First-Person: Vytorin ENHANCE Study and its Implications

The ENHANCE trial for the cholesterol lowering drug Vytorin was completed in 2006, yet the release of the results was delayed by nearly one and a half years, with the results only being shown to the medical establishment and the public yesterday, January 14, 2008. Why the delay? The heart disease moderator at About.Com believes that it is possible that the delay gave the manufacturer time to manipulate the study results to make them appear more positive.

Vytorin is a combination of two expensive and high selling drugs made by Merck/Schering Plough, a large pharmaceuticals company, these drugs being Zetia and Zocor. Significantly, Zocor's patent protection ended in 2006, just around the time the new combination drug Vytorin hit the market. Pharmaceutical makers are well known for repackaging no longer patented drugs in an attempt to continue to make large sums of money from them.

The study is disturbing, in that the results showed that while Vytorin does significantly lower LDL (or BAD) cholesterol, it appears that patients taking the drug had more heart attacks and other problems related to high cholesterol, and that the patients in the study also had MORE plaque in their arteries after the study was concluded than at its onset. In fact, one doctor states unequivocally that Vytorin should be used only as a therapy of last resort when nothing else appears to be working. These results are frightening to those of us taking Vytorin.

Forbes.Com states that perhaps it is time for the outside researchers doing these drug studies to have the control over the databases created for the analysis of study results. I could not agree more, as this will help to prevent the future manipulation and delay of data reaching the health consumers whose very lives depend on the medications being studied.

I have been taking Vytorin for approximately one year now. Up until these test results were released, I considered it to be a miracle drug, as shortly after I began Vytorin therapy my LDL cholesterol lowered significantly, right into the "normal" ranges, albeit at the high end of that. Now that I have read the results of this study, I find myself wondering what my arteries are looking like, and imagining that I can hear them hardening with every bite of food and every dose of Vytorin that I take. I wonder if I would be safer taking no medications whatsoever rather than taking drugs that turn out to be not only potentially useless, but potentially life threatening as well.

Having in the past found that many of the over fifteen medications that I need to take on a daily basis in order to sustain my life have wound up showing that not only are they not all that beneficial, but in many cases dangerous (Phen-fen among others), I find that this study is the final straw for me and that I will no longer accept any medication that has not had a very long and positive track record of at least ten years on the market. It seems to me that the pharmaceutical companies are using the people who rely on their medicines as guinea pigs, and I for one am unwilling to participate in this any longer. I value my life too much, and it is my hope that other patients out there feel the same way.

Big Pharmaceutical needs to stop taking gambles with the lives of those of us who need medication in order to live a long, healthy, and fulfilling life. It is not acceptable for these huge corporations to be getting rich off of selling what, in the final outcome, is just more snake oil. More intensive regulation of these companies, their studies, and their medicines are called for.

It is time for the FDA to do stop dillydallying and do something about the companies that are using the American people as guinea pigs without their consent.

Sources:

Richard N. Forogos, MD - The Vytorin Study Controversy - Now Congress is Getting Into the Act - About.Com
Matthew Herper - The Vytorin Question - Forbes.Com
Matthew Herper - Vytorin Study Shows No Benefit - Forbes.Com
Matthew Arnold - Vytorin Study's A Stinker - Medical Marketing & Media