Bad News Day for Big Pharma

Big news, all bad, for Big Pharma today.

The Supreme Court this morning turned down the Abigail Alliance's claim that dying patients have a constitutional right to investigational drugs. The ruling upholds a core regulatory authority of the Food and Drug Administration, which, if undermined, would have opened the floodgates to reimbursed quackery.

Also, Merck and Schering-Plough released the data from the long-delayed Vytorin trial (the pill combines a drug from an unproven class of cholesterol lowering agents with a generic statin) that showed the pricey combo pill was no better than the generic alone. The companies have been under fire for delaying the results of the ENHANCE trial and changing its endpoints midstream.

The House Energy and Commerce Committee, chaired by Rep. John Dingell (D-MI) vowed to pursue its investigation into the companies' management of the trial. “Heart disease is a serious and growing national problem. American consumers and their doctors should not have had to wait nearly two years for this information. Why did Merck and Schering-Plough go to great lengths to delay the study results? Why did they attempt to manipulate the data?," Dingell said. "We will continue our investigation until these questions are answered.”

Yes, heart disease is a serious problem, and perhaps it's time for Congress to investigate just how much benefit the population at risk is getting from the $20 billion a year that is spent on statin drugs to lower cholesterol, which is, after all, only a surrogate marker for the disease. In an elegantly brief commentary in last week's British Medical Journal, a Scottish physician named Des Spence reviewed the seminal 1995 study of his fellow countrymen that led to widespread use of the drugs:

Whether it’s worth treating high cholesterol is a common enough question. No one who sees the charts and listens to the sales pitch would doubt it—but numbers are open to being spun. Let’s consider the trial known as WOSCOPS—the west of Scotland coronary prevention study (New England Journal of Medicine 1995;333:1301-8). It wasn’t by chance that the west of Scotland was chosen. The participants were men aged between 45 and 64 in the most socially deprived area in western Europe. More than three quarters (78%) were current or former smokers, and their average cholesterol concentration was 7 mmol/l. If lowering of cholesterol concentration was going to work anywhere it was going to work here. The study ran for five years, and the researchers reported a 32% reduction in cardiovascular mortality in the group of men who took statins. (Similar reductions were seen in all vascular events, but death is the irrefutable end point whose delay is most of interest to patients.) Other studies have replicated similar results, and so the pandemic of "cholesterol" swept the world.

But the numbers can be presented in another way. Converting the 32% relative risk reduction into an absolute reduction gives a derisory 0.7% reduction in cardiovascular mortality and a number needed to treat of 143 over the study period. Although it may be cheating, this figure can be annualised to give 715 to prevent one vascular death. So, putting it crudely, some 714 patients a year gain no benefit from treatment, even in the highest risk population in the world.

You can look at that number another way. If a prescription for Vytorin or Lipitor (the world's best-selling statin) costs $85 a month, that's $1,000 a year. So the cost of saving one life via anti-cholesterol drug therapy is $714,000. Or, if it were your money (and not the insurance company's), you'd be paying $1,000 for a one in 714 chance of avoiding a heart attack. Worth it?