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Good news for the shareholders in the mega pharmaceutical company, Bristol Myers Squibb:  the FDA just approved the drug ipilimumab, also know as "Yervoy", for use in metastatic melanoma.    

Bristol-Myers Squibb Co shares rose 3.2 percent to close at $27.29 after the Food and Drug Administration approved its drug under the brand name Yervoy for patients in the late stages of the disease. Analysts see sales reaching $820 million in 2015, according to Thomson Reuters.

The average "dose" for this drug is four infusions.  At a cost of $30,000 per dose, that makes the average four dose cost $120,000.  Cost $30,000 per dose for Yervoy

If you respond to the drug, of course, you may need multiple doses.  

Good news for BMS, good news for BMS shareholders, good news (perhaps) for patients with the brutal and highly resistant to most treatments stage IV melanoma.

My late friend, Will, had stage IV melanoma.

When he was diagnosed in the fall of 2008, his disease was at stage III.  It had been found in one lymph node in addition to the site of origin.  His oncologist was a melanoma specialist - there aren't that many of those, but in Chicago, there are now three - and like many melanoma specialists, this man was a "mud/phud" - an MD/Ph.D - who ran clinical trials.

Clinical trials, of course, are the process by which new drugs get tested and possibly approved for use by the FDA.  They are usually run by drug companies, sometimes in conjunction with the National Institute of Health.  

Getting FDA approval for a drug, especially a drug that treats an otherwise swiftly fatal illness, is a license to print money.  So drug companies are what you might term "highly motivated" to get FDA approval.  

It's a complicated process, of course, as it should be.  Until the drug is approved for use, the manufacturer, in this case Bristol Myers Squibb, owns and controls it.  There are different "stages" of clinical trials, as they test the drug to see if it has a positive impact on the disease process and ultimately, survival time.

But back to Will.  It was September of 2008.  He'd just found out he had stage III melanoma, and his oncologist, as luck would have it, was running a clinical trial using this new drug, ipilimumab (now Yervoy).  Recruiting patients for clinical trials is a tricky thing.  People, naturally, prefer approved drugs - they have a track record, obviously.  And many clinical trials have a "control" arm, using a less effective drug or even a placebo.  You are randomized into these arms.  You may or may not know - depending on whether the trial is "double blind" - which arm you are in.  

Getting into a trial can also be tricky.   In the word of melanoma clinical trials, you are already dealing with people who are sick - they have one of the most aggressive and lethal cancers existent.  But you don't really want people who are TOO sick; they tend to die fast and mess up your research statistics.  So you triage people with a system designed to weed out those who are most likely to die anyway.  In other words, to get into a clinical trial for melanoma you have to be sick, but not too sick, and you have to pass numerous tests to even qualify for participation.  You may need to have particular genetic mutations.  Your bloodwork has to fall within accepted parameters.  And your "performance status" - the degree to which the disease has impacted your ability to carry on with your normal life - has to be acceptable to the trial coordinators.  

It sounds like a lot of work, getting into these trials.  It is.  But you do it, if you have melanoma, because you just don't have many other options.  The average survival rates are grim - often less than a year. And it's frequently a disease of the young.  Will was 43 when he was diagnosed.  But he was still "healthy" (except for that lethal cancer thing) and passed all the tests for getting into the clinical trial using this new drug, ipilimumab.  There was one small complication.  This was a double blind placebo trial.  Half the patients would get absolutely nothing in their infusion except saline water.  They had to sign a 17 page consent form stating they understood this and accepted the risks (and the risks were that your cancer would spread uncontrollably, and you'd die a pretty awful death).  Will, who had mild developmental disabilities, signed the consent form because his doctor recommended it.  

No where in the form did it state, nor did anyone explain, that if this drug proved effective and you were in the placebo group, you couldn't get access to the drug.  

And that's what happened to Will.  He had no side effects at all from this treatment, which, given the generally profound side effects of this drug, was a clear signal that he was in the placebo group.  His cancer progressed.  Subsequent attempts at treatment failed.  And three oncologists that we consulted said "ipilimumab is his best chance."  

So we asked Bristol Myers Squibb to release the still-unapproved but now found to be effective and fastracked-to-be-approved drug to Will under the "compassionate use" program.  

