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Thread: Cure for Hep-C suppressed by big pharma

  1. #1

    Cure for Hep-C suppressed by big pharma

    No need for a conspiracy theory here. People are dying everyday, and there is a cure. Big pharma companies won't cooperate. The FDA won't approve. And Obamacare will most certainly not pay for it.

    100% cure rate, very few side effects.

    A hepatitis C drug combination from Gilead Sciences Inc. (GILD) and Bristol-Myers Squibb Co. (BMY) cured all patients in a trial, demonstrating the success of a cocktail that may never be approved.

    In a study among 41 patients of Gilead’s sofosbuvir with Bristol’s daclatasvir, with or without the generic antiviral ribavirin, 40 were virus-free 12 weeks after six months of treatment, according to results presented yesterday in Amsterdam. The other patient didn’t turn up to the last appointment and was later found to be virus-clear. All the patients had failed prior treatment with either Vertex Pharmaceuticals Inc. (VRTX)’s Incivek or Merck & Co. (MRK)’s Victrelis.

    The lack of a late-stage study, and the expense of the pills, will probably put the Gilead-Bristol combination out of reach for doctors and patients, said Geoffrey Dusheiko, a professor of medicine at the Royal Free Hospital in London.

    “It’s a conundrum for us,” Dusheiko said in an interview after the results were presented at the European Association For the Study of the Liver’s conference. “It looks a very promising regimen, it really does. But I’m really not sure it’ll see the light of day.”

    http://www.bloomberg.com/news/2013-0...-in-study.html
    Hepatitis C kills more people every year than AIDS.

    Let that sink in for a moment.

    Traditionally, hepatitis C has been treated with a combination of an injectable drug called interferon and another orally-administered medicine called ribavirin. It’s a grueling regimen, resulting in nausea, malaise, weight loss, skin and hair changes, anemia, thyroid problems and depression in many patients.

    Moreover, the cure rate (technically called “sustained virologic response,” or SVR) for this regimen is less than 40 percent after 48 weeks of treatment. Many people cannot complete the full course of therapy because of the horrendous side effects.

    Now, to the punchline.

    At a recent national medical meeting of liver specialists, Dr. Mark Sulkowski of Johns Hopkins University Medical Center described a Phase II research protocol using a combination of two new oral medications, daclatasvir and sofosbuvir. This medication combination has almost no side effects.

    The gist of Dr. Sulkowski’s presentation is this: After a mere 12 weeks of treatment with this new regimen, the “cure” (SVR) rate for hepatitis C was an astonishing 93 percent.
    ...
    Hepatitis C patients have been waiting for a treatment regimen like daclatasvir and sofosbuvir for decades. It’s a true rarity in medicine — an honest-to-goodness game-changer, a phenomenally effective regimen for a serious, life-threatening disease that is also safe and well-tolerated.

    The only problem? The two drugs are owned by different companies — daclatasvir is a Bristol-Myers-Squibb drug, while sofosbuvir is made by Gilead Sciences.

    For reasons that are almost certainly financial in nature, Gilead has refused to do further work on this drug combination with Bristol-Myers Squibb, so there will be no further study of the regimen. With no Phase III trials, that means that the daclatasvir/sofosbuvir combination regimen will likely not be approved for use by the FDA.

    Gilead has issued no formal commentary about why it does not wish to pursue further development of the new regimen, although there is speculation that it is altering its focus to produce single-tablet combination regimens — a product line that has been highly successful for the company in the treatment of HIV.

    In fact, Gilead is doing quite well financially. It is a company with over $4 billion in annual revenues and over 4,000 employees. Its average margin of profitability over the last five years has been a whopping 34 percent.

    Moreover, the total return to its shareholders on Gilead’s stock has been nearly 95 percent over the past year.

    Still, the salient question is this: Should Gilead Sciences’ profitability trump doing what is right?

