RE: Advanced PCa Malecare Group from the UK - Treatment and progress update.

[Guest guest]

I’ll just jump in to say that I expect most all drugs are out-sourced to other countries for manufacture.  Drugs from India are more than likely equal to those sold in the U.S. – primarily because those sold in the U.S.- and probably the U.K. - are more than likely out-sourced for manufacture in India as well as other countries.   The government of India has decreed that as long as a drug is produced in the generic form of an otherwise trademarked brand name, and the ingredients are equal to but not precisely identical in all forms to the brand name drug, they are authorized by that government to be manufactured for their own pharmaceutical use. The foregoing remark and the following interesting comment were in a paper no longer available on the internet, but pretty much explains: “However, the major firms say their plants, like this one owned by the Bombay-based Cipla Company, are more than safe. Many, in fact, are inspected by the U.S. Food and Drug Administration, since Indian companies export billions of dollars each year in generic drugs to the American market.†Interesting to note that brand name Actos is actually manufactured and supplied from Japan, as is brand name Flomax.Brand name Avodart is manufactured and supplied from France.The new generic bicalutamide/Casodex has been approved by the FDA to be manufactured and supplied from India. Of interest – with Casodex now available for manufacture in generic bicalutamide form, this generic will likely come up with different names in different countries. Below is an article to which I have added the headquarter locations of each drug manufacturer, and many of these manufacturers have offices in the United States: Wednesday, 8 July, 2009Bicalutamide (Casodex) 50 mg tablets: Generic approvals Various generic players have received final approval to market anti-cancer formulation Bicalutamide (Casodex) 50 mg tablets after the expiry of product patent US4636505 (Expiry: Apr 1, 2009) in USA. Following generic players have got final approval from USFDA:1. Teva - Israel2. Synthon - Netherlands3. Kudoco - Ireland4. Sandoz - Germany5. Accord Healthcare - India6. Zydus Pharma – Germany/India7. Sun Pharma - India8. Mylan – U.S. (but likely out-sources)The generic Bicalutamide (Casodex) 50 mg tablets are bioequivalent to Casodex® tablets from AstraZeneca. As per IMS, Casodex® tablets have annual sales of approximately USD 314 million in the US. Earlier, innovator (My note: India) had approval from USFDA to market this product on October 4, 1995. Above info also available at:http://ippharmdoc.blogspot.com/2009/07/bicalutamide-casodex-50-mg-tablets.html As to Bob being able to get a prescription for Cialis when needed, chalk one up for the NHS in recognizing the importance of PDE5 inhibitors for men with impotence/libido issues as the result of treatment for, in our case, prostate cancer.  Would that our health insurers were as supportive. Chuck " What you leave behind is not what is engraved in stone monuments, but what is woven into the lives of others. " (Chuck) Maack - Prostate Cancer Advocate/Activist Email: maack1@... PCa Help: " Observations " http://www.theprostateadvocate.com From: ProstateCancerSupport [mailto:ProstateCancerSupport ] On Behalf Of CochraneSent: Sunday, March 04, 2012 3:22 PMTo: ProstateCancerSupport Subject: Advanced PCa Malecare Group from the UK - Treatment and progress update. It is my understanding that the NHS sources drugs from many places, sometimes not from the brand manufacturer. This may be so even if the drug is still on patent in the US. Can anyone confirm if medicine in the UK comes from S Africa, India or elsewhere other than brand manufacturers?I actually think that this may be a good idea. I am not criticizing the practice, per se. There is no problem getting Cialis on the NHS in the UK. My doctor prescribes it whenever I ask and since I am over 60 there is no prescription charge. I currently take a 20mg tablet twice a week, which seems to do the trick.Bob From: ProstateCancerSupport [mailto:ProstateCancerSupport ] On Behalf Of El HorizonteSent: 04 March 2012 18:30To: ProstateCancerSupport Subject: -----SPAM----- Re: FW: Advanced PCa Malecare Group from the UK - Treatment and progress update.  Another point is that in the UK we don't have any 'Co-Pay' for drugs as many schemes in the USA I understand have. My Spanish private health insurance is excellent bar the fact that it's 100% co-pay for drugs! The 'price' for premiums being only 110Euros per month with no other limits on treatment. I have friends in UK who receive Viagra on request from the NHS for ED caused by for instance diabetes, with no charge other than the standard one-off prescription charge (last time I was in UK that was £7 I think - not sure of cost now). I would be interested to hear from any one in the UK if the NHS prescribes & funds the new daily 5mg Viagra or Cialis equivalent for post prostatectomy or radiation. Judging by the comments on this site it seems to be a constant battle with insurance companies for prostate cancer patients in the US to get the daily dose as part of their cover. Spain RE: FW: Advanced PCa Malecare Group from the UK - Treatment and progress update. Sorry, Chuck, but with the greatest respect that’s nonsense. Of course cost is a factor – no scheme has unlimited funds - but NICE works very hard to make recommendations based on value for money getting the best value for patients with the money available. That seems perfectly reasonable. They don’t always get it right which is why we are trying to persuade them to reconsider on Abiraterone.BobFrom: ProstateCancerSupport [mailto:ProstateCancerSupport ] On Behalf Of Chuck MaackSent: 04 March 2012 16:58To: ProstateCancerSupport Subject: FW: Advanced PCa Malecare Group from the UK - Treatment and progress update. Unfortunate for and other patients in the UK, but supports my contention that “cost†to the government health system is the prominent concern in the UK, not the patient.Chuck Hi to you allIn view of the current postings about various reactions to Taxo and numbers of infusions to have I thought I would just update my current position.My PSA shot up from 2 to 116 in three months from Dec.10 to Mar.11 having been pretty low and stable for the previous 18 months since diagnosis – (Gleeson 4+3 & tertiary 5, multiple met. spread but no pain) and taking the usual three monthly hormone injection (Triptolerin). Started Taxo Apr.11 on three weekly cycle and PSA reduced quickly to 22 after No.3 and then more slowly to 1.5 after No.7. After No.8 it rose to 1.6 and my ONC stopped it. Side effects were quite tolerable apart from tiredness and hair loss but coming off the prescribed steroids was quite awful (I have since learned that I came off them far too quickly so beware of this). ONC then said play a waiting game but after six weeks PSA had jumped to 23. (Oct.11). Zytiga had then just been approved in the UK so I started on that in Nov.11 and am still on it. PSA has dropped to 8 and I have no side effects at all which is great. My hair has grown back but rather curly and wavy much to my family’s amusement and arm and leg etc. hair now sticks out like small bristles. I have been told that blood pressure rise and potassium levels need watching but both are fine as are my other blood markers. Unfortunately the drug regulating body in the UK (N.I.C.E.) have withdrawn government funding for Zytiga on the grounds that our National Health Service cannot afford the £3000 monthly cost so at the moment my private health insurance is picking up the tab. I do not know for how long Zytiga will be effective so I am keeping my fingers crossed – I also am back on steroids (only 2 prednisolone daily).My excellent ONC reckons that MDV3100 will be approved in the UK by the end of 2012 and that, in conjunction with Zytiga, will continue to keep the beast back in its box.I learn so much from this Group and try to maintain a really positive attitude, do some sensible exercises and have a good diet (principally as Dr. Jane Plant’s book) plus take a few supplements. For me the fear has been taken out of the equation thanks to the doughty fighters here describing their struggle in heartbreaking but inspiring detail. I realise that we cannot defeat the dreaded PCa yet but the advances coming down the medical pipeline give me some guarded hope for a few more years (the big 70 in three weeks).With very best wishes.=

