In a recent article in Chemistry World, the respected scientist and blogger, Dr. Derek Lowe, talks about major failures in the drug industry asking “What are the projects that drug companies wish they’d never started?” Certainly, one doesn’t enter pharmaceutical R&D if he or she is seeking immediate gratification or success. Creating new medicines is extremely difficult and only one in 10 experimental medicines that enter human trials actually results in an FDA approval. Lowe acknowledges these challenges. But he also refers to these failures as “drug development sins” – a comment which seems a bit harsh. He wishes that “all such drug failures had immediate lessons as to what to avoid.”
The Trump administration has indicated plans to reform the U.S. Food and Drug Administration (FDA) “to put greater focus on the need of patients for new and innovative medical products.” So far, it hasn’t selected a commissioner for the FDA, although some of the names suggested, such as Jim O’Neil, a venture capitalist, and Balaji Srinivasan, co-founder of genetics testing company Counsyl, have showed indications that they want to focus on drug safety rather than efficacy, perhaps even cutting the need for in-depth Phase III clinical trials.
Based on an analysis of data by an independent monitoring committee, Merck said it intends to continue the 30,000-patient REVEAL study of anacetrapib, with no changes, keeping it on course for completion in January 2017.
In 2003, Pfizer PFE +0.00% purchased Esperion Therapeutics for $1.3 billion for access to Esperion’s experimental medicine, ETC-216, an early-stage synthetic, biological drug that mimicked the beneficial effects of HDL and in so doing potentially could reverse atherosclerosis. At the time the deal was viewed positively by industry analysts as it put Pfizer in a position to have three blockbuster medicines in its cardiovascular pipeline: Lipitor, ETC-216 and the CETP inhibitor torcetrapib. As enunciated by Pfizer’s research head, ETC-216 would be used by patients in an emergency setting, followed by long-term treatment with a combination of Lipitor and torcetrapib, the latter of which dramatically raises HDL-cholesterol – the so-called good cholesterol. In justifying the deal, Pfizer claimed “we feel all these drugs are complementary, and that patients will need a variety of treatment options.”