    Since Dr. Sulkowski’s data presentation at the AASLD meeting in Boston this past November, over 200,000 hepatitis C patients worldwide have died of complications of their disease. Meanwhile, Gilead, a tremendously profitable corporation, refuses to consider the development of a drug regimen that could have cured most of those individuals in the pursuit of even greater profits.

    http://hepc-cured.com/murphy-hepatit...logy-of-greed/
    "Foreign aid is taking money from the poor people of a rich country, and giving it to the rich people of a poor country." - Ron Paul
    "Beware the Military-Industrial-Financial-Pharma-Corporate-Internet-Media-Government Complex." - B4L update of General Dwight D. Eisenhower
    "Debt is the drug, Wall St. Banksters are the dealers, and politicians are the addicts." - B4L
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  3. #2
    I don't find evidence that it is being supressed. From the article, they chose not to work with other companies on the drug combo.
    For reasons that are almost certainly financial in nature, Gilead has refused to do further work on this drug combination with Bristol-Myers Squibb, so there will be no further study of the regimen. With no Phase III trials, that means that the daclatasvir/sofosbuvir combination regimen will likely not be approved for use by the FDA.
    In Europe, they are trying to acclerate its aproval process. http://finance.yahoo.com/news/gilead...195501176.html
    Gilead Sciences Inc. (GILD) recently announced that its Marketing Authorisation Application (MAA) for HCV candidate sofosbuvir (formerly GS-7977), submitted to the European Medicines Agency (:EMA) on Apr 17, 2013, has been validated and is under review.

    Gilead is looking to get the candidate approved in combination with ribavirin (:RBV) as an all-oral therapy for treating patients affected with genotypes 2 and 3 of the disease. The MAA also includes data backing the use of sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) as a first-line therapy in patients suffering from the genotypes 1, 4, 5 and 6 of the virus.

    Gilead submitted the MAA on the basis of encouraging data from four phase III studies (NEUTRINO, FISSION, POSITRON and FUSION). Data from the studies revealed that sofosbuvir-based therapy for 12 or 16 weeks was either superior or non-inferior to currently available HCV treatment options.

    The EMA granted Gilead’s request for accelerated assessment of the company’s Marketing Authorization Application for sofosbuvir. The acceptance of the request is expected to bring down EMA’s review time of the application by two months. Gilead also intends to seek sofosbuvir approval in other countries. Gilead expects sofosbuvir to be available in the EU by the first half of 2014, assuming approval. Gilead is also seeking US approval for sofosbuvir.

    Approval of sofosbuvir would bring down the duration of HCV therapy to 12-16 weeks. Currently, HCV therapy includes 24-48 weeks of treatment with injectable peg-IFN. Moreover, the current standard of care comes with several side effects which make it difficult for patients to remain on treatment.

    Approval of sofosbuvir would not only boost Gilead’s top line but would also strengthen its position in the lucrative HCV market. A sizeable population suffers from HCV throughout the world. However, the treated population is much lower. This leaves the field open for new treatments. We note that companies such as Johnson & Johnson (JNJ) and Bristol-Myers Squibb (BMY) are also developing therapies to combat HCV.
    The treatment sounds promising. It has about the same results as interferon (or slightly better) with fewer (but not none) side effects.
    Last edited by Zippyjuan; 05-22-2013 at 03:00 PM.

  4. #3
    FDA approval of the individual drugs, and cost, are the only obstacles. Once the FDA approves the two components, they can both be prescribed and used as a cocktail without the permission of the drug companies.

    Presumably you don't think people should be forced to enter into agreements with each other?
    The proper concern of society is the preservation of individual freedom; the proper concern of the individual is the harmony of society.

    "Who would be free, themselves must strike the blow." - Byron

    "Who overcomes by force, hath overcome but half his foe." - Milton

  5. #4
    They aren't forced to. They can get their drug aproved on its own.