They refused.  He had been in a trial, and to release the drug to him might compromise their data.  They wouldn't give him access to the drug until it was FDA approved.  He'd be dead by then, I pointed out.  Sorry, they said, these things happen.

I went to the state's attorney general.  They expressed interest in trying to help  me get BMS to release the drug to Will.  I told BMS this.  They contacted Will's oncologist and said that if I proceeded - I was arguing that he could not possibly have given "informed consent" as the consent did not explain the drug would not be available should he receive the placebo and there was no chance Will, who read with difficulty at about a 2nd grade level, could have understood the 17 page form he signed - Will could be banned from ALL clinical trials.

And in the US, drug companies are not subject to anti-trust laws.  So theoretically, they could conspire together to do such a thing.  There were really no more options.  I gave up, Will fought the disease as best he could, suffered a lot, and died in October 2010 from liver failure, brought on by a combination of liver metastases and the toxicity of the chemotherapy drugs we were using to try and arrest the disease until Bristol Myers Squibb got FDA approval.  

That approval came yesterday, and it came in part due to people like Will, who took a chance and risked their life for science.  And profits.  Dying for monopoly capitalism - it's a noble thing, I guess.  

I don't know if this drug would have extended or saved Will's life.  But he deserved a chance to find out.  Bristol Myers Squibb had a moral obligation to make a drug they now knew was effective available to those who participated in earlier trials and got a placebo.  But to do so might have compromised their fast profits, they feared ( though with some effort on their part, that could have been averted) and that was what mattered most.   When I tried to fight this, they said, in essence, "Nice friend you've got there.  Be a shame if anything happened to him."

He deserved better.  We all do.  The entire US health care system operates, on a macro level, like organized crime, from insurance companies to for-profit hospitals to the multinational pharmaceuticals.    Let's turn it all upside down.

Originally posted to KibbutzAmiad on Sat Mar 26, 2011 at 03:23 PM PDT.

Also republished by Personal Storytellers.

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Comment Preferences

  •  Unfortunately, (6+ / 0-)

    the FDA's responsibility is to determine whether or not a drug is "safe."  They've fucked that up a number of times -- but they aren't responsible for controlling outrageous costs.  Some agency should -- or perhaps, universal health care would grind this greed to a screaming halt.

    Peace and blessings for our brother, Will.  Peace and blessings for his family and friends.  Peace and blessings for those who are victims to the pharma and insurance industries.

    Bless you, KibbutzAmiad, for not only bringing this issue to light here -- but also for being a loving friend of Will's.

    " My faith in the Constitution is whole; it is complete; it is total." Barbara Jordan, 1974

    by gchaucer2 on Sat Mar 26, 2011 at 03:47:52 PM PDT

    •  Thanks and the (4+ / 0-)
      Recommended by:
      gchaucer2, blueyedace2, DRo, DvCM

      truth is, the whole system is broken beyond repair.  People can't get effective drugs, there is a huge financial incentive to get drugs out there that turn out not to be effective (or are dangerous) and the costs are beyond belief.

      A drug that can extend life for 28 days - four weeks - in an advanced cancer patient can yield a half billion dollars profit for a pharmaceutical company.

      People are used as lab rats in atrocious ways, drugs are tested in minute numbers of people who are pre-selected - it's appalling all around.

      "never trust a rich man when he offers you a truce"

      by KibbutzAmiad on Sat Mar 26, 2011 at 03:50:22 PM PDT

      [ Parent ]

      •  My sister is a case in point (5+ / 0-)

        for both the criminal drug and insurance industry.  She had kidney cancer.  She was engaged and her husband moved up the wedding because he was a Captain in the Navy and could provide her with health benefits.  

        She was in remission for about 3 months after the wedding and then deteriorated rapidly.  She was used as a guinea pig for all sorts of drugs while tumors spread to her lungs, brain and heart.  My brother-in-law finally said, stop.  She had zero chance of surviving -- she was just a lab animal.  Thank god hospice eased her out of the nightmare.

        " My faith in the Constitution is whole; it is complete; it is total." Barbara Jordan, 1974

        by gchaucer2 on Sat Mar 26, 2011 at 04:05:23 PM PDT

        [ Parent ]

        •  honesty is (4+ / 0-)
          Recommended by:
          gchaucer2, blueyedace2, DRo, DvCM

          a huge problem with this industry.  And these trials are freaking brutal, in many cases.  

