The FDA adverse event database is an important data source to understand safety issues. Using data cleansing, advanced algorithms and co-relating it with multiple data sources in our PharmaFlare data platform one can understand drug interaction combinations and see potential safety issues in the real world that controlled clinical trials cannot easily determine.  However, one can also use similar analytical approaches to understand physicians prescription patterns and behavior. In a case study of the anti-psychotic market, Our technology, analytics & experts evaluated major anti-psychotic drugs looked at various drug interaction combinations and found some revealing insights. 

A recent clinical study conducted  by the American Society of Clinical Oncology (ASCO) found that continuing Avastin for advanced colorectal cancer patients with a combination of chemotherapy and this tumor-targeting drug appears to prolong survival among those who have undergone the combination therapy at an early stage of disease. With this background, PharmaFlare analyzed patient experiences regarding the efficacy of Avastin in combination with chemotherapy drugs for advanced colorectal cancer.

Through its comprehensive patient, market, and competitive intelligence, PharmaFlare tracks patient views on emergent topics that concern physicians, patients, pharmaceutical firms, and other stakeholders in the healthcare industry. Please email info@pharmaflare.com if you want access to this or other research notes.

This brief research note on patient views regarding Avastin in combination with chemotherapy drugs shows:

•   The percentage of patients and caregivers experiences who were satisfied with the efficacy of Avastin in combination with chemotherapy drugs;
•   The percentage of patients and caregivers who were using this combination but for whom Avastin was not adequately effective;
•   The percentage of patients and caregivers who were using this combination and were concerned with the side effects of Avastin.

Sample of a caregiver’s view about a patient who was satisfied with the efficacy of Avastin in combination with chemotherapy drugs:

This is the first time I am leaving a message on this site, however, I have read your messages every day for the past 6 months.  My brother, age 48, in perfect health was diagnosed 6 months ago with Colon cancer Stage 4 with mets to both lobes of his liver.  He was not a candidate for liver resection.  He was devestated to say the least, as was all of his family.  He has a wife and 2 young children. After receiving chemo for the past 5 months, Folfox V (with 3-day pump infusion) with Avastin, he received his first pet scan   He was terrorized to get the results.  The oncologist told him that his pet scan was excellent; there were no lesions in the liver.  We are all thrilled!  He will continue with oral chemo and Avastin.

Sample of a patient’s view who was taking this combination but for whom Avastin was not adequately effective:

Hi Lorraine, I just came across your message and wanted to let you know that I have taken Avastin and had no side effects whatsoever. I was diagnosed in April 2004 with stage IV colon cancer with mets to the lungs, had colon resection then began chemo with oxaliplatin/5FU/leucovorin and Avastin. It worked well and my scan last February showed no signs of disease. I was then put on Avastin only as a maintenance. Unfortunately it must have not worked because my latest CT scan showed a new nodule and a recurrent one in my lungs. So I will begin my next chemo with camptosar/5FU/leucovorin and Avastin this Thursday. (He wants me to have a longer break from the oxaliplatin.) I will do whatever it takes to beat this evil. One thing you have to do before each dose of Avastin is have your urine checked for protein. Mine was usually just a trace amount, but then it suddenly went up quite high. They took me off the Avastin and I had a 24 hour urine collection. My kidneys were fine and my doctor is not quite sure why the Avastin produces so much protein. There is also a chance of higher blood pressure. I am sorry this is so long. I tend to get wordy in trying to explain simple things.  I pray your husband is doing well. I have heard that patients who get the rash have a much better prognosis and that you want the rash. Your husband is sooo blessed to have you looking out for him.

