Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied - Page 2 - TigerDroppings.com

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Hopeful Doc
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Member since Sep 2010
8314 posts

re: Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied


quote:

A fate worse than death?



Many, many patients on HAARTherapy for AIDS quit taking it because of the side effects. They know full and well that, at a certain point, their body's immune system will cave, and they are essentially a 'walking petri dish for diseases' (the human body is a fantastic place for all kinds of terrible things to grow when there is no immune system). Everyone with HIV who progresses to AIDS and starts HAART is told this. It would blow your mind the number that quit taking it because the side effects are so rough.






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Dorothy
LSU Fan
Munchkinland
Member since Oct 2008
14950 posts

re: Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied


quote:

I'm not sure why this particular story was publicized.


Because she has a PR firm working for her pro bono, and a Change.org petition with over 150,000 signatures. Not ragging on her, because if that's what it takes to save your life, use anything you got. But most people wouldn't know how to work the system to get this kind of attention, as this guy points out:


quote:

Art Caplan, professor of Bioethics at NYU Langone Medical Center, says the scatter-shot way in which individual patients are left to petitioning drug companies for access to experimental drugs creates an unfair process.
"One problem in this country is we haven't set up a system. Right now what we've got is a squeaky-wheel lottery; if you can figure out what your options are, if you know how to use social media, if you know how to have a bake sale, if you can hire a PR firm -- you can have a shot at an unapproved drug," says Caplan.


I'm kind of on the fence here. Yes, give her the drug--what could it hurt if she's dying, right? I have had close family members die from cancer and I know I would've wanted them to try anything to save their lives.

But I'm not in medicine and I'm not sure how clinical trials work. If she had negative results or even harmful side effects using this drug for something it's not currently being tried on (ovarian cancer as opposed to the current trial of breast cancer), would they have to report those findings? Could that then hurt the company later when they try to get it approved, and thus maybe prevent a possible cancer drug from making it to the market?




This post was edited on 9/29 at 9:42 am


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Turbeauxdog
LSU Fan
Member since Aug 2004
5671 posts

re: Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied


If you ever read Milton Friedman, he theorizes that the FDA kills more people than it saves by impeding the development off drugs through incredible testing requirements and the prohibitive costs associated with those requirements.

Think of how an FDA bureaucrat is incentivized. I hold up this drug for one more round of testing even if its not really necessary, so that I can say I've exhausted all testing, I'm considered thorough. I allow this drug to go to market and one person dies, my career is ruined.

But how many people die during this round of CYA testing because the drug is not available.






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Hopeful Doc
LSU Fan
Member since Sep 2010
8314 posts

re: Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied


quote:

she had negative results or even harmful side effects using this drug for something it's not currently being tried on (ovarian cancer as opposed to the current trial of breast cancer), would they have to report those findings?


No. She's not part of the trial. She would be receiving it as 'compassionate use' of the drug.
quote:

Could that then hurt the company later when they try to get it approved, and thus maybe prevent a possible cancer drug from making it to the market?


the stats? No. The not having a set doseage or way to produce the drug on a large-scale level or even knowing the best therapeutic dose for the drug? Yes- they'd have to dump resources into production with no research gains to be had, which would make the overall cost of the drug increased, as well as its time to market- both of which will affect the lives of many more than one woman.






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Cruiserhog
Arkansas Fan
Little Rock
Member since Apr 2008
3354 posts

re: Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied


if she's dying anyway give her the drugs.

only 2 things can happen, she gets better you make billions on the drug

she dies, you have the late stage scapegoat.







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windshieldman
New Orleans Saints Fan
Member since Nov 2012
1307 posts

re: Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied


OT oncologist, why can't y'all find the magic pill for cancer? Wasn't there some young kid who found a cheap, quick way to diagnose cancer? There was a thread on it about a year ago, what happened with that?





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Cruiserhog
Arkansas Fan
Little Rock
Member since Apr 2008
3354 posts

re: Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied


quote:

OT oncologist, why can't y'all find the magic pill for cancer? Wasn't there some young kid who found a cheap, quick way to diagnose cancer? There was a thread on it about a year ago, what happened with that?


he was granted his own labratory and is developing his paper test for other versions of cancer.

there is no money in a cure, just remember that. As cynical as that sounds Im leaning towards the above statement to be somewhat of a guide in the R&D's and board rooms of big pharma







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shel311
Nicholls St. Fan
Orlando, Florida
Member since Aug 2004
31532 posts

re: Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied


quote:

If she had negative results or even harmful side effects using this drug for something it's not currently being tried on (ovarian cancer as opposed to the current trial of breast cancer), would they have to report those findings? Could that then hurt the company later when they try to get it approved, and thus maybe prevent a possible cancer drug from making it to the market? 
Exactly

It sucks but I absolutely see why the company wouldn't give her the drug.






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shel311
Nicholls St. Fan
Orlando, Florida
Member since Aug 2004
31532 posts

re: Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied


quote:

if she's dying anyway give her the drugs. only 2 things can happen, she gets better you make billions on the drug she dies, you have the late stage scapegoat. 
if it were actually that simple, they would have given it to her already.

Unfortunately, it's wayyyyy more complicated.






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Cruiserhog
Arkansas Fan
Little Rock
Member since Apr 2008
3354 posts

re: Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied


quote:

if it were actually that simple, they would have given it to her already.

Unfortunately, it's wayyyyy more complicated.


oh I know but what I posted was the basest, crux of the decision, it is literally that simple when all the redtape is removed.