  6. #5
    Quote Originally Posted by Zippyjuan View Post
    I don't find evidence that it is being supressed. From the article, they chose not to work with other companies on the drug combo.
    If you were a person dying of this right now, it would suppress your access to it.

    Quote Originally Posted by Zippyjuan View Post
    The treatment sounds promising. It has about the same results as interferon (or slightly better) with fewer (but not none) side effects.
    Less than 40% cure is the "same" as almost 100%?
    "Foreign aid is taking money from the poor people of a rich country, and giving it to the rich people of a poor country." - Ron Paul
    "Beware the Military-Industrial-Financial-Pharma-Corporate-Internet-Media-Government Complex." - B4L update of General Dwight D. Eisenhower
    "Debt is the drug, Wall St. Banksters are the dealers, and politicians are the addicts." - B4L
    "Totally free immigration? I've never taken that position. I believe in national sovereignty." - Ron Paul

    Proponent of real science.
    The views and opinions expressed here are solely my own, and do not represent this forum or any other entities or persons.

  7. #6
    Quote Originally Posted by Acala View Post
    FDA approval of the individual drugs, and cost, are the only obstacles. Once the FDA approves the two components, they can both be prescribed and used as a cocktail without the permission of the drug companies.
    Yes, doctors could use them together off-label if they are both approved for use. Then cost and insurance coverage are the major obstacles.
    "Foreign aid is taking money from the poor people of a rich country, and giving it to the rich people of a poor country." - Ron Paul
    "Beware the Military-Industrial-Financial-Pharma-Corporate-Internet-Media-Government Complex." - B4L update of General Dwight D. Eisenhower
    "Debt is the drug, Wall St. Banksters are the dealers, and politicians are the addicts." - B4L
    "Totally free immigration? I've never taken that position. I believe in national sovereignty." - Ron Paul

    Proponent of real science.
    The views and opinions expressed here are solely my own, and do not represent this forum or any other entities or persons.

  8. #7
    Quote Originally Posted by Brian4Liberty View Post
    If you were a person dying of this right now, it would suppress your access to it.



    Less than 40% cure is the "same" as almost 100%?
    From Dr. Jacoboson himself who helped conduct the studies: http://www.medicalnewstoday.com/articles/259545.php
    Dr. Jacobson said "This new treatment represents a paradigm shift in the way that hepatitis C is going to be treated. We are achieving the same or higher cure rates in many patients with sofosbuvir, compared to interferon, and we are doing it in half the time with a drug that has a remarkable safety profile."
    Last edited by Zippyjuan; 05-22-2013 at 03:33 PM.

  9. #8
    Quote Originally Posted by Brian4Liberty View Post
    Yes, doctors could use them together off-label if they are both approved for use. Then cost and insurance coverage are the major obstacles.
    Yup. Government regulation is the problem here. Big surprise.
    The proper concern of society is the preservation of individual freedom; the proper concern of the individual is the harmony of society.

    "Who would be free, themselves must strike the blow." - Byron

    "Who overcomes by force, hath overcome but half his foe." - Milton



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  11. #9
    Quote Originally Posted by Zippyjuan View Post
    From Dr. Jacoboson himself who helped conduct the studies: http://www.medicalnewstoday.com/articles/259545.php
    That is a different study, with a different drug combination.

    It is not the drug combination with almost 100% effectiveness (Gilead’s sofosbuvir and Bristol’s daclatasvir).
    "Foreign aid is taking money from the poor people of a rich country, and giving it to the rich people of a poor country." - Ron Paul
    "Beware the Military-Industrial-Financial-Pharma-Corporate-Internet-Media-Government Complex." - B4L update of General Dwight D. Eisenhower
    "Debt is the drug, Wall St. Banksters are the dealers, and politicians are the addicts." - B4L
    "Totally free immigration? I've never taken that position. I believe in national sovereignty." - Ron Paul

    Proponent of real science.
    The views and opinions expressed here are solely my own, and do not represent this forum or any other entities or persons.

