We will be building this page over time to illustrate the lengths that we have gone to comply with the FDA and get the Valley Fever Task Force, experts, researchers et al on board but to no avail. Actually, we have been blocked every step of the way.

Valley Fever as published in the Fountain Hills Times

Posted Tuesday, November 26, 2013, 5:00 pm

Jane Laulis, Desert Defense Manager

Regarding the guest editorial by Rep. David Schweikert: Valley Fever Awareness.

Since May of this year, we have been trying to contact the co-chairs of the Valley Fever Task Force, Representatives McCarthy and Schweikert, regarding their interest in finding cures, prevention and treatment options for Valley Fever.

We also notified them in writing that since the beginning of all the publicity of Valley Fever that the price of the generic drug fluconazole had increased ten-fold and that there was a need to try and create some options for people and their pets immediately.

We believe based on our initial study of Valley Fever in canines in 2008 and the ensuing five years of data that we have gathered that targeted nutritional supplements such as Desert Defense could have a role in impacting this multi-faceted disease in both pets and people.

Our proposal is that these supplements could be approved and used as a step before drugs or in combination with drugs. They would be tested in a clinical trial but not in the same extensive and expensive format as drugs.

What we are asking is to think outside of the box. People that developed life threatening forms of clostridial infections from antibiotic use had no options until fecal transplants were pioneered. This was considered the last line of treatment – it’s now considered the first. The FDA tried to step in and regulate but has now backed off.

Thus far there has been little response from the Task Force.

ADDITIONAL RESEARCH

We contacted the famous researcher at UC Davis about doing a mouse/Guinea pig study of Desert Defense who often complains there is nothing out there for people and pets and here is his response:

George Thompson <grthompson@ucdavis.edu>ReplyReply allForward

To:​jane rogueresearch.com​

Cc:​info@desertdefense.com​

Tue 3/11/2014 10:45 AM

Jane, thanks for contacting me.  I think we are overly committed to other projects currently and won’t be able to help with this.

Best,

George

EVIDENCE OF DESERT DEFENSE® EFFECTIVENESS

In-house study conducted 2008 to develop the first formula:

A pharmacognosy approach to conventional drug therapy for reducing serologic titers in canine subjects diagnosed with the fungal disease, coccidioidomycosis.

The goal was to support the mammal with complex nutritional tools to maximize the ability of the host to deal with the organism.

Key parameters for success: titer reduction and symptom relief. Analysis conducted by complete lab reports which include Chemistry 27, Comprehensive CBC, T4, and Coccidioidomycosis titers both IgG and IgM plus veterinarian and pet owner feedback.

Initial enrollment of 10 dogs expanded to 22. Results: 74% reduction in titers; 100% reduction in symptoms either partial or complete. We have continued to track many of these dogs throughout their lifetimes. We have also been able to review data on study dogs that went on to have offspring.

This study was reviewed by the Arizona Veterinary Medical Society and was performed correctly in terms of veterinary supervision.

In 2009 we launched one supplement that was developed during this study believing that this supplement would be helpful to prevent VF infection and/or support dogs that had an active infection using a one-size-fits-all approach that is currently followed with drug therapy.

We quickly realized that VF has a multitude of manifestations based upon sex, breed, age, diet, and many other factors. An example of this would be hormone fluctuations in intact male and female dogs vs. spayed and neutered dogs which often create a different response to components.

WE then staged the needs based upon intact or fixed, and combination drug therapy as 1) Dogs that were healthy had lived in the desert environment for years and did not have VF

2) Dogs that were visiting the desert but not sick and needed preventative support or

3) Dogs that were moving from one part of the desert to another or in the path of construction

4) Dogs that had a titer but were considered exposed but not sick

5) Dogs with or without a titer that were sick but with low-grade symptoms

6) Dogs with or without a titer that were sick with VF with lethargy and/or lameness

7) Dogs with dissemination.

We modified the one DD formula to cover all of these areas and now have 3 formulas. For purposes of this study we would want to consider the formulas that cover items 2 through 6. These are Original and Yeast, Fungal & Mold Support (YFM).

Subsets above are dogs on or off antifungal and other drugs.

WE now have veterinarians that use DD on its own, or in combination with drug therapy. It is used to help wean the dog off of medications and prevent the titer fluctuation.

We believe that with the current fervor of finding a “cure” for Valley Fever it would be prudent to conduct an independent study of the effectiveness of these formulations at varying stages of prevention, exposure or disease progression.

In the last 5 years we have not had one report of a dog contracting VF when on our supplement. It’s an interesting fact that is worth exploring. Could DD be the answer to event related exposure?

Based upon report after report it is becoming evident that in many cases DD is actually more effective than fluconazole in treating VF over the long-term. Fluconazole appears to create a drug plateau and relapse syndrome in many cases. DD does not.

If DD is used with drugs then the next step is without the drugs followed again with a milder formula. Thus the strength of the supplementation is gradually reduced over time. This is simply not feasible with pharmaceutical drugs.

While there are cases of VF absolutely so severe that they will need drug therapy it is important that we stage the classification in which DD is effective on its own.

It is possible for us to apply to the FDA for Orphan Drug status for DD formulations. We have spoken extensively to the FDA and they would welcome an application.

However based on the current issues surrounding Valley Fever awareness and practitioner ignorance, we believe that a far better solution is to leave these products on one level in the hands of consumers and provide Professional strength products for practitioners and of course support the continued work on a fungicidal drug and vaccine.

The best and quickest course of action with the proven scientific efficacy in place is for the Congressional Task Force to recommend an Orphan Disease Dietary Supplement classification for humans and animals with DD as the first model.

DESERT DEFENSE® is a registered trademark.

Copyright March 2014

The formulator for Desert Defense visited the Valley Fever Center of Excellence to talk about DD, he was told they do not know much about supplements, but in fact they currently recommend supplements with zero efficacy. They also run studies with zero diet and supplement exclusion and no follow-up for this long-term disease. We never asked for a free study and at this point we would certainly not have them conduct the research.

Shubitz, Lisa – (lfshubit) <lfshubit@email.arizona.edu>ReplyReply allForward

To:​jane rogueresearch.com​

Tue 4/5/2016 8:03 PM

There was no use of Desert Defense in our research study.   I don’t think Desert Defense makes much difference at all and I tell my regular clients they can use it or not as they see fit when they query me about it.  I have the records of all 23 patients to date and not a single one listed Desert Defense as something the dog was taking during the study.  If they gave it on the side, they didn’t report it to me.  We did not follow any dogs past the exit point of the study and what they did after completion of the study was between them and their referring DVM.  

The only diet instructions given to the clients was to give the medication with a meal for absorption. Please don’t contact me again about any ideas that I would conduct research on or with your product.  I declined to do than many years ago when the innovator of the product came and asked me to test it for free.  I told him that if he wanted it tested in a controlled clinical trial, he needed to fund it or find funding for it. 

Sincerely,

Lisa F. Shubitz, DVM

Lisa F. Shubitz, DVM

Valley Fever Center for Excellence

Department of Veterinary Science and Microbiology

The University of ArizonaReplyForward

JR