Webinar on the Social Patient and the Impact on Adherence

https://www2.gotomeeting.com/register/620119786

Please join us for a free Webinar on the Social Patient and the Impact on Adherence. It is Wed. 2/22 at Noon EST. Register at the link above.

Today we are releasing our latest research on oral diabetes medications

We are releasing our latest research today.

In August 2011, we conducted a research study of 21,344 social media conversations on Diabetes and 18 oral diabetes medications that were posted from March 12, 2000 to March 23, 2011 across all blogs, user forums, and message boards on the Internet.

The purpose of the study is to understand how patients talk and feel in open conversations publically available on the Internet about Diabetes and the oral medications that they use.

This study examines at a high level the patient-reported effectiveness and perceived safety of 18 oral medications used for the treatment and management of type II diabetes.

We provide insights into patient opinions about each drug’s performance based on the personal experiences that patients may or may not share with their physicians.

The results are interesting to say the least. Feel free to download:

http://www.woollabs.com/odms.html

Does J&J and BMS's Xarelto have a second chance for approval?

After a tough time in the early part of last week, on September 9, 2011, the FDA panel green-lighted Xarelto after FDA staff rejected it. FDA staff reviewers felt that Xarelto did not prove safety and efficacy for stroke prevention against Coumadin in the 14,000 Afib patients studied. But the FDA panel seems to see the data differently. The American Heart Association is also advocating Xarelto's approval.

Xarelto is already approved for prevention of clots in knee and hip replacements but in our data, cardiologists were skeptical in using Xarelto in their afib patients. And as treatment is likely for life, their concerns have a huge potential impact on their patients. There is no doubt that Coumadin/warfarin has problems but they are known problems and physicians seemed concerned about swapping known problems for unknown problems. And it seems that these specialists are expecting liver and/or bleeding problems with Xarelto

After reading a few transcripts of the FDA hearing, there do seem to be a few key issues that seem to need to be worked out even if approval is granted:

1. Some see that warfarin was not as skillfully used in the Xarelto pivotal trial, ROCKET, as opposed to other trials which makes it harder to evaluate Xarelto's comparative performance.
2. There seemed to have been a reasonably high number of discontinuations during the trial which made it hard to understand how to transition patients to another treatment from Xarelto.
3. Optimal dosage is not clear. Some panelists felt that twice-a-day dosage might be better than once-a-day.

Everyone did agree that the trial was well-designed and executed. But to me that makes the results more murky. One would think that a good trial would answer questions like this. And while the panel voted 9-2 for endorsing the drug, it was not resounding support. There are some that support efficacy parity with warfarin but not superiority. Is that enough? It could be if Xarelto's safety profile was stronger than warfarin.

One thing to remember is that anticoagulation is extremely complex and there may not be any completely solid answers to the outstanding issues. I do believe that if approved, many cardiologists will not be rushing to use the drug until more real world experiences can be reviewed.

A final FDA decision is due in November.

FDA says that J&J and Bayer's Xarelto has insufficient safety and efficacy data

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.

Expensive targeted therapies are on the rise. Does cost ever play a role drug treatment? I think we are going to have to deal with this soon.

As the pharma and biotech industry moves towards more targeted therapies, cost of treatment increase dramatically. The latest cancer drugs are targeted to specific DNA sequeneces and mutations and their costs can be over $100,000 per course of treatment. They also might only extend life for a few months. However, expensive and targeted treatments have given some patients years.

Avastin, which lost its approval for breast cancer, is one of those extremely expensive treatments. Patients and even oncologists do not like losing treatments even if they do not seem to work all of the time or even predictively. Patients on Avastin were horrified to lose the drug's approval and it was heart-wrenching to read their stories.

But does cost play a role in the delivery of US drug treatments? It does in other countries.

