Comments on: FDA To Devise New Guidelines For Drug Cocktails http://www.pharmalot.com/2010/03/fda-to-devise-new-guidelines-for-drug-cocktails/ News, Comment and Conversation Fri, 10 Feb 2012 20:52:32 +0000 http://wordpress.org/?v=2.6.2 By: G http://www.pharmalot.com/2010/03/fda-to-devise-new-guidelines-for-drug-cocktails/#comment-487563 G Wed, 07 Apr 2010 19:30:11 +0000 http://www.pharmalot.com/?p=22035#comment-487563 This is will be of major benefit to patients. Finally, the FDA has done something helpful for drug discovery. This is not a ploy to create super viagra. There are many complex diseases for which no single entity has worked or, indeed, may ever work. If new drugs for these indications that might be useful in combination need to show individual efficacy to reach the clinic there is no chance for them. What are the patients supposed to do, wait for the impossible? As a scientist specialing in severe diseases with unmet need, I say thank you FDA! This is will be of major benefit to patients. Finally, the FDA has done something helpful for drug discovery. This is not a ploy to create super viagra. There are many complex diseases for which no single entity has worked or, indeed, may ever work. If new drugs for these indications that might be useful in combination need to show individual efficacy to reach the clinic there is no chance for them. What are the patients supposed to do, wait for the impossible? As a scientist specialing in severe diseases with unmet need, I say thank you FDA!

]]> By: patrons99 http://www.pharmalot.com/2010/03/fda-to-devise-new-guidelines-for-drug-cocktails/#comment-481609 patrons99 Fri, 19 Mar 2010 13:12:25 +0000 http://www.pharmalot.com/?p=22035#comment-481609 This pharma-driven approach to dis-ease may be completely wrong. Pasteur's Germ Theory and Koch's Postulates may be wrong. Bacteria, bacteriophages, and viruses are virtually certain to win this battle. Should we ask whether multi-drug cocktails will not promote the world-wide development of multi-drug resistant infections and zoonoses? Would our resources not be better spent on trying to lessen the conditions in which diseases thrive: for example, with better hygiene, less crowding, pure drinking water? As long as the soil is fertile for microbes, they will "set up shop". Germs are opportunists. The multi-drug cocktail approach to treating disease, just happens to make society ever more dependent on pharma and their Johnny-on-the-spot remedies. Probiotics and measures to strengthen our natural immunity may be a safer and more effective approach. Perhaps, this is where the research should be directed. Our natural immunity has been increasingly battered by indiscriminate antibiotic use and the stupendous vaccine schedules, from cradle to grave. This pharma-driven approach to dis-ease may be completely wrong. Pasteur’s Germ Theory and Koch’s Postulates may be wrong. Bacteria, bacteriophages, and viruses are virtually certain to win this battle. Should we ask whether multi-drug cocktails will not promote the world-wide development of multi-drug resistant infections and zoonoses? Would our resources not be better spent on trying to lessen the conditions in which diseases thrive: for example, with better hygiene, less crowding, pure drinking water? As long as the soil is fertile for microbes, they will “set up shop”. Germs are opportunists. The multi-drug cocktail approach to treating disease, just happens to make society ever more dependent on pharma and their Johnny-on-the-spot remedies. Probiotics and measures to strengthen our natural immunity may be a safer and more effective approach. Perhaps, this is where the research should be directed. Our natural immunity has been increasingly battered by indiscriminate antibiotic use and the stupendous vaccine schedules, from cradle to grave.

]]> By: JaT http://www.pharmalot.com/2010/03/fda-to-devise-new-guidelines-for-drug-cocktails/#comment-481582 JaT Fri, 19 Mar 2010 06:08:43 +0000 http://www.pharmalot.com/?p=22035#comment-481582 In combining drugs- if you have a problem with either of the medications then one dosage cannot be adjusted while maintaining the other. In combining drugs- if you have a problem with either of the medications then one dosage cannot be adjusted while maintaining the other.

