ALERT: Odanacatib Drug Trial Ended Early. What Could Possibly Go Wrong?
Meet Odanacatib; Merck’s soon-to-be released osteoporosis drug (although it is sure to have a catchier name once it hits the market). Naturally, after taking a big financial hit when its patent for Fosamax expired in 2008, Merck is gearing up for another profitable and, most importantly, patentable osteoporosis drug.
But it gets “better”… This past week, the independent Data Monitoring Committee has halted Phase III trial early due to “a favorable benefit-risk profile”, even though “safety issues remain in certain selected areas.”1 Nobody knows as of yet what those “safety issues” are, but I’m pretty confident that I can predict at least some of them. Here’s why.
Same Old, Same Old…
Odanacatib blocks the enzyme cathepsin K, found in osteoclasts and involved in bone resorption. In other words, cathepsin K breaks down bone tissue. If you have the Save Our Bones Program, you already know the conditions necessary for normal bone remodeling to maintain and increase bone density. The absence of those important processes results in stalled bone resorption, leading to old, brittle bones, which are therefore more prone to fracture.
Bisphosphonates such as alendronate, the generic of Merck’s Fosamax and drugs such as Boniva, Actonel and Reclast also stop bone resorption. Prolia (denosumab) de-activates osteoclasts, resulting in – you guessed it – stalled bone resorption.
Reading the Tea Leaves
Based on Odanacatib’s mechanism of action, it’s easy to predict that the “safety issues” may be the same – or perhaps even worse – than those of bisphosphonates. But of course, this will most likely not be brought to light until much later, as it happened with bisphosphonates.
Alendronate trials were at first of relatively short duration. US and International Phase III trials against placebo were conducted for only three years.2 And during the Fracture Intervention Trials (FIT), study subjects were treated with alendronate for three and four and a half years.2 The Fracture Intervention Trials were followed by the Long-term Extension (FLEX) trials, where it was shown that:
“…for many women, discontinuation of alendronate for up to 5 years does not appear to significantly increase fracture risk.”3
Other long-term studies followed the FLEX trial, including the Phase III 10-year extension study, none of which observed unusual side effects.2 Fosamax was approved in 1996. Bear in mind that since that year, millions of osteoporosis patients were taking the drug, unknowingly acting as guinea pigs. Meanwhile, Fosamax sales for the year 2007 had reached around three billion dollars.4
In September 2011 safety concerns about bisphosphonates were officially announced, linking the drugs to osteonecrosis of the jaw and atypical femur fractures. This, one month after the newly discovered increased risk of esophageal cancer.
To Make a Long Story Short…
It is obvious that the initial drug trials are short for a reason: the big pharmaceutical companies, along with the accommodating regulatory bodies, collude to allow for maximum profits before the very undesirable side effects are discovered. Once approved, doctors will inevitably prescribe the drug to patients, effectively triggering a flood of huge profits which are sure to dwarf the damages they may need to shell out to injured patients in the future.
Indeed, the future looks pretty bright for Odanacatib. As published in Forbes magazine, JP Morgan is very optimistic about the new drug, forecasting
“… a 2014 launch for Odanacatib with sales reaching roughly $1bn by 2017.”1
Unfortunately, a bleak future awaits those who will be the next victims of yet one more of Big Pharma’s deceptions.
Till next time,
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3 Black DM et al. “ Effects of Continuing or Stopping Alendronate After 5 Years of TreatmentThe Fracture Intervention Trial Long-term Extension (FLEX): A Randomized Trial.” JAMA. 2006;296(24):2927-2938.