Does stronger efficacy and more precise patient stratification make very expensive drug use more defensible? Targeted therapies are supposed to be just that, targeted to a particular marker and theoretically they don't work as well or at all in the absence of that marker. But patients report being on Herceptin who do not have HER2+ breast cancer. And we see that there are lung cancer patients on Tarceva who do not have have the EGFR mutation. Sometimes after patients fail on other treatments, we do see the use of targeted therapies in untargeted ways. Should they be if there is no evidence that they would work?

Unfortunately Avastin lost its approval because it was considered to be ineffective and Genentech could not explain why the 17,500 women who found the drug valuable were different. Why does Avastin work for some patients and not for others? If the brand knew that then I think the FDA would have allow the drug to keep its approval for the right patient and people would have been less likely to call out the death panels.

Development of more targeted drugs is a trend on the rise. So astronomical cost for treatment will be on the rise as well. Do we demand more patient stratificatoin and then make everyone stick to it? What is fair to the patient and what is fair for everyone else?

I think we are all going to have to really deal with these issues in the very near future.

Does Facebook matter for pharma companies the way they think it does?

Over the last few weeks, pharma companies and those who follow pharma have been talking about Facebook not allowing pharma to continue to block comments on their pages. I have been confused by all of the fuss this causes.

Wool Labs has been studying patient and physician experiences and behavior online for a few years now. In the hundreds of studies we have performed, Facebook has never been one of the top 200+ sites that houses or shares influential content for patients or physicians. Never. What we mean by influential content is content that patients and/or physicians read, discuss, comment on, share with others, use to make decisions, and change behavior.

So as far as we can see (as we see very far indeed), Facebook pages do not host deep, involved, well-read, or heavily discussed content consumed by patients and/or physicians who suffer from or follow a particular disease/condition or use/prescribe a particular treatment.

Now, of course pharma-sponsored sites don't allow comments so that explains why their sites don't show up in our studies. But presumably a patient who is discussing his/her condition would allow comments and invite others to share similar stories. And we see those but they are not drawing the thousands or tens of thousands of patients that others sites draw. And those non-Facebook sites are what need to matter to pharma.

Patients and physicians share their experiences all across the Internet from well organized disease-specific communities to personal blogs to seemingly unrelated non-health sites.

So while I think it is sad to see some pharma companies pulling Facebook pages, as I always want to see pharma involved with their customers. I would also like to see pharma put as much effort into studying the rest of the Internet as I have seen them put into Facebook.

It is the rest of the Internet that is screaming for pharma to pay attention. It is the rest of the Internet where pharma can learn what their patients and physician believe and how they choose their actions. It is the rest of the Internet that influences and therefore, matters more.

Another Actos Prediction Comes True & Lawsuits Begin

Back in February of this year we studied the oral diabetes drug, Actos. We had previously studied Avandia and found the starter back in 2004 for the lawsuits that eventually happened in 2008. A friend asked me why Avandia became so damaged while Actos seemed to escape the same fate even though we found that Actos had many concerns from cardiac problems to cancer risks. But the one thing that seemed to not haunt Actos was reported deaths attributed to Actos the way that deaths were attributed to Avandia.

That seems to have changed to today. We predicted that if patients and caregivers started to attribute deaths directly to Actos, that lawsuits would happen almost immediately. Avandia lawsuits took years to happen but the legal community has been looking for an Actos weakness for years. And we predicted that once they found it, the lawsuits would follow fast, furious and in large numbers.

The cancer risk problem that had Actos to be removed from the market in Germany and France in June and caused the FDA to increase warnings, is causing deaths from bladder cancer. Patients and caregivers are directly attributing fatal cancers and death to Actos.

One law firm is reporting that they represent 120 clients and every day that they will add 30 or more a week. Dozens of other firms are advertising for clients.

We see this development as the beginning of the end for Actos. Their combination product of Actos + alogliptin should be at risk as should the use of Actos for other indications such as multiple sclerosis.

If we deepen our prediction as lawsuits begin, we believe that Actos will lose FDA approval by end of the year. And the last TZD falls.