Leading doctors urged a return to older, tried-and-true treatments for high cholesterol after hearing full results Sunday of a failed trial of Vytorin.A probe? A probe? You must be kidding me. The drug approval process is broken. Companies can hide poor studies and cherry pick the data while hiding behind "trade secrets" while their friends on the approval board rubber stamp the applications.
Millions of Americans already take the drug or one of its components, Zetia. But doctors were stunned to learn that Vytorin failed to improve heart disease even though it worked as intended to reduce three key risk factors.
"People need to turn back to statins," said Yale University cardiologist Dr. Harlan Krumholz, referring to Lipitor, Crestor and other widely used brands. "We know that statins are good drugs. We know that they reduce risks."
The study was closely watched because Zetia and Vytorin have racked up $5 billion in sales despite limited proof of benefit. Two Congressional panels launched probes into why it took drugmakers nearly two years after the study's completion to release results.
The study tested whether Vytorin was better than Zocor alone at limiting plaque buildup in the arteries of 720 people with super high cholesterol because of a gene disorder.Five billion is sales for nothing but an increased rate in dying and fat drug company profits.
The results show the drug had "no result — zilch. In no subgroup, in no segment, was there any added benefit" for reducing plaque, said Dr. John Kastelein, the Dutch scientist who led the study.
Dr. Robert Spiegel, chief medical officer for Schering-Plough, said the study was done "with the highest integrity" and that doctors can believe the results "because of the time we took to make sure the data are right."Right... Like all the rest of the over-marketed, still-under-patent drugs with little, or no benefit. Even worse, in many cases, extremely cheap old drugs are just as good. But they're not sexy. They're not new. They're not subject to heavy marketing programs built on lies. And they're not, because they're a quasi-monopoly due to the patent, extraordinarily profitable.
"We were disappointed that it was not a very balanced panel discussion" by the heart doctors who urged their peers to focus on more established treatments.
Dr. James Stein, director of preventive cardiology at the University of Wisconsin-Madison, said many doctors prescribe Zetia and Vytorin because they seem to be safe ways to get cholesterol down quickly, without annoying side effects like flushing that some other medicines carry.Which is the way it's supposed to be done. And no hidden data. No off-the-record studies. No cherry-picking studies. And most of all, every study to be used should be monitored closely by independent agents within the FDA. There is just too much at risk and the drug companies, over the past few decades have shown us that they're not on our side.
Stein, who has consulted for Schering-Plough, said that after six years on the market, it would have been good to see better results on a drug so many doctors believed would help, "but the reason we do research is so we don't have to rely on our 'beliefs' — we can rely on data."
"While these corporations profited, Americans were left in the dark," Cuomo said in a written statement Sunday. "The millions who take this drug, taxpayers who subsidize its use through the Medicaid and Medicare programs, and Merck and Schering-Plough's investors deserve to know why it took so long for the results to be made public. This new information underscores our concerns and advances our investigation, which we will pursue aggressively."I hope it's more than a band-aid.