Looks like all this Hype, misleading info, and Petition is for nothing.
In addition, he said, both daclatasvir and sofosbuvir are likely to be approved soon, with an indication for therapy in combination with the standard HCV drugs, pegylated interferon and ribavirin.
There would then be nothing to stop doctors from using them together off-label, while avoiding the other two, which are associated with a host of adverse effects.
http://hepatitiscnewdrugs.blogspot.ca/2012/11/daclatasvir-and-sofosbuvir-promising.html
If a cure exists, and for such a deadly disease, and greed is stopping this cure from happening, the government will step in.
How? This is the definition of socialism. While your zeal is refreshing, I believe it to be a tad naive, just my opinion ...Mark
I'm a sorry a small % of people don't tolerate interferon and ribavirin very well, but continually refering to them as "toxic" is not only misleading hyperbole but may also keep some who need to treat now from doing so. It makes the entire petition suspect, not just from the standpoint of promoting a particular company's interests over others, but also throws the entire project into doubt by its use of exaggeration.
Gilead's treatment with it's cocktail mix of sofosbuvir and 5885 and ribavirin is just as toxic as the treatments we have now. I do not want to be a laboratory animal for any more experimentation by drug companies. When Bistol Myer's daclatasvir is combined with sofosbuvir for 24 weeks we had 100% cure rate without the toxic chemicals ribavirin and interferon. Gilead is only having sucess when it combines sofosbuvir and 5885 with ribavirin. I don't think I can put it any simpler. If a cure exists, and for such a deadly disease, and greed is stopping this cure from happening, the government will step in. This disease is costing billions in healthcare costs....or maybe now with all of changes in health care and the new AFCA maybe they will just decide to let us die cause we cost to much! Sign the petition before its too late and get others to sign as well!
Yes I'm so sorry, I meant it for RK2761 posted the article link.I appreciate your responses to this thread. I'm a believer that one person can make a difference.!
I did not post a link. I think you have confused me with another poster.
From your link
"Some advocates have suggested that Gilead would rather focus on combinations of its own drugs that allow for proprietary single-tablet regimens -- the company's specialty in the HIV arena. Gilead also has a promising NS5A inhibitor, GS-5885. In another study presented at AASLD, sofosbuvir/GS-5885/ribavirin produced high SVR4 rates for genotype 1 treatment-naive patients and prior null responders analyzed to date.
It remains to be seen how well sofosbuvir/GS-5885 without ribavirin works, or whether sofosbuvir/daclatasvir (with or without ribavirin) works for prior non-responders. Notwithstanding company decisions about which investigational agents to test together, once individual drugs are approved, clinicians and patients will be able to mix and match them as they like"
If Gilead only eventually release Sofosbuvir as a bundle with 5885 and never allow it as a single dose drug so my Doctor can decide which drugs to mix and match then that is anti-trust and creates a monopoly. I would sign a petition asking the government to investigate and bring anti trust charges against Gilead!
I need someone to debate and show me where Gilead is committing anti-trust NOW! I'm open minded and would sign petition based on our anti-trust monopoly laws.
We have now focused our efforts on a petition appealing directly to the Obama Administration. There are a variety of links below that you can use to get to the White House petition depending on how you are viewing this.
WHITE HOUSE PETITION LINKS FOR HEPATITIS C
Short URL to White House Petition http://wh.gov/vxtg
Long URL to White House Petition https://petitions.whitehouse.gov/petition/expedite-cure-hepatitis-c-drug-companies-hold-cure-without-toxic-ribavirin-or-interferon/tXC9B6S2
Link for accessing White House Petition mobile phone: http://bit.ly/sign2savelives
As many of you know, Gilead will be applying for FDA approval of sofosbuvir the second quarter, to be used with toxic ribavirin and interferon. We know what those drugs are like and many people (especially 'baby boomers') cannot withstand the effects of those toxic drugs. This is our lives and the lives of our loved ones we are talking about. This is our disease, our fight, and our cure! If we don't stand up now we will never see the combination of sofosbuvir & daclatasvir available to anyone. Gilead intends to co-formulate sofosbuvir and GS-5885 (now called Ledipasvir) into one pill, thereby making it impossible for doctors to prescribe the life-saving combination of sofosbuvir and daclatasvir together. The combination of these two drugs did in fact cure 100% of genotypes 1, 2, and 3 and it was without interferon or ribavirin. You can see these results in an easy to understand slide presentation at:
http://clinicaloptions.com/Boston2012
Pasted below is Dr. Paul Thuluvath's quote from the Wall Street Journal - November 2012 talking about this cure.
"We had never, ever imagined—even in our wildest dreams—we could treat" hepatitis C so quickly, effectively and without serious side effects, said Paul Thuluvath, a doctor at Mercy Medical Center in Baltimore who had six patients test the new treatment. "I think the pharmaceutical companies have a moral responsibility to work together and bring it to market instead of [following] their own vested interests."
Our tax dollars provide these pharmaceutical companies with funding for research, and now together these two companies, Gilead Sciences and Bristol-Myers Squibb, have found a cure and we demand access to it.
Again people, this is our disease, our fight and OUR CURE! It is URGENT you sign this petition to the White House that was initiated on February 19, 2013. If you have already signed the petition at Change.org then you must now sign this one in order for us to have any chance of success. We have 30 days to get 100,000 signatures and there is no reason we can’t get that number. There are over 4 million of us right here in the United States with hepatitis C and ‘We the People’ must take a stand on this, or else our lives are in jeopardy as well as the lives of 170 million people worldwide.
