Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied | TigerDroppings.com

Posted byMessage
East Coast Band
Alabama Fan
Member since Nov 2010
13965 posts

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


LINK

Andrea Sloan is dying of ovarian cancer. Having exhausted all standard treatment options, her doctors say her best hope now is a new class of cancer drugs called PARP inhibitors.

The California pharmaceutical company BioMarin makes one version of these drugs called BMN 673. Earlier this year, the company presented very early data on this experimental drug at a large cancer conference. Initial results in women with breast and ovarian cancer were encouraging.
Sloan says there are doses of BMN 673 sitting on shelves in the same hospital where she's seeking treatment: M.D. Anderson Cancer Center.
But she's not getting the treatment because the company is refusing to give it to her. That's because this drug she wants is still in clinical trials, and the company says hasn't been proven effective.
BioMarin points out that to date their drug has been tested in fewer than 30 patients with ovarian cancer like Sloan.
"It would be unethical and reckless to provide end-stage refractory ovarian cancer patients outside a clinical trial with BMN 673 at this early stage of development," says company spokesperson Debra Charlesworth. "If we did, we would be exposing an experimental drug to a large group without adequate testing. There have been previous circumstances where early access to large groups has resulted in adverse consequences that were worse than the course of the disease."

The FDA has said Sloan qualifies to seek compassionate use of BMN 673, but BioMarin won't provide it and they don't have to.

What side are you on? Let her have the new drug and suffer or enjoy the consequences, or not have it due to the need to properly test a drug before just letting anyone get their hands on it?







Back to top
Share:
Cajun Revolution
Columbia Fan
Member since Apr 2009
40348 posts

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


Oh she fine





Back to top
Yahtzee
Member since Aug 2013
1552 posts

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


Give her the drug.





Back to top
Carson123987
LSU Fan
Middle Court at the Rec
Member since Jul 2011
35860 posts

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


all she needs is a few prolonged bursts of my protein and she'll be cured





Back to top
The Boat
LSU Fan
Bitch I'm from Louisiana
Member since Oct 2008
59816 posts

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


She's too hot to let die.





Back to top
Mizzoufan26
Air Force Fan
Norfolk you buddy!
Member since Sep 2012
7159 posts
 Online 

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


She's to pretty to die from this, let her have it!





Back to top
BuckeyeFan87
USA Fan
Columbus
Member since Dec 2007
21676 posts

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


Kind of says something that the FDA approves something before the company making it will actually back it.





Back to top
Hopeful Doc
LSU Fan
Member since Sep 2010
8181 posts

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


quote:

What side are you on?


Seeing as the drug has only been tested in 30 patients, odds are it's not in any real large-scale production right now. Moreover, the company is probably finding individuals that fit the profile of how the drug is targeted for the limited supply of the drug they do have for testing and close monitoring, which will eventually turn into a larger trial with results that are applicable to lots and lots of people. It sounds cruel to not throw this drug at a dying woman to see how it works, particularly because it's possible that 20 years from now, this drug could be the standard of care in patients such as she. But she doesn't meet the requirements of the trial, and the company feels it would be wrong to give it to her, not knowing the effects it could have.
the "what could it hurt?" mentality is fine to have, but I don't think the drug company is necessarily wrong for denying the drug to her.






Back to top
Hopeful Doc
LSU Fan
Member since Sep 2010
8181 posts

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


quote:

Kind of says something that the FDA approves something before the company making it will actually back it.



Careful how you read into that; compassionate use is the FDA saying it's OK to use stuff that hasn't formally passed trials in patients who are imminently dying and potentially treated with that drug, if the drug company agrees to provide it (and someone can afford to pay for it).






Back to top
foshizzle
LSU Fan
Washington DC metro
Member since Mar 2008
29517 posts

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


quote:

and someone can afford to pay for it


Kind of a key point here. Really early-stage drugs can be pretty damn expensive to make and insurance sure as hell won't cover it.






