Trouble with Statins

In 1987, the first of a new class of powerful cholesterol-inhibiting drugs collectively known as statins was introduced to the market.  By 2005, more than ten percent of the American public had been prescribed some version of the drug, and with sales pushing $20 billion annually, statins had become by far the biggest-selling pharmaceuticals of all time. 

The drug industry has consistently touted the safety and benefits of the drug, and pushed steadily to have what was originally conceived to be for the use only of those at high risk of heart disease approved by the FDA as a general preventative.  There was even talk not too long ago of adding it to the water supply, like fluoride.

But problems with statins have surfaced. It was known from early studies that statins could cause muscle aches and weakness, and in rare instances a severe muscle wasting disease known as rhabdomyolysis—which could be fatal.   But then, in 2001, the statin drug cerivastatin was withdrawn from the market by Bayer A.G. when some 52 fatal cases of rhabdomyolysis were reported resulting from its use.  Other  problems that weren’t noticed in the early clinical trials also were increasingly being reported in the real world, including memory loss, cognitive problems, neuropathy, and pancreatic, liver, and sexual dysfunction.  Then last year the FDA forced manufacturers to label the drugs as increasing risk of diabetes...one of the indicators for its use.

But prescribing statins is now standard treatment for elevated levels of LDL—the so-called “bad cholesterol,” and doctors who fail to follow the guidelines by prescribing it are liable for malpractice suits.  With the powerful pharmaceutical industry watching out for its commercial interests, doctors have been reluctant to express  worries they may have about the steady expansion in use of what some are starting to consider a dangerous drug. 

But some have started to speak out.  One of those is Dr. Barbara H. Roberts, director of the Women’s Cardiac Center at Miriam Hospital in Rhode Island, whose book The Truth About Statins: Risks and Alternatives to Cholesterol-Lowering Drugs was published last year by Pocket Books. 

In the introduction to her book, Dr. Roberts wrote that “In exposing the shoddy science that underlies many of the guidelines that doctors are told they must follow in treating their patients, and in exposing the rampant conflicts of interest among the FDA, Big Pharma, medical scientists, medical centers, and professional medical organizations, I risk being declared a pariah in the medical community.” 

In a phone interview, I asked Dr. Roberts why she decided to take that risk:

The Trouble with Statins

24 minutes