Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied | TigerDroppings.com
Posted by
Message
East Coast Band
Alabama Fan
Member since Nov 2010
16021 posts

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

LINK
Image: http://i2.cdn.turner.com/cnn/dam/assets/130927154050-andrea-sloan-01-story-top.jpg width = 500

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?



Cajun Revolution
George Washington Fan
Member since Apr 2009
44671 posts

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


Replies (0)
Replies (0)
Yahtzee
Member since Aug 2013
1552 posts

re: Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied
Give her the drug.


Replies (0)
Replies (0)
Carson123987
LSU Fan
Middle Court at the Rec
Member since Jul 2011
40541 posts
Online

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


Replies (0)
Replies (0)
The Boat
Florida State Fan
Member since Oct 2008
65721 posts
Online

re: Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied
She's too hot to let die.


Replies (0)
Replies (0)
Mizzoufan26
Air Force Fan
Norfolk you buddy!
Member since Sep 2012
9006 posts

re: Ovarian cancer patient seeks use of experimental pharmaceutical drug, but denied
She's to pretty to die from this, let her have it!


Replies (0)
Replies (0)
BuckeyeFan87
Ohio State Fan
Columbus
Member since Dec 2007
22402 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.


Hopeful Doc
LSU Fan
Member since Sep 2010
9509 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.


Hopeful Doc
LSU Fan
Member since Sep 2010
9509 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).


foshizzle
LSU Fan
Washington DC metro
Member since Mar 2008
31062 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.


Replies (0)
Replies (0)
biglego
LSU Fan
your mom knows
Member since Nov 2007
25140 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.


jclem11
TCU Fan
Houston, Texas
Member since Nov 2011
2982 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.


Replies (0)
Replies (0)
TheDude
LSU Fan
Member since May 2004
1649 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.


Replies (0)
Replies (0)
Elephino
LSU Fan
2nd floor, stall 3. Bring paper
Member since Sep 2008
285 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.


Swoopin
Auburn Fan
Member since Jun 2011
17610 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


Elephino
LSU Fan
2nd floor, stall 3. Bring paper
Member since Sep 2008
285 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.


Bestbank Tiger
Tulane Fan
Landmass
Member since Jan 2005
21889 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.




Replies (0)
Replies (0)
TheFolker
Kentucky Fan
Member since Aug 2011
3355 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?


East Coast Band
Alabama Fan
Member since Nov 2010
16021 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.


Replies (0)
Replies (0)
Hopeful Doc
LSU Fan
Member since Sep 2010
9509 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.


Page 1 of 3

Back to top

Follow TigerDroppings
Follow us on social media and get the latest updates.

FacebookTwitterInstagram