The New Therapeutics: 10 Commandments

I like how the veteran health journalist Andrew Holtz once explained the interesting concept of surrogate or intermediate endpoints for us dull-witted patients. He cites, for example, studies on patients with diabetes that included aggressive control of blood sugar, high blood pressure and cholesterol in people considered to be at very high risk for heart attacks.  But oddly enough, this research showed that:

  • strict management of blood sugar did not reduce heart attack deaths
  • reduction in high blood pressure levels did not reduce heart attack deaths
  • controlling high LDL cholesterol numbers with the use of statin drugs did not reduce heart attack deaths

Holtz explains that lab results may not actually be accurate predictors of mortality – they are merely intermediate or surrogate endpoints along the way.

And just because a drug improves lab test results doesn’t mean it saves lives – despite the efforts of Big Pharma to convince drug prescribers otherwise.  Continue reading

Zetia & Vytorin: how Merck got patients to spend $21 billion on drugs that don’t work

How did drug giants Merck and Schering-Plough persuade patients to spend $21 billion on a cholesterol drug that doesn’t prevent heart attacks? According to a December 14th report in Forbes, the cholesterol-lowering drug Zetia works by a little-understood mode of action, and no research has shown that it prevents heart attacks at all. Physicians have been brutal in their assessment. Zetia’s rise “was the miracle of marketing, not the miracle of medicine,” says cardiologist Dr. Sanjay Kaul of Cedars-Sinai Medical Center. Cleveland Clinic cardiologist Dr. Steven Nissen adds:

“We’ve spent billions on a drug that may turn out to be a placebo.”

Yet Merck’s clever marketers have spun straw into gold. Over the last seven years, they have convinced doctors to prescribe $21 billion worth of Zetia and its sister drug, Vytorin, which combines Zetia with Merck’s old cholesterol drug Zocor. In fact, the drugs are on track to do $4 billion in combined sales this year, despite multiple studies suggesting they fail to prevent clogged arteries. Thanks to an agressive $200 million ad campaign, American sales of Zetia and Vytorin represent 16% of all cholesterol-lowering drug sales, but only a 3% share in Canada, where direct-to-consumer (“Ask your doctor”) advertising is banned.   Continue reading