Oh it is the drugs. Given their mechanism of action, they did exactly what they could have been expected to do. They changed the bone metabolism process, which stopped the resorption of bone cells. In the short run this gave patients more bone mass. But in the long run it gave them dead bone cells. Women were left with bones like dead branches on a tree. Eventually, the truth will show that this was suspected and reasonably predictable from the very start.
If they depose enough drug reps and doctors, they will find that terms like "drug holiday" and "Fosamax holiday" were being promoted and talked about from the very beginning, which tends to show that there were questions or uncertainty about the effects of long term suppression of the natural bone metabolism and formation process. They should have had FORMAL protocols for therapt time frames from the start and they should have given SERIOUS notice to doctors to consider discontinuing therapy to women who had been taking this drug for longer than "X" number of years.
Having your sales force address doctor's concerns of the obvious long term risk of the drug's mechanism by casually promoting "bone holidays" shows prior knowledge and recklessness. If the risk of not taking "bone holidays" is spontaneously exploding femurs, then that treatment protocol should have been developed, addressed and formalized before the drug even came out and gained FDA approval.
Once again, sales and marketing was used to tap dance around a serious scientific question and a safety risk that was reasonably predictable.
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Oh it is the drugs. Given their mechanism of action, they did exactly what they could have been expected to do. They changed the bone metabolism process, which stopped the resorption of bone cells. In the short run this gave patients more bone mass. But in the long run it gave them dead bone cells. Women were left with bones like dead branches on a tree. Eventually, the truth will show that this was suspected and reasonably predictable from the very start.
If they depose enough drug reps and doctors, they will find that terms like "drug holiday" and "Fosamax holiday" were being promoted and talked about from the very beginning, which tends to show that there were questions or uncertainty about the effects of long term suppression of the natural bone metabolism and formation process. They should have had FORMAL protocols for therapt time frames from the start and they should have given SERIOUS notice to doctors to consider discontinuing therapy to women who had been taking this drug for longer than "X" number of years.
Having your sales force address doctor's concerns of the obvious long term risk of the drug's mechanism by casually promoting "bone holidays" shows prior knowledge and recklessness. If the risk of not taking "bone holidays" is spontaneously exploding femurs, then that treatment protocol should have been developed, addressed and formalized before the drug even came out and gained FDA approval.
Once again, sales and marketing was used to tap dance around a serious scientific question and a safety risk that was reasonably predictable.
March 27, 2010 - 9:22amThis Comment
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