  12. #10
    Quote Originally Posted by Acala View Post
    Yup. Government regulation is the problem here. Big surprise.
    Off label use will probably effect insurance coverage, and standard drug company discounts for "needy" patients. It becomes cost prohibitive. Availability may be an issue too.

    Hate to inject ethics into medicine, but the bottom line is that people will die because this cure is not being made available.
    "Foreign aid is taking money from the poor people of a rich country, and giving it to the rich people of a poor country." - Ron Paul
    "Beware the Military-Industrial-Financial-Pharma-Corporate-Internet-Media-Government Complex." - B4L update of General Dwight D. Eisenhower
    "Debt is the drug, Wall St. Banksters are the dealers, and politicians are the addicts." - B4L
    "Totally free immigration? I've never taken that position. I believe in national sovereignty." - Ron Paul

    Proponent of real science.
    The views and opinions expressed here are solely my own, and do not represent this forum or any other entities or persons.

  13. #11
    Quote Originally Posted by Brian4Liberty View Post
    That is a different study, with a different drug combination.

    It is not the drug combination with almost 100% effectiveness (Gilead’s sofosbuvir and Bristol’s daclatasvir).
    Sorry I got them confused.

  14. #12
    And why not throw some blame to Wall St too?

    The reason why this drug combination is not being further moved down the pipeline is that Gilead acquired Pharmasset, Inc, who had developed Sofosbuvir and was working with Bristol on the drug combination.

    Gilead essentially shut this down by buying the maker of one of the drugs in the combination.
    "Foreign aid is taking money from the poor people of a rich country, and giving it to the rich people of a poor country." - Ron Paul
    "Beware the Military-Industrial-Financial-Pharma-Corporate-Internet-Media-Government Complex." - B4L update of General Dwight D. Eisenhower
    "Debt is the drug, Wall St. Banksters are the dealers, and politicians are the addicts." - B4L
    "Totally free immigration? I've never taken that position. I believe in national sovereignty." - Ron Paul

    Proponent of real science.
    The views and opinions expressed here are solely my own, and do not represent this forum or any other entities or persons.

  15. #13
    Not so fun fact: ~25 people will die in the US today from Hepatitis-C.

    How many will die from terrorist attacks in the US today?
    "Foreign aid is taking money from the poor people of a rich country, and giving it to the rich people of a poor country." - Ron Paul
    "Beware the Military-Industrial-Financial-Pharma-Corporate-Internet-Media-Government Complex." - B4L update of General Dwight D. Eisenhower
    "Debt is the drug, Wall St. Banksters are the dealers, and politicians are the addicts." - B4L
    "Totally free immigration? I've never taken that position. I believe in national sovereignty." - Ron Paul

    Proponent of real science.
    The views and opinions expressed here are solely my own, and do not represent this forum or any other entities or persons.

  16. #14
    It has been illegal to claim a "cure" or to actually cure for quite some time now according to lawsbought and paid for buy big pharma. Big pharma owns diseases and the fda approved mainta nence of disease.

    That is why they can force parents to give children vaccines and chemo therapy under threat of imprisonment.

  17. #15
    No IP laws would fix this problem.
    Quote Originally Posted by BuddyRey View Post
    Do you think it's a coincidence that the most cherished standard of the Ron Paul campaign was a sign highlighting the word "love" inside the word "revolution"? A revolution not based on love is a revolution doomed to failure. So, at the risk of sounding corny, I just wanted to let you know that, wherever you stand on any of these hot-button issues, and even if we might have exchanged bitter words or harsh sentiments in the past, I love each and every one of you - no exceptions!

    "When goods do not cross borders, soldiers will." Frederic Bastiat

    Peace.

