Euflexxa will over take Synvisc

[Anonymous]

I think you're giving that poster a little too much benefit of the doubt. He said, "Ass wipe, Genzyme doesnt have to report adverse events because its a myth that you created." Along with his cursing and frothing (and complete disregard for the proper use of an apostrophe), he specifically said that Genzyme doesn't have to report adverse events, not that Synvisc's AEs are a myth. If you are correct, though, it is still a little frightening that a sales rep wouldn't know about Synvisc's AEs.

So, really, why doesn't the FDA know that Genzyme is, apparently, not training their employees that adverse events need to be reported? (So far, no one has come forward refuting this assumption.) I understand that ignorance is bliss (at least as far as FDA red flags go) but what Genzyme appears to be doing is illegal. Shouldn't the FDA know about this? Or am I totally off base and Genzyme is FDA compliant in every way?

 

[Anonymous]

You must have some life trolling around on another company's board trying to stir sh*t up. So if you must keep crying because no one cares.

So, really, why doesn't the FDA know that Genzyme is, apparently, not training their employees that adverse events need to be reported? (So far, no one has come forward refuting this assumption.) I understand that ignorance is bliss (at least as far as FDA red flags go) but what Genzyme appears to be doing is illegal. Shouldn't the FDA know about this? Or am I totally off base and Genzyme is FDA compliant in every way?

 

[Anonymous]

You must have some life trolling around on another company's board trying to stir sh*t up. So if you must keep crying because no one cares.

From the FDA's Medical Device Reporting guidelines..."The term “become aware” is defined in 21 CFR part 803.3 as meaning that an employee of the entity required to report has acquired information reasonably suggesting a reportable adverse event has occurred…. Comments on these final regulations (Dec 11, 1995) read: “FDA believes that manufacturers have a direct responsibility to inform employees to immediately forward adverse event information to the appropriate person appointed by those entities to submit MDR reports. Accordingly, FDA generally considers that a manufacturer becomes aware of an adverse event whenever any employee becomes aware of an adverse event.”"

When you say "no one cares", who exactly do you mean?

 

[Anonymous]

Get a life!

From the FDA's Medical Device Reporting guidelines..."The term “become aware” is defined in 21 CFR part 803.3 as meaning that an employee of the entity required to report has acquired information reasonably suggesting a reportable adverse event has occurred…. Comments on these final regulations (Dec 11, 1995) read: “FDA believes that manufacturers have a direct responsibility to inform employees to immediately forward adverse event information to the appropriate person appointed by those entities to submit MDR reports. Accordingly, FDA generally considers that a manufacturer becomes aware of an adverse event whenever any employee becomes aware of an adverse event.”"

When you say "no one cares", who exactly do you mean?

 

[Anonymous]

Blah, blah, blah, blah

From the FDA's Medical Device Reporting guidelines..."The term “become aware” is defined in 21 CFR part 803.3 as meaning that an employee of the entity required to report has acquired information reasonably suggesting a reportable adverse event has occurred…. Comments on these final regulations (Dec 11, 1995) read: “FDA believes that manufacturers have a direct responsibility to inform employees to immediately forward adverse event information to the appropriate person appointed by those entities to submit MDR reports. Accordingly, FDA generally considers that a manufacturer becomes aware of an adverse event whenever any employee becomes aware of an adverse event.”"

When you say "no one cares", who exactly do you mean?

 

[Anonymous]

Synvisc - Try to find a website like this regarding Euflexxa! Scary!

http://synviscsurvivor.blogspot.com/


Oh and to the person that quoted (Wang) let's talk about that.....Let's ONLY take the studies that have somewhat good data and ONLY use them. My God you guys can make Agent Orange look good.

Everyone Look at these studies:
** Efficacy and Safety of Intraarticular Hylan or Hyaluronic Acids
for Osteoarthritis of the Knee (Juni)
** Inflammatory and Immunological Responses to Hyaluronan Preparations (R. A. Ottaviani, MD)

Why doesn't Genzyme quote these studies?

