How about this as a solution: We tax the crap out of the top 1% (how many houses do Oprah and Brangelina need anyway?). Then we nationalize the pharmaceutical industry, hire the best MDs/Phds available and pay them well to continue the work they are already doing, and re-invest profits from the drug sales for future innovations.
The free market R&D costs are presently grossly inflated because the big pharma companies do not share information and must continue reinventing the wheel. Moreover, the big pharma marketing costs exceed R&D expenses by 19 to 1. Both R&D and marketing costs would be greatly reduced by taking drug development and sales out of the competitive free market system.
That's what I'd do if I was King of the World. Unfortunately, that is unlikely to happen without an endorsement from Oprah.
P.S. Gilead will recoup that 11 billion in the first year of S/L sales. They already broke pharma sales records with 2.3 billion in the first quarter of Sovaldi's release and the S/L combo hasn't even hit the shelves yet!
Tig said
May 24, 2014
Hey Huey,
Nice thought, but it's 11 Billion, not million!
Tig
Huey said
May 24, 2014
Why couldn't Express scripts make a deal with Gilead , " ok you need to recover 11 million, we will buy 11 million dollars worth all at once, but for half the price. " That would at least end the argument about needing to recover initial cost and once they are operating in the margins the stock holders would get plenty!
Isiscat2011 said
May 24, 2014
mallani wrote:
Sovaldi could have easily gone the way of PSI-938.
And, therein lies one of the many problems with placing the future of life saving drugs in the free market system. It can delay and even prevent innovation where it is most needed.
Jaded said
May 24, 2014
It's a great drug. Unfortunately the greed of the company that owns it has caused this drug to do more harm than good to the people who need it today...in terms of stress and anxiety. The drug does not work if you can't get it.
mallani said
May 23, 2014
Hi guys,
The outrage at the cost of Sovaldi was predictable, but it came as no surprise. Gilead's offer of $11 billion was said to be 2 or 3 times higher than what Pharmasset would have accepted.
In any case, it was a brave move by Gilead. Sovaldi could have easily gone the way of PSI-938. Revenue to date would indicate it will take about 3 more years before Gilead covers it's costs. By then, who knows what will happen. We may have a vaccine, an cytoplasmic blocker or cell-entry blocker, and the anti-replication drugs may be superseded. I can live with Gilead's price structure.
I can't live with Janssen's ridiculous price of $66k (for 12 weeks) of Olysio. That really stinks.
If I was a Merck shareholder I'd be pulling my hair out. They had the first DAA to be approved (Victrelis) then sat and watched while Vertex cleaned them up with Incivek. They have sat on MK-5172 for 2 years. This is the only antiprotease that is potent, with an excellent resistance profile. Clinical Trials have been sparse. If you believe in a drug, you have to throw money at it, do countless Trials and get it approved. That's what Gilead did, and they are starting to see the rewards. By the time MK-5172 hits the pharmacies, there will only be crumbs to pick up.
As Matt said, everyone wants to do Trials with Sovaldi. It's too late- Sovaldi/Ledipasvir will pick up 75% of the market share if it is cleverly priced. Cheers.
jimbob said
May 23, 2014
Isiscat2011 wrote:
Matt Chris wrote:
One of the goals is to find the mix/combo of drugs that can reduce treatment time to as little as 4 weeks.
Stay tuned, HCV is getting checked into a corner and will be check mated sometime in the next five years.
Won't that be something to see. One day it will be like taking a cycle of antibiotics and people will be vaccinated against ever contracting it in the first place. Great topic, indeed!
Isis, Chris--
If this "TT-034" should get approval, it may just be a matter of making a single appointment with the doctor. That will truly be amazing. Until then, a single pill for a few weeks sure won't hurt anyone's feelings.
CharlieC said
May 23, 2014
I have been 10 days on Solvadi (400mg) and Daclatasvir (60mg). I am on 24 week course of treatment. I did receive the Daclatasvir for "compassionate" use and the Solvadi was at first rejected by my Insurance but Doctor appealed and was finally approved. Promising trials in the past few years so looking forward to my first follow up in June. Liver enzymes have fallen quite a bit in the last week. I have not been able to touch base with anyone that has been on this treatment. Anyone out there that did this as a Clinical Trial. Great info in this forum thanks for all the info.
