Saturday, July 23, 2011

Another Open Thread -- Featuring FDA Advisory Committee Formation: Fosmax® ONJ Review

Feel free to use the comment section to add your own items of interest, but Injury offers us this as a headliner -- do go read it all:

. . . .On July 11, 2011, the Food and Drug Administration (FDA) announced that it would form an advisory committee to discuss the risks and benefits of long-term bisphosphonate use for the treatment of osteoporosis. The formation of the committee comes in light of growing evidence that bisphosphonate drugs, such as Fosamax®, prescribed to treat osteoporosis, may cause atypical femur fractures and osteonecrosis of the jaw (jawbone death). Fosamax manufacturer Merck & Co., has faced an increasing number of lawsuits from people who have suffered atypical femur fractures or jawbone death while taking Fosamax. In addition to Fosamax, the advisory committee will discuss other bisphosphonate drugs: Actonel®, Atelvia®, Boniva® and Reclast®.

Generally, the FDA convenes an advisory committee on pharmaceutical drugs to receive public input on a broad scope of complex issues including drug safety and risk. These issues typically relate to the development and implementation of a specific regulatory program or the development and implementation of a regulatory policy to approve, recall or update labeling information for a drug.

Over the past few years, there has been an increasing number of reports involving patients who suffered multiple stress fractures and low energy femoral fractures as a result of severely suppressed bone turnover potentially linked to long-term Fosamax use. Various studies have also shown that severely suppressed bone turnover may be associated with long-term Fosamax use. . . .

Now -- what did YOU see this week? Add it in the comments!


Anonymous said...

The best thing that could happen to Merck requires total decapitation of the management. Self-serving and coersive, they will never change. The prevailing attitude is that they are brilliant and special. And well, if their poor decisions and lackey behaviors take the company down, well that's OK by them - they are lining their pockets right now. There have been some recent promotions to higher levels, so they can retire earlier, walking away with even more. Unbelievable. I feel like I am trying to do science in the midst of Armegeddon.

[Originaly Posted on July 22, 2011]

Anonymous said...

Frazier says he will invest in R&D and that R7D is the best in the world. That's not true.

They were years behind companies they purchased, as was Schering Plough.

They did not look how Organon performed R&D and what methods they used, they were for the pipeline and all the R&D had to be discarded, the sooner the better. But the R&D of Organon had the candidates for development, not Merck, not SP, that's why they bought it.

[Originally posted: July 24, 2011 @ 7:01 AM]