In den Annals of Internal Medicine ist jetzt ein Paper publiziert worden, welches das Vorgehen der Firma Merck im ADVANTAGE Trial beschreibt. Erklärtes Studienziel war offiziell ein Vergleich der gastrointestinalen Nebenwirkungen von Vioxx (Rofecoxib) versus Naproxen ("Assessment of Differences between Vioxx and Naproxen To Ascertain Gastrointestinal Tolerability and Effectiveness").
Aus den den Autoren des Artikels vorliegenden Gerichtsdokumenten geht nun hervor, daß die Studie komplett von einem Merck Marketing-Team gestartet und betreut wurde und zum Ziel hatte, die vielen teilnehmenden Ärzte an das Verschreiben von Vioxx zu gewöhnen. (Einfach mal die ersten Absätze dieses Dokumentes lesen).
Aus dem Editorial zum Artikel:
"Why would a drug company go to the expense and bother of conducting a trial involving hundreds of practitioners—each recruiting a few patients—when a study based at a few large medical centers could accomplish the same scientific purposes much more efficiently? The main point of the seeding trial is not to get high-quality scientific information: It is to change the prescribing habits of large numbers of physicians. A secondary purpose is to transform physicians into advocates for the sponsor's drug. The company flatters a physician by selecting him because he is "an opinion leader" and incorporates him in the research team with the title of "investigator." Then, it pays him good money: a consulting fee to advise the company on the drug's use and another fee for each patient he enrolls. The physician becomes invested in the drug's future and praises its good features to patients and colleagues. Unwittingly, the physician joins the sponsor's marketing team. Why do companies pursue this expensive tactic? Because it works."
Zugetraut hätte man es gewissen Kreisen schon lange. Jetzt gibt's den ersten schriftlichen Nachweis von Seeding Trials.
The ADVANTAGE Seeding Trial: A Review of Internal Documents (PDF)
Seeding Trials: Just Say “No” (PDF)
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