Norgard weighs in on Lipitor going generic and what it means to patients, pharmaceutical companies and the future of health care.
"We are in the era of evidence-based medicine and the evidence supports atorvastatin as the statin of choice for cardiovascular protection. Yet as practitioners, we have been sacrificing the benefits that could be gained with atorvastatin for less potent, less effective statins because of cost. The high cost of the brand name statins really places a high burden on our patients. When we try to use the more potent, brand name statins, we have found that more than 50 percent of patients quit taking them within the first year due in large part to cost. This is not at all ideal given the huge benefit these drugs afford. I expect that when atorvastatin goes generic and the cost comes down, the obtainability and adherence of atorvastatin will improve dramatically. And this, in turn, will lead to better protected patients and a reduction in cardiac events, procedures, and hospitalizations.
"The statins, as a class, have been a major advancement in cardiology. It is estimated that almost 11 million Americans take a statin, and that about 25 million more should be on one. Comparatively, taking a statin for cardiac prevention is more effective and probably safer than taking an aspirin a day. Lipitor, generic name atorvastatin, has been one of the top-selling branded pharmaceutical drugs in the world for several years, contributing $10.7 billion to Pfizer’s revenue in 2010 alone. Lower-cost generic versions of Lipitor are set to become available December 1, 2011. I believe that we will see a huge shift in statin use when atorvastatin goes generic.
"Atorvastatin is considered a “potent” statin in terms of its ability to lower LDL cholesterol. At its highest dose, it can lower the LDL cholesterol by over 50%. Only Crestor (rosuvastatin) can produce greater reductions in LDL cholesterol, but will not be available as a generic for several years. Up until now, simvastatin has been the most potent, generically available statin but has recently acquired FDA authorized dosing restrictions because of issues with high doses and drug interactions causing serious adverse effects. Atorvastatin, on the other hand, more effectively lowers cholesterol than simvastatin and has fewer drug interactions.
"However, we must keep in mind that statins do more than just lower cholesterol. The reason we use statins over other types of cholesterol lowering drugs is because they have been shown in clinical trials to unequivocally reduce the risk of heart disease, stroke, and even prolong life. Atorvastatin is the statin with the most evidence from clinical trials to support its use. In fact, atorvastatin is one of the most widely studied drugs in the world. It has been shown to reduce the risk of heart attacks and strokes, regardless of cholesterol level. For people with heart disease, atorvastatin has been shown to be superior to less potent, generically available statins, including pravastatin and simvastatin, at lowering the risk of cardiac events, stokes, and subsequent death."
On the future of cardiovascular drug development:
"Cardiovascular disease remains the #1 cause of death in the world. However, there has been a decline in cardiovascular death rates over the last couple decades, largely due to the huge escalation in the use of statins and our improved efforts in lowering blood pressure and reducing smoking.
"Due to the success of current medications, many believe the era of the blockbuster cardiac drug is over. Plus, in the cardiac field there are multibillion-dollar drug-development costs because of the need for large studies enrolling tens of thousands of patients when testing a cardiovascular drug. It seems that PHRMA recognizes this as they appear to be directing their R&D efforts towards other disease states. For instance, the number of cancer drugs underdevelopment out numbers cardiac drugs underdevelopment almost 7 to 1. It is estimated that cardiovascular-drug projects now comprise only 6% of total PHRMA projects.
"Apart from creating 'me too' drugs and combinations of previously marketed drugs, the development of novel cardiac drugs appears to be a difficult journey for PHRMA at this point. However, there are areas for growth in cardiovascular disease because it’s not like cardiovascular morbidity and mortality have been resolved, by any means. For instance, the growing epidemic of childhood obesity and diabetes may erase the decline in cardiovascular death rates made over the last couple decades. Also, despite some major therapy advancements, heart failure has a shorter life expectancy than almost every cancer. Finally, we are just realizing the power of pharmacogenomics and individualized therapy with cardiovascular drugs, an area that cardiovascular-drug research lags far behind cancer but represents a huge area for growth."
