YOU Choose how many patients need treating before one life maybe saved?
Alison Duff has an article on line raising again the issue of Statins for healthy people, and just why many doctors disagree with the FDA and AstraZeneca on this very thing.
The article is well written and refers back to the original NYT article, by Duff Wilson. Credit where credit is due, both articles are worth reading (links at end of Blog).
It always seems to make big headlines when a company says it can save up to 50% more lives by taking their particular drug. Now no one dare call them fibbers, but you could talk about stretching the truth. Or better still ponder on the phrase, lies, damn lies and statistics!
“I don’t understand the antipathy out there,” said Dr. Steven E. Nissen, chairman of cardiology at the Cleveland Clinic, who has consulted for AstraZeneca among many other companies but says he donates the money to charity. “If somebody comes into my office and meets the criteria, am I going to deny them a drug that reduces their chance of a heart attack or stroke by 40 or 50 percent?”
It’s this kind of comment that will have patients pleading with their doctors to prescribe these pills. However when you get down to the nitty-gritty of the numbers, there turns out another way of telling the story.
In Duff Wilson’s article he highlighted the difference between relative risk and absolute risk.
Relative risk is the statistical difference in outcome between a control group and a group taking an active drug in a study, whereas absolute risk is the actual number of people who might actually benefit from the drug.
Most randomized clinical trials only report relative risk, which often inflates the benefits of the drug being studied.
In Plain Speak what does all this mean?
The rate of heart attacks, for example, was 0.37 percent, or 68 patients out of 8,901 who took a sugar pill. Among the Crestor patients it was 0.17 percent, or 31 patients. That 55 percent relative difference between the two groups translates to only 0.2 percentage points in absolute terms – or 2 people out of 1,000.
Even clearer context:
Stated another way, 500 people would need to be treated with Crestor for a year to avoid one usually survivable heart attack.
“That’s statistically significant but not clinically significant,” said Dr. Steven W. Seiden, a cardiologist in Rockville Centre, N.Y., who is one of many practicing cardiologists closely following the issue.
But critics said the claim of cutting heart disease risk in half — repeated in news reports nationwide — may have misled some doctors and consumers because the patients were so healthy (in the trial) that they had little risk to begin with.
The JUPITER Trial – which is hailed as being the best trial ever for proving that taking Statins as a preventative will work to in preventing heart attack or stroke, was stopped early? Ever wondered why this might be so? Justin Smith has this to say:
One of the many interesting aspects of the JUPITER trial is that it was stopped early. It was stopped after just 1.9 years.
I have always suspected that this trial was stopped early because if it was allowed to continue even the miniscule 0.55 percent benefit would disappear.
A few days ago, a study was published in the Journal of the American Medical Association (JAMA), that looked at the effects of stopping trials early. This study found that trials stopped early almost always show much better results for the drug being tested than if the trial was allowed to run its full duration.
In fact, the JAMA study showed that any drug benefits may be doubled by stopping the trial early. This means that the 0.55 percent reduction in deaths found in the JUPITER trial would have almost completely disappeared if the trial was allowed to run its full course.
The statin used in the JUPITER trial caused more people to develop diabetes, and all statins cause a long list of other adverse effects (some of which result in permanent damage). Knowing this, was it wise for the FDA to approve the wider use of statins based on the results of the JUPITER trial?
Sadly Justin, you will find comments such as: Statins benefits outweigh potential risks, which I find rather peculiar, especially when talking about Diabetes and serious Gastro Intestinal Disorders. I seem to remember the Diabetes is on the rise – catch phrase, and yet the FDA seems to think it’s perfectly OK to possibly cause more cases by virtue of prescribing Crestor to healthy individuals.
Treating healthy individuals will mean, they have to be tested for a blood marker known as CRP, which indicates if you have inflammation. It should be remembered of course, that if you have an in growing toe-nail, or a dose of sinusitis, or are suffering from a bladder irritation, you will also have elevated markers for inflammation.
Treating more people with Stain Medications will also mean far more sick people. Statin Drugs are dangerous.
Another issue to ponder is the fact that Paul Ridker, lead author of the JUPITER trial is the co-inventor of the highly sensitive CRP test, with Brigham and Women’s Hospital; he holds the patent on the test. A conflict of interest perhaps?