 

[Anonymous]

You must have some life trolling around on another company's board trying to stir sh*t up. So if you must keep crying because no one cares.

Stirring sh*t up??? Really??? That sounds like no one there knows that they're supposed to report adverse events. It sounds like this is something that would be very upsetting for them to hear. Sanofi just got a letter from the FDA. When you don't report, sh*t happens.

 

[Anonymous]

I'm a patient. Here's my non-scientific study.

Two years ago, I had five weekly injections of Synvisc which simply didn't work.

Today I had my second weekly injection of Euflexxa. After the first shot, my pain was worse. I hope that today's shot, and next week's, will result in an improvement. If not, I gueaa that the next step will be Makoplasty.

 

[Anonymous]

I'm a patient. Here's my non-scientific study.

Two years ago, I had five weekly injections of Synvisc which simply didn't work.

Today I had my second weekly injection of Euflexxa. After the first shot, my pain was worse. I hope that today's shot, and next week's, will result in an improvement. If not, I gueaa that the next step will be Makoplasty.

Someone should really shoot you, not with a visco, but a bullet.

 

[Anonymous]

I'm a patient. Here's my non-scientific study.

Two years ago, I had five weekly injections of Synvisc which simply didn't work.

Today I had my second weekly injection of Euflexxa. After the first shot, my pain was worse. I hope that today's shot, and next week's, will result in an improvement. If not, I gueaa that the next step will be Makoplasty.

Whoever you are you have no clue what you are talking about ....
Synvisc is 3 or 1 injections -- not 5 And
Euflexxa is 3 only and you said you received 2 shots already and you are scheduled for 2 more... sorry thats not Euflexxa either..
** get your products right before you post.

 

[Anonymous]

You absolutely do not have better efficacy. You can't even get a 26 week indication. It's all in how you counsel the patient will determine what's considered a "side Effect". As for cost, well, you will drag down reimbursement in your JCode with our other competitors, and eventually cause what the offices get back to drop in future quarters. Go learn how to work with the whole office, not just the Dr., Rent-A-Rep.

"How to Counsel the Patient" about your side effects." WTF are you talking about? Are you in the room every time a provider injects? Do you think they are going to spend the time educating the patients on the side effects that none of the other brands have???? Give me a break? You all talk about positive effects on your long half life when in fact it is a Negative because it just means all of your crap just stays in the synovial cavity longer to cause possible infections. And I can't for the life of me understand why a Dr. would want to stock your product other than he is too lazy, greedy or doesn't want to be bothered. The other brands do not have near the side effects you have or infection rates.

And now you are trying to keep Zimmer, single injection out of the market with your bogus law suit, when it's a cleaner product than Synvisc 1? Good luck with that.

 

[Anonymous]

Reading this was quite amusing. I am not a rep for either company but am in the industry. As a distributor I would just like to say that pharmaceutical companes are evil. You charge outrageous amounts to U.S. patients while Canadian patients can get the exact same thing for a fraction of the cost. Then you bullied doctors and went on a scare campaign to make them think they were breaking the law to bring in your DEVICE from Canada. You change your paackage inserts just enough to make it "illegal" to use in the U.S. even though it is the EXACT SAME PRODUCT! I don't know how you all sleep at night knowing that the cost of manufacturing it is so low. What is your profit percentage? 1000% ?

 

[Anonymous]

infections?

talk to the next 100 Doctors you call on and ask them about "infections" as a side effect.

 

[Anonymous]

How much of Synvisc business in your territories is by credit card?

 

[Anonymous]

Whoever you are you have no clue what you are talking about ....
Synvisc is 3 or 1 injections -- not 5 And
Euflexxa is 3 only and you said you received 2 shots already and you are scheduled for 2 more... sorry thats not Euflexxa either..
** get your products right before you post.

