Tuesday, October 16, 2012

Copaxone: New MS Drug Just More of the Same

A big change is coming to one of the major drugs used to treat multiple sclerosis. If you follow my blog, then you will not be surprised by the fact that *I* am not surprised. But then, I am just a blogger with MS and no one will ever put much store in my musings, ideas, or questions. (My last three neurologitst have made that abundantly clear. My questioning of their opinions has been met with anger, revenge, and a quick dismissal of my title of a HUMAN BEING.)

Teva Marion's billion dollar MS drug, Copaxone, is about to receive approval from the FDA (Food and Drug Administration) for a new dosage of Copaxone. Instead of daily doses (by injection) of 20mg, it will be 3 times per week at 40mg. (Drama student putting on her math cap.) That is 120mg per week instead of 140mg, or one injection different.

What? You think more at once somehow changes everything? If that is the case, wouldn't Teva say so? Unless they are hiding some good news like that (and we KNOW how Big Pharma likes to hide good news, as much as Montel Williams likes to hide his MS diagnosis), I haven't read it anywhere.

What? You think this must show better outcome? Well, YOU read the dispatch from Teva and see what you think: "The full set of positive data from a Phase III trial presented at ECTRIMS (European Committee for Treatment and Research in Multiple Sclerosis) of high dosage Copaxone found that it significantly reduced disease activity, and had a favourable safety and tolerability profile. In June, the firm noted that the 40mg dose significantly reduced annualised relapse rates by 34.4% versus placebo." 

Need to read that again? Let me dissect just one part--"annualised," not annual, not yearly, but this means: "To adjust or calculate so as to reflect a rate that is based on a full year." Subtle difference, but enough to keep them away from a court of law.  They could use a couple months data and get away with that percentage. Almost as clever as selling drugs only to pateints during a stage of their disease when the drugs professed results could happen easily without the drug. Almost as clever as paying doctors a little dough on the side to promote their drug. Almost as clever as never telling us what percentage the placebo had for annualised (or better ANNUAL, since it can take a few months, even a year for a full picture of any relapse lasting long enough for you to even remember it happened. "I know I had MS before because such and such happened to me years ago...") relapse rate.

This 'new and improved' (Remember the ads for Rebif? Only by reading the small print could we learn it was just different dose of Avonex.) MS drug will be given to newly diagnosed folks real soon. With the advances in earlier diagnosis, more opportunities to show positive data. The sooner they catch it, the sooner your complete remissions will occur and mild, benign, cases will FILL the data banks! Yea! In 30 years who will remember all the false claims? The twisted words? The lack of anything even NEAR a cure? For Big Pharma (whose CEO's will be retired and on their yachts) it is another win-win.

Did you notice that earlier this year Teva was hand-slapped by the FDA for its ads and testimonials about people with MS mountain climbing, skiing, running, etc., after starting Copaxone? How long have I been complaining about such ads? Even others with MS jumped on me for being too cynical and drenched in "negativity."

Okay, maybe not today, maybe not in a decade, but one day the truth will be known about multiple sclerosis and all the drugs being sold to "halt," (yes, I saw that somewhere) its natural course. Until that day: Up in the top right corner of my blog: This Blog is NOT For Sale, and will remain "100% Big Pharma-Sponsor Free.






4 comments:

Webster said...

A big change is coming to one of the major drugs used to treat multiple sclerosis. If you follow my blog, then you will not be surprised by the fact that *I* am not surprised. But then, I am just a blogger with MS and no one will ever put much store in my musings, ideas, or questions. (My last three neurologitst have made that abundantly clear. My questioning of their opinions has been met with anger, revenge, and a quick dismissal of my title of a HUMAN BEING.)

Teva Marion's billion dollar MS drug, Copaxone, is about to receive approval from the FDA (Food and Drug Administration) for a new dosage of Copaxone. Instead of daily doses (by injection) of 20mg, it will be 3 times per week at 40mg. (Drama student putting on her math cap.) That is 120mg per week instead of 140mg, or one injection different.

