There's a debate brewing about when and how companies should release study data--starring none other than Merck and Schering-Plough's Vytorin debacle. Last year, amid scrutiny over the decision to release results from another study 18 months late, Merck and Schering-Plough made the decision to announce results from its now infamous SEAS study ahead of schedule. Data from the SEAS trial showed that not only was the Zocor-Zetia combo med Vytorin not better than Zetia alone in treating heart-valve disease, but the rate of cancer was 50 percent higher in the group given Vytorin than in the placebo group.
Researchers had planned to present the data to peers at the American Heart Association meeting in November and publish the findings in a peer-reviewed journal. Instead, the drugmakers called a press conference in July primarily aimed at shareholders. The premature announcement of the SEAS results and the controversy that resulted prompted the early release of data from two other ongoing Merck/Schering-backed Vytorin studies--SHARP and IMPROVE-IT. Researchers claimed data from the studies showed that cancer risks presented in the SEAS data were likely the result of chance. The principal investigator for one of those studies, Robert M. Califf, MD, now says that, after the SEAS results were released, he and his fellow researchers at the Duke Translational Medicine Institute were forced into announcing results from the two related studies prematurely to reassure their trial participants that Zetia did not promote cancer.
On the dilemma companies face in deciding when and how to release data, Duke researcher Robert Harrington tells HeartWire, "...There is a fine line between releasing qualitative information and quantitative information." Companies may be justified in announcing qualitative findings--negative or positive results--to shareholders, says Harrington, but releasing quantitative data outside of a medical meeting or peer-reviewed journal "nobody feels good about unless there is some public-safety issue."
To avoid history repeating itself, the Duke researchers have outlined a four-point plan that calls for
trial data to be guarded by non-profit institutions charged with acting in the interest of "common good" rather than shareholders;
enhanced requirements for independent data and safety monitoring committees;
all independent steering committees for all clinical trials be chaired by a noted expert in the field of interest and in "practical" trial management;
SEC to institute "special rules" for clinical trial data that would govern the release of "major" trial results to the public and corporate sponsors.