Congress, heart doctors weigh in on Vytorin
In Washington, the saying goes, it's not the crime but the cover-up that gets you.
Merck/Schering-Plough's Vytorin debacle isn't Watergate. It's not even on par with some of the recent safety scandals still sending ripples through the industry and its watchdogs in Washington —its harshest critics accuse the joint venture of bilking patients and payors, not of endangering public health. But in delaying the public unveiling of the trial results and doing a switcheroo on the primary endpoint before switching it back, the companies invited unwanted attention from congressional investigators and a pummeling in the press.
There was good news and bad news for Merck/Schering-Plough following their release of the data, which found no advantage for Vytorin over simvastatin in retarding the progress of atherosclerosis. On the upside, analysts shrugged and two prominent organizations came to the drug's defense. On the downside, congressional watchdogs saw an opening for an investigation.
Within 24 hours of the mid-January release of the data, the American Heart Association and the American College of Cardiology each released statements downplaying the study results— the ACC release bearing the subhead “Don't panic and talk with your physician.” The ACC said that while deserving of follow-up, the Enhance study “is an imaging study and not a clinical outcome study,” and advised that major clinical decisions not be made on that basis alone. Furthermore, the group recommended “that Zetia remain a reasonable option for patients who are currently on a high dose statin but have not reached their lipid goals.”
Similarly, the AHA advised that “the study was not large enough or long enough to determine whether the combination drug is more or less effective than [simvastatin alone] in reducing heart attacks or deaths.”
The groups' wait-and-see stances contrasted sharply with remarks by Cleveland Clinic's Dr. Steven Nissen, who made the rounds of news media advising that Zetia and Vytorin both be relegated to last-resort status.
Reps. John Dingell and Bart Stupak (both D-MI) promptly sent a letter to Merck and Schering-Plough advising them that their Committee on Energy and Commerce and Subcommittee on Oversight and Investigations would be looking into the “withholding of clinical trial data that may significantly affect the medical management of hypercholesterolemia, as well as the use of misleading statements in direct-to-consumer advertisements for prescription medicines.”
Reps. Dingell and Stupak vowed to examine “the apparent manipulation of the study's endpoints” and the joint venture's exclusion of primary investigator Dr. John Kastelein from an outside advisory panel they convened. They also signaled a focus on Vytorin advertising, demanding records related to Vytorin ads and asserting that “given the frequency of Vytorin advertisements, it concerns us that a study showing that Vytorin provides no increased benefit was not issued for nearly two years while direct-to-consumer advertisements were carried on the airwaves. This situation raises concerns that the drug companies and their advertisement agencies profited at the significant expense of patients' health.”
Analysts were generally sanguine about the prospects for the franchise. In a note to investors on Schering-Plough, Standard & Poor's noted that the data reaffirmed an LDL-lowering advantage for Vytorin and added: “We think more promising results are likely from larger outcomes studies involving 20,000 patients to be released in March.”