Bristol Myers /Gilead Science — Profits Ahead of Life


I have a good news, bad news story to report today.  It is about a combination of life saving drugs that may never see the light of day because the two companies that make them can’t or won’t cooperate with one another.  One woman, Margaret Dudley of San Antonio Texas is doing something about it.  More about her, later.

This is about a combination of drugs from Bristol Myers Squib and Gilead Science that could be a cure for Hepatitis C which affects nearly 200 million people worldwide.  It is a viral infection that can lead to liver failure and death.  End-stage liver disease (cirrhosis) due to chronic hepatitis C has become the leading indication for liver transplantation in the United States.

First the good news, this really could be a cure.   A combination of Gilead’s GS-7977 and Daclatasvir from Bristol Myers Squib shows great promise as a cure according to some limited studies.  These drugs are pretty effective on their own but apparently when combined they could be a cure…yes cure.  I know, cure is pretty strong language in the medical world but it is the medical world that is using the term.

Now the bad news.  The two companies are not cooperating with one another, they can’t seem to agree on anything other than to disagree and in the meantime people are getting sicker and dying.  This is the classic battle over which company will make the most money when the two drugs are combined.

Here’s an Excerpt-The Street

Gilead, Bristol Put Profits Ahead of Best Care for Hep C Patients

“The new Hep C therapy at issue here combines Bristol’s Daclatasvir with Gilead’s GS-7977. Each is a single pill administered once a day. The results from this new therapy are nothing short of spectacular — an early cure rate of 100% for genotype 1 patients and 91% of genotype 2/3 patients, according to data from a mid-stage study announced Thursday at the European Association for the Study of Liver Disease (EASL) meeting.

A 100% cure rate for genotype 1 patients! Obviously, results can’t get better than that.

You’d think there’d be a rush to move the combination regimen of Daclatasvir and GS-7977 into a larger, confirmatory phase III trial, but you’d be mistaken. Amazingly, this most promising new treatment for hepatitis C patients may actually be discontinued because Bristol and Gilead can’t work together.

Good luck understanding why Bristol and Gilead can’t come together to help Hep C patients. The companies can’t even agree on the fact that the two companies are not agreeing”.

This is an incredibly important story and one that needs wide circulation in hopes of forcing these two companies to cooperate for the sake of saving lives instead of who can provide the greatest return on investment.  As mentioned earlier, Hep C affects about 200 million people worldwide.

Typically, to become infected with hepatitis C virus, the blood of an infected person enters the body of someone who is not infected. The most common way involves sharing needles or other equipment used to inject drugs. This kind of Hepatitis C infection is in the news now because an infected healthcare worker at a hospital in New Hampshire used needles on himself then left them for others to use.  Thousands may have been infected as a result and that investigation continues.

It is also possible, but less likely to become infected with shared use of personal care items such as toothbrushes and razors. Infection is also possible through sexual contact. Hepatitis C is not spread by casual contact, kissing, coughing, sneezing, sharing utensils, or breastfeeding.

Other people with greater risk of infection include:

  • People with tattoos or body piercing done with non-sterile equipment.
  • People who received an organ transplant or blood transfusion before July 1992.
  • People with clotting problems who took blood products prior to 1987.
  • People receiving hemodialysis or who have a history of hemodialysis for kidney failure.
  • People with HIV infection.

Since July 1992, all blood and organ donations in the U.S. are screened for the hepatitis C virus. According to the CDC, the number of hepatitis C infections declined by 90% from 1994 to 2006, partially as a result of this.

A diagnosis of hepatitis C infection doesn’t necessarily mean you need treatment. If you have only slight liver abnormalities, you may not need treatment, because your risk of future liver problems is very low. Your doctor may recommend follow-up blood tests to monitor for liver problems.

Hep C symptoms may include:

  • Fatigue
  • Upset stomach and diminished appetite
  • Joint and muscle pain

Also, patients may experience symptoms related to liver cirrhosis, such as:

  • Jaundice, which is a yellowing of the skin and eyes
  • Urine being a dark yellow color
  • An increased tendency to bleed or bruise

Treatment of chronic hepatitis C varies depending on the individual. A person with chronic hepatitis C may not need or benefit from treatment. Some people may not be able to tolerate treatment because of side effects.

Currently, the FDA has approved the following treatments for hepatitis C:

  • Pegylated interferon alfa-2a
  • Pegylated interferon alfa-2b
  • Ribavirin
  • Standard interferon alfa
  • Incivek
  • Victrelis

Common side effects of interferons include fatigue, muscle pain, headache, nausea, vomiting, weight loss, and depression, and changes to your blood cell counts. Side effects of ribavirin include anemia, skin rash, fatigue, and nose/sinus congestion so a new treatment with minimal side effects and greater effectiveness would be cheered wildly.

