Statins Go Prophylactic
In a recession, companies often look for new ways to sell existing products and new customers to sell them to. Recently, the makers of the cholesterol medication Crestor succeeded in that very thing. With a flick of the FDA pen, AstraZeneca received permission to sell its product to a potential new market of 6.5 million people, none of whom actually have cholesterol or heart problems. (You read that correctly -- no problems, no symptoms!) That's because the company got the FDA to agree that Crestor, a statin drug, could be sold as a preventative measure.
Surely the community of pharmaceutical manufacturers is greeting this news with a hearty chorus of "ka-chings." Statins are a top selling class of drugs in the U.S. 2009 sales for Crestor alone were $14 billion and each pill (a day's dose) costs at least $3.50. So adding 6.5 million potential customers is no small thing -- totaling over $8 billion a year in new sales, again for people who have no symptoms or problems.
I've written numerous times on the questionable usefulness of statins. They've been associated with serious side effects and their benefit, especially in patients who don't have heart disease, is negligible to nil. But the new wrinkle in this story is the use of the statin as a preventative measure. How was the FDA able to justify its new classification of the drug? Based on a study paid for by, you guessed it, AstraZeneka.
A Dr. Paul M. Ridker, Professor of Medicine at Harvard and cardiologist at Brigham and Women's Hospital in Boston, convinced AstraZeneca to pay for a clinical trial based on a test he developed called CRP, or the "high-sensitivity C-reactive protein test." The test measures the level of inflammation in the body by tracing the levels of a protein produced by the liver. Apparently, the amount of this protein found in the body rises with inflammation.
Dr. Ridker had long theorized that systemic inflammation is a better indicator of potential heart disease than cholesterol level is. His theory makes good sense, given that inflamed arteries and organs can't perform well and so exert extra stress on the heart. But if inflammation causes or even indicates potential for cardiac degeneration, as Dr. Ridker contends, doesn't it make sense to reduce inflammation rather than to reduce cholesterol? Otherwise, it's like diagnosing a vitamin D deficiency and then treating the patient's foot.
Anyway, after securing the financial support from the drug company, Dr. Ridker then led the trial, which followed 18,000 people around the world who had low cholesterol and an elevated level of CRP. According to Dr. Ridker, the use of Crestor as a preventative was so effective that, "We found a 55 percent reduction in heart attacks, 48 percent reduction in stroke, 45 percent reduction in angioplasty bypass surgery." Pretty heady claims. But a closer look at the data raises questions.
First of all, the sample population was so healthy to begin with that its risk of heart disease was extremely low. Then there's the fact that the numbers may not have clinical significance. For example, of the people in the study who took sugar pills, a mere .37 percent, or 68 patients, had heart attacks. (Note the decimal point. That number was just one-third of a percent.) Among those who took Crestor, we're talking about .17 percent, or 31 patients who had heart attacks. At first glance, that might look significant, but in reality, the results show that 500 people would need to be treated with Crestor for a year to avoid one minor heart attack -- hardly a staggering result. And hardly worth $8 billion. And hardly worth all the potential side effects.
Add to the mix the fact that recently the British medical journal, The Lancet, published a study linking the use of statins to increased risk for diabetes. The research reviewed 13 previous studies on statins involving 91,140 subjects and found that statins raised the incidence of type 2 diabetes by nine percent. Nevertheless, the article announcing the risk had an accompanying editorial authored by Dr. Christopher P. Cannon of Harvard Medical School (the same place that Dr. Ridker hails from), who said that, "The benefit in preventing total vascular events to the risk of diabetes is a ratio of about 9:1 in favour of the cardiovascular benefit -- the benefit seems to greatly outweigh the risk. Whilst a new risk of statins has been identified, the risk seems small and far outweighed by the benefits of this life-saving class of drugs."
One might almost wonder if they get any medical news at Harvard University, given reliable studies that show that statins do indeed do more harm than good. I wrote previously about research that found that for every 100 people, three who don't take statins will have heart attacks; whereas two who do take them will have heart attacks anyway. In other words, statins prevent only one heart attack per 100 users. A parallel study found no statistically significant health benefit whatsoever in those without preexisting heart disease.
The FDA wants to handle the news about diabetes risk by slapping a warning label on the bottle and still selling the pills as preventatives. That's going to be one long warning label if it tells the whole truth: that statins may up the risk for cancer by up to 50 percent, cause structural damage to muscles, as well as severe neuromuscular degeneration similar to multiple sclerosis, not to mention the newly revealed risk of diabetes. Statins also may contribute to memory loss, trouble talking, nerve damage, nausea, trouble swallowing, and vertigo.
Throughout this blog, I've kept repeating that it's not worth $8 billion. Silly me! Of course it's not worth $8 billion…to you or me. But to the drug companies and their friends in the FDA, it certainly is.