“Cholesterol drugs are the largest drug category worldwide, with annual sales of $40 billion.” 1 It’s not surprising that as concerned consumers have swamped doctors’ offices about Vytorin, that the American College of Cardiologists and the American Heart Association have issued statements downplaying the Enhace study results. “Doctors generally believe that the amount by which cholesterol is lowered, not the method of lowering it, is what matters.”1 This explains why many doctors are still advocating Vytorin, a combination of Zetia and Zocor. Many doctors are still advocating Vytorin and Zetia for patients who can’t tolerate statins. (Zetia reduces LDL cholesterol by blocking its absorption in the gut; statins block LDL absorption in the liver.)
Big pharma convinced the FDA to focus on the cholesterol numbers game as well. “So far, proof that a drug lowers LDL cholesterol has generally been enough to lead to approval.”1 “Several major health insurers said they have no plans to reduce their coverage based on the study, in part because it didn’t raise significant safety concerns.”2
Focusing on lowering cholesterol numbers alone is like not seeing the forest for the trees. As The New York Times article points out, “Despite widespread use of the drugs, though, heart disease remains the biggest killer in the United States and other industrialized nations.”1 How many studies have to be released that despite big pharma’s manipulations, still reflect badly on their drugs?
“For the second time in just over a year, a clinical trial found that LDL reduction did not translate into measurable medical benefits.”1 Consider*:
- Pfizer (PFE) stopped development on its HDL (“good cholesterol”) increasing drug torcetrapib in December 2006 as it caused heart attacks and strokes! However, it did raise HDL and lower LDL cholesterol.
- The Vytorin Enhance “study released Monday involved 720 patients. It found that Vytorin failed to slow the growth of carotid artery plaques any more than Zocor, also sold as (generic) simvastatin."3 However, Vytorin study participants did have lower LDL than those who took Zocor alone. Another trial involving Vytorin (Improve-It), being conducted by doctors at Harvard and Duke Universities, won’t be released until 2011.
- AstraZenica (AZN) is naming their Crestor drug studies after planets. It’s Crestor vs. PFE’s Lipitor in the Saturn study. The Jupiter trial will see if Crestor can “prevent heart attacks and deaths in people at low risk of dying of heart disease.”3 In an earlier trial released in November, “researchers found no statistical difference between Crestor and a placebo”3 at preventing “heart attacks and other life-threatening events in patients with coronary artery disease and heart failure.”3
With the FDA, doctors, insurance companies, and obviously Wall Street on their side, perhaps Goldman Sachs (GS) analyst James Kelly declaring the Enhance study a “nonevent” is correct. However, looking at the chart for the date Vytorin was approved does not bear this out. I don’t know how much these studies look at the drug’s effectiveness by gender, but the chart shows that women would be more adversely affected taking Vytorin than men. More negative information and/or investigation may surface on Vytorin in February and March which will probably culminate in October/November 2008.
*The origins of the word consider mean “to go with the stars”. (On the other hand, disaster means to “go against the stars”.)
Vytorin was approved by the FDA on July 23, 2004 according to the FDA’s website.
1. New York Times: “Cholesterol as a Danger Has Skeptics”
3. USA Today:“Drug trials under pressure”
Wall Street Journal: “Cutting Through the Confusion Over Vytorin”
2. Wall Street Journal: “Study Missteps Threaten Turnaround at Schering”
Wall Street Journal: “Antidepressants Under Scrutiny Over Efficacy”
American College of Cardiology: Statement on ENHANCE Trial
American Heart Association: Statement on Enhance study results