Isiscat2011 said
May 23, 2014
Matt Chris wrote:
One of the goals is to find the mix/combo of drugs that can reduce treatment time to as little as 4 weeks.
Stay tuned, HCV is getting checked into a corner and will be check mated sometime in the next five years.
Won't that be something to see. One day it will be like taking a cycle of antibiotics and people will be vaccinated against ever contracting it in the first place. Great topic, indeed!
Tig said
May 23, 2014
Thanks Malcolm for the continuing education! We all know what happens as a result of the use of these drugs, but the why and how often evades discussion. I've posted this monograph link before but think now is a good time to bump it back into the discussion. Lots of good info in it.
Interesting info. I'm curious if the issues being discussed re: Sovaldi/Int/Riba also apply to Sovaldi/Olysio/Riba?
-- Edited by patiently_waiting on Friday 23rd of May 2014 04:43:40 PM
Matt Chris said
May 23, 2014
Hey Malcolm
Great topic, we see that Sovaldi has to be combined with another DAA to be highly effective and in the future we will see many combinations tried. Actually right now its being tested with BMS NS5A Daclatasvir and the most intriguing is the Merck combo trial with Sovaldi, here is the trials description.
This is a study of MK-5172A & Mk-8742 and sofosbuvir (SOF) in treatment-naive participants with chronic hepatitis C (HCV) genotype 1 (GT1) or genotype 3 (GT3).
The Mercks NS3/4a protease inhibitor (MK-5172a) and the NS5A inhibitor (MK-8742) are regarding as some of the best new 2nd generation DAA on the market with high barrier to RAV's , also Abbvie's ABT-530 NS5A has great possibilities as well to be combine with Sovaldi.
One might think that why would these other drug companies bother with Sovaldi since they have there own combos. But the FDA suggested / requested in there Guidelines document that big Pharma cross collaborate with the other companies in the HCV trials to address the need for the patients that happen to fail or relapsed on DAA's. One of the goals is to find the mix/combo of drugs that can reduce treatment time to as little as 4 weeks.
Stay tuned, HCV is getting checked into a corner and will be check mated sometime in the next five years.
matt
Isiscat2011 said
May 22, 2014
JLynch30 wrote:
yes, the gamble with me is whether they will pay again if needed.
I think they will but first they will make you stand on your head, repeat the alphabet backwards 6 times, and then do a few back-flips for them.
Seriously though, they seem to be taking a look-see approach with the 12 week tx approvals. If 12 weeks work, great. If not then they pay for another 12 weeks later--the incremental approach--hoping to save some money that way. In the meantime tx costs will get lower as the market heats up.
This will change as the AASLD guidelines are updated and the SOC for tx lengths is firmed up. If 24 weeks becomes SOC then the insurance companies will pay for 24. Change takes time.
JLynch30 said
May 22, 2014
yes, the gamble with me is whether they will pay again if needed.
Isiscat2011 said
May 22, 2014
mallani wrote:
Hi John,
Until Ledipasvir is approved, SVR rates are a bit of a lottery.
So true, and this is another reason insurance companies are being a pain in the butt for so many people. They want less risk and the highest possible success rates.
Well, actually, they would probably rather not pay at all, but if they have to then they want tx to be successful. That makes sense.
mallani said
May 22, 2014
Hi John,
Until Ledipasvir is approved, SVR rates are a bit of a lottery.
For Sovaldi/ Peg and Riba, we still have a problem with non-CC allele at IL28B, cirrhotics (or F3's) and high starting VL. These patients have only a quoted 71% SVR rate with the 12 week course. They really should have 24 weeks. Cheers.
Isiscat2011 said
May 22, 2014
I won't forget them.
JLynch30 said
May 22, 2014
any data on relapse with solvaldi, interferon and rib?
mallani said
May 22, 2014
Hi all,
We talk about Sovaldi as if it's an old friend. It really had a turbulent beginning. It was developed by Pharmasset in 2010 as a second-string NS-5B nucleoside inhibitor, to go with it's PSI-938, the first nucleoside inhibitor. For a company with no drug products and only 80 employees, the share price went beserk after the first Trials. However, worries about liver toxicity led to suspension of PSI-938 in 2011. Nevertheless, Gilead Sciences went ahead and purchased the company for the well-published $11 billion, in November 2011. This was an incredible risk.
