One week after the slightly premature release of ARBITER 6, the most important clinical trial in the history of medicine a small surrogate endpoint trial, the medical experts, Wall Street analysts, and the media have declared that nothing really changed because of the trial.
ARBITER 6: Not too bad for ezetimbe
After weeks of nervous anticipation on Wall Street, Merck shares never took a hit and moved up throughout the week. Bernstein analyst Timothy Anderson said that Merck is “out of the woods” on the matter. Even some of the strongest critics of ezetimibe took a “toned-down approach,” in his opinion. Of course, that may have been a result of near universal agreement that the trial was deeply flawed, making any firm conclusions difficult to reach.
Ezetimibe’s real value may not be known for a long time. As we wrote one week ago:
Kastelein and Bots raise the question whether we will ever find out the truth about ezetimibe: In their editorial they write that “the large number of hard clinical end points (>5000) required to achieve sufficient statistical power in IMPROVE-IT makes it uncertain whether the trial will ever reach completion.” CardioBrief received the following response to this statement from IMPROVE-IT PI Robert Harrington: “IMPROVE IT is moving along nicely. Patients being enrolled and events accruing. Trial leadership continues to evaluate trial assumptions based on accumulating aggregated data. DSMB continues to review safety. Not much more to report other than trials studying chronic diseases take time.”
A story by Matt Herper on Forbes.com provides a nice discussion of this problem. He quotes Elliott Antman, who observes that bad publicity could cause patients to withdraw from the study or not enroll in it: ”If we never get an answer, we will all regret that,” Antman is quoted as saying in the article. Herper also quotes Rory Collins, who points out the possibility that even with 18,000 patients there is still a real possibility the trial could return a false negative result.
CIMT as a surrogate endpoint comes in for close scrutiny in a MedPage Today story by Peggy Peck. She quotes Anthony DeMaria: ”The best endpoints are living long and living happy.”
ARBITER 6: how good for niacin?
In a story in the Wall Street Journal, Ron Winslow wrote: “Bring out the niacin.” And undoubtedly many more physicians and patients will be willing to give niacin a try, but niacin’s tolerability remains a troublesome obstacle.
Another obstacle for niacin is Abbott, which for now controls the long-acting niacin franchise. Abbott is unlikely to heavily promote the trial’s results, writes Peter Loftus in a Down Jones news story. Although Abbott funded ARBITER 6, it can’t unleash its sales force to push the trial because Niaspan when taken with statins doesn’t have an FDA indication for atherosclerosis regression.
Finally, in his blog, CNBC reporter Mike Huckman continues his crusade to get ARBITER 6 PI Allen Taylor to fully disclose how much money he has received from Abbott. He quotes a spokesperson from Taylor’s Washington Hospital Center:
“Allen Taylor, MD, has disclosed all lecture fees received from Abbott while employed at Washington Hospital Center. Dr. Taylor has consistently disclosed this information and has fully complied with the Hospital Center’s conflict of interest policy. The fees collected in the 2009 calendar year have been donated to two established medical-related scholarship funds.”
Huckman, however, isn’t happy with this vague disclosure, and asks whether Taylor’s donation occurred recently.
Editorial note: On his blog Huckman took issue with my negative characterization of his hostile questioning of Taylor at the ARBITER 6 news conference in Orlando. Let me clarify my position. First of all, I think every reporter has the right, and often the obligation, to ask about conflicts of interest. And in general I strongly support open disclosure and transparency, especially when important public health issues are involved.
But let’s be clear: Huckman prefaced his press conference question by stating that he had already asked Taylor to fully disclose his financial conflicts in a previous interview, at which time Taylor had refused to comment beyond stating that he had received more than $10,000 from Abbott. So Huckman’s purpose in asking the question wasn’t to gain new information– he knew what Taylor was going to say– but to embarrass and humiliate Taylor and to congratulate himself on his own self-righteousness.
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