          And then when a drug DOES work, they deny to those who underwent the endless scans, bloodwork, needle sticks, you  name it - and where the end result of NOT taking the drug will be death.  

          It's cruel on every imaginable level.

          I am so sorry about your sister.  Going through this with someone you love is as close to hell as I ever want to get.

          "never trust a rich man when he offers you a truce"

          by KibbutzAmiad on Sat Mar 26, 2011 at 04:11:31 PM PDT

          [ Parent ]

  •  Yes, real single-payer reform will require massive (3+ / 0-)
    Recommended by:
    KibbutzAmiad, blueyedace2, DRo

    disciplining of the drug companies to keep costs under control.

  •  I should make (3+ / 0-)
    Recommended by:
    blueyedace2, DRo, DvCM

    it clear that in this case, I am not blaming the FDA for the outrages in this particular case.  This one is owned fully by BMS.  

    And they have quite a track record when it comes to exploiting the sick, on many levels.

    Sadly, they have a lot of company in the pharmaceutical field.

    "never trust a rich man when he offers you a truce"

    by KibbutzAmiad on Sat Mar 26, 2011 at 03:51:44 PM PDT

  •  there is actually (3+ / 0-)
    Recommended by:
    blueyedace2, DRo, DvCM

    one other person in this story who bears some responsibility - well, a lot of it.  Will's initial oncologist - Dr. Infallible, I'll call him - is a world respected melanoma doctor.  He has an interesting history of stuffing people into clinical trials that he just happens to be running.   Sometimes without knowing the details of those trials.  

    Lab rats are valuable and the research oncs make their money from grants from the pharma companies.

    It's a foul and filthy system, I can't really imagine it being salvageable.  We need single payer and pharmaceuticals need to be public property, in my socialist and radical view.

    "never trust a rich man when he offers you a truce"

    by KibbutzAmiad on Sat Mar 26, 2011 at 03:56:35 PM PDT

  •  on the melanoma (2+ / 0-)
    Recommended by:
    DRo, DvCM

    patients board I still frequent, there is huge concern because while the drug was not FDA approved but obviously effective and given out under compassionate use in many cases (though not Will's), it was cheap or covered by BMS's research dollars (usually heavily tax payer subsidized).  

    Now, the insurance companies are already figuring out ways to avoid covering it.  It's too new, it was tested on too few people, etc.  

    At $30,000 a shot, how many people will be able to afford it?  They are already holding penny jar and spaghetti dinner fundraisers to cover radiation, chemo, etc.

    "never trust a rich man when he offers you a truce"

    by KibbutzAmiad on Sat Mar 26, 2011 at 04:25:16 PM PDT

  •  But Obama's back room deal w Big Pharma fixed it! (3+ / 0-)
    Recommended by:
    KibbutzAmiad, puzzled, Marie


    "We do not inherit the Earth from our Ancestors, we borrow it from our Children"

    by Lefty Coaster on Sat Mar 26, 2011 at 04:27:04 PM PDT

  •  I'm not following (1+ / 0-)
    Recommended by:
    Will could be banned from ALL clinical trials.

    So what?  As long as they gave him the drug, he had a chance at living.  Without it, he had none.  Who cares whether he would be banned from all future clinical trials?

    •  they would (0+ / 0-)

      not give him the drug under "compassionate use" guidelines.  And if I tried to force them to do it, they'd blackball him from any other clinical trials.

      When you have stage IV melanoma, pretty much all that is open to you are clinical trials.  The threat was to get me to back down from pursuing the drug via the state's attorney general.

      "never trust a rich man when he offers you a truce"

      by KibbutzAmiad on Sat Mar 26, 2011 at 04:42:27 PM PDT

      [ Parent ]

      •  the reason they (0+ / 0-)

        would not release the drug to him was because he was in a clinical trial - a double blind placebo trial - using this drug (but he certainly got the placebo based on lack of side effects).

        The trial had not reached it's "end point".  They would not unblind the data.  That was fine - I didn't care.  I just wanted them to release the drug to him under their "compassionate use" guidelines.  They refused because they feared it might delay approval or somehow "taint" their data - e.g. cost them money.

        When I pursued this through Lisa Madigan's office (IL attorney general), BMS threatened me.  Back down, or Will would be blackballed from ALL future chances at a drug, should he live long enough to qualify for any other clinical trials.

