Clinical Data Suggest Decreased Bleeding Risk in People With Severe Hemophilia A While Maintaining Factor VIII Levels Above One Percent
Anther press release on PRNewswire from Baxter that details a study that seems to prove the obvious.
Saturday, July 28, 2007
Bayer shows progress on longer-acting rFVIII
Bayer has been working on a PEGylated form of Recombinant Factor VIII. Read the press release on PRNewswire here.
Friday, July 27, 2007
Generic Biologicals ?
Sound crazy? Sound too good to be true? Maybe. But Ramesh Ponnuru at National Review Online has written about a new bill with bipartisan support that would increase competition for biologicals.
Hemophilia is easily one of the most expensive chronic care conditions to treat. Think of the difference between a 'dispense as written' name brand drug for say $140 (even with insurance) and a $5 co-pay for the generic. Now imagine those market forces at play with factor products. I'm sure even 'generic' factor products would still be expensive to produce but any price break would be welcome when worrying about lifetime caps.
Ponnuru states "The principal argument against the bill is that replicating biologics is much harder than producing generic versions of other medicines, and that generic biologics could therefore be unsafe." Safety is, of course, of prime concern. Ponnuru continues "But there is no reason to think that the FDA would approve unsafe generic biologics."
Generic clotting factor products may never be viable. But at least with passage of a bill like this they could be possible.
Read the whole thing here.
Hemophilia is easily one of the most expensive chronic care conditions to treat. Think of the difference between a 'dispense as written' name brand drug for say $140 (even with insurance) and a $5 co-pay for the generic. Now imagine those market forces at play with factor products. I'm sure even 'generic' factor products would still be expensive to produce but any price break would be welcome when worrying about lifetime caps.
Ponnuru states "The principal argument against the bill is that replicating biologics is much harder than producing generic versions of other medicines, and that generic biologics could therefore be unsafe." Safety is, of course, of prime concern. Ponnuru continues "But there is no reason to think that the FDA would approve unsafe generic biologics."
Generic clotting factor products may never be viable. But at least with passage of a bill like this they could be possible.
Read the whole thing here.
Drugs in the Pipeline and the FDA
Here's a piece at Reason online about experimental drugs for terminally ill patients and the debate concerning those patients' rights to access those drugs before they have been FDA approved.
The issues here concern the safety and efficacy of new drugs offset by urgent needs of these patients for potentially life-saving or life-extending drugs.
In the hemophilia community we're always hopeful for new factor products. We hope in the near term for factor with longer half-lives or oral or topical factor products. We hope eventually for a cure. But new pharmaceuticals take time and research and clinical trial and lots and lots of money. But does it take too much time? Can more new drugs be fast-tracked, saving time and costs that you know will end up being paid by the end-user (or rather the third party payer).
With good reason this community is cautious of product safety and is suspicious of product sales taking precedence over product safety. It’s a delicate balance to want the product improvements from the very industry that many still mistrust.
I don't know the answers. I know I want a cure for Jack as soon as possible And in lieu of that I want better and easier factor products. But at what risks?
The issues here concern the safety and efficacy of new drugs offset by urgent needs of these patients for potentially life-saving or life-extending drugs.
In the hemophilia community we're always hopeful for new factor products. We hope in the near term for factor with longer half-lives or oral or topical factor products. We hope eventually for a cure. But new pharmaceuticals take time and research and clinical trial and lots and lots of money. But does it take too much time? Can more new drugs be fast-tracked, saving time and costs that you know will end up being paid by the end-user (or rather the third party payer).
With good reason this community is cautious of product safety and is suspicious of product sales taking precedence over product safety. It’s a delicate balance to want the product improvements from the very industry that many still mistrust.
I don't know the answers. I know I want a cure for Jack as soon as possible And in lieu of that I want better and easier factor products. But at what risks?
Big brother Mike and MRAP's
Last week was also a big week for the extended Brogan family. Brother Mike had some face time at a Pentagon press briefing and before the House Armed Services committee. Mike is a USMC Brigadier General, Commander of Marine Corps Systems Command, the acquisition command for the Marines.
The briefing and congressional appearance had to do with an urgent request to shift defense money into acquiring MRAP’s (mine resistant ambush protected vehicles) for our warfighters in Iraq.
Mike handled himself well in front of both the press and the House committee.
Watching both events I can’t help but note the stark difference between the poise, demeanor and character of the men in uniform in comparison to the journalists and the politicians.
Needless to say we're especially proud of Mike and of all the men and women in uniform serving our country.
Mike (far right) at Pentagon briefing
The Pentagon MRAP site is here.
The briefing and congressional appearance had to do with an urgent request to shift defense money into acquiring MRAP’s (mine resistant ambush protected vehicles) for our warfighters in Iraq.
Mike handled himself well in front of both the press and the House committee.
Watching both events I can’t help but note the stark difference between the poise, demeanor and character of the men in uniform in comparison to the journalists and the politicians.
Needless to say we're especially proud of Mike and of all the men and women in uniform serving our country.
Mike (far right) at Pentagon briefing
The Pentagon MRAP site is here.
Hemophilia Camp
Jack went to camp for the first time this year. Wohoo!! Without a doubt he had a blast. I knew he would. I had a blast last year when I volunteered as a counselor (it was hot, sweaty, tiring and hard work but worth every minute of it).
In Texas our hemophilia camp is Camp Ailihpomeh held at Camp John Marc near Meridian. John Marc is a great camp run by Vance and Karen Gilmore and their wonderful staff.
I want to give a special thanks to the Camp Ailihpomeh organizers and volunteers from the Texas NHF Chapters and treatment centers and all across the community who work so hard to make this such a fun week for the boys.
Here are some pics of Jack from the week.
The rest of the camp pics can be seen here
In Texas our hemophilia camp is Camp Ailihpomeh held at Camp John Marc near Meridian. John Marc is a great camp run by Vance and Karen Gilmore and their wonderful staff.
I want to give a special thanks to the Camp Ailihpomeh organizers and volunteers from the Texas NHF Chapters and treatment centers and all across the community who work so hard to make this such a fun week for the boys.
Here are some pics of Jack from the week.
The rest of the camp pics can be seen here
Let's try again
Well that was an inauspicious beginning. First post and then nothing, zippo, nada for three weeks. A lot has happened in three weeks and I'll try to post on the happenings.
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