]]> By: Condor http://www.pharmalot.com/2010/03/fda-to-devise-new-guidelines-for-drug-cocktails/#comment-481539 Condor Thu, 18 Mar 2010 19:42:22 +0000 http://www.pharmalot.com/?p=22035#comment-481539 Well, pharmavet -- there is a shorter period of exclusivity (at FDA, via ORange book pubication), but it is longer than three years, at the US PTO -- the patent office. Each of these turns on various distinct factors, including how much time is left on the applicable patent(s) in the non-combined form. There is no hard and fast rule, here, that applies to all combo drugs. For example, Merck's Zocor was coming off patent in 2006 -- and now, combined with what was Schering-Plough's (now Merck's) Zetia, and called Vytorin, it boasts patent exclusivity until 2017. That's a lot longer than three years, at least. . . . In <i>theory, anyway</i>. In fact, though, Teva has already declared its intention to make a generic version of the Vytorin cholesterol combo-pill, and <a href="http://shearlingsplowed.blogspot.com/2010/03/first-mylan-and-glenmark-now-teva-to.html" rel="nofollow">Merck has sued Teva</a>, alleging patent infringement, as of March 2, 2010. That may result in a "<i>paid delay</i>" by Teva, or it may result in generic Vytorin by the end of 2010. Who knows? Namaste Well, pharmavet — there is a shorter period of exclusivity (at FDA, via ORange book pubication), but it is longer than three years, at the US PTO — the patent office.

Each of these turns on various distinct factors, including how much time is left on the applicable patent(s) in the non-combined form. There is no hard and fast rule, here, that applies to all combo drugs.

For example, Merck’s Zocor was coming off patent in 2006 — and now, combined with what was Schering-Plough’s (now Merck’s) Zetia, and called Vytorin, it boasts patent exclusivity until 2017. That’s a lot longer than three years, at least. . . .

In theory, anyway.

In fact, though, Teva has already declared its intention to make a generic version of the Vytorin cholesterol combo-pill, and Merck has sued Teva, alleging patent infringement, as of March 2, 2010.

That may result in a “paid delay” by Teva, or it may result in generic Vytorin by the end of 2010. Who knows?

Namaste

]]> By: A CMl Patient http://www.pharmalot.com/2010/03/fda-to-devise-new-guidelines-for-drug-cocktails/#comment-481538 A CMl Patient Thu, 18 Mar 2010 19:20:45 +0000 http://www.pharmalot.com/?p=22035#comment-481538 I am not opposed to this. Just recently it was announced that a combination of Peg Interferon (or Intron A for that matter) with a TKI like Gleevec or Sprycel or Tasigna could cure CML patients. Roche and or schering could partner with these other companies and sponsor trials. They could if seeking a cure was really the goal... What do you think? I am not opposed to this.

Just recently it was announced that a combination of Peg Interferon (or Intron A for that matter) with a TKI like Gleevec or Sprycel or Tasigna could cure CML patients. Roche and or schering could partner with these other companies and sponsor trials.

They could if seeking a cure was really the goal…

What do you think?

]]> By: pharmavet http://www.pharmalot.com/2010/03/fda-to-devise-new-guidelines-for-drug-cocktails/#comment-481536 pharmavet Thu, 18 Mar 2010 19:07:45 +0000 http://www.pharmalot.com/?p=22035#comment-481536 Condor, I believe that new formulations only carry three years of additional exclusivity for each drug. Condor, I believe that new formulations only carry three years of additional exclusivity for each drug.

]]> By: JaT http://www.pharmalot.com/2010/03/fda-to-devise-new-guidelines-for-drug-cocktails/#comment-481525 JaT Thu, 18 Mar 2010 17:04:43 +0000 http://www.pharmalot.com/?p=22035#comment-481525 Aggrenox Aggrenox

]]> By: Condor http://www.pharmalot.com/2010/03/fda-to-devise-new-guidelines-for-drug-cocktails/#comment-481510 Condor Thu, 18 Mar 2010 15:45:20 +0000 http://www.pharmalot.com/?p=22035#comment-481510 Think also of Vytorin (Merck's Zocor plus Zetia), of Tri-Cor (Abbott) -- and dozens of others, here. Think also of Vytorin (Merck’s Zocor plus Zetia), of Tri-Cor (Abbott) — and dozens of others, here.

]]> By: Condor http://www.pharmalot.com/2010/03/fda-to-devise-new-guidelines-for-drug-cocktails/#comment-481509 Condor Thu, 18 Mar 2010 15:43:26 +0000 http://www.pharmalot.com/?p=22035#comment-481509 Ding. Spot on, JaT. In this way, a 17 year long monopoly-at-law (via patent statute), may become up to a 32 year long monopoly, via creative ledger-domain (this is the case with Temodar). Namaste Ding.

Spot on, JaT.

In this way, a 17 year long monopoly-at-law (via patent statute), may become up to a 32 year long monopoly, via creative ledger-domain (this is the case with Temodar).

Namaste

]]> By: JaT http://www.pharmalot.com/2010/03/fda-to-devise-new-guidelines-for-drug-cocktails/#comment-481502 JaT Thu, 18 Mar 2010 14:20:15 +0000 http://www.pharmalot.com/?p=22035#comment-481502 So basically they aren't developing anything new and want to re-patent their drugs. So basically they aren’t developing anything new and want to re-patent their drugs.

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