FEATURE ARTICLE
Statins: From Fungus to Pharma
The curiosity of biochemists, mixed with some obvious economic incentives, created a family of powerful cardiovascular drugs
Philip A. Rea
Needs for Proceeds
With the niches for statin drugs quickly filling up, Parke-Davis wanted to get Lipitor to customers as soon as possible. To do that, the company needed to convince the FDA that Lipitor should be put on the fast track for approval, a privilege reserved for products that address an "unmet medical need."
To find that need, Parke-Davis used a version of Merck's earlier technique. Parke-Davis contacted two South African doctors who were treating a group of young patients with the homozygous form of familial hypercholesterolemia. This is where an individual has not just one but two copies of the disease-causing gene. Characterized by cholesterol levels of 600 milligrams per deciliter or more, children with this condition typically suffer a heart attack or undergo bypass surgery before or soon after entering their teens. Because these doctors had previously tried Merck's Zocor (trade name for simvastatin) with little effect, these children faced a grim prognosis. With very little to lose they agreed to try Lipitor.
The blood cholesterol levels of the children in the trial started to come down within a month. One child with an untreated blood cholesterol level of 1,100 milligrams per deciliter achieved a new steady state of 700. Others with somewhat lower untreated levels achieved 300-400 milligrams per deciliter. Having at least gone some way toward meeting this unmet medical need, Lipitor received a priority review from the FDA.
To get a similarly fast and favorable "review" from customers, Parke-Davis made an equally strategic marketing decision: They elected to co-market Lipitor with Pfizer. At the time, 1996, Pfizer was the fifth most-profitable pharmaceutical company, renowned for its acumen in sales and marketing, but also a company that lacked a statin of its own.
Disadvantages would seem to be inevitable when entering a market late in the game, but if there is an advantage to be had it is that the latecomer has ready access to the competitor's products to test against their own. To set off Lipitor from other statins, Parke-Davis and Pfizer therefore commissioned a head-to-head trial—called the CURVES study—of comparative-dose efficacies of Lipitor (atorvastatin) against four other statins in patients with hypercholesterolemia. Lipitor won hands down. For example, at a dose of 10 milligrams per day, it lowered LDL cholesterol by 38 percent, which was significantly better than what patients experienced with equivalent doses of fluvastatin (17 percent), lovastatin (29 percent), pravastatin (24 percent) and simvastatin (28 percent).
In January 1997, when the FDA approved Lipitor, it went so far as to allow Parke-Davis and Pfizer to include data from the CURVES study in every package of the drug sold. Lipitor captured 18 percent of the statin market over the next 18 months, in large part through Pfizer's sales prowess—making it second only to Merck's Zocor, which had 37 percent. In 2000, Pfizer purchased Warner-Lambert—the parent company of Parke-Davis—and became the sole owner of Lipitor. By 2004, annual sales of Lipitor surpassed $12 billion, making it the world's best-selling drug by a wide margin.
In one case, though, even Congress believed that Pfizer's marketing of Lipitor went too far. In January 2006, Pfizer launched a Lipitor-advertising campaign centered on Robert Jarvik—known for developing the Jarvik artificial heart. Under Congressional criticism, Pfizer pulled this $258 million advertising campaign early in 2008. As Stephanie Saul wrote in the February 25, 2008, issue of The New York Times: "[T]he campaign had come under scrutiny from a Congressional committee that is examining consumer drug advertising and has asked whether the ads misrepresented Dr. Jarvik and his credentials. Although he has a medical degree, Dr. Jarvik is not a cardiologist and is not licensed to practice medicine." Saul went on to note: "One television ad depicted Dr. Jarvik as an accomplished rower gliding across a mountain lake, but the ad used a body double for the doctor, who apparently does not row."
As of March 2010 Lipitor's patent is due to expire, at which point it will face competition from generic versions. In this eventuality, Pfizer will need more than sheer marketing power to replace Lipitor's revenue stream.
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