PARP Inhibitor Prescription, Please.

May 5, 2015

The PARP Inhibitor BMN 673 trial was working very well for me.  But a routine scan in late February showed a new spot on my liver.  A tiny spot.  A barely visible on the scan spot. However, four different radiologists examined the scans independently of one another and all reached the conclusion that it was in fact new cancer.

“A trial sponsor measures successes and failures in treatment differently than an oncologist does,” Dr. H explained.  He went on to say that with any treatment you may have spots that shrink, spots that maintain and new spots that surface. As an oncologist, he looks at the overall picture.  He felt that BMN 673 was still working based on all the spots that had disappeared.  He deemed this overall shrinkage as success over the one tiny new spot.

The pharmaceutical trial sponsor BioMarin viewed the new spot as treatment failure; confirmation that the drug was no longer working for me.  This has a lot to do with how the FDA drug approval process works, what they need their numbers to look like in order for a drug to reach the market and how closely a company must follow guidelines in order to keep their drug from being dismissed by the FDA on a technicality.

Dr. H also felt like this new spot coincided with a dose reduction that BioMarin had forced on us due to some of these aforementioned guidelines.  He felt like the lowered dose just wasn’t strong enough.  Oncologists tinker with doses all the time when overseeing chemo or other treatment because every patient is different and every cancer responds differently.  It’s like solving a puzzle to figure out what will work for each individual.

Based on his strong feeling that continuing this treatment was in the best interest of my health and longevity, Dr. H filed for compassionate use of the drug.  And after many screaming matches with with BioMarin peeps over the phone (“This is NOT how we treat patients!”), he was denied this request.

After speaking with some people who know more about compassionate use than me, it seems to be that compassionate use in general is just a scapegoat.  The FDA gets to say that they are not denying anyone the right to put medication into their bodies.  But pharmaceutical companies have no legal obligation to grant use.  Ever.  So appealing something like this would mean expending enough energy to gain national attention through the media and essentially bully BioMarin until they give in.  (It is more likely that I could grow to be six feet tall.)

“Is that really how you want to be spending your time and energy when you are unsure of how much time you have left? Time and energy that may never lead to anything?” Dr. H asked.

No.  It isn’t at all.

Thus, I have no access to the medication that was working so well for me until it is FDA approved.  The drug has been fast-tracked for approval.  But even with fast-tracking, it could be another 2-5 years before it’s released to the market.

This leaves me with the following options:

1) No more treatment.

Live for as long as I’ve got left and be at peace with the fact that death is not a tragedy, it’s just part of the deal.

2) Alternative treatments.

I’m still seeing a reiki healer.  I’m ingesting frankincense. I’m doing lots of yoga.  I’m drinking lots of juice.

I also recently spent some (absurdly surreal) time in California at a cannabis clinic.  Very long story short… turns out an appropriate, daily dose of medical marijuana is too much for me.  Being on it long term is not a great option.

3) More chemo.

Dr. H says there’s a “gentle” platin-based chemo regimen he could put me on that he has had a lot of success with in metastatic patients.  Platin based chemos aren’t as harsh as they used to be.  I’ve never been on one before, so he has every reason to believe my cancer would respond to the new drug.  He could break up the dose, giving me a very low hit once a week.  He says some women get through this way with no side effects.  Not even hair loss.

But I don’t want more chemo.  Last go round, it proved not effective.  And just everything about it… nothing tastes good, the malaise, what it does to my skin, the smell, all the other medications you have to take just to be able to get out of bed.  And the fact that I would have no freedom to roam the way I like.  I would be committed to being in that chair once a week indefinitely.  No thank you.  I’d rather stick with option number 1.

4) A different PARP inhibitor.

In December, Lynparza became the first FDA approved PARP Inhibitor.  So Dr. H can just write me a prescription for it.

Here’s the catch… It’s only been approved for ovarian cancer patients.  Therefore, my insurance company will not cover the prescription because I have breast cancer and not ovarian cancer.  I can still fill the prescription, but I would have to pay for the drug out of pocket.  And it’s brand spankin’ new, which means it is costly.

How costly, you ask?


Per month.

Any treatment decision at this point is a decision meant to buy some time until BMN 673 is approved, or Lynparza is approved for breast cancer patients (this process has also been fast-tracked) so that I can get the meds I need with insurance coverage.  And even with the cost, this last option is the best one for me.

My dear fundraising warriors have started a campaign in the hopes that we can cover the cost of the Lynparza until my insurance will.

Donations may be made here: Team Gwen

Thank you in advance for contributions.  Here’s hoping we reach our goal.

End cancer: the sequel, chapter 6.


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