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Amgen’s “Positive” Romosozumab Study Shows a Clear Conflict of Interest
Pharma News

Amgen is announcing the results of a recent study that shows its new drug, romosozumab, increases bone mineral density (BMD) in postmenopausal women, especially when compared to Fosamax and Forteo.

News Excerpt:

“Romosozumab is an investigational medicine in phase III clinical development for the treatment of osteoporosis in postmenopausal women and is not currently approved by any regulatory authority. Romosozumab is being co-developed by Amgen and UCB.

In this phase II trial, each of the five romosozumab dose regimens significantly increased BMD compared with pooled placebo groups at the lumbar spine, total hip and femoral neck regions (all p<0.001). The largest increases were observed with the romosozumab 210 mg once-monthly dose, with mean increases compared with baseline of 11.3 per cent at the lumbar spine, 4.1 per cent at the total hip and 3.7 per cent at the femoral neck.

 Additionally, in exploratory analyses, BMD gains were significantly greater than active comparators at month 12, with romosozumab treatment achieving a mean increase of 11.3 per cent at the lumbar spine compared to increases of 4.1 per cent and 7.1 per cent at the same region achieved with FOSAMAX and FORTEO, respectively. At the total hip, romosozumab treatment increased BMD 4.1 per cent, while observed gains with FOSAMAX were 1.9 per cent and with FORTEO were 1.3 per cent (all <0.001).1.” 2

Interestingly, several of the study’s authors revealed financial ties to Amgen and UCB Pharma. In addition, the study itself was funded by these drug companies. So the researchers had a strong financial interest in presenting romosozumab in a positive light.

As Savers know, romosozumab’s mechanism of action is the suppression of a protein called sclerostin. Sclerostin’s role in bone remodeling is to regulate the formation of new bone; it temporarily stops the formation of new bone so old bone can be shed.

Like many osteoporosis drugs, romosozumab may indeed increase bone mineral density; but the problem is, this is achieved artificially by suppressing the body’s natural remodeling process. The bone then becomes hard and brittle, and more prone to breakage. Romosozumab is no exception to this bone-damaging rule.

The study also reported adverse side effects in the participants, including upper respiratory tract infections, back and joint pain, and headaches. “These reactions did not lead to study drug discontinuation or study withdrawal; the safety of romosozumab will be further addressed in subsequent larger studies,”2 the authors note.

In other words, the safety of this new drug has not even been tested yet…which leads us to our next news story about the vacillation between “safe” and “risky” labels on osteoporosis drugs.

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