  18. #16
    It's all about control. I only wished we had a truly free market to allow people REAL choice for curing diseases.
    “The spirits of darkness are now among us. We have to be on guard so that we may realize what is happening when we encounter them and gain a real idea of where they are to be found. The most dangerous thing you can do in the immediate future will be to give yourself up unconsciously to the influences which are definitely present.” ~ Rudolf Steiner



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  20. #17
    Update:

    For those who haven't followed the strategy of Gilead on this cure for Hepatitis C, they purchased the small company that had a key drug, and then worked on a new drug to replace the previous partner drug from Bristol-Myers Squibb. Thus they would have a monopoly on both drugs in the combination.

    $84,000 + $95,000 = $179,000 to treat an infection...

    The hepatitis C virus caused nearly 20,000 deaths in the United States in 2013,
    ...
    There are four new drugs approved to treat hepatitis C: Sovaldi and Harvoni, made by Gilead Sciences; ... The cost for Sovaldi is $84,000 for a standard 12-week course of treatment, which breaks down to about $1,000 for each pill, taken daily. ... Harvoni is even more expensive, with a list price of about $95,000 for a 12-week course of treatment without a discount.
    ...
    http://www.nytimes.com/2015/09/02/op...-everyone.html
    "Foreign aid is taking money from the poor people of a rich country, and giving it to the rich people of a poor country." - Ron Paul
    "Beware the Military-Industrial-Financial-Pharma-Corporate-Internet-Media-Government Complex." - B4L update of General Dwight D. Eisenhower
    "Debt is the drug, Wall St. Banksters are the dealers, and politicians are the addicts." - B4L
    "Totally free immigration? I've never taken that position. I believe in national sovereignty." - Ron Paul

    Proponent of real science.
    The views and opinions expressed here are solely my own, and do not represent this forum or any other entities or persons.

  21. #18
    Quote Originally Posted by Brian4Liberty View Post
    Update:

    For those who haven't followed the strategy of Gilead on this cure for Hepatitis C, they purchased the small company that had a key drug, and then worked on a new drug to replace the previous partner drug from Bristol-Myers Squibb. Thus they would have a monopoly on both drugs in the combination.

    $84,000 + $95,000 = $179,000 to treat an infection...
    Not likely many people are going to buy that treatment out of pocket. So if insurance doesn't cover it, the price will come down to the point where people will buy it. In any event, the patents will expire in a few years and then the price will plummet.
    The proper concern of society is the preservation of individual freedom; the proper concern of the individual is the harmony of society.

    "Who would be free, themselves must strike the blow." - Byron

    "Who overcomes by force, hath overcome but half his foe." - Milton

  22. #19
    Big Pharma didn't and doesn't get rich by curing stuff.

  23. #20
    Quote Originally Posted by Acala View Post
    Not likely many people are going to buy that treatment out of pocket. So if insurance doesn't cover it, the price will come down to the point where people will buy it. In any event, the patients will expire in a few years and then the price will plummet.
    I read this as...

  24. #21
    Quote Originally Posted by The Northbreather View Post
    I read this as...
    Yes, the patients will expire long before the patents...
    "Foreign aid is taking money from the poor people of a rich country, and giving it to the rich people of a poor country." - Ron Paul
    "Beware the Military-Industrial-Financial-Pharma-Corporate-Internet-Media-Government Complex." - B4L update of General Dwight D. Eisenhower
    "Debt is the drug, Wall St. Banksters are the dealers, and politicians are the addicts." - B4L
    "Totally free immigration? I've never taken that position. I believe in national sovereignty." - Ron Paul

    Proponent of real science.
    The views and opinions expressed here are solely my own, and do not represent this forum or any other entities or persons.

