Xarelto is the anticoagulant pill from J&J and Bayer. It was supposed to be a major blockbuster and compete with Pradaxa from Boehringer Ingelheim. Now analysts are saying that it might end up as a third line treatment behind warfarin and Pradaxa, if it even gets approval. The FDA is looking for more safety as well as more efficacy data in the prevention of stroke among Afib patients. Ouch. I think this is a big hurt for Bayer.
The market seemed surprised as the FDA seemed more upbeat about the product back in July.
Lovenox, which was the branded gold standard, is off patent this year so new products were highly anticipated. Coumadin/warfarin has been used for decades but it has bleeding, stop/start and food interference issues.
Having three drugs so close together in approval (Pradaxa, Xarelto and apixaban) was actually amazing since no new drugs have been approved since Lovenox.
Now, we did a review of anticoagulation back in October 2010. So looking back at the study, we did see evidence that cardiologists were critical of Xarelto's data and were worried about liver and non-major bleeding problems in their Afib patients. So I guess I am less surprised than others on this one.
At the time, we reported being less than enthusiastic with the data ourselves. I really am not a big fan of warfarin, mostly because physicians like to put patients on it for life and it restricts them so much in terms of having an active life. But is has been used for decades so anything replacing it really needs to be more safe and more effective, IMHO.
Wool Labs is working to develop Phase IV/V programs to look at safety and efficacy of products through the lens of how patients report performance and experience. We already work with clients as well as publish our own research on how patients discuss their diseases and conditions, medication, and safety and efficacy measures. So the point to this blog is to explore this concept further.
Showing posts with label safety. Show all posts
Showing posts with label safety. Show all posts
Tuesday, September 6, 2011
Tuesday, July 19, 2011
Proactive Product Safety and Efficacy Surveillance Through Observational Research
I just read an article in PharmaVoice on the value of proactive pharmacoviligance . It was dated February 2011; I'm a bit behind on my reading.
However, I couldn't agree more. Manufacturers need to study their products closely post commercialization in order to understand how those products perform once they are used outside of the clinical setting. It is unrealistic to assume that patients and physicians will always have the exact same experiences observed in clinical trials. The world outside of the clinical trial is filled with comordities, concomitant medication, variable adherence, and more. Post-marketing surveillance studies can also serve as a way to catch concerns and address them before they become real issues like lawsuits and loss of approval.
Manufacturers should also want to preserve their products for potential future indications and to ensure that the right patients get the right treatment. I expect executives to would want to know how physician and patient experiences are going to impact the company's bottom line.
Let's face it, all safety and efficacy issues bubble to the surface eventually. We assume that executives would want to proactively manage their portfolios not just because it is good patient care, but because it is good business too.
We spend a good deal of time analyzing patient and physician experiences with pharmaceutical products. We get a real look at how patients and physicians use drugs and devices in real-world settings. We see safety and efficacy issues that definitely can pose potential problems for brands and for companies. We see misunderstandings that offer companies the opportunity to fix things at the source.
When we did our 10-year retrospective study on Avandia, we learned that problems were evident as early as 2004. GSK would have had time to change their label and marketing, instruct physicians, and educate patients. Maybe then in 2008 lawsuits would not have been the recourse patients/caregivers felt that they had to take. Maybe it didn't have to cost GSK so much in legal fees and consumer trust.
When we studied Actos earlier this year, we learned that Takeda faces some real problems with Actos that could impact approvals for future indications. Bladder cancer, bone fractures, and cardiovascular risks are not going away. We believe that Takeda needs to address these risks now for both their current diabetes patients as well as for new trials in different disease states..
So why isn't pharma being more proactive in pharmacoviligance as well as efficacy studies?
We believe that observational research and surveillance studies need to start as soon as a drug or device is in market. It is not only in the best interest of the patient but it is also ultimately in the best interest of the company and the industry. The contributors to the article I read were mostly from non-manufacturers like we are at Wool Labs.
How do we get more of the manufacturers on board?
However, I couldn't agree more. Manufacturers need to study their products closely post commercialization in order to understand how those products perform once they are used outside of the clinical setting. It is unrealistic to assume that patients and physicians will always have the exact same experiences observed in clinical trials. The world outside of the clinical trial is filled with comordities, concomitant medication, variable adherence, and more. Post-marketing surveillance studies can also serve as a way to catch concerns and address them before they become real issues like lawsuits and loss of approval.
Manufacturers should also want to preserve their products for potential future indications and to ensure that the right patients get the right treatment. I expect executives to would want to know how physician and patient experiences are going to impact the company's bottom line.
Let's face it, all safety and efficacy issues bubble to the surface eventually. We assume that executives would want to proactively manage their portfolios not just because it is good patient care, but because it is good business too.
We spend a good deal of time analyzing patient and physician experiences with pharmaceutical products. We get a real look at how patients and physicians use drugs and devices in real-world settings. We see safety and efficacy issues that definitely can pose potential problems for brands and for companies. We see misunderstandings that offer companies the opportunity to fix things at the source.
When we did our 10-year retrospective study on Avandia, we learned that problems were evident as early as 2004. GSK would have had time to change their label and marketing, instruct physicians, and educate patients. Maybe then in 2008 lawsuits would not have been the recourse patients/caregivers felt that they had to take. Maybe it didn't have to cost GSK so much in legal fees and consumer trust.
When we studied Actos earlier this year, we learned that Takeda faces some real problems with Actos that could impact approvals for future indications. Bladder cancer, bone fractures, and cardiovascular risks are not going away. We believe that Takeda needs to address these risks now for both their current diabetes patients as well as for new trials in different disease states..
So why isn't pharma being more proactive in pharmacoviligance as well as efficacy studies?
We believe that observational research and surveillance studies need to start as soon as a drug or device is in market. It is not only in the best interest of the patient but it is also ultimately in the best interest of the company and the industry. The contributors to the article I read were mostly from non-manufacturers like we are at Wool Labs.
How do we get more of the manufacturers on board?
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