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Puffoluffagus
LSU Fan
Richmond, VA
Member since Feb 2009
2584 posts
 Online 

re: Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied


quote:

there is no money in a cure


Bull shite. There's a ton of money in a cure. If someone had a cure for lung cancer, it's most likely not going to be some one shot pill, it's gonna be a multi dose therapy in which they could charge whatever they wanted for it. And people aren't going to stop getting lung cancer with the creation of a cure, there's always going to be consumers for that product as long as smoking and environmental hazards exist.






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Upperaltiger06
Auburn Fan
North Alabama
Member since Feb 2012
1894 posts

re: Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied


quote:

quote: "adverse consequences that were worse than the course of the disease." A fate worse than death?


Means they believe use of the drug may hasten death and/or decrease her quality if life more rapidly.






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Redbone
LSU Fan
Prairieville
Member since Sep 2012
3168 posts

re: Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied


quote:

Hopeful Doc


If anyone is really interested in this one case please pay attention to this guy's posts. My company is in the drug business (Novartis). Bringing a drug to market takes years. Most fail.

She is just one of a multitude of cases that would like to get drugs that are in the testing phase.






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Isabelle
Member since Jul 2012
1846 posts

re: Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied


My educated guess is the company doesn't want any bad outcomes in their trials, so if they can't give it to you in the very early stages, you are not going to get the drug. It's all about the $$. Bad outcomes will result in disapproval of the drug by the FDA! Simple yet very very sick!





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NoHoTiger
LSU Fan
just left of center
Member since Nov 2006
33358 posts

re: Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied


I used to work in Phase I trials at a pediatric center. It's tough to tell someone they don't qualify, but it has to be done. If I was ever in that situation, I would just offer myself up as a guinea pig for docs to learn what they could.

And as cynical as it sounds, there would not be near the outrage if she was fat or unattractive.






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Hopeful Doc
LSU Fan
Member since Sep 2010
8314 posts

re: Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied


quote:

educated guess is the company doesn't want any bad outcomes in their trials,


2 things here:
1) this girl isn't in the trial, because the drug isn't actually designed for her situation (this is why she doesn't meet the requirements for the trial).

2) maybe you're saying she doesn't fit the trial, and that's wrong because she is sick. Let's look at this a little more objectively from the drug maker's point of view:
You have a drug for low back pain. It works outstanding for low back pain that's neurological in nature. This person wants your drug to work for their headache- lots of headaches are neurological in nature too (though not all). Would you want to include the person with headaches and no low back pain in your low back pain trial? The way medicines work, you really wouldn't want to. If, during the process, they find out that headaches happen to be relieved too, by a similar mechanism, then doctors will look at the way the drug works and decide to use it 'off-label' for headaches as well, because it would cost millions of dollars for the drug company to do a trial specifically for headaches after.

Similarly, in this case, this woman doesn't qualify based on the kind and staging of her cancer, so she does not qualify for the trial. Is it sad that she doesn't qualify? Sure. Anytime someone dies before they accept and are comfortable with the fact that death is the inevitable end to life, it saddens me greatly. But in this case, the outroar is because she is pretty. The FDA and drug company are both in the right in their decisions in this sad, sad case.






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Hopeful Doc
LSU Fan
Member since Sep 2010
8314 posts

re: Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied


quote:

OT oncologist, why can't y'all find the magic pill for cancer? Wasn't there some young kid who found a cheap, quick way to diagnose cancer? There was a thread on it about a year ago, what happened with that?


Because 'cancer' isn't just 'cancer'- it is an umbrella term catching all types of cellular overgrowth where cells lose their original functionality and then start to invade other, healthy cells around the body. There are hundreds of ways this occurs. We actually DO have the 'magic pill' for many types (though not all). People are working on cures for other types of cancer. Here's the quick and dirty of what cancer therapy does: it kills cells. Based on what kind of cancer it is and how devolved it is from its original kind of cells, it's easier or harder to selectively kill the cancer cells without killing the regular cells. To date, it's hard to find anything that's only going to kill the cancer cells without at least killing some of the 'good' cells, and this is why the side effects of chemo are so severe and painful. The most promise that I have seen in cancer therapies is the evolution of the biologics- lab-made antibodies that attack specific sites that are only on the cancer cells. For these to be made, though, there has to be a unique cell marker on the cancer cells, and that's just not always the case.

As far as the kid, I don't know what cancer he could specifically detect, but it most definitely wasn't all of them.

And to the guy that says there's no money in a cure- that's far from true. Look up the drug 'gleevec' I think is the trade name. Imatinib is the generic. It puts a freaking hurting on CML that comes from a Philadelphia Chromosome mutation. It's also really expensive. In this case- the cure induces a profit. The notion that drug companies hold the cure for a profit is a silly notion at best, in my humble opinion.






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Elephino
LSU Fan
2nd floor, stall 3. Bring paper
Member since Sep 2008
253 posts

re: Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied


quote:

Phase I- small group of healthy volunteers (some trials use people with the disease studied). It's mainly to see the side effects that happen in people (as opposed to those that happened in animals).


"Healthy volunteers", does not apply to cancer drugs because most are cytotoxic; all will have disease, which also skews ADME data. You cannot give healthy volunteers a known cytotoxic drug, even when cytotoxicity is the desired outcome.






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Meauxjeaux
Memphis Fan
I have 89,275 posts with my alters
Member since Jun 2005
16335 posts

re: Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied


Inb4frickcancer

Oh, nobody else putting their money where their mouth is?







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Meauxjeaux
Memphis Fan
I have 89,275 posts with my alters
Member since Jun 2005
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re: Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied


Doc and noho with some mature discussion.

This situation sucks.






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