a revolving door between drug approvals and industry jobs.

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The Studies That Disappeared

Every approved drug in the United States comes with a promise: that the benefits outweigh the risks, and that the science proving it has been rigorously reviewed. A GripeNation investigation suggests that promise is broken more often than patients know.

We reviewed more than 2,400 pages of internal documents from three pharmaceutical companies, obtained through a combination of whistleblower disclosures and litigation discovery records made public in unrelated cases. The documents reveal a systematic practice of selective data submission — presenting favorable trial results to regulators while quietly shelving studies that showed significant risks.

The Coroven Approval

In 2023, the FDA approved Coroven, a cholesterol-lowering medication manufactured by Veridian Therapeutics, for broad use in patients aged 45 and older. The drug quickly became one of the fastest-growing prescriptions in the country, with more than 4 million patients currently taking it.

What the public was not told: at least two of Veridian's own internal trials showed elevated rates of muscle degradation — a condition that, in severe cases, can lead to kidney failure — in patients over 60. Those trials were completed in 2021 and 2022. Neither was included in the New Drug Application submitted to the FDA.

A statistician who worked on one of the suppressed trials told GripeNation: "We flagged it internally. We were told the data was 'inconsistent with the larger dataset' and that it wouldn't be submitted. I raised it again and was removed from the project."

Veridian said in a written response that all required trial data was submitted to regulators and that the company "categorically denies any suggestion of data suppression." The company declined to provide a list of all trials conducted on Coroven.

Revolving Door at the FDA

The problem doesn't begin or end with Veridian. Our investigation identified at least 14 former FDA officials who, within 24 months of leaving the agency, accepted senior positions at pharmaceutical companies whose drugs they had overseen during their tenure.

Among them: Dr. Alan Pruitt, who served as director of the FDA's Center for Drug Evaluation and Research from 2019 to 2022, and who now serves on the board of directors at Halcyon Biopharma — a company that received three accelerated approvals during his tenure.

Dr. Pruitt did not respond to requests for comment. Halcyon Biopharma said his appointment "followed all applicable ethics regulations."

Federal post-employment restrictions technically prohibit former officials from lobbying their former agency for one to two years, but they impose no restrictions on executive employment, advisory roles, or equity compensation.

"The restrictions are a fig leaf," said one former FDA scientist who left the agency in frustration. "The real problem is that everyone in both buildings knows who their future employers are going to be. That shapes decisions in ways that are invisible to the public."

What Patients Don't Know

When a patient fills a prescription, they typically see a list of documented side effects. They do not see the studies that were never submitted. They do not see the communications between company scientists and their superiors about data that was set aside.

GripeNation has submitted requests to the FDA for access to all clinical trial data submitted for Coroven's approval. The agency has indicated the request may take up to 18 months to process.

In the meantime, an estimated 4 million people are taking a drug whose complete safety profile remains, by the agency's own processing timeline, more than a year away from public scrutiny.

If you have worked in pharmaceutical research or drug regulation and have information relevant to this investigation, please contact us through our secure submission portal. Your identity will be protected.

Source documents cited in this investigation are available to credentialed journalists upon verified request.

Tags:#pharmaceuticals#FDA#clinical trials#drug safety#regulatory capture

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