The first Trials of PSI-7977 were interesting. Virtually all patients became Undetected by 3 weeks, even with monotherapy, and irrespective of the initial VL. This is by far the most potent DAA. However, after 6, 8 and 12 weeks of monotherapy, all patients relapsed. No explanation of this was ever given apart from 'no resistant variants were found'. I take this to mean that any RAV's could not be identified or were transient.
As the aim was to be Interferon free, Ribavirin was added and the SVR rates skyrocketed. Other drugs were added and it took 2 years of trial and error to come up with the combos we have today. It's been an intense, fascinating 2 years of research and we will soon forget the thousands of patients that put their lives on the line to get to today's easy treatment. Thanks be to them!
Huey:
How about this as a solution: We tax the crap out of the top 1% (how many houses do Oprah and Brangelina need anyway?). Then we nationalize the pharmaceutical industry, hire the best MDs/Phds available and pay them well to continue the work they are already doing, and re-invest profits from the drug sales for future innovations.
The free market R&D costs are presently grossly inflated because the big pharma companies do not share information and must continue reinventing the wheel. Moreover, the big pharma marketing costs exceed R&D expenses by 19 to 1. Both R&D and marketing costs would be greatly reduced by taking drug development and sales out of the competitive free market system.
That's what I'd do if I was King of the World. Unfortunately, that is unlikely to happen without an endorsement from Oprah.
P.S. Gilead will recoup that 11 billion in the first year of S/L sales. They already broke pharma sales records with 2.3 billion in the first quarter of Sovaldi's release and the S/L combo hasn't even hit the shelves yet!
Hey Huey,
Nice thought, but it's 11 Billion, not million!
Tig
Why couldn't Express scripts make a deal with Gilead , " ok you need to recover 11 million, we will buy 11 million dollars worth all at once, but for half the price. " That would at least end the argument about needing to recover initial cost and once they are operating in the margins the stock holders would get plenty!
And, therein lies one of the many problems with placing the future of life saving drugs in the free market system. It can delay and even prevent innovation where it is most needed.
Hi guys,
The outrage at the cost of Sovaldi was predictable, but it came as no surprise. Gilead's offer of $11 billion was said to be 2 or 3 times higher than what Pharmasset would have accepted.
In any case, it was a brave move by Gilead. Sovaldi could have easily gone the way of PSI-938. Revenue to date would indicate it will take about 3 more years before Gilead covers it's costs. By then, who knows what will happen. We may have a vaccine, an cytoplasmic blocker or cell-entry blocker, and the anti-replication drugs may be superseded. I can live with Gilead's price structure.
I can't live with Janssen's ridiculous price of $66k (for 12 weeks) of Olysio. That really stinks.
If I was a Merck shareholder I'd be pulling my hair out. They had the first DAA to be approved (Victrelis) then sat and watched while Vertex cleaned them up with Incivek. They have sat on MK-5172 for 2 years. This is the only antiprotease that is potent, with an excellent resistance profile. Clinical Trials have been sparse. If you believe in a drug, you have to throw money at it, do countless Trials and get it approved. That's what Gilead did, and they are starting to see the rewards. By the time MK-5172 hits the pharmacies, there will only be crumbs to pick up.
As Matt said, everyone wants to do Trials with Sovaldi. It's too late- Sovaldi/Ledipasvir will pick up 75% of the market share if it is cleverly priced. Cheers.
Isis, Chris--
If this "TT-034" should get approval, it may just be a matter of making a single appointment with the doctor. That will truly be amazing. Until then, a single pill for a few weeks sure won't hurt anyone's feelings.
I have been 10 days on Solvadi (400mg) and Daclatasvir (60mg). I am on 24 week course of treatment. I did receive the Daclatasvir for "compassionate" use and the Solvadi was at first rejected by my Insurance but Doctor appealed and was finally approved. Promising trials in the past few years so looking forward to my first follow up in June. Liver enzymes have fallen quite a bit in the last week. I have not been able to touch base with anyone that has been on this treatment. Anyone out there that did this as a Clinical Trial. Great info in this forum thanks for all the info.
