A Wisconsin baby needs help

[dmr]

I followed a DU Link regarding the obituary of Sally Baron; at that link, another story grabbed ahold of my heart about a 15-month old baby who needs a special prescription formula to stay alive. The formula has been taken off the market by the FDA, though the parents don't know why (it is available via Canada).

I don't normally post my activism activities, I just do it and hope it helps. Anyway, I thought I'd share this, and maybe some of you would like to write to your various contacts and hopefully this would be a way to expedite an FDA response.

Below is my email to the reporter and email sent out to about a hundred different people or groups. I tried to keep my email as non-political as I could, though I stumbled a bit with the Bush* administration.

To the reporter Toni Morrissey ([e-mail]):
Earlier today, I followed a link to another story on your website, and the Tyler Tracy story caught my eye. The story broke my heart to the point where I felt compelled to write to everyone and anyone who may have the power to bring this story to attention of the American public and /or apply pressure to the Food and Drug Administration. Thus far, I have written to the various entities at NBC, CBS, ABC, CNN, MSNBC, radio talk show hosts, and each member of the Wisconsin legislation. I hope in some small way this will help. I am a mom. I have also lost a child, the pain of which is near unbearable. Tyler, his mom and his dad are in my thoughts and prayers.

This is what I wrote to various contacts:

While reading the Internet newspapers today, I came upon an article (link added below) that made my heart ache for a family in Wisconsin whose 15-month old son needs a special government-suspended formula (Ketocal), and without this formula he will die. As a mom myself, it angers me that while this child suffers, our country can spend billions of dollars at a drop of a hat, and have a president that advertises "leave no child behind' and the 'right to life'. How we, as a nation, can justify not being able to provide a life-sustaining sustenance to this child is beyond my comprehension. Having an ill child is traumatic, but adding this stress for a mommy and daddy who know that the attainable sustenance to help their baby is being made unattainable by their own government, must be gut wrenching. Please look into this story, and find in your heart to bring this story to light and find resolution.

Thank you,

My name
New York

http://www.channel3000.com/health/2387373/detail.html


Thanks, DU for listening. I was originally going to post this in the Health/Education/Social Policy Forum, but my son urged me to post here in GD where it may be seen by many, I hope it doesn't get lost up here.

[htuttle]

1. A bit of good news

The story has spread elsewhere, and they are getting some (at least temporary) help.

Here's a link to the story from a Kansas City TV channel:

http://www.thekansascitychannel.com/health/2388601/detail.html

U.S. Rep. Tammy Baldwin, D-Wis., is working directly with the Food and Drug Administration and the Department of Health and Human Services on behalf of the family.

UPDATE: After the story about the Tracy family was published, a pharmacist arranged for a case of Ketocal -- at no cost to the family.

The pharmacist, who wishes to remain unidentified, is just one of many viewers who e-mailed and called to offer help.

He is trying to find more formula for Tyler Tracy while the family looks for a long-term solution to the problem.

BTW: something odd at first -- the video on the kansas city site is directly from WISC-TV in Madison, WI (I recognize it -- I live here). For moment, I was worried that this was a canned feature (as seen in Toxic Sludge is Good for You), and there may have been another motivation for the same feature story being on two local channels. It does seem to be a genuine local story, however, and it just seems that Kansas City picked the story up from WISC-TV, Madison.

(on edit...later)

Here's something else weird. I've been trying to figure out why Ketocal is no longer available here in the US.

I found this document from the Iowa WIC office, which states:

Week ending February 14, 2003 Issue 2003-17
http://www.idph.state.ia.us/wic/frifacts/2003/facts021403.htm

New WIC Medical Food Approved: KetoCal
The state WIC office recently approved the medical food, KetoCal. This product is manufactured by Scientific Hospital Supply (SHS). It contains a 4 to1 ratio (fat: carbohydrate+protein) enabling an individual to achieve and maintain a high level of ketosis. The product is intended to provide complete or supplemental nutrition support for individuals over the age of one with intractable epilepsy. It is available only in the powdered form.

It's disappearance must be very recent. IA WIC just started approving it for WIC last February.

[htuttle]

2. Found out why you can't get it...sort of

The FDA seems to have blocked it's import on May 13, 2003:
http://www.fda.gov/ora/oasis/5/ora_oasis_c_gb.html
(look under 'SHS International').

All of their shipments were impounded due to this reason code:

Reason: OMITTED
Section: 402(b)(1), 801(a)(3); ADULTERATION
Charge: It appears that a valuable constituent of the
article has been in whole or in part omitted or abstraced
from the article.

Anyone speak 'FDA'?
(definition from http://www.fda.gov/ora/oasis/ora_oasis_viol.html#55 )

[dmr]

3. I couldn't follow that either, htuttle, and

I'm pretty familar with the FDA. If you click on the 'omitted', it gives a brief description, but I am uncertain which description actually applies to KetoCal.

I did find this: http://www.fda.gov/ora/oasis/ora_oasis_viol.html#55

March 2003

FDA Import Alert - KETOCAL


We are writing to inform you that our product KETOCAL is currently subject to an FDA Import Alert.

The alert relates to an ongoing inquiry by the FDA into the analytical methodology used for determining the level of carbohydrate in KETOCAL. Both SHS North America and our parent company, SHS International Ltd. in the United Kingdom which developed KETOCAL and now manufactures the product, are confident that our methodology is appropriate. We have consulted external analytical laboratories, who support our position, and we are currently working with the FDA to resolve the issue.

SHS is confident that KETOCAL is fit for the purpose of managing Intractable Epilepsy, and that the nutritional specification of the product fully matches its label claims. However, the Import Alert means that KETOCAL is not available for distribution at present, so we are writing to notify you of the situation in case you need to consider an alternative dietary regimen for your patients in the short term.

SHS is committed to resolving this issue, and continue to give the absolute top priority in order to restore the supply of KETOCAL as soon as possible. We will contact you again as soon as KETOCAL is once more available. In the meantime, if you have any queries please call Jennifer Devaney, Product Manager on 1-800-365-7354.

Yours sincerely, SHS North America

B.G.A. Gill, President

Sadly, little Tyler has tried the alternative dietary supplements, and only responds to KetoCal.

[htuttle]

4. From that, it seems as if the FDA is alleging 'mislabeling'

Now I'm starting to sniff something foul.

Any idea which companies make the alternative dietary supplements?

(googling....)

[dmr]

5. That was my original thought

have you found anything yet?

[htuttle]

6. So far...

...the only other alternative products I've been able to find are made/imported by the same company. They are all branded with the 'SHS International' logo, so I'd assume they were the manufacturer/at least distributor.

I'll have to see if there are any more alternative products.

[dmr]

7. So far, Lamictal manufactured for GlaxoSmithKline

Research Triangle Park, NC 27709 by DSM Pharmaceuticals, Inc. Greenville, NC 27834 or GlaxoSmithKline Research Triangle Park, NC 27709/

Found the info starting here: http://www.stanford.edu/group/ketodiet/whatnew.shtml
to here: http://www.rxlist.com/cgi/generic/lamotrigine_ids.htm but the age to begin treatment is over 2 years.