Sample of a caregiver’s view about a patient who was taking this combination but was concerned about the side effects of Avastin:

My husband was diagnosed with stage 4 colorectal cancer withs mets to the lymph nodes and liver 2 years ago.His first chemo treatment consisted of the same as your husband. His cea dropped from 2000 to 300 after 3 treatments. The avastin is very powerful but unfortunately we had to discontinue it because one of the side effects of avastin is that it causes blood clots. One morning he woke up in severe pain and couldn't walk, he was rushed to the hospital by ambulance where they found blood clots in each leg plus one clot the size of a thumb flapping on the aorta. We had to discontinue the avastin and he now has to take cumadin/ warfin to control blood clotting. We are now trying to get ready to start the same treatment again but he will have to receive shots everyday to control his blood clotting. Unfortunately this is a common side effect of avastin, some people have this and others don't, I would have them give him a pro-time test if they are not already doing so just as a precaution. With all chemo treatments there are side effects but very worth the outcome. I'm very excited that we will be starting the avasitn again and very hopeful that we will receive the same results that we had before minus the clots.He still gets light headed but the doctor gave him testosterone patches to help control it along with the sweats and hunger issues. I hope this helps with some of your concerns. By the way my husband was diagnosed 2 years ago and was told he had 2 months to live, they sent him home with a bottle of 500mg vicodin and told there was nothing they could do. That was not acceptable to me so with the change of Doctor, research, pure stubbornness and the help of this form he's still here today!!
           
http://www.prlog.org/11903317-patient-experiences-regarding-the-efficacy-of-avastin-in-combination-with-chemotherapy-drugs.html

The recent news that Pradaxa increases the risk of bleeding has prompted a discussion regarding the risks associated with Pradaxa use. In addition, Cardiologists & other physicians want to know patient perceptions about the bleeding risk.

PharmaFlare  through its comprehensive patient, market, and competitive intelligence, PharmaFlare tracks patient views on emergent topics that concern physicians, patients, pharmaceutical firms, and other stakeholders in the healthcare industry. Please email info@pharmaflare.com if you want access to this or our other research notes.

Our brief research note on patient viewpoints on the bleeding risk associated with Pradaxa includes:

• Representative sample views of patients using Pradaxa and concerned about bleeding risk
• Percentage of patients who faced bleeding due to Pradaxa and their views
• Percentage of patients who were switching from Pradaxa to other drugs because of bleeding and other issues, the reasons for the switch, and their views  
• Percentage of patients concerned about the mortality rate associated with Pradaxa and their views

Sample view of a patient who experienced bleeding due to Pradaxa:

Have been on Pradaxa for 17 days. Have daily nosebleeds and bloodclots. Anyone else have this problem? I was told there shouldn't be any blood anywhere. Otherwise, I tolerate it very well.

Sample view of a patient on the bleeding risk associated with Pradaxa and the resulting fatality:

Just to let you know, Pradaxa has some catastrophic side effects like spontaneous bleeding of a blood vessel in the brain causing death. I saw this for my self. A family member of mine took it for about 3-4 weeks ended up with a stroke (spontaneous bleed)- that got worse with in 8-10 hrs, was in a coma for a week and passed away a week after teh initial stroke. There are no medications to reverse the effects like with coumadin.

Sample view of a patient who switched from Pradaxa to another drug because of the bleeding risk:

Hi everyone. I was scheduled for a cardioversion next month and my new cardiologist wanted me on Pradaxa for a month prior. I asked for Pradaxa rather than warfarin. that was about a week ago.

Well yesterday I woke up and there was blood in the corner of my left eye, as if the blood vessels had burst. Today it was a bit worse. I called my Dr. and he immiediately took me off Pradaxa and postponed my cardioversion indefinitely. I also have to see an eye doctor now. I'm pretty bummed."

Further, PharmaFlare analyzed  FDA adverse events  of Pradaxa with role code as the primary suspect, the following are the findings:

• Gastrointestinal Hemorrhage ( 1214 cases reported to FDA in 2011, of which 748 cases states that Pradaxa alone is the reason for the gastrointestinal hemorrhage)
• Hemorrhage ( 713 cases reported to FDA in 2011, of which 483 cases states that Pradaxa alone is the reason for the hemorrhage)
• Death ( 425 cases reported to FDA in 2011, of which 325 cases states that Pradaxa alone is the reason for the death)

                  http://www.prlog.org/11895421-pradaxa-bleeding-risk-what-do-patients-think.html

The recent news of Actos's increased Bladder Cancer Risk has gotten everybody talking about the increased risk of using Actos. Endocrinologists and Physicians have told us that patients come to their offices with concerns about the increased bladder cancer risk & they want to know what patients are thinking about this issue.

