http://www.bloomberg.com/news/2014-12-05/mona-lisa-was-first-patient-in-blockbuster-heart-category.html
Cardiologist Dan Rader has an unnerving party trick. When he meets people with subtle signs of sky-high cholesterol, he may ask to feel their Achilles tendons. Several times he’s diagnosed a condition that makes them 20 times more likely to die young of a heart attack.
Rader, head of preventive cardiology and human genetics at the University of Pennsylvaniain Philadelphia, is looking for fatty buildups in the knees and ankles or white arcs around the cornea of the eye. The hereditary condition he’s seeking, known as familial hypercholesterolemia, affects as many as 1.5 million Americans -- a group drug companies see as one of the first markets for a set of potential blockbuster cholesterol drugs.
Diagnosing the patients and their family members won’t only improve their chances for a long and healthy life, it will identify the most robust market for the new drugs. Called PCSK9 inhibitors, analysts estimate the injections will generate more than $2 billion a year each for companies including Amgen Inc., Pfizer Inc. (PFE), Sanofi and Regeneron Pharmaceuticals Inc.
To capture those sales, drugmakers first need doctors to think like Rader and find the patients.
“Most physicians rarely, if ever, make the diagnosis,” said Rader. “On the patient level, there is virtually no recognition whatsoever. FH is essentially unknown.”
Familial hypercholesterolemia, or FH, increases LDL, or bad, cholesterol levels to as high as 400 milligrams per deciliter, compared with a goal level of 100 milligrams. Already at a greater risk of heart attack and early death, patients also have a 50 percent chance of passing it on to their children.
Family Ties
While there’s a genetic cause of FH, doctors diagnose it based on dramatically high bad cholesterol levels and family history, rather than a DNA test.
Patients are typically treated first with statins, like Pfizer’s Lipitor, though the medicines aren’t usually enough. The PCSK9 drugs are likely to be used at first in patients who can’t take statins, have FH, or who for some other reason can’t get their bad cholesterol levels down.
Taking No Chances
The industry isn’t leaving the discovery of the highest-risk patients to chance. At an American Heart Association meeting last month, the companies highlighted the progress made with antibodies to block PCSK9, a protein that interferes with the body’s removal of cholesterol. The medicines can cut cholesterol more than 70 percent and may be the best hope for getting FH patients to healthy levels.
The market for PCSK9 drugs got another boost last month from a study of a different drug, Merck & Co.’s Zetia, helping calm a debate about cholesterol reduction. A trial of the drug showed that heart risk was reduced when patients got their cholesterol rates even lower than statins could accomplish alone. That bolsters the case for PCSK9s, since it adds to the evidence that FH patients could benefit from cutting cholesterol beyond what statins can do.
Mona Lisa’s Disease
Mona Lisa, the woman famously painted by Leonardo da Vinci, is thought to have been a patient. An analysis of the painting found signs of the disease on Mona Lisa’s eye and hand and concluded that she was “probably the first case of familial hypercholesterolemia,” according to a 2008 study in the journal Current Cardiology Reviews.
Widow-Maker Artery
Wilemon knew at age 15 that her bad cholesterol topped 300, though she had no idea why. By the time she was 38, Wilemon had suffered a massive heart attack. A key artery, one doctors call the widow-maker, was completely blocked.
Wilemon’s foundation is sponsoring a patient registry and encourages screening for family members. It’s also trying to get a separate billing code for the condition.
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