  25. #22
    Quote Originally Posted by Acala View Post
    Not likely many people are going to buy that treatment out of pocket. So if insurance doesn't cover it, the price will come down to the point where people will buy it. In any event, the patents will expire in a few years and then the price will plummet.
    Sovaldi Patent expires March 26, 2029.
    Harvoni has multiple patents, last one expires December 11, 2030.
    "Foreign aid is taking money from the poor people of a rich country, and giving it to the rich people of a poor country." - Ron Paul
    "Beware the Military-Industrial-Financial-Pharma-Corporate-Internet-Media-Government Complex." - B4L update of General Dwight D. Eisenhower
    "Debt is the drug, Wall St. Banksters are the dealers, and politicians are the addicts." - B4L
    "Totally free immigration? I've never taken that position. I believe in national sovereignty." - Ron Paul

    Proponent of real science.
    The views and opinions expressed here are solely my own, and do not represent this forum or any other entities or persons.

  26. #23
    Quote Originally Posted by Brian4Liberty View Post
    Sovaldi Patent expires March 26, 2029.
    Harvoni has multiple patents, last one expires December 11, 2030.
    That's when the price will plummet. Or as soon as a serious competitor hits the market. Putting aside all the ways in which government makes this worse, the fact is that when the market sets prices, it sets them as high as the demand will support. And when you are the only game in town and the stakes are life and death, the market will support a high price. It sucks to have a fatal disease without a cheap and effective cure, but it is better than having a fatal disease with NO cure.
    The proper concern of society is the preservation of individual freedom; the proper concern of the individual is the harmony of society.

    "Who would be free, themselves must strike the blow." - Byron

    "Who overcomes by force, hath overcome but half his foe." - Milton

  27. #24
    Quote Originally Posted by Acala View Post
    That's when the price will plummet. Or as soon as a serious competitor hits the market. Putting aside all the ways in which government makes this worse, the fact is that when the market sets prices, it sets them as high as the demand will support. And when you are the only game in town and the stakes are life and death, the market will support a high price. It sucks to have a fatal disease without a cheap and effective cure, but it is better than having a fatal disease with NO cure.
    Yes, that would suck. Because of that, and as sure as the sun will rise tomorrow, the taxpayers will be the ones who inevitably pay that high price. The government involves itself in the market in more ways than one.
    "Foreign aid is taking money from the poor people of a rich country, and giving it to the rich people of a poor country." - Ron Paul
    "Beware the Military-Industrial-Financial-Pharma-Corporate-Internet-Media-Government Complex." - B4L update of General Dwight D. Eisenhower
    "Debt is the drug, Wall St. Banksters are the dealers, and politicians are the addicts." - B4L
    "Totally free immigration? I've never taken that position. I believe in national sovereignty." - Ron Paul

    Proponent of real science.
    The views and opinions expressed here are solely my own, and do not represent this forum or any other entities or persons.



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  29. #25
    FYI, I actually sat in on a 2 day mock trial with said companies above. I cannot say which companies are involved except to say it dealt with Hep C treatment. The treatment didn't have a 100% cure rate but damn close and such treatment greatly reduced the amount of time from like 1-2 years current treatment for Hep C with about 50% success rate to about 12 weeks to over 80% from what I can recall. Both companies (A and B) products were approved by the FDA and both companies had patents. One company(A) bought another company(C) who was "close" to a treatment and that company's(A) ingredient combined with the company's(C) purchased ingredient (BIG BUCKS talking BILLIONS here) made A's formation a success. Problem was this, company (B) had there own ingredients, different ingredients, BUT get this, ALSO owned some computer spit out formulation they designed (software) that predicted the success rate of said ingredients (talking hundreds). Company B has a patent on that software. So B is suing A for patent infringement and says A must pay them a license to proceed because A's ingredients are in such software program. Yes, a very shady way to prevent B's competitor A to bring A's product to Hep C patients. I don't know the out come but at least one or maybe both treatments will prevail and be offered to patients. And yes, the treatment for 12 weeks would run about $100K.
    Last edited by Liberty74; 10-08-2015 at 06:54 PM.
    If Rand does not win the Republican nomination, he should buck the controlled two party system and run as an Independent for President in 2016 and give Americans a real option to vote for.

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