PharmaFlare  through its comprehensive patient, market & competitive intelligence tracks patient views on leading topics that concern physicians, patients, pharmaceutical firms & other stakeholders in the healthcare industry. Please email info@pharmaflare.com if you want access to this or our other research notes.

Our brief research note on patient viewpoints on the Actos- Bladder Cancer Risk includes:

•   Representative sample views of patients using Actos AND concerned about Bladder cancer
•   Percentage of patients & sample views on why they are sticking with Actos despite news of bladder cancer risks in the media
•   Percentage of patients & sample views on why they are switching away from Actos because of bladder cancer risk and other issues
•   Percentage of patients & sample views on why despite the higher efficacy they are moving away from Actos because of the media reports

Example Patient View & their interaction with physicians on the Actos- Bladder Cancer risk:

I discussed the bladder cancer issue with my endocrinologist. He said there were some shoddy tests done in France and he was not impressed at all. He also claimed that according to these tests, there was only a fractional (minute) increase of getting bladder cancer. I then did my own research and found that additional testing was done here in the U.S. and they claimed a 40% increase in the chance of getting bladder cancer under certain conditions. Apparently the FDA felt compelled enough to issue warnings. It definitely helped with my bg in a big way, but I don't feel it's worth the risk. It is a personal decision to be determined by you and your doctor.

Example Patient View on Actos & Bladder Cancer risk:

One thing I have learned is to not blame myself as the disease progresses. My body is making less and less insulin and the resistance is increasing. At first when a new drug would be added I had a great sense of failure. I have since gotten over that. I've been on insulin, Byetta, and unfortunately Actos - which caused my bladder cancer. When I am ill or when the cancer is growing, my blood sugars are ridiculous. I currently take Victoza, metformin and glipizide. The combination seems to be working for now.

 http://www.prlog.org/11893778-actos-bladder-cancer-risk-what-do-patients-think.html

Key Insight: PharmaFlare analysis reveals that 70.8% of patient views ( Preferring combination ( n=34), total ( n=48)) are having a positive attitude towards the combination of Remicade and Imuran as Imuran is preventing the body making antibodies against the Remicade, as well as helping achieve remission. But at the same time 29.2% (Risk of Lymphoma (n=14), total (n=48)) of the patients are concerned about the risk of Lymphoma by using the combination.

In this note, many of the Gastroenterologists and managed care organization’s pharmacy directors from the US asked us to analyze patient viewpoints on Remicade and Imuran for moderate to severe ulcerative colitis.

PharmaFlare analyzed 48 different patient viewpoints on Remicade and Imuran combination, 34 of which were favorable to the combination and the rest 14 had concerns about the combination.

Sample Positive Attitudes Towards Remicade and Imuran Combination (Total 34 Comments):

Reasons for positive attitudes towards the combination:

• High Efficacy (27)
• Physician Advice (7)

Sample Comment 1:

Although ive never had a fistula, I started on imuran 1st then went on to remicade as well. Most people at my hospital are on both as the imuran helps stop the body from rejecting the remicade. Luckily i can tolerate imuran (others get side effects) and ive not had any problem with these two combinations (also on mezavant as well). I read about the increase of chance of getting cancer, but I thought the risk was worth taking to have a good quality life now.

Sample Comment 2:

Hi ddg! I am also Remicade and Imuran. Like rygon, I started Imuran first as a maintenance drug, and then added on Remicade, and I don't have a fistula. I'm also on Pred -- I ended up in the hospital for a few days with an obstruction in early March, so they loaded me up with drugs! So far, so good, though. My doc says that he will take me off of the Imuran once I am feeling better (he said maybe 3 months) because it is mainly helpful for preventing the development of antibodies in when you are first receiving
Remicade (I am doing my own little lit review on this, though -- I will post on the remi subforum if I find anything interesting). For me, I was ok with the increased cancer risk of the two drugs combined because of the added benefits the Imuran would give.