Liver transplant
if your liver has been severely damaged, a liver transplant may be an option. During a liver transplant, the surgeon removes your damaged liver and replaces it with a healthy liver. Most transplanted livers come from deceased donors, though a small number come from living donors who donate a portion of their livers.

For people with hepatitis C infection, a liver transplant is not a cure. Treatment with antiviral medications usually continues after a liver transplant, since hepatitis C infection is likely to recur in the new liver.

Now to our hero 61 year old Margaret Dudley of San Antonio, Texas.  Margaret thinks this situation is intolerable and she has launched a petition drive to encourage the two companies to work together to save lives.

Last fall, she was tested for hepatitis C she believes she contracted from some earlier tattoos.  “I had no idea,” Dudley said. “I had no reason to think it would come back positive, but it did.”

Then she found out about Bristol Myers Squib and Gilead.  “That’s basically what me and millions of others have been waiting for,” Dudley commented.  We’re asking these companies put best patient health before profits.”

She has several thousand on her online petition so far and says public pressure may spark the pharmaceutical companies to keep going with clinical trials.  Dudley’s goal is to gather 100,000 signatures by July 28, 2012, which is World Hepatitis Day.  We encourage you to sign the petition.  Just go to: http://tinyurl.com/cow2uwt  We just can’t let profitability trump human life.

Some of the information in this blog was drawn from the following sources.

http://www.hcvadvocate.org/hcsp/articles/Shaw-Stiffel-1.html

http://tinyurl.com/d55az86

http://www.webmd.com/hepatitis/hepc-guide/chronic-hepatitis-c

Bob Aronson of Bob’s Newheart is a 2007 heart transplant recipient, the founder of Facebook’s nearly 2,500 member Organ Transplant Initiative and the author of most of these donation/transplantation blogs.

You may comment in the space provided or email your thoughts to me at bob@baronson.org. And – please spread the word about the immediate need for more organ donors. There is nothing you can do that is of greater importance. If you convince one person to be an organ and tissue donor you may save or positively affect over 60 lives. Some of those lives may be people you know and love.

Please view our video “Thank You From the Bottom of my Donor’s heart” on http://www.organti.org This video was produced to promote organ donation so it is free and no permission is needed for its use.

If you want to spread the word personally about organ donation, we have another PowerPoint slide show for your use free and without permission. Just go to http://www.organti.org and click on “Life Pass It On” on the left side of the screen and then just follow the directions. This is NOT a stand-alone show, it needs a presenter but is professionally produced and factually sound. If you decide to use the show I will send you a free copy of my e-book, “How to Get a Standing “O” that will help you with presentation skills. Just write to bob@baronson.org and usually you will get a copy the same day.

Also…there is more information on this blog site about other donation/transplantation issues. Additionally we would love to have you join our Facebook group, Organ Transplant Initiative The more members we get the greater our clout with decision makers.

 