What? You think more at once somehow changes everything? If that is the case, wouldn't Teva say so? Unless they are hiding some good news like that (and we KNOW how Big Pharma likes to hide good news, as much as Montel Williams likes to hide his MS diagnosis), I haven't read it anywhere.

What? You think this must show better outcome? Well, YOU read the dispatch from Teva and see what you think: "The full set of positive data from a Phase III trial presented at ECTRIMS (European Committee for Treatment and Research in Multiple Sclerosis) of high dosage Copaxone found that it significantly reduced disease activity, and had a favourable safety and tolerability profile. In June, the firm noted that the 40mg dose significantly reduced annualised relapse rates by 34.4% versus placebo." 

Need to read that again? Let me dissect just one part--"annualised," not annual, not yearly, but this means: "To adjust or calculate so as to reflect a rate that is based on a full year." Subtle difference, but enough to keep them away from a court of law.  They could use a couple months data and get away with that percentage. Almost as clever as selling drugs only to pateints during a stage of their disease when the drugs professed results could happen easily without the drug. Almost as clever as paying doctors a little dough on the side to promote their drug. Almost as clever as never telling us what percentage the placebo had for annualised (or better ANNUAL, since it can take a few months, even a year for a full picture of any relapse lasting long enough for you to even remember it happened. "I know I had MS before because such and such happened to me years ago...") relapse rate.

This 'new and improved' (Remember the ads for Rebif? Only by reading the small print could we learn it was just different dose of Avonex.) MS drug will be given to newly diagnosed folks real soon. With the advances in earlier diagnosis, more opportunities to show positive data. The sooner they catch it, the sooner your complete remissions will occur and mild, benign, cases will FILL the data banks! Yea! In 30 years who will remember all the false claims? The twisted words? The lack of anything even NEAR a cure? For Big Pharma (whose CEO's will be retired and on their yachts) it is another win-win.

Did you notice that earlier this year Teva was hand-slapped by the FDA for its ads and testimonials about people with MS mountain climbing, skiing, running, etc., after starting Copaxone? How long have I been complaining about such ads? Even others with MS jumped on me for being too cynical and drenched in "negativity."

Okay, maybe not today, maybe not in a decade, but one day the truth will be known about multiple sclerosis and all the drugs being sold to "halt," (yes, I saw that somewhere) its natural course. Until that day: Up in the top right corner of my blog: This Blog is NOT For Sale, and will remain "100% Big Pharma-Sponsor Free.






Stumble Upon Toolbar
Karen said...

A big change is coming to one of the major drugs used to treat multiple sclerosis. If you follow my blog, then you will not be surprised by the fact that *I* am not surprised. But then, I am just a blogger with MS and no one will ever put much store in my musings, ideas, or questions. (My last three neurologitst have made that abundantly clear. My questioning of their opinions has been met with anger, revenge, and a quick dismissal of my title of a HUMAN BEING.)

Teva Marion's billion dollar MS drug, Copaxone, is about to receive approval from the FDA (Food and Drug Administration) for a new dosage of Copaxone. Instead of daily doses (by injection) of 20mg, it will be 3 times per week at 40mg. (Drama student putting on her math cap.) That is 120mg per week instead of 140mg, or one injection different.

What? You think more at once somehow changes everything? If that is the case, wouldn't Teva say so? Unless they are hiding some good news like that (and we KNOW how Big Pharma likes to hide good news, as much as Montel Williams likes to hide his MS diagnosis), I haven't read it anywhere.

What? You think this must show better outcome? Well, YOU read the dispatch from Teva and see what you think: "The full set of positive data from a Phase III trial presented at ECTRIMS (European Committee for Treatment and Research in Multiple Sclerosis) of high dosage Copaxone found that it significantly reduced disease activity, and had a favourable safety and tolerability profile. In June, the firm noted that the 40mg dose significantly reduced annualised relapse rates by 34.4% versus placebo." 

