Bad News For Statins

I’ve been working on a software project for the past 13 hours, and I’m too fried to write much of a post.  But a reader brightened my evening by sending me a link to an article in the Los Angeles Times that’s bad news for statin-makers.  When the big newspapers start picking up on this stuff, the pharmaceutical companies have reason to worry.  Here are some quotes and comments:

At the zenith of their profitability, these medications raked in $26.2 billion a year for their manufacturers.  The introduction in recent years of cheaper generic versions may have begun to cut into sales revenues for the brand-name drugs that came first to the market, but better prices have only fueled the medications’ use: In 2009, U.S. patients filled 201.4 million prescriptions for statins, according to IMS Health, which tracks prescription drug trends. That’s nearly double the number of prescriptions written for statins in 2001, four years after they arrived on the American pharmaceutical landscape.

It’s nice to know people can permanently weaken their muscles now without spending too much.  I knew people were popping statins like they’re tic-tacs, but 201 million prescriptions?!  That’s disturbing.  Worse, the statin-makers want doctors to prescribe these poisons to kids. 

But in recent months the drugs’ touted medical reputation has come under tough scrutiny.

Better ten years too late than never.

Statins were initially approved by the Food and Drug Administration for the prevention of repeat heart attacks and strokes in patients with high cholesterol who had already had a heart attack. And used for that purpose – called “secondary prevention” – the drugs are powerful and effective medications, driving down patients’ risk of another heart attack or stroke by lowering their levels of LDL (or “bad”) cholesterol.

AAARRGGHH!!  No, for @#$% sake, lowering cholesterol is just a nasty little side effect.  To the extent that statins do any good, they do it by lowering inflammation.  You can lower inflammation by cutting the garbage out of your diet.

Then physicians came to believe statins could also reduce the risk of a first heart attack in people who have high LDL cholesterol but are nonetheless healthy. This use of statins – called “primary prevention” – has driven the growth in the market for statins over the last decade.

It’s amazing what you can believe when a hot little pharmaceutical rep in a tight skirt gives you a sales pitch.  When we’re giving drugs to people who are “nonetheless healthy,” something is very, very wrong.

Today, a majority of people who use statins are doing so for primary prevention of heart attacks and strokes. It is this use of statins that has come under recent attack.

“There’s a conspiracy of false hope,” says Harvard Medical School’s Dr. John Abramson, who has cowritten several critiques of statins’ rise, including one published in June in the Archives of Internal Medicine. “The public wants an easy way to prevent heart disease, doctors want to reduce their patients’ risk of heart disease and drug companies want to maximize the number of people taking their pills to boost their sales and profits.”

False hope?  But Dr. Abramson, those Lipitor commercials are so convincing.  Every time I see the one where the guy is pleading with his older brother to take statins, it brings a tear to my eye.  (If I ever told my older brother to take statins, it would be to weaken him to the point that I could finally beat him in arm-wrestling.  But I don’t want to win that badly.)

Heart patients and their physicians are not the only ones to pin their hopes on statins. The drug companies that brought statins to the market have explored the medications’ benefits in prevention or treatment of such conditions as Alzheimer’s disease, rheumatoid arthritis, prostate and breast cancer, kidney disease, macular degeneration and diabetic neuropathy. Although clear proof that statins could forestall or treat any of these diseases might bring in millions of new, paying customers, results have largely been mixed, inconclusive or disappointing.

Well, I am just stunned that beating down your liver’s ability to produce cholesterol hasn’t turned out to be a cure for damned near everything.  Perhaps we need to start removing livers completely.  Tonsils at age 5, then livers a year or so later.  We’ll lie to kids and tell them they can rub all the ice cream they want on their bellies afterwards.

In an ideal world, debate over the clinical virtues or vices of a drug would be long settled by the time the medication saw a meteoric rise in use. But in a healthcare system that relies on commercial incentives to spur drug development, prescription medications are a product like any other.

Yeah, that’s bound to be a problem with our current system of direct-to-consumer sales by pharmaceutical companies.  If only we could place some kind of responsible intermediary between them … perhaps someone in a white coat.

Sometimes, by the time the deliberate pace of medical research and debate suggests that a drug is not all it’s been cracked up to be, it’s already become a bestseller.

That’s why I refer to Dane Cook as the Lipitor of comedy.

And yet, the relationship between cholesterol-lowering and heart disease is not perfectly understood.

Well, there’s an explanation for that.  I’ll use an analogy to clarify:  You could spend dozens of years and millions of dollars trying to understand the relationship between me and Salma Hayek and not get anywhere.  The reason?  We don’t have a relationship … other than the one time we passed each other in a hallway at Disney.

In the first of three studies published in the Archives last month, medical researchers found that, contrary to widely held belief, statins do not drive down death rates among those who take them to prevent a first heart attack.

And yet they lower cholesterol rather dramatically.  Hey, I’m starting to wonder if high cholesterol causes heart disease at all …

A second article cast significant doubt on the influential findings of a 2006 study, called JUPITER, that has driven the expansion of statins’ use by healthy people with elevated blood levels of C-reactive protein, a measure of inflammation. A third article suggested potential ethical, clinical and financial conflicts of interest at work in the execution of the JUPITER study and concluded the widely hailed trial was “flawed” and raises “troubling questions concerning the role of commercial sponsors.”

I’ve read critiques of JUPITER written by skeptical doctors who crunched the data.  Bottom line is that it’s one of worst studies ever.  Here’s just one example:  At one point, the statin-takers showed slightly better results.  Later, the difference between statin-takers and placebo-takers began to shrink to nothing.  So the researchers conveniently chose to place the study’s “end point” at a time when there was still a difference.  Those are the numbers they reported.

As many as three-quarters of patients currently taking statins haven’t yet had a stroke or heart attack; they have diabetes or high LDL cholesterol, conditions widely thought to put them at high risk of having one.

Those patients largely joined the ranks of statin consumers after 2001, when the National Heart, Blood and Lung Institute adopted guidelines on the treatment of patients with high cholesterol. The guidelines, updated again in 2004, suggested that as many as 36 million Americans should take statins – essentially tripling overnight the potential American market for the drugs. Of the nine experts involved in drafting the cholesterol treatment guidelines, the National Institutes of Health later acknowledged that eight had substantial financial ties to statin makers – links that may have predisposed them to view evidence of statins’ benefit in its most positive light.

I think that last sentence pretty much says it all.