The End of the Age of Lipitor? You'd Better Hope Not.
Today Lipitor, the world’s best selling drug and Pfizer’s single most profitable product, loses patent protection and goes generic. If Lipitor (generic name atorvastatin) holds true to form for other generic transitions, Pfizer can expect to lose much of its market share and the price of atorvastatin will eventually plummet by as much as 80%. But while everyone is celebrating the “birth” of yet another cheap generic from an expensive blockbuster, it would be good for policymakers and the press to pause and reflect on where generic drugs come from.
The stork doesn’t bring them to your local pharmacy. They are often the products of years or even decades of enormously expensive and painstaking research by innovative (and yes, profit-driven) companies.
What is the proper response to Lipitor going generic? Thank God for blockbuster drugs.
Because without those drugs we wouldn’t have the tremendous health gains from statins and other widely used drugs to treat stroke and hypertension - or the cheap generics that the health care system gains once those drugs lose patent protection.
Cardiovascular disease has been the leading killer in the U.S. every year since 1900, except for 1918 (pandemic flu?). Mortality peaked in 1950, but declined by 60 percent between 1950-1999. Undoubtedly, much of that decline was driven by changes in population health (i.e, declining smoking rates, etc).
However, as the chart above shows, declines in cardiovascular disease - with the exception of a slight uptick for hypertension - continue in the most recent data. For instance, U.S. age-adjusted mortality rates (per 100,000 population) for coronary heart disease fell by 35% from 1999-2007 (from 194.6 to 126); for stroke by 31% (from 61.6 to 42.2); and by 43% for myocardial infarction (from 73.2 to 41.4). Those gains are not all attributable to statins - stents, better drugs for hypertension, better surgeries and diagnostics all play a role - but medical innovation is a central part of the story.
Those gains are even more remarkable considering recent and rapidly rising obesity rates in the U.S., since obesity is a known risk factor for cardiovascular disease (particularly through complications like diabetes). This massive decline in mortality rates from cardiovascular disease is one of the most astonishing phenomenons of modern American medicine - and yet it goes largely unnoticed.
Fifty-something year-old men dying of heart attacks used to be unremarkable. Now, it is considered a terrible tragedy.
Statins were not developed by the U.S. government, or the NIH. As Zycher, Dimasi, and Milne wrote in a 2008 Manhattan Institute report:
The development of statins also depended on the passionate belief of industry scientists that they had discovered life-saving medicines, and who championed their development even when bad data suggested that they probably should give up. As Harvard Medical School Professor Thomas Stossel wrote in the Boston Globe in 2008:
Stossel’s concern is sadly warranted. Policymakers and the media need to be continually reminded that there is still much about human biology that we do not understand, or understand incompletely, but that ignorance should not be taken to be an indictment of industry or cause to embrace a precautionary principle that penalizes innovation through risk-averse FDA regulations or reimbursement strategies that limit physicians to prescribing cheap generics.
Several years ago, Pfizer lost over $800 million dollars when their attempt to improve on statins by raising “good” HDL cholesterol through a new drug called torcetrapib imploded in a late stage clinical trial. Companies continue to take those enormous risks because of the tremendous good they can achieve when they are successful, and because the financial rewards of success still (at least for the time being) compensate them for their many failures.
Patent expiration - for Lipitor or any other drug - is part of a virtuous cycle of innovation than can take decades. Losing sure cash-cows like Lipitor pushes companies to invest billions of dollars in the hope that they will uncover even better drugs for treating heart disease and stroke, or cure Alzheimer’s. Some of these drugs may be blockbusters that treat large populations, and others will be “niche busters” that treat patients who don’t respond (for genetic or other reasons) to those blockbusters.
But we must continue to defend and explain the virtuous cycle of innovation if we want companies to find the next public health breakthrough, like statins. Even though, in time, we’ll take those miracle drugs for granted too - and cheer loudly when they become cheap generics.
This piece originally appeared in Medical Progress Today
This piece originally appeared in Medical Progress Today