[Guest guest]



According to The Times yesterday the big drug companies are playing games and restricting the availablility of drugs in the UK. If this is the case they are acting pretty naughty

B

RE: FW: Advanced PCa Malecare Group from the UK - Treatment and progress update.

Sorry, Chuck, but with the greatest respect that’s nonsense. Of course cost is a factor – no scheme has unlimited funds - but NICE works very hard to make recommendations based on value for money getting the best value for patients with the money available. That seems perfectly reasonable. They don’t always get it right which is why we are trying to persuade them to reconsider on Abiraterone.

Bob

From: ProstateCancerSupport [mailto:ProstateCancerSupport ] On Behalf Of Chuck MaackSent: 04 March 2012 16:58To: ProstateCancerSupport Subject: FW: Advanced PCa Malecare Group from the UK - Treatment and progress update.

Unfortunate for and other patients in the UK, but supports my contention that “cost†to the government health system is the prominent concern in the UK, not the patient.

Chuck

Hi to you all

In view of the current postings about various reactions to Taxo and numbers of infusions to have I thought I would just update my current position.

My PSA shot up from 2 to 116 in three months from Dec.10 to Mar.11 having been pretty low and stable for the previous 18 months since diagnosis – (Gleeson 4+3 & tertiary 5, multiple met. spread but no pain) and taking the usual three monthly hormone injection (Triptolerin). Started Taxo Apr.11 on three weekly cycle and PSA reduced quickly to 22 after No.3 and then more slowly to 1.5 after No.7. After No.8 it rose to 1.6 and my ONC stopped it. Side effects were quite tolerable apart from tiredness and hair loss but coming off the prescribed steroids was quite awful (I have since learned that I came off them far too quickly so beware of this).