        "never trust a rich man when he offers you a truce"

        by KibbutzAmiad on Sat Mar 26, 2011 at 04:44:52 PM PDT

        [ Parent ]

      •  I understand the set of circumstances. (1+ / 0-)
        Recommended by:

        I just don't understand why, if

        "ipilimumab is his best chance."

        you or your friend would care whether he was blocked from future clinical trials as long as he was able to get the ipilimumab, the drug you and the attorney general's office were trying to force them to release to your friend.

        •  I'm not explaining this (0+ / 0-)

          well.  BMS would NOT give him the ipi.  They refused.  They own the drug.   If the state's attorney general pursued them, there was no guarantee Will would be given the drug, no guarantee we'd win.  And time was of the essence.  

          If we pursued it, he'd also be banned (they said) from all other clinical trials.  So let's say while we were waiting to see what happened with the state's attorney general's office and ipi and BMS, a trial opened with Pfizer for another possible drug.  Will would be blackballed from that too....

          We had very little time.  His cancer had spread to his liver and was growing.  They were NOT going to release this drug without a fight and there was no guarantee the state's attorney general would be successful fast.  Other trials were an option we couldn't risk.  And if we DID get the ipi and it failed and we wanted to get him into another trial, we'd be screwed.

          "never trust a rich man when he offers you a truce"

          by KibbutzAmiad on Sat Mar 26, 2011 at 04:55:02 PM PDT

          [ Parent ]

  •  What is insane also (3+ / 0-)
    Recommended by:
    KibbutzAmiad, DvCM, Marie

    is that this "success" is not a cure,

    In a randomized clinical trial, patients with metastatic melanoma treated with Yervoy lived a median of about 10 months, compared with 6.4 months for patients in a control group, who received a treatment believed to have had little effect.

    You have to read the fine print!

    “The treatment is of the immune system, it’s not of the tumor,” said James P. Allison, head of the immunology program at the Memorial Sloan-Kettering Cancer Center in New York, whose work led to the development of the drug.

    The drawback is that loosening the restraints on the immune system can lead to dangerous side effects, the most worrisome being colitis and diarrhea, but also hepatitis, endocrine dysfunction and skin problems. The F.D.A. said that 12.9 percent of patients treated with Yervoy suffered severe or fatal autoimmune reactions.
    I'm very interested in this subject because I had melanoma removed from a spot on my neck.

    Be the change you want to see in the world. -Gandhi

    by DRo on Sat Mar 26, 2011 at 04:48:32 PM PDT

    •  it's sure not (2+ / 0-)
      Recommended by:
      DRo, DvCM

      any magic bullet.

      And it's a risky treatment.

      Will had responded to Interleukin 2, another brutal immune system treatment, quite well and there was reason to think he would respond to "ipi" because there was data showing people who'd done well on IL2 and gone on to ipi had good responses.

      It's a "trying to buy time" kind of thing.  He was also HLA A2 secreting; our ultimate hope was to get him into the National Institute of health trial for that particular situation.

      "never trust a rich man when he offers you a truce"

      by KibbutzAmiad on Sat Mar 26, 2011 at 04:51:17 PM PDT

      [ Parent ]

    •  Your reading the results wrong (0+ / 0-)

      Some drugs in fact do little but add a few months of life.

      What this result means is the median or middle person in the trial died at that point.

      There are a minority but real people alive with no diease 5 years on the trial.  Cured?  Probably but its also possible that the tumor is too small to see and is being kept in check for the time being by the immune system

  •  As long as (1+ / 0-)
    Recommended by:

    the medical field is a profit-driven industry rather than a non-profit system we'll have stories like this. This story needs to be told, so thanks for sharing it. You sound like a really good friend.

    Breathe. If you can, you ain't dead yet.

    by Socratic Method on Sat Mar 26, 2011 at 07:37:18 PM PDT

    •  thank you (1+ / 0-)
      Recommended by:
      Socratic Method

      and I agree that for-profit health care is simply unethical and immoral in the most basic way.

      I wish Les Enterline of BMS, who refused to give Will the compassionate use of this drug, would close his eyes every night and see him dying, the way I do.

      "never trust a rich man when he offers you a truce"

      by KibbutzAmiad on Sat Mar 26, 2011 at 07:40:30 PM PDT

      [ Parent ]

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