Back to top
biglego
LSU Fan
your mom knows
Member since Nov 2007
19955 posts

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


The poor woman is dying and there's nothing to lose by letting her try. If it were our daughter or wife or mom we'd be pretty disgusted she's denied a chance, however slim. It's total BS and makes me hate people.





Back to top
jclem11
TCU Fan
Houston, Texas
Member since Nov 2011
2856 posts

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


quote:

The poor woman is dying and there's nothing to lose by letting her try. If it were our daughter or wife or mom we'd be pretty disgusted she's denied a chance, however slim. It's total BS and makes me hate people.


Exactly. Well said.






Back to top
TheDude
LSU Fan
Member since May 2004
1541 posts

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


quote:

The poor woman is dying and there's nothing to lose by letting her try. If it were our daughter or wife or mom we'd be pretty disgusted she's denied a chance, however slim. It's total BS and makes me hate people.


Speaking as a man whose wife is currently enrolled in a clinical trial, these are my thoughts exactly. Some of the treatment decisions I've seen have blown me away.






Back to top
Elephino
LSU Fan
2nd floor, stall 3. Bring paper
Member since Sep 2008
248 posts

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


Unfortunately, she is one of thousands in similar situations, and the biotech company is not a charity. This drug is only in Phase I with strict requirements on patient enrollment. In Phase I oncology trials, the objective isn't "curative effects". Dosing isn't always consistent or even therapeutic; dosing may be varied to examine patient and cancer cell response. Essentially, these participants are enrolled for the collection of useful data, not because a high percentage are expected to go into remission (or any of them). If she is not enrolled in the trial, there is a good possibility that insurance would deny coverage, especially if this drug has no proven efficacy on her type of cancer. This drug has shown the greatest activity against specific cancers with BRCA or PTEN mutations.





Back to top
Swoopin
Auburn Fan
Member since Jun 2011
16296 posts

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


Would the company be open to lawsuits? The FDA doesn't have anything to do with preventing that do they





Back to top
Elephino
LSU Fan
2nd floor, stall 3. Bring paper
Member since Sep 2008
248 posts

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


On what grounds? The drug is not approved or licensed for sale. It's not the same as being denied sale or service in any other context. I'm not sure why this particular story was publicized. This is not a rare occurrence.





Back to top
Bestbank Tiger
Tulane Fan
Landmass
Member since Jan 2005
19100 posts

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


quote:

The poor woman is dying and there's nothing to lose by letting her try. If it were our daughter or wife or mom we'd be pretty disgusted she's denied a chance, however slim. It's total BS and makes me hate people.








Back to top
TheFolker
Kentucky Fan
Member since Aug 2011
2789 posts

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


quote:

"adverse consequences that were worse than the course of the disease."


A fate worse than death?






Back to top
East Coast Band
Alabama Fan
Member since Nov 2010
13965 posts

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


quote:

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

Her attractiveness has something to do with it, IMO.






Back to top
Hopeful Doc
LSU Fan
Member since Sep 2010
8181 posts

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


quote:

In Phase I oncology trials, the objective isn't "curative effects". Dosing isn't always consistent or even therapeutic; dosing may be varied to examine patient and cancer cell response. Essentially, these participants are enrolled for the collection of useful data, not because a high percentage are expected to go into remission (or any of them).


Put a little more simply, though not necessarily correct overview of how Trials work:
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).
Phase II- this is where a moderate sized group of people who are affected with a specific disease are given the drug at varying doses to measure the response
Phase III- This trial is huge. And it's across multiple centers. People are given a drug or something else (traditionally, you think of the 'something else' as a placebo, but as it would be cruel to treat a heart attack with a placebo rather than with the current standard of care therapy, therefore, depending on the situation, you can show efficacy vs placebo, or efficacy vs a specific treatment (typically the standard of care, otherwise you're setting up a tin man to knock down and your trial will show poor results).

In shortest, grossest terms, the stage that his drug is at is the "Let's see if it will kill people if they're given it for two weeks" stage.






Back to top


Back to top




//