Recalculate the Euflexxa. It adds up to 3, sorry to burst your math bubble. From first-hand experience, Euflexxa has also left me worse than I was pre-injection. No, I'm not a rep nor a Dr. but a real person with a real problem only aggrivated by Euflexxa. I simply cannot trust any viscosupplimentation after what I went through with a product that has no more efficacy than water.

 

[Anonymous]

I had SynviscOne injections and have experienced a reduction in knee pain. My insurance company will now only cover Euflexxa or Orthovisc injections. How does it save money to visit a surgeon three times vs. one time? And how does Orthovisce compare to Euflexxa and Synvisc?

 

[Anonymous]

I too, had a bad reaction to Synvisc. Worked great the first time for six months, but second go round my knees swelled up like balloons and excess fluid had to be removed. I was in great pain. Dr. said a small percentage of people have such a reaction but only to Synvisc (which they prefer to use in their clinic). Dr. suggested we try Euflexxa switch brands and said is was a "synthetic" version of the same medicine. I had my first shot in each knee yesterday and so far so good, in fact, I dare say I feel less pain today and up to going to work. Perhaps it boils down to what works for each individual and having competition in the marketplace is a good thing. I will post a follow up after 12 weeks to see how this worked for me. Mrs. T

 

[Anonymous]

"How to Counsel the Patient" about your side effects." WTF are you talking about? Are you in the room every time a provider injects? Do you think they are going to spend the time educating the patients on the side effects that none of the other brands have???? Give me a break? You all talk about positive effects on your long half life when in fact it is a Negative because it just means all of your crap just stays in the synovial cavity longer to cause possible infections. And I can't for the life of me understand why a Dr. would want to stock your product other than he is too lazy, greedy or doesn't want to be bothered. The other brands do not have near the side effects you have or infection rates.

And now you are trying to keep Zimmer, single injection out of the market with your bogus law suit, when it's a cleaner product than Synvisc 1? Good luck with that.

Youre an idiot! I guess you have a Law Degree to make your professional judgement, you must be one of those contract hacks.

 

[Anonymous]

I think you're giving that poster a little too much benefit of the doubt. He said, "Ass wipe, Genzyme doesnt have to report adverse events because its a myth that you created." Along with his cursing and frothing (and complete disregard for the proper use of an apostrophe), he specifically said that Genzyme doesn't have to report adverse events, not that Synvisc's AEs are a myth. If you are correct, though, it is still a little frightening that a sales rep wouldn't know about Synvisc's AEs.

Hey, buddy, Genzyme does report adverse events, if not for Synvisc, at least for Seprafilm! Just take a look at this one that was just posted on the FDA's MAUDE database. If this doesn't provide enough information about Seprafilm's adverse events, I don't know what does....

GENZYME BIOSURGERY (SEPRAFILM/PACK) SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE BIORESORBABLE ADHESION BARRIER Back to Search Results
Event Type Patient Outcome Other;
Event Description

Event that was similar [adverse event]. Case description: spontaneous report was received on (b)(6) 2011 from a physician via a company sales rep regarding a pt, initials not provided. The pt's medical history was not provided. On an unspecified date, the pt had an unspecified surgery during which seprafilm, lot number unk, was applied. On an unk date, the pt experienced an "event" that was similar to three other patients. Location of event, past surgical history, allergies, and exposure during surgery were all unk. The action taken with seprafilm was not provided. The pt's outcome for the event was not provided. Concomitant medications were not provided. The reporting physician assessed the relationship between seprafilm and the unspecified adverse event as definitely related. See manufacturer's control number (b)(4) for other adverse events from this reporter.

 

[Anonymous]

I was trying to find information about pseudosepsis and this site came up in the search. I can't believe what I've read... this is nothing but juvenile testosterone-driven name-calling appropriate for the playground. What's it going to be next: My great-aunt's attorney's dog can take your great-aunts attorney's dog?