At this moment, a trial is underway in India. This trial, named the TIPS trial, involves a new medication — a so-called “polypill” — which contains three antihypertensive drugs, a statin, and aspirin. Its researchers enthuse that it may cut the risk of cardiovascular disease by half in healthy people. So far, the study has shown that the side effects of this medication are minimal, or at least not any worse than those of any of the individual components alone. It’s also demonstrated small but significant reductions in blood pressure and cholesterol. The bigger question is: why do we think we really need this medication in the first place?

What these researchers and others before them have done is taken a representative swath of humanity and labeled them as “healthy.” The JUPITER trial, for example, looked at using a statin for so-called “healthy” individuals and found that it reduced their risk of cardiovascular events. However, these people weren’t healthy. Average, yes; representative of the United States population, yes. Healthy, no. Seventy-five percent of the subjects in the JUPITER trial were overweight or obese and also had a blood test abnormality. Similarly, in the TIPs study the subjects did not have pre-existing cardiovascular disease but did have type 2 diabetes, increased waist-to-hip ratio, abnormal lipids, high blood pressure, or a history of recent smoking. In other words, not “healthy.” Notable, too, is the fact that each and every one of the things that renders these individuals unhealthy is almost entirely preventable with lifestyle modifications.

The fact that legitimate research is being conducted on this “polypill” is a sad commentary on the faith that the healthcare industry has in people to save themselves. Although the researchers in the TIPS trial point out that their medication is not intended to be a substitute for diet and exercise, as Dr. Clyde Yancy, medical director of the Baylor Heart Institute in Dallas, was quoted in Clinical Endocrinology News, “There is nothing more effective than modifying lifestyle, but people may tend to dismiss that concept if they believe a pill is lowering their risk of heart disease.”

In a few years, we’ll get the final results on the TIPS trial. I predict that it will show a benefit. I also predict that the drug will be heavily marketed to people who have had the power to lower their risk of cardiovascular disease in their own hands all along. It is up to us to decide if we want our health to be determined by our own efforts or those of the pharmaceutical industry.

References

Xavier, D., Pais, P., Sigamani, A., Pogue, J., Afzal, R., & Yusuf, S. (2008). The need to test the theories behind the Polypill: rationale behind the Indian Polycap Study Nature Clinical Practice Cardiovascular Medicine, 6 (2), 96-97 DOI: 10.1038/ncpcardio1438

Ridker, P., Danielson, E., Fonseca, F., Genest, J., Gotto, A., Kastelein, J., Koenig, W., Libby, P., Lorenzatti, A., MacFadyen, J., Nordestgaard, B., Shepherd, J., Willerson, J., Glynn, R., & , . (2008). Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein New England Journal of Medicine, 359 (21), 2195-2207 DOI: 10.1056/NEJMoa0807646