I was emailed an article from the LA TImes called: 'Boston Legal' lawyer makes his case for Alzheimer's drug' (http://www.latimes.com/features/printedition/health/la-he-unreal15-2008dec15,0,5785716.column)

I watched the season finale where they argue before the Supreme Court to allow "Denny" (played by William Shatner) to be able to use the drug Dimebon.

What do we have to lose by asking our spouse's physician's to fill out the form and request it.

Here's some info:


Physician Request for a Single Patient IND for Compassionate or Emergency Use

When a physician would like to request an Investigational New Drug (IND) application to use an unapproved drug or other product for a single patient, the first step is to obtain permission from the manufacturer. Without the consent of the manufacturer, the unapproved product will not be available to the patient. After the manufacturer agrees to provide the product, the recommended procedure is to submit the following information to the appropriate review division. The request may be made by fascimile with a letter to follow.

1. Request for a single patient IND for Compassionate or Emergency Use should be stated at the top of the correspondence.
2. Brief Clinical History of the patient including the diagnosis, the disease status, prior therapy, response to prior therapy and the rationale for requesting the proposed treatment.
3. Proposed Treatment Plan including the dose, route, planned duration, monitoring procedures and modifications (e.g. dose reduction or treatment delay) for toxicity. Reference a published protocol or journal article if appropriate.
4. Drug Supply Reference Statement which would name the supplier or manufacturer and a statement that a Letter of Authorization to cross reference an appropriate IND of the supplier or Drug Master File (DMF) of the manufacturer is included. The treating physician must contact the supplier or manufacturer for such a statement.
5. Informed Consent Statement that states that informed consent and approval of an appropriate Institutional Review Board (IRB) will be obtained prior to initiating treatment. There are some IRBs that have specific procedures for approving emergency requests.
6. Investigator Qualification Statement that specifies the training, experience, and licensure of the treating physician. The first two pages of a Curriculum Vitae typically contain this information and are usually sufficient.
7. FDA Form 1571 completed with the treating physician listed as the sponsor. Form 1571 and other forms can be downloaded from the Internet.
8. Contact telephone number and facsimile number. If the request is approved, an IND number will be issued by the FDA and the treating physician will be contacted by phone or fax with a letter to follow. The IND is considered active upon issuance of the number. The IND sponsor (treating physician) will then contact the drug supplier and provide the IND number. The supplier may then ship the drug directly to the treating physician.


http://www.fda.gov/Cder/cancer/SingleIND.htm


http://www.fda.gov/opacom/morechoices/fdaforms/cder.html

No they don't. But next Monday I'm going to ask my wife's Neuro to do this.

I'll let you know.

My only question is do I bring my baseball bat with me? It's a really good Louisville Slugger!

Well I don't know about 'demand', but I was going to strongly plead that my wife be allowed Dimebon.

If anyone knows of any other clinical trial drug that shows greater promise, let me know. I have nothing to lose.

Thanks Joan,

I called the study for Dimebon and they told my that my wife is not eligible because she is already on Arecipt and Namenda. I asked if she was off the medications for a period of time, would she be eligible then? They did not recommend she stop the medication. So I don't think I have anything to lose by asking the Neuro if he would allow for the compassionate use.

Guy, I think the biggest question is whether you will be able to get your hands on the Dimebon. Most experimental drugs are not available other than through a trial.