The Answer from Wyeth/Pfizer Is NO (sort of ...)

I spent three days or so this past week researching the whole "compassionate use/expanded access" issue for neratinib, the new breast cancer targeted therapy that is now in clinical trials. 

And then I wrote a memo summarizing my findings and the steps my oncologist and I would have to take to get the drug ... most of this from the FDA's Web site and from e-mail exchanges with various people. 

Step One was for Dr. Lee, my oncologist, to talk to an oncologist at Wyeth (now part of Pfizer) to see if the drug company was willing to give me neratinib on compassionate use grounds since I do not qualify for a clinical trial. 

Dr. Lee called the Wyeth oncologist, Dr. Anna Berkenbilt, yesterday morning. 

And, not to drag this out, the answer was NO. 

Even though I'd been kind of expecting this, it hit me pretty hard. After all, this is a life-and-death issue for me. 

Dr. Berkenbilt gave Dr. Lee several reasons, they included the fact that Wyeth/Pfizer has no compassionate use program for neratinib at this time. (Well, according to the FDA, they don't need to have any program, they just need to agree to supply me with the drug.)

The second reason was the recent merger between the two drug companies, which has things in a bit of an uproar. (See: Merger) 

And the third reason, which Dr. Lee repeated to me, was the FDA memo or announcement, which is only two months old, and which has not yet been "digested" by the huge bureaucracy that is this drug company. (See: New FDA Rules ) 

Now, I understand these reasons, but from a cancer patient's point of view, they are rather lame. The only reason I'm not launching a huge lobbying effort here involving all sorts of people is that the doctor seemed to want to help me, according to Dr. Lee, and she asked him to call her back in two weeks. 

So I can wait two weeks. I'm spending next week in Nebraska anyway. 

And I'm doing my best not to let this get to me. My sense is that all I need is one person of goodwill inside the drug company who is willing to fight for me. Is Dr. Berkenbilt that person? Too soon to tell. 

Read more: Neratinib

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@ Jeanne Sather 2009. 

 

Comments

[carver]

Jeanne I am so sorry to hear this. It makes me so mad that it's so difficult to get compassionate use drugs. My good thoughts are as ever with you, Carver

[Nat]

Is this a case where the American Cancer Society, Komen, or some other institution that claims to benefit cancer patients, be of any help?
The fact that you have to go through all of this to get a drug you need, truly angers me. Hang in there Jeanne

[Lisa O]

Jeanne
I am so sad (and MAD) for you! This is just not right and I so wish there was something I could do to help.
On a lighter note I hope you have a good visit in NE.
Hugs

[jeanne Sather]

Lisa--thanks! If Dr. Berkenbilt doesn't say YES when my oncologist calls her in two weeks, then there will be things you can do: Write letters and make phone calls on my behalf.

Because it sounds like the squeaky wheel gets the life-saving drug, and the quiet, polite cancer patient stays at home and dies.

[Jeannie]

Jeanne,
Keep us posted on this and if the answer continues to be NO then you can bet we will rally behind you, writing letters and making calls.
Enjoy the trip to NE and may you stay flu free.

-Jeannie

[fer]

Hello
I can understand that You are going through so much pain and I think you are inspiration for all others.I will pray for you.Thank you very much for sharing this with us.