Know Your Number? Not this One!

By Cynthia Pearson

I’m just barely old enough to remember the ads, and I never really understood why the celebrity spokesperson was thought to be a celebrity, but I still remember the punch line – “I always know my number.  Now you need to know yours.”  The so-called celebrity was Jimmy the Greek, a famous gambler.  The number Jimmy wanted us all to know was our blood pressure.  At the time, in the 1970s, blood pressure was a pretty obscure test.  Most adults had likely had their blood pressure taken at one time or another, but they didn’t know what doctors did with that information, and certainly didn’t think they needed to know the information themselves.

The point of the “know your number” advertisement was to create public awareness of blood pressure results as something that people who cared about their health should know.  And, to educate the public that, if the number was too high, it was a sign of being at risk for a stroke or other health problems. Those ads worked!  I know my most recent blood pressure reading and I’ll bet that most of you reading this article also know your typical blood pressure reading. What’s the point of all this knowledge?  The numbers provide information about the state of our overall health, and if the numbers creep up too high, we can take steps to improve our overall health by reducing our blood pressure. 

But now, jump forward to sometime next year, when I predict that we’ll all be seeing the 21st century version of the “know your number” ads.  This time, instead of a famous middle-aged man, we’re likely to see a famous, or at least a very attractive, middle-aged woman. She will deliver much the same message, that knowing your “number” can help you improve your overall health.  The new number we’re going to be told we need to know is the results of a test called c-Reactive Protein, or CRP for short.  CRP is a marker of inflammation. It seems to be associated with increased risk for lots of things, including heart disease, diabetes, and other conditions.  It’s pretty interesting from a scientific perspective, but its value as a test that can help individuals improve their overall health is far from proven.

So why do I predict that we will soon be seeing ads targeted at women and telling us that it’s important for us to know our CRP number?  Earlier this year, the Food and Drug Administration (FDA) gave approval to pharmaceutical manufacturer AstraZeneca to market a drug called rosuvastatin to lower the risk of stroke and heart attack if a person’s CRP number is over 2 (technically 2mg/L).  Rosuvastatin is the first drug to be approved by the FDA to reduce the risk of heart disease in patients without high cholesterol, and the potential market for its use is huge.  But to reach that market -- especially those who do not have heart disease and have no risk factors for heart disease -- AstraZeneca will have to convince millions of healthy adults to take the CRP test.  That’s where the ads come in.  Ads are powerful motivators.  Women need to arm themselves with information, and use that information to help them understand what’s behind the ads, and what they need to do to make good choices for their own health. 

The Network has prepared the following information to support women who want to know more about this issue.  The information will also be available on our website and as a fact sheet. NWHN believes that there a lot of good reasons for most women to avoid taking a CRP test and accepting a rosuvastatin prescription.  Here are a few of the most important of those reasons.

Rosuvastatin – Do Women Really Benefit? 

AstraZeneca enrolled nearly 18,000 adults in a trial comparing rosuvastatin to placebo. The trial was stopped early when it became clear that the volunteers taking the drug were having fewer heart attacks and strokes than those in the group receiving the placebo.  The company’s analysis of the trial concluded that everyone benefited, including women, and that the number of risk factors a person had for heart disease didn’t matter, either. 

When I saw those claims in the materials AstraZeneca submitted to the FDA, I had my doubts. It seemed to me that most of the women in the trial were at low risk for heart disease to begin with, and it wasn’t so obvious that they actually benefited from taking the drug.  I took these concerns to the FDA, and spoke up at an Advisory Committee meeting late last year. Many of the FDA’s own scientists and advisors raised similar concerns as well. As a result of our questions, new analyses were presented by AstraZeneca that made it clear that women whose only risk factor for heart disease was their age and a high CRP test result did not benefit from taking rosuvastatin. 

Did any women in the study benefit from taking rosuvastatin?  Yes, very likely they did.  Although the results weren’t quite strong enough to be absolutely certain, it appears that the women who might benefit are those who are over age 60; have a CRP over 2; and have at least one other risk factor, such as smoking, high blood pressure, family history of premature heart disease, or low HDL levels. Could those women have reduced their risk for heart attack and stroke in other ways, without using a prescription drug? Sure. But that’s another article!

Is Rosuvastatin Safe?

Rosuvastatin is already used by millions of patients to lower cholesterol and its safety is a matter of controversy.  The FDA believes it is safe enough to remain on the market, but the consumer advocacy group Public Citizen believes that rosuvastatin is uniquely dangerous compared to other statin drugs, and should be pulled from the market.  (For more information about Public Citizens concerns, see www.worstpills.org). 

The AstraZeneca trial was stopped when most of the participants had only been on the drug for two years, making it hard to completely understand what rosuvastatin’s risks might be. The drug seemed to cause a slight increase in the risk of developing diabetes, increasing the likelihood of developing diabetes by one person in every 200 (or 0.5%).  Severe damage to muscle tissue (the main reason for Public Citizen’s opposition to rosuvastatin) didn’t appear in this study, but reports of muscle pain were noted. 

And, like with other statin drugs, there were compelling reports of volunteers on rosuvastatin who had sudden problems with memory and confusion, which cleared up when the drug was withdrawn.  During the advisory committee meeting, the experts noted that many physicians persist in telling patients that statins can’t cause confusion, but the FDA believes it to be a possible effect of statins, and is conducting a surveillance review to look more closely at this possible harmful effect. 

What to Do When You See the Ads

When you see those ads encouraging you to “know your number”, just say no to the CRP test, unless you already know that you’re at increased risk of heart attack and stroke. If you’re like many women whose only risk factor is age, following sensible guidelines for a heart-healthy lifestyle will do more to improve your health than taking a test that will likely lead to being prescribed a drug that probably won’t help you — and might cause new problems.

Cynthia Pearson is the NWHN’s Executive Director