The fall-out from the Vytorin data published by Merck & Co and Schering-Plough has again hurt the share price of the two firms but the cholesterol drug has received support from the American College of Cardiology.
S-P’s stock fell back again, this time down 6.8% to $23.78, while Merck slipped 2.7% to $58.18 as data from the ENHANCE trial did not show that Vytorin (10mg ezetimibe + 80mg simvastatin) is any more effective than simvastatin on its own in affecting the rate of atherosclerosis progression. Given the difference in price between Vytorin and simvastatin, a number of observers have said that there is no good reason to prescribe the Merck/S-P drug.
However the ACC is taking a more measured approach. It issued a statement saying that “major clinical decisions not be made on the basis of the ENHANCE study alone”, as it deserves “serious thought and follow-up”. The overall incidence rates of cardiac events were nearly identical between both treatment groups and both were generally well tolerated, it says, so “there should no be reason for patients to panic”.
The ACC noted that patients should never stop taking any prescribed medications without first discussing the issue with their doctors and further research will be needed to provide conclusive evidence “about which lipid-lowering strategy is preferred”, ie statin alone or statin plus Zetia (ezetimibe). It adds that the ENHANCE trial “is an imaging study and not a clinical-outcome study” and conclusions should not be made until three large clinical-outcome trials are presented within the next two to three years.
The ACC ends by recommending that Zetia “remain a reasonable option for patients who are currently on a high dose statin but have not reached their goal”. However, other organisations feel more needs to be done.
Sidney Wolfe, director of Health Research Group at influential consumer body Public Citizen, said that “we first warned against using Vytorin in December 2004” and suggested people should wait at least seven years before taking the treatment as it was not a ‘breakthrough’ drug. He noted that the US Food and Drug Administration’s own pharmacology reviewer recommended against approval of Vytorin and the ENHANCE trial “adds to our concerns”.
Dr Wolfe said it is disturbing that the companies completed the trial in April 2006 “but found excuse after excuse” not to release the unfavourable results. “Unfortunately, we are not surprised,” he continued, as “there’s a $20 billion market for cholesterol-lowering drugs and companies will do whatever it takes to get as much of that market as they can, even if it means letting people continue to take prescription drugs that they know are not beneficial and that even may be harmful”.
Negative findings buried in FDA files
He said that “we wish we could say this is an isolated case but there are too many other examples of negative findings being buried in the FDA’s files”. This year, the pharma industry gave $400 million to the drug division of the FDA, which funds most of the salaries of those scientists who review therapies, he noted, adding that “you would have to be living on a cloud to think that the money doesn’t have an impact on the FDA’s drug approvals or regulation of the industry”.
Dr Wolfe concluded by saying that “at the very least, what we learned today is that people who have been taking Vytorin should talk with their doctors and find a better medication”.