Need to read that again? Let me dissect just one part--"annualised," not annual, not yearly, but this means: "To adjust or calculate so as to reflect a rate that is based on a full year." Subtle difference, but enough to keep them away from a court of law.  They could use a couple months data and get away with that percentage. Almost as clever as selling drugs only to pateints during a stage of their disease when the drugs professed results could happen easily without the drug. Almost as clever as paying doctors a little dough on the side to promote their drug. Almost as clever as never telling us what percentage the placebo had for annualised (or better ANNUAL, since it can take a few months, even a year for a full picture of any relapse lasting long enough for you to even remember it happened. "I know I had MS before because such and such happened to me years ago...") relapse rate.

This 'new and improved' (Remember the ads for Rebif? Only by reading the small print could we learn it was just different dose of Avonex.) MS drug will be given to newly diagnosed folks real soon. With the advances in earlier diagnosis, more opportunities to show positive data. The sooner they catch it, the sooner your complete remissions will occur and mild, benign, cases will FILL the data banks! Yea! In 30 years who will remember all the false claims? The twisted words? The lack of anything even NEAR a cure? For Big Pharma (whose CEO's will be retired and on their yachts) it is another win-win.

Did you notice that earlier this year Teva was hand-slapped by the FDA for its ads and testimonials about people with MS mountain climbing, skiing, running, etc., after starting Copaxone? How long have I been complaining about such ads? Even others with MS jumped on me for being too cynical and drenched in "negativity."

Okay, maybe not today, maybe not in a decade, but one day the truth will be known about multiple sclerosis and all the drugs being sold to "halt," (yes, I saw that somewhere) its natural course. Until that day: Up in the top right corner of my blog: This Blog is NOT For Sale, and will remain "100% Big Pharma-Sponsor Free.






Stumble Upon Toolbar
kmilyun said...

A big change is coming to one of the major drugs used to treat multiple sclerosis. If you follow my blog, then you will not be surprised by the fact that *I* am not surprised. But then, I am just a blogger with MS and no one will ever put much store in my musings, ideas, or questions. (My last three neurologitst have made that abundantly clear. My questioning of their opinions has been met with anger, revenge, and a quick dismissal of my title of a HUMAN BEING.)

Teva Marion's billion dollar MS drug, Copaxone, is about to receive approval from the FDA (Food and Drug Administration) for a new dosage of Copaxone. Instead of daily doses (by injection) of 20mg, it will be 3 times per week at 40mg. (Drama student putting on her math cap.) That is 120mg per week instead of 140mg, or one injection different.

What? You think more at once somehow changes everything? If that is the case, wouldn't Teva say so? Unless they are hiding some good news like that (and we KNOW how Big Pharma likes to hide good news, as much as Montel Williams likes to hide his MS diagnosis), I haven't read it anywhere.

What? You think this must show better outcome? Well, YOU read the dispatch from Teva and see what you think: "The full set of positive data from a Phase III trial presented at ECTRIMS (European Committee for Treatment and Research in Multiple Sclerosis) of high dosage Copaxone found that it significantly reduced disease activity, and had a favourable safety and tolerability profile. In June, the firm noted that the 40mg dose significantly reduced annualised relapse rates by 34.4% versus placebo." 

Need to read that again? Let me dissect just one part--"annualised," not annual, not yearly, but this means: "To adjust or calculate so as to reflect a rate that is based on a full year." Subtle difference, but enough to keep them away from a court of law.  They could use a couple months data and get away with that percentage. Almost as clever as selling drugs only to pateints during a stage of their disease when the drugs professed results could happen easily without the drug. Almost as clever as paying doctors a little dough on the side to promote their drug. Almost as clever as never telling us what percentage the placebo had for annualised (or better ANNUAL, since it can take a few months, even a year for a full picture of any relapse lasting long enough for you to even remember it happened. "I know I had MS before because such and such happened to me years ago...") relapse rate.

This 'new and improved' (Remember the ads for Rebif? Only by reading the small print could we learn it was just different dose of Avonex.) MS drug will be given to newly diagnosed folks real soon. With the advances in earlier diagnosis, more opportunities to show positive data. The sooner they catch it, the sooner your complete remissions will occur and mild, benign, cases will FILL the data banks! Yea! In 30 years who will remember all the false claims? The twisted words? The lack of anything even NEAR a cure? For Big Pharma (whose CEO's will be retired and on their yachts) it is another win-win.

