Amazing. University of Minnesota researchers have created a brand-new rat heart using baby rat cells. It’s almost impossible to believe, and more than a little creepy to boot.
In other hard-to-believe news: Schering-Plough spokesman Lee Davies’ contends that his company learned only two weeks ago of Vytorin’s dismal performance in a clinical trial that concluded more than two years ago.
On Monday, Schering-Plough and Merck (which market Vytorin jointly) released some of the results of that trial, after months of delay, and the public learned what many had feared — that Vytorin, which some 5 million people worldwide use to lower their cholesterol and reduce their risk of heart attack and stroke, isn’t doing the job any better than older, cheaper drugs.
The results showed that patients using Vytorin (a combo pill containing statin drug Zocor and the newer non-statin Zetia) did have lower cholesterol than patients only using Zocor. But that decrease didn’t translate into a reduction in the fatty plaque deposits that form on arterial walls and that cause heart attacks and strokes. In fact, trial participants taking Vytorin experienced an increase in plaque deposits, though the sample size in the study was too small to draw definitive conclusions from that. Noted cardiologist Steve Nissen described the news as “shocking” and called for a moratorium on Vytorin’s use.
Judging from the announcement’s effect on Schering-Plough‘s share price, I can certainly understand why the companies might want to keep such unpleasant news under wraps. (The news also hurts Merck, of course, but Schering-Plough is more dependent on Vytorin profits.) But considering the industry’s purported efforts over the past few years to be more transparent about clinical data, this latest indication of withholding is especially dispiriting. And Schering-Plough‘s explanation that it was innocently analyzing the data all this time without any inkling that the results would be bad — well, it strains credulity, to say the least.
Merck and Schering-Plough were scheduled to release the results early in 2007. But several delays followed, the excuse being the complexity of the data under analysis. More controversy erupted when the companies changed the “primary endpoint” for the study — the clinical equivalent of moving the goalposts. Then the press got involved and a Congressional committee started knocking on the door, and voilà! A month later, the trial results have come out.
Press scrutiny and Congressional oversight eventually got the job done in this case, but they can’t work every time. This past fall, Congress passed, and President Bush signed, a law that imposes more stringent disclosure requirements on pharmaceutical companies, and one hopes it will have a more salutary effect than the industry’s self-imposed “standards.”
Now if we could just get those University of Minnesota scientists to work making new hearts for Big Pharma executives.
I know that more government oversight isn’t the answer to everything, but I’m wondering if it might be good to require drug companies to periodically file the results of drug studies just as public companies are required to file financial information. A requirement like that might prevent unpleasant surprises a la Vytorin.