Below is an article on why I have chosen not to take Forteo, even though my dr. has recommended that I should. I just don't think there is enough clinical data done to support this drug, not to mention that it would be a year before I would know if I was improving. This group, Public Citizen, has included this drug in their "Do Not Use" list. It's quite obvious that the public isn't educated enough about this drug, because a lot of people who are taking Forteo aren't even aware of the Black Box Warning the government (FDA) has placed on this medication.
"US consumer group Public Citizen is warning the public against Forteo due to cancer fears."
April 14, 2003 2:10 PM GMT (Datamonitor) - Lilly's osteoporosis drug Forteo already has a black box warning, advertising ban and detailing restrictions to contend with, putting it at a significant disadvantage at launch to most other drugs. With 'cancer scare' ideas being pushed to the public by advocacy groups, its first-to-market position and massive untapped patient potential may not be enough to combat consumer fears.
Eli Lilly's Forteo is under fire again, this time from powerful US consumer watchdog Public Citizen. Forteo, a novel bone building drug, indicated to treat osteoporosis patients at high risk of fracture, was launched in the US in December 2002. The advocacy group issued a 'Do Not Use' warning for Forteo in its 'Worst Pills' list due to the potential risk of osteosarcoma, observed in tests of the drug in rats. Lilly argues that clinical trials in humans have shown no sign of the condition.
Public Citizen has taken its case to the people after the FDA ignored its advice not to approve the drug. The group's quarrel with Forteo is not only with its safety profile, but also clinical data in fracture reduction, male osteoporosis and its high price point.
The road to Forteo's approval was delayed by safety and manufacturing concerns. Despite receiving an FDA advisory board recommendation in 2001, it took over a year to gain final approval. This has squeezed the market exclusivity period for Forteo, while Lilly has had to agree to a black box warning on the risk of osteosarcoma and restrictive marketing guidelines. These include a DTC advertising ban, limited detailing, issuing patient medication guides and initiating physician education programs. Lilly is also funding a 10-year program to track Forteo patients for osteosarcoma occurrence.
Drugs like Forteo are a much needed addition to the osteoporosis market, due to the dearth of products for severe disease, and thus have huge patient potential. Indeed, Forteo could be a blockbuster. But with Lilly unable to promote Forteo's benefits to the public while consumer groups raise fears, uptake of the drug will suffer significantly.
Lilly's other osteoporosis drug, Evista, is also the first in its class on the market. However, uptake has been slower than anticipated despite aggressive DTC advertising and detailing. Without these tools at its disposal, Lilly will find success in the market even more difficult for Forteo.
Related Research: Datamonitor, "Drugs of Tomorrow: Osteoporosis - Will Bone Building Drugs Revolutionise the Market?" (DMHC 1796)
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o hear from you soon. Sheila MY email address is [email protected] if you would rather email me which I think is eaiser.
