Miltex denied!!

[Sandy H.]

I am glad I was able to take a couple of trips. Went to Lake Tahoe with my hubbie and then spent 10 days in CA with my friend. This is what I came back to. My oncologist has spent 2 months trying to get the Miltex here from Europe. It got to JFK airport and the FDA denied it!! I am kind of bummed out as what I had left from last year (I had gotten it twice from Germany) was working great. It cleared up my skin mets and kept me off chemo nearly 7 months now. My doctor is appealing it but he says it doesn't look good. So my only recourse now I feel is go to my local congress men and if I have to go to the President. I am not going to give up. Any suggestions from the board???? Hugs, Sandy

[Merridith]

Hi SandyH:

What form of medication is Miltex? Pills? Injection? Chemo? Is it in a form that you can self-medicate? I've never heard of it.

I can quite sympathize with you if you have had good success with it in clearing your skin mets for 7 whole months. I would be quite keen to get that medication if I were you too.

I do have ideas, but they don't involve lobbying (as I suspect THAT would take some rediculous amount of time that you don't have) and how useful they would be would depend on how aggressive and desperate that you are as well as what kind of political gain/votes would be in it for the politician that you approached.

1) Get yourself a mailbox in Mexico and have it mailed to yourself there, then physically bring it over the border in another type of prescription pill bottle.

2) Take a holiday in Germany.

3) Arrange for a friend/mule to bring it.

Illegal substances are brought into the States on a regular basis. There is a way of doing this if you are willing and desperate enough to think about it and to flout the law.

If you don't want to break US law, I would suggest taking a holiday in a cheap country such as India. You can live there for about $5-600 @ month in a house including expenses. The doctors are very good there. Arrange to have a Indian doctor give it to you while you holiday over there for a few months (or whatever the necessary time period is). India is an especially good choice because if you have money (and as a US citizen you are relatively rich there) you can buy top-quality medical care and their rules aren't nearly as strict. There are also some states in India were there is an extremely high percentage of Ex-pats living there so there would be LOTS of English speaking people, food and services there that would be comparible to what you could expect in the States.

Hope this gives you food for thought and hope.

Regards,
Merridith

[rosie]

Dear Sandy

While I can believe anything with the FDA, I am shocked that they could deny something that has worked for you. The FDA has a patient advocate office that you should contact. I think contacting your congressperson is a great idea.

But if all else fails, are you well enough to take a trip to Europe to stock up? That seems like the fastest and perhaps the most enjoyable way.

I wish you all the best. How frustrating!!!

[Esther]

Sandy can you just order it again, and see what happens? If it has reached you twice before, it might make it through the next time.

That might have been a fluke that occured and got your shipment snagged up.

[Tom]

I found an article online describing how to obtain Miltex in the U.S. under a compassionate use exemption. Follow the link to the site. It gives all the necessary information, as well as the forms that need to be filled out by your doctor in order to receive the drug. I hope this helps.

http://breastcancer.about.com/od/miltex/

[lindaw]

Dear Sandy
I am keeping miltex in mind for later after this chemo and in the meantime wanted to investigate how to get it . I emailed the company Baxter Oncology and they sent me allsorts of info on how to obtain it in Australia.
I can email you the contacts if you like or look at their website.
love
linda

[Sandy H.]

You are all so very caring and compassionate! Thank you all for your help. First of all it is a topical solution and comes in 1 oz glass, brown bottle. A shipment contains about 10 or 12 bottles with several boxes of gloves to apply it with. The forms on the web site are no longer being used and they are no longer located in Germany. A doctor has to apply for it under the compassionate program and has to show that this is last resort for treatment for the patient. My doctor and his nurses spent hours and hours trying to get the correct forms, and their location in Europe. It all went through and the shipment arrived at a New York airport It had to be released by the FDA and it was refused. I understand this has happened to another lady and hers arrived in Ohio airport. I would appreciated the info from Baxter Oncology and I will contact them as well. I will keep you updated on how this goes. I am not giving up. By the way my nurse in Oncology asked me if I could get some help off this board!!!! I like that. Hugs, Sandy

[Sandy H.]

I have a few corrections to make on my previous posting. I called my oncology and talked to the nurse working on my case and she said the place that has it is in Baxter, Germany. It is now being held at JFK airport and the FDA has refused to release it to my doctor. He is appealing the decision with the FDA. I did call Baxter Oncology and they told me they were in the same situation not able to get it because of the FDA refusing to release it at the customs!! She said she did not know of any other place it could be obtained. Only a doctor can fill out the forms to get it. I have also sent my congress woman a letter for help. I am not lobying only asking for help. I also got the FDA number and will call them as well. Any more questions please let me know. I will keep you all updated on how this goes. hugs, Sandy

[StephN]

NOTHING worse than government Red Tape!
Then you get some egomaniac who wants to interpret things his own way and take off on some power trip of his own just to show people "who is in charge."
Yikes!
Keep after the creeps, and God bless your doctor for doing all he can to pry your med out of the hands of the self-important functionaires.
Hope it is done before the expiration date!

Glad you are feeling well otherwise, but GOT to keep those skin mets undercontrol.

[Sandy H.]

Thanks Steph: I have e-mailed 3 of my Congress man today. I have left a message with the FDA person who refused to release it at JFK asking him to please call me as to why he would not release it. I will be surprised if I hear but will keep calling every day if I have to. They will be so sick of me they will hate me before this is over. If I don't get any results I will go to the press. I will fight to the bitter end with this. I have had so many responses it motivates me to fight even harder. I knew in the beginning this was going to be tough one. Will keep you posted. Hugs, Sandy

[Merridith]

I think that the press is a good idea.

Perhaps if you picked a suitable newspaper/TV show etc you could let us know your choice and we could all support you with emails. The technique worked a few months back for a woman who's son paid for flowers that weren't delivered. That company backed right off....

Merridith

[lindaw]

Dear sandy
here is the details I recived from baxter Oncology

Dear Mrs. Ward,

Thank you for contacting Baxter Oncology.

Miltex is a topical treatment for skin mets deriving from breast cancer. I
t is marketed in a number of countries but it is not approved in Australia.

Of course we would like to support you to get the product to treat your
skin lesions and hopefully you will benefit from the use of Miltex as other
patients do.

I see three potential ways to obtain the product:

1. To obtain the product via an international pharmacy (e.g. from France,
Germany, Italy, Spain where the product is approved). Here we can provide
you with contact details if needed.

2. To check with our local Medical Director for Australia - Dr. Barry Dale
- about possible local opportunities to get Miltex in Australia (I have Dr.
Dale copied in this e-mail and by that you have his e-mail contact as
well).

3. To check with our global Medical team (Drs. Gimonet and Martinez) -
about specifics programs they might propose you to participate if there are
any (I have Dr. Gimonet and Dr. Martinez copied in this e-mail and by that
you have their e-mail contacts as well).

With my very best regards.

Dr. Udo Müller

_________________________________________________
Udo W. Müller M.D.
Director Medical Marketing Europe, Middle East and Africa
Baxter Deutschland GmbH
Im Breispiel 13, D - 69126 Heidelberg
Home Office: Müllheimer Strasse 20, D - 79292 Pfaffenweiler
Phone Baxter Office: +49-6221-397-346, Tie Line 243-346
Phone Home Office: +49-7664-611-161
Fax Home Office: +49-7664-611495
Mobile Phone: +49-172-3862-610
E-mail to: udo_mueller@baxter.com


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