About Bob Aronson

About Bob Aronson On August 21, 2007 I received a new heart at the Mayo Clinic in Jacksonville, Florida. All these years later I am very active, happy and loving life. God bless my donor and his family. His generosity toward a complete stranger will never be forgotten. I am retired and live with my wife Robin and two dogs Reilly the main dog and Ziggy the backup. We are a very happy family. My gratitude to my wonderful caregiver wife, my donor, his family and the Mayo Clinic is beyond my ability to express. Suffice it to say I will do whatever is in my power to promote organ and tissue donation and to help and support everyone affected by the issue. As a result of receiving the “Gift of Life” I have made a major commitment to organ/tissue/blood donation, transplantation and related issues. I am the founder of Facebook's over 4,000 member support group, Organ Transplant Initiative (OTI) and the blog site, “Bob’s Newheart” www.bobsnweheart.wordpress.com. I have authored the great majority of the nearly 250 blogs listed there. The remainder were written by excellent guest bloggers. The posts span a wide variety of topics mostly involving organ/tissue donation/transplantation and related issues, but also covering important current medical news and information. Wordpress data indicate the blogs have readers in 162 countries. Bob's Newheart is quickly becoming the news and information source of choice for those with an interest in organ/tissue donation/transplantation along with current developments in medical news and health care. Born In Chisholm, Minnesota I now reside in Jacksonville, Florida. I have three children and one step son, 8 grandchildren and 3 great grandchildren. My three grown children are Roger Aronson a well-known and respected Minneapolis, Minnesota Attorney, Dr. Colleen Hegranes Senior Vice President St. Catherine University in St. Paul, Minnesota and Harryet (Hank) Freeman who is probably the best history teacher in America, at least that's what her students at Woodbury, Minnesota High school tell me. Stepson Tim Grant and wife Jennifer live a couple of blocks from us in Jacksonville. Jen is a talented cook, baker, and mother. Tim is an in-demand electrician in Jacksonville who can really make almost anything work. Stella and Lily Grant are two very bright and talented granddaughters. For 25 plus years I owned the Aronson Communications Group an international consultancy specializing in health care communication. The Mayo Clinic was my first consulting client, a relationship that lasted until my retirement. I also worked with 3M health care, UNOS, LIfeSource, Dartmouth University Medical Center and CH2M HILL, one of the nation's largest environmental engineering firms. Prior to being a consultant I served for four years as the first Anchor for Morning Edition on the Minnesota Public Radio Network; was the Communications director for Minnesota Governor Rudy Perpich and before that held positions as a broadcast journalist at several Midwest facilities. I also served as the Director of broadcast communications at Moorhead State University in Moorhead, Minnesota. While I am retired Robin is not and I assist her efforts as founder and owner of Jingler’s Jewelry. She designs and makes colorful, "Fun" anodized aluminum jewelry and is also an accomplished printmaker. She sells her creations at art shows, festivals and gift shops in states east of the Mississippi but mostly in the south. Her website is www.jinglersjewelry.com. When I have time, my hobbies include reading, music and woodworking. One of my most notable projects was completing a wood scale model of the mom and pop grocery store my parents ran for 50 years in Chisholm, Minnesota. The model now resides in Chisholm in my sister's home. Our parents were wonderful people who instilled in us a very strong work ethic and a sense of fairness and equality. I also built a dollhouse for granddaughter Lily Grant and just completed designing and building a CD box that looks like an accordion. A friend commissioned me to make it in memory of his father who was an accomplished accordion musician. I have a brother and sister of whom I am very proud . They are twins. Terry is a Minnesota District Court Judge and Mary a retired but still the best 3rd grade teacher in America. I am proud of them for what they have done but more importantly for who they are. My wife Robin is a caregiver, musician, artist, entrepreneur and the best friend I have. While we do a lot of things together we especially like making music. Often in the evening you can hear the strains of folk, Blue Grass, country and other music coming from our family room. Robin plays several instruments including string bass, accordion, guitar, ukulele, mandolin and...well the list goes on. I play harmonica and have one in almost every key. She's really good...I'm not. Quantity does not ensure quality. One more thing. I am also a recovering Alcoholic and a former smoker. I emerged from a 28 day in-patient alcoholism treatment program in August of 1982 and have managed to stay sober with the help of a lot of people both in and out of Alcoholics Anonymous. I quit smoking in January of 1991 after a 37 year habit of up to four packs of cigarettes a day. It wasn’t easy but I’m living proof that it can be done. I am available to anyone suffering from or affected by any addiction at any time through my email address bob@baronson.org or via phone 904-434-6512.

Posted on July 25, 2012, in Hepatitis C and tagged , , , , , , , , , , , , , , , , , , , . Bookmark the permalink. 5 Comments.

  1. Thank You Margaret Dudley for being an advocate for THE CURE! People need to be aware of what Gilead Sciences is refusing to do. We need a public outcry to get attention for this cause. Please sign this petition and do your part! http://www.change.org/petitions/gilead-sciences-please-collaborate-with-bristol-myers-for-the-cure-for-hepatitis-c-now

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  2. We learn from every transplant we perform, and carefully study advancements in organ transplantation as we care for our patients.

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  3. A liver transplant is performed in cases of end-stage liver disease (ESLD) or liver failure. Diseases and conditions resulting in end-stage liver disease for which transplantation may be indicated include primary biliary cirrhosis, sclerosing cholangitis, liver cancer, and alcohol/drug abuse. Hepatitis B and C viruses can also develop into liver failure, possibly requiring a transplant. However, a transplant does not cure hepatitis. Early diagnosis and disease management can help patients decrease their risk of hospitalization. The goal of the Liver Transplant Program is to exhaust all medical therapies before resorting to a liver transplant, which is reserved as a final life-saving option. The Liver Failure Clinic at the Texas Transplant Institute offers comprehensive treatment programs for liver failure management. Our hepatologist has extensive experience with the latest clinical treatments including radio frequency ablation , chemoebolization , as well as access to new clinical research and treatment protocols. In addition, the Liver Failure Clinic offers ongoing educational sessions for patients and their families; licensed nurses, dietitians, social workers, and chemical dependency counselors provide information and answer questions regarding physical, psychological, and social issues.

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  4. Selling organs is illegal. Do not make offers to sell them on this site.

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  1. Pingback: S-adenosylmethionine – natural help for Arthritic Pain & Depression? « Earl's View

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