Tag Archives: pharmaceutical trials

Journalist recounts the pressure of GSK clinical trial

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

In the wake of questions about GlaxoSmithKline’s Avandia clinic trials, the Austin American-Statesman‘s Ana Cantú talks about her own experience in a different GSK clinical trial five years ago. Her column isn’t long, but she manages to capture the pharmaceutical giant’s desperation and the pressure put on participants. It helps that Cantú was, in some ways, a fulcrum for the study’s success.

I don’t want to spoil the story, but it all revolves around the requirement that seven of the 20 participants complete the study to garner sufficient data for submission to the FDA. After 13 participants dropped by the wayside, a sick and unhappy Cantú found herself on the bubble. She needed a medical authorization to drop out and still receive the $4,800 she was due for her participation, but the physicians in charge of the study were under immense pressure to keep her around and maintain that all-important quorum.

In the end, there’s a reason she refers to it as the “most miserable month of my life,” but at the time Cantú had only scratched the surface of the significance of her participation. Now, her reflections are revealing.

Foreign trial data used in 4/5 of approved drugs

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

FairWarning’s Lea Yu and The New York Times‘ Gardiner Harris drew our attention to a report from the HHS Office of Inspector General which reviewed 2008 data and found that “Eighty percent of approved marketing applications for drugs and biologics contained data from foreign clinical trials.” Furthermore, the OIG found, “Over half of clinical trial subjects and sites were located outside the United States.”

The OIG expects the trend to grow in the future, writing that “Western Europe accounted for most foreign clinical trial subjects and sites; however, Central and South America had the highest average number of subjects per site.”

The FDA only inspected a minuscule percentage of these foreign test sites, but says it has taken the OIG’s advice and is stepping up efforts to put together agreements with its foreign counterparts and to figure out other methods to standardize and evaluate these foreign trials.

Study authors don’t always have access to raw data

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates AHCJ's social media efforts and edits and manages production of association guides, programs and newsletters.

John Fauber of the Milwaukee Journal Sentinel reports on outside authors of drug company-funded studies who do not have access to the raw data behind the study.

In the latest installment of Side Effects, a series examining doctors, drug companies and conflicts of interest, Fauber reports that a researcher who co-authored a study of Multaq that led to the drug’s FDA approval “vouched for the accuracy and completeness of the study despite not seeing the raw data.”

The researcher, Richard Page, chairman of the department of medicine at the University of Wisconsin School of Medicine and Public Health, says he trusts the Sanofi-Aventis, the drug’s manufacturer.

Fauber delves into the differing editorial policies of the Journal of the American Medical Association and the New England Journal of Medicine when it comes to studies in which drug company employees perform the data analysis.

In the case of the Multaq trial, published by the New England Journal of Medicine, the FDA got unanalyzed raw data and did its own analysis. Fauber reports that “one FDA panel member questioned differences between the information included in the published February 2009 study and what was submitted to the FDA.”

Related

BMJ wants raw data for all drug trials to be shared

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

Under the headline “We want raw data, now,” BMJ editor Fiona Godlee recounts the story of how BMJ had to pressure a drug company into releasing full study reports verifying their claims as to the effectiveness of oseltamivir (Tamiflu).

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Tamiflu. Photo by Richard Sunderland via Flickr.

Godlee says that researchers updating their Cochrane review of the drug “failed to verify claims, based on an analysis of 10 drug company trials, that oseltamivir reduced the risk of complications in healthy adults with influenza. These claims have formed a key part of decisions to stockpile the drug and make it widely available.”

Only after Roche was questioned by the BMJ and Channel 4 News did the manufacturer commit to making “full study reports” available. Godlee says that some questions remain, including how patients were recruited and why some neuropsychiatric adverse events were not reported.

Godlee argues that “it can’t be right that the public should have to rely on detective work by academics and journalists to patch together the evidence for such a widely prescribed drug,” saying that “Individual patient data from all trials of drugs should be readily available for scientific scrutiny.”

How the pharma research ‘sausage’ is made

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

Reporting on Health’s William Heisel has posted the latest installment in his series highlighting the spiciest entries in the Drug Industry Document Archive, this time focusing on the cold mechanics of the drug industry’s research paper assembly line, and its intimate relationship with pharmaceutical marketing.

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Photo by somegeekintn via Flickr.

Again, Heisel focuses on the deposition of Wyeth ghostwriter Karen Mittleman and related documents and memorandums. He lists the names of some key ghostwriters to look out for, then details a number of specific cases when production and marketing concerns clearly outweighed science, at least as far as the pharmaceutical manufacturers were concerned.