HCV Coalition for The Cure
www.HepC-Cured.org
ps- to all you who are signing and sharing- THANKS!
hey y'all thanks for the points you made- all makes sense to me.
i do believe that capitalism has it's values and indeed we should not force anyone to act against their best interest. that's a good bullet.
i do see that there's so much money to be made in this field, that it would be nice to see business, for once, act in the interest of a bigger picture! but likely a long shot.
the government should only intervene in terms of provoking social pressure- that seems to adjust attitudes in commerce. it all about public pressure at this point and we are looking for ways to open up the discussion.
i agree with Md that this tx is already proven a great track record and why should we WAIT any longer if we can access success now or sooner? are you all aware of the trial drug that BMS made that caused problems and had to be shut down- that was in the effort to copy the winning combo! and hardly ANY side effects.. would be nice, eh?
maybe it's not fully 100% but in two classes it was. and i been thru tx 2x now and i ma ready for tx i can tolerate and have SVR with! I am broken from the SOC i took several years ago...for me, doing something is better that doing nothing towards solutions!
I support the movement and of course I voted for it, but I agree with desrt that it probably will not be effective.
We can only try.
I'm so used to 7985 What is imprinted on Gileads pill and accidently put 7987 in the above post. Oops.
medhelp needs an edit - Sorry
II DID NOT add myself to the list. Gilead has 5885 to combine with sofosbuvir. The government can't force them to combine with Bristol Meyers and Bristol should not be forced to combine with Gilead. Notice this current trial is 1 pill with 7987/5885 in one. Purposely combined to be the one pill.
Competition is a good thing for bottom line price to you and me once these drugs are approved. Bristol Meyers will develope a nucleotide inhibitor to combine with their Daclatasvir BMS-790052 soon. Watch for these clinical trials that will be coming soon.
Done I'm adding my name to that list. Plus I am grabbing anyone I know friends an family.
From all Ive read...I agree with you. Gilead has GS-5885 combined with sofosbuvir...and they are banking on that.
Ledipasvir (GS-5885)
Ledipasvir, formerly known as GS-5885, is a new treatment for hepatitis C. It is a compound in clinical development by Gilead. Ledipasvir (GS-5885) is a drug that blocks NS5A, a viral protein critical for hepatitis C replication (Lawitz et al. 2012)*.
Ledipasvir has been coformulated in a single pill with sofosbuvir. Very encouraging sustained virological response has been reported in interim reports of this combination, with an overall response of 100% in 25 patients, as recently presented at the Liver Meeting 2012 in Boston. More than 1000 patients have been treated with GS-5885 in phase 2 studies so far, with no signals of toxicity. The selected dose for further development is 90 mg QD.
http://hepaton.com/tag/hepatitis-c-treatment
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I think desrt hit it on the money..."the fact that you're trying to force a corporation to do something it doesn't want to do - and lose money to boot. You would have to effectively stand the whole system on its head, rewrite international patent law, and set some very large, very new precedents to do this"
Very well said.
The problem I see is not so much the exaggerated claims that rk2761 posted on, but rather the fact that you're trying to force a corporation to do something it doesn't want to do - and lose money to boot. You would have to effectively stand the whole system on its head, rewrite international patent law, and set some very large, very new precedents to do this.
I wish Ms. Dudley good luck in her efforts, but I don't see it happening.
Ledipasvir-5885 owned by Gilead compared to Daclatasvir BMS-790052 owned by Bristol-Meyers with Sofosbuvir?
Gilead is going with the 5885 because they control the money. This petition is saying that 790052 is the answer? Gilead paid 11 billion to buy Pharmasset for ownership of Sobosvbuvir betting that combo GS-5885 will bring home the money. I'm hoping this is the right decision. I have many HIV friends still alive because of Gilead.
What do you from this forum think? Those that signed this petition? Those like myself on Gilead trial Sofosbuvir/5885? I think Gilead wouldn't have invested 11 billion unless they were going to be successful with remarkable result with the combo they own. Obviously any negotiations with Bristol-Meyers when they have 5885 wasn't worth the money. Others opinions would be appreciated. Thanks
I hate to rain on this parade, but I don't think these folks do themselves any favors exaggerating the success rates of the sofosubuvir/daclatasvir combination treatment. While it is higher than current treatment protocols, it's not, as they claim, 100%. The petition and their campaign will loses credibility in the eyes of politicians because of the exaggerated claim.
http://bit.ly/XwAMFG
Too bad, because I really do think the companies should be pressured into moving forward with research. But telling half truths diminishes the effectiveness of the argument.
rk
Thanks for posting. Added my signature.
We the People is a section of the whitehouse.gov website, launched September 22, 2011, for petitioning the current administration's policy experts. Petitions that meet a certain threshold of signatures will be reviewed by officials in the Administration and an official response will be issued. It is a web site where you can create a petition.
The creator is M.D. San Antonio ~ meaning Margaret Dudley.
Here's the link with the original:
http://www.medhelp.org/posts/Hepatitis-Social/Sign-petition-to-put-pressure-on/show/1722631#post_8817062
And here is the petition:
http://www.change.org/petitions/gilead-sciences-please-collaborate-with-bristol-myers-for-the-cure-for-hepatitis-c-now
This is a new petition that was started 2/19/13.....just signed it....watched the youtube videos. 100K in 30 days....