April 19th, 2018
The CMS National Coverage Decision on NGS
New Insights: As a result of the recent CMS National Coverage Decision on NGS, the MolDX® program of Palmetto GBA® is now actively considering cover...
Trial Chairman: Paul M Ridker, MD
The JUPITER Trial (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) was a multicenter, randomized, double-blind, placebo-controlled 4-year trial funded by AstraZeneca to assess whether rosuvastatin (20 mg daily) can prevent major cardiovascular events among nearly 18,000 healthy men aged 55 and older and women aged 65 and older with normal levels of low-density lipoprotein (LDL) cholesterol but elevated levels of C-reactive protein, a marker of chronic low-level inflammation. The trial was stopped ahead of schedule in 2008 because of a statistically extreme 44% reduction in risk for a first major cardiovascular event among the group of participants assigned torosuvastatin.
JUPITER was a personalized medicine trial using a high-sensitivity CRP test to isolate patient groups at high risk of heart disease.
Its publication enabled AstraZeneca's Crestor to achieve 35 per cent annual growth.
Publication of the JUPITER Study in 2008 made personalized medicine newsworthy. A public profile can help create new competitive dynamics between established therapies.
Merck Establishes New, Non-Profit Bone Measurement Institute
WEST POINT, Pa., Aug. 1995 PRNewswire
Today Merck & Co. Inc. announced it is establishing a new, non-profit organization call the Bone Measurement Institute. “The Bone Measurement Institute will conduct activities to help increase the availability of bone measurement technologies, increase their accessibility to physicians and reduce the cost of bone mass measurement to health care payers.” Said Jeremy Allen, Vice President Merck U.S Human Health, and President of the Institute. It also will provide educational support to physicians about the role of bone measurements and promote scientific research and development of bone testing methodologies.
A personalized medicine strategy created the bisphosphonates market.
Successful personalized medicine campaigns always have a simple message and an understandable clinical rationale. The injunction to "Know Your T-score" is key to defining a patient's bone density and treatment options.
A successful personalized medicine strategy is best executed when it is an integrated part of a therapy's overall launch and promotion.
Merck used such a strategy and paved the way for Fosamax to become a billion-dollar drug.
GSK used the abacavir example with investors to illustrate its personalized medicine strategy.
Abacavir hypersensitivity significantly impacted GSK’s sales and resulted in a prescription ratio of only 1 to every 4 prescriptions of its nearest competitor drug, Truvada from Gilead.
One person treating HIV clearly described the impact:
“In the past, we always had to expose a patient to a drug to see if there is a reaction. This, to the best of my knowledge, is the first example where we can predict an allergic response without having to expose the patient."
Personalized medicine can help manage adverse events and restore a therapy's clinical utility.