Did you notice that earlier this year Teva was hand-slapped by the FDA for its ads and testimonials about people with MS mountain climbing, skiing, running, etc., after starting Copaxone? How long have I been complaining about such ads? Even others with MS jumped on me for being too cynical and drenched in "negativity."

Okay, maybe not today, maybe not in a decade, but one day the truth will be known about multiple sclerosis and all the drugs being sold to "halt," (yes, I saw that somewhere) its natural course. Until that day: Up in the top right corner of my blog: This Blog is NOT For Sale, and will remain "100% Big Pharma-Sponsor Free.






Stumble Upon Toolbar
Sherri said...

A big change is coming to one of the major drugs used to treat multiple sclerosis. If you follow my blog, then you will not be surprised by the fact that *I* am not surprised. But then, I am just a blogger with MS and no one will ever put much store in my musings, ideas, or questions. (My last three neurologitst have made that abundantly clear. My questioning of their opinions has been met with anger, revenge, and a quick dismissal of my title of a HUMAN BEING.)

Teva Marion's billion dollar MS drug, Copaxone, is about to receive approval from the FDA (Food and Drug Administration) for a new dosage of Copaxone. Instead of daily doses (by injection) of 20mg, it will be 3 times per week at 40mg. (Drama student putting on her math cap.) That is 120mg per week instead of 140mg, or one injection different.

What? You think more at once somehow changes everything? If that is the case, wouldn't Teva say so? Unless they are hiding some good news like that (and we KNOW how Big Pharma likes to hide good news, as much as Montel Williams likes to hide his MS diagnosis), I haven't read it anywhere.

What? You think this must show better outcome? Well, YOU read the dispatch from Teva and see what you think: "The full set of positive data from a Phase III trial presented at ECTRIMS (European Committee for Treatment and Research in Multiple Sclerosis) of high dosage Copaxone found that it significantly reduced disease activity, and had a favourable safety and tolerability profile. In June, the firm noted that the 40mg dose significantly reduced annualised relapse rates by 34.4% versus placebo." 

Need to read that again? Let me dissect just one part--"annualised," not annual, not yearly, but this means: "To adjust or calculate so as to reflect a rate that is based on a full year." Subtle difference, but enough to keep them away from a court of law.  They could use a couple months data and get away with that percentage. Almost as clever as selling drugs only to pateints during a stage of their disease when the drugs professed results could happen easily without the drug. Almost as clever as paying doctors a little dough on the side to promote their drug. Almost as clever as never telling us what percentage the placebo had for annualised (or better ANNUAL, since it can take a few months, even a year for a full picture of any relapse lasting long enough for you to even remember it happened. "I know I had MS before because such and such happened to me years ago...") relapse rate.

This 'new and improved' (Remember the ads for Rebif? Only by reading the small print could we learn it was just different dose of Avonex.) MS drug will be given to newly diagnosed folks real soon. With the advances in earlier diagnosis, more opportunities to show positive data. The sooner they catch it, the sooner your complete remissions will occur and mild, benign, cases will FILL the data banks! Yea! In 30 years who will remember all the false claims? The twisted words? The lack of anything even NEAR a cure? For Big Pharma (whose CEO's will be retired and on their yachts) it is another win-win.

Did you notice that earlier this year Teva was hand-slapped by the FDA for its ads and testimonials about people with MS mountain climbing, skiing, running, etc., after starting Copaxone? How long have I been complaining about such ads? Even others with MS jumped on me for being too cynical and drenched in "negativity."

Okay, maybe not today, maybe not in a decade, but one day the truth will be known about multiple sclerosis and all the drugs being sold to "halt," (yes, I saw that somewhere) its natural course. Until that day: Up in the top right corner of my blog: This Blog is NOT For Sale, and will remain "100% Big Pharma-Sponsor Free.






Stumble Upon Toolbar
 
Outpost