___________________________________________________________________________________________________________
Won't that be something to see. One day it will be like taking a cycle of antibiotics and people will be vaccinated against ever contracting it in the first place. Great topic, indeed!
Thanks Malcolm for the continuing education! We all know what happens as a result of the use of these drugs, but the why and how often evades discussion. I've posted this monograph link before but think now is a good time to bump it back into the discussion. Lots of good info in it.
Tig
Sovaldi Monograph
Interesting info. I'm curious if the issues being discussed re: Sovaldi/Int/Riba also apply to Sovaldi/Olysio/Riba?
-- Edited by patiently_waiting on Friday 23rd of May 2014 04:43:40 PM
Hey Malcolm
Great topic, we see that Sovaldi has to be combined with another DAA to be highly effective and in the future we will see many combinations tried. Actually right now its being tested with BMS NS5A Daclatasvir and the most intriguing is the Merck combo trial with Sovaldi, here is the trials description.
This is a study of MK-5172A & Mk-8742 and sofosbuvir (SOF) in treatment-naive participants with chronic hepatitis C (HCV) genotype 1 (GT1) or genotype 3 (GT3).
The Mercks NS3/4a protease inhibitor (MK-5172a) and the NS5A inhibitor (MK-8742) are regarding as some of the best new 2nd generation DAA on the market with high barrier to RAV's , also Abbvie's ABT-530 NS5A has great possibilities as well to be combine with Sovaldi.
One might think that why would these other drug companies bother with Sovaldi since they have there own combos. But the FDA suggested / requested in there Guidelines document that big Pharma cross collaborate with the other companies in the HCV trials to address the need for the patients that happen to fail or relapsed on DAA's. One of the goals is to find the mix/combo of drugs that can reduce treatment time to as little as 4 weeks.
Stay tuned, HCV is getting checked into a corner and will be check mated sometime in the next five years.
matt
I think they will but first they will make you stand on your head, repeat the alphabet backwards 6 times, and then do a few back-flips for them.
Seriously though, they seem to be taking a look-see approach with the 12 week tx approvals. If 12 weeks work, great. If not then they pay for another 12 weeks later--the incremental approach--hoping to save some money that way. In the meantime tx costs will get lower as the market heats up.
This will change as the AASLD guidelines are updated and the SOC for tx lengths is firmed up. If 24 weeks becomes SOC then the insurance companies will pay for 24. Change takes time.
yes, the gamble with me is whether they will pay again if needed.
_____________________________________________________________________________________________________________
So true, and this is another reason insurance companies are being a pain in the butt for so many people. They want less risk and the highest possible success rates.
Well, actually, they would probably rather not pay at all, but if they have to then they want tx to be successful. That makes sense.
Hi John,
Until Ledipasvir is approved, SVR rates are a bit of a lottery.
For Sovaldi/ Peg and Riba, we still have a problem with non-CC allele at IL28B, cirrhotics (or F3's) and high starting VL. These patients have only a quoted 71% SVR rate with the 12 week course. They really should have 24 weeks. Cheers.
I won't forget them.
any data on relapse with solvaldi, interferon and rib?
Hi all,
We talk about Sovaldi as if it's an old friend. It really had a turbulent beginning. It was developed by Pharmasset in 2010 as a second-string NS-5B nucleoside inhibitor, to go with it's PSI-938, the first nucleoside inhibitor. For a company with no drug products and only 80 employees, the share price went beserk after the first Trials. However, worries about liver toxicity led to suspension of PSI-938 in 2011. Nevertheless, Gilead Sciences went ahead and purchased the company for the well-published $11 billion, in November 2011. This was an incredible risk.
The first Trials of PSI-7977 were interesting. Virtually all patients became Undetected by 3 weeks, even with monotherapy, and irrespective of the initial VL. This is by far the most potent DAA. However, after 6, 8 and 12 weeks of monotherapy, all patients relapsed. No explanation of this was ever given apart from 'no resistant variants were found'. I take this to mean that any RAV's could not be identified or were transient.
As the aim was to be Interferon free, Ribavirin was added and the SVR rates skyrocketed. Other drugs were added and it took 2 years of trial and error to come up with the combos we have today. It's been an intense, fascinating 2 years of research and we will soon forget the thousands of patients that put their lives on the line to get to today's easy treatment. Thanks be to them!