Sample Negative Attitudes Towards Remicade and Imuran Combination (Total 14 Comments):

Reasons for negative attitudes towards the combination:

• Side Effects ( 12, of which 7 are concerned about Lymphoma)
• Efficacy (1)
• Physician Advice (1)

Sample Comment 1:

My doctor wants me to stay on Remicade even though I was recently in the hospital from a partial small bowel obstruction due to inflammation. I would think that that would mean the Remicade wasn't working. He's going to keep me on the Imuran for 6-9 months and said that there's an increased risk of lymphoma when you're on both at the same time. That makes me incredibly nervous. I was nervous enough on the Remicade alone.

Sample Comment 2:

I was on azathioprine when I started Remicade, but my doctor discontinued it shortly thereafter because of a very slightly increased incidence of lymphoma for people taking both. The aza hadn't done much for me anyway, so I didn't notice any difference.
  http://www.prlog.org/11888567-remicade-and-imuran-combination-patient-experiences.html

Since there is a shortage of Voltaren Gel in the market, most of the Orthopedicians asked us to compare patient viewpoints on Pennsaid Vs Voltaren to manage the prescription choice (Pennsaid Vs Voltaren).

PharmaFlare analyzed 35 different patient viewpoints on Pennsaid VS Voltaren, 25 of which were more favorable to Pennsaid than Voltaren and the rest 10 in which Voltaren was more favorable than Pennsaid.

Sample Patient Experiences where Pennsaid was more positive than Voltaren (Total 25 Comments):

Reasons for staying with Pennsaid as compared to Voltaren:

• High Efficacy (21)
• Side Effects of Voltaren (2)
• Physician Advice (2)

Sample Comment 1:

Yeah my hands (and feet) are getting bad. No damage that I can see, but the pain and stiffness is much worse over the last year or so. I asked my dr about it and he said it's part of spondylitis and the treatment would be the same as it is with AS so diagnosis isn't important right now. But as I said My fingers slightly different now, but I'm not sure it's anything too serious yet. Like some days my wedding ring slides right off and an hour later it'll be red/blue because it's so tight. Pennsaid works well on them luckily. Pennsaid is a liquid version of voltaren, slightly better then the gel version.

Sample Comment 2:

I can't have any NSAID pills, but I've had good luck with topical NSAIDS. I've used Voltaren, Pennsaid, and a 10% ketoprofen cream made for me by a compounding pharmacist. So far, Pennsaid seems to be the strongest, though it's also the most expensive ($170 for a 2-3 month's supply.) It's worth it to be able to move, though.

Sample Comment 3:

Frankie is right. I've been using pennsaid for my elbow for the past year. It's has greatly helped my pain levels. I have found that it works much better than voltaren, which I had used previously to no avail.

Sample Patient Experiences where Voltaren was more positive than Pennsaid (Total 10 Comments):

Reasons for Switching to Voltaren from Pennsaid:

• Low Efficacy (8)
• Side Effects of Pennsaid (1)
• Physician Advice (1)

Sample Comment 1:

First, I must apologise for laughing. And I was definitely NOT laughing at your pain, but viualizing you smacking the doc while he was choking on the aspercream. Sorry. The ice thing is probably a good idea. 20 minutes on, 20 minutes off. Keep repeatting this process. But try and get some voltaren emulgel. You can get it at just aboutt any pharmacy or walmart, etc.... It works quite well. It's the same drug as the prescription Pennsaid. I was using pennsaid for about 4 years until they came out with the voltarenemulgel. I find the emulgel actually works better than the pennsaid. Try this as soon as you can. I hope it helps.

Sample Comment 2:

 I've tried both. It is my understanding that dimetyl sulfoxide would ccontribute more to the epidermal absorbtion of diclofenac sodium at 16.05 mg than the topical emugel voltaten. The use of pennsaid requires more application and would prove more expensive in the long run compared to the voltaren emugel which, i believe, delivers less diclofenic sodium.

Sample Comment 3:

Something that works well for some folks is a topical form of diclofenac (which is an anti-inflammatory). We don't want to overload our smaller stomachs with anti-inflamatories, so topical is a good option.  The topical form comes in a liquid called Pennsaid or in a gel called Voltaren.  I prefer the Voltaren.  It is less messy.  Both of these meds are expensive, so a good RX plan is necessary.
http://www.prlog.org/11885888-pennsaid-vs-voltaren-patient-experiences.html