ONC then said play a waiting game but after six weeks PSA had jumped to 23. (Oct.11). Zytiga had then just been approved in the UK so I started on that in Nov.11 and am still on it. PSA has dropped to 8 and I have no side effects at all which is great. My hair has grown back but rather curly and wavy much to my family’s amusement and arm and leg etc. hair now sticks out like small bristles. I have been told that blood pressure rise and potassium levels need watching but both are fine as are my other blood markers. Unfortunately the drug regulating body in the UK (N.I.C.E.) have withdrawn government funding for Zytiga on the grounds that our National Health Service cannot afford the £3000 monthly cost so at the moment my private health insurance is picking up the tab. I do not know for how long Zytiga will be effective so I am keeping my fingers crossed – I also am back on steroids (only 2 prednisolone daily).

My excellent ONC reckons that MDV3100 will be approved in the UK by the end of 2012 and that, in conjunction with Zytiga, will continue to keep the beast back in its box.

I learn so much from this Group and try to maintain a really positive attitude, do some sensible exercises and have a good diet (principally as Dr. Jane Plant’s book) plus take a few supplements. For me the fear has been taken out of the equation thanks to the doughty fighters here describing their struggle in heartbreaking but inspiring detail. I realise that we cannot defeat the dreaded PCa yet but the advances coming down the medical pipeline give me some guarded hope for a few more years (the big 70 in three weeks).

With very best wishes.

=

[Guest guest]

The US is having a problem with drug shortages also. http://online.wsj.com/article/SB10001424052970203986604577253242913478400.html?mod=googlenews_wsj Kathy From: ProstateCancerSupport [mailto:ProstateCancerSupport ] On Behalf Of MetcalfSent: Sunday, March 04, 2012 6:59 PMTo: ProstateCancerSupport Subject: Re: Advanced PCa Malecare Group from the UK - Treatment and progress update.  According to The Times yesterday the big drug companies are playing games and restricting the availablility of drugs in the UK. If this is the case they are acting pretty naughty B RE: FW: Advanced PCa Malecare Group from the UK - Treatment and progress update. Sorry, Chuck, but with the greatest respect that’s nonsense. Of course cost is a factor – no scheme has unlimited funds - but NICE works very hard to make recommendations based on value for money getting the best value for patients with the money available. That seems perfectly reasonable. They don’t always get it right which is why we are trying to persuade them to reconsider on Abiraterone.BobFrom: ProstateCancerSupport [mailto:ProstateCancerSupport ] On Behalf Of Chuck MaackSent: 04 March 2012 16:58To: ProstateCancerSupport Subject: FW: Advanced PCa Malecare Group from the UK - Treatment and progress update. Unfortunate for and other patients in the UK, but supports my contention that “cost†to the government health system is the prominent concern in the UK, not the patient.Chuck Hi to you allIn view of the current postings about various reactions to Taxo and numbers of infusions to have I thought I would just update my current position.My PSA shot up from 2 to 116 in three months from Dec.10 to Mar.11 having been pretty low and stable for the previous 18 months since diagnosis – (Gleeson 4+3 & tertiary 5, multiple met. spread but no pain) and taking the usual three monthly hormone injection (Triptolerin). Started Taxo Apr.11 on three weekly cycle and PSA reduced quickly to 22 after No.3 and then more slowly to 1.5 after No.7. After No.8 it rose to 1.6 and my ONC stopped it. Side effects were quite tolerable apart from tiredness and hair loss but coming off the prescribed steroids was quite awful (I have since learned that I came off them far too quickly so beware of this). ONC then said play a waiting game but after six weeks PSA had jumped to 23. (Oct.11). Zytiga had then just been approved in the UK so I started on that in Nov.11 and am still on it. PSA has dropped to 8 and I have no side effects at all which is great. My hair has grown back but rather curly and wavy much to my family’s amusement and arm and leg etc. hair now sticks out like small bristles. I have been told that blood pressure rise and potassium levels need watching but both are fine as are my other blood markers. Unfortunately the drug regulating body in the UK (N.I.C.E.) have withdrawn government funding for Zytiga on the grounds that our National Health Service cannot afford the £3000 monthly cost so at the moment my private health insurance is picking up the tab. I do not know for how long Zytiga will be effective so I am keeping my fingers crossed – I also am back on steroids (only 2 prednisolone daily).My excellent ONC reckons that MDV3100 will be approved in the UK by the end of 2012 and that, in conjunction with Zytiga, will continue to keep the beast back in its box.I learn so much from this Group and try to maintain a really positive attitude, do some sensible exercises and have a good diet (principally as Dr. Jane Plant’s book) plus take a few supplements. For me the fear has been taken out of the equation thanks to the doughty fighters here describing their struggle in heartbreaking but inspiring detail. I realise that we cannot defeat the dreaded PCa yet but the advances coming down the medical pipeline give me some guarded hope for a few more years (the big 70 in three weeks).With very best wishes.=